Description

Fudosteine Impurity 2 is a designated impurity standard used in the analytical profiling and quality control of the active pharmaceutical ingredient (API) Fudosteine. This compound is critical for ensuring the purity, safety, and efficacy of pharmaceutical formulations by serving as a reference marker in chromatographic analysis. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies involved in research, development, and quality assurance of mucolytic drug products.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of impurities in Fudosteine API and finished dosage forms.
• Analytical Method Development & Validation: Essential for developing, optimizing, and validating stability-indicating HPLC or UPLC methods in compliance with ICH guidelines.
• Quality Control & Batch Release Testing: Employed in routine QC laboratories to monitor impurity profiles and ensure batch-to-batch consistency of the API.
• Regulatory Submissions: Supports regulatory filings (e.g., for FDA, EMA) by providing necessary impurity characterization data for drug master files (DMFs) and marketing authorization applications.
• Stability Studies: Acts as a key marker in forced degradation and long-term stability studies to track impurity formation over time.
• Pharmacopoeial Testing: Used for testing against monograph specifications in pharmacopoeias such as USP, EP, or JP where applicable.

Basic Information

Product Name	Fudosteine Impurity 2
CAS No.	1480319-53-6
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Fudosteine Related Compound 2; Fudosteine Impurity B; Fudosteine Specified Impurity 2; (2R)-2-Amino-3-(3-hydroxypropyl)sulfanylpropanoic acid impurity; S-Carboxyethylcysteine impurity; (-)-S-Carboxyethyl-L-cysteine impurity; Fudosteine Process Impurity
EINECS	Contact for details

Quality Control

Our Fudosteine Impurity 2 is manufactured under strict quality management systems. Each batch is characterized and tested using advanced analytical techniques including HPLC, GC-MS, and NMR to ensure high purity and accurate identification. Certificates of Analysis (COA) are provided, detailing batch-specific results for identity, purity, and impurities. The material is suitable for use as a pharmaceutical reference standard in compliance with ICH Q3A/B and current Good Manufacturing Practice (cGMP) principles.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (typically 15-25°C). This material is hygroscopic (moisture-sensitive) and should be handled in a dry environment to prevent degradation.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual impurity: ≤ 1.0% Total impurities: ≤ 5.0%
Water Content (KF)	≤ 5.0%
Residue on Ignition	≤ 0.5%

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