Description

Acetylcysteine Impurity 14 Hcl Dihcl is a high-purity chemical reference standard used for analytical and quality control purposes in pharmaceutical development. This compound is critical for ensuring the safety and efficacy of Acetylcysteine-based drug products by enabling the accurate identification and quantification of related substances. It is an essential tool for researchers and quality assurance professionals in the pharmaceutical and biotechnology industries who require reliable impurity standards for method validation, stability studies, and regulatory compliance.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material for the identification and quantification of impurities in Acetylcysteine Active Pharmaceutical Ingredients (APIs) and finished drug products.
• Analytical Method Development & Validation: Used to develop, optimize, and validate chromatographic methods (e.g., HPLC, UPLC) for impurity profiling.
• Quality Control & Batch Release Testing: Serves as a system suitability standard and a quantitative marker in the routine QC testing of Acetylcysteine to ensure compliance with pharmacopeial monographs (USP, EP, JP).
• Stability Studies: Employed in forced degradation and long-term stability studies to monitor the formation of this specific impurity over time and under various stress conditions.
• Regulatory Submissions: Provides essential data for regulatory filings (e.g., FDA, EMA) to establish impurity thresholds and justify specifications.
• Research & Development: Used in synthetic chemistry and process development to understand and control impurity formation during API manufacturing.

Basic Information

Product Name	Acetylcysteine Impurity 14 Hcl Dihcl
CAS No.	438542-17-7
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	N-Acetyl-L-cysteine Impurity 14; Acetylcysteine Related Compound 14; N-Acetylcysteine Impurity 14 Hydrochloride; (2R)-2-Acetamido-3-sulfanylpropanoic acid impurity; ACC Impurity 14; NAC Impurity 14 HCl; S-Carboxymethylcysteine Impurity; Acetylcysteine EP Impurity H
EINECS	Contact for details

Quality Control

Every batch of Acetylcysteine Impurity 14 Hcl Dihcl is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and assay testing using validated analytical methods (including HPLC, NMR, and MS) to ensure they meet the high standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results and confirming compliance with in-house specifications aligned with ICH guidelines.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the label or COA. This material is hygroscopic (moisture-sensitive) and must be kept in a dry environment. For long-term storage, consider desiccants or inert atmosphere to ensure stability.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 95.0%
Assay	90.0% - 110.0% (on anhydrous basis)
Water Content (KF)	≤ 5.0%
Residue on Ignition	≤ 0.5%
Heavy Metals	≤ 20 ppm

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