At Aurigene, we have a well-experienced team that is skilled with global quality and regulatory guidelines to complement your projects with the right set of analytical activities. We have a state-of-the-art analytical lab through which we can develop a variety of analytical methods. We plan the analytical strategy based on the project lifecycle and customer needs. We have capabilities across method verification, development, validation and impurity profiling that includes isolation, identification & characterization and assessment of nitrosamine or other genotoxic impurities. We also conduct stability studies as per ICH guidelines.
Mass spectrometer (LC-MS and HR-MS)
For early phase projects, we develop analytical methods in hand-in-hand with the process development program. For critical quality attributes of the final product such as assay, related substances, and residual solvents analytical methods are verified. Our standard analytical method verification procedures check LOD, LOQ, linearity, precision, specificity, accuracy, robustness, solution stability and mobile phase stability. Along with these verifications, fit-for-purpose analytical methods for testing raw materials, in-process controls, and intermediate analysis are developed. Post mapping of equipment at the manufacturing facility, an appropriate residue method is also developed and validated. We generate and qualify the appropriate quantity of reference standards to support the analysis and method transfers.
We perform method validation as per the internal SOP of Aurigene against the predefined specification. The method will be validated as per ICH guidelines for parameters like LOD, LOQ, linearity, repeatability, recovery, solution stability, specificity, precision, accuracy, robustness and mobile phase stability. Analytical activities also depend on whether we are working on intermediates, RSM or the final API.
We perform analytical validation in compliance with the Pharmacopoeia, current Good Manufacturing Practices (cGMP) and ICH requirements as per customer needs. Following are the salient features of our method validation activities:
We perform stability studies for developmental APIs, intermediates, RSMs and drug products.
We have the stability chambers, refrigerator and deep fridge storage suiting to requirements of different climatic zone.
Expertise in global quality & regulatory guidelines
Phase appropriate standard operating procedures
Breadth of analytical services
Expertise in the niche analytical requirements for various technology classes
APRIL 24, 2023
Both natural and unnatural catastrophic events inflict negative consequences due to the ever-increasing interconnectedness of the global economy. Those consequences are certain to last for longer duration. e.g.; The Covid-19 pandemic is still having a negative impact on the global economy. Maintaining continuity is critical for all businesses, but perhaps no othe...Read More
Genomics plays a vital role in identifying which gene is associated with a specific disease. A gene called CNOT1 is for example known for it's effect on brain development and for impairing memory and learning. Despite the great promise genomics provides in understanding the disease, genes are not the best drug targets....Read More
Aurigene Pharmaceutical Services has experience, expertise and infrastructure to develop and manufacture oncology drug candidates including HPAPI ...Read More
Project Challenge: Existing formulation (lower strength - 50 mg) was manufactured using direct compression process. This formulation posed poor powder flow and content uniformity issues during scale-up. Development of new strength 150 mg without any process issues was a challenge. Solution design: Preliminary pre-formulation, stress study and PSD impact assessmen...Read More
A robust and metal catalyst-free method has been developed for the general and green synthesis of racemic (3,4-dihydro-2H-benzo[b][1,4] oxazin-2-yl)methanol derivatives. This simple, mild and practical method involves the reaction of 2-aminophenols with ()-epichlorohydrin in the presence of NaOH in water at room temperature. The reaction features high regioselec...Read More
Scalable alternate end-game strategies for the synthesis of the anti-COVID drug molecule Nirmatrelvir (1,PF-07321332) have been described. The first involves a direct synthesis of 1 via amidation of the carboxylic acid 7 (suitably activated as a mixed anhydride with either pivaloyl chloride or T3P) with the ...Read More
Mutations in MEK1/2 have been described as a resistance mechanism to BRAF/MEK inhibitor treatment. We report the discovery of a novel ATP-competitive MEK1/2 inhibitor with efficacy in wildtype (WT) and mutant MEK12 models. Starting from a HTS hit, we obtained selective, cellularly active ...Read More
Synthesis of the anti-covid therapeutic Nirmatrelvir by using flow chemistry to enhance efficiency of amide to nitrile conversion in a functionally and Stereochemically Embellished environment. ...Read More
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.