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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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