Olanzapine EP Impurity C

RP-​HPLC method development, validation and stability indicating study of olanzapine in tablet dosage form
By Bhatt, Rahul; Singh, Gurdeep; Tiwari, Apoorva; Jain, Neetesh K.
From International Journal of Pharmacy and Life Sciences (2020), 11(11), 7079-7084.
 
The analytical method development and validation for the simultaneous estimation of flouxetine & olanzapine by using RP-​HPLC
By Patnaik, D. Kishore Kumar; Hotta, Santanu Kumar; Bangari, Chaitanya; Raju, M. B. Venkatapati
From Indo American Journal of Pharmaceutical Sciences (2020), 7(5), 680-698.
 
A validated stability indicating high performance liquid chromatographic method for olanzapine
By Rakibe, Udaykumar; Rane, Vipul; Yeole, Ravindra; Afnan, Ali; Wakte, Pravin
From Latin American Journal of Pharmacy (2017), 36(7), 1462-1468
 

Olanzapine EP Impurity C is chemically 1-(Chloromethyl)-1-methyl-4-(2-methyl-10H-thieno[2,3-b][1,5]benzodiazepin-4-yl)piperazin-1-ium chloride (as per EP); 1-Chloromethyl-1-methyl-4-(2-methyl-10H-benzo[b]thieno[2,3-e][1,4]diazepin-4-yl)piperazin-1-ium chloride (as per USP). It is also known as Chloromethyl Olanzapinium chloride. Olanzapine EP Impurity C is supplied with detailed characterization data compliant with regulatory guideline. Olanzapine EP Impurity C can be used for the analytical method development, method validation (AMV), Quality Controlled (QC) application for Abbreviated New Drug Application (ANDA) or during commercial production of Olanzapine.

The product can be used as reference standards and further traceability against pharmacopeial standards (USP or EP) can be provided based on feasibility. SynZeal products are for analytical purpose only and not for human use.