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This is a draft proposal for The International Pharmacopoeia (Working document QAS/15.644, November 2015).
The working document with line numbers is available for comment at www.who. int/medicines/areas/qualitv safetv/qualitv assurance/pro|ects/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].
C18Hl6N8Na207S3,3V2H20
Relative molecular mass. 661.60
Chemical name. Disodium (6R,7R)-7-[[(2Z)-(2-aminothiazol-4-yl)(methoxyimino) acetyl] amino]-3-[[(2-methyl-6-oxido-5-oxo-2,5-dihydro-1,2,4-triazin-3-yl)sulfanyl]meth- yl]-8-oxo-5thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylate 3.5 hydrate.
Description. Almost white or yellowish, slightly hygroscopic, crystalline powder.
Solubility. Freely soluble in water, sparingly soluble in methanol, very slightly soluble in anhydrous ethanol.
Labelling. The label states, where applicable;
* that the substance is free of bacterial endotoxins;
* that the substance is sterile.
Category. Antibacterial
Storage. Ceftriaxone sodium should be kept in an air-tight container protected from light. If the substance is sterile, store in a sterile and air-tight container protected from light.
Requirements
Ceftriaxone sodium contains not less than 96.0% and not more than 102.0% of the labelled amount of ceftriaxone sodium (C18H16N8Na207S3), calculated with reference to the anhydrous substance.
Identity tests
* Either tests A and C 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 ceftriaxone sodium RS or with the reference spectrum of ceftriaxone sodium.
B. Carry out the test as described under 1.14.4 High-performance liquid chromatography using the conditions given under the Assay test. The retention time of the principal peak in the chromatogram obtained with solution (1) corresponds to the retention time of the peak corresponding to ceftriaxone in the chromatogram obtained with solution (2).
C. When tested for sodium as described under 2.1 General identification tests, yields the characteristic reaction.
Specific optical...