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Montelukast Sodium
C35H35CINNaO3S
151767-02-1
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Certificate of Analysis
Identification:To meet CPS-QC-1001 specification
Characteristics:White to yellowish powder
Specific Rotation:+102?
Physical chemistry Identification:Must conforms to standard
HPLC:The retention time of test sample major peak complies to reference standard.
Infrared Absorption:Complies to reference standard
Sodium Identification:The solution so obtained responds to the tests for sodium
PH :9.8
Impurity:Not more than 1.0%
S-Isomer:Not more than 1.0%
OVI:Conform
Loss on drying:0.3%
Heavy Metal:Not more than 20ppm
Assay (C35H35CINNaO3S):99.2%
Conclusion:Conforms to standard
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