Brivaracetam API
| CAS No. | 357336-20-0 |
| Category | Neurology & Psychiatry |
| Technology | Synthetic |
| Dosage Form | Oral Solids |
| Innovator Brand | Briviact(USA) |
| Registration Status | Technical Package |
| Polymorph | N/A |
| GMP | FDA(USA)/NMPA(China)/MFDS(Korea) approved |
| EHS | ISO 14001 & 45001 certified |
Product Description
- Grade: Active Pharmaceutical Ingredient(API)
- Chemical Name: (2S)-2-[(4R)-2-oxo-4-propylpyrrolidin-1-yl]butanamide
- Molecular Formula:C11H20N2O2
- Molecular Weight: 212.289
- Specification: Enterprise Standard established according to ChP/USP/EP
- Appearance: Powder
- Total impurities: not more than 0.5%
- Purity: not less than 99%
- Residual Solvents: fully comply with ICH Q3C
- Mutagenic impurities: fully comply with ICH M8
- Nitrosamine assessment: available
- Particle size: regular grade and micronized(D90＜10μm)
- Storage: Room temperature
- Production capacity: Commercial
- Standard Package: 1kg/bag, 5kg/bag, or according to the customer’s requirement
Applications of Brivaracetam API
- Brivaracetam API is a racetam derivative of levetiracetam used in the treatment of partial-onset seizures. Brivaracetam binds SV2A with 20 times higher affinity than levetiracetam. It is available under the brand name Briviact made by UCB. Briviact received FDA approval on February 19, 2016.
- Brivaracetam, a chemical analog of Levetiracetam, is a racetam derivative with anticonvulsant effect. It is used for the treatment of partial-onset seizures with or without secondary generalization, in combination with other antiepileptic drugs. The exact mechanism of brivaracetam’s anti-epileptogenic activity is unknown. What is known is that brivaracetam binds SV2A with high affinity. SV2A is known to play a role in epileptogenesis through modulation of synaptic GABA release. It is thought that brivaracetam exerts its anti-epileptogenic effects through its binding to SV2A. Brivaracetam can also inhibit Na+ channels which may also contribute to its anti-epileptogenic action.
Why Choose Us as Your Brivaracetam API Manufacturer?
- As a Brivaracetam manufacturer, Qingmu’s factory is established according to ICH/USFDA/EU/JAPAN/China regulations and current GMP, totally complies with environmental law in China, and no risk of removing the factory. Our 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. So please feel free to choose us as your partner.
- 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) and also customer audits from Europe, USA and Japan, etc.
- Qingmu successfully exported products to more than 40 countries including Japan, USA, Germany, Spain, the Netherlands, Russia, South Korea, and Brazil.
