Description

Pidotimod Impurity 5 is a specified impurity and reference standard used in the analytical profiling and quality control of the immunomodulatory drug Pidotimod. This compound is critical for pharmaceutical manufacturers and analytical laboratories to ensure product purity, safety, and regulatory compliance. It is primarily utilized in research and development, method validation, and as a critical component in stability studies for Pidotimod-based formulations.

Application

• Pharmaceutical Reference Standard: Serves as a certified reference material (CRM) for the identification and quantification of Pidotimod Impurity 5 in active pharmaceutical ingredients (APIs) and finished drug products.
• Analytical Method Development & Validation: Essential for developing, calibrating, and validating chromatographic methods, such as HPLC and UPLC, to monitor impurity profiles.
• Quality Control & Assurance (QC/QA): Used in routine batch testing to ensure Pidotimod API and formulations meet stringent pharmacopeial (e.g., USP, EP) and ICH guidelines for impurity limits.
• Stability Studies: Employed to track the formation and level of this specific degradation product under various stress conditions (e.g., heat, humidity, light) as part of drug shelf-life determination.
• Regulatory Submissions: Provides necessary data and characterization for regulatory filings (e.g., FDA, EMA) to demonstrate thorough impurity control strategies.
• Process Chemistry Research: Aids in optimizing synthesis and purification processes to minimize the formation of this impurity during Pidotimod manufacturing.

Basic Information

Product Name	Pidotimod Impurity 5
CAS No.	156523-77-2
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 impurity; Pidotimod Related Compound; Pidotimod Impurity C; Pidotimod EP Impurity C; Pidotimod USP Impurity
EINECS	Contact for details

Quality Control

Every batch of Pidotimod Impurity 5 is manufactured under controlled conditions and undergoes rigorous analytical testing to ensure identity, purity, and consistency. Our quality system is designed to meet the exacting standards of pharmaceutical reference material production. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing results for assay, purity, and specified impurities by validated methods such as HPLC, NMR, and MS. We support compliance with ICH Q3A/B, USP, and EP guidelines.

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. For long-term storage, consider storing at 2-8°C.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Assay	95.0% - 105.0% (on anhydrous basis)
Water Content (KF)	≤ 2.0%
Residue on Ignition	≤ 0.5%
Heavy Metals	≤ 20 ppm
Related Substances (HPLC)	Individual unknown impurity: ≤ 0.5% Total impurities: ≤ 2.0%

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