Impurity reference standards
Tofacitinib impurities & reference standards
Characterised Tofacitinib impurities, degradation products and related compounds for analytical method development, validation, QC release and regulatory filings.
71reference materials
1nitrosamine impurities
COAHPLC · NMR · MS on request
Parent API: Tofacitinib
477600-75-2 · C16H20N6O
Tofacitinib Related Compound 2 Hydrochloride
- CAS
- 1640971-87-4
- Formula
- C10H18ClN3O
- MW
- 231.72 g/mol
VQ-042579
FAQs — Tofacitinib impurities
Which Tofacitinib impurities do you supply?
We list 71 Tofacitinib-related reference materials, including process impurities, degradation products, nitrosamine impurities and related compounds. Each is supplied with a COA, and characterisation data (HPLC, 1H-NMR, MS, IR) can be provided on request.
What are Tofacitinib 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 Tofacitinib 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 Tofacitinib impurity standards
We reply within one business day with price, pack options, lead time and documentation.