MOLCEL® ACE

Cellulose Acetate

(Pharmaceutical Excipient / Film-Coating)

cellulose-acetate-bp
MOLCEL® ACE is a cellulose derivative, also known as Cellulose Acetate. It is used in pharmaceutical formulations as a film-coating agent and controlled-release excipient. It helps form protective coatings on tablets and pellets, improving product appearance, stability, taste masking and modified drug-release performance.

MOLCEL® ACE

by Muby Chem

cellulose-acetate-i

Cellulose Acetate

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.

We follow Good Manufacturing Practices (GMP) and adhere to international regulatory standards to ensure quality consistency with continuous supply.

SPECIFICATION

#TESTSPECIFICATION - BP
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).

PACKAGING

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.

SHELF LIFE, STORAGE AND PACKING

The shelf life is 3 years. Preserve in tight containers.

ACCREDITATIONS

fda
health canada
edqm1
edqm
sgs
ANVISA
sfda
saphra
tga
china
mhra
cdsco
who
eu
exci
ecovadis

Disclaimer

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:

  1. To the fullest extent not prohibited by the applicable laws, MUBY CHEM EXPRESSLY DISCLAIMS ALL REPRESENTATIONS, WARRANTIES, CONDITIONS OR GUARANTEES OF ANY KIND, WHETHER EXPRESS OR IMPLIED, WRITTEN OR ORAL, BY FACT OR LAW, INCLUDING ANY IMPLIED WARRANTIES, REPRESENTATIONS OR CONDITIONS OF MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE, SATISFACTORY QUALITY, NON-INFRINGEMENT, AND ANY REPRESENTATIONS, WARRANTIES, CONDITIONS OR GUARANTEES, ARISING FROM STATUTE, COURSE OF DEALING OR USAGE OF TRADE AND MUBY CHEM HEREBY EXPRESSLY EXCLUDES AND DISCLAIMS. ANY LIABILITY RESULTING FROM OR IN CONNECTION WITH THIS DOCUMENT OR ANY INFORMATION PROVIDED HEREIN, including, without limitation, any liability for any direct, consequential, special, or punitive damages relating to or arising therefrom, except in cases of (i) death or personal injury, (ii) Muby Chem or its agents and assistants willful misconduct, fraud or fraudulent misrepresentation or (iii) any matter in respect of which it would be unlawful for Muby Chem to exclude or restrict liability under the applicable laws;
  2. Any information provided herein can be changed at Muby Chem sole discretion anytime and neither this document nor the information provided herein may be relied upon to satisfy any obligations you may have to undertake your own inspections and evaluation.
  3. Muby Chem rejects any obligation to, and will not, automatically update this document and any information provided herein, unless required by applicable law; and
  4. You are responsible for confirming that you have retrieved the most current version of this document from Muby Chem.