Loxoprofeno

828

Loxoprofen Sodium Hydrate / O‹cial Monographs
calculated on the anhydrous basis.

JP XV

Purity (1) Chloride —To 1.0 g of Lorazepam add 50 mL of water, allow to stand for 1 hour with occasional shaking, and ˆlter. To 25 mL of the ˆltrate add 6 mL of dilute nitric acid and water to make 50 mL. Perform the test using this solution as the test solution. Prepare the control soluL tionwith 0.20 mL of 0.01 mol W hydrochloric acid VS (not more than 0.014z). (2) Heavy metals —Proceed with 1.0 g of Lorazepam according to Method 2, and perform the test. Prepare the control solution with 2.0 mL of Standard Lead Solution (not more than 20 ppm). (3) Arsenic —Prepare the test solution with 1.0 g of Lorazepam according to Method 3, and perform the test (not more than 2 ppm). (4) Relatedsubstances—Dissolve 0.10 g of Lorazepam in 20 mL of ethanol (95), and use this solution as the sample solution. Pipet 1 mL of the sample solution, add ethanol (95) to make exactly 100 mL, and use this solution as the standard solution. Perform the test with these solutions as directed under Thin-layer Chromatography . Spot 10 mL each of the sample solution and standard solution on a plate of silicagel with ‰uorescent indicator for thin-layer chromatography. Develop the plate with a mixture of chloroform, 1,4-dioxane and acetic acid (100) (91:5:4) to a distance of about 15 cm, and air-dry the plate. Examine under ultraviolet light (main wavelength: 254 nm): the spots other than the principal spot from the sample solution are not more intense than the spot from the standard solution. Loss ondrying 1059 3 hours). C, Not more than 0.5z (1 g, in vacuum, Not more than 0.3z (1 g).

Description Loxoprofen Sodium Hydrate occurs as white to yellowish white crystals or crystalline powder. It is very soluble in water and in methanol, freely soluble in ethanol (95), and practically insoluble in diethyl ether. A solution of Loxoprofen Sodium Hydrate (1 in 20) does not show optical rotation.The pH of a solution of Loxoprofen Sodium Hydrate in freshly boiled and cooled water (1 in 20) is between 6.5 and 8.5. Identiˆcation (1) Determine the absorption spectrum of a solution of Loxoprofen Sodium Hydrate (1 in 55,000) as directed under Ultraviolet-visible Spectrophotometry , and compare the spectrum with the Reference Spectrum: both spectra exhibit similar intensities of absorption at thesame wavelengths. (2) Determine the infrared absorption spectrum of Loxoprofen Sodium Hydrate as directed in the potassium bromide disk method under the Infrared Spectrophotometry , and compare the spectrum with the Reference Spectrum: both spectra exhibit similar intensities of absorption at the same wave numbers. (3) A solution of Loxoprofen Sodium Hydrate (1 in 10) responds to the QualitativeTests for sodium salt. Purity (1) Clarity and color of solution—Dissolve 1.0 g of Loxoprofen Sodium Hydrate in 10 mL of water: the solution is clear and colorless or pale yellow. The color is not darker than that of diluted Matching Fluid for Color A (1 in 2). (2) Heavy metals —Proceed with 2.0 g of Loxoprofen Sodium Hydrate according to Method 2, and perform the test. Prepare the control solutionwith 2.0 mL of Standard Lead Solution (not more than 10 ppm). (3) Related substances—Dissolve 1.0 g of Loxoprofen Sodium Hydrate in 10 mL of methanol, and use this solution as the sample solution. Pipet 1 mL of the sample solution, add methanol to make exactly 200 mL, and use this solution as the standard solution. Perform the test with these solutions as directed under Thin-layer Chromatography. Spot 10 mL each of the sample solution and standard solution on a plate of silica gel with ‰uorescent indicator for thin-layer chromatography. Develop the plate with a mixture of 1,2dichloroethane and acetic acid (100) (9:1) to a distance of about 15 cm, and air-dry the plate. Examine under ultraviolet light (main wavelength: 254 nm): the spots other than the principal spot from the sample...