The Department confirms that a medicine is compliant with its stated label claim using
the industry recognized monographs and standards of the British Pharmacopoeia (BP) and United States
Pharmacopeia and National Formulary (USP). The Pharmacopoeias specify the required tests and acceptable limits
for individual medicinal formulations. Manufacturer’s test methods and reference standards are employed when the
product makes no stated claim to either standard.
Medicines quality control evaluates the product parameters of potency, dose uniformity, specificity, efficacy,
stability, identity and purity. Similarly, efficacy and safety studies of medicines and their usefulness in
therapeutic and medical treatment are dependent upon the amount of active pharmaceutical ingredient present in
the product. These limits are established on both scientific data and the relationship between an ineffective
dose and a therapeutically useful dose in comparison to a therapeutically useful dose and a toxic dose.
The Department employs chemical methods of analysis including simple
physico-chemical analysis, titrimetric analysis and chromatography. Technological innovation allowed expansion
of the type of medicines that can be analysed through reduction in analytical time and improvement in detection
limits with more complex techniques such as Spectrometry (UV/Vis, Infra-red) and the most commonly used method
in medicines analysis, High-Pressure Liquid Chromatography (HPLC).
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