Analytical & QC-Asymchem Labs.

Analysis and Quality Control

Covering three major fields: R&D analysis, formulation quality control and microbiological testing. Relying on a comprehensive analytical technology and testing system, we provide GMP analytical testing and release services covering the full life cycle. Laboratories are equipped with advanced instruments, capable of analyzing various complex formulations including tablets, capsules, enteric coated formulations, granules, topical formulations, injections, eye drops, lyophilized powders, microemulsions, liposomes and more, ensuring product quality meets global regulatory requirements.

Service Capabilities

R&D Analysis

Analytical method development, validation, verification and transfer

Analytical testing and preliminary stability studies for R&D samples

Packaging material screening and preliminary compatibility studies

Establishment of quality specifications for raw materials, excipients, packaging materials and products

Rapid resolution of various complex analytical issues encountered during project execution

Formulation QC

Testing and release of drug substances, excipients and packaging materials

Testing and release of finished pharmaceutical products and intermediates

Analytical method transfer and validation

Various stability studies, including stability studies under ICH‑specified storage conditions

Microbiological Testing

Development, validation and verification of microbiological analytical methods

Microbiological testing for drug substances, excipients and packaging materials

Microbial limit testing for non sterile formulations

Sterility testing and endotoxin testing for multiple sterile dosage forms

Environmental monitoring of workshops and microbiological testing of water systems

Analytical Equipment

LCMS system

Headspace gas chromatography

Mass spectrometer

Dissolution tester

Ultraviolet visible spectrophotometer

Osmotic pressure tester

Residual oxygen analyzer

Clarity tester

Particle size analyzer

Turbidimeter

Stability chamber

Large equipment laboratory equipped with LCMS/ICPMS/ICPOES/NMR

High performance liquid chromatograph

QE liquid chromatography mass spectrometer

Stability Test Chamber

Liquid chromatography mass spectrometer

Dissolution Tester

Gas Chromatograph

D8 X ray diffractometer

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