Impurity reference standards
Buprenorphine impurities & reference standards
Characterised Buprenorphine impurities, degradation products and related compounds for analytical method development, validation, QC release and regulatory filings.
12reference materials
COAHPLC · NMR · MS on request
Parent API: Buprenorphine
52485-79-7 · C29H41NO4
Buprenorphine Related Compound A CII(Secondary Standards traceble to USP)
- CAS
- 457071-73-7
- Formula
- C29H41NO4
- MW
- 467.6 g/mol
VQ-035514
FAQs — Buprenorphine impurities
Which Buprenorphine impurities do you supply?
We list 12 Buprenorphine-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 Buprenorphine 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 Buprenorphine 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 Buprenorphine impurity standards
We reply within one business day with price, pack options, lead time and documentation.