Description

Roflumilast Impurity 14 is a high-purity chemical reference standard used in the pharmaceutical development and quality control processes. This compound is critical for ensuring the safety and efficacy of the active pharmaceutical ingredient (API) Roflumilast by serving as a well-characterized impurity marker. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method validation, stability studies, and batch release testing. The availability of this certified impurity standard is essential for maintaining compliance with stringent global pharmacopeial guidelines.

Application

• Pharmaceutical Reference Standard: Used as a certified impurity standard for the qualitative and quantitative analysis of Roflumilast API and its formulations.
• Analytical Method Development & Validation (HPLC/LC-MS): Essential for developing, optimizing, and validating chromatographic methods to accurately detect and quantify this specific impurity.
• Quality Control & Batch Release: Employed in routine QC testing of Roflumilast drug substance and drug products to ensure impurity levels are within specified safety limits (ICH guidelines).
• Stability Studies: Used to monitor the formation and growth of Roflumilast Impurity 14 over time under various stress conditions (thermal, humidity, photolytic).
• Regulatory Submissions: Provides necessary data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs) to regulatory agencies like the FDA and EMA.
• Research & Development: Supports impurity profiling, degradation pathway studies, and process chemistry optimization during API synthesis.

Basic Information

Product Name	Roflumilast Impurity 14
CAS No.	2206113-97-3
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Roflumilast Related Compound 14; 3-Cyclopropylmethoxy-4-difluoromethoxy-N-(3,5-dichloropyridin-4-yl)benzamide Impurity; PDE4 Inhibitor Impurity; 3-(Cyclopropylmethoxy)-4-(difluoromethoxy)-N-(3,5-dichloropyridin-4-yl)benzamide Impurity; Roflumilast EP Impurity; Roflumilast USP Impurity; Daxas Impurity
EINECS	Contact for details

Quality Control

Every batch of Roflumilast Impurity 14 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity confirmation, purity assay, and impurity profiling using advanced analytical techniques such as HPLC, LC-MS, and NMR to ensure compliance with pharmacopeial standards (USP/EP/ICH). A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results, chromatograms, and traceability data.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the certificate of analysis. Keep the container in a dry, cool, and well-ventilated area. For long-term storage, consider storing under inert atmosphere to ensure stability.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Conforms
Identification (IR)	Conforms to reference spectrum
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual unspecified impurity: ≤ 1.0% Total impurities: ≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 1.0%

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