坎地氢噻片项目信息
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%
112.354680084680704678844677754678884679250.03
212.324658684660914659800.04
单位质量响应值RSD%判断
37888.6637823.050.13数据可信
供试品溶液-2024082821批-坎地沙坦酯-0.35tw20
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1362249-36224968.69162.859.8468.6962.859.84
2341305-34130564.72064.72
3324092-32409261.45661.46
4269794-26979451.16051.16
5342569-34256964.96064.96
6348548-34854866.09366.09
10min1475442-47544290.15683.176.4590.2783.286.45
2441584-44158483.73583.84
3453769-45376986.04686.15
4389895-38989573.93474.02
5433247-43324782.15482.26
6437796-43779683.01783.13
15min1483573-48357391.69786.984.0291.9687.224.03
2458968-45896887.03287.28
3473581-47358189.80390.05
4430805-43080581.69181.90
5452081-45208185.72685.97
6453030-45303085.90686.15
20min1486498-48649892.25288.453.2092.6788.843.21
2467329-46732988.61789.01
3480420-48042091.09991.50
4446448-44644884.65885.00
5458179-45817986.88287.27
6459719-45971987.17487.57
30min1488472-48847292.62690.382.5993.2090.922.59
2477984-47798490.63891.18
3494013-49401393.67794.22
4465447-46544788.26088.75
5467143-46714388.58289.11
6466746-46674688.50789.04
45min1490972-49097293.10091.912.8793.8392.602.87
2489294-48929492.78293.47
3507142-50714296.16796.87
4478071-47807190.65491.29
5471884-47188489.48190.16
6470778-47077889.27189.96
60min1492044-49204493.30492.613.3894.1893.453.37
2496869-49686994.21995.06
3515176-51517697.69098.55
4481009-48100991.21192.00
5474701-47470190.01590.84
6470668-47066889.25090.08
极限1521073-52107398.80898.020.9999.8499.021.00
2509836-50983696.67797.68
3524158-52415899.393100.42
4514878-51487897.63498.57
5514775-51477597.61498.59
6516859-51685998.00998.99
坎地氢噻片项目信息
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%
115.513020103019623020253021053020853020370.02
215.473026613027683027140.03
单位质量响应值RSD%判断
19473.6919567.810.35数据可信
供试品溶液-2024082821批-氢氯噻嗪-0.35tw20
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1147014-14701442.27839.487.9442.2839.487.94
2140099-14009940.29040.29
3134724-13472438.74438.74
4116624-11662433.53933.54
5142578-14257841.00341.00
6142675-14267541.03141.03
10min1237748-23774868.37264.076.0768.4464.146.07
2223881-22388164.38464.45
3228266-22826665.64565.71
4197277-19727756.73356.79
5225264-22526464.78164.85
6224371-22437164.52564.59
15min1268630-26863077.25374.123.9677.4474.293.97
2257374-25737474.01674.19
3264981-26498176.20376.38
4239416-23941668.85169.00
5260548-26054874.92875.10
6255489-25548973.47473.65
20min1285584-28558482.12879.573.0482.4479.873.05
2277411-27741179.77880.08
3283505-28350581.53081.83
4262356-26235675.44875.71
5278819-27881980.18380.48
6272517-27251778.37178.67
30min1301891-30189186.81884.852.2987.2785.282.30
2294780-29478084.77385.20
3303879-30387987.39087.83
4287291-28729182.61983.01
5293935-29393584.53084.96
6288608-28860882.99883.43
45min1309490-30949089.00387.442.3489.6088.012.34
2305334-30533487.80888.38
3314446-31444690.42891.01
4299175-29917586.03786.57
5300606-30060686.44887.02
6295274-29527484.91585.48
60min1311276-31127689.51788.042.4090.2688.762.40
2308602-30860288.74889.47
3316571-31657191.04091.77
4301634-30163486.74487.42
5302216-30221686.91187.63
6296527-29652785.27585.98
极限1319781-31978191.96391.350.7492.8592.220.75
2314582-31458290.46891.33
3320985-32098592.30993.19
4317174-31717491.21392.03
5316235-31623590.94391.81
6317233-31723391.23092.08
坎地氢噻片项目信息
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%
112.354664064661674663694669824665094664870.07
212.324658874659614659240.02
单位质量响应值RSD%判断
37772.2337818.510.09数据可信
供试品溶液-2024083021批-坎地沙坦酯-0.35tw20
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1258671-25867149.12946.1912.3749.1346.1912.37
2188597-18859735.82035.82
3265021-26502150.33550.33
4227029-22702943.11943.12
5261598-26159849.68549.68
6258231-25823149.04549.05
10min1397385-39738575.47572.454.3775.5672.534.37
2374145-37414571.06171.12
3398288-39828875.64675.73
4355325-35532567.48667.56
5374301-37430171.09071.17
6389302-38930273.93974.02
15min1449374-44937485.34983.612.3285.5683.812.31
2444621-44462184.44684.62
3446631-44663184.82885.04
4433196-43319682.27682.46
5422828-42282880.30780.51
6444812-44481284.48284.69
20min1474303-47430390.08388.462.1790.4388.792.17
2471281-47128189.51089.83
3470200-47020089.30489.66
4465242-46524288.36388.68
5446144-44614484.73585.07
6467267-46726788.74789.09
30min1494353-49435393.89292.451.5294.3992.931.52
2488231-48823192.72993.20
3492840-49284093.60494.10
4486662-48666292.43192.90
5473634-47363489.95690.43
6484840-48484092.08592.58
45min1507954-50795496.47595.611.2397.1396.241.23
2503206-50320695.57396.20
3511157-51115797.08397.74
4505571-50557196.02296.64
5496129-49612994.22994.86
6496262-49626294.25494.90
60min1514528-51452897.72397.361.0598.5498.161.05
2513271-51327197.48598.27
3520030-52003098.76899.59
4513813-51381397.58898.37
5510376-51037696.93597.72
6503825-50382595.69196.49
极限1518336-51833698.44798.580.4399.4399.540.43
2518875-51887598.54999.49
3523315-52331599.392100.37
4518380-51838098.45599.40
5518598-51859898.49699.44
6516850-51685098.16499.13
坎地氢噻片项目信息
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%
115.513026763026713026743024553024213025790.05
215.473026423026923026670.02
单位质量响应值RSD%判断
19508.6419564.770.21数据可信
供试品溶液-2024083021批-氢氯噻嗪-0.35tw20
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min199140-9914028.48727.659.9828.4927.649.98
278767-7876722.63322.63
3103575-10357529.76229.76
491485-9148526.28826.29
5102776-10277629.53229.53
6101512-10151229.16929.17
10min1189809-18980954.54153.783.3154.5953.833.32
2180666-18066651.91351.95
3192585-19258555.33855.39
4178016-17801651.15251.20
5191522-19152255.03355.08
6190419-19041954.71654.76
15min1237892-23789268.35768.800.7868.5068.940.78
2240067-24006768.98269.11
3242009-24200969.54069.68
4237551-23755168.25968.39
5238075-23807568.41068.55
6240995-24099569.24969.39
20min1269827-26982777.53377.360.8477.7977.610.83
2271981-27198178.15278.39
3269807-26980777.52877.79
4269022-26902277.30277.54
5265148-26514876.18976.44
6269582-26958277.46377.72
30min1297384-29738485.45285.081.0985.8385.461.08
2299595-29959586.08786.46
3297140-29714085.38185.77
4297527-29752785.49385.86
5290441-29044183.45783.84
6294501-29450184.62385.01
45min1309770-30977089.01188.781.0589.5389.301.04
2311434-31143489.48990.00
3311730-31173089.57490.10
4311028-31102889.37289.89
5305197-30519787.69788.22
6304614-30461487.52988.05
60min1311949-31194989.63789.670.9090.3190.340.89
2313790-31379090.16690.83
3315427-31542790.63691.31
4313488-31348890.07990.74
5309991-30999189.07489.74
6307765-30776588.43589.11
极限1314970-31497090.50590.900.5991.3391.720.59
2317129-31712991.12591.94
3319435-31943591.78892.62
4316791-31679191.02891.84
5314425-31442590.34891.16
6315238-31523890.58291.40
坎地氢噻片项目信息
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%
112.354646034648424649604645214648634647580.05
212.324643784645654644720.03
单位质量响应值RSD%判断
37632.2337700.650.13数据可信
供试品溶液-2024090121批-坎地沙坦酯-0.35tw20
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1253739-25373948.35750.5514.5548.3650.5514.54
2264497-26449750.40750.41
3230825-23082543.99043.99
4258716-25871649.30649.31
5243591-24359146.42346.42
6340135-34013564.82264.82
10min1417864-41786479.63676.206.4979.7276.296.50
2375427-37542771.54871.63
3379067-37906772.24272.32
4387804-38780473.90773.99
5396075-39607575.48375.56
6442894-44289484.40684.51
15min1465331-46533188.68285.064.1188.9085.274.12
2429019-42901981.76281.96
3431689-43168982.27182.46
4435677-43567783.03183.24
5443784-44378484.57684.78
6472493-47249390.04790.30
20min1478682-47868291.22688.503.0291.5988.853.03
2449827-44982785.72786.07
3452996-45299686.33186.66
4456575-45657587.01387.36
5464419-46441988.50888.85
6483642-48364292.17292.57
30min1491816-49181693.72991.842.0194.2492.342.02
2470971-47097189.75790.24
3476953-47695390.89791.37
4477067-47706790.91991.41
5478901-47890191.26891.76
6495691-49569194.46895.02
45min1505366-50536696.31295.031.4896.9895.681.50
2490905-49090593.55694.19
3496041-49604194.53595.16
4495990-49599094.52595.17
5493548-49354894.06094.70
6509886-50988697.17397.88
60min1512754-51275497.72096.871.0798.5597.681.09
2502915-50291595.84596.63
3507773-50777396.77197.55
4506734-50673496.57397.37
5503079-50307995.87696.68
6516482-51648298.43099.30
极限1513073-51307397.78197.880.4298.7798.850.44
2511188-51118897.42198.37
3513469-51346997.85698.80
4513276-51327697.81998.78
5512891-51289197.74698.71
6517540-51754098.63299.67
坎地氢噻片项目信息
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%
115.513012463013183015723016433016133014780.07
215.473024923021893023400.08
单位质量响应值RSD%判断
19437.6519543.630.39数据可信
供试品溶液-2024090121批-氢氯噻嗪-0.35tw20
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1101069-10106929.11030.8513.7729.1130.8513.77
2106138-10613830.57030.57
395993-9599327.64827.65
4104784-10478430.18030.18
598513-9851328.37428.37
6136204-13620439.23039.23
10min1202309-20230958.27057.285.8958.3257.335.90
2191999-19199955.30155.35
3190309-19030954.81454.86
4194458-19445856.00956.06
5192940-19294055.57255.62
6221182-22118263.70663.77
15min1251488-25148872.43570.623.6472.5870.773.66
2239860-23986069.08669.23
3238163-23816368.59768.73
4240558-24055869.28769.43
5240474-24047469.26369.40
6260586-26058675.05575.23
20min1276439-27643979.62177.742.7879.8978.012.79
2265609-26560976.50276.76
3263018-26301875.75676.01
4264947-26494776.31176.57
5267636-26763677.08677.34
6281855-28185581.18181.48
30min1298464-29846485.96584.601.7586.3684.991.76
2289769-28976983.46183.85
3290193-29019383.58383.96
4290423-29042383.64984.04
5291675-29167584.01084.39
6301818-30181886.93187.36
45min1309098-30909889.02888.251.1189.5788.781.12
2304162-30416287.60688.13
3306056-30605688.15288.67
4304068-30406887.57988.10
5303167-30316787.32087.84
6311758-31175889.79490.37
60min1311521-31152189.72689.070.8490.4289.760.85
2308253-30825388.78589.46
3309871-30987189.25189.91
4307492-30749288.56589.24
5305783-30578388.07388.74
6312633-31263390.04690.77
极限1313753-31375390.36990.100.4791.2190.930.49
2311512-31151289.72390.54
3313213-31321390.21391.03
4311477-31147789.71390.53
5311936-31193689.84590.66
6315077-31507790.75091.63
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