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Pharmaceutical Excipient

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

20.0-45.0

30.0-50.0

≤30.0

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

No.1958 Liyu Road Jinhua, Zhejiang, China

0086-579-82270620

expo@synose.com

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