Emedastine API is a second-generation antihistamine and selective histamine H1-receptor antagonist used in pharmaceutical formulations for allergic conditions. Emedastine is commonly supplied in its difumarate salt form, which is used in pharmaceutical products including preparations for allergic conjunctivitis and other allergic disorders.
Emedastine difumarate is described as a white to yellowish crystalline powder and is soluble in water. It is also described as sparingly soluble in anhydrous ethanol and very slightly soluble in acetone. The compound exhibits polymorphism.
Swapnroop provides pharmaceutical-grade Emedastine API / Emedastine Difumarate for pharmaceutical development and manufacturing applications, subject to applicable quality and regulatory requirements.
| Parameter | Specification |
|---|---|
| Appearance | White to off-white crystalline powder |
| Identification | IR & HPLC compliant |
| Assay (HPLC) | 99.0% – 101.0% on dried substance |
| Loss on Drying | NMT 1.0% |
| Residue on Ignition | NMT 0.5% |
| Heavy Metals | NMT 10 ppm |
| pH (1% Solution) | 2.0 – 3.0 |
| Individual Impurity | NMT 0.5% |
| Total Impurities | NMT 1.0% |
| Water Content | NMT 1.0% |
| Melting Point | 150°C – 154°C |