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Impurity reference standards

Sulfamethoxazole impurity standards

For Sulfamethoxazole, 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, 1 nitrosamine, 1 isotope-labelled standard and 1 metabolite or hydroxylated analogue.

9reference materials
3pharmacopoeial
1nitrosamines
1isotope labelled

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

Pharmacopoeial3EP, USP, BP or JP named impurities
Nitrosamines1N-nitroso impurities for ICH M7 work
Isotope labelled1Deuterated, 13C or 15N internal standards
Metabolites1Hydroxy, desmethyl and conjugated forms

Counts are based on product names. One compound can fall into more than one type.

All Sulfamethoxazole reference materials

Questions

Sulfamethoxazole impurities, answered

What Sulfamethoxazole reference materials are available?
The catalogue currently lists 9 compounds for Sulfamethoxazole, including 3 pharmacopoeial impurities, 1 nitrosamine, 1 isotope-labelled standard 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 Sulfamethoxazole 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 Sulfamethoxazole 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 Sulfamethoxazole nitrosamine impurities?
Yes. 1 N-nitroso compound is listed for Sulfamethoxazole. 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 Sulfamethoxazole 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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