XI'AN GUOKANG RUIJIN PHARMACEUTICAL CO.,LTD
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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:
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Jiangxi Yuneng Pharmaceutical Co., Ltd.
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The company's factory mainly produces corticosteroids, sex hormones, progesterone and other raw materials and intermediates, and its production technology has reached the domestic or international leading level. The products that have been produced on a large scale and supplied normally include: difcotte, hydrocortisone, dexamethasone, dexamethasone sodium phosphate, budenide, estradiol, estradiol, estradiol, 17α- hydroxyprogesterone, progestin, etc., among which difcotte has an annual capacity of 12 tons and hydrocortisone has an annual capacity of 15T. The company's products are produced according to the requirements of GMP, and the quality of the products meets the international quality standards of American pharmacopoeia and European pharmacopoeia.
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