Dexamethasone Acetate GMP

Product：Dexamethasone acetate  

 Category: adrenocortical hormone APIs
 Quality standard: CP/BP/USP/EP
 Specification: 1kg/tin, 2kg/tin, 5/tin

Product name: Dexamethasone acetate
Chemical name: (11beta,16alpha)-9-fluoro-11,21-dihydroxy-16-methyl-3,20-dioxopregna-1,4-dien-17-yl acetate
Category: adrenocortical hormone APIs
Specifications: 1kg/tin
Standard: CP/BP/USP/EP
Approval number: Chinese Drug Approval Number H20053752

Quality standard:  Chinese Pharmacopoeia 2015 edition

Properties: white or off-white crystal or crystalline powder. No odor, has a little bitter taste.
Identification: positive reaction

Melting point: 223℃~233℃.
Specific rotation: +82º~+88º
Absorbance: 343~371.
Related substancesmaximum impurity≤0.5％, total impurities≤1.0%.
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: C24H31FO6 content in dry product is 97.0%~102.0%.
Storage: the product should be tightly sealed and kept in shading place.
Chemical structural formula: