Stability Studies

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Contract Laboratory Services > Pharmaceutical Analysis > >  Stability Analysis

addressing the stability requirements of pharmaceutical manufacturers

 

 

Do you need to outsource stability storage, analysis, qualification (of storage instruments)? Look no further. Choksi Laboratories provide one stop solution for all your stability outsourcing.

 

CLL provides stability testing and storage to support both generic products as well as for national/international regulatory submissions for new products. CLL’s stability storage facility maintains storage chambers with complete power backup and continuous monitoring of environment conditions & security.

 

Our Calibration staff periodically validates these stability chambers, apart from the initial IQ/OQ/PQ protocols to verify proper installation, operation, performance. Temperature and humidity are calibrated on multiple points against NPL / NIST-traceable devices, and the storage units are fully mapped on full, half & complete loads.

 

Analytical data is recorded in our 21 CFR Part 11-compliant Laboratory Information Management System.

 

ANALYTICAL SUPPORT - CAPACITY AND CONFIDENCE

 

There is only one word to describe CLL’s infrastructure in meeting your analytical requirements for stability samples - MASSIVE. With over 35+ HPLCs (Agilent, Waters, Shimadzu), LC-MS/MS, 20+ GCs, GC-MS, 8 USP-NF compliant Dissolution Systems, CLL can provide the speed and sample handling capacity that no other laboratory can match. Our central laboratory at Indore has a strategic tie-up with the largest USFDA approved pharmaceutical exporter from India for handling its complete requirements for outsourcing of stability samples.

 

CLL’s facilities have been audited & trusted by the top pharmaceutical MNCs world-wide.

 

 To request for more information on Stability Studies, contact us at info@choksilab.com .

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