HPLC.
High Performance Liquid Chromatography systems optimized for rigorous impurity profiling, method validation, and pharmaceutical QA/QC across Nepal.
High-Performance Liquid Chromatography (HPLC) systems provide superior molecular separation, identification, and quantitative analysis of complex mixtures. By utilizing advanced column technologies and high-pressure pumps, HPLC allows laboratories to routinely analyze Active Pharmaceutical Ingredients (APIs), trace-level impurities, and perform strict stability testing.
Our Waters HPLC systems are engineered to meet the stringent injection precision and resolution requirements cited in United States Pharmacopeia (USP) General Chapter <621> and European Pharmacopoeia (EP) 2.2.46. Integrated with industry-leading Chromatography Data Systems (CDS), they ensure full compliance with ALCOA+ data integrity regulations, making them the gold standard for pharmaceutical quality control across Nepal.
Pharmaceutical Quality Control
Routine analysis of Active Pharmaceutical Ingredients (APIs) and finished drug products for assay and dissolution testing per United States Pharmacopeia (USP) and European Pharmacopoeia (EP) monographs.
Impurity Profiling
High-sensitivity detection and quantification of trace-level organic impurities and degradation products, ensuring medications meet stringent ICH Q3A and Q3B safety limits.
Method Modernization
Transfer legacy pharmacopoeial methods to novel sub-2-µm column technologies while operating precisely within the system suitability and allowable adjustment criteria of USP <621>.
Food & Environmental Analysis
Precise determination of additives, mycotoxins, and environmental pollutants in complex sample matrices according to ISO, AOAC, and EPA (e.g., EPA Method 8330) standardized procedures.
- Rs — Resolution
- N — Plate Count / Efficiency
- Tf — Symmetry / Tailing Factor
- tR — Retention Time
- RSD% — Relative Standard Deviation
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