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Reference Standards: Residual Solvents

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Pharmaceutical Impurities Standard (2 components)

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  • Features two common alkyl halideschloromethane and chloroethanethat can form during drug synthesis.
  • High-concentration (5,000 μg/mL) solution maximizes flexibility; ideal for analyzing pharmaceutical genotoxic impurities (GTIs).
  • Quantitatively tested to confirm composition and stability; detailed support documentation provided.

Residual Solvents Class 2 - Mix A (2013 Rev) (16 components)

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  • Detect and quantify USP <467> Class 2 residual solvents in pharmaceuticals.
  • Reformulated to include cumene, added to USP <467> Class 2 list in August 2013.
  • Quantitatively tested to confirm composition and stability; detailed support documentation provided.
  • Restek is your complete supplier for world-class USP <467> residual solvent analysis: reference standards, Rxi-624Sil MS (G43) and Stabilwax (G16) GC columns, inlet liners, accessories, applications, and more.

Residual Solvents Class 2 - Mix A (15 components)

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Note: The USP <467> Class 2 residual solvents list was updated to add cumene in August 2013.

Residual Solvents Class 2 - Mix B (8 components)

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**Actual concentration of n-hexane reported (determined via a calibration curve) may be below General Chapter <467> limits and could produce a false positive result.

Residual Solvents Class 2 - Mix B (8 components)

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**Actual concentration of n-hexane reported (determined via a calibration curve) may be below General Chapter <467> limits and could produce a false positive result.

Residual Solvents Class 3 - Mix A (24 Components)

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  • Multicomponent mixes simplify standard prep and reduce variability.
  • Ideal for USP <467> residual solvents analysis.
  • Verified composition and stability.

Residual Solvents Class 3 - Mix B (2 components)

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  • Multicomponent mixes simplify standard prep and reduce variability.
  • Ideal for USP <467> residual solvents analysis.
  • Verified composition and stability.

USP <467> Singles

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**Actual concentration of n-hexane reported (determined via a calibration curve) may be below General Chapter <467> limits and could produce a false positive result.

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