Analytical Research & Development
Analytical Research and Development involves pre-formulation, stability and degradation studies on APIs and other drugs, and preparation of technical dossiers for registration in India and other countries. The Analytical Development team provides specific services to various departments of Mankind Research Centre.
Mankind provides method development and validation services for a wide range of analytical technologies. Compliance with both GLP and cGMP regulations enables the company to support all stages of pharmaceutical development in accordance with client-specific protocols, internal SOPs and FDA and ICH guidelines. The Analytical Development lab is equipped with HPLCs with PDA/UV detector, GC-FID with head space sampler, GC-HS-MS, UPLC, UPLC-MS, Ion chromatograph, Atomic-absorption Spectrophotometer, FTIR, UV-Vis Spectrophotometer, Total organic carbon analyser, NMR and XRD.
Analytical Development has the following capabilities:
- Analytical method development and their validation to assess precision, accuracy,specificity, linearity, range limit of detection, limit of quantization and ruggedness.
- Development/preparation of complete specifications for raw materials, APIs, finished products, intermediates, excipients along with coordination with product development.
- Inclusion of in-house tests for strict control of pharmacopoeial materials and products.
- Stability study of APIs and formulations as per ICH guidelines.
- Pre-formulations study of APIs.
- Structure elucidation and characterization of impurities by UV, IR, Chromatography, DSC, Elemental analysis, Mass and NMR.
- Characterization of polymorphs using differential scanning calorimetry and XRD.
- Analysis of active ingredients and key raw materials.
- Provide quick and accurate analytical support to API’s formulation divisions.
- Develop analytical methods (Instrumental and wet analysis).
- Validate analytical methods as per regulatory guidelines (ICH and USFDA).
- Impurity profiling, isolation and characterization.
- Provide microbiological support and analysis (Sterility, MLT, Antibiotic and Vitamin assay, Water analysis.)
- Environmental monitoring and analysis.
- Instrument calibrations as per cGLP.
- Complete documentation as per cGLP.
- Evaluate existing analytical methods at manufacturing plants and provide quick, accurate and cost effective analytical solutions as per plant requirement.