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Impurity reference standards

Umeclidinium Bromide impurity standards

8 characterised compounds linked to Umeclidinium Bromide are catalogued here, from named pharmacopoeial impurities to synthesis intermediates and breakdown products. Highlights of the range are 1 nitrosamine and 4 metabolites or hydroxylated analogues.

8reference materials
1nitrosamines
4metabolites

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

Nitrosamines1N-nitroso impurities for ICH M7 work
Metabolites4Hydroxy, desmethyl and conjugated forms

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

All Umeclidinium Bromide reference materials

Questions

Umeclidinium Bromide impurities, answered

How many Umeclidinium Bromide impurity standards does Zemixal list?
The catalogue currently lists 8 compounds for Umeclidinium Bromide, including 1 nitrosamine and 4 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 Umeclidinium Bromide 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 Umeclidinium Bromide 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 Umeclidinium Bromide nitrosamine impurities?
Yes. 1 N-nitroso compound is listed for Umeclidinium Bromide. They are used for confirmatory testing and method validation in line with ICH M7 and the nitrosamine guidance from the major regulators.
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