Description

Dapsone Impurity 8 is a high-purity chemical reference standard used for analytical and research purposes. This compound is critical for ensuring the quality, safety, and regulatory compliance of Dapsone, a key pharmaceutical active ingredient. It is primarily required by analytical laboratories, quality control units, and research scientists in the pharmaceutical industry for method development, validation, and impurity profiling studies.

Application

• Pharmaceutical Reference Standard: Used as a certified impurity standard for the identification and quantification of Dapsone Impurity 8 in Dapsone Active Pharmaceutical Ingredient (API) and finished drug products.
• Analytical Method Development & Validation: Essential for developing and validating chromatographic methods, such as HPLC and UPLC, to monitor impurities in accordance with ICH guidelines.
• Quality Control & Assurance (QC/QA): Serves as a critical tool for in-house quality control testing to ensure Dapsone batches meet stringent pharmacopeial specifications (e.g., USP, EP).
• Regulatory Compliance & Filing: Supports regulatory submissions (e.g., to FDA, EMA) by providing necessary data on impurity profiles for drug master files (DMFs) and new drug applications (NDAs).
• Stability Studies: Employed to track the formation and level of this specific impurity during forced degradation and long-term stability testing of Dapsone formulations.
• Research & Development: Used in R&D to study the degradation pathways, synthesis impurities, and metabolic profiles related to Dapsone.

Basic Information

Product Name	Dapsone Impurity 8
CAS No.	14665-52-2
Molecular Formula	C12H12N2O2S
Molecular Weight	248.30 g/mol
Synonyms	4,4'-Sulfonylbis(2-methylaniline); 4-Amino-4'-(2-methylamino)diphenyl sulfone; Dapsone N-Methyl Impurity; Dapsone Related Compound B (in some references); N-Methyl Dapsone; Bis(4-amino-3-methylphenyl) sulfone; 4,4'-Sulfonylbis(2-methylbenzenamine); DADPS Impurity
EINECS	Contact for details

Quality Control

Every batch of Dapsone Impurity 8 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and assay testing using advanced analytical techniques like HPLC, GC, and NMR to ensure compliance with industry standards. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with each shipment to support your quality and regulatory requirements.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry environment. This material is light-sensitive (store away from light) and should be handled to minimize prolonged exposure to air and moisture.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any individual unknown impurity ≤ 0.5%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 0.5% w/w

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