Description

S,S-Endo-Lurasidone Hcl is a specific stereoisomeric form of the active pharmaceutical ingredient Lurasidone Hydrochloride, identified by the CAS registry number 1318074-27-9. This high-purity intermediate is critical for ensuring the final drug product's efficacy, safety, and regulatory compliance. It is primarily required by pharmaceutical manufacturers and advanced research institutions engaged in the development and production of antipsychotic medications.

Application

• Active Pharmaceutical Ingredient (API) Intermediate: A key chiral building block in the synthesis of the antipsychotic drug Lurasidone Hydrochloride.
• Pharmaceutical R&D: Used in process development, optimization, and scale-up studies for new drug formulations.
• Reference Standard: Serves as a high-purity analytical standard for quality control and method validation in pharmaceutical laboratories.
• Regulatory Submissions: Provides the necessary defined stereochemistry for inclusion in Drug Master Files (DMFs) and regulatory dossiers (e.g., for FDA, EMA).
• Contract Manufacturing: Supplied to CDMOs (Contract Development and Manufacturing Organizations) for the production of finished dosage forms.
• Stability Studies: Employed in research to understand the degradation pathways and shelf-life of pharmaceutical products containing the S,S-endo isomer.

Basic Information

Item	Details
Product Name	S,S-Endo-Lurasidone Hcl
CAS No.	1318074-27-9
Molecular Formula	C28H37ClN4O2S
Molecular Weight	529.13 g/mol
Synonyms	(3aR,4S,7R,7aS)-2-[(1R,2R)-2-[4-(1,2-Benzisothiazol-3-yl)piperazin-1-ylmethyl]cyclohexylmethyl]hexahydro-4,7-methano-2H-isoindole-1,3-dione hydrochloride; Lurasidone Hydrochloride S,S-endo Isomer; (3aR,4S,7R,7aS)-Hexahydro-2-[[(1R,2R)-2-[[4-(1,2-benzisothiazol-3-yl)-1-piperazinyl]methyl]cyclohexyl]methyl]-4,7-methano-1H-isoindole-1,3(2H)-dione hydrochloride; SM-13496 (S,S-endo form); Endo-Lurasidone HCl
EINECS	Contact for details

Quality Control

Our S,S-Endo-Lurasidone Hcl is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing, including chiral HPLC for stereochemical purity, to ensure it meets stringent pharmaceutical-grade specifications. A detailed Certificate of Analysis (COA) is provided with every shipment, confirming identity, purity, and compliance with relevant internal and ICH guidelines.

Storage

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

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Assay (HPLC)	≥ 98.5%
Chiral Purity (S,S-endo)	≥ 99.0%
Related Substances (HPLC)	Total impurities ≤ 1.0% Any single impurity ≤ 0.5%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Water Content (KF)	≤ 0.5%
Residue on Ignition	≤ 0.1%

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