Description

Sodium Cromoglicate Impurity CAS NO 16130-28-2 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 purity, safety, and efficacy of Sodium Cromoglicate (Cromolyn Sodium) drug products by enabling the accurate identification and quantification of related substances. It is an essential material for analytical chemists, quality assurance laboratories, and regulatory affairs professionals working in the pharmaceutical and life sciences sectors.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for calibrating analytical instruments and validating testing methods in compliance with ICH, USP, and EP guidelines.
• Impurity Profiling and Identification: Used in HPLC, UPLC, and LC-MS analyses to identify, characterize, and quantify this specific impurity in Sodium Cromoglicate active pharmaceutical ingredient (API) and finished drug formulations.
• Method Development and Validation: Serves as a critical component in developing and validating stability-indicating assay methods for Sodium Cromoglicate to meet regulatory submission requirements.
• Quality Control (QC) Testing: Employed in routine QC laboratories to monitor impurity levels throughout the API synthesis and drug product manufacturing process, ensuring batch-to-batch consistency.
• Stability Studies: Used as an analytical marker in forced degradation and long-term stability studies to understand the degradation pathways of Sodium Cromoglicate.
• Regulatory Compliance and Filing: Essential for preparing regulatory documentation (e.g., Drug Master Files, CMC sections) to demonstrate comprehensive impurity control to agencies like the FDA and EMA.

Basic Information

Product Name	Sodium Cromoglicate Impurity
CAS No.	16130-28-2
Molecular Formula	C23H14Na2O11
Molecular Weight	512.33 g/mol
Synonyms	Disodium 5,5'-[(2-Hydroxytrimethylene)dioxy]bis[4-oxo-4H-1-benzopyran-2-carboxylate]; Cromolyn Sodium Impurity; Cromoglycic Acid Impurity; 1,3-Bis(2-carboxy-4-oxochromen-5-yloxy)-2-propanol Disodium Salt; Cromolyn Disodium Impurity; FPL 670 Impurity; Intal Impurity; Aarane Impurity
EINECS	Contact for details

Quality Control

Every batch of Sodium Cromoglicate Impurity CAS 16130-28-2 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and assay testing using advanced chromatographic (HPLC, UPLC) and spectroscopic (NMR, MS) techniques to ensure compliance with pharmaceutical reference standard requirements. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results for purity, related substances, and residual solvents.

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 should be handled in a low-humidity environment to prevent degradation. For long-term storage, consider desiccated conditions.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Assay (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any single unknown impurity ≤ 0.5%
Water Content (KF)	≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines

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