Dipivefrine is a synthetic ophthalmic prodrug of epinephrine (adrenaline) and a pharmaceutical active ingredient used primarily in ophthalmic preparations for the management of glaucoma and ocular hypertension. It is designed to improve ocular penetration compared with epinephrine.
Dipivefrine is identified by CAS No. 52365-63-6. Its molecular formula is C19H29NO5 and its molecular weight is approximately 351.44 g/mol.
Dipivefrine is a lipophilic derivative of epinephrine. After topical administration to the eye, it is hydrolyzed by ocular esterases to form epinephrine, which produces the principal pharmacological effect.
Dipivefrine is an adrenergic ophthalmic agent. Following conversion to epinephrine, it can reduce intraocular pressure by increasing aqueous humor outflow through the trabecular and uveoscleral pathways.
Dipivefrine penetrates the cornea and is converted enzymatically to epinephrine within ocular tissues. Epinephrine stimulates alpha- and beta-adrenergic receptors, resulting in changes in aqueous humor dynamics and reduction of intraocular pressure.
Dipivefrine is used in ophthalmic pharmaceutical formulations for:
Its approved use and availability may vary by country and regulatory authority.
Dipivefrine is relevant to pharmaceutical manufacturers and formulation-development organizations working on ophthalmic and antiglaucoma products.
It is primarily associated with ophthalmic dosage forms, particularly sterile eye-drop formulations, according to the approved product specification.
Dipivefrine API quality evaluation may include:
For ophthalmic products, additional controls relating to sterility, particulate matter and microbiological quality apply to the finished dosage form.
Dipivefrine intended for pharmaceutical manufacturing should comply with applicable GMP, quality-control and regulatory requirements.
The final API specification should correspond to the intended market, applicable pharmacopoeial requirements and the manufacturer's approved product specification.
A batch-specific Certificate of Analysis (CoA) should provide relevant analytical results and acceptance criteria.
Dipivefrine should be stored in tightly closed, appropriately labelled containers under the manufacturer's recommended storage conditions. Appropriate protection from light, heat, moisture and oxidation should be maintained where specified by the manufacturer.
Dipivefrine is relevant to pharmaceutical companies developing and manufacturing ophthalmic antiglaucoma formulations.
For commercial applications, customers should verify the API identity, chemical form, grade, assay, purity, impurity profile, regulatory documentation and batch-specific CoA before use.
Consistent Dipivefrine API quality is important for reliable ophthalmic formulation development and pharmaceutical manufacturing. Control of identity, assay, purity and related substances supports reproducible product quality.
Appropriate documentation may include a Certificate of Analysis, specification sheet, safety documentation and applicable regulatory information.
| Parameter | Specification |
|---|---|
| Appearance | White to off-white crystalline powder |
| Identification | IR & HPLC compliant |
| Assay (HPLC) | NLT 98.0% by HPLC |
| Loss on Drying | NMT 1.0% |
| Residue on Ignition | NMT 0.5% |
| Heavy Metals | NMT 10 ppm |
| pH (1% Solution) | 2.0 – 4.0 |
| Water Content | NMT 1.0% |
| Melting Point | 150°C – 154°C |