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Impurity reference standards

Hydrochlorothiazide impurity standards

This page brings together 22 Hydrochlorothiazide related compounds that analytical teams use to identify, quantify and control impurities in the active ingredient and the finished dosage form. The range includes 3 pharmacopoeial impurities, 1 nitrosamine and 2 isotope-labelled standards.

22reference materials
3pharmacopoeial
1nitrosamines
2isotope labelled
Hydrochlorothiazide structure
Parent API

Hydrochlorothiazide

CAS
58-93-5
Formula
C7H8ClN3O4S2
MW
297.7 g/mol
Code
ZX-004093

Every standard comes with a certificate of analysis. Structure confirmation data, typically NMR, MS and chromatographic purity, is available on request. They are bought for system suitability, peak identification, quantitation against limits and the impurity justification sections of regulatory submissions. 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 labelled2Deuterated, 13C or 15N internal standards

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

All Hydrochlorothiazide reference materials

1–22 of 22 standards
Questions

Hydrochlorothiazide impurities, answered

What Hydrochlorothiazide reference materials are available?
The catalogue currently lists 22 compounds for Hydrochlorothiazide, including 3 pharmacopoeial impurities, 1 nitrosamine and 2 isotope-labelled standards. Each product page shows the CAS number where one is assigned, the structure, formula and molecular weight.
What documents come with a Hydrochlorothiazide 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 Hydrochlorothiazide 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 Hydrochlorothiazide nitrosamine impurities?
Yes. 1 N-nitroso compound is listed for Hydrochlorothiazide. 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 Hydrochlorothiazide standards available?
Yes. 2 stable-isotope labelled compounds are listed, suitable as internal standards for LC-MS bioanalysis and trace impurity quantitation.

Nearby APIs in the index

Hydantoin 4Hydralazine 19Hydrocodone 3Hydrocortisone 63Hydromorphone 1Hydroquinone 4Hydroxocobalamin 2Hydroxychloroquine 34Hydroxyproline 1Hydroxyzine 8All APIs
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