Cyclopentolate is a synthetic antimuscarinic pharmaceutical active ingredient primarily used in ophthalmic preparations. It produces temporary mydriasis (pupil dilation) and cycloplegia (temporary paralysis of accommodation), making it useful in ophthalmic diagnostic procedures and eye examinations.
Cyclopentolate is an anticholinergic compound that acts by blocking muscarinic acetylcholine receptors in the eye. It is commonly formulated as cyclopentolate hydrochloride ophthalmic solution.
Cyclopentolate is identified by CAS No. 512-15-2. It has the molecular formula C17H25NO3 and a molecular weight of approximately 291.39 g/mol.
Cyclopentolate produces a temporary reduction in the action of the parasympathetic nervous system on the iris sphincter and ciliary muscle. This results in dilation of the pupil and temporary loss of the eye's ability to accommodate for near vision.
Its relatively rapid onset and temporary duration of action make it particularly useful in ophthalmic diagnostic applications.
Cyclopentolate is a competitive muscarinic receptor antagonist. By blocking muscarinic receptors in the iris sphincter muscle, it causes relaxation of the muscle and produces mydriasis.
Blocking muscarinic receptors in the ciliary muscle produces cycloplegia, temporarily preventing accommodation and allowing accurate ophthalmic examination and refractive assessment.
Cyclopentolate is primarily used in ophthalmic formulations for:
The specific concentration and formulation depend on the intended pharmaceutical product and applicable regulatory requirements.
Cyclopentolate is commonly used in pharmaceutical formulations as cyclopentolate hydrochloride. The hydrochloride salt is particularly relevant for ophthalmic formulation development.
When entering product information in a pharmaceutical CMS, the free base and hydrochloride salt should not be treated as identical materials. The CAS number, molecular formula, molecular weight and specifications should correspond to the actual API form being supplied.
Cyclopentolate API quality evaluation may include:
Testing should be performed using validated analytical procedures appropriate for the API and intended ophthalmic formulation.
Cyclopentolate intended for pharmaceutical manufacturing should comply with applicable GMP, quality-control and regulatory requirements. Specifications should be established according to the intended market, applicable pharmacopoeial standards and the manufacturer's approved product specification.
For ophthalmic applications, additional controls may be required for the finished dosage form, including sterility and other ophthalmic product quality attributes.
Cyclopentolate API should be stored in suitable, tightly closed packaging under the conditions specified by the manufacturer. The material should be protected from excessive heat, moisture and unsuitable environmental exposure.
Cyclopentolate is relevant to pharmaceutical manufacturers and formulation-development companies working on ophthalmic diagnostic products and antimuscarinic eye preparations.
For commercial pharmaceutical applications, customers should verify the API form, grade, specification, assay, impurity profile, regulatory documentation and batch-specific Certificate of Analysis (CoA) before use.
Consistent Cyclopentolate API quality is important for reliable pharmaceutical formulation and manufacturing. Appropriate control of identity, assay, purity and related substances supports reproducible pharmaceutical production.
Quality documentation such as a Certificate of Analysis, specification sheet, safety documentation and applicable regulatory information can support pharmaceutical development and commercial manufacturing requirements.
| 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 |
| Individual Impurity | NMT 1.0% |
| Water Content | NMT 1.0% |
| Melting Point | 150°C – 154°C |