Description

Erdosteine is a synthetic mucolytic agent and thiol derivative, widely recognized for its therapeutic role in respiratory health. Its primary value lies in its ability to break down mucus proteins, facilitating easier clearance from the airways and providing antioxidant protection to lung tissue. This makes it a critical active pharmaceutical ingredient (API) for manufacturers developing medications to treat chronic obstructive pulmonary disease (COPD), bronchitis, and other respiratory conditions. Global pharmaceutical companies and contract manufacturing organizations (CMOs) seeking a reliable, high-purity API for solid dosage forms will find this product essential for their production lines.

Application

• Pharmaceutical API: Primary use as the active ingredient in prescription mucolytic medications for treating acute and chronic bronchopulmonary diseases.
• Tablet Formulation: Incorporated into immediate-release and film-coated tablets designed for oral administration.
• Capsule Production: Used in the manufacture of hard gelatin or vegetarian capsules for respiratory therapeutics.
• Granule & Sachet Products: Serves as the key component in granules or powders intended for oral suspension.
• Respiratory Disease Management: Formulated into drugs targeting symptoms of COPD, chronic bronchitis, and bronchiectasis.
• Contract Pharmaceutical Manufacturing: Supplied to CMOs and generic drug manufacturers for production under GMP guidelines.
• Clinical Trial Materials: Sourced for use in preclinical studies and Phase I-III clinical trials for new respiratory formulations.
• Veterinary Pharmaceuticals: Potential application in veterinary medicines for treating respiratory conditions in animals.

Basic Information

Product Name	Erdosteine
CAS No.	84611-23-4
Molecular Formula	C8H11NO4S2
Molecular Weight	249.31 g/mol
Synonyms	N-(Carboxymethylthioacetyl)homocysteine thiolactone; (R,S)-2-[(2-Oxo-2-[(tetrahydro-2-oxo-3-thienyl)amino]ethyl)thio]acetic acid; Erdosteinum; Dithiosteine; EST; MUCOCIS; MUCODYNE; ERDOMUC; VECTIC
EINECS	Contact for details

Quality Control

Our Erdosteine is manufactured under strict quality management systems to ensure it meets the stringent requirements for pharmaceutical actives. Each batch is tested against comprehensive specifications, which typically include identification, assay, related substances, residual solvents, and specific tests for enantiomeric purity. A Certificate of Analysis (COA) is provided with every shipment, detailing the results against relevant pharmacopeial standards such as USP or EP. We are committed to cGMP compliance and can support regulatory filings with necessary documentation.

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 in a dry environment to prevent degradation. For long-term storage, consider using desiccants in the container.

Specification

Item	Specification
Appearance	White to off-white crystalline powder
Identification (IR)	Conforms to reference standard
Identification (HPLC)	Retention time matches reference
Assay (HPLC)	98.0% - 102.0% (on anhydrous basis)
Related Substances (HPLC)	Individual impurity: NMT 0.5% Total impurities: NMT 1.5%
Water Content (KF)	NMT 1.0%
Residue on Ignition	NMT 0.1%
Heavy Metals	NMT 20 ppm
Specific Rotation	-25.0° to -30.0° (c=1 in water)
Enantiomeric Purity (Chiral HPLC)	NLT 99.0%

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