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Product:Dexamethasone sodium phosphate  

Category: adrenocortical hormone APIs
Quality standard: CP/BP/USP/EP

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

Product name: Dexamethasone sodium phosphate
Chemical name: isodium (11beta,16alpha)-9-fluoro-11,17-dihydroxy-16-methyl-3,20-dioxopregna-1,4-dien-21-yl phosphate
Category: adrenocortical hormone APIs
Specifications: 1kg/tin
Standard: CP/BP/USP/EP
Approval number: Chinese Drug Approval Number H20053753

Quality standard: Chinese Pharmacopoeia 2015 edition

Properties: white to yellowish powder; no odor, has a little bitter taste.  

Identification: positive reaction
Specific rotation: +72º~+80º.
Basicity: PH value is 7.5~10.5.
Free phosphate: no larger than absorbance of reference solution.
Clarity and color: clear and colorless.
Related substances: dexamethasone≤0.5%, other single impurities≤0.5%, other impurities≤2.0%.
Drying loss: ≤16.0%
Residual solvents: acetone≤0.5%, methyl alcohol≤0.3%.
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:  C22H28FNa2O8P content in dry product is 96.0~102.0%.
Storage:  the product must be tightly sealed and kept in dry and shading place.
Chemical structural formula: 
 


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