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Impurities

Characterized impurities and reference standards.

A searchable catalogue of pharmaceutical impurities by parent API, plus peptide impurities, nitrosamines, metabolites and reference standards — each supplied with a full certificate of analysis.

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By Type

Pharmaceutical Impurities

9,600+ listings, searchable A–Z by parent API.

Peptide Impurities

Deletion, truncation, oxidation and racemization variants.

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Nitrosamine Impurities

NDSRIs and small nitrosamines for risk assessment.

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Metabolites & Glucuronides

Phase I and II metabolites for bioanalysis.

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Chiral Impurities

Enantiomers and diastereomers with chiral purity.

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Reference Standards

Working Standards

Traceable secondary standards for routine QC.

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Certified Reference Materials

CRMs with certified values and uncertainty.

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Stable-Isotope Standards

Deuterated and 13C-labeled internal standards.

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Intermediates & Fine Chemicals

Process intermediates and starting materials.

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Services

Custom Impurity Synthesis

Synthesis and isolation of hard-to-find impurities.

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Characterization Package

HPLC, 1H/13C NMR, LC-MS, IR, KF/TGA on every COA.

Characterization Package

What's on every COA

Each impurity and reference standard ships with a certificate of analysis. Additional tests such as 2D NMR or chiral purity are available on request.

Identity
1H NMR, 13C NMR, mass spectrometry, IR
Chromatographic purity
HPLC with chromatogram and integration report
Water content
Karl Fischer titration or TGA
Residual solvents
GC-headspace, where applicable
Sulphated ash
Where applicable
Assay
Titrimetry or mass balance, reported on an as-is basis

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