Description

Tiopronin Impurity 1 is a high-purity chemical reference standard used for analytical and quality control purposes. This compound is critical for pharmaceutical manufacturers and research laboratories to ensure the purity, safety, and efficacy of the active pharmaceutical ingredient Tiopronin. It serves as an essential tool for method development, validation, and regulatory compliance in the pharmaceutical and life sciences industries. Precise identification and quantification of this impurity are fundamental to meeting stringent pharmacopeial standards.

Application

• Pharmaceutical Reference Standard: Primary use as a certified impurity standard for the quality control of Tiopronin API (Active Pharmaceutical Ingredient) batches.
• Analytical Method Development: Used in R&D laboratories to develop and optimize HPLC, UPLC, or GC methods for impurity profiling.
• Regulatory Compliance & Documentation: Essential for preparing regulatory submission documents (e.g., for FDA, EMA) to demonstrate thorough impurity characterization.
• Pharmacopeial Testing: Employed in testing to comply with monographs from USP (United States Pharmacopeia), EP (European Pharmacopoeia), or other international pharmacopeias.
• Stability Studies: Used as a marker to monitor the formation of degradation products in Tiopronin drug substance and drug product stability programs.
• Contract Research & Testing (CRO/CMO): Supplied to third-party testing facilities that provide analytical services to the pharmaceutical industry.

Basic Information

Product Name	Tiopronin Impurity 1
CAS No.	21269-37-4
Molecular Formula	C5H9NO3S
Molecular Weight	163.19 g/mol
Synonyms	N-(2-Mercaptopropionyl)glycine Impurity 1; Thiola Impurity 1; (2S)-2-(2-Sulfanylcarbamoyl)propanoic acid; α-Mercaptopropionylglycine Related Compound A; Tiopronin EP Impurity A; Tiopronin USP Related Substance; Acetylcysteine analogue impurity
EINECS	Contact for details

Quality Control

Every batch of Tiopronin Impurity 1 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity confirmation, purity assay, and impurity profiling using advanced chromatographic (HPLC/UPLC) and spectroscopic (NMR, MS) techniques to ensure compliance with pharmacopeial and client-specific standards. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results, analytical methods, and traceability.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). This material is hygroscopic (moisture-sensitive); ensure the container is sealed tightly after each use to prevent degradation from atmospheric moisture.

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)	Single unspecified impurity ≤ 1.0% Total impurities ≤ 2.0%
Water Content (KF)	≤ 1.0%
Residue on Ignition	≤ 0.1%

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