Levetiracetam API

Name of Product	Levetiracetam API
CAS No	102767‑28‑2
Therapeutic use:-	Racetam anticonvulsant – used as monotherapy or adjunct for partial-onset, myoclonic, and generalized tonic‑clonic seizures
Grade	USP/EP/BP/IP/IH
Form:-	API Powder
Status	Commercial

Product Overview

Levetiracetam is an active pharmaceutical ingredient (API) used in the management of epilepsy.

It is soluble in solvents like chloroform and ethanol, and is freely soluble in water.

The medication is stable when stored under the conditions specified.

It may degrade in the presence of high temperature, direct light, or humidity.

Levetiracetam is a pyrrolidone derivative.

It is different from the older antiepileptic drugs in that it has a novel mechanism of action.

It is not precisely understood how it works, though, but it is an SV2A synaptic vesicle protein binder.

This reduces the abnormal burst firing of neurons and controls seizures.

Levetiracetam is mainly used in the treatment of epilepsy.

It is effective for several seizure types, including partial-onset seizures, myoclonic seizures, and generalized tonic-clonic seizures.

Because of its unique action on the SV2A protein, Levetiracetam offers strong seizure control with a lower risk of drug interactions.

It does not act directly on sodium or calcium channels, unlike many older antiepileptic drugs.

Levetiracetam is valued for its broad safety profile.

It is usually given to patients who are not tolerant or responsive to other antiepileptics.

The API is also studied in neurological conditions linked to abnormal excitatory activity.

CAS number: 102767-28-2.
Molecular formula: C8H14N2O2
Molecular weight: 170.21 g/mol.
Appearance: White to off-white crystalline powder.
Identification: Positive by IR and HPLC retention time.
Assay (on dried basis): 98.0–102.0% by HPLC.
Impurities: Any single impurity ≤0.5%; total impurities ≤1.0%.
Loss on drying: ≤0.5%.
Residue on ignition: ≤0.1%.
Specific optical rotation: Meets standard specifications.
Elemental impurities: Meets ICH Q3D.
Residual solvents: Complies with ICH Q3C guidelines.
Particle size: Micronized material available; typical D90 ≤250 μm.
Microbial quality: Total aerobic count ≤10³ CFU/g; free of harmful organisms.
Stability: Demonstrated by real-time and accelerated studies for 36 months or longer.

Standard kinds of packaging are 25 kg fiber drums with inner double liners for maintaining humidity control.

Smaller packs from 1 to 5 kg are also available for pilot use and research projects.

Each pack is tamper-evident and carries the product name, batch number, net weight, and storage instructions.

The recommended storage is at 15–25 °C, dry, and away from strong light.

The material should be protected from high humidity and strong oxidizing agents.

Under these conditions, Levetiracetam remains stable for up to 36 months.

During handling, workers should use gloves, protective clothing, and eye protection.

Local exhaust systems are advised to reduce dust exposure.

Actiza Pharmaceutical Pvt. Ltd. supplies Levetiracetam with a focus on quality, compliance, and reliability.

Our product is manufactured in the highest quality cGMP facilities with validated processes.

Each lot is extensively tested before release.

We provide customers with a full COA, MSDS, impurity profile, and stability data.

Customization is possible. Customers can request micronized particle sizes, specialized packaging, or additional impurity controls.

Our technical team provides method transfer support and ensures USP, EP, and JP compliance.

Our supply chain is secure and dependable.

We have safety stocks, use qualified raw material suppliers, and ensure on-time delivery.