Category
Testosterone
CAS Number
63-05-8
Molecular Formula
C₁₉H₂₆O₂
Molecular Weight
286.4 g/mol
Synonym

(8R,9S,10R,13S,14S)-10,13-dimethyl-2,6,7,8,9,11,12,14,15,16-decahydro-1H-cyclopenta[a]phenanthrene-3,17-dione; 4-Androstene-3,17-dione; Androstenedione; Androst-4-ene-3,17-dione; Testosterone Related Compound A (As per USP Commenting Opening 51(3)); Androst-4-ene-3,17-dione; Androstenedione (EP) ; Testosterone USP Related Compound A

Keywords
Fine Chemicals
Pharmaceutical Standards
Impurities
Intermediates
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Purity:

Above - 95.0%

Technical Data:

We will provide complete documentation support for every Standard Material. All analytical reports such as ¹H NMR, ¹³C NMR, Mass, FT-IR, HPLC Purity/GC Purity/QNMR Purity, Water content by KF/ Loss on Drying/TGA (Thermo-gravimetric Analysis). Certificate of Analysis with potency report. Each Standard Material SER (Structure Elucidation Report) with NMR, Mass, IR spectral interpretation. This whole analytical document can be included in eCTD, ANDA, DMF submissions to regulatory agencies.

Testosterone EP Impurity A is a pharmacopoeial (European Pharmacopoeia) specified related substance associated with Testosterone. It typically refers to a structurally defined steroidal impurity formed during synthesis or degradation, often through oxidation or minor rearrangements of the testosterone molecule. Like other EP-listed impurities, it has strict identification and limit criteria to ensure the quality, purity, and safety of testosterone-based pharmaceuticals. Analytical techniques such as HPLC are used to detect and quantify this impurity according to European Pharmacopoeia standards.