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
212.124526644521434524040.09
单位质量响应值RSD%判断
37574.4437327.060.47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%
5min1271843-27184352.10656.619.3352.1156.619.33
2273559-27355952.43552.44
3307660-30766058.97258.97
4293074-29307456.17656.18
5344508-34450866.03566.03
6281483-28148353.95453.95
10min1415536-41553679.64980.333.3679.7480.433.36
2404658-40465877.56477.65
3421909-42190980.87180.97
4415625-41562579.66679.76
5445347-44534785.36385.47
6411503-41150378.87678.97
15min1460241-46024188.21889.001.4588.4489.231.46
2454969-45496987.20787.42
3472891-47289190.64390.88
4466585-46658589.43489.66
5470076-47007690.10390.36
6461172-46117288.39688.62
20min1478119-47811991.64592.611.4092.0192.981.40
2476126-47612691.26391.62
3493844-49384494.65995.04
4487155-48715593.37793.75
5478627-47862791.74292.14
6484928-48492892.95093.32
30min1496098-49609895.09195.731.8095.6196.261.78
2495858-49585895.04595.56
3509377-50937797.63698.18
4505381-50538196.87097.40
5484875-48487592.94093.50
6504950-50495096.78897.31
45min1508641-50864197.49597.912.4598.1798.602.43
2511801-51180198.10198.77
3519631-51963199.602100.31
4520277-52027799.726100.42
5487083-48708393.36394.07
6517499-51749999.19399.88
60min1514270-51427098.57498.822.7899.4199.672.75
2519270-51927099.533100.37
3524453-524453100.526101.40
4525370-525370100.702101.56
5487480-48748093.43994.31
6522315-522315100.116100.97
极限1513724-51372498.46999.820.9799.47100.840.97
2519444-51944499.566100.57
3527823-527823101.172102.21
4523937-523937100.427101.45
5517188-51718899.133100.16
6522591-522591100.169101.19
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
212.124499944501594500760.03
单位质量响应值RSD%判断
37694.7537134.981.06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%
5min1230379-23037944.20351.1421.6044.2051.1421.60
2233064-23306444.71844.72
3382287-38228773.35073.35
4255786-25578649.07849.08
5250337-25033748.03248.03
6247481-24748147.48447.48
10min1412185-41218579.08680.938.6879.1681.018.69
2388131-38813174.47174.55
3490955-49095594.20094.32
4395993-39599375.97976.06
5418361-41836180.27180.35
6425012-42501281.54781.63
15min1462387-46238788.71888.185.8088.9288.405.81
2424912-42491281.52881.73
3505707-50570797.03097.31
4445156-44515685.41285.62
5459809-45980988.22488.44
6459561-45956188.17688.39
20min1484041-48404192.87391.834.1393.2392.204.15
2448900-44890086.13186.47
3508482-50848297.56398.00
4469695-46969590.12190.47
5485756-48575693.20293.56
6474843-47484391.10891.47
30min1492455-49245594.48794.942.8695.0095.462.88
2470466-47046690.26890.75
3511422-51142298.12798.73
4493516-49351694.69195.19
5505899-50589997.06797.58
6494984-49498494.97395.49
45min1498510-49851095.64996.251.8696.3196.931.89
2485545-48554593.16293.79
3512049-51204998.24799.01
4502281-50228196.37397.03
5509106-50910697.68298.36
6502351-50235196.38697.06
60min1501390-50139096.20296.521.3297.0397.361.35
2491598-49159894.32395.11
3510358-51035897.92398.85
4503121-50312196.53497.35
5508614-50861497.58898.43
6503357-50335796.57997.41
极限1510740-51074097.99698.240.7398.9899.240.75
2507785-50778597.42998.37
3516185-51618599.041100.13
4514919-51491998.79899.78
5507926-50792697.45698.46
6514553-51455398.72799.72
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
212.124507974508254508110.01
单位质量响应值RSD%判断
37445.6337195.630.48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%
5min1301731-30173158.03761.889.8458.0461.889.83
2285988-28598855.00955.01
3375217-37521772.17272.17
4323410-32341062.20762.21
5337108-33710864.84164.84
6306801-30680159.01259.01
10min1405745-40574578.04481.695.2878.1481.795.28
2400019-40001976.94277.03
3461319-46131988.73388.85
4436381-43638183.93684.04
5427341-42734182.19782.31
6417318-41731880.27080.37
15min1444397-44439785.47888.232.9985.7088.463.00
2446785-44678585.93786.16
3478159-47815991.97292.24
4472405-47240590.86591.11
5454315-45431587.38687.63
6456034-45603487.71687.95
20min1462152-46215288.89390.962.0589.2691.352.06
2471328-47132890.65891.02
3483698-48369893.03793.46
4485290-48529093.34493.74
5464140-46414089.27689.67
6470859-47085990.56890.95
30min1474821-47482191.33093.711.9991.8594.251.99
2493029-49302994.83295.35
3490124-49012494.27394.85
4498365-49836595.85996.41
5475671-47567191.49492.03
6491230-49123094.48695.02
45min1482606-48260692.82795.512.5593.5096.202.53
2506859-50685997.49298.16
3490803-49080394.40495.14
4508369-50836997.78398.49
5482680-48268092.84293.53
6507958-50795897.70498.39
60min1483577-48357793.01496.163.0893.8497.023.05
2514529-51452998.96899.80
3490961-49096194.43495.33
4511835-51183598.45099.32
5484009-48400993.09793.94
6514817-51481799.02399.87
极限1521143-521143100.240100.031.24101.22101.041.23
2515618-51561899.177100.18
3526388-526388101.249102.30
4512055-51205598.49299.53
5516688-51668899.383100.38
6528319-528319101.620102.63
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
212.124487134485924486520.02
单位质量响应值RSD%判断
37450.0437017.490.83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%
5min1273204-27320452.67449.219.8952.6749.219.89
2250592-25059248.31448.31
3219585-21958542.33642.34
4270194-27019452.09352.09
5233269-23326944.97444.97
6284583-28458354.86754.87
10min1449045-44904586.57678.8810.2286.6678.9610.22
2378269-37826972.93073.01
3367431-36743170.84070.91
4432669-43266983.41883.51
5369863-36986371.30971.38
6457620-45762088.22988.32
15min1494659-49465995.37089.925.8095.6090.135.80
2435023-43502383.87284.07
3463342-46334289.33289.52
4467061-46706190.04990.27
5438765-43876584.59484.79
6499495-49949596.30296.54
20min1510932-51093298.50795.033.5198.9095.393.52
2483957-48395793.30793.65
3495931-49593195.61595.95
4488158-48815894.11694.49
5466473-46647389.93690.27
6511809-51180998.67699.08
30min1512899-51289998.88798.550.9899.4499.081.00
2510701-51070198.46398.96
3511834-51183498.68199.18
4509822-50982298.29398.83
5503216-50321697.02097.50
6518594-51859499.985100.55
45min1511455-51145598.60898.730.3999.3399.420.41
2511599-51159998.63699.30
3510810-51081098.48499.15
4513534-51353499.00999.71
5509854-50985498.29998.95
6515275-51527599.345100.07
60min1509123-50912398.15998.440.3499.0499.300.35
2510599-51059998.44399.27
3511918-51191898.69799.52
4510677-51067798.45899.32
5508348-50834898.00998.82
6512974-51297498.90199.80
极限1507306-50730697.80898.000.5798.8699.020.58
2507455-50745597.83798.83
3510003-51000398.32899.32
4508324-50832498.00499.03
5504121-50412197.19498.17
6512635-51263598.83699.90
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
10min12245-22450.6610.664.740.710.704.73
22182-21820.6430.69
32304-23040.6790.72
42238-22380.6590.71
52052-20520.6050.65
62359-23590.6950.75
15min12397-23970.7060.674.080.760.724.07
22236-22360.6590.71
32326-23260.6850.73
42135-21350.6290.68
52264-22640.6670.71
62347-23470.6920.75
20min12194-21940.6460.708.030.700.757.73
22733-27330.8050.86
32269-22690.6690.71
42281-22810.6720.73
52360-23600.6950.74
62366-23660.6970.76
30min12186-21860.64416.63234.760.7016.68234.00
22292-22920.6750.73
32257-22570.6650.71
42437-24370.7180.77
5326910-32691096.32496.37
62572-25720.7580.82
45min12535-25350.7470.704.660.800.7810.86
22250-22500.6630.72
32303-23030.6790.72
42343-23430.6900.75
52463-24630.7260.94
62299-22990.6770.74
60min12268-22680.6680.696.130.730.7711.18
22520-25200.7430.80
32388-23880.7040.75
42178-21780.6420.70
52454-24540.7230.93
62189-21890.6450.71
极限12292-22920.6750.643.860.730.729.30
22110-21100.6220.68
32229-22290.6570.70
42139-21390.6300.69
52156-21560.6350.85
62059-20590.6070.67
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