Olanzapine lactam impurity is a potential impurity found in commercial preparations of olanzapine.1It is a degradation product formed by exposure to thermal or oxidative stress. 1.Baertschi, S.W., Brunner, H., Bunnell, C.A., et al.Isolation, identification, and synthesis of two oxidative degradation products of olanzapine (LY170053) in solid oral formulationsJ. Pharm. Sci.97(2)883-892(2008)
Olanzapine HCl is an atypical antipsychotic. It is approved by the U.S. Food and Drug Administration (FDA) for the treatment of schizophrenia and bipolar disorder. Olanzapine is structurally similar to clozapine and quetiapine. It is a dopamine antagonist and is classified as a thienobenzodiazepine.
Olanzapine Samidorphan is a combination of olanzapine and the opioid receptor antagonist samidorphan is under development for the treatment of schizophrenia and bipolar I disorder. The single-tablet combination treatment is intended to provide the efficacy of olanzapine while mitigating olanzapine-associated weight gain.