Androst-4-en-3-one, 17-hydroxy-, (17β)-.
17β-Hydroxyandrost-4-en-3-one [58-22-0]
BRIEFING
Testosterone. This proposal is based on the version of the monograph official as of May 1, 2020. The proposal which appeared in PF 41(4) [July–Aug. 2015] was canceled and is replaced with the following proposal:
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The molecular weight for Testosterone in the chemical information section is updated to be consistent with IUPAC and the USP Dictionary.
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The nonspecific UV absorption procedure in the Assay is replaced with a specific liquid chromatographic procedure validated using the Poroshell 120 Phenyl-Hexyl brand of column with L11 packing. The typical retention time for testosterone is about 3.8 min.
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The Acceptance criteria in the Definition and Assay are revised from NLT 97.0% and NMT 103.0% to NLT 98.0% to NMT 102.0% to be consistent with agency approval for the manufacturer.
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Identification A is updated to reference 197A to allow for flexibility for users.
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The UV absorption test in Identification B is replaced with a retention time match of the testosterone peak, as obtained in the Assay.
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Add an Organic Impurities test using a liquid chromatographic procedure. The procedure was validated using the Poroshell 120 Phenyl-Hexyl brand of column with L11 packing. The typical retention time for testosterone is about 3.8 min.
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The Loss on Drying test is updated to harmonize the procedure with the European Pharmacopoeia monograph.
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The nonspecific test for Melting Range or Temperature is deleted as the proposed test for Organic Impurities is sufficient.
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In the Packaging and Storage section, updated the storage condition to "controlled room temperature" to be consistent with USP style.
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The Optical Rotation test is revised to harmonize with the European Pharmacopoeia monograph.
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USP Exemestane Related Compound C RS, USP Testosterone Related Compound A RS, USP Testosterone Related Compound C RS, and USP Testosterone Related Compound I RS are added to the USP Reference Standards section to support the proposed test for Organic Impurities.
Additionally, minor editorial changes have been made to update the monograph to current USP style.
(SM5: S. Shivaprasad)
Case ID—SUB-1000