New capabilities on Nitrosamines testing for pharmaceuticals and glass delamination studies at Megsan
Ms. Jyothirmai, Director of Megsan Labs, has announced that Megsan now offers special capabilities to support pharmaceutical clients on nitrosamines as per USFDA and EMEA guidelines, using six GCMS and three LCMS devices.
Currently, Megsan Labs serve all major pharmaceutical companies across India to support them with regulatory issues.With its excellent scientific team, they develop and validate methods according to regulatory requirements.
Megsan Labs has hands on experience in evaluating the inner surface durability of glass containers as per USP 1660. These containers are used in various aqueous liquid formulations in glass delamination studies. They support the regulatory applications of various customers, by using advanced techniques such as ICPMS, SEM, and Inverted Microscopes.
Megsan develops and validates the quantification methods for >24 elemental impurities as per ICH Q3D and USP 232 studies for >500 various parenteral and oral products sample matrices. Examples of these matrices are raw materials, active pharmaceutical products, and pharmaceutical products such as tablets, capsules, injections, oral suspensions and other formulations for customers. Furthermore, Megsan conducts screening studies for 40+ elemental impurities and supports customers in their risk assessments.
Note from Mr. Jayapal Reddy, CEO: “We look forward to adding other verticals at Megsan such as Medical Device Testing as per ISO 17025 for Chemical and Microbiology areas. Also, we’re planning to establish a new business unit ‘Megsan Diagnostics’ which will be active in the diagnostics, pharmacy, retail and clinics chain.”
About Megsan Labs
Megsan is a US-FDA Inspected & approved, ISO 17025 Accredited, FSSAI approved and DCGI (Drug Controller General of India -Indian FDA) approved Laboratory, which provides analytical testing services to pharmaceutical and related companies. The services comprise elemental impurity studies, E&L studies, method development & validation and microbiological testing.
Jayapal Reddy and Jyothirmai founded the company in 2012. Today Megsan employs more than 140 people. For more information, please visit www.megsanlabs.com
Director Megsan Labs
040 30272727, Ext.: 5108.