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Impurity reference standards

Irinotecan impurity standards

18 characterised compounds linked to Irinotecan are catalogued here, from named pharmacopoeial impurities to synthesis intermediates and breakdown products. Highlights of the range are 9 pharmacopoeial impurities, 1 nitrosamine, 1 metabolite or hydroxylated analogue and 1 degradation product.

18reference materials
9pharmacopoeial
1nitrosamines
1metabolites

Each lot ships with a certificate of analysis, and characterisation data such as 1H-NMR, mass spectrum and HPLC purity can be shared before you order. Laboratories use them to validate related-substance methods, set specification limits under ICH Q3A and Q3B, and identify unknown peaks in stability samples. The nitrosamine entries support ICH M7 risk assessments and confirmatory testing at trace levels.

By impurity type

Pharmacopoeial9EP, USP, BP or JP named impurities
Nitrosamines1N-nitroso impurities for ICH M7 work
Metabolites1Hydroxy, 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 Irinotecan reference materials

1–18 of 18 standards
Questions

Irinotecan impurities, answered

How many Irinotecan impurity standards does Zemixal list?
The catalogue currently lists 18 compounds for Irinotecan, including 9 pharmacopoeial impurities, 1 nitrosamine, 1 metabolite or hydroxylated analogue 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 Irinotecan 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 Irinotecan 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 Irinotecan nitrosamine impurities?
Yes. 1 N-nitroso compound is listed for Irinotecan. 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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