Ketorolac

TESTS	SPECIFICATIONS	RESULTS
Appearance	White or almost white, crystalline powder	Almost white crystalline powder
Solubility	Freely soluble in water and in methanol; slightly soluble in alcohol, in dehydrated alcohol, and in tetrahydrofuran; practically insoluble in acetone, in dichloromethane, in toluene, in ethyl acetate,in dioxane,in hexane,in butyl alcohol,and acetonitrile	Conforms
Identification	UV:Maximum absorption at 243nm,318nm.Minimum absorption at 268nm	Conforms
	TLC:color and position of principal spot obtained with test solution consistent with that of the reference solution	Conforms
	IR	Conforms
pH	5.7~6.7	6.1
Melting range	165~170°C	166~168°C
Clarity and color of solution	The solution should be clear and colorless ,if not ,not more intensely turbid than No.1 reference solution and not more intensely colored than reference solution of Y1	Conforms
Related substances	1-ketone-ketorolac acid≤0.1%	0.0027%
	1-hydroxyl-ketorolac acid≤0.1%	N.D
	Other single impurity≤0.5%	0.12%
	Total impurities≤1.0%	0.17%
Dichloromethane	Peak area of dichloromethane in test solution is not more than that of reference solution	N.D
Loss on drying	≤0.5%	0.08%
Residue on ignition	≤0.1%	0.09%
Heavy metals	≤0.002%	Conforms
Assay (on the dried basis)	98.5~101.5%	99.2%
Conclusion	The product meets the requirements of USP

Packaging details:

Packaging details:	25kg/drum with double plastic bags inside; packed in a cardboard drum or fiber HDPE drum.
Storage:	Stored in a clean, cool, dry area; keep away from moisture and strong, direct light/heat
Shelf Life:	5 years if sealed and store away from direct sun light.