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Impurity reference standards

Cinacalcet impurity standards

This page brings together 69 Cinacalcet related compounds that analytical teams use to identify, quantify and control impurities in the active ingredient and the finished dosage form. The range includes 3 pharmacopoeial impurities, 1 nitrosamine, 1 isotope-labelled standard and 1 degradation product.

69reference materials
3pharmacopoeial
1nitrosamines
1isotope labelled
Cinacalcet structure
Parent API

Cinacalcet

CAS
226256-56-0
Formula
C22H22F3N
MW
357.4 g/mol
Code
ZX-006467

Every standard comes with a certificate of analysis. Structure confirmation data, typically NMR, MS and chromatographic purity, is available on request. 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

Pharmacopoeial3EP, USP, BP or JP named impurities
Nitrosamines1N-nitroso impurities for ICH M7 work
Isotope labelled1Deuterated, 13C or 15N internal standards
Degradants1N-oxides, dimers, lactones and breakdown products

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

All Cinacalcet reference materials

1–60 of 69 standards
Questions

Cinacalcet impurities, answered

What Cinacalcet reference materials are available?
The catalogue currently lists 69 compounds for Cinacalcet, including 3 pharmacopoeial impurities, 1 nitrosamine, 1 isotope-labelled standard 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 Cinacalcet 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 Cinacalcet 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 Cinacalcet nitrosamine impurities?
Yes. 1 N-nitroso compound is listed for Cinacalcet. 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 Cinacalcet standards available?
Yes. 1 stable-isotope labelled compound is listed, suitable as internal standards for LC-MS bioanalysis and trace impurity quantitation.

Nearby APIs in the index

Cinchocaine 9Cinchonidine 1Cineole 1Cinitapride 3Cinnamic Acid 11Cinnarizine 10All APIs
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