Description

Molindone Impurity 3 is a designated reference standard used in the analytical profiling and quality control of the antipsychotic pharmaceutical, Molindone Hydrochloride. This compound is critical for ensuring the purity, safety, and efficacy of the active pharmaceutical ingredient (API) by serving as a benchmark for identifying and quantifying process-related impurities. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for research, method development, and compliance testing. The availability of a well-characterized impurity standard is essential for meeting stringent pharmacopeial requirements and maintaining robust quality assurance protocols in drug production.

Application

• Pharmaceutical Reference Standard: Serves as a certified external standard for the identification and quantification of Molindone Impurity 3 in Molindone Hydrochloride API and finished dosage forms.
• Analytical Method Development and Validation (HPLC/GC): Used as a critical component in developing, optimizing, and validating chromatographic methods for impurity profiling.
• Quality Control & Stability Studies: Employed in routine batch release testing and forced degradation studies to monitor impurity levels and ensure product stability over time.
• Regulatory Compliance and Filings: Essential for preparing regulatory documentation (e.g., for FDA, EMA) to demonstrate control over the impurity profile as per ICH guidelines.
• Research and Development: Used in synthetic chemistry research to study the formation pathways and chemical behavior of this specific impurity.

Basic Information

Item	Details
Product Name	Molindone Impurity 3
CAS No.	22770-60-1
Molecular Formula	C16H22N2O2
Molecular Weight	274.36 g/mol
Synonyms	3-Ethyl-1,5,6,7-tetrahydro-2-methyl-4H-indol-4-one; 3-Ethyl-2-methyl-4,5,6,7-tetrahydro-1H-indol-4-one; Molindone Related Compound C; Molindone EP Impurity C; Molindone Process Impurity; 4(1H)-Indolone, 3-ethyl-1,5,6,7-tetrahydro-2-methyl-
EINECS	Contact for details

Quality Control

Every batch of Molindone Impurity 3 is manufactured and controlled under a strict quality management system. The product undergoes comprehensive analytical testing, including HPLC for purity and identity confirmation via spectroscopic methods (IR, NMR, MS), to ensure it meets the high standards required for use as a pharmaceutical reference material. A detailed Certificate of Analysis (COA) is provided with each shipment, documenting batch-specific results. Our quality protocols are designed to support compliance with relevant pharmacopeial guidelines (USP, EP) and ICH Q3A/B standards for impurities in new drug substances and products.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). Due to its hygroscopic nature, the container must be kept tightly sealed in a dry environment to prevent moisture absorption, which could affect stability and purity. For long-term storage, consider desiccants or inert atmosphere conditions.

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 unknown impurity ≤ 0.5%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Water Content (KF)	≤ 1.0% w/w

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