Description

Cromoglicic Acid Impurity 11 is a high-purity chemical reference standard, specifically identified as a process-related impurity of Cromoglicic Acid (Cromolyn Sodium). This compound is critical for analytical method development, validation, and quality control in pharmaceutical manufacturing. It is primarily utilized by research institutions, quality control laboratories, and pharmaceutical companies involved in the production and testing of mast cell stabilizer medications to ensure product safety and regulatory compliance.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of impurities in Cromoglicic Acid and Cromolyn Sodium active pharmaceutical ingredients (APIs).
• Analytical Method Development: Essential for developing and validating HPLC, UPLC, or GC methods to monitor impurity profiles during API synthesis and purification processes.
• Quality Assurance & Control (QA/QC): Serves as a system suitability standard and for preparing calibration curves to ensure the accuracy and precision of impurity assays in compliance with ICH Q3A/B guidelines.
• Stability Studies: Employed in forced degradation and long-term stability testing of Cromoglicic Acid-based drug products to track impurity formation over time.
• Regulatory Submissions: Provides necessary impurity characterization data for Drug Master Files (DMFs), Investigational New Drug (IND) applications, and New Drug Applications (NDAs).
• Process Chemistry Research: Used by chemists to study and optimize synthesis pathways to minimize the formation of this specific impurity.

Basic Information

Product Name	Cromoglicic Acid Impurity 11
CAS No.	149992-30-3
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Cromolyn Impurity 11; Cromoglycic Acid Impurity 11; Disodium Cromoglycate Impurity 11; 1,3-Bis(2-carboxychromon-5-yloxy)-2-hydroxypropane Impurity; FPL 670 Impurity; Intal Impurity; Opticrom Impurity; Respiratory Anti-inflammatory Agent Impurity
EINECS	Contact for details

Quality Control

Every batch of Cromoglicic Acid Impurity 11 is manufactured and handled under strict quality management systems. It undergoes comprehensive analytical testing, including chromatographic purity assays and spectroscopic identification, to ensure it meets the high standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) detailing batch-specific results, including purity by HPLC, is provided with each shipment to support your regulatory and quality needs.

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 reference spectrum
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual unspecified impurity: ≤ 1.0% Total impurities: ≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Water Content (KF)	≤ 5.0% w/w

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