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Impurity reference standards

Lisinopril impurity standards

For Lisinopril, the Zemixal catalogue holds 22 impurity and reference standards that support release testing, stability programmes and regulatory dossiers. Counted by type, there are 10 pharmacopoeial impurities and 1 nitrosamine.

22reference materials
10pharmacopoeial
1nitrosamines
Lisinopril structure
Parent API

Lisinopril

CAS
76547-98-3
Formula
C21H31N3O5
MW
405.5 g/mol
Code
ZX-006619

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

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

All Lisinopril reference materials

1–22 of 22 standards
Questions

Lisinopril impurities, answered

What Lisinopril reference materials are available?
The catalogue currently lists 22 compounds for Lisinopril, including 10 pharmacopoeial impurities and 1 nitrosamine. Each product page shows the CAS number where one is assigned, the structure, formula and molecular weight.
What documents come with a Lisinopril 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 Lisinopril 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 Lisinopril nitrosamine impurities?
Yes. 1 N-nitroso compound is listed for Lisinopril. They are used for confirmatory testing and method validation in line with ICH M7 and the nitrosamine guidance from the major regulators.

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