Description

Probenecid Impurity 6 (Probenecid Isopropyl Ester) 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 Probenecid. It is primarily required by pharmaceutical manufacturers, contract research organizations (CROs), and analytical laboratories for ensuring drug purity, stability testing, and regulatory compliance.

Application

• Pharmaceutical Reference Standard: Serves as a certified impurity standard for the identification and quantification of related substances in Probenecid Active Pharmaceutical Ingredient (API) and finished dosage forms.
• Analytical Method Development & Validation: Essential for developing, calibrating, and validating HPLC, UPLC, and GC methods to monitor impurities during drug manufacturing.
• Stability Studies: Used to track the formation of degradation products in Probenecid under various stress conditions (e.g., heat, humidity, light) as per ICH guidelines.
• Quality Assurance/Quality Control (QA/QC): A key component in the impurity profile analysis to ensure batch-to-batch consistency and compliance with pharmacopeial standards (USP, EP).
• Regulatory Submissions: Provides necessary data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs).
• Research & Development: Utilized in metabolic and pharmacokinetic studies to understand the drug's impurity pathways and toxicological profiles.

Basic Information

Product Name	Probenecid Impurity 6 (Probenecid Isopropyl Ester)
CAS No.	70190-78-2
Molecular Formula	C16H21NO5S
Molecular Weight	339.41 g/mol
Synonyms	Benzoic acid, 4-[(dipropylamino)sulfonyl]-, 1-methylethyl ester; Probenecid Isopropyl Ester; Probenecid EP Impurity F; Probenecid Isopropyl Ester Impurity; 4-[(Dipropylamino)sulfonyl]benzoic acid isopropyl ester; 1-Methylethyl 4-[(dipropylamino)sulfonyl]benzoate; Probenecid Related Compound F; p-[(Dipropylamino)sulfonyl]benzoic acid isopropyl ester
EINECS	Contact for details

Quality Control

Every batch of Probenecid Impurity 6 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and impurity profile testing using advanced analytical techniques (HPLC, GC-MS, NMR) to ensure compliance with pharmacopeial and in-house specifications. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with each shipment to support your regulatory and research needs.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry environment. The material is stable under these conditions for extended periods.

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)	Individual impurity ≤ 0.5% Total impurities ≤ 2.0%
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.