Impurity reference standards
Theophylline impurity standards
For Theophylline, the Zemixal catalogue holds 15 impurity and reference standards that support release testing, stability programmes and regulatory dossiers. Counted by type, there are 1 pharmacopoeial impurity and 1 isotope-labelled standard.
15reference materials
1pharmacopoeial
1isotope labelled
Every standard comes with a certificate of analysis. Structure confirmation data, typically NMR, MS and chromatographic purity, is available on request. They are bought for system suitability, peak identification, quantitation against limits and the impurity justification sections of regulatory submissions.
By impurity type
Pharmacopoeial1EP, USP, BP or JP named impurities
Isotope labelled1Deuterated, 13C or 15N internal standards
Counts are based on product names. One compound can fall into more than one type.
All Theophylline reference materials
1–15 of 15 standards
Questions
Theophylline impurities, answered
What Theophylline reference materials are available?
The catalogue currently lists 15 compounds for Theophylline, including 1 pharmacopoeial impurity and 1 isotope-labelled standard. Each product page shows the CAS number where one is assigned, the structure, formula and molecular weight.
What documents come with a Theophylline 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 Theophylline 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.
Are isotope-labelled Theophylline standards available?
Yes. 1 stable-isotope labelled compound is listed, suitable as internal standards for LC-MS bioanalysis and trace impurity quantitation.