153832-38-3 Ertapenem disodium disodium (4R,5R,6S)-3-[(3S,5S)-5-[(3-carboxylatophenyl)carbamoyl]pyrro lidin-3-yl]sulfanyl-6-(1-hydroxyethyl)-4-methyl-7-oxo-1-azabicyclo[3.2.0]hept-2-ene-2-carboxylate
Name: Ertapenem disodium
Synonyms: disodium (4R,5R,6S)-3-[(3S,5S)-5-[(3-carboxylatophenyl)carbamoyl]pyrro lidin-3-yl]sulfanyl-6-(1-hydroxyethyl)-4-methyl-7-oxo-1-azabicyclo[3.2.0]hept-2-ene-2-carboxylate; 1-Azabicyclo(3.2.0)hept-2-ene-2-carboxylic acid, 3-(((3S,5S)-5-(((3-ca rboxyphenyl)amino)carbonyl)-3-pyrrolidinyl)thio)-6-((1R)-1-hydroxyethy l)-4-methyl-7-oxo-, monosodium salt, (4R,5S,6S)-; disodium (4R,5S,6S)-3-({(3S,5S)-5-[(3-carboxylatophenyl)carbamoyl]pyrrolidin-3-yl}sulfanyl)-6-[(1R)-1-hydroxyethyl]-4-methyl-7-oxo-1-azabicyclo[3.2.0]hept-2-ene-2-carboxylate; disodium (4R,5R,6S)-3-[(3S,5S)-5-[(3-carboxylatophenyl)carbamoyl]pyrrolidin-3-yl]sulfanyl-6-(1-hydroxyethyl)-4-methyl-7-oxo-1-azabicyclo[3.2.0]hept-2-ene-2-carboxylate
CAS: 153832-38-3
MF: C22H23N3Na2O7S
Item |
Standard |
Test Results |
|
Identification |
A.H-NMR:Comply with the structure |
Complies |
|
B.LC-MS:Comply with the structure |
Complies |
||
C.The IR spectrum of sample should be identical with that of reference standard; |
Complies |
||
D.HPLC-ESI-MS |
Complies |
||
The retention time of the major peak in the chromatogram of the Assay preparation corresponds to that in the chromatogram of the Standard preparation, as obtained in the Assay. |
|||
Heavy metals |
≤10 ppm |
<10ppm |
|
Water |
≤1.0% |
0.10% |
|
Sulphated ash |
≤0.5%, determined on 1.0 g. |
0.01% |
|
Related substances |
Unspecified impurities: for each impurity |
≤0.10% |
<0.10% |
Total Impurity |
≤0.5% |
0.18% |
|
Purity |
≥99.0% |
99.70% |
|
Assay |
99.0%~101.0% (anhydrous substance). |
99.80% |
|
Storage |
Preserve in well-closed, light-resistant and airtight containers. |
Complies |
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