For more than two decades, we are providing comprehensive pharmaceutical analytical services to clients across the industry. Our services include method verification, development and validation, impurity identification and characterizations and isolation of impurities by preparative scale purification, reverse phase/normal phase, ion-exchange or gel filtration chromatographic techniques. Our analytical team works in close collaboration with our process chemistry team to ensure that every method suits the process requirements for raw materials, APIs and formulations.
Our pharmaceutical analytical services research team is well versed with current regulatory requirements to support you from early research to market.
Aurigene Pharmaceutical Services is
that provides contract research and manufacturing services
|<1225>&<1226>1226>||US Pharmacopoeia chapter|
|CDER Guidance||Guideline for Submitting Samples and Analytical Data for Methods Validation. February 1987.|
|CDER Reviewer Guidance||Validation of Chromatographic methods. November 19|
|ICH Q2 (R1)||Validation of Analytical Procedures: Text and Methodology, International Conference on Harmonization|
|ICH Q6A||Specifications: Test Procedures and Acceptance Criteria for New Drug Substances and New Drug Products: Chemical Substances, International Conference on Harmonization.|
|ICH Q7||GMP Guidance for Active Pharmaceutical Ingredients, International Conference on Harmonization.|
|RDC.N°17||Good Practices for medicament manufacturing|
|RDC.N°53||“Establishes parameters for reporting, identification and qualification of degradation products in synthetic drugs with active substances and semi-synthetic classified as new, generic and the like, and other measures”.|
|RE.N°166||Guide for validation of Analytical and Bio-analytical methods|
|USP General chapters||General tests and assays.|
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