Quality Control and Stability Studies Services
Aptys pharma®’s analytical laboratory is both GMP compliant and WHO accredited. It is comprehensively fitted out with the necessary equipment for the quality control of raw ingredients, medicines and stability studies that include High-Performance Liquid Chromatography (HPLC), Thin Layer Chromatography (TLC), UV and IR Spectroscopy, AT 7 and USP 4 dissolution testing apparatus, ICH stability-controlled chambers (25°C/60% RH, 30°C/65%RH, 40°C/75% RH, 5°C, -20°C). The laboratory’s equipment is accredited, and its IT systems have been validated to 21 CFR part 1 standards.
QC COVERS THE FOLLOWING ASPECTS:
- The appearance, solubility, average mass, mass uniformity, hardness, friability, disintegration, pH, density, extractable volume, average volume, water content (coulometric titration), loss on drying, residual humidity, sulphuric and total ash;
- Identification by liquid and thin layer chromatography, UV and IR spectrophotometry, colorimetry testing;
- Assay and uniformity of dosage of active substances and preservatives by HPLC, UV and IR spectrophotometry and potentiometry;
- Assay of related substances by HPLC and TLC;
- Microbiology and sterility, which are subcontracted.
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