Description

Roflumilast Related Substance CAS NO 1243391-44-7 is a high-purity chemical reference standard used in the pharmaceutical development and quality control processes for the active pharmaceutical ingredient (API) Roflumilast. This compound is critical for ensuring the identity, purity, and potency of the final drug product by serving as a benchmark in analytical testing. It is an essential material for analytical laboratories, research institutions, and pharmaceutical manufacturers engaged in the production, regulatory submission, and batch release of Roflumilast-based medications.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for the identification and quantification of Roflumilast and its related impurities in compliance with ICH guidelines.
• Analytical Method Development & Validation: Serves as a critical component in developing and validating High-Performance Liquid Chromatography (HPLC), Ultra-Performance Liquid Chromatography (UPLC), and other chromatographic methods.
• Quality Control & Batch Release Testing: Used in routine QC laboratories to monitor and control the purity profile of Roflumilast API, ensuring it meets pharmacopeial specifications (e.g., USP, EP).
• Stability Studies & Degradation Profiling: Employed to identify and track potential degradation products formed during stability testing of the API and finished dosage forms.
• Regulatory Documentation & Submission: Provides essential data for regulatory filings (e.g., with FDA, EMA) to demonstrate comprehensive impurity control and characterization.
• Research on Metabolic Pathways: Can be utilized in research settings to study the metabolism and pharmacokinetics of Roflumilast.

Basic Information

Product Name	Roflumilast Related Substance CAS NO 1243391-44-7
CAS No.	1243391-44-7
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Roflumilast Impurity; Roflumilast Related Compound; 3-(Cyclopropylmethoxy)-N-(3,5-dichloropyridin-4-yl)-4-(difluoromethoxy)benzamide Related Substance; Daxas Impurity; PDE4 Inhibitor Related Substance; 1243391-44-7; Roflumilast API Impurity
EINECS	Contact for details

Quality Control

Our Roflumilast Related Substance is manufactured and handled under strict quality management systems. Each batch undergoes rigorous analytical testing, including chromatographic purity assays and spectroscopic identification, to ensure it meets the high standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results for identity, purity, and related substances. Our quality commitment aligns with the requirements for chemical reference standards used in GMP environments.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (typically 15-25°C). The container should be kept in a desiccated environment to prevent moisture uptake. For long-term storage, consider conditions as per the stability data provided in the COA.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Individual impurity: ≤ 0.5% Total impurities: ≤ 2.0%
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.