Description

Pidotimod Impurity 2 CAS NO 135124-63-9 is a specified impurity of the immunomodulatory drug Pidotimod, used as a critical reference standard in pharmaceutical development and quality control. This compound is essential for ensuring the purity, safety, and efficacy of Pidotimod drug substances and finished products by enabling accurate identification and quantification. It is primarily needed by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies involved in research, process validation, and compliance testing.

Application

• Pharmaceutical Reference Standard: Used as a certified impurity standard for the analytical method development and validation of Pidotimod.
• Quality Control & Assurance: Critical for the identification and quantification of impurities in Pidotimod Active Pharmaceutical Ingredient (API) batches to meet pharmacopeial specifications (e.g., EP, USP).
• Stability Studies: Employed to monitor the formation of degradation products in Pidotimod formulations under various storage conditions.
• Process Chemistry R&D: Serves as a key marker to optimize synthesis pathways and purification processes to minimize impurity levels in the final API.
• Regulatory Submissions: Provides essential data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs).
• Contract Research & Testing: Utilized by third-party laboratories offering analytical services for impurity profiling and specification testing.

Basic Information

Item	Detail
Product Name	Pidotimod Impurity 2
CAS No.	135124-63-9
Molecular Formula	C9H12N2O4S
Molecular Weight	244.27 g/mol
Synonyms	(4R)-3-[(2S)-2-Amino-2-carboxyethyl]-1,3-thiazolidine-4-carboxylic acid; L-Cysteinyl-L-thiazolidine-4-carboxylic acid derivative; Pidotimod Related Compound B; Pidotimod EP Impurity B; Pidotimod USP Impurity; (R)-3-((S)-2-Amino-2-carboxyethyl)thiazolidine-4-carboxylic acid; Immunomodulator impurity
EINECS	Contact for details

Quality Control

Our Pidotimod Impurity 2 is manufactured under strict quality management systems. Each batch is subjected to comprehensive analytical testing, including HPLC purity assay, related substance analysis, and identity confirmation (IR, MS), to ensure it meets the stringent requirements for use as a pharmaceutical reference standard. Certificates of Analysis (COA) with detailed chromatographic data are provided and traceable to primary standards.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry environment. The product is light-sensitive and should be handled accordingly to maintain stability.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to reference
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any single unknown impurity ≤ 0.5%
Water Content (KF)	≤ 1.0%
Residue on Ignition	≤ 0.2%

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