(Pharmaceutical Excipient / Film-Forming Agent / Binder)
by Muby Chem
Muby Chem operates a state-of-the-art manufacturing facility producing high quality Chitosan, 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 with exceptional purity and quality, making it an ideal choice for a variety of applications.
Applications: MOLSUGAR™ C 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, wound care products, and specialty formulations to improve stability, controlled release and overall formulation performance.
| # | TEST | SPECIFICATION - USP |
|---|---|---|
| 1 | Description | It occurs as a White or almost white powder or granules. |
| 2 | Identification Test (A) Test (B) |
(A) Infrared spectroscopy. (B) A gelatinous mass is formed. |
| 3 | Solubility | It is Soluble in aqueous solutions of glycolic acid, of formic acid, of acetic acid, of hydrochloric acid, and of lactic acid practically insoluble in organic solvents and in water. |
| 4 | Residue on Ignition | Not more than 1.0 %. |
| 5 | Limit of Lead, Mercury, Chromium, Nickel, Cadmium and Arsenic. | Specified test. |
| 6 | Limit of Iron | Not more than 10 ppm of Iron. |
| 7 | Limit of Protein Content | Not more than 0.2% of protein. |
| 8 | Apparent Average Molecular Weight and Molecular Weight Distribution | The values of apparent weight-average molecular weight and polydispersity are NLT 85% and NMT 115% of their respective values stated on the label. |
| 9 | Loss on drying | Not more than 5.0%. |
| 10 | Assay Degree of Deacetylation |
The degree of deacetylation is not less than 70.0% and not more than 95.0%. |
MOLSUGAR™ C 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. It is stored in a tightly closed container in a cool, well-ventilated area, away from incompatible substances such as oxidizing agents.
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