Analytical Development
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Analytical Development services
Analytical development lab provides a solution for all small molecules for analytical method development and validate the analytical methods. Analytical development offers standalone services and supports formulation development activities. The AD teams are integrated with product development and Quality assurance teams to ensure effective and accelerated product development.
Analytical method development for finished products and intermediates.
Analytical method validation for finished products.
Analytical method validation for all small molecules.
Analytical method transfer.
Analytical method verification.
Cleaning method development and validation.
Evaluation of Elemental impurities as per ICH guidelines.
Development stability studies as per ICH guidelines.
Pre-formulation studies.
Extractables and Leachables Testing.
Qualification of Working Standards.
Intrinsic dissolution.
Impurity profiling and characterization.
Analytical support for regulatory filing.
LIST OF EQUIPMENTS
KMS Pharma is a DSIR approved & ISO certified company established in 2011 at Chennai, Tamilnadu, India.
Shimadzu HPLC system with UV
Gas chromatography-Mass spectrometry (GC-MS)
Franz diffusion apparatus
Dionex Ion Chromatography
Temp/Humidity controlled Stability chambers & Photo stability chambers
UV-Spectrophotometer
Centrifuge, Automatic Shaker, Sonicator, etc.
Inductively coupled plasma mass spectrometry (ICP-MS)
Liquid chromatography-Mass spectrometry (LC-MS)
Dissolution apparatus with Auto sampler
Dissolution apparatus USP 3 & 7 – Electrolab
