Impurity reference standards
Bupivacaine impurity standards
This page brings together 19 Bupivacaine related compounds that analytical teams use to identify, quantify and control impurities in the active ingredient and the finished dosage form. The range includes 6 pharmacopoeial impurities, 2 isotope-labelled standards, 1 metabolite or hydroxylated analogue and 2 degradation products.
19reference materials
6pharmacopoeial
2isotope labelled
1metabolites
Each lot ships with a certificate of analysis, and characterisation data such as 1H-NMR, mass spectrum and HPLC purity can be shared before you order. Laboratories use them to validate related-substance methods, set specification limits under ICH Q3A and Q3B, and identify unknown peaks in stability samples.
By impurity type
Pharmacopoeial6EP, USP, BP or JP named impurities
Isotope labelled2Deuterated, 13C or 15N internal standards
Metabolites1Hydroxy, desmethyl and conjugated forms
Degradants2N-oxides, dimers, lactones and breakdown products
Counts are based on product names. One compound can fall into more than one type.
All Bupivacaine reference materials
1–19 of 19 standards
1-Butyl-N-(2,4-dimethylphenyl)piperidine-2-carboxamide
- CAS
- 2774312-11-5
- Formula
- C18H28N2O
- MW
- 288.4 g/mol
ZX-023672
Questions
Bupivacaine impurities, answered
What Bupivacaine reference materials are available?
The catalogue currently lists 19 compounds for Bupivacaine, including 6 pharmacopoeial impurities, 2 isotope-labelled standards, 1 metabolite or hydroxylated analogue and 2 degradation products. Each product page shows the CAS number where one is assigned, the structure, formula and molecular weight.
What documents come with a Bupivacaine 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 Bupivacaine 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.
Are isotope-labelled Bupivacaine standards available?
Yes. 2 stable-isotope labelled compounds are listed, suitable as internal standards for LC-MS bioanalysis and trace impurity quantitation.