Description

Asenapine 11-Hydroxysulfate is a key pharmaceutical intermediate and reference standard, identified by CAS NO 1399103-21-9. This compound is critical for ensuring the quality, safety, and efficacy of the final active pharmaceutical ingredient (API) in drug development and manufacturing. It is primarily required by pharmaceutical companies, contract research organizations (CROs), and analytical laboratories engaged in the synthesis, impurity profiling, and quality control of the antipsychotic drug Asenapine.

Application

• Pharmaceutical Intermediate: A crucial building block in the multi-step synthesis of the antipsychotic API, Asenapine Maleate.
• Reference Standard: Used as a certified standard in analytical methods (e.g., HPLC, LC-MS) for the identification and quantification of Asenapine and its related substances.
• Impurity Profiling: Essential for method development and validation to monitor and control specific process-related impurities and degradation products.
• Regulatory Compliance & Filings: Supports the preparation of Chemistry, Manufacturing, and Controls (CMC) documentation for regulatory submissions (e.g., FDA, EMA).
• Research & Development: Facilitates metabolic and pharmacokinetic studies to understand the drug's behavior in biological systems.
• Quality Control (QC) Testing: Employed in in-house QC laboratories to verify the purity and consistency of Asenapine API batches against established specifications.

Basic Information

Product Name	Asenapine 11-Hydroxysulfate
CAS No.	1399103-21-9
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	11-Hydroxyasenapine sulfate; Asenapine 11-Hydroxy Sulfate; Asenapine 11-Hydroxy Sulphate; 11-Hydroxy Asenapine Sulfate; 5-Chloro-2,3,3a,12b-tetrahydro-2-methyl-1H-dibenz[2,3:6,7]oxepino[4,5-c]pyrrole-11-ol sulfate; ORG 5228 11-Hydroxysulfate; (3aR,12bR)-5-Chloro-2-methyl-2,3,3a,12b-tetrahydro-1H-dibenzo[2,3:6,7]oxepino[4,5-c]pyrrol-11-ol sulfate
EINECS	Contact for details

Quality Control

Our Asenapine 11-Hydroxysulfate is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including HPLC for purity and identity confirmation, to ensure it meets the high standards required for pharmaceutical development. Certificates of Analysis (COA) with detailed chromatographic data are provided to support your regulatory and quality assurance needs.

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 (moisture-sensitive) nature, the container must be kept tightly sealed in a dry environment to prevent degradation. For long-term storage, consider desiccants or inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference standard
Identification (HPLC)	Retention time matches reference
Assay (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any single impurity ≤ 1.0%
Water Content (KF)	≤ 1.0%
Residue on Ignition	≤ 0.1%

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