Levetiracetam

동의어: (S)-2-(2-Oxopyrrolidin-1-yl)butanamide, α-Ethyl-2-oxo-1-pyrrolidineacetamide, Keppra, Etiracetam, UCB L059, Levitiracetam

Levetiracetam has become a go-to API for formulators targeting epilepsy and beyond. Its unique binding to synaptic vesicle protein 2A (SV2A) sets it apart from traditional sodium-channel blockers, driving demand in both human and veterinary neurology. As patents expire, generic entries are surging, and procurement teams are actively qualifying new suppliers to secure consistent, high-purity material. The compound also shows promise in neuropathic pain and mood disorders, widening its commercial footprint.

This second-generation antiepileptic is a chiral pyrrolidine derivative, synthesized through a multi-step route that demands tight stereochemical control. The (S)-enantiomer is the active form, and regulatory agencies enforce strict limits on the (R)-impurity. Manufacturers must navigate complex crystallization and purification to meet pharmacopeial standards, making supplier selection a critical decision for both quality and cost.

LyvBio supplies Levetiracetam with assay 98.0–102.0% (HPLC) and full documentation, including elemental impurities and residual solvents. Our material is manufactured under cGMP and is available in commercial quantities. Whether you are developing a generic oral solid or exploring new delivery systems, our team supports your technical and regulatory needs with responsive service and reliable supply.

제품 개요 및 성분

Levetiracetam is a white to off-white crystalline powder, freely soluble in methanol and ethanol, and sparingly soluble in water. It is chemically stable under normal storage conditions, with a molecular weight of 170.21 g/mol. The API is typically milled to a consistent particle size distribution to ensure blend uniformity in tablet and capsule formulations.

Our Levetiracetam is produced via a proprietary synthesis that minimizes chiral impurities and controls particle size. Each batch is tested for assay, related substances, residual solvents, and heavy metals to meet EP, USP, and ICH Q3A/B requirements. The material is non-hygroscopic and compatible with common excipients.

주요 적용 분야

• Epilepsy treatment: As monotherapy or adjunctive therapy for partial-onset, myoclonic, and primary generalized tonic-clonic seizures in adults and children.
• Veterinary medicine: Used off-label for seizure control in dogs and cats, often where phenobarbital is ineffective or poorly tolerated.
• Neuropathic pain: Investigated as an adjunct in diabetic neuropathy and postherpetic neuralgia, though not FDA-approved for these indications.
• Mood disorders: Studied for bipolar disorder and anxiety, with some evidence of mood stabilization.
• Research: Employed as a reference standard in analytical method development and as a tool compound in SV2A binding studies.

품질 및 표준

포장 및 공급

• 포장: 25 kg fiber drum with double polyethylene liner, or as per customer request.
• 최소 주문 수량(MOQ): 25 kg.
• 리드 타임: 3-5 business days (stock items)
• 문서: COA, MSDS, TDS, and regulatory support (CEP, DMF) available upon request.

견적 요청

• LyvBio 주식회사. — 이메일: info@lyvbio.com