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Impurity reference standards

Phenylephrine impurity standards

For Phenylephrine, the Zemixal catalogue holds 29 impurity and reference standards that support release testing, stability programmes and regulatory dossiers. Counted by type, there are 6 pharmacopoeial impurities, 1 nitrosamine, 1 isotope-labelled standard and 9 metabolites or hydroxylated analogues.

29reference materials
6pharmacopoeial
1nitrosamines
1isotope labelled
Phenylephrine structure
Parent API

Phenylephrine

CAS
61-76-7
Formula
C9H14ClNO2
MW
203.66 g/mol
Code
ZX-004180

Every standard comes with a certificate of analysis. Structure confirmation data, typically NMR, MS and chromatographic purity, is available on request. Typical uses are method development and validation, relative response factor work, forced degradation studies and the impurity sections of ANDA, DMF or CEP filings. For nitrosamine risk evaluation, the N-nitroso standards allow confirmatory LC-MS testing against the acceptable intake limits.

By impurity type

Pharmacopoeial6EP, USP, BP or JP named impurities
Nitrosamines1N-nitroso impurities for ICH M7 work
Isotope labelled1Deuterated, 13C or 15N internal standards
Metabolites9Hydroxy, desmethyl and conjugated forms

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

All Phenylephrine reference materials

1–29 of 29 standards
Questions

Phenylephrine impurities, answered

What Phenylephrine reference materials are available?
The catalogue currently lists 29 compounds for Phenylephrine, including 6 pharmacopoeial impurities, 1 nitrosamine, 1 isotope-labelled standard and 9 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 Phenylephrine 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 Phenylephrine 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 Phenylephrine nitrosamine impurities?
Yes. 1 N-nitroso compound is listed for Phenylephrine. 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 Phenylephrine 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

Phellandrene 1Phenacetin 3Phenelzine 1Phenethylamine 1Phenibut 2Phenindione 2Pheniramine 6Phenobarbital 5Phenothiazine 19Phenoxybenzamine 5Phenoxymethylpenicillin 1Phentermine 6All APIs
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