Description

Sodium Cromoglicate Impurity 12 is a high-purity chemical reference standard, specifically identified as an impurity of the active pharmaceutical ingredient Sodium Cromoglicate. This compound is critical for analytical method development, validation, and quality control processes in pharmaceutical manufacturing. It is essential for researchers and quality assurance professionals in the pharmaceutical and fine chemical industries who require precise impurity profiling to ensure drug safety, efficacy, and regulatory compliance.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of impurities in Sodium Cromoglicate API and finished drug products.
• Analytical Method Development: Serves as a critical component in developing and validating HPLC, UPLC, or GC methods for impurity analysis.
• Quality Control & Assurance (QC/QA): Employed in routine batch testing to monitor and control impurity levels, ensuring adherence to pharmacopeial specifications (e.g., USP, EP, ICH Q3A/B).
• Stability Studies: Used to identify and track degradation products in stability testing of Sodium Cromoglicate formulations.
• Regulatory Submissions: Provides essential data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs).
• Research & Development: Facilitates process chemistry research aimed at understanding and minimizing impurity formation during API synthesis.

Basic Information

Product Name	Sodium Cromoglicate Impurity 12
CAS No.	802857-44-9
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Cromoglicic Acid Impurity 12 (Sodium Salt); Disodium 5,5'-[(2-Hydroxytrimethylene)dioxy]bis(4-oxo-4H-1-benzopyran-2-carboxylate); Cromolyn Sodium Impurity 12; Sodium Cromoglycate Impurity 12; Intal Impurity 12; FPL 670 Impurity 12; 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 12 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity confirmation, purity assay, and impurity profiling using advanced analytical techniques such as HPLC, NMR, and MS to ensure compliance with industry standards. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results. We support compliance with ICH guidelines and relevant pharmacopeial requirements for impurity standards.

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 dry environment to prevent degradation. For long-term storage, consider desiccated conditions.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (HPLC)	Conforms
Identification (IR)	Conforms to reference spectrum
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual impurity: ≤ 1.0% Total impurities: ≤ 5.0%
Water Content (KF)	≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C

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