Sucrose Stearate ( USP/EP/ChP )
Quality Standard: ChP2020 of the first supplement
|
Item |
Specification |
|
|
Appearance |
White to almost white powder |
|
|
Acid value |
≤6.0 |
|
|
Identification（1） |
Blue to green appears at the interface between the two liquid layers |
|
|
Identification（2） |
The retention time of the corresponding peaks of fatty acid composition is consistent |
|
|
Free sucrose，% |
≤4.0 |
|
|
Water，% |
≤4.0 |
|
|
Residue on ignition，% |
≤1.5 |
|
|
Heavy metals，% |
≤0.002 |
|
|
Arsenic，% |
≤0.0001 |
|
|
Fatty acid composition |
Lauric acid，% |
≤ 3.0 |
|
Myristic acid，% |
≤ 3.0 |
|
|
Palmitic acid，% |
25.0~40.0 |
|
|
Stearic acid，% |
55.0~75.0 |
|
|
Sum of palmitic acid and stearic acid，% |
≥90.0 |
|
|
Various type and ester content, % |
See the form below |
|
|
Type |
Monoesters，% |
Diesters，% |
Triesters and Polyesters，% |
|
Ia |
≥65.0 |
≤30.0 |
≤15.0 |
|
Ⅰb |
50.0~65.0 |
≤40.0 |
≤25.0 |
|
Ⅱ |
20.0-45.0 |
30.0-50.0 |
≤30.0 |
|
Ⅲ |
15.0~25.0 |
30.0-45.0 |
35.0-50.0 |
Properties: This product is white to almost white powder, soluble in trichloromethane or tetrahydrofuran, very slightly soluble in water.
Use: Pharmaceutical excipients, solubilizing agent, emulsifier and lubricant, etc.
Storage: Seal and store in a dry place.
Package: 25kgs/drum or as required by the customer.
Expiration Date: 2 years
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