Description

Lorcaserin n-Hydroxy Impurity is a high-purity reference standard critical for pharmaceutical research and development. This compound is essential for the accurate identification, quantification, and control of a key process-related impurity during the synthesis of the weight management drug Lorcaserin. It is primarily required by analytical chemists and quality control laboratories in the pharmaceutical industry to ensure product safety, regulatory compliance, and batch-to-batch consistency.

Application

• Pharmaceutical Reference Standard: Serves as a certified reference material (CRM) for method development and validation in HPLC and LC-MS analysis.
• Impurity Profiling: Used to identify and quantify the n-Hydroxy impurity in active pharmaceutical ingredient (API) batches of Lorcaserin hydrochloride.
• Quality Control & Assurance: Critical for establishing and meeting International Council for Harmonisation (ICH) Q3A/B guidelines for impurities in new drug substances and products.
• Regulatory Submissions: Supports the preparation of Chemistry, Manufacturing, and Controls (CMC) documentation for regulatory filings with agencies like the FDA and EMA.
• Stability Studies: Employed to monitor the formation of this specific degradation product under various stress conditions.
• Process Chemistry R&D: Aids in optimizing synthetic routes to minimize the formation of this impurity during Lorcaserin manufacturing.

Basic Information

Item	Details
Product Name	Lorcaserin n-Hydroxy Impurity
CAS No.	1421747-19-4
Molecular Formula	C11H14ClNO2
Molecular Weight	227.69 g/mol
Synonyms	(1R)-8-Chloro-1-methyl-2,3,4,5-tetrahydro-1H-3-benzazepine N-Oxide; Lorcaserin N-Oxide; Lorcaserin Impurity N-Oxide; Belviq N-Oxide Impurity; (R)-8-Chloro-1-methyl-2,3,4,5-tetrahydro-1H-3-benzazepine 1-Oxide; APD356 N-Oxide; Lorcaserin Related Compound N-Oxide
EINECS	Contact for details

Quality Control

Every batch of Lorcaserin n-Hydroxy Impurity is manufactured and analyzed under strict quality management systems. We provide comprehensive Certificates of Analysis (COA) that include data from orthogonal analytical techniques such as HPLC, GC, NMR, and MS to confirm identity and purity. Our standards are developed to support compliance with ICH, USP, and EP guidelines, ensuring reliability for your critical analytical work.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry environment. For long-term storage, consider storing desiccated at 2-8°C.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time matches reference standard
Identification (MS)	Mass spectrum conforms to structure
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Total impurities ≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 1.0%

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