Clozapine Related Compounds & Impurities

Clozapine is an atypical dibenzodiazepine antipsychotic uniquely effective in treatment-resistant schizophrenia, requiring mandatory haematological monitoring due to its risk of potentially fatal agranulocytosis.

Simson Pharma Limited along with its subsidiary offices Simson Pharma Global Ltd. (UK) and Simson Pharma Global LLC (USA) is a trusted manufacturer and supplier of high-quality pharmaceutical reference standards, offering a comprehensive portfolio of Clozapine reference standards, pharmacopeial and non-pharmacopeial Clozapine impurities, related compounds, related substances, metabolites, stable isotope-labelled compounds, deuterium labelled compounds and nitrosamine (N-NO) reference standards.

These materials support pharmaceutical research and development, product development, ANDA and DMF submissions, quality control (QC), analytical method development and validation, stability studies, impurity identification, and genotoxic impurity assessment.

Our Clozapine-related reference standards are thoroughly characterized using advanced analytical techniques and are supplied with comprehensive Certificates of Analysis (COA) and supporting analytical data from our USFDA certified, ISO 17025 and ISO 17034 accredited Lab, to meet global regulatory expectations. EP and USP traceable reference standards can also be provided upon request, subject to availability. Simson is also a provider of EP and USP traceable standards. To ensure consistent quality and reliability, our reference standards are periodically re-tested according to established quality management procedures.

Pharmaceutical Reference Standards / Impurity Standards

Clozapine
Clozapine EP impurity C
Clozapine N-oxide
Clozapine EP impurity D
Clozapine EP impurity A
Clozapine EP impurity B
Clozapine Impurity 10
Clozapine Impurity 11
Clozapine Impurity 5
1,2-Dimethylpiperazine
Clozapine Impurity 9
Deschloro Clozapine
Clozapine Impurity 1
Clozapine-D8
N-Nitroso Clozapine
N-Nitroso desmethyl Clozapine impurity
8-Chloro-5-nitroso-5H-dibenzo[b,e][1,4]diazepin-1(10H)-one
2-((4-chloro-2-nitrophenyl)(nitroso)amino)benzoic acid
2-((2-amino-4-chlorophenyl)(nitroso)amino)benzoic acid
N-Nitroso Clozapine EP Impurity B (possibility 1)
N-Nitroso Clozapine EP Impurity B (possibility 2)
Clozapine Impurity 2
Clozapine Impurity 4

Metabolites

Clozapine Nitroso EP Impurity C

Isotope Labelled Compounds

Clozapine-D3
Clozapine Impurity 3 D8
N-Nitroso Clozapine EP Impurity C d8