(Bulking Agent / Binder / Sweetening Agent)
by Muby Chem
Muby Chem operates a state-of-the-art manufacturing facility that produces high-quality Isomalt, renowned for its exceptional purity and effectiveness. This versatile compound is widely used in the pharmaceutical industry for its valuable functional properties.
Our advanced technology ensures the production of Isomalt with exceptional purity and quality, making it an ideal choice for use in the pharmaceutical industry.
Application: MOLHOL® ISM is mainly used in the pharma industry as a sweetener and bulking agent. It is most commonly used in lozenges, chewable tablets, and orally disintegrating tablets (ODTs) due to its good taste and low hygroscopicity. It is preferred for sugar-free, diabetic-friendly and pediatric formulations.
| # | TEST | SPECIFICATION - BP |
|---|---|---|
| 1 | Appearance | It occurs as white or almost white powder or granules. |
| 2 | Identification Test (A) Test (B) Test (C) |
(A)The 2 principal peaks in the chromatogram obtained with the test solution are similar in retention time to the 2 principal peaks in the chromatogram obtained with reference solution (a). (B) Thin Layer Chromatography. (C) A pink colour develops. |
| 3 | Solubility | Freely soluble in water, practically insoluble in anhydrous ethanol. |
| 4 | Conductivity | Maximum 20 µS cm-1. |
| 5 | Reducing Sugars | Maximum 0.3 %. |
| 6 | Related Substances | Specified test. |
| 7 | Water | Maximum 7.0%. |
| 8 | Assay | Not less than 98.0% and not more than 102.0%. |
MOLHOL® ISM is packed in HDPE bag or drum with double PE liners inside having bar-coded label and 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: