Impurity reference standards
Buprenorphine impurity standards
For Buprenorphine, the Zemixal catalogue holds 9 impurity and reference standards that support release testing, stability programmes and regulatory dossiers. Counted by type, there are 3 pharmacopoeial impurities and 1 metabolite or hydroxylated analogue.
9reference materials
3pharmacopoeial
1metabolites
Every standard comes with a certificate of analysis. Structure confirmation data, typically NMR, MS and chromatographic purity, is available on request. Typical uses are method development and validation, relative response factor work, forced degradation studies and the impurity sections of ANDA, DMF or CEP filings.
By impurity type
Pharmacopoeial3EP, USP, BP or JP named impurities
Metabolites1Hydroxy, desmethyl and conjugated forms
Counts are based on product names. One compound can fall into more than one type.
All Buprenorphine reference materials
1–9 of 9 standards
Buprenorphine Related Compound A CII(Secondary Standards traceble to USP)
- CAS
- 457071-73-7
- Formula
- C29H41NO4
- MW
- 467.6 g/mol
ZX-032960
Questions
Buprenorphine impurities, answered
What Buprenorphine reference materials are available?
The catalogue currently lists 9 compounds for Buprenorphine, including 3 pharmacopoeial impurities and 1 metabolite or hydroxylated analogue. Each product page shows the CAS number where one is assigned, the structure, formula and molecular weight.
What documents come with a Buprenorphine impurity standard?
A certificate of analysis travels with every lot. On request we share the characterisation set, usually 1H-NMR, mass spectrum, HPLC purity and IR, and for some materials TGA or water content. Ask for the data before ordering if your QA team needs to review it.
Can Zemixal make a Buprenorphine impurity that is not listed?
Often yes. Send the structure, name or CAS number with the quantity you need and our sourcing team checks custom synthesis options, usually from 10 mg up to gram scale, with a quoted lead time.