Impurity reference standards
Amine impurities & reference standards
Characterised Amine impurities, degradation products and related compounds for analytical method development, validation, QC release and regulatory filings.
6reference materials
6isotope-labelled
COAHPLC · NMR · MS on request
FAQs — Amine impurities
Which Amine impurities do you supply?
We list 6 Amine-related reference materials, including process impurities, degradation products, stable-isotope-labelled standards and related compounds. Each is supplied with a COA, and characterisation data (HPLC, 1H-NMR, MS, IR) can be provided on request.
What are Amine impurity standards used for?
They are used for analytical method development and validation, impurity identification and quantification, forced-degradation and stability studies, and to support ANDA, DMF and other regulatory submissions under ICH Q3A/Q3B (and ICH M7 for mutagenic impurities).
Can you synthesise a Amine impurity that is not listed?
Yes. Our custom synthesis service can prepare and characterise unlisted impurities, metabolites and labelled analogues from milligram to gram scale. Share the structure or name and required quantity for a quotation.
Request Amine impurity standards
We reply within one business day with price, pack options, lead time and documentation.