Impurity reference standards
Nitroso impurities & reference standards
Characterised Nitroso impurities, degradation products and related compounds for analytical method development, validation, QC release and regulatory filings.
22reference materials
18nitrosamine impurities
COAHPLC · NMR · MS on request
N-(4,5-Dichloro-2-nitrophenyl)-N-nitrosoacetamide
- CAS
- 15862-04-1
- Formula
- C8H5Cl2N3O4
- MW
- 278.05 g/mol
VQ-044593
N-Nitroso 4-Hydroxy-2,2,6,6-tetramethylpiperidine
- CAS
- 55556-90-6
- Formula
- C9H18N2O2
- MW
- 186.25 g/mol
VQ-040502
FAQs — Nitroso impurities
Which Nitroso impurities do you supply?
We list 22 Nitroso-related reference materials, including process impurities, degradation products, nitrosamine impurities and related compounds. Each is supplied with a COA, and characterisation data (HPLC, 1H-NMR, MS, IR) can be provided on request.
What are Nitroso impurity standards used for?
They are used for analytical method development and validation, impurity identification and quantification, forced-degradation and stability studies, and to support ANDA, DMF and other regulatory submissions under ICH Q3A/Q3B (and ICH M7 for mutagenic impurities).
Can you synthesise a Nitroso impurity that is not listed?
Yes. Our custom synthesis service can prepare and characterise unlisted impurities, metabolites and labelled analogues from milligram to gram scale. Share the structure or name and required quantity for a quotation.
Request Nitroso impurity standards
We reply within one business day with price, pack options, lead time and documentation.