1192JP XV Tranexamic Acid Capsules/O‹cial Monographs
2hours).
Residue on ignition<2.44>Not more than0.1z(1g). Assay Weigh accurately about50mg each of Tranexamic Acid and Tranexamic Acid Reference Standard,previously dried,dissolve in water to make exactly25mL,and u the solutions as the sample solution and standard solution.Per-form the test with exactly20m L each of the sample solution and standard solution as directed under Liquid Chro-matography<2.01>according to the following conditions, and determine the peak areas,A T and A S,of tranexamic acid.
Amount(mg)of C8H15NO2＝W S×(A T/A S)
W S:Amount(mg)of Tranexamic Acid Reference Standard Operating conditions—
Detector:An ultraviolet absorption photometer (wavelength:220nm).
Column:A stainless steel column 6.0mm in inside diameter and25cm in length,packed with octadecylsilanized silica gel for liquid chromatography(5m m in particle diameter).
Column temperature:A constant temperature of about 259C.
Mobile pha:Dissolve11.0g of sodium dihydrogen phos-phate in500mL of water,and add5mL of triethylamine and 1.4g of sodium lauryl sulfate.Adjust the pH to2.5with phosphoric acid or diluted phosphoric acid(1in10),add water to make600mL,and add400mL of methanol.
Flow rate:Adjust the‰ow rate so that the retention time of tranexamic acid is about20minutes.
System suitability—
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System performance:To5mL of the standard solution add1mL of a solution of4-(aminomethyl)benzoic acid(1in 10,000)and water to make50mL.When the procedure is run with20m L of this solution under the above operating condi-tions,tranexamic acid and4-(aminomethyl)benzoic acid are eluted in this order with the resolution between the peaks being not less than5.
System repeatability:When the test is repeated6times with 20m L of the standard solution under the above operating conditions,the relative standard deviation of the peak area of tranexamic acid is not more than0.6z.
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Tranexamic Acid Capsules
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Tranexamic Acid Capsules contain not less than 95.0z and not more than105.0z of the labeled amount of tranexamic acid(C8H15NO2:157.21). Method of preparation Prepare as directed under Capsules, with Tranexamic Acid.
Identiˆcation Take an amount of powdered contents of Tranexamic Acid Capsules,equivalent to0.5g of Tranexam-ic Acid according to the labeled amount,add50mL of water, shake well,andˆlter.To5mL of theˆltrate add1mL of nin-hydrin TS,and heat for3minutes:a dark purple color de-velops.
Uniformity of dosage units<6.02>It meets the requirement of the Mass variation test.
Dissolution<6.10>Perform the test according to the follow-ing method:it meets the requirement.
Perform the test with1capsule of Tranexamic Acid Cap-sules at50revolutions per minute according to the Paddle methed using a sinker and using900mL of water as the disso-lution medium.Withdraw20mL or more of the dissolved so-lution15minutes after starting the test,andˆlter through a membraneˆlter with pore size of not more than0.45m m. Discard theˆrst10mL of theˆltrate,pipet the subquent V mL,add water to make exactly V?mL so that each mL con-tains abo
ut0.28mg of tranexamic acid(C8H15NO2)accord-ing to the labeled amount,and u this solution as the sample solution.Separately,weigh accurately about28mg of Tranexamic Acid Reference Standard,previously dried at 1059C for2hours,dissolve in water to make exactly100mL, and u this solution as the standard solution.Perform the test with exactly10m L each of the sample solution and stan-dard solution as directed under Liquid Chromatography <2.01>according to the following conditions,and determine the peak areas of tranexamic acid,A T and A S.The dissolu-tion rate in15minutes is not less than80z.
Dissolution rate(z)with respect to the labeled amount of tranexamic acid(C8H15NO2)
＝W S×(A T/A S)×(V?/V)×(1/C)×900
W S:Amount(mg)of Tranexamic Acid Reference Stan-dard
C:Labeled amount(mg)of tranexamic acid(C8H15NO2)in 1capsule
Operating conditions—
Detector:An ultraviolet absorption photometer (wavelength:220nm).
Column:A stainless steel column 4.6mm in inside di-ameter and15cm in length,packed with octadecylsilanized silica gel for liquid chromatography(5m m in particle di-ameter).
Column temperature:A constant temperature of about 259C.
Mobile pha:Dissolve11.0g of anhydrous sodium di-hydrogen phosphate in500mL of water,and add10mL of triethylamine and1.4g of sodium lauryl sulfate.Adjust the pH to2.5with phosphoric acid,add water to make600mL, and add400mL of methanol.
Flow rate:Adjust the‰ow rate so that the retention time of tranexamic acid is about8minutes.
System suitability—
荧光棒System performance:When the procedure is run with10 m L of the standard solution under the above operating condi-tions,the number of theoretical plates and the symmetry fac-tor of the peak of tranexamic acid are not less than4000and not more than2.0,respectively.
System repeatability:When the test is repeated6times with 10m L of the standard solution under the above operating conditions,the relative standard deviation of the peak area of tranexamic acid is not more than2.0z.
Assay Weigh accurately the mass of the contents of not less than20Tranexamic Acid Capsules,and powder.Weigh ac-curately an amount of the powder,equivalent to about0.1g
倒车入库八字口诀1193 JP XV O‹cial Monographs/Tranexamic Acid Tablets
of tranexamic acid(C8H15NO2),add30mL of water,shake well,and add water to make exactly50mL.Centrifuge,ˆlter the supernatant liquid through a membraneˆlter with pore size of not more than0.45m m,discard theˆrst10mL of the ˆltrate,and u the subquentˆltrate as the sample solution. Separately,weigh accurately about50mg of Tranexamic Acid Reference Standard,previously dried at1059C for2 hours,dissolve in water to make exactly25mL,and u this solution as the standard solution.Perform the test with ex-actly30m L each of the sample solution and standard solution as directed under Liquid Chromatography<2.01>according to the following conditions,and determine the peak areas,A T and A S,of tranexamic acid.
Amount(mg)of tranexamic acid(C8H15NO2)
＝W S×(A T/A S)×2
W S:Amount(mg)of Tranexamic Acid Reference Standard Operating conditions—
Detector,column,and mobile pha:Proceed as directed in the operating conditions in the Assay under Tranexamic Acid.
Column temperature:A constant temperature of about 359C.
Flow rate:Adjust the‰ow rate so that the retention time of tranexamic acid is about16minutes.
System suitability—
System performance:To5mL of the standard solution add1mL of a solution of4-(aminomethyl)benzoic acid(1in 10,000)and water to make50mL.When the procedure is run with30m L of this solution under the above operating condi-tions,tranexamic acid and4-(aminomethyl)benzoic acid are eluted in this order with the resolution between the peaks being not less than3.
System repeatability:When the test is repeated6times with 30m L of the standard solution under the above operating conditions,the relative standard deviation of the peak area of tranexamic acid is not more than1.0z.
Containers and storage Containers—Tight containers. Tranexamic Acid Injection
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Tranexamic Acid Injection is an aqueous injection.
It contains not less than95.0z and not more than 105.0z of the labeled amount of tranexamic acid (C8H15NO2:157.21).
Method of preparation Prepare as directed under Injections,with Tranexamic Acid.
Description Tranexamic Acid Injection is a clear and color-less liquid.
Identiˆcation To a volume of Tranexamic Acid Injection, equivalent to50mg of Tranexamic Acid according to the labeled amount,add water to make5mL,add1mL of ninhydrin TS,and heat:a dark purple color develops.
pH<2.54>7.0–8.0
Bacterial endotoxins<4.01>Not more than0.12EU/mg. Extractable volume<6.05>It meets the requirement.Foreign insoluble matter<6.06>Perform the test according to Method1:it meets the requirement.
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Insoluble particulate matter<6.07>Perform the test accord-ing to Method1:it meets the requirement.
Sterility<4.06>Perform the test according to the Membrane ˆltration method:it meets the requirement.
Assay Take accurately a volume of Tranexamic Acid Injection,equivalent to about0.1g of tranexamic acid (C8H15NO2),add water to make exactly50mL,and u this solution as the sample solution.Separately,weigh accurately about50mg of Tranexamic Acid Reference Standard, previously dried at1059C for2hours,dissolve in water to make exactly25mL,and u this solution as the standard so-lution.Perform the test with exactly30m L each of the sample solution and standard solution as directed under Liquid Chromatography<2.01>according to the following conditions,and determine the peak areas,A T and A S,of tranexamic acid.
Amount(mg)of tranexamic acid(C8H15NO2)
＝W S×(A T/A S)
W S:Amount(mg)of Tranexamic Acid Reference Standard
Operating conditions—
Detector,column,and mobile pha:Proceed as directed in the operating conditions in the Assay under Tranexamic Acid.
Column temperature:A constant temperature of about 359C.
Flow rate:Adjust the‰ow rate so that the retention time of tranexamic acid is about16minutes.
System suitability—
System performance:To5mL of the standard solution add1mL of a solution of4-(aminomethyl)benzoic acid(1in 10,000)and water to make50mL.When the procedure is run with30m L of this solution under the above operating condi-tions,tranexamic acid and4-(aminomethyl)benzoic acid are eluted in this order with the resolution between the peaks being not less than3.
System repeatability:When the test is repeated6times with 30m L of the standard solution under the above operating conditions,the relative standard deviation of the peak area of tranexamic acid is not more than1.0z.
Containers and storage Containers—Hermetic containers. Tranexamic Acid Tablets
トラネキサム酸錠
Tranexamic Acid Tablets contain not less than 95.0z and not more than105.0z of the labeled amount of tranexamic acid(C8H15NO2:157.21).
Method of preparation Prepare as directed under Tablets, with Tranexamic Acid.
Identiˆcation To an amount of powdered Tranexamic Acid Tablets,equivalent to0.5g of Tranexamic Acid according to the labeled amount,add50mL of water,shake well,and ˆlter.To5mL of theˆltrate add1mL of ninhydrin TS,and
