Description

Ramelteon Impurity 22 CAS NO 1252018-55-5 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 Ramelteon, a medication used to treat insomnia. It is an essential tool for pharmaceutical manufacturers and analytical laboratories engaged in method development, stability studies, and impurity profiling. The availability of this well-characterized impurity standard is vital for maintaining stringent quality control in drug production.

Application

• Pharmaceutical Impurity Profiling and Identification: Used as a certified reference material to identify, quantify, and monitor this specific impurity during the development and manufacturing of Ramelteon API.
• Analytical Method Development and Validation: Serves as a critical standard for developing, optimizing, and validating HPLC, UPLC, or LC-MS methods to ensure accurate detection and quantification limits.
• Stability Studies and Forced Degradation: Employed in stability-indicating assays to track the formation of this impurity under various stress conditions (e.g., heat, light, humidity) as per ICH guidelines.
• Quality Control and Batch Release Testing: Essential for in-process control and final release testing of Ramelteon drug substance and drug products to confirm they meet pharmacopeial or internal specification limits.
• Regulatory Submissions and Compliance: Provides necessary data for regulatory filings (e.g., FDA, EMA) to establish impurity thresholds and demonstrate control strategies for the drug substance.
• Research and Development: Used in R&D laboratories to study the metabolic pathways, degradation mechanisms, and toxicological profile associated with Ramelteon.

Basic Information

Product Name	Ramelteon Impurity 22
CAS No.	1252018-55-5
Molecular Formula	C16H21NO2
Molecular Weight	259.35 g/mol
Synonyms	Ramelteon Related Compound 22; (S)-N-[2-[(8S)-1,6,7,8-Tetrahydro-2H-indeno[5,4-b]furan-8-yl]ethyl]propionamide; Ramelteon EP Impurity H; Ramelteon USP Related Compound C; TAK-375 Impurity 22; 8-[(1S)-2-(Propionylamino)ethyl]-6,7-dihydro-5H-indeno[5,4-b]furan; UNII-7F1U6V31PJ
EINECS	Contact for details

Quality Control

Every batch of Ramelteon Impurity 22 is manufactured and analyzed under strict quality management systems. The product undergoes rigorous identity confirmation, purity assay, and impurity profiling using advanced analytical techniques such as HPLC, GC, MS, and NMR to ensure it meets the high standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) is provided with each lot, detailing batch-specific results, analytical methods, and traceability. Our quality processes are designed to support compliance with cGMP, ICH Q3A/B, and relevant pharmacopeial guidelines (USP, EP).

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, typically between 15-25°C (59-77°F). The material should be kept in a cool, dry, and well-ventilated area. For long-term storage, consider conditions that minimize exposure to temperature fluctuations and humidity.

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 ≤ 1.0% Total impurities ≤ 2.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 0.5% w/w
Assay (HPLC)	97.0% - 103.0% (on anhydrous basis)

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