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Quality & Analytical Support

Quality and Analytical Support

Documentation Matched to Your Product Requirements

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Analytical requirements depend on the material, intended application and customer specification. XinChem coordinates available testing and supporting information with the relevant manufacturer or laboratory. Methods, acceptance criteria, costs and lead time should be agreed before additional testing is commissioned.

Analytical Support

Chromatographic Analysis

HPLC or GC may be considered for purity, assay, volatile components or residual-solvent analysis, where suitable for the product and method.

Identity and Impurity Assessment

NMR, LC-MS, GC-MS or other methods may be evaluated when appropriate and available.

Additional Tests

Water content, chiral purity and other product-specific tests can be discussed according to the specification and available laboratory capability.

Documentation That May Be Available

  • Batch-specific Certificate of Analysis

 

  • Safety Data Sheet
  • Product specification or Technical Data Sheet

 

  • Analytical reports, spectra or chromatograms

 

  • Relevant batch and packaging information

The availability and scope of each document are confirmed for the product or project. Additional work may require a separate quotation.

Project Data and Regulatory Information

Raw-data access, record-retention periods and confidentiality arrangements should be confirmed in writing where required. 

Requests for information supporting regulatory submissions are evaluated case by case. 

The availability of a DMF, authorization letter or specific filing package must be confirmed for the particular product and manufacturer.

Request Analytical Documentation?

Please send the product name or CAS number, required tests, test methods, acceptance criteria and desired reporting format.