Description

Pidotimod Impurity Eeter CAS NO 131805-70-4 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 the immunomodulatory drug Pidotimod. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method development, validation, and impurity profiling.

Application

• Pharmaceutical Impurity Profiling: Serves as a certified reference standard for the identification and quantification of specific impurities in Pidotimod Active Pharmaceutical Ingredient (API) and finished drug products.
• Analytical Method Development & Validation: Used as a critical component in developing and validating HPLC, UPLC, or GC methods to ensure accurate detection limits and specificity.
• Quality Control & Assurance (QC/QA): Employed in routine batch testing within pharmaceutical QC laboratories to monitor and control impurity levels against ICH guidelines.
• Regulatory Compliance & Documentation: Essential for preparing regulatory submission dossiers (e.g., for FDA, EMA) that require detailed impurity characterization and control strategies.
• Stability Studies: Used as a marker to track the formation of degradation products during forced degradation and long-term stability studies of Pidotimod formulations.
• Research & Development (R&D): Supports synthetic chemistry research aimed at understanding degradation pathways and improving the synthesis process of Pidotimod.

Basic Information

Product Name	Pidotimod Impurity Eeter
CAS No.	131805-70-4
Molecular Formula	C9H12N2O4S
Molecular Weight	244.27 g/mol
Synonyms	(4R)-3-[(2S)-2-Amino-2-carboxyethyl]-1,3-thiazolidine-4-carboxylic acid ethyl ester; L-Cysteinyl-L-thiazolidine-4-carboxylic acid ethyl ester; Pidotimod Ethyl Ester; Pidotimod Related Compound E; Pidotimod Ester Impurity; PGT/EE
EINECS	Contact for details

Quality Control

Every batch of Pidotimod Impurity Eeter is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and impurity testing using advanced chromatographic (HPLC, UPLC) and spectroscopic (NMR, MS) techniques to ensure compliance with pharmacopeial standards. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with each shipment.

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 hygroscopic (moisture-sensitive) and should be handled under anhydrous conditions to maintain stability.

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 unknown impurity: ≤ 0.5% 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.