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This is a draft proposal for The International Pharmacopoeia (Working document QAS/15.642, November 2015).
The working document with line numbers is available for comment at www.who. int/medicines/areas/qualitv safetv/qualitv assurance/proiects/en/. 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. The following monograph is proposed for inclusion in The International Pharmacopoeia. Comments are in particular sought on the suitability of the proposed content limits for misoprostol (95.0% to 105.0%> of the amount of Misoprostol stated on the label).]
Description. A white or almost white powder.
Category. Prostaglandin (PGE^ analogue.
Storage. Misoprostol is hygroscopic, it should be stored below 8°C under nitrogen in sealed containers and should not be exposed to moisture.
Requirements
Definition. Misoprostol dispersion is a mixture of Misoprostol and Hypromellose. It contains not less than 95.0% and not more than 105.0% of the amount of C22H3805 stated on the label.
Identity tests
Either tests A and C or tests B and C may be applied.
A. Carry out the test as described under 1.14.4 High-performance liquid chromatography using the conditions given under "Assay". The retention time of the principal peak in the chromatogram obtained from solution (1) corresponds to the retention time of the peak due to misoprostol in the chromatogram obtained from solution (2).
B. Carry out the test as described under 1.14.1 Thin-laver chromatography using silica gel R3 as the coating substance and a mixture of 8 volumes of toluene R, 2 volumes of ethyl acetate R, 1 volume of dehydrated ethanol R and 0.1 volume of glacial acetic acid R as the mobile phase, prepared immediately before use. Apply separately to the plate 100 pL of each of the following two solutions in dehydrated ethanol R. For solution (1 ) shake mechanically a quantity of the dispersion equivalent to 1 mg of misoprostol with 10.0 ml_ of dehydrated ethanol R for 10 minutes, filter and use the clear filtrate. For solution (2) use 0.1 mg of misoprostol RS per ml_. After removing the plate from the chromatographic chamber allow it to dry in air, expose it to the vapour of iodine R and examine the chromatogram in daylight.
The principal...