Description

Lorcaserin Impurity 4 CAS NO 2028497-65-4 is a high-purity chemical reference standard used for analytical and research purposes. This compound is critical for ensuring the quality, safety, and regulatory compliance of the active pharmaceutical ingredient (API) Lorcaserin. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method development, validation, and quality control testing. The availability of this well-characterized impurity standard is essential for maintaining stringent pharmacopeial standards in drug development and production.

Application

• Pharmaceutical Reference Standard: Used as a certified impurity standard for the identification and quantification of related substances in Lorcaserin API and finished dosage forms.
• Analytical Method Development & Validation: Essential for developing, optimizing, and validating HPLC, UPLC, or LC-MS methods for impurity profiling.
• Quality Control & Assurance (QC/QA): Serves as a system suitability and calibration standard in routine quality control testing to ensure batch-to-batch consistency.
• Regulatory Compliance & Filings: Supports the preparation of regulatory documentation (e.g., for FDA, EMA) by providing necessary impurity data for drug master files (DMFs) and investigational new drug (IND) applications.
• Stability Studies: Employed in forced degradation and long-term stability studies of Lorcaserin to monitor impurity formation over time and under various stress conditions.
• Research & Development: Used in pharmaceutical R&D to study the degradation pathways, metabolism, and synthesis of Lorcaserin.

Basic Information

Product Name	Lorcaserin Impurity 4
CAS No.	2028497-65-4
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Lorcaserin Related Compound 4; Lorcaserin Impurity D; Lorcaserin EP Impurity D; Lorcaserin USP Impurity; (1R)-8-Chloro-1-methyl-2,3,4,5-tetrahydro-1H-3-benzazepine; Belviq Impurity 4; APD356 Impurity 4
EINECS	Contact for details

Quality Control

Every batch of Lorcaserin Impurity 4 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and impurity profile testing using advanced analytical techniques such as HPLC, GC, MS, and NMR to ensure compliance with pharmacopeial standards (e.g., USP, EP, ICH guidelines). A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results, chromatograms, and spectral data.

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 material is hygroscopic (moisture-sensitive) and must be kept under inert atmosphere or desiccated conditions upon opening to prevent degradation. For long-term storage, consider storing at 2-8°C.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any individual impurity ≤ 1.0%
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.