(2,4-Difluorophenyl)(4-Piperidinyl)Methanone Oxime
- CAS
- 84163-46-2
- Formula
- C12H15ClF2N2O
- MW
- 276.71 g/mol
ZX-011795
Impurity reference standards
Risperidone impurity standards
Zemixal lists 40 reference materials related to Risperidone, covering the drug substance itself, its process impurities and the products it forms on storage. Among them are 14 pharmacopoeial impurities, 1 nitrosamine, 2 isotope-labelled standards, 3 metabolites or hydroxylated analogues and 6 degradation products.
40reference materials
14pharmacopoeial
1nitrosamines
2isotope 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. The nitrosamine entries support ICH M7 risk assessments and confirmatory testing at trace levels.
By impurity type
Pharmacopoeial14EP, USP, BP or JP named impurities
Nitrosamines1N-nitroso impurities for ICH M7 work
Isotope labelled2Deuterated, 13C or 15N internal standards
Metabolites3Hydroxy, desmethyl and conjugated forms
Degradants6N-oxides, dimers, lactones and breakdown products
Counts are based on product names. One compound can fall into more than one type.
All Risperidone reference materials
1–40 of 40 standards
2,4-Difluorophenyl-(4-piperidinyl)methanone oxime Hydrochloride
- CAS
- 135634-18-3
- Formula
- C12H15ClF2N2O
- MW
- 276.71 g/mol
ZX-011945
3-(4-Piperidinyl)-1,2-benzisoxazole hydrochloride
- CAS
- 84163-22-4
- Formula
- C12H15ClN2O
- MW
- 238.71 g/mol
ZX-012061
Questions
Risperidone impurities, answered
How many Risperidone impurity standards does Zemixal list?
The catalogue currently lists 40 compounds for Risperidone, including 14 pharmacopoeial impurities, 1 nitrosamine, 2 isotope-labelled standards, 3 metabolites or hydroxylated analogues and 6 degradation products. Each product page shows the CAS number where one is assigned, the structure, formula and molecular weight.
What documents come with a Risperidone 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 Risperidone 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 Risperidone nitrosamine impurities?
Yes. 1 N-nitroso compound is listed for Risperidone. They are used for confirmatory testing and method validation in line with ICH M7 and the nitrosamine guidance from the major regulators.
Are isotope-labelled Risperidone standards available?
Yes. 2 stable-isotope labelled compounds are listed, suitable as internal standards for LC-MS bioanalysis and trace impurity quantitation.