坎地沙坦酯氢氯噻嗪片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号100309-202205对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.70对照品水分(%)0对照品稀释倍数1000
标示量(mg)12.5供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
112.014499814514664513804515844519354512690.17
212.064526644521434524040.09
单位质量响应值RSD%判断
37574.4437512.770.12数据可信
供试品溶液-2024052121批-氢氯噻嗪-pH6.8(内含0.35%Tween80)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1271843-27184351.97756.479.3351.9856.479.33
2273559-27355952.30552.30
3307660-30766058.82558.83
4293074-29307456.03656.04
5344508-34450865.87165.87
6281483-28148353.82053.82
10min1415536-41553679.45180.133.3679.5480.233.36
2404658-40465877.37177.46
3421909-42190980.67080.77
4415625-41562579.46879.56
5445347-44534785.15185.26
6411503-41150378.68078.77
15min1460241-46024187.99988.781.4588.2289.011.46
2454969-45496986.99187.21
3472891-47289190.41890.65
4466585-46658589.21289.44
5470076-47007689.87990.13
6461172-46117288.17788.40
20min1478119-47811991.41792.381.4091.7892.751.40
2476126-47612691.03691.40
3493844-49384494.42494.81
4487155-48715593.14593.52
5478627-47862791.51491.92
6484928-48492892.71993.09
30min1496098-49609894.85595.491.8095.3796.021.78
2495858-49585894.80995.32
3509377-50937797.39497.93
4505381-50538196.63097.16
5484875-48487592.70993.26
6504950-50495096.54797.07
45min1508641-50864197.25397.672.4597.9398.362.43
2511801-51180197.85798.53
3519631-51963199.354100.06
4520277-52027799.478100.17
5487083-48708393.13193.84
6517499-51749998.94799.63
60min1514270-51427098.32998.572.7899.1799.422.76
2519270-51927099.285100.12
3524453-524453100.276101.14
4525370-525370100.452101.31
5487480-48748093.20794.07
6522315-52231599.868100.72
极限1513724-51372498.22599.580.9799.23100.590.97
2519444-51944499.319100.32
3527823-527823100.921101.96
4523937-523937100.178101.20
5517188-51718898.88799.91
6522591-52259199.920100.93
坎地沙坦酯氢氯噻嗪片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号100685-201903对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.80对照品水分(%)0对照品稀释倍数1000
标示量(mg)16供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
116.013077073078583079873080223080613079270.05
215.853014983010663012820.11
单位质量响应值RSD%判断
19233.4219008.330.84数据可信
供试品溶液-2024052121批-坎地沙坦酯-pH6.8(内含0.35%Tween80)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min164807-6480719.02820.3710.2019.0320.3710.20
263140-6314018.53818.54
372972-7297221.42521.42
468909-6890920.23220.23
581819-8181924.02224.02
664614-6461418.97118.97
10min1145832-14583242.81744.494.8942.8544.524.90
2145752-14575242.79342.82
3153656-15365645.11445.15
4151551-15155144.49644.53
5165159-16515948.49148.53
6147242-14724243.23143.26
15min1194956-19495657.24058.652.3257.3458.762.32
2194627-19462757.14357.25
3202638-20263859.49559.61
4200627-20062758.90559.01
5206669-20666960.67960.80
6199075-19907558.44958.55
20min1224971-22497166.05267.271.7766.2567.481.77
2223531-22353165.62965.83
3234015-23401568.70768.92
4229972-22997267.52067.73
5231234-23123467.89168.11
6231064-23106467.84168.04
30min1258333-25833375.84777.432.0576.1677.752.04
2257793-25779375.68976.00
3270291-27029179.35879.68
4266036-26603678.10978.43
5261132-26113276.66977.00
6268787-26878778.91779.23
45min1284142-28414283.42584.681.9683.8685.121.96
2284858-28485883.63584.07
3294152-29415286.36486.82
4293260-29326086.10286.55
5281155-28115582.54883.01
6292856-29285685.98386.43
60min1296275-29627586.98788.232.1087.5688.822.09
2299579-29957987.95788.53
3305958-30595889.83090.43
4305414-30541489.67090.26
5290433-29043385.27285.87
6305398-30539889.66690.25
极限1305334-30533489.64791.261.3090.3791.991.30
2309335-30933590.82291.54
3316070-31607092.79993.55
4313812-31381292.13692.88
5307797-30779790.37091.11
6312536-31253691.76192.50
坎地沙坦酯氢氯噻嗪片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号100309-202205对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.70对照品水分(%)0对照品稀释倍数1000
标示量(mg)12.5供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
112.014529454527404527464525974525444527140.04
212.064499944501594500760.03
单位质量响应值RSD%判断
37694.7537319.730.71数据可信
供试品溶液-505806批-氢氯噻嗪-pH6.8(内含0.35%Tween80)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1230379-23037944.09351.0221.6044.0951.0221.60
2233064-23306444.60744.61
3382287-38228773.16773.17
4255786-25578648.95548.96
5250337-25033747.91247.91
6247481-24748147.36647.37
10min1412185-41218578.88980.728.6878.9680.818.70
2388131-38813174.28574.36
3490955-49095593.96594.09
4395993-39599375.79075.87
5418361-41836180.07180.15
6425012-42501281.34481.42
15min1462387-46238788.49787.965.8088.7088.185.82
2424912-42491281.32581.52
3505707-50570796.78897.07
4445156-44515685.19985.41
5459809-45980988.00488.22
6459561-45956187.95688.17
20min1484041-48404192.64191.604.1392.9991.974.15
2448900-44890085.91686.25
3508482-50848297.31997.76
4469695-46969589.89690.25
5485756-48575692.97093.33
6474843-47484390.88191.24
30min1492455-49245594.25294.702.8694.7695.222.88
2470466-47046690.04390.52
3511422-51142297.88298.48
4493516-49351694.45594.95
5505899-50589996.82597.34
6494984-49498494.73695.25
45min1498510-49851095.41196.011.8696.0796.691.89
2485545-48554592.92993.56
3512049-51204998.00298.77
4502281-50228196.13296.79
5509106-50910697.43998.12
6502351-50235196.14696.82
60min1501390-50139095.96296.281.3296.7897.121.35
2491598-49159894.08894.87
3510358-51035897.67898.61
4503121-50312196.29397.11
5508614-50861497.34598.18
6503357-50335796.33897.17
极限1510740-51074097.75198.000.7398.7398.990.75
2507785-50778597.18698.12
3516185-51618598.79499.88
4514919-51491998.55199.53
5507926-50792697.21398.21
6514553-51455398.48199.47
坎地沙坦酯氢氯噻嗪片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号100685-201903对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.80对照品水分(%)0对照品稀释倍数1000
标示量(mg)16供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
116.013077263078243076913075383075993076760.04
215.852988372988922988640.02
单位质量响应值RSD%判断
19217.7418855.771.35数据可信
供试品溶液-505806批-坎地沙坦酯-pH6.8(内含0.35%Tween80)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min137329-3732911.00912.2122.2111.0112.2122.21
237241-3724110.98310.98
359582-5958217.57217.57
442106-4210612.41812.42
535233-3523310.39110.39
636974-3697410.90410.90
10min1119325-11932535.19138.0312.0435.2138.0512.05
2118589-11858934.97434.99
3159949-15994947.17247.20
4125341-12534136.96536.99
5124036-12403636.58036.60
6126404-12640437.27937.30
15min1191815-19181556.56958.038.1356.6558.118.13
2181574-18157453.54953.63
3227958-22795867.22967.34
4191065-19106556.34856.43
5193515-19351557.07157.15
6194579-19457957.38557.46
20min1244104-24410471.99072.036.2872.1672.216.29
2225737-22573766.57466.74
3272268-27226880.29680.52
4238120-23812070.22670.40
5244056-24405671.97672.15
6241203-24120371.13571.31
30min1299681-29968188.38188.193.9788.6788.503.99
2279016-27901682.28682.56
3315054-31505492.91593.27
4299254-29925488.25588.55
5305190-30519090.00690.30
6296094-29609487.32387.62
45min1327727-32772796.65296.052.5497.0996.502.56
2311090-31109091.74692.16
3334156-33415698.54899.06
4325599-32559996.02596.46
5332439-33243998.04298.49
6323058-32305895.27595.72
60min1333790-33379098.44097.581.7899.0498.181.79
2320070-32007094.39494.96
3335845-33584599.04699.72
4331813-33181397.85798.46
5334906-33490698.76999.38
6328753-32875396.95597.55
极限1341720-341720100.77999.471.15101.54100.241.15
2331965-33196597.90298.63
3338626-33862699.866100.70
4340207-340207100.333101.10
5333295-33329598.29499.07
6337873-33787399.644100.40
坎地沙坦酯氢氯噻嗪片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号100309-202205对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.70对照品水分(%)0对照品稀释倍数1000
标示量(mg)12.5供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
112.014497124497384497674496894497024497220.01
212.064507974508254508110.01
单位质量响应值RSD%判断
37445.6337380.680.13数据可信
供试品溶液-2024052121批-氢氯噻嗪-pH6.8(内含0.5%Tween20)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1301731-30173157.89361.739.8357.8961.729.83
2285988-28598854.87254.87
3375217-37521771.99271.99
4323410-32341062.05262.05
5337108-33710864.68064.68
6306801-30680158.86558.87
10min1405745-40574577.85081.485.2877.9581.595.28
2400019-40001976.75176.84
3461319-46131988.51388.63
4436381-43638183.72883.83
5427341-42734181.99382.10
6417318-41731880.07080.17
15min1444397-44439785.26688.012.9985.4988.243.00
2446785-44678585.72485.94
3478159-47815991.74492.01
4472405-47240590.64090.88
5454315-45431587.16987.41
6456034-45603487.49987.73
20min1462152-46215288.67290.742.0589.0491.122.06
2471328-47132890.43390.80
3483698-48369892.80693.23
4485290-48529093.11293.51
5464140-46414089.05489.44
6470859-47085990.34390.72
30min1474821-47482191.10393.481.9991.6294.021.99
2493029-49302994.59795.11
3490124-49012494.03994.61
4498365-49836595.62196.17
5475671-47567191.26691.80
6491230-49123094.25294.78
45min1482606-48260692.59795.272.5593.2695.962.53
2506859-50685997.25097.92
3490803-49080394.17094.90
4508369-50836997.54098.25
5482680-48268092.61193.30
6507958-50795897.46198.15
60min1483577-48357792.78395.933.0793.6196.783.05
2514529-51452998.72299.55
3490961-49096194.20095.09
4511835-51183598.20599.08
5484009-48400992.86693.71
6514817-51481798.77799.62
极限1521143-52114399.99199.781.24100.97100.791.23
2515618-51561898.93199.93
3526388-526388100.997102.04
4512055-51205598.24799.28
5516688-51668899.136100.14
6528319-528319101.368102.38
坎地沙坦酯氢氯噻嗪片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号100685-201903对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.80对照品水分(%)0对照品稀释倍数1000
标示量(mg)16供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
116.013073663073373072813072623070753072640.04
215.853020923018623019770.06
单位质量响应值RSD%判断
19192.0019052.180.52数据可信
供试品溶液-2024052121批-坎地沙坦酯-pH6.8(内含0.5%Tween20)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1119415-11941535.05838.609.4735.0638.609.47
2116668-11666834.25134.25
3150290-15029044.12244.12
4132523-13252338.90638.91
5138921-13892140.78440.78
6131164-13116438.50738.51
10min1202165-20216559.35162.575.8059.4162.635.81
2197001-19700157.83557.89
3231289-23128967.90167.97
4218172-21817264.05064.12
5218255-21825564.07564.14
6211804-21180462.18162.25
15min1240830-24083070.70273.353.5170.8673.523.52
2239658-23965870.35870.51
3262138-26213876.95877.14
4256480-25648075.29775.47
5248694-24869473.01173.19
6251203-25120373.74873.92
20min1262997-26299777.21079.432.5677.4979.722.56
2265100-26510077.82878.10
3278729-27872981.82982.14
4278639-27863981.80282.10
5266235-26623578.16178.46
6271636-27163679.74680.04
30min1283257-28325783.15885.402.2283.5685.832.22
2290959-29095985.41985.82
3293224-29322486.08486.54
4300116-30011688.10788.54
5283909-28390983.34983.78
6293999-29399986.31286.74
45min1292606-29260685.90388.052.3186.4588.622.30
2304500-30450089.39489.94
3297840-29784087.43988.03
4308097-30809790.45091.03
5291664-29166485.62686.19
6304917-30491789.51790.08
60min1294290-29429086.39788.682.4587.0889.402.44
2309104-30910490.74691.44
3298568-29856887.65388.39
4309409-30940990.83691.57
5293796-29379686.25286.96
6307313-30731390.22090.94
极限1314522-31452292.33792.260.6993.1793.120.69
2313595-31359592.06592.91
3318321-31832193.45294.34
4312146-31214691.63992.52
5313163-31316391.93892.79
6313792-31379292.12292.99
坎地沙坦酯氢氯噻嗪片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号100309-202205对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.70对照品水分(%)0对照品稀释倍数1000
标示量(mg)12.5供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
112.014498694494804496404499064499824497750.05
212.064487134485924486520.02
单位质量响应值RSD%判断
37450.0437201.660.48数据可信
供试品溶液-505806批-氢氯噻嗪-pH6.8(内含0.5%Tween20)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1273204-27320452.54249.099.8952.5449.089.89
2250592-25059248.19448.19
3219585-21958542.23042.23
4270194-27019451.96451.96
5233269-23326944.86244.86
6284583-28458354.73154.73
10min1449045-44904586.36078.6910.2286.4578.7710.22
2378269-37826972.74872.83
3367431-36743170.66470.73
4432669-43266983.21183.30
5369863-36986371.13271.21
6457620-45762088.00988.10
15min1494659-49465995.13289.705.8095.3689.915.80
2435023-43502383.66383.86
3463342-46334289.11089.30
4467061-46706189.82590.05
5438765-43876584.38384.58
6499495-49949596.06396.30
20min1510932-51093298.26294.793.5198.6595.153.52
2483957-48395793.07493.42
3495931-49593195.37795.71
4488158-48815893.88294.26
5466473-46647389.71290.05
6511809-51180998.43198.83
30min1512899-51289998.64098.310.9899.1998.831.00
2510701-51070198.21898.71
3511834-51183498.43698.93
4509822-50982298.04998.58
5503216-50321696.77897.26
6518594-51859499.736100.30
45min1511455-51145598.36398.480.3999.0899.170.42
2511599-51159998.39099.05
3510810-51081098.23998.90
4513534-51353498.76299.46
5509854-50985498.05598.70
6515275-51527599.09799.83
60min1509123-50912397.91498.200.3498.8099.050.35
2510599-51059998.19899.02
3511918-51191898.45299.28
4510677-51067798.21399.07
5508348-50834897.76598.57
6512974-51297498.65599.55
极限1507306-50730697.56597.760.5798.6198.770.59
2507455-50745597.59398.58
3510003-51000398.08399.07
4508324-50832497.76098.78
5504121-50412196.95297.92
6512635-51263598.59099.65
坎地沙坦酯氢氯噻嗪片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号100685-201903对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.80对照品水分(%)0对照品稀释倍数1000
标示量(mg)16供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
116.013075303072983069393072063075233072990.09
215.852997252997962997600.02
单位质量响应值RSD%判断
19194.1918912.301.05数据可信
供试品溶液-505806批-坎地沙坦酯-pH6.8(内含0.5%Tween20)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1104840-10484030.89129.5810.7330.8929.5810.73
299170-9917029.22129.22
383019-8301924.46224.46
4106978-10697831.52131.52
594560-9456027.86227.86
6113770-11377033.52233.52
10min1236437-23643769.66664.5010.2169.7264.5510.21
2203408-20340859.93459.98
3195232-19523257.52557.57
4233441-23344168.78468.84
5198414-19841458.46358.51
6246424-24642472.60972.66
15min1299214-29921488.16482.717.0088.3382.867.00
2259713-25971376.52576.67
3270993-27099379.84879.98
4286300-28630084.35984.53
5261694-26169477.10877.25
6306319-30631990.25790.43
20min1324862-32486295.72191.814.4096.0492.104.41
2300193-30019388.45288.73
3309254-30925491.12291.39
4310586-31058691.51491.82
5294637-29463786.81587.09
6329948-32994897.21997.55
30min1337328-33732899.39498.551.6799.8798.991.69
2331229-33122997.59798.02
3334955-33495598.69599.12
4333034-33303498.12998.59
5326910-32691096.32496.74
6343234-343234101.134101.62
45min1337286-33728699.38299.610.37100.02100.220.39
2337672-33767299.495100.08
3337296-33729699.38599.97
4338980-33898099.881100.50
5337048-33704899.31299.89
6340157-340157100.228100.89
60min1335391-33539198.82399.160.3699.6399.940.38
2336425-33642599.12899.88
3335878-33587898.96799.72
4336943-33694399.281100.07
5335834-33583498.95499.70
6338711-33871199.802100.63
极限1334007-33400798.41598.730.4799.3999.680.49
2334818-33481898.65499.57
3334028-33402898.42299.34
4335940-33594098.98599.94
5333863-33386398.37399.28
6337868-33786899.553100.54
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