(Pharmaceutical Excipient / Film-Coating)
by Muby Chem
Muby Chem operates a state-of-the-art manufacturing facility producing Cellulose Acetate, known for its exceptional purity and efficacy. This compound is valuable in pharmaceutical applications.
Our advanced processing delivers pharmaceutical-grade Cellulose Acetate designed to enhance stability, safety and performance across a range of pharmaceutical applications.
Applications: MOLCEL® ACE is widely used in pharmaceutical formulations as a film-forming and controlled-release excipient. It is commonly applied as a coating material for tablets, capsules and pellets to improve appearance, protect the active ingredient from moisture and light, and mask unpleasant taste or odour. Its water-insoluble, yet permeable, film helps regulate the release of active ingredients in modified-release dosage forms.
| # | TEST | SPECIFICATION - EP |
|---|---|---|
| 1 | Appearance | It occurs as a white, yellowish-white or greyish-white, hygroscopic powder or granules. |
| 2 | Identification Test (A) |
(A) Infrared absorption spectrophotometry. |
| 3 | Solubility | It is practically insoluble in water, soluble in acetone, in formic acid and in a mixture of equal volumes of methanol and methylene chloride, practically insoluble in ethanol (96%). |
| 4 | Free acid | Not more than 0.1% calculated as acetic acid (dried substances). |
| 5 | Loss on drying | Not more than 5.0%. |
| 6 | Sulfated ash | Not more than 0.1%. |
| 7 | Assay (A) Acetyl groups (B) Nominal content |
(A) Not less than 29.0% and not more than 44.8% (dried substance). (B) Not less than 90.0% and not more than 110.0% (dried substance). |
MOLCEL® ACE 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. Preserve in tight containers.
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: