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AmiLife® Soya Hydrogenated Phosphatidylcholine (PC) 90%
PRODUCT DESCRIPTION
The hydrogenation of Soya phosphatidylcholine 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 has the antioxidant capacity, so the preparation of liposomes with HPC improves the drug efficacy. 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 APPLICATION
AmiLife® L-α-phosphatidylcholine, hydrogenated (Soy) is majorly used in the synthesizing liposomes. It is also used in small unilamellar vesicles (SUVs) synthesis.
L-α-phosphatidylcholine, hydrogenated (Soy) is used in liposome generation for reconstitution of complement active human plasma, bupivacaine and dexamethasone loading.
| PRODUCT PHYSICAL SPECIFICATION | ||
|---|---|---|
| Parameters | Specification | Test Method |
| Color | White – Light Yellow | AAPPL/ SOP/02 |
| Consistency | Powder, porous agglomerates | Visual |
| Identity (TLC ) | Complies | TLC |
| PRODUCT TYPICAL/CHEMICAL SPECIFICATION | ||
| Moisture / Loss On Drying | 3 % (Max) | |
| Hydrogenated Phosphatidylcholine (HSPC) | 90% Min. | |
| Peroxide Value | 5 Meqo2/Kg (Max) | |
| Acid Value | 2 Mg KOH /gms (Max) | |
| Hexane Insoluble | 0.3% Max | |
| Iodine Value | 2 Max | |
| PRODUCT MICROBIOLOGICAL PARAMETERS | ||
| Total Plate Count | Max. 1000 cfu/g | |
| Salmonella | Negative / 25 gm | |
| E. Coli | Absent cfu/g | |
| Entrobacteriaceae | <10 cfu/g | |
| Coliforms | <10 cfu/g | |
| Yeast & Mould | Max. 100 cfu/g | |
| SHELF LIFE | AmiLife® Hydrogenated Phosphatidylcholine Soya minimum 24 months from the date of manufacture when stored in unopened original packing at temperature of -20 ˚C for better shelf life. |
| PACKING | It is available in pack size of 1 Kg, 5Kg and 10 Kg. It is packed in inner LDPE linear with outer aluminum foil. |
815, Shekhar Central, Plot no.
4 & 5, Manoramaganj, A.B. Road,
Indore (MP) 452001