Description

Asenapine Maleate is the maleate salt form of asenapine, a high-potency atypical antipsychotic agent. This active pharmaceutical ingredient (API) is critical for the formulation of effective treatments for central nervous system disorders, offering a favorable receptor binding profile. It is primarily utilized by pharmaceutical manufacturers and research institutions engaged in the development and production of neuropsychiatric medications. Our supply ensures the high purity and consistency required for stringent pharmaceutical applications.

Application

• Primary Pharmaceutical Ingredient: Core API in the manufacture of antipsychotic medications, particularly sublingual tablets.
• Research & Development: Used in preclinical and clinical studies for investigating new therapeutic applications in psychiatry.
• Dosage Form Development: Key component in formulating various delivery systems to optimize bioavailability and patient compliance.
• Reference Standard: Serves as an analytical standard in quality control laboratories for drug testing and verification.
• Generic Drug Production: Essential for companies developing bioequivalent versions of branded antipsychotic drugs.

Basic Information

Product Name	Asenapine Maleate
CAS No.	85650-56-2
Molecular Formula	C21H25ClN2O • C4H4O4
Molecular Weight	401.87 (Free base: 285.79)
Synonyms	trans-5-Chloro-2-methyl-2,3,3a,12b-tetrahydro-1H-dibenz[2,3:6,7]oxepino[4,5-c]pyrrole maleate; Org 5222 Maleate; (3aRS,12bRS)-5-Chloro-2-methyl-2,3,3a,12b-tetrahydro-1H-dibenz[2,3:6,7]oxepino[4,5-c]pyrrole (Z)-butenedioate; Asenapine (Maleate); Saphris (as the maleate salt); Sycrest
EINECS	Contact for details

Quality Control

Our Asenapine Maleate is manufactured under strict quality management systems, targeting purity levels suitable for pharmaceutical development. Each batch is tested against rigorous in-house specifications, which typically include identity, assay, impurity profile, and residual solvents. A Certificate of Analysis (COA) documenting these results is provided with every shipment. While we currently offer a high-purity grade, we can discuss compliance with specific pharmacopeial standards such as USP or ICH guidelines upon request.

Storage

Preserve in a tightly closed container, protected from light. Due to its hygroscopic nature, the container should be kept in a cool, dry place with controlled humidity. Recommended long-term storage temperature is between 2°C and 8°C. For extended stability, consider storage under an inert atmosphere. Keep the container sealed after each use to minimize exposure to moisture.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms
Identification (HPLC)	Conforms
Assay (HPLC)	98.0% - 102.0% (on anhydrous basis)
Water Content (KF)	≤ 1.0%
Residue on Ignition	≤ 0.1%
Related Substances (HPLC)	Total impurities ≤ 1.0% Any single impurity ≤ 0.5%
Heavy Metals	≤ 20 ppm
Residual Solvents (GC)	Complies with ICH Q3C

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