Impurity reference standards
Pharacine impurities & reference standards
Characterised Pharacine impurities, degradation products and related compounds for analytical method development, validation, QC release and regulatory filings.
5reference materials
COAHPLC · NMR · MS on request
FAQs — Pharacine impurities
Which Pharacine impurities do you supply?
We list 5 Pharacine-related reference materials, including process impurities, degradation products and related compounds. Each is supplied with a COA, and characterisation data (HPLC, 1H-NMR, MS, IR) can be provided on request.
What are Pharacine 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 Pharacine 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 Pharacine impurity standards
We reply within one business day with price, pack options, lead time and documentation.