Description

Dapsone Impurity 9 CAS NO 53347-49-2 is a specified impurity of the pharmaceutical compound Dapsone, used as a critical reference standard in analytical chemistry. This compound is essential for ensuring the quality, safety, and efficacy of Dapsone-based drug products by enabling accurate identification and quantification of impurities during manufacturing and quality control processes. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies involved in research, development, and compliance testing.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of Dapsone Impurity 9 in active pharmaceutical ingredients (APIs) and finished drug products.
• Method Development and Validation: Essential for developing, optimizing, and validating analytical methods, such as HPLC and UPLC, to monitor impurities in Dapsone synthesis.
• Quality Control & Assurance (QC/QA): Serves as a benchmark in routine quality control testing to ensure Dapsone batches meet stringent pharmacopeial purity specifications (e.g., USP, EP, ICH guidelines).
• Stability Studies: Employed in forced degradation and long-term stability studies of Dapsone to understand impurity profiles and degradation pathways.
• Regulatory Submissions: Critical for preparing regulatory documentation (e.g., for FDA, EMA) to demonstrate comprehensive impurity control and characterization.
• Research and Development: Used in R&D to study the synthesis, metabolism, and toxicological profile of Dapsone-related compounds.

Basic Information

Product Name	Dapsone Impurity 9
CAS No.	53347-49-2
Molecular Formula	C12H12N2O2S
Molecular Weight	248.30 g/mol
Synonyms	4,4'-Sulfonylbis(2-methylaniline); 4,4'-Sulfonylbis(o-toluidine); 2,2'-Dimethyl-4,4'-sulfonyldianiline; Bis(2-methyl-4-aminophenyl) sulfone; Dapsone Impurity F; Dapsone Related Compound F; Dapsone EP Impurity F; Dapsone USP Impurity F
EINECS	Contact for details

Quality Control

Our Dapsone Impurity 9 is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including HPLC purity analysis and spectroscopic identification (IR, NMR, MS), to ensure it meets the high standards required for use as a pharmaceutical reference standard. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results, and our quality systems support compliance with relevant pharmacopeial guidelines (USP, EP) and ICH Q3A/B.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). Due to its hygroscopic (moisture-sensitive) nature, the container should be kept in a desiccated environment to prevent degradation. For long-term storage, consider storing under an inert atmosphere.

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)	Total impurities ≤ 2.0% Any individual unspecified impurity ≤ 0.5%
Water Content (KF)	≤ 1.0% w/w
Residue on Ignition	≤ 0.1%

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