Fluoxymesterone API Manufacturer in India

Swapnroop Pharma · WHO-GMP Certified · +91 87670 62101

Fluoxymesterone API Manufacturer in India

Fluoxymesterone API is a synthetic androgenic steroid belonging to the testosterone-derived class of pharmaceutical compounds. It is identified by CAS Number 76-43-7, with the molecular formula C₂₀H₂₉FO₃ and molecular weight 336.44 g/mol.

Fluoxymesterone is chemically identified as 9-Fluoro-11β,17β-dihydroxy-17-methylandrost-4-en-3-one. It occurs as a white or practically white, odorless crystalline powder and is practically insoluble in water. It is sparingly soluble in alcohol and slightly soluble in chloroform.

Fluoxymesterone Chemical Properties

Fluoxymesterone has a molecular formula of C₂₀H₂₉FO₃ and molecular weight of 336.44 g/mol. Its CAS Registry Number is 76-43-7. The compound has a reported melting point of approximately 240°C with decomposition.

Fluoxymesterone API Quality

The USP specification states that Fluoxymesterone contains 97.0%–102.0% of C₂₀H₂₉FO₃, calculated on the dried basis. USP also specifies loss on drying NMT 1.0% and chromatographic purity limits of NMT 1.0% for any individual impurity and NMT 2.0% for total impurities.

Fluoxymesterone also has a specific optical rotation requirement of +104° to +112° at the specified test conditions.

Fluoxymesterone API Applications

Fluoxymesterone is an androgenic steroid used in pharmaceutical applications. Its use and handling are subject to applicable pharmaceutical and regulatory requirements.

Quality and Documentation

Fluoxymesterone API should be manufactured and tested according to the applicable pharmacopoeial or approved manufacturer specification. Batch-specific quality should be confirmed through the relevant Certificate of Analysis (CoA).

Detailed Specifications

Parameter Specification
Appearance White to off-white crystalline powder
Identification IR & HPLC compliant
Assay (HPLC) 97.0% – 102.0%
Loss on Drying NMT 1.0%
Residue on Ignition NMT 0.2%
Heavy Metals NMT 10 ppm
pH (1% Solution) 2.0 – 4.0
Individual Impurity NMT 1.0%
Total Impurities NMT 2.0%
Water Content NMT 1.0%
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