Description

Sodium Cromoglicate Impurity 4 is a high-purity reference standard critical for pharmaceutical quality control and analytical research. This compound is essential for the accurate identification, quantification, and monitoring of process-related impurities in Sodium Cromoglicate (Cromolyn Sodium) drug substances and finished pharmaceutical products. It is primarily used by analytical laboratories, quality assurance departments, and research institutions within the global pharmaceutical and life sciences industries to ensure product safety, efficacy, and regulatory compliance.

Application

• Pharmaceutical Impurity Profiling and Characterization: Serves as a certified reference material for identifying and quantifying this specific impurity in Sodium Cromoglicate API and formulations.
• Analytical Method Development and Validation: Used as a critical standard to develop, optimize, and validate HPLC, UPLC, or other chromatographic methods for impurity analysis.
• Quality Control and Batch Release Testing: Essential for routine QC testing in pharmaceutical manufacturing to ensure batches meet stringent pharmacopeial (e.g., USP, EP, BP) impurity limits.
• Stability Studies: Employed to monitor the formation of this impurity over time under various stress conditions, supporting drug shelf-life determination.
• Regulatory Submissions: Provides necessary data for regulatory filings (e.g., with FDA, EMA) to demonstrate thorough impurity control strategies.
• Research on Degradation Pathways: Aids in research to understand the synthesis, degradation mechanisms, and fate of impurities in Sodium Cromoglicate.

Basic Information

Product Name	Sodium Cromoglicate Impurity 4
CAS No.	40786-63-8
Molecular Formula	C23H14Na2O11
Molecular Weight	528.33 g/mol
Synonyms	Disodium 5,5'-[(2-Hydroxytrimethylene)dioxy]bis(4-oxo-4H-1-benzopyran-2-carboxylate); Cromolyn Sodium Impurity 4; Cromoglycic Acid Impurity 4; Cromolyn Impurity D (Disodium salt); 1,3-Bis(2-carboxy-4-oxochromen-5-yloxy)propan-2-ol disodium salt
EINECS	Contact for details

Quality Control

Every batch of Sodium Cromoglicate Impurity 4 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and impurity profile testing using advanced analytical techniques (HPLC, NMR, MS) to ensure compliance with industry standards for reference materials. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results, chromatographic purity, and traceability.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). This product is hygroscopic (moisture-sensitive); ensure the container is sealed tightly after each use to prevent absorption of atmospheric moisture.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any individual unknown impurity ≤ 0.5%
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.