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Headspace gas chromatography is a very precise and well accepted method for the analysis of residual solvents in drug substances and products according to the ICH (International Conference of Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use), USP and Ph. Eur.
Loba Chemie GC-HS solvents have been developed for more sensitive GC-headspace analysis of volatile organic impurities, specially tested to ensure, optimal solvent purity and no peaks elute in the same retention time range as the OVIs. This helps in accurate identification and quantification of the residual solvents present in the drug substances, excipients and drug products. Each solvent is application optimized and function tested to ensure optimal performance. The handling of these solvents during manufacturing evolves micro-filtration and packaging under an inert atmosphere.
Features and Benefits:
- Function tested to ensure optimization for headspace applications.
- Exclusively designed for analyses of residual solvents described in the European Pharmacopoeia (Ph. Eur.), United States Pharmacopoeia (USP) and Q3C guidelines of International Conference on Harmonization (ICH).
- Elimination of any major interference peaks in the elution range of target analytes.
- Solvent matrixes with highest achievable purity and extremely low or negligible levels of residual solvent impurities.
- Produced in ISO-certified facilities to provide excellent batch-to-batch consistency saving you valuable time and money by avoiding the need for repeat
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