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Impurity reference standards

Propranolol impurity standards

34 characterised compounds linked to Propranolol are catalogued here, from named pharmacopoeial impurities to synthesis intermediates and breakdown products. Highlights of the range are 1 pharmacopoeial impurity, 1 nitrosamine, 3 isotope-labelled standards and 5 metabolites or hydroxylated analogues.

34reference materials
1pharmacopoeial
1nitrosamines
3isotope labelled
Propranolol structure
Parent API

Propranolol

CAS
318-98-9
Formula
C16H22ClNO2
MW
295.8 g/mol
Code
ZX-004104

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. 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

Pharmacopoeial1EP, USP, BP or JP named impurities
Nitrosamines1N-nitroso impurities for ICH M7 work
Isotope labelled3Deuterated, 13C or 15N internal standards
Metabolites5Hydroxy, desmethyl and conjugated forms

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

All Propranolol reference materials

1–34 of 34 standards
Questions

Propranolol impurities, answered

How many Propranolol impurity standards does Zemixal list?
The catalogue currently lists 34 compounds for Propranolol, including 1 pharmacopoeial impurity, 1 nitrosamine, 3 isotope-labelled standards and 5 metabolites or hydroxylated analogues. Each product page shows the CAS number where one is assigned, the structure, formula and molecular weight.
What documents come with a Propranolol 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 Propranolol 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 Propranolol nitrosamine impurities?
Yes. 1 N-nitroso compound is listed for Propranolol. 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 Propranolol standards available?
Yes. 3 stable-isotope labelled compounds are listed, suitable as internal standards for LC-MS bioanalysis and trace impurity quantitation.

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