(Sweetening Agent / Pharmaceutical Excipient)
by Muby Chem
Muby Chem operates a state-of-the-art manufacturing facility that produces Aspartame, renowned for its exceptional purity and efficacy. This compound is particularly valuable in the pharmaceutical industry.
Our advanced technology ensures the production of Aspartame with exceptional purity and quality, making it an ideal choice for use in the pharma industry.
Application: MOLSUGAR™ A is commonly used as a pharmaceutical excipient to improve the taste and palatability of oral formulations. It is incorporated into tablets, chewable tablets, powders, syrups, and oral solutions to mask unpleasant or bitter tastes and make medicines more acceptable to patients.
| # | PROPERTY | TYPICAL VALUE |
|---|---|---|
| 1 | Molecular Formula | C14H18N2O5 |
| 2 | Molecular Weight | 294.3 g/mol |
| # | TEST | SPECIFICATION - IP |
|---|---|---|
| 1 | Appearance | It occurs a white, crystalline powder. |
| 2 | Identification Test A Test B |
(A) Infrared absorption spectrophotometry. (B) When examined in the range 230 nm to 300 nm, a 0.1 per cent w/v solution in ethanol (95%) shows absorption maxima at about 247 nm, 252 nm, 258 nm and 264 nm. |
| 3 | pH | 4.0 to 6.0 |
| 4 | Specific optical rotation | +14.5° to +16.5° |
| 5 | Light absorption | Not more than 0.022. |
| 6 | 5-Benzyl-3,6-dioxo-2-piperazineacetic acid. | Determine by liquid chromatography |
| 7 | Other Related substances. | Specified test. |
| 8 | Arsenic | Not more than 3ppm |
| 9 | Sulphated ash | Not more than 0.2% |
| 10 | Loss on drying | Not more than 4.5% |
| 11 | Assay | Not less than 98.0% and not more than 102.0% of C14H18N2O5, calculated on the dried basis. |
PACKAGING
MOLSUGAR™ A 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 well-closed containers.