Ketorolac Tromethamine CAS No 74103 -07-4

Model NO.
SAMREAL-0186
Trademark
samreal
Origin
China
Reference Price
$ 0.81 - 0.90

Product Description

Ketorolac Tromethamine CAS No 74103-07-4
Test Specification Results
Description Appearance:White or almost white crystalline powder Almost white crystalline powder
Identification
 
IR:concordant with the spectrum obtained with Ketorolac tromethamine CRS. Conforms
TLC:color and position of principal spot obtained with test
solution consistent with that of the reference solution
Conforms
pH 5.7-6.7 6.0
Related substance Impurity RRT0.54:NMT 0.5% undetectable
Impurity RRT0.66:NMT 0.5% 0.0040%
Ketorolac 1-keto analog:NMT 0.1% 0.0031%
Ketorolac 1-hydroxyl analog:NMT 0.1% undetectable
Any other single impurity:NMT 0.5% 0.079%
Total impurities:NMT 1.0% 0.15%
Residual solvents Dichloroethane:NMT 5ppm undetectable
Anhydrous ethanol:NMT 5000ppm 503ppm
Loss on drying NMT 0.5% 0.02%
Residue on ignition NMT 0.1% 0.04%
Heavy metals NMT 20ppm <20ppm
Microorganism Limits Bacteria amount:NMT 10 3 cfu/g <lcfu/g
Mould and yeast amount:NMT 10 2 cfu/g <lcfu/g
Escherichia.Coli:A bsent Absent
Bacterial Endotoxin NMT 5EU/mg <5EU/mg
Assay
(on the dried basis)
98.5%~101.5% 99.3%
Storage Preserve in tight, light-resistant containers. Store at 25, excursions permitted between 15°and30°.
  For customer reference only
Ketorolac Tromethamine CAS No 74103-07-4 Ketorolac Tromethamine CAS No 74103-07-4 Ketorolac Tromethamine CAS No 74103-07-4 Ketorolac Tromethamine CAS No 74103-07-4

 

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