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Impurity reference standards

Loratadine impurity standards

This page brings together 29 Loratadine related compounds that analytical teams use to identify, quantify and control impurities in the active ingredient and the finished dosage form. The range includes 6 pharmacopoeial impurities, 4 metabolites or hydroxylated analogues and 2 degradation products.

29reference materials
6pharmacopoeial
4metabolites
2degradants
Loratadine structure
Parent API

Loratadine

CAS
79794-75-5
Formula
C22H23ClN2O2
MW
382.9 g/mol
Code
ZX-004176

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.

By impurity type

Pharmacopoeial6EP, USP, BP or JP named impurities
Metabolites4Hydroxy, 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 Loratadine reference materials

1–29 of 29 standards
Questions

Loratadine impurities, answered

What Loratadine reference materials are available?
The catalogue currently lists 29 compounds for Loratadine, including 6 pharmacopoeial impurities, 4 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 Loratadine 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 Loratadine 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.
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