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Qualification and release analysis

Release analysis of raw materials, intermediates or pharmaceutical ingredients

ChemCon provides you with comprehensive analysis and documentation to certify your substances for use as a pharmaceutical ingredient. We also release starting materials or intermediates according to regulatory requirements, for example the use in GMP manufacturing.

Obtain your release certificates for:

APIs according to current monographs
Pharmaceutical ingredients according to documented quality control protocols
Raw materials and intermediates
Key staring materials for GMP manufacturing
Reference standards

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Your requirements for the supply chain

Raw material release

Impeccable raw material release, particularly in a GMP environment, is becoming increasingly more important.

At ChemCon you benefit from many years of experience with quality control and release of starting materials for in-house GMP-compliant manufacturing. We release single batches or establish the routine release of recurring raw material.

Product release

ChemCon analyses products for use as pharmaceutical ingredients or drugs according to documented quality control protocols. If already available, we establish your methods and protocols in our laboratories. Otherwise, method development and validation is an integral part of our services (see here). All selected tests will ensure the clear determination of your required specifications according to quality control protocols or international current monographs (including Ph. Eur., USP).Once all methods are established, your release analysis will be processed reliably to your routine.

Drug substances for pharmaceutical application will be released by our independent quality assurance team, which reviews all related documentation before issuing your certificates of analysis (CoA) and compliance (CoC).

Synthesis and qualification

Reference standards

ChemCon’s analytical staff takes care of the comprehensive analysis and qualification of your required compound as a reference standard. We can qualify both commercially available samples and compounds that have been synthesized in-house.

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