Pharmaceuticals
Caring Biosciences has grown steadily and has been recognized as an established player in manufacturing of Pharmaceutical APIs, Excipients and Intermediates.
| Technical | Details |
|---|---|
| Product | Bone Gelatin |
| Grade | RC-240 & RC-210 |
| CAS No | 9000-70-8 |
| Mol. Formula | Not applicable |
| Mol. Weigh | Not applicable |
| Specification | Details |
|---|---|
| Description | Light amber to faintly yellow, translucent flakes, sheets, shreds, powder or granules; odour, slight. |
| Identification: A. Addition of 0.05 ml of CuSO4solution and 0.5 ml of 2 M NaOH to 2 ml pf 1% w/w substance solution B. Heating at 60 0C and then cooling at 0 0C of 5 % w/w solution |
– Gives violet colour – Gives very viscous solution |
| Appearance of solution | To comply with test of Pharmacopoeia |
| pH (1% w/v) | 3.8 – 7.6 |
| Arsenic | Not more than 2 ppm |
| Heavy metals | Not more than 50 ppm |
| Sulphur dioxide | Not more than 200 ppm |
| Microbial contamination: A. TAMC B. E. Coli C. Salmonellae |
– Not more than 1000 CFU/gm – Absent in 1.0 gm – Absent in 10.0 gm |
| Ash | Not more than 3.25 % w/w |
| Loss on drying (105 0C for 2 hr) | Not more than 16.0 % w/w |
| Jelly strength | > 200 |
| Viscosity | > 40 |
| Technical | Details |
|---|---|
| Product | Bone Gelatin |
| Grade | RC-180 & RC-150 |
| CAS No | 9000-70-8 |
| Mol. Formula | Not applicable |
| Mol. Weigh | Not applicable |
| Specification | Details |
|---|---|
| Description | Light amber to faintly yellow, translucent flakes, sheets, shreds, powder or granules; odour, slight. |
| Identification: A. Addition of 0.05 ml of CuSO4solution and 0.5 ml of 2 M NaOH to 2 ml pf 1% w/w substance solution B. Heating at 60 0C and then cooling at 0 0C of 5 % w/w solution |
– Gives violet colour – Gives very viscous solution |
| Appearance of solution | To comply with test of Pharmacopoeia |
| pH (1% w/v) | 3.8 – 7.6 |
| Arsenic | Not more than 2 ppm |
| Heavy metals | Not more than 50 ppm |
| Sulphur dioxide | Not more than 200 ppm |
| Microbial contamination: A. TAMC B. E. Coli C. Salmonellae |
– Not more than 1000 CFU/gm – Absent in 1.0 gm – Absent in 10.0 gm |
| Ash | Not more than 3.25 % w/w |
| Loss on drying (105 0C for 2 hr) | Not more than 16.0 % w/w |
| Jelly strength | < 200 |
| Viscosity | < 40 |
| Technical | Details |
|---|---|
| Product | Bone Gelatin |
| Grade | RP-240 & RP-180 |
| CAS No | 9000-70-8 |
| Mol. Formula | Not applicable |
| Mol. Weigh | Not applicable |
| Specification | Details |
|---|---|
| Description | Light amber to faintly yellow, translucent flakes, sheets, shreds, powder or granules; odour, slight. |
| Identification: A. Addition of 0.05 ml of CuSO4solution and 0.5 ml of 2 M NaOH to 2 ml pf 1% w/w substance solution B. Heating at 60 0C and then cooling at 0 0C of 5 % w/w solution |
– Gives violet colour – Gives very viscous solution |
| Appearance of solution | To comply with test of Pharmacopoeia |
| pH (1% w/v) | 3.8 – 7.6 |
| Arsenic | Not more than 2 ppm |
| Heavy metals | Not more than 50 ppm |
| Sulphur dioxide | Not more than 200 ppm |
| Microbial contamination: A. TAMC B. E. Coli C. Salmonellae |
– Not more than 1000 CFU/gm – Absent in 1.0 gm – Absent in 10.0 gm |
| Ash | Not more than 3.25 % w/w |
| Loss on drying (105 0C for 2 hr) | Not more than 16.0 % w/w |
| Jelly strength | ~ 200 |
| Viscosity | ~ 35 |
| Technical | Details |
|---|---|
| Product | Bone Gelatin |
| Grade | RE-120 & Technical grade |
| CAS No | 9000-70-8 |
| Mol. Formula | Not applicable |
| Mol. Weigh | Not applicable |
| Specification | Details |
|---|---|
| Description | Light amber to faintly yellow, translucent flakes, sheets, shreds, powder or granules; odour, slight. |
| Identification: A. Addition of 0.05 ml of CuSO4solution and 0.5 ml of 2 M NaOH to 2 ml pf 1% w/w substance solution B. Heating at 60 0C and then cooling at 0 0C of 5 % w/w solution |
– Gives violet colour – Gives very viscous solution |
| Appearance of solution | To comply with test of Pharmacopoeia |
| pH (1% w/v) | 3.8 – 7.6 |
| Arsenic | Not more than 2 ppm |
| Heavy metals | Not more than 50 ppm |
| Sulphur dioxide | Not more than 200 ppm |
| Ash | Not more than 3.25 % w/w |
| Loss on drying (105 0C for 2 hr) | Not more than 16.0 % w/w |
Active Pharmaceutical Ingredients
APIs can be manufactured as per pharmacopoeia guidelines of various countries, as well as per customer specifications. They will be produced according to client requirements without infringing patent laws and with all pertinent documentations.
Uses of Product:
It acts as anamebicidal and so used in the treatment of amoebiasis, Balantidiasis (an infection caused by protozoa).
| Technical | Details |
|---|---|
| CAS No | 83-73-8 |
| Mol. Formula | C9H5I2NO |
| Mol. Weigh | 396.95 |
| Category | Antiamoebic |
| Specification | Details |
|---|---|
| Description | Light yellowish to yellowish brown, microcrystalline powder; odourless or with a faint odour |
| Solubility | Sparingly soluble in alcohol and in ether; practically insoluble in water |
| Acidity or Alkalinity | Passes as per Pharmacopoeia |
| Free Iodine & Iodine | Passes as per Pharmacopoeia |
| Related Substance | Passes as per Pharmacopoeia |
| Residue on ignition/Sulphated ash | Not more than 0.1 % w/w |
| Loss on drying | Not more than 0.5 % w/w |
| Assay | Between 97.0 and 100.5 % w/w |
Uses of Product:
It has primarily been used as an anti-diarrheal medication. It is used in the treatment of acute and chronic amoebic dysentery, colitis, in GItrack infections like amoebiasis, in dermatophytosis, mycosis barbae. seborrhoeicdermatitis, infected eczema, furunculosis and pityriasis versicoior {athlete’s foot}, ermatitis, Impetigo, monilial and trichomonas vaginitis, Giardiasis.
| Technical | Details |
|---|---|
| CAS No | 130-26-7 |
| Mol. Formula | C9H5ClINO |
| Mol. Weigh | 305.5 |
| Category | Antiamoebic & Topical Anti-infective |
| Specification | Details |
|---|---|
| Description | Yellowish white to brownish yellow powder; odour, faint and characteristic |
| Solubility | Practically insoluble in water, sparingly soluble in methylene chloride, soluble in hot ethyl acetate and in hot glacial acetic acid, Freely soluble in dimethylformamide and in pyridine |
| Melting Point | About 1800C |
| Acidity or Alkalinity | Passes as per Pharmacopoeia |
| Halides | Not more than 140 PPM |
| Free Iodine & Iodine | Passes as per Pharmacopoeia |
| Related Substance | Passes as per Pharmacopoeia |
| Residue on ignition/Sulphated ash | Not more than 0.1 % w/w |
| Loss on drying | Not more than 0.5 % w/w |
| Assay | Between 97.0 and 100.5 % w/w |
Uses of Product:
- It is often used to prevent surgical skin infection in any major operations. As a surgical scrub, it is broadly applicable for pre and post operative skin cleansing.
- It works like antibacterial in dental procedures.
- Works great as antiseptic cleanser for surgeons before surgery.
- Most suitable for the treatment and prevention against infection in ulcers, burns and cuts.
- Effective against the treatment of wounds, yeasts, molds, fungi, protozoans, viruses, etc.
- It is used as a dispersing and suspending agent in drugs and as a plasma volume expander
| Technical | Details |
|---|---|
| CAS No | 25655-41-8 |
| Mol. Formula | (C6H9NO)n•xI |
| Category | Antiamoebic & Topical Anti-infective |
| Specification | Details |
|---|---|
| Description | Yellowish brown or reddish brown amorphous powder; odour slight and characteristic of iodine |
| Solubility | Soluble in water and in alcohol, practically insoluble in chloroform, in carbon tetrachloride, in ether, in solvent hexane, and in acetone |
| pH of 10% solution | 1.5 to 5.0 |
| Iodide | Not more than 6.0 % w/w |
| Nitrogen | Between 9.5 and 11.5 % w/w |
| Heavy metals | Passes as per Pharmacopoeia |
| Loss on drying | Not more than 8.0 % w/w |
| Residue on ignition/Sulphated ash | Not more than 0.025 % w/w |
| Assay | Between 9 and 12 % w/w |
Uses of Product:
Potassium iodide salt is suitable against yeasts, molds, fungi, viruses, and protozoan. It is good for treating skin infections and other wound treatments. The other use of potassium iodide salts is as a cosmetic agent. It is suitable for pre- and post-operative skin cleansing and can also be used a surgical scrub. Potassium Iodide salts are good for treating ulcers, cuts, bumps etc. It is better to use this products under expert’s advice only.
| Technical | Details |
|---|---|
| CAS No | 7681-11-0 |
| Mol. Formula | KI |
| Mol. Weigh | 166 |
| Category | Antithyroid & Antifungal |
| Specification | Details |
|---|---|
| Description | White or almost white powder or colourless crystals; odourless |
| Solubility | Very soluble in water and even more soluble in boiling water, freely soluble in glycerol, soluble in ethanol |
| Appearance of solution | 10 % aqueous solution is clear and colourless |
| Alkalinity | Passes as per Pharmacopoeia |
| Iodates | Passes as per Pharmacopoeia |
| Sulphates | Passes as per Pharmacopoeia |
| Thiosulphates | Passes as per pharmacopoeia |
| Heavy metals | Passes as per Pharmacopoeia |
| Potassium | Passes as per pharmacopoeia |
| Barium | Passes as per pharmacopoeia |
| Nitrate, Nitrite & Ammonia | Passes as per pharmacopoeia |
| Iron | Passes as per pharmacopoeia |
| Loss on drying | Not more than 1.0 % w/w |
| Assay | Between 99.0 and 100.5 % w/w |
Uses of Product:
It is used to treat and prevent iodine deficiency. It is used in thyroid function tests and thyroid imaging and to treat hyperthyroidism and thyroid carcinoma.
| Technical | Details |
|---|---|
| CAS No | 7681-82-5 |
| Mol. Formula | NaI |
| Mol. Weigh | 149.89 |
| Category | Expectorant & Iodine Supplement |
| Specification | Details |
|---|---|
| Description | White or almost white, crystalline powder or colourless crystals; odourless; hygroscopic |
| Solubility | Very soluble in water, freely soluble in alcohol and in glycerin |
| Appearance of solution | 10 % aqueous solution is clear and colourless |
| Alkalinity | Passes as per Pharmacopoeia |
| Iodates | Passes as per Pharmacopoeia |
| Sulphates | Passes as per Pharmacopoeia |
| Thiosulphates | Passes as per pharmacopoeia |
| Heavy metals | Passes as per Pharmacopoeia |
| Potassium | Passes as per pharmacopoeia |
| Barium | Passes as per pharmacopoeia |
| Nitrate, Nitrite & Ammonia | Passes as per pharmacopoeia |
| Iron | Passes as per pharmacopoeia |
| Loss on drying | Not more than 2.0 % w/w |
| Assay | Between 99.0 and 100.5 % w/w |
Uses of Product:
It is used as a dough conditioner.
It is an oxidant added to lotions and ointments as an antiseptic, disinfectant and deodorant.
It is used in animal feed to correct iodine deficiency and prevent various animal diseases.
In food industry it is used for iodization of table salt.
| Technical | Details |
|---|---|
| CAS No | 41372-10-5 |
| Mol. Formula | (C4H10N2)3,2C6H8O7 |
| Mol. Weigh | 642.7 |
| Category | Anthelmintic |
| Specification | Details |
|---|---|
| Description | A white or almost white granular powder, almost odourless |
| Melting Point | About 190 ºC |
| Solubility | Freely soluble in water, practically insoluble in alcohol and in ether |
| Appearance of solution | 5% aqueous solution is clear and colourless |
| pH of 5% solution | Between 5.0 and 6.0 |
| Heavy metals | Passes as per Pharmacopoeia |
| Related substances / Chromatographic purity | Passes as per Pharmacopoeia |
| Sulphated ash | Not more than 0.1 % w/w |
| Water | Not more than 12 % w/w |
| Assay | Between 98.0 and 100.5 % w/w |
Uses of Product:
It is used to effectively eliminate threadworms (pinworms) and roundworms from the bowel of children, dogs, and cats.
| Technical | Details |
|---|---|
| CAS No | 18534-18-4 |
| Mol. Formula | C4H10N2•H3PO4•H2O |
| Mol. Weigh | 202.15 |
| Category | Anthelmintic |
| Specification | Details |
|---|---|
| Description | White crystalline powder; odourless or almost odourless |
| Solubility | Sparingly soluble in water; practically insoluble in ethanol |
| pH of 5% solution | Between 6.0 and 6.5 |
| Heavy metals | Passes as per Pharmacopoeia |
| Chromatographic purity | Passes as per Pharmacopoeia |
| Water | Between 8.0 % and 9.5 % w/w |
| Assay | Between 98.5 and 100.5 % w/w |
Uses of Product:
Piperazine adipate is used to treat intestinal roundworms or pinworm infection found inside both humans and farm animals.
| Technical | Details |
|---|---|
| CAS No | 142-88-1 |
| Mol. Formula | C4H10N2•C6H10O4 |
| Mol. Weigh | 232.28 |
| Category | Anthelmintic |
| Specification | Details |
|---|---|
| Description | White or almost white crystalline powder |
| Melting Point | About 250˚C |
| Solubility | Soluble in water, practically insoluble in alcohol |
| Appearance of solution | 5% aqueous solution is clear and colourless |
| pH of 5% solution | Between 5.0 and 6.0 |
| Heavy metals | Passes as per Pharmacopoeia |
| Related substances / Chromatographic purity | Passes as per Pharmacopoeia |
| Sulphated ash / Residue on ignition | Not more than 0.1 % w/w |
| Water | Not more than 0.5 % w/w |
| Assay | Between 98 and 101 % w/w |
Uses of Product:
Piperazine Hexahydrate is used for treating common roundworms and pinworms infection.
| Technical | Details |
|---|---|
| CAS No | 142-63-2 |
| Mol. Formula | C4H10N2•6H2O |
| Mol. Weigh | 194.23 |
| Category | Anthelmintic |
| Specification | Details |
|---|---|
| Description | Colourless, glassy deliquescent crystals |
| Melting Point | About 43˚C |
| Solubility | Freely soluble in water and in alcohol; slightly soluble in ether |
| Appearance of solution | 5 % aqueous solution is clear and colourless |
| pH of 5% solution | Between 10.5 and 12.0 |
| Heavy metals | Passes as per Pharmacopoeia |
| Related substances | Passes as per Pharmacopoeia |
| Sulphated ash | Not more than 0.1 % w/w |
| Assay | Between 98.0 and 101.0 % w/w |
Uses of Product:
It is used as a one-day wormer, either in water or feed, for the control of round worms in poultry, swine, and horses. It also controls nodular worms in swine, and small strongyles in horses.
| Technical | Details |
|---|---|
| CAS No | 142-64-3 |
| Mol. Formula | C4H10N2•2HCl |
| Mol. Weigh | 159.08 |
| Category | Anthelmintic |
| Specification | Details |
|---|---|
| Description | White crystalline powder |
| Solubility | Soluble in water, practically insoluble in alcohol |
| pH of 5% solution | Between 3.0 and 3.4 |
| Residue on ignition | Not more than 0.1 % w/w |
| Chromatographic purity | Passes as per Pharmacopoeia |
| Heavy metals | Passes as per the test |
| Water | Not more than 10 % w/w |
| Assay | Between 98.5 and 100.5 % w/w |
Uses of Product:
- Mainly used as food additive and preservative
- The anticoagulant in blood transfusions
- Used to relieve discomfort in urinary tract infections
- It also works as buffering agent in food and acidity regulator as antacid
- Used as a sequestrant – to improve the quality and stability of the food products
- Used as an emulsifier – to stabilize processed foods like cheese
| Technical | Details |
|---|---|
| CAS No | 6132-04-3 |
| Mol. Formula | C6H5Na3O7•2H2O |
| Mol. Weigh | 294.1 |
| Category | Anticoagulant |
| Specification | Details |
|---|---|
| Description | White or almost white, crystalline powder or granular crystals |
| Solubility | Freely soluble in water and very soluble in boiling water; insoluble in alcohol and in ether |
| Appearance of solution | 10% aqueous solution is clear and colourless |
| Acidity or Alkalinity | Passes as per the Pharmacopoeia |
| Chlorides | Passes as per Pharmacopoeia |
| Sulphates | Passes as per Pharmacopoeia |
| Heavy metals | Passes as per Pharmacopoeia |
| Arsenic | Passes as per Pharmacopoeia |
| Oxalates | Passes as per Pharmacopoeia |
| Readily carbonisable substances | Passes as per Pharmacopoeia |
| Tartrate | Passes as per Pharmacopoeia |
| Pyrogens | Passes as per Pharmacopoeia |
| Water | Between 11.0 and 13.0 % w/w |
| Assay | Between 99.0 and 100.5 % w/w |
Uses of Product:
Used to make urine less acidic by helping the kidneys get rid of uric acid, thereby helping to prevent gout and kidney stones.
| Technical | Details |
|---|---|
| CAS No | 6100-05-6 |
| Mol. Formula | C6H5K3O7•H2O |
| Mol. Weigh | 324.42 |
| Category | Anticoagulant |
| Specification | Details |
|---|---|
| Description | White or almost white, granular powder or transparent crystals; odourless; hygroscopic |
| Solubility | Very soluble in water, practically insoluble in alcohol |
| Appearance of solution | 10% aqueous solution is clear and colourless |
| Acidity or Alkalinity | Passes as per Pharmacopoeia |
| Sodium | Not more than 0.3 % w/w |
| Chlorides | Passes as per Pharmacopoeia |
| Sulphates | Passes as per Pharmacopoeia |
| Heavy metals | Passes as per Pharmacopoeia |
| Arsenic | Passes as per Pharmacopoeia |
| Oxalates | Passes as per Pharmacopoeia |
| Readily carbonisable substances | Passes as per Pharmacopoeia |
| Tartrate | Passes as per Pharmacopoeia |
| Loss on drying / Water | Between 4.0 and 6.0 % w/w |
| Assay | Between 99.0 and 100.5 % w/w |
Uses of Product:
Used to treat various tissue diseases and other health problems. It is also good for intestinal treatment, chronic and acute amoebic dysentery.
| Technical | Details |
|---|---|
| CAS No | 3736-81-0 |
| Mol. Formula | C14H11Cl2NO4 |
| Mol. Weigh | 328.15 |
| Category | Antiamoebic & Antiprotozoal |
| Specification | Details |
|---|---|
| Description | White or almost white, crystalline powder; odourless or almost odourless |
| Solubility | Freely soluble in chloroform; slightly soluble in alcohol and in ether; very slightly soluble in water |
| Melting Point | Between 114 and 116˚C |
| Free acidity | Passes as per Pharmacopoeia |
| Related substances / Compounds | Passes as per Pharmacopoeia |
| Sulphated ash / Residue on ignition | Not more than 0.1 % w/w |
| Loss on drying | Not more than 0.5 % w/w |
| Assay | Between 98.0 and 102.0 % w/w |
Uses of Product:
It is used as an anthelmintic against tapeworms and other intestinal fluke infections.
| Technical | Details |
|---|---|
| CAS No | 50-65-7 |
| Mol. Formula | C13H8Cl2N2O4•H2O |
| Mol. Weigh | 345.1 |
| Category | Anthelmintic |
| Specification | Details |
|---|---|
| Description | Yellowish fine crystals |
| Solubility | Practically insoluble in water; sparingly soluble in acetone; slightly soluble in anhydrous ethanol |
| Melting Point | 227 to 232 °C |
| Related substances | Passes as per Pharmacopoeia |
| 5-Chlorosalicylic acid | Not more than 60 PPM |
| 2-Chloro-4-nitroaniline | Not more than 100 PPM |
| Chlorides | Not more than 500 PPM |
| Sulphated ash | Not more than 0.1 % w/w |
| Loss on drying | Between 4.5 and 6.0 % w/w |
| Assay | Between 98.0 and 101.0 % w/w |
Uses of Product:
Used for the treatment, control, prevention, & improvement of blood coagulation and urinary bladder calculi.
Uses of Product:
Can be used in flavorings, cosmetics, candy, gelatin, jams, jellies, soft drinks and fruit. It has the ability to minimize discoloration and retain flavor and vitamins.
Uses of Product:
A powerful irritant and carminative used as counter irritant in lumbago and neuralgia. It can also be used to treat stomach ache that involves poorly functioning stomach muscles and as an antibacterial agent.
| Technical | Details |
|---|---|
| CAS No | 8023-77-6 |
| Category | Stomachic and Carminative |
| Specification | Details |
|---|---|
| Description | Red to brownish red oily viscous liquid |
| Odor | Pungent and characteristic of chillies |
| Taste | Highly pungent |
| Solubility | Soluble in alcohol, in acetone, in ether in chloroform and in volatile oils |
| Color | 1000 c.u. to 10,000 c.u. |
| Residual Solvent | Not more than 20 PPM |
| Capsaicin content | Not less than 8 %(Other grade 2 % to 20 %) |
Uses of Product:
Used to break up phlegm, to treat respiratory diseases related to excessive mucus.
| Technical | Details |
|---|---|
| CAS No | 23828-92-4 |
| Mol. Formula | C13H18Br2N2O·HCl |
| Mol. Weigh | 414.56 |
| Technical | Details |
|---|---|
| Description | A White or yellowish crystalline powder |
| Solubility: A. Methanol B. Water C. Methylene Chloride |
– Soluble – Sparingly soluble – Practically insoluble |
| Identification: A. UV Absorption (245 nm) B. IR Spectrum C. TLC D. Test of chloride |
– Ratio: 3.2 – 3.4 – To comply – To comply – To comply |
| Appearance of solution (5% Methanolic solution) |
Clear and colourless |
| pH (1 % w/v in water) | 4.5 -6.0 |
| Heavy metals | Not more than 20 ppm |
| Loss on drying (105 0C) | Not more than 0.5 % w/w |
| Sulphated ash | Not more than 0.1 % w/w |
| Related substances | To comply with test of pharmacopoeia |
| Residual solvent | To comply with test of relevant pharmacopoeia |
| Assay | 99.0 % w/w – 101.0 % w/w |
Uses of Product:
Used as an expectorant to treat coughs and congestion.
| Technical | Details |
|---|---|
| CAS No | 93-14-1 |
| Mol. Formula | C10H14O4 |
| Mol. Weigh | 198.2 |
| Technical | Details |
|---|---|
| Description | White or almost white, crystalline powder; odourless or a slight characteristic odour |
| Solubility: A. Water, Chloroform, Alcohol. Propylene glycol B. Glycerin |
– Soluble – Sparingly soluble |
| Identification: A. IR spectrum B. UV Absorption C. Chemical test |
– To comply – To comply – Cherry-red to purple colour |
| Melting ranges | 79 0C – 83 0C |
| Appearance of solution | 2.0 % w/v solution is clear and colourless |
| Heavy metals | Not more than 25 ppm |
| Loss on drying (60 0C for 3 hr) | Not more than 0.5 % w/w |
| Assay (on dried basis) | 98.0 % w/w – 101.5 % w/w |
Intermediates
Intermediates can be manufactured as per pharmacopoeia guidelines of various countries, as well as per customer specifications. They will be produced according to client requirements without infringing patent laws and with all pertinent documentations.
| Technical | Details |
|---|---|
| CAS No | 96-99-1 |
| Specification | Details |
|---|---|
| Description | White crystalline powder. |
| Melting Point | 178-1820C |
| Technical | Details |
|---|---|
| CAS No | 56107-02-9 |
| Specification | Details |
|---|---|
| Description | Yellow crystalline powder. |
| Melting Point | 102-1070C |
| Technical | Details |
|---|---|
| CAS No | 31431-19-3 |
| Specification | Details |
|---|---|
| Description | Yellow amorphous powder. |
| Melting Point | 141-1440C |
| Technical | Details |
|---|---|
| CAS No | 39070-63-8 |
| Specification | Details |
|---|---|
| Description | Yellow crystalline powder. |
| Melting Point | 114-1180C |
| Technical | Details |
|---|---|
| CAS No | 54965-21-8 |
| Specification | Details |
|---|---|
| Description | Cream amorphous powder |
TYPICAL CERTIFICATE OF ANALYSIS
Client Name: XYZ
Name of the Product: Disodium Edetate Dihydrate
Mfg. dt.: FEB 2018 Batch No.: DSE/D/1718/001
Exp. dt.: JAN 2023 A.R. No.: QC/180203/27
Release dt.: 03/02/2018 Analysis dt.: 03/02/2018
IN-HOUSE TEST CARRIED OUT
| No. | Tests | Specifications | Results |
|---|---|---|---|
| 1 | Description | A white, crystalline powder; odorless | Conforms to the specification |
| 2 | Solubility | Soluble in water; practically insoluble in ethanol 95 % | Conforms to the specification |
| 3 | Identification A | Infrared absorption spectrophotometry | Passes the test |
| 3 | Identification B | No precipitate should be produced | No precipitate is produced |
| 3 | Identification C | No precipitate should be produced | No precipitate is produced |
| 3 | Identification D | Gives the reactions of sodium salts | Passes the test |
| 4 | Appearance of solution | 5.0 % w/v solution Clear and colorless | Clear and colorless |
| 5 | pH of 5.0 % w/v solution | 4.0 to 5.5 | 5.41 |
| 6 | Impurity A | As per the test | Passes the test |
| 7 | Heavy metals | Not more than 20 PPM | Passes the test |
| 8 | Iron | Not more than 80 PPM | Passes the test |
| 9 | Loss on drying | Between 8.7 and 11.4 % | 9.53 % |
| 10 | Assay (on dry basis) | Between 98.5 and 101 % | 99.17 % |
Remark: The product complies with the in-house standards of quality.
Uses of Product:
Used as anthelmintic for treatment of tapeworm infections.
| Technical | Details |
|---|---|
| CAS No | 54965-21-8 |
| Mol. Formula | C12H15N3O2S |
| Mol. Weigh | 265.33 |
| Technical | Details |
|---|---|
| Identification: A. IR Spectrum B. RF Value |
– To comply – To comply |
| Loss on drying (105 0C, 4 hr) | Not more than 0.5 % w/w |
| Residue on ignition | Not more than 0.2 % w/w |
| Chromatographic purity | To comply |
| Residual solvent | To comply with test of relevant pharmacopoeia |
| Assay | 98.0 % w/w – 102.0 % w/w |
Uses of Product:
Used as anthelmintic in treatment for infections of pinworm, whipworm, roundworm, hookworm.
| Technical | Details |
|---|---|
| CAS No | 31431-39-7 |
| Mol. Formula | C16H13N3O3 |
| Mol. Weigh | 295.29 |
| Technical | Details |
|---|---|
| Identification (IR Spectrum) | To comply |
| Loss on drying (105 0C, 4 hr) | Not more than 0.5 % w/w |
| Residue on ignition | Not more than 0.1 % w/w |
| Heavy metal | Not more than 0.002 % w/w |
| Chromatographic purity | To comply |
| Residual solvent | To comply with test of relevant pharmacopoeia |
| Assay | 98.0 % w/w – 102.0 % w/w |
Excipients
Excipients (superdisintegrants) can be manufactured as per pharmacopoeia guidelines of various countries, as well as per customer specifications. They will be produced according to client requirements without infringing patent laws and with all pertinent documentations.
SPECIFICATION
Name of the Product: Croscarmellose Sodium U.S.P. / N.F.
| No. | Tests | Specifications (U.S.P. 38 / N.F. 33) |
|---|---|---|
| 1. | Identification | A. Settled as a blue, fibrous mass with methylene blue solution. B. Reddish-violet colour developed at interface with1-naphthol solution and sulfuric acid C. Gives test of Sodium. |
| 2. | Residue on ignition (%) (On dried basis) | 14.0 to 28.0 |
| 3. | Heavy metals (ppm) | NMT 10.0 ppm |
| 4. | Sodium chloride and sodium glycolate (%) | The sum of the percentages of sodium chloride and sodium glycolate is NMT 0.5% |
| 5. | Content of water soluble substances (%) | NMT 10.0% |
| 6. | Degree of substitution | 0.60 to 0.85, calculated with reference to the dried substance. |
| 7. | Loss on drying (%) | NMT 10.0% |
| 8. | Microbial contamination: a) TAMC b) TYMC c) Escherichia coli |
NMT 1000 cfu/g NMT 100 cfu/g Absent |
| 9. | pH (1% w/v in water) | 5.0 to 7.0 |
| 10. | Settling volume (ml) | 10.0 to 30.0 |
TYPICAL CERTIFICATE OF ANALYSIS
Client Name: XYZ
Name of the Product: Croscarmellose Sodium U.S.P. / N.F.
Mfg. dt.: MAR 2018 Batch No.: 01117/18
Exp. dt.: FEB 2023 Quantity: 25 kg
| No. | Tests | Results | Specifications (U.S.P. 38 /N.F. 33) |
|---|---|---|---|
| 1. | Description | White or greyish white powder. | - |
| 2. | Identification | Complies with tests A, B & C. | A. Settled as a blue, fibrous mass with methylene blue solution. B. Reddish-violet colour developed at interface with1-naphthol solution and sulfuric acid C. Gives test of Sodium. |
| 3. | Residue on ignition (%) (On dried basis) | 15.8 % | 14.0 to 28.0 |
| 4. | Heavy metals (ppm) | Below 10 | NMT 10.0 ppm |
| 5. | Sodium chloride and sodium glycolate (%) | Below 0.5 | The sum of the percentages of sodium chloride and sodium glycolate is NMT 0.5% |
| 6. | Content of water soluble substances (%) | Below 10 | NMT 10.0% |
| 7. | Degree of substitution | 0.67 % | 0.60 to 0.85, calculated with reference to the dried substance. |
| 8. | Loss on drying (%) | 4.9 % | NMT 10.0% |
| 9. | Microbial contamination: a) TAMC b) TYMC c) Escherichia coli |
Below 1000 Below 100 Absent |
NMT 1000 cfu/g NMT 100 cfu/g Absent |
| 10. | pH (1% w/v in water) | 6.3 | 5.0 to 7.0 |
| 11. | Settling volume (ml) | 20 ml | 10.0 to 30.0 |
REMARK: – This is to certify that the product complies with the prescribed standards of quality as per U.S.P.
SPECIFICATION
Name of the Product: Carboxymethylcellulose Calcium U.S.P. / N.F.
| No. | Tests | Specifications (U.S.P. 38 /N.F. 33) |
|---|---|---|
| 1. | Identification | A. Gives Red-purple color develops in Carboxymethylcellulose Calcium solution in Sodium Hydroxide with chromotorpic acid on heating. B. Gives white, flocculent precipitate with acetone. C. Gives white, flocculent precipitate with ferric chloride solution. D. Test of Calcium. |
| 2. | Residue on Ignition | 10.0 % – 20.0 % |
| 3. | Chloride And Sulphate | Chloride : NMT 0.36% Sulfate : NMT 1.0 % |
| 4. | Alkalinity | No red colour develops with phelolphthalein |
| 5. | Loss on drying (%) (Dried at 1050 C for 3 hr) | NMT 10.0 % |
TYPICAL CERTIFICATE OF ANALYSIS
Client Name: XYZ
Name of the Product: Carboxymethylcellulose Calcium U.S.P. / N.F.
Mfg. dt.: MAR 2018 Batch No.: 12003/18
Exp. dt.: FEB 2023 Quantity: 25 kg
| No. | Tests | Results | Specifications (U.S.P. 38 /N.F. 33) |
|---|---|---|---|
| 1. | Description | White or yellowish-white powder, hygroscopic after drying. | - |
| 2. | Identification | A. Gives Red-purple color develops in Carboxymethylcellulose Calcium solution in Sodium Hydroxide with chromotorpic acid on heating. Complies with Test A, B, C and D. B. Gives white, flocculent precipitate with acetone. C. Gives white, flocculent precipitate with ferric chloride solution. D. Test of Calcium. |
|
| 3. | Residue on Ignition | 18.5 | 10.0 % – 20.0 % |
| 4. | Chloride And Sulphate | Below 20.0 | Chloride : NMT 0.36% Sulfate : NMT 1.0 % |
| 5. | Alkalinity | Complies | No red colour develops with phelolphthalein |
| 6. | Loss on drying (%) (Dried at 1050 C for 3 hr) | 5.6 | NMT 10.0 % |
REMARK: – This is to certify that the product complies with the prescribed standards of quality as per U.S.P.
SPECIFICATION
Name of the Product: Polacrilin Potassium U.S.P. / N.F.
| No. | Tests | Specifications (U.S.P. 38 /N.F. 33) |
|---|---|---|
| 1. | Identification | A. Infrared Absorption. B. Potassium Test: Aqueous phase of Sample solution A (1 gm with 10 ml of water) doesn’t meet with the requirements of Potassium test while Aqueous phase of Sample solution B (1 gm with 10 ml of 0.1 N hydrochloric acid) meets with the requirements of Potassium test |
| 2. | Assay (Content of Potassium) (%) | 20.6% – 25.1% |
| 3. | Heavy metals (µg/g) | NMT 20 µg/g |
| 4. | Iron (%) | NMT 0.01% |
| 5. | Limit of Sodium (%) | NMT 0.20% |
| 6. | Powder Fineness: Retained on 100 No. sieve (%) Retained on 200 No. sieve (%) |
NMT 1.0% NMT 30.0% |
| 7. | Loss on drying (%) (at 105°C for 6 hr) | NMT 10.0% |
SPECIFICATION
Name of the Product: Sodium Starch Glycolate (Type-A) U.S.P. / N.F.
| No. | Tests | Specifications (U.S.P. 38 /N.F. 33) |
|---|---|---|
| 1. | Identification | A. IR Spectrum of Test specimen should complies with IR Spectrum of Reference Standard. B. Gives blue to violet color by addition of Iodine and Potassium iodide to acidified solution of sample. C. A dense precipitate is formed with Potassium pyroantimonate solution. D. Intense yellow colour to nonluminous flame. |
| 2. | Assay (On dried basis) (%) |
2.8 to 4.2 |
| 3. | Sodium chloride (%) | NMT 7.0% |
| 4. | Sodium Glycolate (%) | NMT 2.0% |
| 5. | Heavy metals (ppm) | NMT 20 ppm |
| 6. | Iron (%) | NMT 0.002% |
| 7. | Microbial limits: A. Salmonella species B. Escherichia coli |
Absent Absent |
| 8. | pH (1g in 30 ml water) | 5.5 to 7.5 |
| 9. | Loss on drying. (Dry at 1300 C) (%) |
NMT 10.0% |
TYPICAL CERTIFICATE OF ANALYSIS
Client Name: XYZ
Name of the Product: Sodium Starch Glycolate (Type A) U.S.P. / N.F.
Mfg. dt.: MAR 2018 Batch No.: 05008/18
Exp. dt.: FEB 2023 Quantity: 25 kg
| No. | Tests | Results | Specifications (U.S.P. 38 /N.F. 33) |
|---|---|---|---|
| 1. | Description | White or almost white, fine free-flowing powder, hygroscopic | —- |
| 2. | Identification | Complies with tests A, B, C & D. | A. IR Spectrum of Test specimen should complies with IR Spectrum of Reference Standard. B. Gives blue to violet color by addition of Iodine and Potassium iodide to acidified solution of sample. C. A dense precipitate is formed with Potassium pyroantimonate solution. D. Intense yellow colour to nonluminous flame. |
| 3. | Assay (On dried basis) (%) |
3.5 | 2.8 to 4.2 |
| 4. | Sodium chloride (%) | Below 7.0 | NMT 7.0% |
| 5. | Sodium Glycolate (%) | Below 2.0 | NMT 2.0% |
| 6. | Heavy metals (ppm) | Below 20 | NMT 20 ppm |
| 7. | Iron (%) | Below 0.002 | NMT 0.002% |
| 8. | Microbial limits: A. Salmonella species B. Escherichia coli |
Absent Absent |
Absent Absent |
| 9. | pH (1g in 30 ml water) | 7.0 | 5.5 to 7.5 |
| 10. | Loss on drying. (Dry at 1300 C) (%) |
4.5 | NMT 10.0% |
REMARK: – This is to certify that the product complies with the prescribed standards of quality as per U.S.P.
SPECIFICATION
Name of the Product: Sodium Starch Glycolate (Type-B) U.S.P. / N.F.
| No. | Tests | Specifications (U.S.P. 38 /N.F. 33) |
|---|---|---|
| 1. | Identification | A. IR Spectrum of Test specimen should complies with IR Spectrum of Reference Standard. B. Gives blue to violet color by addition of Iodine and Potassium iodide to acidified solution of sample. C. A dense precipitate is formed with Potassium pyroantimonate solution. D. Intense yellow colour to nonluminous flame. |
| 2. | Assay (On dried basis) (%) |
2.0 to 3.4 |
| 3. | Sodium chloride (%) | NMT 7.0% |
| 4. | Sodium Glycolate (%) | NMT 2.0% |
| 5. | Heavy metals (ppm) | NMT 20 ppm |
| 6. | Iron (%) | NMT 0.002% |
| 7. | Microbial limits: A. Salmonella species B. Escherichia coli |
Absent Absent |
| 8. | pH (1g in 30 ml water) | 3.0 to 5.0 |
| 9. | Loss on drying. (Dry at 1300 C) (%) |
NMT 10.0% |
TYPICAL CERTIFICATE OF ANALYSIS
Client Name: XYZ
Name of the Product: Sodium Starch Glycolate (Type B) U.S.P. / N.F.
Mfg. dt.: MAR 2018 Batch No.: 05009/18
Exp. dt.: FEB 2023 Quantity: 25 kg
| No. | Tests | Results | Specifications (U.S.P. 38 /N.F. 33) |
|---|---|---|---|
| 1. | Description | White or almost white, fine free-flowing powder, hygroscopic | —- |
| 2. | Identification | Complies with tests A, B, C & D. | A. IR Spectrum of Test specimen should complies with IR Spectrum of Reference Standard. B. Gives blue to violet color by addition of Iodine and Potassium iodide to acidified solution of sample. C. A dense precipitate is formed with Potassium pyroantimonate solution. D. Intense yellow colour to nonluminous flame. |
| 3. | Assay (On dried basis) (%) |
2.8 | 2.0 to 3.4 |
| 4. | Sodium chloride (%) | Below 7.0 | NMT 7.0% |
| 5. | Sodium Glycolate (%) | Below 2.0 | NMT 2.0% |
| 6. | Heavy metals (ppm) | Below 20 | NMT 20 ppm |
| 7. | Iron (%) | Below 0.002 | NMT 0.002% |
| 8. | Microbial limits: A. Salmonella species B. Escherichia coli |
Absent Absent |
Absent Absent |
| 9. | pH (1g in 30 ml water) | 4.5 | 3.0 to 5.0 |
| 10. | Loss on drying. (Dry at 1300 C) (%) |
5.5 | NMT 10.0% |
REMARK: – This is to certify that the product complies with the prescribed standards of quality as per U.S.P.
Uses of Product:
Used as pharmaceutical excipient, texturizer, anti-caking agent, fat substitute, emulsifier, bulking agent.
| Technical | Details |
|---|---|
| CAS No | 9004-34-6 |
| Mol. Formula | N/A |
| Mol. Weigh | N/A |
| Technical | Details |
|---|---|
| Identification: A. Reaction with iodinated zinc chloride solution B. Degree of polymerization |
– Violet-blue color – Not more than 350 |
| Microbial limit: A. TAMC B. TYMC C. Staphylococcus aureus D. Pseudomonas aeruginosa E. Escherichia coli |
– 1000 CFU/gm – 100 CFU/gm – Absent – Absent – Absent |
| Conductivity | Not more than 75 µS/cm of that of water |
| pH (of supernant of suspension) | 5.0 – 7.5 |
| Loss on drying (105 0C, 3 hr) | Not more than 7.0 % w/w |
| Residue on ignition | Not more than 0.1 % w/w |
| Water soluble substances | Not more than 0.25 % w/w |
| Ether soluble substances | Not more than 0.05 % w/w |
| Heavy metal | Not more than 0.001 % w/w |
| Organic volatile impurities | To comply with test of relevant pharmacopoeia |
| Residual solvent | To comply with test of relevant pharmacopoeia |
TYPICAL CERTIFICATE OF ANALYSIS
Client Name: XYZ
Name of the Product: Disodium Edetate Dihydrate
Mfg. dt.: FEB 2018 Batch No.: DSE/D/1718/001
Exp. dt.: JAN 2023 A.R. No.: QC/180203/27
Release dt.: 03/02/2018 Analysis dt.: 03/02/2018
IN-HOUSE TEST CARRIED OUT
| No. | Tests | Specifications | Results |
|---|---|---|---|
| 1 | Description | A white, crystalline powder; odorless | Conforms to the specification |
| 2 | Solubility | Soluble in water; practically insoluble in ethanol 95 % | Conforms to the specification |
| 3 | Identification A | Infrared absorption spectrophotometry | Passes the test |
| 3 | Identification B | No precipitate should be produced | No precipitate is produced |
| 3 | Identification C | No precipitate should be produced | No precipitate is produced |
| 3 | Identification D | Gives the reactions of sodium salts | Passes the test |
| 4 | Appearance of solution | 5.0 % w/v solution Clear and colorless | Clear and colorless |
| 5 | pH of 5.0 % w/v solution | 4.0 to 5.5 | 5.41 |
| 6 | Impurity A | As per the test | Passes the test |
| 7 | Heavy metals | Not more than 20 PPM | Passes the test |
| 8 | Iron | Not more than 80 PPM | Passes the test |
| 9 | Loss on drying | Between 8.7 and 11.4 % | 9.53 % |
| 10 | Assay (on dry basis) | Between 98.5 and 101 % | 99.17 % |
Remark: The product complies with the in-house standards of quality.
Uses of Product:
- Mainly used as food additive and preservative
- The anticoagulant in blood transfusions
- Used to relieve discomfort in urinary tract infections
- It also works as buffering agent in food and acidity regulator as antacid
- Used as a sequestrant – to improve the quality and stability of the food products
- Used as an emulsifier – to stabilize processed foods like cheese
| Technical | Details |
|---|---|
| CAS No | 6132-04-3 |
| Mol. Formula | C6H5Na3O7•2H2O |
| Mol. Weigh | 294.1 |
| Category | Anticoagulant |
| Specification | Details |
|---|---|
| Description | White or almost white, crystalline powder or granular crystals |
| Solubility | Freely soluble in water and very soluble in boiling water; insoluble in alcohol and in ether |
| Appearance of solution | 10% aqueous solution is clear and colourless |
| Acidity or Alkalinity | Passes as per the Pharmacopoeia |
| Chlorides | Passes as per Pharmacopoeia |
| Sulphates | Passes as per Pharmacopoeia |
| Heavy metals | Passes as per Pharmacopoeia |
| Arsenic | Passes as per Pharmacopoeia |
| Oxalates | Passes as per Pharmacopoeia |
| Readily carbonisable substances | Passes as per Pharmacopoeia |
| Tartrate | Passes as per Pharmacopoeia |
| Pyrogens | Passes as per Pharmacopoeia |
| Water | Between 11.0 and 13.0 % w/w |
| Assay | Between 99.0 and 100.5 % w/w |
--
SPECIFICATION
Name of the Product: MICOAT L-100[METHACRYLIC ACID COPOLYMER U.S.P. (TYPE A) (L-100)]
| No. | Tests | Specifications |
|---|---|---|
| 1. | Description and Solubility | White powder having a faint characteristic odor. Freely soluble in ethanol, methanol, isopropanol, acetone. Soluble in dilute alkali. Insoluble in dilute acids. |
| 2. | Identification | A. Infrared Absorption B. Assay |
| 3. | Assay [ Methacrylic Acid Units, Dried Basis (%) ] | 46.0 to 50.6 |
| 4. | Residue on Ignition (%) | NMT 0.1 |
| 5. | Heavy Metals (µg/g) | NMT 20 |
| 6. | Limit of Monomers (%) | NMT 0.05 |
| 7. | Viscosity – Rotational Method (mPa.s) | 60 to 120 |
| 8. | Loss on Drying (%) | NMT 5.0 |
| 9. | Organic Volatile Impurities | Nil |
TYPICAL CERTIFICATE OF ANALYSIS
Client Name: XYZ
Name of the Product: MICOAT L-100[METHACRYLIC ACID COPOLYMER U.S.P. (TYPE A) (L-100)]
Mfg. dt.: MAR 2018Batch No.: MAC-01/0318
Exp. dt.: FEB 2023 Quantity: 50 gm
| No. | Tests | Results | Specifications |
|---|---|---|---|
| 1. | Description and Solubility | White powder having a faint characteristic odor. Freely soluble in ethanol, methanol, isopropanol, acetone. Soluble in dilute alkali. Insoluble in dilute acids. |
White powder having a faint characteristic odor. Freely soluble in ethanol, methanol, isopropanol, acetone. Soluble in dilute alkali. Insoluble in dilute acids. |
| 2. | Identification | Complies with tests A, & B. | C. Infrared Absorption D. Assay |
| 3. | Assay [ Methacrylic Acid Units, Dried Basis (%) ] | 48.7 | 46.0 to 50.6 |
| 4. | Residue on Ignition (%) | Below 0.1 | NMT 0.1 |
| 5. | Heavy Metals (µg/g) | Below 20 | NMT 20 |
| 6. | Limit of Monomers (%) | Below 0.05 | NMT 0.05 |
| 7. | Viscosity – Rotational Method (mPa.s) | 109 | 60 to 120 |
| 8. | Loss on Drying (%) | 2.1 | NMT 5.0 |
| 9. | Organic Volatile Impurities | Nil | Nil |
REMARK: – This is to certify that the product complies with the prescribed standards of quality as per U.S.P.
SPECIFICATION
Name of the Product: MICOAT S-100[METHACRYLIC ACID COPOLYMER U.S.P. (TYPE B) (S-100)]
| No. | Tests | Specifications |
|---|---|---|
| 1. | Description and Solubility | White powder having a faint characteristic odor. Freely soluble in ethanol, methanol, isopropanol, acetone. Soluble in dilute alkali. Insoluble in dilute acids. |
| 2. | Identification | A. Infrared Absorption B. Assay |
| 3. | Assay [ Methacrylic Acid Units, Dried Basis (%) ] | 27.6 to 30.7 |
| 4. | Residue on Ignition (%) | NMT 0.1 |
| 5. | Heavy Metals (µg/g) | NMT 20 |
| 6. | Limit of Monomers (%) | NMT 0.05 |
| 7. | Viscosity – Rotational Method (mPa.s) | 50 to 200 |
| 8. | Loss on Drying (%) | NMT 5.0 |
| 9. | Organic Volatile Impurities | Nil |
SPECIFICATION
Name of the Product: MICOAT L-30 D[METHACRYLIC ACID COPOLYMER U.S.P. (TYPE C) (L-30 D)]
| No. | Tests | Specifications |
|---|---|---|
| 1. | Description and Solubility | White colored liquid of low viscosity, miscible with water in all proportions |
| 2. | Identification | A. Infrared Absorption: Matches the Infrared spectrum of working standard B. Film forming capability: To form a clear film |
| 3. | pH | 2.0 to 3.0 |
| 4. | Loss on drying (1100C; 6 hrs) (%) | 68.5 to 71.5 |
| 5. | Residue on Ignition (%) | Maximum 0.2 |
| 6. | Limit of Heavy Metals (ppm) | Maximum 20 |
| 7. | Limit of monomers (A+B) (ppm) | Maximum 100 |
| 8. | Viscosity (cps) | Maximum 15 |
| 9. | Coagulum content (%) | Maximum 1.0 |
| 10. | Assay on dried basis (%) | 46.0 to 50.6 |
TYPICAL CERTIFICATE OF ANALYSIS
Client Name: XYZ
Name of the Product : MICOAT L-30 D[METHACRYLIC ACID COPOLYMER U.S.P. (TYPE C) (L-30 D)]
Mfg. dt.: MAR 2018 Batch No.: MAC-03/0318
Exp. dt.: FEB 2023 Quantity: 50 Kg
| No. | Tests | Results | Specifications |
|---|---|---|---|
| 1. | Description and Solubility | White colored liquid of low viscosity, miscible with water in all proportions | White colored liquid of low viscosity, miscible with water in all proportions |
| 2. | Identification | Complies with tests A, & B. | C. Infrared Absorption: Matches the Infrared spectrum of working standard D. Film forming capability: To form a clear film |
| 3. | pH | 2.61 | 2.0 to 3.0 |
| 4. | Loss on drying (1100C; 6 hrs) (%) | 69.5% | 68.5 to 71.5 |
| 5. | Residue on Ignition (%) | 0.04 | Maximum 0.2 |
| 6. | Limit of Heavy Metals (ppm) | Below 20 | Maximum 20 |
| 7. | Limit of monomers (A+B) (ppm) | Below 100 | Maximum 100 |
| 8. | Viscosity (cps) | 5.1 | Maximum 15 |
| 9. | Coagulum content (%) | Below 1 | Maximum 1.0 |
| 10. | Assay on dried basis (%) | 49.1 | 46.0 to 50.6 |
REMARK: – This is to certify that the product complies with the prescribed standards of quality as per U.S.P.
SPECIFICATION
Name of the Product: Alginic Acid U.S.P. / N.F.
| No. | Tests | Specifications |
|---|---|---|
| 1 | Description | A white to yellowish-brown, amorphous powder. |
| 2 | Solubility | Very slightly soluble or practically insoluble in ethanol, practically insoluble in organic solvent, soluble in alkali hydroxides. |
| 3. | Identification | A. voluminous, gelatinous precipitate with calcium chloride solution B. Heavy, gelatinous precipitate with 4N sulphuric acid. C. Deeper bluish hue of upper layer with alcoholic 1,3-naphthalenediol & isopropyl ether. |
| 4. | Arsenic (ppm) | Maximum 3.0 |
| 5. | Lead ( ppm) | Maximum 10.0 |
| 6. | Heavy metal (ppm) | Maximum 40.0 |
| 7. | Microbial contamination: A) TAMC (CFU/g) B) Salmonella species C) Escherichia coli |
Maximum 200 Absent Absent |
| 8. | pH (3% w/v in water) | 1.5 to 3.5 |
| 9. | Loss on drying (%) | Maximum 15.0 |
| 10. | Total Ash (%) | Maximum 4.0 |
| 11. | Acid value | Minimum 230 |
TYPICAL CERTIFICATE OF ANALYSIS
Client Name: XYZ
Name of the Product: Alginic Acid U.S.P. / N.F.
Mfg. dt.: MAR 2018 Batch No.: 11002/18
Exp. dt.: FEB 2023 Quantity: 25 kg
| No. | Tests | Results | Specifications |
|---|---|---|---|
| 1. | Appearance | A white to yellowish-brown, amorphous powder. | --- |
| 2. | Solubility | Very slightly soluble or practically insoluble in ethanol, practically insoluble in organic solvent, soluble in alkali hydroxides. | --- |
| 3. | Identification | Complies with Test A, B and C. | A. voluminous, gelatinous precipitate with calcium chloride solution B. Heavy, gelatinous precipitate with 4N sulphuric acid. C. voluminous, gelatinous precipitate with calcium chloride solution |
| 4. | Arsenic (ppm) | Below 3.0 | Maximum 3.0 |
| 5. | Lead (ppm) | Below 10 | Maximum 10.0 |
| 6. | Heavy metal (ppm) | Below 40 | Maximum 40.0 |
| 7. | Microbial contamination: A) TAMC (CFU/g) B) Salmonella species C) Escherichia coli |
Below 200 Absent Absent |
Maximum 200 Absent Absent |
| 8. | pH (3% w/v in water) | 2.8 | 1.5 to 3.5 |
| 9. | Loss on drying (%) | 5.6 | Maximum 15.0 |
| 10. | Total Ash (%) | 2.6 | Maximum 4.0 |
| 11. | Acid value | 254 | Minimum 230 |
REMARK: – This is to certify that the product complies with the prescribed standards of quality as per U.S.P./N.F.
SPECIFICATION
Name of the Product: Sodium Alginate U.S.P. / N.F.
| No. | Tests | Specifications |
|---|---|---|
| 1. | Appearance | White or pale yellowish-brown powder. |
| 2. | Solubility | Soluble in water, practically insoluble in ethanol. |
| 3. | Identification | A. Voluminous, gelatinous precipitate formed with calcium chloride solution. B. Heavy, gelatinous precipitate formed with dilute sulfuric acid. |
| 4. | Assay (%) | 90.8 to 106.0 |
| 5. | Arsenic (ppm) | Maximum 1.5 |
| 6. | Lead (ppm) | Maximum 10 |
| 7. | Heavy metals (ppm) | Maximum 40 |
| 8. | Microbial limit: A. Total bacterial count (CFU/g) B. Salmonella species C. Escherichia coli |
Maximum 200 Absent Absent |
| 9. | Loss on drying (%) | Maximum 15.0 |
| 10. | Total ash (%) (On dried basis) | 18.0 to 27.0 |
TYPICAL CERTIFICATE OF ANALYSIS
Client Name: XYZ
Name of the Product: Sodium Alginate U.S.P. / N.F.
Mfg. dt.: MAR 2018 Batch No.: 06003/18
Exp. dt.: FEB 2023 Quantity: kg
| No. | Tests | Results | Specifications |
|---|---|---|---|
| 1. | Appearance | White or pale yellowish-brown powder. | --- |
| 2. | Solubility | Soluble in water, practically insoluble in ethanol. | --- |
| 3. | Identification | Complies with Test A and B. | A. Voluminous, gelatinous precipitate formed with calcium chloride solution. B. Heavy, gelatinous precipitate formed with dilute sulfuric acid. |
| 4. | Assay (%) | 99.8 | 90.8 to 106.0 |
| 5. | Arsenic (ppm) | Below 1.5 | Maximum 1.5 |
| 6. | Lead (ppm) | Below 10 | Maximum 10 |
| 7. | Heavy metals (ppm) | Below 40 | Maximum 40 |
| 8. | Microbial limit: A. Total bacterial count (CFU/g) B. Salmonella species C. Escherichia coli |
Below 200 Absent Absent |
Maximum 200 Absent Absent |
| 9. | Loss on drying (%) | 5.6 | Maximum 15.0 |
| 10. | Total ash (%) (On dried basis) | 22.3 | 18.0 to 27.0 |
REMARK: – This is to certify that the product complies with the prescribed standards of quality as per U.S.P./N.F.
Uses of Product:
Used as a pharmaceutical excipient (lubricant) and food additive.
| Technical | Details |
|---|---|
| CAS No | 4070-80-8 |
| Mol. Formula | C22H39NaO4 |
| Mol. Weigh | 390.54 |
| Specification | Details |
|---|---|
| Identification (IR Spectrum) | To comply |
| Water by KF | Not more than 5.0 % w/w |
| Lead | Not more than 0.001 % w/w |
| Heavy metals | Not more than 0.002 % w/w |
| Saponification value (on anhydrous basis) | 142.2 – 146.0 |
| Limit of sodium stearyl maleate and stearyl alcohol | To comply with test of Pharmacopoeia |
| Organic volatile impurities | To comply with test of relevant Pharmacopoeia |
| Residual solvents | To comply with test of relevant Pharmacopoeia |
| Assay (on anhydrous basis) | 99.0 % w/w – 101.5 % w/w |
