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Product:Betamethasone  

Category: adrenocortical hormone APIs

 Quality standard: CP/BP/USP/EP

 Specification: 1kg/tin, 2kg/tin,5/tin

Product name: Betamethasone

Chemical name: 9a-fluoro-11b,17a,21-trihydroxy-16b-methylpregna-1,4-diene-3,20-dione

Category: adrenocortical hormone APIs

Specifications: 1kg/tin

Standard: CP/BP/USP/EP

Approval number: Chinese Drug Approval Number H20055125

Quality standard: Chinese Pharmacopoeia 2015 edition

Properties: white or off-white crystalline powder; no odor.

Identification: positive reaction

Melting point: 236℃~244℃.

Specific rotation:  +115º~+121º.

Absorbance: 382~406.  

Related substances maximum impurity≤1.0%, other single impurities≤0.5%, total impurities≤2.0%.

Drying loss: ≤0.5%.

Residue on ignition: ≤0.1%.

Microbial limit: total amount of aerobe≤103cfu/g; mould and yeast≤102cfu/g; no escherichia coli can be detected.

Content:  C22H29FO5 in dry product is 97.0%~103.0%.

Storage: the product should be tightly sealed and kept in shading place.

Chemical structural formula: 

 

 

 


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