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Specifications
| Grade | USP–NF 2024 |
| Appearance | White or almost white, hygroscopic, crystalline powder |
| Solubility | Soluble in water; insoluble in alcohol and in chloroform |
| Identification (IR) | The infrared spectrum of the sample solution is consistent with that of a similarly prepared reference solution |
| Identification (HPLC) | The retention time of the major peak of the sample solution corresponds to that of the reference solution |
| Identification (General test <191>) | Complies |
| Water | ≤ 10.0% |
| Heavy metals | ≤ 0.002% |
| Limit of oxalate | The absorbance of the sample solution is NLT that of the standard solution (NMT 0.35% of oxalate) |
| Related Substances (HPLC) | |
| Cromolyn tricarboxylic acid analog | ≤ 0.25% |
| 2-Acetylresorcinol | ≤ 0.1% |
| Cromolyn related compound A | ≤ 0.1% |
| Cromolyn related compound B | ≤ 0.1% |
| Any other individual unspecified impurity | ≤ 0.1% |
| Total impurities | ≤ 0.5% |
| Ethanol | ≤ 0.5% |
| Assay (on the anhydrous basis) | 98.0% – 101.0% |
Applications
Sodium cromoglycate is widely used in pharmaceutical and clinical settings as an anti-allergic and anti-inflammatory agent. It is commonly formulated for the prevention and management of allergic conditions such as bronchial asthma, allergic rhinitis, allergic conjunctivitis, and food-related hypersensitivity reactions. The compound is administered via inhalation, nasal sprays, ophthalmic solutions, or oral formulations, depending on the therapeutic indication. In respiratory care, sodium cromoglycate is used as a prophylactic treatment to reduce asthma symptoms triggered by allergens or exercise. It is also applied in clinical and pharmacological research to investigate mast cell stabilization, allergic response pathways, and immune-mediated inflammation.
Benefits
Sodium cromoglycate offers several advantages due to its unique mechanism of action and favorable safety profile. It works by stabilizing mast cells and preventing the release of inflammatory mediators such as histamine and leukotrienes, thereby reducing allergic reactions before they occur. The compound is non-steroidal and does not cause immunosuppression, making it suitable for long-term use and for pediatric or sensitive patient populations. Its low systemic absorption when administered topically minimizes the risk of systemic side effects. Additionally, sodium cromoglycate is chemically stable and compatible with multiple dosage forms, supporting consistent therapeutic performance and reliable formulation.
Conclusion
Sodium cromoglycate is a well-established anti-allergic agent with broad applications in the prevention of asthma and other allergic conditions. Its benefits, including mast cell stabilization, non-steroidal action, high tolerability, and suitability for long-term use, make it an important option in allergy management and respiratory care. The compound continues to play a significant role in both clinical therapy and research focused on allergic and inflammatory diseases.
