Description

3-Ethyl-2-Methyl-6,7,8,9-Tetrahydro-4H-Pyrido[1,2-α]Pyrimidin-4-One (Risperidone Impurity) is a high-purity chemical reference standard critical for pharmaceutical research and development. This compound is essential for the identification, quantification, and control of process-related impurities in the synthesis of the active pharmaceutical ingredient Risperidone. It is primarily used by analytical chemists, quality control laboratories, and regulatory affairs professionals within the pharmaceutical industry to ensure drug safety, efficacy, and compliance with stringent global pharmacopeial standards.

Application

• Pharmaceutical Impurity Reference Standard: Serves as a certified reference material (CRM) for method development and validation in HPLC, GC, and LC-MS analysis of Risperidone.
• Quality Control & Assurance (QC/QA): Used for routine batch testing and impurity profiling to ensure Risperidone API and finished drug products meet ICH Q3A/B guidelines.
• Regulatory Compliance & Filing: Critical for preparing regulatory submission documents (e.g., for FDA, EMA) that require detailed impurity identification and characterization.
• Process Chemistry Research: Employed in route scouting and optimization studies to understand and minimize the formation of this specific impurity during synthesis.
• Stability Studies: Used as a marker to monitor impurity levels in stability samples of Risperidone under various ICH-prescribed conditions.
• Contract Research Organizations (CROs) & Testing Labs: A vital reagent for third-party laboratories offering analytical and compliance testing services to pharmaceutical companies.

Basic Information

Product Name	3-Ethyl-2-Methyl-6,7,8,9-Tetrahydro-4H-Pyrido[1,2-α]Pyrimidin-4-One (Risperidone Impurity)
CAS No.	70381-58-7
Molecular Formula	C₁₃H₁₈N₂O
Molecular Weight	218.30 g/mol
Synonyms	Risperidone Impurity; Risperidone Related Compound; 3-Ethyl-2-methyl-6,7,8,9-tetrahydro-4H-pyrido[1,2-a]pyrimidin-4-one; 4H-Pyrido[1,2-a]pyrimidin-4-one, 3-ethyl-2-methyl-6,7,8,9-tetrahydro-; Risperidone EP Impurity; Risperidone USP Impurity
EINECS	Contact for details

Quality Control

Every batch of 3-Ethyl-2-Methyl-6,7,8,9-Tetrahydro-4H-Pyrido[1,2-α]Pyrimidin-4-One is manufactured and tested under strict quality management systems. Our products undergo rigorous analytical testing, including HPLC, GC-MS, and NMR, to ensure identity, purity, and consistency align with pharmacopeial expectations. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results for all critical quality attributes. We support compliance with ICH, USP, and EP guidelines for impurity standards.

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 product is hygroscopic (moisture-sensitive) and light-sensitive; therefore, containers must be kept tightly sealed in a desiccated environment and handled under conditions that minimize exposure to ambient light and humidity to maintain stability and purity.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
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)	≤ 0.5%

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