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Impurity reference standards

Amlodipine impurity standards

Zemixal lists 64 reference materials related to Amlodipine, covering the drug substance itself, its process impurities and the products it forms on storage. Among them are 12 pharmacopoeial impurities, 1 nitrosamine, 1 isotope-labelled standard, 6 metabolites or hydroxylated analogues and 2 degradation products.

64reference materials
12pharmacopoeial
1nitrosamines
1isotope labelled
Amlodipine structure
Parent API

Amlodipine

CAS
88150-42-9
Formula
C20H25ClN2O5
MW
408.9 g/mol
Code
ZX-004078

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. Typical uses are method development and validation, relative response factor work, forced degradation studies and the impurity sections of ANDA, DMF or CEP filings. The nitrosamine entries support ICH M7 risk assessments and confirmatory testing at trace levels.

By impurity type

Pharmacopoeial12EP, USP, BP or JP named impurities
Nitrosamines1N-nitroso impurities for ICH M7 work
Isotope labelled1Deuterated, 13C or 15N internal standards
Metabolites6Hydroxy, 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 Amlodipine reference materials

1–60 of 64 standards
Questions

Amlodipine impurities, answered

How many Amlodipine impurity standards does Zemixal list?
The catalogue currently lists 64 compounds for Amlodipine, including 12 pharmacopoeial impurities, 1 nitrosamine, 1 isotope-labelled standard, 6 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 Amlodipine 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 Amlodipine 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 Amlodipine nitrosamine impurities?
Yes. 1 N-nitroso compound is listed for Amlodipine. They are used for confirmatory testing and method validation in line with ICH M7 and the nitrosamine guidance from the major regulators.
Are isotope-labelled Amlodipine standards available?
Yes. 1 stable-isotope labelled compound is listed, suitable as internal standards for LC-MS bioanalysis and trace impurity quantitation.
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