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Misoprostol 1%

Chemical Name

:Misoprostol 1%  

Category

:Steroids

Specification

:EP/USP/BP

HS Code

:29375000.00
CHEMCIAL PROPERTY

Structure Formula

CAS Number

:59122-46-2

Molecular Formula

:C22H38O5

Usage

:Misoprostol 1% is used in gastric and duodenal ulcer, hemorrhagic gastritis, acute gastric mucosal lesion,etc.
TECHNICAL DATA

Items

Standard

Appearance

Reddish purple powder

Odor

Characteristic

Extracted part used

Fresh fruit

Extract solvent

Ethanol & water

Ration/herb/native extract

10:1

Dry fashion

Spray drying

Particle Size

95% through 80 meshes

Loss on drying

5.00%MAX

Total Ash

3.00MAX

Lead (Pb)

0.50ppm MAX

Heavy metals

10ppmMAX

Arsenic (As)

0.50ppm MAX

Cadmium (Cd)

0.50ppm MAX

Mercury (Hg)

Negative

Pesticides

USP standard

Solvent residuals

<0.05%

Total bacterial count

1000cfu/g max

Total molds count

100cfu/g max

Staphylococcus aureus

Negative

Salmonella

Negative

E.Coli

Negative

DOCUMENT SERVICE

The available documents are: 

Chinese GMP

CEP

DMF/CTD format

The available registered countries are:

Algeria

Spain

Australia

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