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Impurity reference standards

Diltiazem impurity standards

This page brings together 27 Diltiazem related compounds that analytical teams use to identify, quantify and control impurities in the active ingredient and the finished dosage form. The range includes 11 pharmacopoeial impurities, 1 nitrosamine, 1 isotope-labelled standard, 7 metabolites or hydroxylated analogues and 2 degradation products.

27reference materials
11pharmacopoeial
1nitrosamines
1isotope labelled
Diltiazem structure
Parent API

Diltiazem

CAS
42399-41-7
Formula
C22H26N2O4S
MW
414.5 g/mol
Code
ZX-006503

Batches are supplied with a certificate of analysis, and the supporting spectra can be sent ahead of a purchase order so your QA team can review them. 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

Pharmacopoeial11EP, USP, BP or JP named impurities
Nitrosamines1N-nitroso impurities for ICH M7 work
Isotope labelled1Deuterated, 13C or 15N internal standards
Metabolites7Hydroxy, 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 Diltiazem reference materials

1–27 of 27 standards
Questions

Diltiazem impurities, answered

What Diltiazem reference materials are available?
The catalogue currently lists 27 compounds for Diltiazem, including 11 pharmacopoeial impurities, 1 nitrosamine, 1 isotope-labelled standard, 7 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 Diltiazem 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 Diltiazem 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 Diltiazem nitrosamine impurities?
Yes. 1 N-nitroso compound is listed for Diltiazem. 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 Diltiazem 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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