Impurity reference standards
Melphalan impurity standards
Zemixal lists 14 reference materials related to Melphalan, covering the drug substance itself, its process impurities and the products it forms on storage. Among them are 5 pharmacopoeial impurities and 1 isotope-labelled standard.
14reference materials
5pharmacopoeial
1isotope labelled
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
Pharmacopoeial5EP, 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 Melphalan reference materials
1–14 of 14 standards
Questions
Melphalan impurities, answered
How many Melphalan impurity standards does Zemixal list?
The catalogue currently lists 14 compounds for Melphalan, including 5 pharmacopoeial impurities 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 Melphalan 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 Melphalan 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 Melphalan standards available?
Yes. 1 stable-isotope labelled compound is listed, suitable as internal standards for LC-MS bioanalysis and trace impurity quantitation.