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Impurity reference standards

Abacavir impurity standards

For Abacavir, the Zemixal catalogue holds 38 impurity and reference standards that support release testing, stability programmes and regulatory dossiers. Counted by type, there are 10 pharmacopoeial impurities, 1 nitrosamine, 1 isotope-labelled standard, 2 metabolites or hydroxylated analogues and 2 degradation products.

38reference materials
10pharmacopoeial
1nitrosamines
1isotope labelled
Abacavir structure
Parent API

Abacavir

CAS
136470-78-5
Formula
C14H18N6O
MW
286.33 g/mol
Code
ZX-006366

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. For nitrosamine risk evaluation, the N-nitroso standards allow confirmatory LC-MS testing against the acceptable intake limits.

By impurity type

Pharmacopoeial10EP, USP, BP or JP named impurities
Nitrosamines1N-nitroso impurities for ICH M7 work
Isotope labelled1Deuterated, 13C or 15N internal standards
Metabolites2Hydroxy, 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 Abacavir reference materials

1–38 of 38 standards
Questions

Abacavir impurities, answered

What Abacavir reference materials are available?
The catalogue currently lists 38 compounds for Abacavir, including 10 pharmacopoeial impurities, 1 nitrosamine, 1 isotope-labelled standard, 2 metabolites or hydroxylated analogues 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 Abacavir 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 Abacavir 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.
Do you supply Abacavir nitrosamine impurities?
Yes. 1 N-nitroso compound is listed for Abacavir. They are used for confirmatory testing and method validation in line with ICH M7 and the nitrosamine guidance from the major regulators.
Are isotope-labelled Abacavir standards available?
Yes. 1 stable-isotope labelled compound is listed, suitable as internal standards for LC-MS bioanalysis and trace impurity quantitation.

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