Pharmaffiliates - Ropinirole - A Dopamine Agonist Drug

Dopamine agonist drugs are the class of drugs, that activates signaling pathways through dopamine receptors and trimeric G-proteins, which ultimately leads to changes in gene transcription.

Ropinirole (Requip) is one of the dopamine agonist drug, approved by FDA for the treatment of treatment of Parkinson's disease and restless legs syndrome (RLS).

Ropinirole is a second generation non-ergoline class of medication and is manufactured by Glaxo Smith Kline (GSK), Cipla, Dr. Reddy's Laboratories and Sun Pharmaceutical.

Roinirole mimics the role of dopamine in the brain, causing the neurons to react as they would to dopamine.

Synthesis of Ropinirole involves regioselective chemical reactions and number of impurities arises during the process. Other than this various metabolites and degradants are also associated with Ropinirole in the form of impurities.

Pharmaffiliates Analytics and Synthetics P. Ltd., which is one of the leading CRO’s worldwide, has been able to identify and synthesize 11 impurity standards of Ropinirole. These impurity standards are listed and classified below:-

1. Propylidene Ropinirole Hydrochloride (E/Z-mixture) - a propylidene impurity of Ropinirole.
2. Ropinirole - impurity D (N-des propyl Ropinirole) - a major metabolite of Ropinirole. Also known as SKF 104557
3. Ropinirole - impurity F (4-(2-hydroxyethyl)-1,3-dihydro-2h-indolin-2-one) - a key intermediate in the synthesis of Ropinirole.
4. 2-[2-(Dipropylamino)ethyl]-6-Nitrophenyl Acetic Acid hydrochloride – a metabolite of Ropinirole.
5. N-Hydroxy Ropinirole hydrochloride - an N-hydroxy impurity of Ropinirole.
6. Ropinirole - impurity C - Ropinirole propylidene impurity
7. Ropinirole Cyclo pentanyl indolinone impurity – chemically this compound is 3,4- Dihydro-1H-cyclopenta[cd]indol-2(2ah)-one, an impurity of Ropinirole.
8. N-Hydroxy methyl Ropinirole – a hydroxy methyl derivative present as an impurity.
9. Ropinirole methylene dimer – a dimeric impurity of Ropinirole
10. Ethyl Ropinirole – an impurity of Ropinirole.
11. Ropinirole N-oxide – an N-oxide metabolite of Ropinirole.

All the above mentioned reference materials are available at Pharmaffiliates in a pack size of 25mg and 50 mg. Customized pack sizes are also available as per the customer’s need.

Majority of the above mentioned impurities, synthesized at Pharmaffiliates are 98% pure and each of these standards are been identified through an elaborate structure elucidation data and Certificate of Analysis is provided for the same.

Apart from the above mentioned In-house impurity standard, USP reference standard of Ropinirole hydrochloride is also available at Pharmaffiliates at a very competitive price.

We are fast growing Indian pharmaceutical company engaged in developing, manufacturing and marketing broad range of pharmaceutical products globally.