Lecithin is a mixture of various phospholipids with phosphatidylcholine (PC) as the main component. It is defined by USP NF as a mixture of phospholipids insoluble in acetone and is now used as a pharmaceutical excipient.
PC-98T, a white to light-yellow powder, is egg yolk lecithin with high purity of PC. Its PC purity can reach 98% and it doesn't contain phosphatidylethanolamine (PE). Therefore, its emulsifying performance is weaker than PL-100M. In terms of application, in addition to being used as an emulsifier for fat emulsions, it is more suitable for the preparation of liposomes. Despite of its weak emulsifying performance, PC-98T is currently the only effective emulsifier for preparing Alprostadil fat emulsion injection because of its high purity of PC and absence of PE, which will not cause the structural drug inactivation.
NMPA CDE registration no.: F20170000623（A）
USFDA DMF no.: 007659
Product Name | Egg yolk lecithin PC—98T (for Injection) |
Chemical Name | / |
CAS No. | 93685-90-6 |
NMPA CDE registration no. | F20170000623（A） |
USFDA DMF No. | 7659 |
Quality grade | Injection |
Quality standards | Conforms with USP, JP, ChP standards |
Molecular Formula | / |
Applications and examples | lprostadil injection, liposomes |
Product code | N01001 |
Package sizes | 1kg |
Storage condition | -20°C, protect from light *In solvent : -80°C, 6 months; -20°C, 1 month (protect from light) |
1. Its special extraction process enables the content of phosphatidylcholine to exceed 98%.
2. It is the only high-purity injection-grade egg yolk lecithin approved by the NMPA.
3. It has been successfully applied in products such as Alprostadil fat microsphere injection (Kaishi®, Beijing Tide Pharmaceutical).
PC-98T is a white to light-yellow egg yolk lecithin powder with PC purity reaching 98%.
Its emulsifying performance is weaker than PL-100M and It is more suitable for the preparation of liposomes. However, currently PC-98T is the only effective emulsifier for preparing Alprostadil fat emulsion injection.
If you have any questions, please don't hesitate to contact us. We're always here to help with Pharmaceutical Excipients for your business. We can provide products ranging from grams to tons. AVT is able to produce and even register the product in US FDA according to your special needs.
EN
jp 
ko 
fr 
es 
ru 
ms 
id 
bn 
