Description

Dapsone Impurity 10 is a high-purity chemical reference standard used for analytical and research purposes. This compound is critical for pharmaceutical quality control, specifically in the development and validation of analytical methods for the drug Dapsone. It is primarily utilized by pharmaceutical manufacturers, analytical laboratories, and research institutions to ensure product purity, safety, and regulatory compliance.

Application

• Pharmaceutical Reference Standard: Used as a certified impurity standard for the identification and quantification of related substances in Dapsone Active Pharmaceutical Ingredient (API) and finished drug products.
• Analytical Method Development & Validation (HPLC/LC-MS): Essential for developing, calibrating, and validating chromatographic methods to monitor impurities during manufacturing and stability studies.
• Quality Assurance & Control (QA/QC): Serves as a benchmark in routine quality control testing to ensure Dapsone batches meet stringent pharmacopeial specifications (e.g., USP, EP, ICH guidelines).
• Regulatory Compliance & Documentation: Supports regulatory filings (e.g., FDA, EMA) by providing necessary data on impurity profiles for drug master files and new drug applications.
• Stability Studies: Employed to track the formation and levels of this specific impurity under various storage conditions over time.
• Research & Development: Used in academic and industrial R&D to study the degradation pathways, metabolism, and synthesis of Dapsone and its related compounds.

Basic Information

Item	Details
Product Name	Dapsone Impurity 10
CAS No.	116435-84-8
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	4,4'-Sulfonylbis(2-methylaniline); Bis(2-methyl-4-aminophenyl) sulfone; Dapsone Impurity J; Dapsone Related Compound J; 2,2'-Dimethyldapsone; 4-Amino-2-methylbenzenesulfonamide derivative; DDS Impurity 10
EINECS	Contact for details

Quality Control

Every batch of Dapsone Impurity 10 is manufactured and tested under strict quality management systems. We provide comprehensive analytical data to support its use as a reference standard, ensuring identity, purity, and strength. A detailed Certificate of Analysis (COA) is supplied with each shipment, documenting results from advanced techniques like HPLC and mass spectrometry. Our quality commitment aligns with ICH Q3A/B guidelines for impurities and relevant pharmacopeial standards.

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 nature, the container must be kept tightly sealed in a dry environment to prevent moisture absorption, which could affect stability and purity. For long-term storage, consider desiccants or inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Total impurities ≤ 5.0%
Water Content (KF)	≤ 2.0%
Residue on Ignition	≤ 0.5%

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