Description

Ramelteon Impurity CAS NO 1204581-51-0 is a high-purity chemical reference standard used in the analytical profiling and quality control of Ramelteon, a prescription medication for insomnia. This impurity is critical for pharmaceutical manufacturers and research laboratories to ensure the safety, efficacy, and regulatory compliance of the final drug product. It is primarily utilized by professionals in pharmaceutical development, quality assurance (QA), and quality control (QC) for method validation, stability studies, and impurity identification.

Application

• Pharmaceutical Impurity Profiling: Used as a certified reference material for the identification and quantification of specific impurities in Ramelteon active pharmaceutical ingredient (API) and finished dosage forms.
• Analytical Method Development and Validation: Serves as a critical standard for developing, optimizing, and validating HPLC, UPLC, or LC-MS methods for Ramelteon analysis.
• Quality Control (QC) Testing: Employed in routine batch release testing in pharmaceutical manufacturing to monitor and control impurity levels against ICH guidelines.
• Stability Studies: Used to track the formation of degradation products in Ramelteon under various stress conditions (e.g., heat, light, humidity) as per ICH stability protocols.
• Regulatory Compliance and Submissions: Essential for preparing regulatory documentation (e.g., for FDA, EMA) to demonstrate thorough impurity characterization and control strategies.
• Research and Development: Utilized in synthetic chemistry R&D to understand degradation pathways and to synthesize purer batches of Ramelteon.

Basic Information

Product Name	Ramelteon Impurity
CAS No.	1204581-51-0
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Ramelteon Related Compound; Ramelteon Specified Impurity; Ramelteon Degradant; Ramelteon Process Impurity; (S)-N-[2-(1,6,7,8-Tetrahydro-2H-indeno[5,4-b]furan-8-yl)ethyl]propionamide Impurity; TAK-375 Impurity
EINECS	Contact for details

Quality Control

Every batch of Ramelteon Impurity (CAS 1204581-51-0) is manufactured and analyzed under strict quality management systems. Our products undergo rigorous quality testing, including advanced chromatographic techniques, to ensure compliance with pharmaceutical reference standard requirements. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing purity, identity, and impurity profile. We support compliance with ICH Q3A/B, USP, and EP guidelines.

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. Handle the material in accordance with good laboratory practices.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time corresponds to reference standard
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual impurity: ≤ 1.0% Total impurities: ≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C

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