Impurity reference standards
Cetirizine impurity standards
Zemixal lists 44 reference materials related to Cetirizine, covering the drug substance itself, its process impurities and the products it forms on storage. Among them are 8 pharmacopoeial impurities, 1 nitrosamine and 2 degradation products.
44reference materials
8pharmacopoeial
1nitrosamines
2degradants
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. The nitrosamine entries support ICH M7 risk assessments and confirmatory testing at trace levels.
By impurity type
Pharmacopoeial8EP, USP, BP or JP named impurities
Nitrosamines1N-nitroso impurities for ICH M7 work
Degradants2N-oxides, dimers, lactones and breakdown products
Counts are based on product names. One compound can fall into more than one type.
All Cetirizine reference materials
1–44 of 44 standards
(R)-De(carboxymethoxy) Cetirizine Acetic Acid
- CAS
- 942193-17-1
- Formula
- C19H21ClN2O2
- MW
- 344.8 g/mol
ZX-028547
(R)-De(carboxymethoxy) Cetirizine Acetic Acid Hydrochloride
- CAS
- 942132-30-1
- Formula
- C19H22Cl2N2O2
- MW
- 381.3 g/mol
ZX-025363
(S)-(+)-1-[(4-Chlorophenyl)phenylmethyl]piperazine
- CAS
- 439858-21-6
- Formula
- C17H19ClN2
- MW
- 286.8 g/mol
ZX-028549
4-Benzhydryl-1-piperazineethanol Dihydrochloride
- CAS
- 108983-83-1
- Formula
- C19H26Cl2N2O
- MW
- 369.3 g/mol
ZX-023891
Cetirizine 3-Chloro Impurity Dihydrochloride
- CAS
- 1232460-29-5
- Formula
- C21H25ClN2O3
- MW
- 388.9 g/mol
ZX-004511
Questions
Cetirizine impurities, answered
How many Cetirizine impurity standards does Zemixal list?
The catalogue currently lists 44 compounds for Cetirizine, including 8 pharmacopoeial impurities, 1 nitrosamine 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 Cetirizine 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 Cetirizine 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 Cetirizine nitrosamine impurities?
Yes. 1 N-nitroso compound is listed for Cetirizine. They are used for confirmatory testing and method validation in line with ICH M7 and the nitrosamine guidance from the major regulators.