Description

Ramelteon Impurity 1 is a designated reference standard used in the analytical profiling and quality control of the active pharmaceutical ingredient, Ramelteon. This compound is critical for pharmaceutical manufacturers and analytical laboratories to ensure product purity, safety, and regulatory compliance. It serves as a key marker for identifying and quantifying process-related impurities during the synthesis and formulation of Ramelteon-based sleep disorder medications.

Application

• Pharmaceutical Reference Standard: Primary use as a certified impurity standard for HPLC, LC-MS, and other chromatographic methods in QC/QA labs.
• Method Development and Validation: Essential for developing, validating, and transferring analytical methods for Ramelteon API and finished dosage forms.
• Regulatory Compliance and Filing: Supports regulatory submissions (e.g., FDA, EMA) by providing necessary impurity data for drug master files (DMFs) and CMC sections.
• Stability Studies: Used to monitor the formation of this specific impurity in Ramelteon products under various storage conditions over time.
• Process Chemistry Optimization: Helps synthetic chemists identify and minimize the formation of this impurity during the API manufacturing process.
• Pharmacopoeial Testing: Employed in testing to meet the specifications of pharmacopoeias such as USP or EP where applicable.

Basic Information

Product Name	Ramelteon Impurity 1
CAS No.	880152-63-6
Molecular Formula	C₁₆H₂₁NO₂
Molecular Weight	259.35 g/mol
Synonyms	(S)-N-[2-[(8S)-1,6,7,8-Tetrahydro-2H-indeno[5,4-b]furan-8-yl]ethyl]propionamide; Ramelteon Related Compound A; Ramelteon EP Impurity A; Ramelteon USP Impurity 1; TAK-375 Impurity 1; (S)-8-(2-Propionamidoethyl)-6,7-dihydro-5H-indeno[5,4-b]furan; Rozerem Impurity 1
EINECS	Contact for details

Quality Control

Every batch of Ramelteon Impurity 1 is manufactured and handled under strict quality management systems. The material undergoes comprehensive analytical characterization using techniques including HPLC, GC, NMR, and MS to confirm identity and purity. A detailed Certificate of Analysis (COA) is provided with each lot, documenting batch-specific results. Our quality protocols are designed to support compliance with cGMP and ICH Q3A/B guidelines for impurities in new drug substances.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, typically between 15-25°C. The material should be kept in a cool, dry, and well-ventilated area. For long-term storage, consider storing under inert atmosphere to maintain stability.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time matches reference standard
Identification (IR)	Spectrum conforms to reference
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Individual impurity: ≤ 0.5% Total impurities: ≤ 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.