Pharmaceutical Ketorolac Tromethamine Powder API High Purity CAS 74103 -07-4

Model NO.
py0467
MOQ
1kg
Mf.
C19h24n2o6
CAS
74103-07-4
Transport Package
25kg/Drum
Specification
99%
Trademark
puya
Origin
China
Production Capacity
10ton/Year
Reference Price
$ 270.00 - 405.00

Product Description

Ketorolac Tromethamine  CAS 74103-07-4
Product Name Ketorolac tromethamine
Synonyms KETOROLACTRISSALT;KETOROLACTROMETHAMINE;KETOROLACTROMETHAMINESALT;(+/-)-5-BENZOYL-2,3-DIHYDRO-1H-PYRROLIZINE-1-CARBOXYLICACID,TRIS(HYDROXYMETHYL)AMINOMETHANESALT;(+/-)-5-benzoyl-2,3-dihyChemicalbookdro-1h-pyrrolizine-1-carboxylicacidtris(hydroxymethyl)methylaminesalt;(+/-)-5-BENZOYL-2,3-DIHYDRO-1H-PYRROLIZINE-1-CARBOXYLICACIDTRISSALT;KETROLACTROMETHAMINESALT;(±)-Formtromethaminesalt
MOQ 1kg
CAS 74103-07-4
Appearance White 
Molecular Formula C19H24N2O6
Molecular Weight 376.4
Assay >99%
Packing 25kg/drum
Storage
Store in a well-closed,light-resistant container
Remarks NA
Custom synthesis Available

Ketorolac tromethamine is a nonsteroidal antiinflammatory agent that exhibits analgesic and antipyretic activity. The compound is effective in the management of moderate to severe postoperative pain. It is, however, the first of this type of agent to be administered parenterally as an analgesic and is specifically indicated for intramuscular injection. Ketorolac represents a useful alternative to the narcotic analgesics due to its lack of abuse potential.

Specition
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°.

 

 

GOUV.NE, 2023