Cromoglicic Acid is a pharmaceutical active ingredient with mast-cell stabilizing and anti-allergic properties. It is used to help prevent the release of inflammatory mediators such as histamine and other substances from mast cells.
Cromoglicic Acid, also known as Cromolyn Sodium in its commonly used pharmaceutical salt form, is a synthetic anti-allergic compound. It is used in various pharmaceutical formulations for the prevention and management of allergic conditions.
Cromoglicic Acid is identified by CAS No. 16110-51-3. The compound is commonly supplied as its disodium salt, sodium cromoglicate/cromolyn sodium, for pharmaceutical applications.
Cromoglicic Acid stabilizes mast cells and inhibits the release of inflammatory mediators involved in allergic reactions. It does not act as a conventional antihistamine; instead, its principal action is preventive, reducing mediator release following allergen exposure.
Cromoglicic Acid is used in pharmaceutical formulations for conditions such as allergic rhinitis, allergic conjunctivitis, asthma and certain food-allergic or gastrointestinal allergic conditions, depending on the dosage form and applicable regulatory approval.
Cromoglicic Acid can be supplied for pharmaceutical research, development, formulation and manufacturing applications, subject to applicable quality and regulatory requirements.
Quality evaluation may include identification, assay, related substances, water content, residue on ignition, pH, elemental impurities and other applicable pharmaceutical quality attributes.
Final acceptance criteria should always be based on the approved product specification, validated analytical methods and batch-specific Certificate of Analysis (CoA).
| Parameter | Specification |
|---|---|
| Appearance | White to off-white crystalline powder |
| Identification | IR & HPLC compliant |
| Assay (HPLC) | NLT 98.0% by HPLC |
| Loss on Drying | NMT 2.0% |
| Heavy Metals | NMT 10 ppm |
| pH (1% Solution) | 5.5 – 7.5 |
| Water Content | NMT 2.0% |
| Melting Point | 150°C – 154°C |