We provide analytical services for NCEs, APIs and formulation of DS and DP. We are well equipped with high-end instruments for purification like Mass Directed Purification (MDD) and Supercritical Fluid Chromatography (SFC). We also facilitate impurity identification, characterization and isolation. We provide end-to-end support for analytical services. The state-of-the-art infrastructure at our R and D centers is well-equipped with the latest analytical instruments that enable us to provide high-quality, cost-effective services for our customers.
Hyphenated analytical instruments
Experience in handling complex molecules
Strong data integrity and digitization
End-to-end support for analytics
We can analyze the below development samples related to
Below are the set of guidelines used for method validation
|<1225>&<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.|
Below is the list of equipments or instruments used
Stability indicating nature of analytical method will be demonstrated during analytical method development of drug substance related substances and assay method. To demonstrate the stability indicating nature of analytical method, degradation samples shall be generated by stressing the test sample with acid, base, water hydrolysis, oxidative, thermal and photostability study. The degraded sample shall be analyzed and demonstrated the separation of degradation impurities from known impurities and analyte peak. Photostability study shall be carried out as per ICH QIB.
You are about to leave Aurigene Pharmaceutical Services and affiliates website. Aurigene Pharmaceutical Services assumes no responsibility for the information presented on the external website or any further links from such sites. These links are presented to you only as a convenience, and the inclusion of any link does not imply endorsement by Aurigene Pharmaceutical Services.
If you wish to continue to this external website, click Proceed.