Impurity reference standards
Mitotane impurities & reference standards
Characterised Mitotane impurities, degradation products and related compounds for analytical method development, validation, QC release and regulatory filings.
2reference materials
COAHPLC · NMR · MS on request
FAQs — Mitotane impurities
Which Mitotane impurities do you supply?
We list 2 Mitotane-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 Mitotane 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 Mitotane 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 Mitotane impurity standards
We reply within one business day with price, pack options, lead time and documentation.