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Levetiracetam 102767-28-2 Levetiracetam 102767-28-2

Levetiracetam 102767-28-2
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Basic information of Levetiracetam:

Name

Levetiracetam

Alias

(s)-2-(2-oxopyrrolidin-1-yl)butanamide; (S)-1-pyrrolidineacetamid; (+-)-alpha-Ethyl-2-oxo-1-pyrrolidineacetamide; (S)-alpha-Ethyl-2-oxo-1-pyrrolidineacetamide; 1-Pyrrolidineacetamide; alpha-ethyl-2-oxo-; alpha-Ethyl-2-oxo-1-pyrrolidineacetamide; Etiracetam; Etiracetam [INN]; Etiracetamum [INN-Latin]; Keppra; Levetiracetam [INN]; Levetiracetamum [INN-Latin]; LEVITIRACETAM; UCB 6474; UCB-6474; UCB-L 059

CAS NO.

102767-28-2

Molecular Formula

C8H14N2O2

Molecular Weight

170.21

Grade Standard

Medicine grade  / 99% min / USP/ GMP / PMDA / DMF

Package Size

25kg/drum

Storage:

Keep in a well-closed container, protected from light and stored at a temperature of 2 to 8


Use of Levetiracetam: 

Levetiracetam is used as a dosing therapy for adults and partial seizures of epilepsy in adolescents over 16 years of age. During the 16-week treatment period, the frequency of epileptic seizures can be reduced and the safety tolerance is better.

COA of Levetiracetam:

ITEMS

SPECIFICATIONS

RESULTS

APPEARANCE

WHITE CRYSTALLINE POWDER

CONFORMS

SOLUBILITY

FREELY SOLUBLE IN WATER

CONFORMS

IDENTIFICATION

1)THE INFRARED ABSORPTION SPECTRUM IS

CONFORMS

CONCORDANT WITH THE REFERENCE

SPECTRUM OBTAINED WITH LEVETIRACETAM RS.

2) THE RETENTION TIME OF THE MAJOR PEAK FOR LEVETIRACETAM IN THE CHROMATOGRAM OF THE TEST SOLUTION CORRESPONDS TO THE RETENTION TIME OF THE LEVETIRACTEM S-ENANTIOMER IN THE CHROMATOGRAM OF THE SYSTEM SUITABILITY SOLUTION, AS OBTAINED IN THE TEST FOR LIMIT OF LEVETIRACEAM R-ENANTIOMER

CONFORMS

WATER

NOT MORE THAN 0.5%

<0.1%

RESIDUE ON IGNITION

 

 

HEAVY METALS

NOT MORE THAN 10PPM

<10PPM%

ENANTIOMERIC IMPURITY

NOT MORE THAN 0.2%

0.10%

RELATED SUBSTANCES(HPLC)

 

 

IMPURITY A*

NOT MORE THAN 0.15%

N.D

SINGLE UNKNOWN IMPURITY

NOT MORE THAN 0.10%

N.D

TOTAL IMPURITIES

NOT MORE THAN 0.50%

N.D

ASSAY

98.0%-102.0%(CALCULATED ON DRIED BASIS)

99.70%

RESIDUAL SOLVENTS(GC)

 

 

ETHYL ACETATE

NOT MORE THAN 5000PPM

N.D

ACETONE

NOT MORE THAN 5000PPM

104PPM

METHYLENE CHLORIDE

NOT MORE THAN 600PPM

N.D

METHANOL

NOT MORE THAN 3000PPM

N.D

CONCLUSION

COMPLIES



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MORE_DETAIL Levetiracetam 102767-28-2

Basic information of Levetiracetam:

Name

Levetiracetam

Alias

(s)-2-(2-oxopyrrolidin-1-yl)butanamide; (S)-1-pyrrolidineacetamid; (+-)-alpha-Ethyl-2-oxo-1-pyrrolidineacetamide; (S)-alpha-Ethyl-2-oxo-1-pyrrolidineacetamide; 1-Pyrrolidineacetamide; alpha-ethyl-2-oxo-; alpha-Ethyl-2-oxo-1-pyrrolidineacetamide; Etiracetam; Etiracetam [INN]; Etiracetamum [INN-Latin]; Keppra; Levetiracetam [INN]; Levetiracetamum [INN-Latin]; LEVITIRACETAM; UCB 6474; UCB-6474; UCB-L 059

CAS NO.

102767-28-2

Molecular Formula

C8H14N2O2

Molecular Weight

170.21

Grade Standard

Medicine grade  / 99% min / USP/ GMP / PMDA / DMF

Package Size

25kg/drum

Storage:

Keep in a well-closed container, protected from light and stored at a temperature of 2 to 8


Use of Levetiracetam: 

Levetiracetam is used as a dosing therapy for adults and partial seizures of epilepsy in adolescents over 16 years of age. During the 16-week treatment period, the frequency of epileptic seizures can be reduced and the safety tolerance is better.

COA of Levetiracetam:

ITEMS

SPECIFICATIONS

RESULTS

APPEARANCE

WHITE CRYSTALLINE POWDER

CONFORMS

SOLUBILITY

FREELY SOLUBLE IN WATER

CONFORMS

IDENTIFICATION

1)THE INFRARED ABSORPTION SPECTRUM IS

CONFORMS

CONCORDANT WITH THE REFERENCE

SPECTRUM OBTAINED WITH LEVETIRACETAM RS.

2) THE RETENTION TIME OF THE MAJOR PEAK FOR LEVETIRACETAM IN THE CHROMATOGRAM OF THE TEST SOLUTION CORRESPONDS TO THE RETENTION TIME OF THE LEVETIRACTEM S-ENANTIOMER IN THE CHROMATOGRAM OF THE SYSTEM SUITABILITY SOLUTION, AS OBTAINED IN THE TEST FOR LIMIT OF LEVETIRACEAM R-ENANTIOMER

CONFORMS

WATER

NOT MORE THAN 0.5%

<0.1%

RESIDUE ON IGNITION

 

 

HEAVY METALS

NOT MORE THAN 10PPM

<10PPM%

ENANTIOMERIC IMPURITY

NOT MORE THAN 0.2%

0.10%

RELATED SUBSTANCES(HPLC)

 

 

IMPURITY A*

NOT MORE THAN 0.15%

N.D

SINGLE UNKNOWN IMPURITY

NOT MORE THAN 0.10%

N.D

TOTAL IMPURITIES

NOT MORE THAN 0.50%

N.D

ASSAY

98.0%-102.0%(CALCULATED ON DRIED BASIS)

99.70%

RESIDUAL SOLVENTS(GC)

 

 

ETHYL ACETATE

NOT MORE THAN 5000PPM

N.D

ACETONE

NOT MORE THAN 5000PPM

104PPM

METHYLENE CHLORIDE

NOT MORE THAN 600PPM

N.D

METHANOL

NOT MORE THAN 3000PPM

N.D

CONCLUSION

COMPLIES


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