The International Pharmacopoeia, Volume 5
World Health Organization, 2003 - 371 pages
The International Pharmacopoeia contains a collection of recommended methods for analysis and quality specifications for pharmaceutical substances, excipients and products. Volume five of this publications describes methods and procedures for the quality control of pharmaceutical substances and tablets, tests for dosage forms for suppositories and opthalmic preparations, and a new section on quality control of anti-malarials. Supplementary information on International Chemical Reference Substances and International Reference Spectra, and on the establishment, maintenance and distribution of chemical reference substances are also included.
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absorption spectrum acetone acetonitrile Add the following Additional requirements Apply separately Artemether Artemisinin Artenimol Artesunate Assay bacterial endotoxins Carry chemical reference substances chloride chro chromatogram chromatogram obtained chromatographic chamber ciprofloxacin coating substance contains not less dehydrated ethanol described under Spectrophotometry described under Test described under Thin-layer detector dichloromethane dilute Dissolve drug dry in air erythromycin ethanol examine the chromatogram filter filtrate following statement hydrochloric acid hydrochloride Identity tests infrared infrared absorption spectrum infrared region International Chemical Reference International Pharmacopoeia IU of endotoxin minutes mixture ml of water mobile phase monograph for Parenteral obtained with solution parenteral Parenteral preparations parenteral use Complies peak responses obtained perchloric acid pharmaceutical powdered tablets equivalent reference spectrum Related substances removing the plate residue silica gel sodium hydroxide soluble solvent Spectrophotometry spectrum is concordant spectrum obtained statement and test stationary phase sulfuric acid test as described Test for bacterial titration tube volumes of acetonitrile water-bath