Description

Roflumilast-D4 CAS NO 1398065-69-4 is a deuterated internal standard of the selective phosphodiesterase-4 (PDE4) inhibitor Roflumilast, specifically designed for use in quantitative bioanalytical methods. This stable isotope-labeled compound is essential for ensuring the accuracy, precision, and reliability of pharmacokinetic and metabolism studies. It is a critical tool for pharmaceutical R&D laboratories, contract research organizations (CROs), and quality control units engaged in the development and analysis of respiratory therapeutics.

Application

• Quantitative Bioanalysis: Serves as a deuterated internal standard in Liquid Chromatography-Mass Spectrometry (LC-MS/MS) for the precise quantification of Roflumilast in biological matrices like plasma, serum, and tissue homogenates.
• Pharmacokinetic (PK) Studies: Enables accurate tracking of drug absorption, distribution, metabolism, and excretion (ADME) profiles in preclinical and clinical research.
• Drug Metabolism Studies: Used in metabolite identification and profiling to understand the biotransformation pathways of Roflumilast.
• Method Development & Validation: Critical for developing and validating robust, regulatory-compliant analytical methods for drug substance and product testing.
• Quality Control & Assurance: Supports impurity profiling and assay verification in pharmaceutical manufacturing to ensure batch-to-batch consistency.
• Regulatory Submissions: Provides the high-quality reference material required for supporting data in filings to agencies like the FDA and EMA.

Basic Information

Product Name	Roflumilast-D4
CAS No.	1398065-69-4
Molecular Formula	C17H10D4Cl2F2N2O3
Molecular Weight	405.22 g/mol (approximate)
Synonyms	3-(Cyclopropylmethoxy)-N-(3,5-dichloro-4-pyridinyl)-4-(difluoromethoxy-d2)-benzamide-d2; 3-(Cyclopropylmethoxy)-4-(difluoromethoxy-d2)-N-(3,5-dichloropyridin-4-yl)benzamide-d2; Roflumilast-d4; Dalfopristin-d4 (obsolete); APTA 2217-d4; BY 217-d4; B9302-107-d4; Deuterated Roflumilast
EINECS	Contact for details

Quality Control

Our Roflumilast-D4 is manufactured under strict quality systems to ensure the high chemical and isotopic purity required for analytical reference standards. Each batch is supported by a comprehensive Certificate of Analysis (COA) detailing parameters such as isotopic enrichment (D-content), chemical purity by HPLC, and identity confirmation. We adhere to relevant industry guidelines for reference materials to support your regulatory and research needs.

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 product is hygroscopic (moisture-sensitive) and should be handled in a dry environment to maintain stability. For long-term storage, consider desiccated conditions.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (Mass Spectrometry)	Conforms
Purity (HPLC)	≥ 98.0%
Isotopic Purity (D-content)	≥ 98.0 atom % D
Chemical Purity (by HPLC)	≥ 95.0%
Water Content (KF)	≤ 1.0%
Residue on Ignition	≤ 0.1%

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