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Levetiracetam is a broad-spectrum antiepileptic drug (AED) widely used for the treatment of partial-onset seizures, myoclonic seizures, and generalized tonic-clonic seizures. It acts through binding to the synaptic vesicle protein SV2A, modulating neurotransmitter release, and stabilizing neuronal activity without affecting normal neurotransmission.
Bluepill Express manufactures high-purity Levetiracetam API under WHO-GMP, ISO 9001:2015, and cGMP-certified facilities, ensuring consistent quality, stability, and compliance with global pharmacopoeial standards (IP, BP, USP, EP). This API is suitable for tablet, oral solution, and intravenous formulations, catering to both domestic and international pharmaceutical markets.
Therapeutic Uses
- Partial-Onset Seizures: Effective as monotherapy or adjunctive therapy
- Myoclonic Seizures: Reduces sudden jerks in adolescents and adults
- Generalized Tonic-Clonic Seizures: Prevents convulsive episodes
- Combination Therapy: Used with other antiepileptic drugs for refractory epilepsy
- Off-label Use: Neuropathic pain and other neurological disorders (under medical supervision)
Mechanism of Action
Levetiracetam selectively binds to synaptic vesicle protein 2A (SV2A):
- Modulates neurotransmitter release in hyperexcitable neurons
- Stabilizes synaptic transmission and prevents seizure propagation
- Minimal interaction with other CNS drugs
- Favorable safety profile with low risk of hepatotoxicity or drug interactions
Pharmacological Information
- Chemical Name: (S)-α-ethyl-2-oxo-1-pyrrolidineacetamide
- Molecular Formula: C8H14N2O2
- Molecular Weight: 170.21 g/mol
- CAS Number: 102767-28-2
- Therapeutic Class: Antiepileptic Drug (AED)
- Pharmacological Class: CNS Agent / SV2A Modulator
- ATC Code: N03AX14
Physical & Chemical Properties
| Property | Description |
|---|---|
| Appearance | White to off-white crystalline powder |
| Solubility | Freely soluble in water; slightly soluble in ethanol |
| Melting Point | 217°C – 219°C |
| pH (1% aqueous solution) | 5.5 – 6.5 |
| Storage | Store below 25°C in a dry, ventilated area, protected from light and moisture |
Technical Specifications
| Parameter | Specification |
|---|---|
| Appearance | White to off-white crystalline powder |
| Identification | IR, UV, and HPLC positive |
| Assay (Purity) | ≥ 99.0% (HPLC) |
| Loss on Drying | ≤ 0.5% |
| Residue on Ignition | ≤ 0.1% |
| Heavy Metals | ≤ 10 ppm |
| Related Substances | ≤ 0.5% (individual impurity) |
| Bulk Density | 0.35 – 0.50 g/mL |
| Tapped Density | 0.50 – 0.65 g/mL |
Applications
Levetiracetam API is used in:
- Tablet, oral solution, and intravenous formulations
- Adjunctive therapy in refractory epilepsy
- Combination antiepileptic therapy
- Pharmaceutical bulk production for domestic and international markets
Documentation Provided
- Certificate of Analysis (COA)
- Material Safety Data Sheet (MSDS)
- Technical Data Sheet (TDS)
- Method of Analysis (MOA)
- Stability Data (ICH-compliant)
- Regulatory Dossier / DMF (on request)
Packaging & Export Details
- Available Packs: 1 kg | 5 kg | 10 kg | 25 kg HDPE drums with double poly liners
- Labeling: Product name, batch number, manufacturing/expiry dates, storage instructions
- Shelf Life: 36 months under recommended storage conditions
- Export Markets: Africa, Asia, Latin America, Europe, Middle East
