(Film-Forming Agent / Coating Polymer)
by Muby Chem
Muby Chem operates a state-of-the-art manufacturing facility producing high quality Cellulose Acetate Phthalate, known for its exceptional purity and effectiveness. This versatile compound is widely used across various industries, including pharmaceutical industry.
Our advanced technology ensures the production of Cellulose Acetate Phthalate with exceptional purity and quality, making it an ideal choice for a variety of applications.
Applications: MOLCEL® CAP is widely used in pharmaceutical formulations as an enteric coating polymer and film-forming agent. It is commonly incorporated into tablet coating systems, capsules, pellets and controlled-release formulations to provide acid resistance, protect acid-sensitive active ingredients from gastric fluids and enable targeted drug release in the intestinal tract.
| # | TEST | SPECIFICATION - IP |
|---|---|---|
| 1 | Description | It occurs as a white, free-flowing powder or colourless flakes; odourless or with a faint odour of acetic acid; hygroscopic. |
| 2 | Identification Test (A) Test (B) |
(A) Infrared absorption spectrophotometry. (B) The solution shows a vivid green fluorescence. |
| 3 | Solubility | It is freely soluble in acetone; soluble in diethylene glycol and in dioxan; practically insoluble in water, in ethanol (95%), in toluene and in chlorinated and non-chlorinated aliphatic hydrocarbons, it dissolves in dilute solutions of alkalis. |
| 4 | Viscosity | Between 50 mm2s-1 to 90 mm2s-1. |
| 5 | Appearance of a film | A thin, colourless, transparent and glossy film is produced. |
| 6 | Free acid | Not more than 3.0%. |
| 7 | Heavy metals | Not more than 20 ppm. |
| 8 | Sulfated ash | Not more than 0.1%. |
| 9 | Water | Not more than 5.0%. |
| 10 | Assay (A) Phthaloyl groups (B) Acetyl groups |
(A) Not less than 30.0 % and not more than 40.0%. (B) Not less than 17.0 % and not more than 26.0%. |
MOLCEL® CAP 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 an airtight container.
This document and any information provided herein does not constitute a legally binding obligation of Muby Chem and has been prepared in good faith and is believed to be accurate as of the date of issuance. Unless expressly agreed otherwise in writing in a supply contract or other written agreement between you and Muby Chem: