Status: Version effective from 01/012017 Meloxicam Injection General Notices Action and use Cyclo-oxygenase inhibitor; analgesic; anttintammatory DEFINITION Meloxicam Injection is a sterile solution of Meloxicam in Water for Injections. The injection complies with the requirements stated under Pareneral Preparations and wih the following requirements Content of meloxicam, CulH.N,0,5; 95,0 o 105.0% ofthe states amount, IDENTIFICATION ‘A. Carryout the method fr thin-layer chromatography, Auoendi iA, using the folowing sobs. (1) Dilute a volume ofthe inection containing 10 mg of Metoxicam to 20 mi. with acetone, stir for 15 minutes, fer and use te fiat, (@) Dissolve 10 mg of meloxicam BPCRSin 10 ml of scsione, add 2 ml of water and dlute to 20 mL with acetone. (8) Use a slic asl Fz, plate (Merck HPTLC plates are sultable) (©) Use the motile phase described below. (©) Apply 20 ul of each solution. (8) Develop the plate to 8 em. (©) After removal of the plate, dyin air and examine under ulraviole! lat (254 om) + yolume of 13.54 ammonia, 20 volumes of mothano! and 80 volumes of sicheremethane, ‘The principal spot inthe chromatogram obtained with solution (1) coresponds to thal inthe chromatogram obtained with solution (2), 8. Inthe Assay the retention tme of the principal peak in the chromatogram obtained with solution (1) corresponds to that ofthe principal peak in the chromatogram obtained with solution (2). TESTS Alkalinity PH, 7.50 9.1, Aopondic VL. Rolated substances Carry out the method for linuid chromatography, Aapendic ILD, using the folowing solutions. (1) Add 0.3 mL of 0.4 sodium hydroxide to a volume ofthe injection containing 40 mg of Melbxicam and dlute wth methanol (40%) to praduce 10 mL @) Dilute 4 mL of soluton (1) to 100 mL with methano (40%). (8) Add 0.3 ml of O.4u sodium hydroxide to 40 mg of meloxcam impunty standard BPCRS and dive with methanol (40%) to produce 10 mL, (8) Use a stainless stel column (10 om 4.0 mm) packed with octadecylsiy sliea gel for chromatography (10 ym) (Kromasil 100 C18 i suitable), (©) Use gragint elution and the mobile hase descrived below.(©) Use a flow rate of 1.0 ml per minute (4)__Use an ambient column temperature (6) Use detection wavelengths of 260 nm and 350 nm. (9. Inet 10 pL of each solution, Mobile phase A 0.1% wiv solution of potassium cihydrogen orthophosphete adjusted to pH 6.0 wih 2 sodium hydroxide Mobile phase & methanol “Tame Motil ase A Mable phase B Gamer inwes) cai) come ‘The chromatogram obtained vth solution (3): resembles that supplled with meloxicam impurty standard BPCRS at 260.nm and 360 nm an the resolution between the peaks due to melbxicam and impurity A at 250 nm is atleast 3.0 ‘he resolution between the peaks due to impurily B and meloxcam at 260 nm is atleast 3.0 Identity any peaks inthe chromatogram obtained with solution (1) corresponding fo impurty A and impurty 8 using the chromatogram obtained wih solution (8) and the chromatogram supplied wih meloxcam impurity standard BPCRS. Inthe chromatogram obtained with soto (1: Identity any peak corresponding to impurty &at 350 nm and muliply the area of ths peak by a correction factor of 2.0; the area of any peak corresponding to impurity 8 at 260 nm snot greater than twice solution (2) (2.0%) 12 area ofthe principal peak inthe chromatogram obtain with ihe area of ary peak corresponding to impurty A at 360 nm Is not greater tnan the area of the principal peak inthe chromatogram obtained with solution (2) (1.056, In both the chromatograms obtained with solution (1) at 350 nm and at 260 nm the area of any other secondary peaks not greater than the area ofthe peak Inthe chromatogram obtained with soluton (2) a that wavelength (1.0%) ‘The nominal total content of any such impurties isnot greater than 3.5%, Disregara ary peak wth an atea less than 0.3 times the area ofthe principal peak inthe chromatogram obtaines wth soktion (2) a he same wavelength (0.9%). ASSAY Carry out the method for lau chromatography, Aependbs ILD, using the folowing solitons. (1). To volume of he injection containing 40 mg of Meloxicam adi 0.3 mL of 0.4 sodium hydroxide and add suiient methanol (40%) to produce 10 mL. Oiute t mL ofthe resulting solution to 10 mL with methanol (40%), (2) 0.04% wv of mefoxicam BPCRS in meihancl (40%), (8) Add 0.8 mL of 0.4 sodium bucroxde to 40 mg of meloxicam impunty standard BPCRS and dite with methano| (40%) to produce 10 mL,‘The chromatographic pracedure descrited under Related substances may be used but witha detection wavelength of 250 Am ‘The tests not val unless the chromatogram obtained with solution (3) closely resembles the chromatogram supplied vth meloxicam impunty standard BPCRS at 360 rm: the resolution between the peaks due to meloxicam and impurity A at 250 nm is atleast 2.0, Caloulate the content of CH sN;O,S, using the declared content of CyH,N,0.S, in meloxicam BPRS, IMPURITIES The impuries limited by the requicements of ths monograph include these listed under Meloxicam. (© Crom Copyrgnt 2016 <5tso