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Impurity reference standards

Bilastine impurity standards

For Bilastine, the Zemixal catalogue holds 37 impurity and reference standards that support release testing, stability programmes and regulatory dossiers. Counted by type, there are 1 nitrosamine, 2 metabolites or hydroxylated analogues and 3 degradation products.

37reference materials
1nitrosamines
2metabolites
3degradants
Bilastine structure
Parent API

Bilastine

CAS
202189-78-4
Formula
C28H37N3O3
MW
463.6 g/mol
Code
ZX-006423

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. 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

Nitrosamines1N-nitroso impurities for ICH M7 work
Metabolites2Hydroxy, desmethyl and conjugated forms
Degradants3N-oxides, dimers, lactones and breakdown products

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

All Bilastine reference materials

1–37 of 37 standards
Questions

Bilastine impurities, answered

What Bilastine reference materials are available?
The catalogue currently lists 37 compounds for Bilastine, including 1 nitrosamine, 2 metabolites or hydroxylated analogues and 3 degradation products. Each product page shows the CAS number where one is assigned, the structure, formula and molecular weight.
What documents come with a Bilastine 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 Bilastine 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 Bilastine nitrosamine impurities?
Yes. 1 N-nitroso compound is listed for Bilastine. 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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