Olanzapine Related Compounds & Impurities

Olanzapine is an atypical antipsychotic with multi-receptor antagonism, used for schizophrenia, bipolar mania and treatment-resistant depression.

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 Olanzapine reference standards, pharmacopeial and non-pharmacopeial Olanzapine 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 Olanzapine-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

Olanzapine
Olanzapine Form II (Crystalline)
Olanzapine Form I
Olanzapine pamoate monohydrate
Desmethyl Olanzapine
Olanzapine EP Impurity B
Olanzapine EP Impurity C
Olanzapine EP Impurity D
Olanzapine EP Impurity D Hydrochloride
Olanzapine Amine Impurity
Olanzapine Lactam
Olanzapine EP Impurity A
Olanzapine Thiolactum
Olanzapine Thiolactum
N-Desmethyl N-Ethyl Olanzapine
Olanzapine Impurity 1
Olanzapine Impurity 1 Acetate
2-Amino-5-Methyl-3-Thiophenecarbonitrile
O-Fluoronitrobenzene
Methyl 2-amino-5-methylthiophene-3-carboxylate
1,3-Dicyclohexyl-3-hydroxy-1-propanone
Olanzapine N-Formyl Impurity
Olanzapine Impurity 13
1,1-dimethyl-4-(2-methyl-10H-thieno[2,3-b][1,5]benzodiazepine)piperaziniumion
Olanzapine Impurity 12 Hydrochloride
Olanzapine Amino Methanone Impurity
Olanzapine Thiohydroxymethylidene
Olanzapine Acetoxymethylidene (Imp 4)
N-Demethyl-N-formylolanzapine
Olanzapine Impurity 15
Olanzapine Impurity 16
2-methyl-10H-thieno[2,3-b][1,5]benzodiazepin-4-ol
Bis-[10(2-methyl-4H-3-thia-4,9-diazabenzo[f]azulene)]-1,4-piperazine
Olanzapine N-Formyl
Olanzapine Impurity 1
Olanzapine Impurity 2
Olanzapine Impurity 3
4-Fluoro Olanzapine
1,1-dimethyl-4-(2-methyl-10H-benzo[b]thieno[2,3-e][1,4]diazepin-4-yl)piperazin-1-ium
Olanzapine Impurity 4
Olanzapine Impurity 9
Olanzapine 10-N-glucuronide
N-Nitroso Olanzapine
2-methyl-10-nitroso-10H-benzo[b]thieno[2,3-e][1,4]diazepin-4-amine
Olanzapine Nitroso Impurity 2
Olanzapine Nitroso Impurity 1
Olanzapine Ketothiolactam S-Oxide
N-Nitroso N-Desmethyl Olanzapine
Olanzapine Formyl Impurity
Olanzapine open ring analog
Olanzapine (Form-II)
Olanzapine Impurity 5
Olanzapine impurity 6
Olanzapine Impurity 7

Metabolites

2-Hydroxymethyl Olanzapine
7-Hydroxy Olanzapine

Isotope Labelled Compounds

Olanzapine-d3
Olanzapine-D8
Olanzapine-D4