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Impurity reference standards

Salbutamol impurity standards

Zemixal lists 30 reference materials related to Salbutamol, covering the drug substance itself, its process impurities and the products it forms on storage. Among them are 17 pharmacopoeial impurities, 1 nitrosamine, 1 isotope-labelled standard, 2 metabolites or hydroxylated analogues and 1 degradation product.

30reference materials
17pharmacopoeial
1nitrosamines
1isotope labelled
Salbutamol structure
Parent API

Salbutamol

CAS
18559-94-9
Formula
C13H21NO3
MW
239.31 g/mol
Code
ZX-006802

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. The nitrosamine entries support ICH M7 risk assessments and confirmatory testing at trace levels.

By impurity type

Pharmacopoeial17EP, USP, BP or JP named impurities
Nitrosamines1N-nitroso impurities for ICH M7 work
Isotope labelled1Deuterated, 13C or 15N internal standards
Metabolites2Hydroxy, 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 Salbutamol reference materials

1–30 of 30 standards
Questions

Salbutamol impurities, answered

How many Salbutamol impurity standards does Zemixal list?
The catalogue currently lists 30 compounds for Salbutamol, including 17 pharmacopoeial impurities, 1 nitrosamine, 1 isotope-labelled standard, 2 metabolites or hydroxylated analogues 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 Salbutamol 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 Salbutamol 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 Salbutamol nitrosamine impurities?
Yes. 1 N-nitroso compound is listed for Salbutamol. 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 Salbutamol 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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