Product Name |
Meropenem |
CAS No |
119478-56-7 |
Molecular Formula |
C17H25N3O5S |
Molecular Weight |
383.46 |
Appearance |
White or slight-yellow crystal powder |
Rotation |
-17 to -21 |
Solubility |
Soluble in Methanol, 0.1mmol/L NaOH; Sligh sluble in H2O and 0.1mol/L; Insoluble in Acetone, Ethanol and Ether. |
IDENTIFICATION |
IR Spectrum |
Accords with that of standards. |
HPLC |
Retention time accords with that of standards. |
EXAMINATION |
Acidity |
PH value: 4.0-6.0 |
Related substance |
Single impurity no more 0.5% |
| |
Total Impurities no more than 1.5% |
Methylene chloride |
No more than 0.06% |
Acetone |
No more than 0.5% |
Water(K.F.) |
11.4% - 13.4% |
Residue on Ignition |
No more than 0.2% |
Heavy Metals |
No more than 20 ppm. |
Assay |
98% min. (C17H25N3O5S) |
OTHERS |
Packing |
25kg/drum; 100g/bottle (sample). |
Storage |
Close tightly, store in cool, dry place |
Shelf life |
24 months |
NOTE: This product was manufactured and analyzed following the instruction of Chinese pharmacopoeia (Edit 2005). But this does not not mean that it could be directly applied to pharmaceutical purpose. It should still be further processed. So this product could only be regarded as raw materials, or intermediates, or as pharmaceutical chemicals.
Also this product is not sterilized, although almost all of the items that analyzed meet the requirement ofChinese pharmacopoeia (Edit 2005). Several steps are still required to deliminate contamination of microorganisms and endotoxin before it could be applied to pharmaceutical purpose.
