Description

Olanzapine Pamoate Hydrate is a long-acting, injectable salt form of the atypical antipsychotic olanzapine, designed for sustained release. This formulation is critical for ensuring patient compliance and providing stable therapeutic plasma levels in the management of psychiatric conditions. It is primarily required by pharmaceutical manufacturers engaged in the development and production of long-acting injectable (LAI) depot formulations for schizophrenia and bipolar I disorder.

Application

• Long-Acting Injectable (LAI) Antipsychotic Formulations: As the active pharmaceutical ingredient (API) in depot injections for sustained release over weeks.
• Treatment of Schizophrenia: For the maintenance treatment of schizophrenia in patients who require extended therapy.
• Management of Bipolar I Disorder: Used for the maintenance monotherapy of bipolar I disorder.
• Pharmaceutical Research & Development (R&D): Serves as a key intermediate in the development of novel delivery systems and generic LAI products.
• Controlled-Release Drug Delivery Systems: A model compound for studying pamoate salt technology and microcrystalline suspension formulations.

Basic Information

Product Name	Olanzapine Pamoate Hydrate
CAS No.	221373-18-8
Molecular Formula	C₃₃H₃₀N₄O₂ • C₂₃H₁₆O₆ • xH₂O
Molecular Weight	759.90 (Anhydrous base) + 388.37 (Pamoic acid) + (18.02*x) (Hydrate)
Synonyms	Olanzapine Pamoate; Olanzapine Embonate; Zyprexa Relprevv (Brand Name Equivalent); LY170053; 2-Methyl-4-(4-methyl-1-piperazinyl)-10H-thieno[2,3-b][1,5]benzodiazepine Pamoate Salt Hydrate; 4-(4-Methylpiperazin-1-yl)-10H-thieno[2,3-b][1,5]benzodiazepine pamoate hydrate
EINECS	Contact for details

Quality Control

Our Olanzapine Pamoate Hydrate is manufactured under strict quality management systems. We provide material that meets high-purity standards suitable for pharmaceutical development and manufacturing. Each batch is supported by a comprehensive Certificate of Analysis (COA) detailing identity, purity, impurity profile, and residual solvents, ensuring traceability and compliance with cGMP principles and ICH guidelines.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). This material is hygroscopic (moisture-sensitive) and must be kept in a dry environment to prevent degradation and ensure stability.

Specification

Item	Specification
Appearance	Yellow to light yellow powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to reference standard
Assay (HPLC)	98.0% - 102.0% (on anhydrous basis)
Water Content (KF)	≤ 5.0%
Related Substances (HPLC)	Individual impurity: ≤ 0.5% Total impurities: ≤ 2.0%
Residual Solvents (GC)	Complies with ICH Q3C
Heavy Metals	≤ 20 ppm
Microbial Enumeration	Complies with Ph. Eur. 2.6.12 / USP <61>

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