China 99% USP35 GMP Levetiracetam Antiepileptic API Levetiracetam, Find details about China Levetiracetam, Levetiracetam Powder from 99% USP35 GMP Levetiracetam Antiepileptic API Levetiracetam
Product Name | Levetiracetam |
Synonyms | Levetiracetam Powder |
CAS | 102767-28-2 |
MF | C8H14N2O2 |
MW | 170.20896 |
Purity | 99% HPLC |
Appearance | white crystalline powder |
Certification | USP, BP, GMP |
Standard | Enterprise standard |
Grade | Pharmaceutical grade |
Usage | Antiepileptic |
Storage | Store in a cool and dry area and keep away from direct sunlight |
Levetiracetam has been approved in the United States as add-on treatment for partial (focal), myoclonic, and tonic-clonic
seizures. Levetiracetam has been approved in the European Union as a monotherapy treatment for epilepsy in the case of
partial seizures, or as an adjunctive therapy for partial, myoclonic, and tonic-clonic seizures.Levetiracetam has been shown
to reduce partial (focal) seizures by 50% or more as an add-on medication.It is also used in veterinary medicine for similar
purposes. Based on low-quality evidence, levetiracetam is about as effective as phenytoin for prevention of early seizures
after traumatic brain injury.
Name of Product | LEVETIRACETAM |
Characters | White Or White crystals Powder |
Identification | |
A:Specific optical rotation | -76°to -82° |
B:IR | The spectrum obtained from samples consists with that obtained from reference substance |
C:Enantiomeric purity | Meet the requirement (see tests) |
TESTS | |
Appearance of solution | Clear and not more intensely coloured than BY6 |
Enantiomeric purity (impurity D ) | Not more than 0.8% |
Related substances | |
Impurity A | Not more than 0.3% |
Unspecified impurity | Not more than 0.05% |
Sunof unspecified impurities | Not more than 0.1% |
Total impurities | Not more than 0.4% |
Impurity F | Not more than 0.1% |
Heavy metals | Not more than 10ppm |
Water | Not more than 0.5% |
Sulfated Ash | Not more than 0.1% |
Residual solvents | |
Acetone | Not more than 5000ppm |
Assay Dichloromethane | Not more than 600ppm |
Ethyl acetate | Not more than 5000ppm |
Benzene | Not more than 2ppm |
Assay (on anhydrous basis ) | 98.0%-102.0% OF C8H4N2O2 |
Levetiracetam is suitable for assistant treatment of partial or secondary generalized epileptic seizures in adult epilepsy patients.
1) Levetiracetam has been approved in the European Union as a monotherapy treatment for epilepsy in the case
of partial seizures
2) Levetiracetam has potential benefits for other psychiatric and neurologic conditions such as Tourette syndrome
3) It is also sometimes used to treat neuropathic pain