Description

Sodium Cromoglicate Impurity CAS NO 3361-18-0 is a high-purity reference standard used for analytical and quality control purposes in pharmaceutical development and manufacturing. This compound is critical for ensuring the safety and efficacy of pharmaceutical products by enabling the accurate identification, quantification, and control of process-related impurities. It is an essential material for analytical chemists, quality assurance professionals, and researchers working in the pharmaceutical and life sciences sectors who require reliable reference standards for method validation and regulatory compliance.

Application

• Pharmaceutical Impurity Profiling: Used as a certified reference material for the identification and quantification of specific impurities in Sodium Cromoglicate API and finished drug products.
• Analytical Method Development and Validation: Serves as a critical standard for developing, optimizing, and validating HPLC, UPLC, and GC analytical methods to ensure accuracy and reproducibility.
• Quality Control (QC) and Quality Assurance (QA): Employed in routine QC testing within pharmaceutical manufacturing to monitor batch-to-batch consistency and ensure product purity meets pharmacopeial standards (e.g., USP, EP).
• Stability Studies: Used as a marker in forced degradation and long-term stability studies to understand the degradation pathways of Sodium Cromoglicate.
• Regulatory Submissions: Provides essential data for regulatory filings (e.g., with FDA, EMA) to demonstrate comprehensive impurity control strategies.
• Research and Development: Supports synthetic chemistry research aimed at understanding impurity formation and developing purer synthetic routes for active pharmaceutical ingredients (APIs).

Basic Information

Product Name	Sodium Cromoglicate Impurity
CAS No.	3361-18-0
Molecular Formula	C23H14Na2O11
Molecular Weight	512.33 g/mol
Synonyms	Disodium Cromoglicate Impurity; Cromolyn Sodium Impurity; 5,5'-[(2-Hydroxytrimethylene)dioxy]bis(4-oxo-4H-1-benzopyran-2-carboxylic acid) Disodium Salt; 1,3-Bis(2-carboxy-4-oxochromen-5-yloxy)-2-propanol Disodium Salt; FPL 670 Impurity; Intal Impurity; Opticrom Impurity
EINECS	Contact for details

Quality Control

Every batch of Sodium Cromoglicate Impurity CAS 3361-18-0 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and impurity profile testing using advanced analytical techniques (HPLC, GC-MS, NMR) to ensure compliance with industry and pharmacopeial standards. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with each shipment to support your quality and regulatory requirements.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry environment. For long-term storage, consider storing under inert atmosphere to maintain stability.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any individual impurity ≤ 0.5%
Water Content (KF)	≤ 1.0%
Residue on Ignition	≤ 0.1%

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