Swapnroop Drugs & Pharmaceuticals is a pharmaceutical API manufacturer and supplier of Tolcapone API in India, supporting pharmaceutical formulation, generic drug development, bulk API procurement and international pharmaceutical supply requirements.
Tolcapone is a catechol-O-methyltransferase (COMT) inhibitor used as an adjunct to levodopa/carbidopa therapy in the treatment of Parkinson's disease. It inhibits COMT and thereby affects the metabolism of levodopa, increasing the amount available for conversion to dopamine. (pubchem.ncbi.nlm.nih.gov)
Tolcapone is identified by CAS Number 134308-13-7, with the molecular formula C₁₄H₁₁NO₅ and molecular weight 273.24 g/mol. (pubchem.ncbi.nlm.nih.gov)
Tolcapone is chemically known as 3,4-dihydroxy-4'-methyl-5-nitrobenzophenone. It is a benzophenone derivative containing catechol and nitrophenyl structural features. PubChem describes Tolcapone as a yellow, odorless, non-hygroscopic crystalline compound. (pubchem.ncbi.nlm.nih.gov)
Tolcapone is classified as a COMT inhibitor and is associated with the antiparkinson therapeutic category. Its ATC classification is N04BX01. (pubchem.ncbi.nlm.nih.gov)
| Parameter | Details |
|---|---|
| Product Name | Tolcapone |
| CAS Number | 134308-13-7 |
| UNII | CIF6334OLY |
| Molecular Formula | C₁₄H₁₁NO₅ |
| Molecular Weight | 273.24 g/mol |
| Chemical Name | 3,4-Dihydroxy-4'-methyl-5-nitrobenzophenone |
| IUPAC Name | (3,4-Dihydroxy-5-nitrophenyl)(4-methylphenyl)methanone |
| Development Code | Ro 40-7592 |
| Drug Class | Catechol-O-Methyltransferase (COMT) Inhibitor |
| Therapeutic Category | Antiparkinson Agent |
| ATC Code | N04BX01 |
| Physical Form | Yellow, fine crystalline powder |
| Optical Activity | Achiral |
PubChem confirms CAS 134308-13-7, formula, molecular weight and chemical identity. (pubchem.ncbi.nlm.nih.gov)
Tolcapone inhibits catechol-O-methyltransferase (COMT), an enzyme involved in the metabolism of levodopa and dopamine. By inhibiting peripheral COMT, tolcapone can increase the systemic availability of levodopa and prolong its pharmacological effect when administered with levodopa/carbidopa. (dailymed.nlm.nih.gov)
Tolcapone API is used in the development and manufacture of pharmaceutical formulations intended for Parkinson's disease management as an adjunct to levodopa/carbidopa therapy.
Its pharmaceutical applications include:
Historical/current U.S. labeling describes 100 mg Tolcapone tablets for use as an adjunct to levodopa/carbidopa therapy. (dailymed.nlm.nih.gov)
Swapnroop Drugs & Pharmaceuticals supplies Tolcapone API for pharmaceutical companies requiring COMT inhibitor active pharmaceutical ingredients.
As a Tolcapone API supplier in India, Swapnroop supports bulk API procurement, formulation development, generic pharmaceutical manufacturing and international API supply, subject to applicable product specifications and regulatory requirements.
Tolcapone API can be supplied for:
The USP Tolcapone monograph specifies 98.5–101.5% Tolcapone on the anhydrous and solvent-free basis. It also specifies water NMT 0.1%, residue on ignition NMT 0.1%, and heavy metals 0.002% (20 ppm). (drugfuture.com)
The USP chromatographic purity requirements include Tolcapone Related Compound A NMT 0.1%, Related Compound B NMT 0.2%, unknown individual impurities NMT 0.1%, unknown total impurities NMT 0.2%, and total impurities NMT 0.5%. (drugfuture.com)
The USP monograph specifies that Tolcapone should be preserved in tight, light-resistant containers and stored between 20°C and 25°C. (drugfuture.com)
The API should be appropriately protected from contamination and excessive environmental exposure during storage and transportation.
Documentation for Tolcapone API may include:
Tolcapone is a well-characterized COMT inhibitor API used in Parkinson's disease therapy as an adjunct to levodopa/carbidopa. Swapnroop Drugs & Pharmaceuticals supports pharmaceutical companies seeking Tolcapone API in India for formulation development, bulk procurement, manufacturing and export requirements.
| Parameter | Specification |
|---|---|
| Appearance | white to off-white crystalline powder |
| Identification | IR & HPLC compliant |
| Assay (HPLC) | 98.5–101.5% |
| Loss on Drying | NMT 0.1% |
| Residue on Ignition | NMT 0.1% |
| Heavy Metals | NMT 20 ppm |
| Individual Impurity | NMT 0.1% |
| Total Impurities | NMT 0.5% |
| Water Content | NMT 0.1% |