(1R,2R)-1,2-Bis(2-hydroxyphenyl)ethylenediamine
- CAS
- 870991-70-1
- Formula
- C14H16N2O2
- MW
- 244.29 g/mol
ZX-039512
Impurity reference standards
Orphenadrine impurity standards
For Orphenadrine, the Zemixal catalogue holds 21 impurity and reference standards that support release testing, stability programmes and regulatory dossiers. Counted by type, there are 7 pharmacopoeial impurities, 1 nitrosamine, 4 metabolites or hydroxylated analogues and 2 degradation products.
21reference materials
7pharmacopoeial
1nitrosamines
4metabolites
Batches are supplied with a certificate of analysis, and the supporting spectra can be sent ahead of a purchase order so your QA team can review them. Typical uses are method development and validation, relative response factor work, forced degradation studies and the impurity sections of ANDA, DMF or CEP filings. For nitrosamine risk evaluation, the N-nitroso standards allow confirmatory LC-MS testing against the acceptable intake limits.
By impurity type
Pharmacopoeial7EP, USP, BP or JP named impurities
Nitrosamines1N-nitroso impurities for ICH M7 work
Metabolites4Hydroxy, desmethyl and conjugated forms
Degradants2N-oxides, dimers, lactones and breakdown products
Counts are based on product names. One compound can fall into more than one type.
All Orphenadrine reference materials
1–21 of 21 standards
2-(Di-o-tolylmethoxy)-N,N-dimethylethanamine Hydrochloride
- CAS
- 18483-53-9
- Formula
- C19H26ClNO
- MW
- 319.9 g/mol
ZX-030977
Questions
Orphenadrine impurities, answered
What Orphenadrine reference materials are available?
The catalogue currently lists 21 compounds for Orphenadrine, including 7 pharmacopoeial impurities, 1 nitrosamine, 4 metabolites or hydroxylated analogues and 2 degradation products. Each product page shows the CAS number where one is assigned, the structure, formula and molecular weight.
What documents come with a Orphenadrine 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 Orphenadrine 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 Orphenadrine nitrosamine impurities?
Yes. 1 N-nitroso compound is listed for Orphenadrine. They are used for confirmatory testing and method validation in line with ICH M7 and the nitrosamine guidance from the major regulators.