To avoid manufacturing errors, accepting incoming materials for pharmaceutical manufacture requires verification of the material’s identity. The resources needed to do this testing can be high, particularly where 100 % testing is mandatory or desirable. Chemetrix offers a range of Spectroscopy and Chromatography based solutions for fast and efficient Raw materials verification.
Drug dissolution testing provides necessary in vitro drug release information for pharmaceutical manufacturing quality control, making it a critical tool for performance characterization of diverse dosage forms. Agilent offers pharmaceutical dissolution testing products for product formulation and other applications.
Residual solvent impurities in pharmaceuticals are trace amounts of volatile organic compounds used in drug production that remain in the final drug product. Strict regulations require close monitoring on the presence of residual solvent, as even trace amounts can impact drug safety and efficacy.
With increasing awareness of the potential harmful effects of inorganic contaminants, regulatory organizations have provided new guidelines recommending analytical techniques, such as ICP-OES and ICP-MS, to monitor elemental impurities. Agilent offers integrated solution for confident elemental impurities testing.
Several drug products were recently recalled due to the presence of unacceptable amounts of mutagenic nitrosamine impurities. Chemetrix offers relevant GC/MS, LC/MS and high-throughput MS-based analytical technologies to accurately detect and quantify trace mutagenic and genotoxic impurities in drug products.
Extractables and leachables (E&Ls) analysis is challenging and requires complete confidence in the results to ensure regulatory compliance. No single analytical tool can analyze all E&Ls; we offer diverse analytical technologies and expertise for the accurate identification and quantification of potential E&Ls.
Pharmaceutical Companies have to meet major global regulatory requirements when using water in their manufacturing processes and final products, including USP <643> and <645>, EP 2.2.44 Total Organic Carbon, IP 2.4.30, CP Appendix VIII R, and JP16 2.59 monographs for Purified Water and Water for Injection. Chemetrix offers the industry leading range of Suez TOC products to help pharmaceutical manufacturers to meet these requirements.
Is your lab struggling with a growing caseload of samples that require fast, accurate analysis? Identify controlled substances with little or no sample preparation! Agilent QuickProbe technology delivers direct analysis on GC/MS or on a TOF/Q-TOF/MS using the DART (direct analysis in real time) interface. Handheld Raman and FTIR systems for portable or out-of-laboratory measurements are also available. Whichever option is best suited to your needs, Agilent can help you identify your unknowns with confidence.
Seeking to expand, update, or enhance your lab’s capacity for forensic drug testing? ASTM E2329-17 Standard Practice for the Identification of Seized Drugs describes the minimum criteria and approved technologies required for the qualitative analysis of controlled substances. Learn how Chemetrix can help you comply with this standard and identify your unknowns with confidence.
Chemetrix Export (Pty) Limited
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