Description

Pidotimod Impurity D CAS NO 162148-15-4 is a specified impurity reference standard used in the analytical profiling and quality control of the immunomodulatory drug Pidotimod. This high-purity compound is critical for pharmaceutical manufacturers and analytical laboratories to ensure product safety, efficacy, and regulatory compliance. It is primarily utilized in research and development, method validation, and routine batch testing within the pharmaceutical industry.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of Pidotimod Impurity D in active pharmaceutical ingredients (APIs) and finished drug products.
• Analytical Method Development & Validation: Essential for developing, optimizing, and validating stability-indicating HPLC, UPLC, or LC-MS methods for Pidotimod.
• Quality Control & Batch Release: Serves as a system suitability standard and a calibrant in routine QC testing to monitor impurity levels against ICH Q3A/B guidelines.
• Stability Studies: Employed to track the formation of this specific degradation product under various stress conditions (e.g., heat, light, humidity) as part of forced degradation and shelf-life studies.
• Regulatory Submissions: Provides necessary data for regulatory filings (e.g., FDA, EMA) to establish impurity thresholds and justify specifications.
• Pharmacopoeial Testing: Supports testing in compliance with pharmacopoeial monographs where this impurity is controlled.

Basic Information

Product Name	Pidotimod Impurity D
CAS No.	162148-15-4
Molecular Formula	C9H12N2O4S
Molecular Weight	244.27 g/mol
Synonyms	(4R)-3-[(2S)-2-Amino-2-carboxyethyl]-1,3-thiazolidine-4-carboxylic acid; (R)-3-[(S)-2-Amino-2-carboxyethyl]thiazolidine-4-carboxylic acid; L-Cysteinyl-D-thiazolidine-4-carboxylic acid; Pidotimod Related Compound D; Pidotimod EP Impurity D; Pidotimod USP Impurity D
EINECS	Contact for details

Quality Control

Every batch of Pidotimod Impurity D is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and assay testing using advanced chromatographic (HPLC, LC-MS) and spectroscopic (NMR, IR) techniques to ensure compliance with pharmacopoeial standards (e.g., USP, EP) and customer-specific requirements. 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 in a cool, dry place at a controlled room temperature (15-25°C). This product is hygroscopic (moisture-sensitive) and must be kept under inert conditions or in a desiccator after opening to prevent degradation.

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%
Assay (on dried basis)	97.0% - 102.0%
Water Content (KF)	≤ 1.0%
Residue on Ignition	≤ 0.1%
Heavy Metals	≤ 20 ppm
Related Substances (HPLC)	Individual unknown impurity: ≤ 0.10% Total impurities: ≤ 1.0%

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