ChemWerth FDA-Approved Shanghai Laboratory

In 1998, ChemWerth established a laboratory as part of our Shanghai operations to provide analytical support for our partner manufacturers and customers. Using modern, state-of-the-art equipment and software, and operated by a highly skilled, bi-lingual and knowledgeable staff, our lab provides analytical services in the areas of method development, method validation, and routine analysis of drug substances, including key raw materials and intermediates.

The ChemWerth owned Shanghai Laboratory is fully independent and FDA/cGMP compliant, allowing us unlimited resources in method development, analysis and cGMP release testing of product.

 

Test Methods

Our Shanghai laboratory uses a wide range of methods to test API products in accordance with compendial procedures including but not limited to:

  • USP/NF/PF
  • BP/EP/JP/CP
  • ICH GUIDELINES
  • IN-HOUSE, MANUFACTURER OR CUSTOMER SUPPLIED METHODS

The lab also develops ChemWerth's own HPLC/GC methods for non-compendial APIs and submits these methods to USP for monographic adoption as needed.

 

Analytical Services

ChemWerth Shanghai Laboratory provides analytical services in numerous routine and specialized techniques to both API manufacturers and finish dosage customers for NDA, 505(b)(2), and ANDA submissions.

  • Analytical Method Development & Validation
  • HPLC Assay And lmpurity Analysis with RI and DAD Detectors
  • Ion Chromatography with PAD and Conductivity Detectors
  • GC (Head Space) Assay, Impurity & Residual Solvent Analysis
  • Organic Volatile Impurities (OVI)
  • Degradation Studies
  • Spectroscopy Analysis (FTIR and UV-VIS)
  • Malvern Laser Particle Size Determination
  • Air Jet Particle Size Determination
  • pH/Conductivity Determination
  • Optical Rotation Determination (Specific Rotation Spectrophotometer)
  • Volumetric KF/Coulumetric KF Water Determination
  • Miscellaneous Analysis Consultation