Description

Roflumilast Related Substance CAS NO 475271-62-6 is a high-purity chemical reference standard used for analytical and research purposes. This compound is critical for ensuring the quality, safety, and efficacy of the active pharmaceutical ingredient (API) Roflumilast through precise identification and quantification of related substances. It is an essential tool for pharmaceutical manufacturers, quality control laboratories, and research institutions engaged in the development and production of chronic obstructive pulmonary disease (COPD) therapeutics.

Application

• Pharmaceutical Impurity Profiling: Primary use as a certified reference standard for the identification and quantification of specific impurities and degradation products in Roflumilast API and finished dosage forms.
• Analytical Method Development & Validation: Serves as a critical component in developing, validating, and verifying HPLC, UPLC, and other chromatographic methods for purity analysis.
• Quality Control & Assurance (QC/QA): Used in routine batch release testing to monitor and control impurity levels, ensuring compliance with pharmacopeial standards (e.g., USP, EP, ICH Q3A/B guidelines).
• Stability Studies: Employed as a marker to track the formation of related substances under various stress conditions (heat, light, humidity) during drug product shelf-life studies.
• Regulatory Submissions: Provides essential data for regulatory filings (e.g., FDA, EMA) to demonstrate comprehensive control of the drug substance's impurity profile.
• Research & Development: Supports synthetic chemistry research, metabolic studies, and the investigation of degradation pathways for Roflumilast.

Basic Information

Product Name	Roflumilast Related Substance CAS NO 475271-62-6
CAS No.	475271-62-6
Molecular Formula	C17H14Cl2F2N2O3
Molecular Weight	403.21 g/mol
Synonyms	3-(Cyclopropylmethoxy)-N-(3,5-dichloropyridin-4-yl)-4-(difluoromethoxy)benzamide; Roflumilast Impurity; Roflumilast Related Compound; 4-(Difluoromethoxy)-3-(cyclopropylmethoxy)-N-(3,5-dichloropyridin-4-yl)benzamide; Benzamide, 3-(cyclopropylmethoxy)-N-(3,5-dichloropyridin-4-yl)-4-(difluoromethoxy)-; UNII-7V314KQ86P; Roflumilast API Impurity
EINECS	Contact for details

Quality Control

Our Roflumilast Related Substance is manufactured under strict quality systems and undergoes rigorous analytical testing to ensure it meets the high standards required for pharmaceutical reference materials. Each batch is characterized and controlled against a certified primary reference standard. We provide comprehensive Certificates of Analysis (COA) detailing purity, identity, and impurity profiles, supporting compliance with ICH guidelines and relevant pharmacopeial requirements.

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 material is hygroscopic (moisture-sensitive) and should be handled in a dry environment to prevent degradation.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Assay (HPLC)	≥ 98.0%
Purity (HPLC, Area %)	≥ 99.0%
Single Unknown Impurity	≤ 0.10%
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.