Description

Olanzapine is a potent atypical antipsychotic agent belonging to the thienobenzodiazepine class. It is a critical active pharmaceutical ingredient (API) essential for the formulation of medications used to treat psychiatric and neurological disorders. This high-purity compound is primarily required by pharmaceutical manufacturers and research institutions engaged in the development and production of solid dosage forms.

Application

• Pharmaceutical API: Primary use as the active ingredient in the manufacture of antipsychotic tablets, orally disintegrating tablets (ODTs), and other solid oral dosage forms.
• Generic Drug Production: Sourcing for the formulation of bioequivalent generic versions of brand-name olanzapine medications.
• Clinical Research: Utilization in preclinical and clinical studies investigating new therapeutic applications or delivery mechanisms for olanzapine.
• Reference Standard: Serves as a high-purity chemical reference standard for quality control and analytical method development in pharmaceutical laboratories.
• Formulation Development: Used in R&D for developing new drug delivery systems, such as extended-release formulations or combination therapies.

Basic Information

Product Name	Olanzapine
CAS No.	132539-06-1
Molecular Formula	C17H20N4S
Molecular Weight	312.44 g/mol
Synonyms	2-Methyl-4-(4-methyl-1-piperazinyl)-10H-thieno[2,3-b][1,5]benzodiazepine; LY-170053; Zyprexa (Trade Name); Olanzapinum; Olanzapina; Olanzapin; EINECS 603-850-2
EINECS	603-850-2

Quality Control

Our Olanzapine is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing to ensure it meets stringent specifications for identity, purity, and potency, aligning with major pharmacopeial standards (e.g., USP, EP). A detailed Certificate of Analysis (COA) providing batch-specific results is available upon request to support your regulatory and quality assurance requirements.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). Due to its hygroscopic nature, the container must be kept tightly sealed in a low-humidity environment to prevent moisture absorption.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms
Identification (HPLC)	Conforms
Assay (HPLC)	98.0% - 102.0%
Related Substances (HPLC)	Individual impurity ≤ 0.5% Total impurities ≤ 2.0%
Residual Solvents (GC)	Meets ICH Q3C guidelines
Heavy Metals	≤ 20 ppm
Loss on Drying	≤ 1.0%
Sulfated Ash	≤ 0.1%

Note: Specifications can be tailored. Please contact us for the detailed technical data sheet of a specific grade.