Description

Probenecid Impurity 4 (Probenecid EP Impurity D) is a high-purity chemical reference standard critical for pharmaceutical quality control and analytical research. This compound is essential for the accurate identification, quantification, and monitoring of a specified impurity during the development and manufacturing of Probenecid, a uricosuric agent. It is primarily required by pharmaceutical R&D laboratories, quality assurance/quality control (QA/QC) departments, and regulatory compliance teams to ensure drug safety and meet stringent pharmacopeial standards such as EP and USP.

Application

• Pharmaceutical Reference Standard: Serves as a certified reference material (CRM) for the identification and quantification of Probenecid EP Impurity D in active pharmaceutical ingredient (API) batches.
• Method Development and Validation: Used in analytical laboratories to develop, optimize, and validate HPLC, UPLC, or GC methods for impurity profiling.
• Quality Control & Assurance: Critical for routine QA/QC testing to ensure Probenecid API and finished drug products comply with pharmacopeial monographs (EP, USP, ICH Q3A/B guidelines).
• Stability Studies: Employed as a marker to track impurity formation and degradation pathways in stability testing of Probenecid under various ICH conditions.
• Regulatory Submissions: Provides essential data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs) to regulatory bodies like the FDA and EMA.
• Research and Development: Used in synthetic chemistry research to study impurity formation mechanisms and to develop purification processes for Probenecid.

Basic Information

Product Name	Probenecid Impurity 4 (Probenecid EP Impurity D)
CAS No.	70190-76-0
Molecular Formula	C13H19NO4S
Molecular Weight	285.36 g/mol
Synonyms	Probenecid Impurity D; Probenecid Related Compound D; 4-[(Dipropylamino)sulfonyl]benzoic Acid Impurity; Benzoic acid, 4-[(dipropylamino)sulfonyl]-; 4-(N,N-Dipropylsulfamoyl)benzoic Acid; Probenecid Process Impurity; Probenecid Specified Impurity
EINECS	Contact for details

Quality Control

Every batch of Probenecid Impurity 4 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous quality testing using advanced analytical techniques to ensure identity, purity, and consistency, supporting compliance with ICH guidelines and pharmacopeial standards. Comprehensive Certificates of Analysis (COA) detailing batch-specific results are provided and available upon request.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). This material is hygroscopic (moisture-sensitive) and should be handled in a dry environment to prevent degradation.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any individual impurity ≤ 0.5%
Water Content (KF)	≤ 0.5%
Residue on Ignition	≤ 0.1%

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