NMP

SupraSolv^® for headspace gas chromatography (GC-HS) is a dedicated high-purity solvent grade specifically formulated to meet the stringent analytical demands of residual solvent determination in pharmaceutical active pharmaceutical ingredients (APIs), drug products, and other regulated matrices.In headspace GC, the solvent serves as the diluent medium in which the sample is dissolved prior to equilibrium partitioning of volatile analytes into the gaseous headspace phase for subsequent chromatographic injection. Consequently, the chemical purity of the solvent is of critical analytical importance: any residual volatile impurities intrinsic to the solvent matrix may co-elute with target analytes, generating false-positive signals or suppressing accurate quantification. SupraSolv^® headspace solvents are therefore specifically developed and tested to contain extremely low concentrations of residual solvents, as mandated by regulatory guidelines.

SupraSolv^® headspace GC solvents are indispensable in pharmaceutical residual solvent testing, polymer and excipient quality control, food packaging safety assessment, and industrial material characterization — analytical contexts in which solvent purity is a direct regulatory and safety requirement, and where the integrity of trace-level volatile quantification is non-negotiable.

SupraSolv^® headspace solvents adhere to the residual solvent classification thresholds defined by the International Council for Harmonisation (ICH Q3C) and referenced in pharmacopoeial standards (Ph. Eur. and USP), with certified limits including:

• Class 1 solvents (known human carcinogens / environmental hazards): ≤ 1 µg/g
• Class 2 solvents (non-genotoxic, dose-dependent toxicants): ≤ 10 µg/g
• Class 3 solvents (low toxic potential): ≤ 50 µg/gThese specifications are verified lot-by-lot via GC/HS analysis, providing robust certification of compliance and analytical traceability.

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SUPRASOLV is a registered trademark of Merck KGaA, Darmstadt, Germany