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151767-02-1 Montelukast Sodium Montelukast Sodium Amorphous
CAS Number:151767-02-1
Name:Montelukast sodium
Formula:C35H35ClNNaO3S
Molecular Weight:608.17
Synonyms:Cyclopropaneacetic acid,1-[[[(1R)-1-[3-[(1E)-2-(7-chloro-2- quinolinyl)ethenyl]phenyl]-3-[2-(1-hydroxy- 1-methylethyl)phenyl]propyl]thio]methyl]-,monosodium salt;Singulair (TN);Singulair;sodium 2-[1-[[(1R)-1-[3-[2-(7-chloroquinolin-2-yl)ethenyl]phenyl]-3-[2-(2-hydroxypropan-2-yl)phenyl]propyl]sulfanylmethyl]cyclopropyl]acetate;MK 476;
Boiling Point:750.5 °C at 760 mmHg
Flash Point:407.7 °C
Item |
Specification |
Description |
White or off-white powder |
Assay |
≥99.0% |
Identification |
|
Chemistry |
Must conforms to standard |
Identification (HPLC) |
The retention time of test sample major peak complies to reference standard |
Infrared absorption |
Must complies to reference standard |
Sodium identification |
The solution so obtained responds to the tests for sodium |
pH |
9.0~10.5 |
Impurity |
Not more than 0.5% of any individual impurity is found, the sum of all impurities found is not more than 1.0% |
S-isomer |
NMT 1.0% |
OVI |
Must conforms to standard |
Heavy metals |
NMT 20ppm |
Loss on drying |
NMT 1.0% |
microbe |
|
Bacterium |
NMT 1000 cfu/g |
Mildew |
NMT 100 cfu/g |
Coliform |
NMT 0 cfu/g |
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