(Binder / Coating Agent)
by Muby Chem
Muby Chem operates a state-of-the-art manufacturing facility producing Ethyl Cellulose known for its exceptional purity and efficacy. This compound is valuable in pharmaceutical applications.
Our advanced processing delivers pharmaceutical-grade Ethyl Cellulose designed to enhance stability, safety and performance across a range of pharmaceutical applications.
Applications: MOLCEL® ETH is commonly used as a film-forming agent to create protective coatings, which help mask taste and improve patient compliance in tablet manufacturing. It is used as a thickening and suspending agent in oral and topical suspensions. MOLCEL® ETH also used in sustained-release formulations to help regulate the release of active ingredients and improve product stability.
| # | TEST | SPECIFICATION - IP |
|---|---|---|
| 1 | Description | It occurs as a white to light tan powder. |
| 2 | Identification Test (A) |
(A) Infrared absorption spectrophotometry. |
| 3 | Solubility | It is freely soluble in tetrahydrofuran, in methyl acetate, in chloroform, and in mixtures of aromatic hydrocarbons with ethanol (95 %). |
| 4 | PH | Between 5.5 to 8.0. |
| 5 | Arsenic | Not more than 3 ppm. |
| 6 | Loss on drying | Not more than 3.0%. |
| 7 | Sulphated Ash | Not more than 0.5%. |
| 8 | Sulfated ash | Not more than 0.5%. |
| 9 | Assay | Not less than 44.0% and not more than 51.0% of ethoxy (-OC2H5) groups calculated on the dried substance. |
MOLCEL® ETH 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 well-closed 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: