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DRAFT FOR COMMENTS
Please send any comments you may have on this draft working document to Dr Herbert Schmidt, Technical Officer, Norms and Standards for Pharmaceuticals, Technical Standards and Specifications ([email protected]), with a copy to Ms Sinéad Jones ([email protected]) by 3 September 2021.
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[Note from the Secretariat. It is proposed to include a monograph on Ulipristal acetate in The International Pharmacopoeia. The draft monograph is based on information provided by a manufacturer and on laboratory investigations.]
ULIPRISTAL ACETATE
UULI PRISTALI ACETAS)
Molecular formula. C30H37NO4
Relative molecular mass. 475.63
Graphic formula
Chemical name. 19-Norpregna-4,9-diene-3,20-dione, 17-(acetyloxy)-11-[4(dimethylamino)phenyl]-.(11ß)-; 11ß- [4-(Dimethylamino)phenyl] -3,20-dioxo-19norpregna-4,9-dien-17-yl acetate; CAS Reg. No. 126784-99-4.
Description. A white to yellowish crystalline powder
Solubility. Freely soluble in dichloromethane R; soluble in methanol R, acetone R and ethanol, dehydrated, R; practically insoluble in water.
Category. Oral hormonal contraceptive.
Storage. Ulipristal acetate should be kept in a well-closed container, protected from light.
Additional information. Ulipristal acetate exhibits polymorphism.
Requirements
Definition. Ulipristal Acetate contains not less than 98.0% and not more than 102.0% of C30H37NO4, calculated with reference to the anhydrous substance.
Identity tests
* Either test A alone, or any two of tests B, C or D may be applied.
A. Carry out the test as described under 1.7 Spectrophotometry in the infrared region. The infrared absorption spectrum is concordant with the spectrum obtained from ulipristal acetate RS.
If the spectra thus obtained are not concordant, repeat the test using the residues obtained by separately dissolving the test substance and ulipristal acetate RS in a small amount of dehydrated ethanol R and evaporating to dryness. The infrared absorption spectrum is concordant with the spectrum obtained from ulipristal acetate RS.
B. Carry out the test as described under 1.14.4 High-performance liquid chromatography using the conditions given under "Assay", Method A. The retention time of the principal peak in the chromatogram obtained with solution (1) corresponds to the retention time of the peak due to ulipristal acetate in...