Description

Lorcaserin Impurity D is a specified impurity and degradation product associated with the active pharmaceutical ingredient Lorcaserin Hydrochloride. This compound is critical for pharmaceutical research and development, serving as a key reference standard for analytical method development, validation, and quality control processes. It is primarily utilized by pharmaceutical manufacturers, contract research organizations (CROs), and analytical laboratories to ensure the purity, safety, and efficacy of Lorcaserin-based drug products.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of impurities in Lorcaserin API and finished dosage forms.
• Analytical Method Development: Essential for developing and validating stability-indicating HPLC, UPLC, or LC-MS methods to monitor impurity profiles.
• Quality Control & Assurance: Employed in routine batch release testing to ensure drug substance and product compliance with ICH Q3A/B guidelines and regulatory specifications.
• Stability Studies: Used to track the formation of degradation products under various stress conditions (e.g., heat, light, humidity) as per ICH stability protocols.
• Regulatory Submissions: Provides necessary data for impurity characterization reports required for Drug Master Files (DMFs), ANDAs, and INDs.
• Process Chemistry Research: Aids in understanding the formation pathways of this impurity during API synthesis, helping to optimize manufacturing processes.

Basic Information

Product Name	Lorcaserin Impurity D
CAS No.	1030624-36-2
Molecular Formula	C11H14ClN
Molecular Weight	195.69 g/mol
Synonyms	(1R)-8-Chloro-1-methyl-2,3,4,5-tetrahydro-1H-3-benzazepine; Lorcaserin Related Compound D; (R)-8-Chloro-1-methyl-2,3,4,5-tetrahydro-1H-3-benzazepine; Belviq Impurity D; APD356 Impurity D; 1H-3-Benzazepine, 8-chloro-2,3,4,5-tetrahydro-1-methyl-, (1R)-; (R)-8-Chloro-1-methyl-1,2,4,5-tetrahydro-3H-3-benzazepine
EINECS	Contact for details

Quality Control

Every batch of Lorcaserin Impurity D 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, NMR, and MS to ensure compliance with ICH guidelines and customer-specific requirements. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results for purity, assay, and related substances.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, typically between 15-25°C (59-77°F). For long-term storage, consider storing desiccated at 2-8°C. The material is hygroscopic (moisture-sensitive) and should be handled in a dry environment to prevent degradation.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Any individual impurity ≤ 0.5% Total impurities ≤ 1.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 0.5% w/w
Assay (on dried basis)	97.0% - 103.0%

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