Rotigotine API
| CAS No. | 99755-59-6 |
| Therapeutic Category | Neurology & Psychiatry |
| Technology | Synthetic |
| Dosage Form | Transdermal patches |
| Innovator Brand | Neupro, Leganto(USA) |
| Registration Status | China: Under preparing US: DMF 038363 EU: CEP 2022-035 Others: DMF |
| GMP | FDA(USA)/NMPA(China)/MFDS(Korea) approved |
| EHS | ISO 14001 & 45001 certified |
Product Description of Rotigotine API
- Grade: Active Pharmaceutical Ingredient(API)
- Chemical Name: (6S)-6-[Propyl(2-thiophen-2-ylethyl)amino]-5,6,7,8-tetrahydronaphthalen-1-ol
- Molecular Formula: C19H25NOS
- Molecular Weight: 315.473
- Specification: In-house Standard established according to ChP/USP/EP/JP
- Appearance: White to light brown porwder.
- Related substances:
- Specified impurities: not more than 0.2%
- Any unspecified impurity: not more than 0.10%
- Total impurities: not more than 0.6%
- Purity: not less than 99%
- Assay: 98.0%~102.0% (On the anhydrous basis)
- Residual Solvents: fully comply with ICH Q3C
- Mutagenic impurities: fully comply with ICH M8
- Nitrosamine assessment: available
- Particle size: regular grade or milling/sieving according to customer’s requirement.
- Storage: Keep in an airtight container and protected from light.
Applications of Rotigotine API
- Rotigotine API (CAS 99755-59-6) is a non-ergoline dopamine agonist used in the treatment of Parkinson’s disease and restless legs syndrome (RLS). It is widely applied in transdermal patch drug delivery systems and CNS formulation development.
- Rotigotine API (Neupro) is a non-ergoline dopamine agonist indicated for the treatment of Parkinson’s disease (PD) and restless legs syndrome (RLS) in Europe and the United States. It is formulated as a once-daily transdermal patch which provides a slow and constant supply of the drug over the course of 24 hours.
- Like other dopamine agonists, rotigotine has been shown to possess antidepressant effects and may be useful in the treatment of depression as well.
- Rotigotine was developed by Aderis Pharmaceuticals. In 1998 Aderis licensed worldwide development and commercialization rights to Schwarz Pharma of Germany. It was approved by the European Medicines Agency in 2006 and by the FDA in 2007. Rotigotine has been authorized as a treatment for RLS since August 2008.
- In addition to neurological indications, dopamine agonist mechanisms also support potential research in mood-related disorders and other CNS therapeutic areas.
Why Choose Us as Your Rotigotine API Factory?
- As a Rotigotine API factory, Qingmu’s Rotigotine API has been approved in China (DMF filed and listed on CDE’s website), USDMF and CEP certificates have also been granted, and DMF in CTD format is available and can be supported for registration worldwide.
- Qingmu’s factory is established according to ICH/USFDA/EU/JAPAN/China regulations and current GMP, totally complies with environmental law in China, no risk to removing the factory. A new API factory is under design and is predicted to be put into use in 2025.
- Qingmu’s team has rich experience in patent challenges on crystalline form & synthesis processes and also synthetic route development and scale-up & quality research.
- Qingmu’s lab is equipped with HPLC, GC, ICP-MS, GC-MS, CAD, microbalance, Malvern particle analyzer, etc. Qingmu passed the site inspection from NMPA(China), FDA(USA), and MFDS(Korea) as well as customer audits from Europe, USA, Japan, etc.
- Qingmu, as one of the leading Rotigotine API manufacturers, successfully exported products to more than 60 countries including Japan, USA, Germany, Spain, the Netherlands, Russia, South Korea, and Brazil. We are always ready to provide all customers with the best quality products and services
