Description

Acetylcysteine Impurity 4 Disodium Salt is a high-purity reference standard critical for pharmaceutical research and development. This compound serves as a key impurity marker for the quality control and validation of Acetylcysteine, an essential mucolytic and antidotal agent. It is primarily required by analytical laboratories and pharmaceutical manufacturers to ensure product safety, efficacy, and regulatory compliance. The use of this well-characterized standard is fundamental for method development, stability studies, and batch release testing.

Application

• Pharmaceutical Reference Standard: Used as a certified impurity standard for the identification and quantification of related substances in Acetylcysteine Active Pharmaceutical Ingredients (APIs) and finished dosage forms.
• Analytical Method Development & Validation: Essential for developing and validating HPLC, UPLC, or GC methods to monitor impurities during stability studies and release testing.
• Quality Control & Assurance (QC/QA): Provides a benchmark for impurity profiling to ensure batches of Acetylcysteine meet stringent pharmacopeial specifications (e.g., USP, EP, JP).
• Regulatory Compliance & Filings: Supports the preparation of regulatory documentation (e.g., CMC sections for FDA, EMA) by providing characterized impurity data.
• Stability Studies: Employed to track the formation and levels of this specific degradation product under various stress conditions.
• Research & Development: Used in metabolic and pharmacokinetic studies to understand the impurity's profile and behavior.

Basic Information

Product Name	Acetylcysteine Impurity 4 Disodium Salt
CAS No.	282727-77-9
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	N-Acetyl-L-cysteine Impurity 4 Disodium Salt; Disodium N-Acetylcysteine Impurity 4; Acetylcysteine Related Compound 4 Disodium Salt; N-Acetylcysteine Impurity D Disodium; L-Cysteine, N-acetyl-, impurity 4 disodium salt; Acetylcysteine EP Impurity D Disodium; Acetylcysteine USP Impurity 4 Disodium
EINECS	Contact for details

Quality Control

Every batch of Acetylcysteine Impurity 4 Disodium Salt is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and impurity testing to ensure they meet the high standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA), detailing results from advanced analytical techniques like HPLC and MS, is provided with each shipment to guarantee traceability and compliance.

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 material is hygroscopic (moisture-sensitive) and must be kept in a desiccated environment to maintain stability and purity. Handle the container with care to minimize exposure to atmospheric humidity.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 95.0%
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.