AmiLife® Soya Hydrogenated Phosphatidylcholine (HSPC) 90% Powder
The hydrogenation of Soya phosphatidylcholine (PC) produces hydrogenated soya phosphatidylcholine (HSPC) with higher oxidative stability and lower hygroscopicity, in the form of a white solid with improved color and less unpleasant odor. HSPC vesicles (Liposomes) are closed vesicles of PC bilayers or lamellae with enclosed aqueous layers and cores, are able to encapsulate hydrophobic and hydrophilic ingredients into their structure. Liposomes with HSPC have significant performance in increasing encapsulation capacity and improving stability. Therefore, HSPC has an important role in pharmaceutical preparations. The solubility of the drug can be improved by preparing an amorphous solid dispersion, and the bioavailability of the drug also improves owing to the optimized saturation solubility in gastrointestinal fluids.
| PRODUCT PHYSICAL SPECIFICATION | ||
|---|---|---|
| Parameter | Specification | Test Method |
| Color | White - Light Yellow | AAPPL/ SOP/02 |
| Consistency | Powder, porous agglomerates | Visual |
| Identity (TLC) | Complies | TLC |
| PRODUCT TYPICAL/CHEMICAL SPECIFICATION | ||
| Parameter | Specification | Test Method |
| Moisture / LOD | 3% (Max) | |
| Peroxide Value | 5 MeqO2/Kg (Max) | |
| Acid Value | 10 Mg KOH/gms (Max) | |
| Insoluble Impurities | 0.3% Max | |
| Iodine Value | 3 Max | |
| Hydrogenated Phosphatidylcholine (HSPC) | 90% Min | |
| PRODUCT MICROBIOLOGICAL PARAMETERS | ||
| Parameter | Specification | Test Method |
| Total Plate count | Max. 1000 cfu/g | |
| Salmonella | Negative / 25 gm | |
| E. coli | Absent cfu/g | |
| Enterobacteriaceae | <10 cfu/g | |
| Coliforms | <10 cfu/g | |
| Yeast & Mould | Max. 100 cfu/g | |
