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Impurity reference standards

Loperamide impurity standards

Zemixal lists 16 reference materials related to Loperamide, covering the drug substance itself, its process impurities and the products it forms on storage. Among them are 6 pharmacopoeial impurities, 1 metabolite or hydroxylated analogue and 1 degradation product.

16reference materials
6pharmacopoeial
1metabolites
1degradants
Loperamide structure
Parent API

Loperamide

CAS
34552-83-5
Formula
C29H34Cl2N2O2
MW
513.5 g/mol
Code
ZX-004196

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
Metabolites1Hydroxy, desmethyl and conjugated forms
Degradants1N-oxides, dimers, lactones and breakdown products

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

All Loperamide reference materials

1–16 of 16 standards
Questions

Loperamide impurities, answered

How many Loperamide impurity standards does Zemixal list?
The catalogue currently lists 16 compounds for Loperamide, including 6 pharmacopoeial impurities, 1 metabolite or hydroxylated analogue and 1 degradation product. Each product page shows the CAS number where one is assigned, the structure, formula and molecular weight.
What documents come with a Loperamide 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 Loperamide 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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