Description

Lorcaserin Impurity 3 is a designated impurity standard used in the analytical profiling and quality control of the active pharmaceutical ingredient (API) lorcaserin hydrochloride. This high-purity reference material is critical for ensuring the safety, efficacy, and regulatory compliance of pharmaceutical formulations. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method development, validation, and routine batch testing.

Application

• Pharmaceutical Reference Standard: Serves as a certified impurity standard for the identification and quantification of related substances in lorcaserin API and finished drug products.
• Analytical Method Development & Validation: Used to establish and validate chromatographic methods (e.g., HPLC, UPLC) for impurity profiling in compliance with ICH Q3A(R2) and Q3B(R2) guidelines.
• Quality Control & Batch Release: Essential for routine quality control testing to monitor impurity levels and ensure drug substance and product specifications are met.
• Stability Studies: Employed as a marker to track impurity formation and degradation pathways during forced degradation and long-term stability studies of lorcaserin.
• Regulatory Submissions: Provides necessary data for Drug Master Files (DMFs), Investigational New Drug (IND) applications, and New Drug Applications (NDAs).
• Research & Development: Used in synthetic chemistry R&D to understand and control impurity formation during the manufacturing process of lorcaserin.

Basic Information

Product Name	Lorcaserin Impurity 3
CAS No.	847063-14-3
Molecular Formula	C11H14ClNO
Molecular Weight	211.69 g/mol
Synonyms	(1R)-8-Chloro-1-methyl-2,3,4,5-tetrahydro-1H-3-benzazepine; (R)-8-Chloro-1-methyl-2,3,4,5-tetrahydro-1H-3-benzazepine; Lorcaserin Related Compound C; Lorcaserin Impurity C; APD356 Impurity 3; Belviq Impurity 3
EINECS	Contact for details

Quality Control

Our Lorcaserin Impurity 3 is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including HPLC for purity, NMR and MS for structural confirmation, and residual solvent analysis. We provide comprehensive Certificates of Analysis (COA) detailing all test results, ensuring compliance with pharmacopeial standards and ICH guidelines for impurity reference materials.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, typically between 15-25°C. The compound is hygroscopic (moisture-sensitive); therefore, the container should be kept in a dry environment. For long-term storage, consider storing under an inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time corresponds to reference standard
Identification (IR)	Spectrum matches reference spectrum
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0%
Any single unknown impurity	≤ 0.5%
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.