Impurity reference standards
Gliclazide impurity standards
Zemixal lists 13 reference materials related to Gliclazide, covering the drug substance itself, its process impurities and the products it forms on storage. Among them are 4 pharmacopoeial impurities.
13reference materials
4pharmacopoeial
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
Pharmacopoeial4EP, USP, BP or JP named impurities
Counts are based on product names. One compound can fall into more than one type.
All Gliclazide reference materials
1–13 of 13 standards
2-AMinotetrahydro-Cyclopenta[c] pyrrole-1,3(2H,3aH)-dione
- CAS
- 1050666-51-7
- Formula
- C7H10N2O2
- MW
- 154.17 g/mol
ZX-039549
Questions
Gliclazide impurities, answered
How many Gliclazide impurity standards does Zemixal list?
The catalogue currently lists 13 compounds for Gliclazide, including 4 pharmacopoeial impurities. Each product page shows the CAS number where one is assigned, the structure, formula and molecular weight.
What documents come with a Gliclazide 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 Gliclazide 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.