Description

Cromolyn Disodium Salt is a synthetic chromone derivative and a mast cell stabilizer. This compound is valued for its potent anti-inflammatory and anti-allergic properties, making it a critical active pharmaceutical ingredient (API). It is primarily required by pharmaceutical manufacturers for the formulation of ophthalmic solutions, nasal sprays, and inhalation products designed to manage conditions like asthma, allergic rhinitis, and allergic conjunctivitis.

Application

• Pharmaceutical API: Primary use as the active ingredient in prescription medications for asthma prophylaxis and allergy management.
• Ophthalmic Solutions: Formulation of eye drops for the treatment of allergic conjunctivitis and vernal keratoconjunctivitis.
• Nasal Sprays: Key component in nasal sprays used to relieve symptoms of allergic rhinitis.
• Inhalation Products: Used in nebulizer solutions and metered-dose inhalers (MDIs) for controlling airway inflammation.
• Research & Development: Utilized in biochemical and pharmacological research to study mast cell function and allergic response pathways.
• Veterinary Medicine: Potential application in veterinary formulations for managing allergic conditions in animals.

Basic Information

Product Name	Cromolyn Disodium Salt
CAS No.	15826-37-6
Molecular Formula	C23H14Na2O11
Molecular Weight	512.33 g/mol
Synonyms	Disodium Cromoglycate; Cromoglicic Acid Disodium Salt; Cromolyn Sodium; Intal; Fisons 670; Sodium Cromoglicate; 5,5'-[(2-Hydroxytrimethylene)dioxy]bis(4-oxo-4H-1-benzopyran-2-carboxylic acid) Disodium Salt; DSCG
EINECS	239-926-7

Quality Control

Our Cromolyn Disodium Salt is manufactured under strict quality management systems. It undergoes comprehensive analytical testing to meet high-purity standards suitable for pharmaceutical applications. A Certificate of Analysis (COA) detailing identity, purity, and impurity profiles is provided with each batch to ensure traceability and compliance with relevant pharmacopeial guidelines.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). This material is hygroscopic (moisture-sensitive) and must be kept in a dry environment to prevent degradation and clumping.

Specification

Item	Specification
Appearance	White to off-white crystalline powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Assay (HPLC)	98.0% - 102.0% (on anhydrous basis)
Water Content (KF)	≤ 10.0%
pH (1% Solution)	4.0 - 7.0
Related Substances (HPLC)	Total impurities ≤ 2.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Heavy Metals	≤ 20 ppm

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