(Pharmaceutical Excipient / Film-Forming Agent / Binder)
by Muby Chem
Muby Chem operates a state-of-the-art manufacturing facility producing high quality Chitosan HCl, known for its exceptional purity and effectiveness. This versatile compound is widely used across various industries, including pharmaceutical and healthcare formulations.
Our cutting-edge technology ensures the production of Chitosan HCl with exceptional purity and quality, making it an ideal choice for a variety of applications.
Applications: MOLSUGAR™ CHCL is commonly used as a film-forming agent, binder, and pharmaceutical excipient in pharmaceutical, nutraceutical, and healthcare formulations. It is incorporated into tablets, capsules, oral films, and specialty formulations to improve stability and overall formulation performance.
| # | TEST | SPECIFICATION - BP |
|---|---|---|
| 1 | Appearance | It occurs as a White or almost white, fine powder. |
| 2 | Identification Test (A) Test (B) Test (C) Test (D) |
(A) Infrared absorption spectrophotometry. (B) It gives reaction (a) of chlorides. (C) A voluminous gelatinous mass is formed. (D) A voluminous gelatinous mass is formed. |
| 3 | Solubility | It is Sparingly soluble in water, practically insoluble in anhydrous ethanol. |
| 4 | Appearance of solution | Solution S is not more opalescent than reference suspension II and not more intensely coloured than reference solution BY5. |
| 5 | Matter insoluble in water | Not more than 0.5 % |
| 6 | pH | 4.0 to 6.0 |
| 7 | Viscosity | Not less than 80% and not more than 120%. |
| 8 | Degree of deacetylation | The degree of deacetylation is not less than 70.0% and not more than 95.0%. |
| 9 | Chlorides | Not less than 10.0 % and not more than 20.0 %. |
| 10 | Loss on drying | Not more than 10% |
| 11 | Sulfated ash | Not more than 1.0%. |
MOLSUGAR™ CHCL is packed in HDPE bag or HDPE drum with double PE liners inside and is provided with a barcoded label and a tamper-evident seal.
The shelf life is 3 years. At a temperature of 2 °C to 8 °C, protected from moisture and light.