Description

Sodium Cromoglicate Impurity 5 is a specified impurity and reference standard used in the quality control of the active pharmaceutical ingredient, Sodium Cromoglycate. This compound is critical for ensuring the purity, safety, and efficacy of pharmaceutical formulations, particularly for respiratory medications. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for research, method development, and compliance testing.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of impurities in Sodium Cromoglycate API.
• Analytical Method Development & Validation: Essential for developing and validating HPLC, UPLC, or other chromatographic methods in quality control laboratories.
• Pharmacopoeial Compliance: Supports testing to meet stringent purity criteria outlined in pharmacopoeias such as USP, EP, BP, and IP.
• Stability Studies: Employed in forced degradation and long-term stability studies to monitor impurity profiles in drug substances and products.
• Regulatory Submissions: Provides critical data for regulatory filings (e.g., ANDA, NDA) to demonstrate control of the manufacturing process.
• Research & Development: Used in synthetic chemistry R&D to understand degradation pathways and improve synthesis processes.

Basic Information

Product Name	Sodium Cromoglicate Impurity 5
CAS No.	40820-38-0
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Cromoglicic Acid Impurity 5; Disodium 5,5'-[(2-Hydroxytrimethylene)dioxy]bis(4-oxo-4H-1-benzopyran-2-carboxylate); 1,3-Bis(2-carboxy-4-oxochromen-5-yloxy)propan-2-ol disodium salt; Sodium Cromoglycate Impurity 5; Cromolyn Sodium Impurity 5; FPL 670 Impurity; Intal Impurity 5
EINECS	Contact for details

Quality Control

Every batch of Sodium Cromoglicate Impurity 5 is manufactured and analyzed under strict quality management systems. The product undergoes rigorous identity confirmation, purity assay, and impurity profiling using advanced analytical techniques such as HPLC and NMR to ensure it meets the high standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results.

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.

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	≤ 1.0%

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