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This is a draft proposal of a revised monograph for The International Pharmacopoeia (Working document QAS/16.647, June 2016).
The working document with line numbers and tracked changes is available for comment at www.who.int/medicines/areas/quality safety/quality assurance/ projects. Please address any comments to: World Health Organization, Quality Assurance and Safety: Medicines, Dr Herbert Schmidt, 1211 Geneva 27, Switzerland; fax: +41 22 791 4730; email: [email protected].
[Note from the Secretariat. Following information received from our custodian centre for International Chemical Reference Substances (ICRS), the European Directorate for the Quality of Medicines & HealthCare, it is proposed to revise the monograph on Medroxyprogesterone acetate.]
[Note from the editor. In accordance with WHO editorial policy the text reproduced below does not include tracked changes. Changes from the current monograph are indicated by insert and ^strike-through delete^ in the working document available at the above-mentioned web address.]
2016-01
C^sub 24^H^sub 34^O^sub 4^
Relative molecular mass. 386.5
Chemical name. 6a-methyl-3,20-dioxopregn-4-en-17-yl acetate; (6a)-17-(acetyloxy)-6-methylpregn-4-ene-3,20-dione; 17-hydroxy-6a-methylprogesterone acetate; CAS Reg. No. 71-58-9.
Description. A white or almost white, crystalline powder.
Solubility. Practically insoluble in water; soluble in acetone R and dioxan R; slightly soluble in ethanol (~750 g/L) TS, methanol R and ether R.
Category. Progestogen.
Storage. Medroxyprogesterone acetate should be kept in a tight container, protected from light.
Requirements
Definition. Medroxyprogesterone acetate contains not less than 97.0% and not more than the equivalent of 103.0% of C^sub 24^H^sub 34^O^sub 4^, calculated with reference to the dried substance.
Identity tests
* Either test A or tests B and C may be applied.
A. Carry out the examination as described under 1.7 Spectrophotometry in the infrared region. The infrared absorption spectrum is concordant with the spectrum obtained from medroxyprogesterone acetate RS or with the reference spectrum of medroxyprogesterone acetate.
B. Carry out test B.1 or, where UV detection is not available, test B.2.
B.1 Carry out the test as described under 1.14.1. Thin-layer chromatography using silica R5 as the coating substance and a mixture of 10 volumes of dichloromethane R and 1 volume of ethyl acetate R as the mobile phase. Apply separately to the plate 10 µL of each of the following three solutions in dichloromethane R. For solution (A) use 25 mg of Medroxyprogesterone acetate per mL. For solution (B) use 2.5 mg...