Nitrosamine and Impurity Reference Standards: Enabling Precision in Pharmaceutical Analysis
The identification and control of impurities, particularly nitrosamines, remain a central focus in pharmaceutical quality control and regulatory compliance. Even in trace concentrations, nitrosamine impurities can present carcinogenic risks, compelling organizations such as the USFDA, EMA, and WHO to strengthen impurity testing frameworks.
At Pharmaffiliates, we empower global laboratories and formulation scientists through an extensive range of certified impurity and nitrosamine reference standards. These reference substances ensure analytical reproducibility, traceability, and compliance with international guidelines.
As a leading pharmaceutical impurity standard manufacturer in India, Pharmaffiliates contributes to safer medicines and more reliable analytical outcomes across global research initiatives.
(6aR,9R,10aR)-7-Allyl-N-(ethylcarbamoyl)-N-(3-(methyl(nitroso)amino)propyl)-4,6,6a,7,8,9,10,10a-octahydroindolo[4,3-fg]quinoline-9-carboxamide
Product Code: PA 03 0021006
A structurally complex indoloquinoline derivative, this compound functions as a nitrosamine impurity reference standard in heterocyclic and alkaloid-based drug studies. It aids researchers in quantifying nitrosamine formation and degradation intermediates during synthesis optimization and toxicological profiling.
Analytical Use: Nitrosamine quantification, impurity pathway tracking, LC–MS/MS validation. View Product
N-(2,6-Dichlorophenyl)-1-nitroso-4,5-dihydro-1H-imidazol-2-amine
Product Code: PA 03 0661003CAS Number: 148950-49-6Synonyms: N-Nitroso Clonidine; 1H-Imidazol-2-amine, N-(2,6-dichlorophenyl)-4,5-dihydro-1-nitroso
This imidazoline-based nitrosamine impurity is a critical analytical marker for Clonidine and related compounds. It supports nitrosamine risk assessment, enabling sensitive detection through LC–MS and GC–MS techniques.
Analytical Use: Nitrosamine impurity calibration, toxicological evaluation, regulatory method validation.View Product
N-Nitroso-Cinacalcet (Racemic)
Product Code: PA 03 3381002Synonyms: N-(1-(Naphthalen-1-yl)ethyl)-N-(3-(3-(trifluoromethyl)phenyl)propyl)nitrous amide
This racemic N-nitroso derivative of Cinacalcet is significant in impurity profiling and stability studies of calcimimetic agents. It provides a validated reference for stress degradation pathway elucidation and residual nitrosamine estimation during formulation stability testing.
Analytical Use: Impurity mapping, degradation study, nitrosamine profiling.View Product
Cephalexin Diketopiperazine
Product Code: PA 03 35520CAS Number: 59865-11-1Synonyms: Cefalexin Diketopiperazine Derivative; 2-(3,6-Dioxo-5-phenylpiperazin-2-yl)-5-methyl-3,6-dihydro-2H-1,3-thiazine-4-carboxylic Acid
A degradation impurity of Cephalexin, this diketopiperazine compound serves as a reference in beta-lactam stability studies.It supports hydrolytic degradation profiling, forced degradation validation, and pharmaceutical stability evaluations under ICH conditions.
Analytical Use: Cephalexin degradation monitoring, stability testing, forced degradation assay.View Product
(2S,3S)-2-(4-Methoxyphenyl)-5-(2-(methyl(nitroso)amino)ethyl)-4-oxo-2,3,4,5-tetrahydrobenzo[b][1,4]thiazepin-3-yl Acetate
Product Code: PA 04 0261012
CAS Number: 3036581-85-5Synonyms: N-Nitroso Desmethyl Diltiazem; 1,5-Benzothiazepin-4(5H)-one, 3-(acetyloxy)-2,3-dihydro-2-(4-methoxyphenyl)-5-[2-(methylnitrosoamino)ethyl]-, (2S,3S)
A nitrosamine impurity standard for Diltiazem and related benzothiazepine compounds, used extensively in toxicological evaluation and LC–HRMS quantification. It ensures precision in low-level nitrosamine detection and supports ICH M7 impurity risk assessments.
Analytical Use: Nitrosamine detection, cardiovascular API impurity control, analytical method validation.View Product
N,N-Dimethyl-2-(3-phenyl-1H-inden-2-yl)ethanamine
Product Code: PA 04 0280070CAS Number: 803617-18-7Synonyms: N,N-Dimethyl-2-(3-phenyl-1H-inden-2-yl)ethan-1-amine; Indene-2-ethylamine, N,N-dimethyl-3-phenyl; N,N-Dimethyl-3-phenyl-1H-indene-2-ethanamine
An impurity reference compound of Dimetindene Maleate, this standard is used in chiral degradation profiling and NMR validation studies.
It facilitates impurity quantification and process monitoring during the manufacturing of antihistamine formulations.
Analytical Use: Impurity quantification, chiral degradation tracking, assay development.View Product
Conclusion
These high-purity nitrosamine and impurity reference materials underscore Pharmaffiliates’ scientific rigor and regulatory alignment. Each compound is synthesized, characterized, and validated under stringent GLP and ISO-accredited protocols, ensuring analytical precision and reproducibility.
As a trusted manufacturer of certified pharmaceutical impurity standards in India, Pharmaffiliates continues to support global pharmaceutical research with traceable, quality-assured reference substances that strengthen impurity profiling, risk assessment, and regulatory compliance worldwide.
