Impurity reference standards

Cilazapril impurity standards

This page brings together 7 Cilazapril related compounds that analytical teams use to identify, quantify and control impurities in the active ingredient and the finished dosage form. The range includes 4 pharmacopoeial impurities and 1 nitrosamine.

7reference materials

4pharmacopoeial

1nitrosamines

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

Pharmacopoeial4EP, 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 Cilazapril reference materials

1–7 of 7 standards

Cilazapril

CAS: 88768-40-5
Formula: C₂₂H₃₁N₃O₅
MW: 417.5 g/mol

ZX-028605

Cilazapril EP Impurity A

CAS: 106860-19-9
Formula: C₂₆H₃₉N₃O₅
MW: 473.6 g/mol

ZX-021207

Cilazapril EP Impurity B

CAS: 90139-06-3
Formula: C₂₀H₂₇N₃O₅
MW: 389.4 g/mol

ZX-021209

Cilazapril EP Impurity C

CAS: 1905397-51-4
Formula: C₂₄H₃₅N₃O₅
MW: 445.6 g/mol

ZX-023940

Cilazapril EP impurity D

CAS: 106928-09-0
Formula: C₂₂H₃₁N₃O₅
MW: 417.5 g/mol

ZX-021208

Cilazapril monohydrate

CAS: 92077-78-6
Formula: C₂₂H₃₃N₃O₆
MW: 435.5 g/mol

ZX-038953

N-Nitroso Cilazapril

CAS: 1053740-92-3
Formula: C₂₂H₃₀N₄O₆
MW: 446.5 g/mol

ZX-028606

Questions

Cilazapril impurities, answered

What Cilazapril reference materials are available?

The catalogue currently lists 7 compounds for Cilazapril, including 4 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 Cilazapril 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 Cilazapril 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 Cilazapril nitrosamine impurities?

Yes. 1 N-nitroso compound is listed for Cilazapril. 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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