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Impurity reference standards

Tiotropium impurity standards

Zemixal lists 16 reference materials related to Tiotropium, covering the drug substance itself, its process impurities and the products it forms on storage. Among them are 7 pharmacopoeial impurities.

16reference materials
7pharmacopoeial

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. Typical uses are method development and validation, relative response factor work, forced degradation studies and the impurity sections of ANDA, DMF or CEP filings.

By impurity type

Pharmacopoeial7EP, USP, BP or JP named impurities

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

All Tiotropium reference materials

1–16 of 16 standards
Questions

Tiotropium impurities, answered

How many Tiotropium impurity standards does Zemixal list?
The catalogue currently lists 16 compounds for Tiotropium, including 7 pharmacopoeial impurities. Each product page shows the CAS number where one is assigned, the structure, formula and molecular weight.
What documents come with a Tiotropium 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 Tiotropium 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.
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