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%
112.694823944821534818844816754819684820150.06
212.714798074797234797650.02
单位质量响应值RSD%判断
37983.8537747.050.45数据可信
供试品溶液-2024082821批-氢氯噻嗪-pH4.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1363132-36313268.84261.487.6968.8461.487.69
2325158-32515861.64361.64
3335144-33514463.53663.54
4320346-32034660.73160.73
5314943-31494359.70659.71
6287176-28717654.44254.44
10min1493082-49308293.47891.602.1393.5991.702.13
2482189-48218991.41391.52
3496753-49675394.17494.28
4471741-47174189.43289.53
5472550-47255089.58589.68
6482608-48260891.49291.58
15min1517786-51778698.16199.971.0598.43100.231.04
2530835-530835100.635100.89
3531495-531495100.760101.02
4526309-52630999.777100.03
5532310-532310100.914101.16
6525326-52532699.59099.83
20min1522294-52229499.016101.771.4199.45102.201.40
2542783-542783102.900103.32
3539763-539763102.327102.76
4536085-536085101.630102.05
5542014-542014102.754103.17
6538075-538075102.007102.42
30min1524333-52433399.402102.261.44100.00102.851.43
2545811-545811103.474104.07
3543397-543397103.016103.62
4539123-539123102.206102.79
5543308-543308102.999103.59
6540407-540407102.449103.03
45min1527042-52704299.916102.421.29100.68103.191.28
2546281-546281103.563104.33
3544930-544930103.307104.08
4539833-539833102.341103.10
5543034-543034102.948103.71
6540521-540521102.471103.22
60min1526709-52670999.853102.241.23100.78103.171.23
2545295-545295103.376104.32
3543560-543560103.047103.99
4539468-539468102.271103.20
5541860-541860102.725103.66
6538871-538871102.158103.08
极限1533316-533316101.105102.530.77102.20103.630.77
2544912-544912103.304104.42
3542547-542547102.855103.97
4539600-539600102.296103.39
5541103-541103102.581103.68
6543563-543563103.048104.14
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%
116.343002783002703003823002783000543002520.05
216.282997262997452997360.01
单位质量响应值RSD%判断
18375.2818411.300.14数据可信
供试品溶液-2024082821批-坎地沙坦酯-pH4.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1-0.0000.00-0.000.00-
2-0.0000.00
3-0.0000.00
4-0.0000.00
5-0.0000.00
6-0.0000.00
10min1-0.0000.00-0.000.00-
2-0.0000.00
3-0.0000.00
4-0.0000.00
5-0.0000.00
6-0.0000.00
15min1-0.0000.00-0.000.00-
2-0.0000.00
3-0.0000.00
4-0.0000.00
5-0.0000.00
6-0.0000.00
20min1-0.0000.00-0.000.00-
2-0.0000.00
3-0.0000.00
4-0.0000.00
5-0.0000.00
6-0.0000.00
30min1-0.0000.00-0.000.00-
2-0.0000.00
3-0.0000.00
4-0.0000.00
5-0.0000.00
6-0.0000.00
45min1-0.0000.00-0.000.00-
2-0.0000.00
3-0.0000.00
4-0.0000.00
5-0.0000.00
6-0.0000.00
60min1-0.0000.00-0.000.00-
2-0.0000.00
3-0.0000.00
4-0.0000.00
5-0.0000.00
6-0.0000.00
极限1-0.0000.00-0.000.00-
2-0.0000.00
3-0.0000.00
4-0.0000.00
5-0.0000.00
6-0.0000.00
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%
112.694793044793994790814793784792344792790.03
212.714787454787324787380.01
单位质量响应值RSD%判断
37768.2437666.250.20数据可信
供试品溶液-2024083021批-氢氯噻嗪-pH4.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1340949-34094964.89059.778.8064.8959.778.80
2317388-31738860.40660.41
3317043-31704360.34060.34
4262450-26245049.95049.95
5312245-31224559.42759.43
6334078-33407863.58263.58
10min1519564-51956498.88491.044.8598.9991.144.85
2450159-45015985.67585.78
3482492-48249291.82991.93
4465292-46529288.55588.64
5476652-47665290.71790.82
6475972-47597290.58890.69
15min1542589-542589103.26799.832.13103.54100.082.13
2507827-50782796.65196.89
3526624-526624100.228100.48
4522008-52200899.34999.58
5525435-525435100.002100.25
6522691-52269199.47999.74
20min1545047-545047103.734102.291.14104.18102.711.14
2529458-529458100.767101.17
3535060-535060101.834102.25
4544457-544457103.622104.02
5535606-535606101.937102.35
6535209-535209101.862102.28
30min1546099-546099103.935103.141.07104.55103.721.07
2537808-537808102.357102.93
3538869-538869102.559103.15
4551835-551835105.026105.60
5538136-538136102.419103.01
6538655-538655102.518103.11
45min1545231-545231103.769103.151.11104.56103.911.10
2540117-540117102.796103.54
3539099-539099102.602103.36
4552670-552670105.185105.93
5536785-536785102.162102.92
6537849-537849102.364103.13
60min1543099-543099103.364102.891.12104.33103.821.10
2538954-538954102.575103.49
3537392-537392102.277103.21
4551659-551659104.993105.91
5535718-535718101.959102.89
6536747-536747102.155103.09
极限1542661-542661103.280102.711.11104.42103.811.10
2538426-538426102.474103.56
3536214-536214102.053103.16
4550320-550320104.738105.83
5534690-534690101.763102.86
6535630-535630101.942103.05
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%
116.343002503006523003683003963002153003760.06
216.282993832996082994960.06
单位质量响应值RSD%判断
18382.8618396.560.06数据可信
供试品溶液-2024083021批-坎地沙坦酯-pH4.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1-0.0000.00-0.000.00-
2-0.0000.00
3-0.0000.00
4-0.0000.00
5-0.0000.00
6-0.0000.00
10min1-0.0000.00-0.000.00-
2-0.0000.00
3-0.0000.00
4-0.0000.00
5-0.0000.00
6-0.0000.00
15min1-0.0000.00-0.000.00-
2-0.0000.00
3-0.0000.00
4-0.0000.00
5-0.0000.00
6-0.0000.00
20min1-0.0000.00-0.000.00-
2-0.0000.00
3-0.0000.00
4-0.0000.00
5-0.0000.00
6-0.0000.00
30min1-0.0000.00-0.000.00-
2-0.0000.00
3-0.0000.00
4-0.0000.00
5-0.0000.00
6-0.0000.00
45min1-0.0000.00-0.000.00-
2-0.0000.00
3-0.0000.00
4-0.0000.00
5-0.0000.00
6-0.0000.00
60min1-0.0000.00-0.000.00-
2-0.0000.00
3-0.0000.00
4-0.0000.00
5-0.0000.00
6-0.0000.00
极限1-0.0000.00-0.000.00-
2-0.0000.00
3-0.0000.00
4-0.0000.00
5-0.0000.00
6-0.0000.00
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%
112.694781404780014778124777784779894779440.04
212.714763044762024762530.02
单位质量响应值RSD%判断
37663.0437470.730.37数据可信
供试品溶液-2024090121批-氢氯噻嗪-pH4.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1336255-33625564.25361.585.7264.2561.585.72
2316420-31642060.46360.46
3295410-29541056.44856.45
4341189-34118965.19665.20
5308191-30819158.89158.89
6335984-33598464.20164.20
10min1496338-49633894.84290.912.8194.9591.012.81
2477175-47717591.18191.28
3465218-46521888.89688.99
4475726-47572690.90491.01
5457992-45799287.51587.61
6481980-48198092.09992.21
15min1529701-529701101.21899.561.04101.4899.811.04
2521418-52141899.63599.89
3521445-52144599.64099.88
4514419-51441998.29798.56
5516346-51634698.66698.91
6522811-52281199.901100.16
20min1532568-532568101.765101.250.48102.20101.670.48
2530819-530819101.431101.85
3531173-531173101.499101.91
4525255-525255100.368100.79
5529710-529710101.219101.63
6529577-529577101.194101.62
30min1533523-533523101.948102.040.58102.55102.630.58
2536965-536965102.606103.19
3536857-536857102.585103.16
4528789-528789101.043101.63
5535336-535336102.294102.87
6532649-532649101.781102.38
45min1533901-533901102.020102.290.68102.79103.050.67
2538290-538290102.859103.62
3538728-538728102.943103.69
4529529-529529101.185101.94
5537842-537842102.773103.52
6533598-533598101.962102.73
60min1532325-532325101.719102.090.67102.66103.020.66
2537944-537944102.793103.72
3537160-537160102.643103.56
4528713-528713101.029101.96
5536424-536424102.502103.42
6533009-533009101.850102.78
极限1532879-532879101.825102.000.64102.94103.100.63
2537010-537010102.614103.72
3537087-537087102.629103.72
4528246-528246100.940102.04
5535183-535183102.265103.35
6532402-532402101.734102.84
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%
116.342998962998212997352999172998302998400.03
216.282992382993972993180.04
单位质量响应值RSD%判断
18350.0618385.630.14数据可信
供试品溶液-2024090121批-坎地沙坦酯-pH4.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1-0.0000.00-0.000.00-
2-0.0000.00
3-0.0000.00
4-0.0000.00
5-0.0000.00
6-0.0000.00
10min1-0.0000.00-0.000.00-
2-0.0000.00
3-0.0000.00
4-0.0000.00
5-0.0000.00
6-0.0000.00
15min1-0.0000.00-0.000.00-
2-0.0000.00
3-0.0000.00
4-0.0000.00
5-0.0000.00
6-0.0000.00
20min1-0.0000.00-0.000.00-
2-0.0000.00
3-0.0000.00
4-0.0000.00
5-0.0000.00
6-0.0000.00
30min1-0.0000.00-0.000.00-
2-0.0000.00
3-0.0000.00
4-0.0000.00
5-0.0000.00
6-0.0000.00
45min1-0.0000.00-0.000.00-
2-0.0000.00
3-0.0000.00
4-0.0000.00
5-0.0000.00
6-0.0000.00
60min1-0.0000.00-0.000.00-
2-0.0000.00
3-0.0000.00
4-0.0000.00
5-0.0000.00
6-0.0000.00
极限1-0.0000.00-0.000.00-
2-0.0000.00
3-0.0000.00
4-0.0000.00
5-0.0000.00
6-0.0000.00
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%
112.694780214779704780404778874779524779740.02
212.714750974752544751760.03
单位质量响应值RSD%判断
37665.4137386.000.53数据可信
供试品溶液-516246批-氢氯噻嗪-pH4.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1276164-27616452.82947.1410.7552.8347.1410.75
2241449-24144946.18846.19
3206531-20653139.50839.51
4275025-27502552.61152.61
5232729-23272944.52044.52
6246675-24667547.18847.19
10min1490947-49094793.91681.328.2594.0081.408.24
2430310-43031082.31682.39
3388785-38878574.37374.44
4418223-41822380.00480.09
5408195-40819578.08678.16
6414136-41413679.22279.30
15min1531838-531838101.73893.136.14101.9893.346.14
2504637-50463796.53596.75
3443670-44367084.87285.06
4475212-47521290.90691.13
5489220-48922093.58693.79
6476453-47645391.14391.35
20min1537837-537837102.88697.294.41103.3097.664.42
2523884-523884100.217100.59
3474196-47419690.71291.04
4499062-49906295.46895.84
5516813-51681398.86499.22
6499654-49965495.58295.94
30min1538987-538987103.106100.462.49103.69101.002.50
2529257-529257101.245101.79
3500997-50099795.83896.32
4521781-52178199.814100.35
5530168-530168101.419101.94
6529838-529838101.356101.88
45min1542131-542131103.707101.601.29104.46102.301.31
2530440-530440101.471102.18
3520735-52073599.614100.26
4529895-529895101.367102.06
5530926-530926101.564102.26
6532544-532544101.873102.56
60min1542984-542984103.870101.940.97104.80102.800.99
2530472-530472101.477102.36
3530232-530232101.431102.24
4529564-529564101.303102.17
5530438-530438101.470102.33
6533548-533548102.065102.93
极限1546496-546496104.542102.021.25105.65103.061.26
2528965-528965101.189102.24
3531968-531968101.763102.74
4529161-529161101.226102.26
5530647-530647101.510102.54
6532663-532663101.896102.93
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%
116.342997003001362994942995442995092996770.09
216.282986482988872987680.06
单位质量响应值RSD%判断
18340.0918351.840.05数据可信
供试品溶液-516246批-坎地沙坦酯-pH4.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1-0.0000.00-0.000.00-
2-0.0000.00
3-0.0000.00
4-0.0000.00
5-0.0000.00
6-0.0000.00
10min1-0.0000.00-0.000.00-
2-0.0000.00
3-0.0000.00
4-0.0000.00
5-0.0000.00
6-0.0000.00
15min1-0.0000.00-0.000.00-
2-0.0000.00
3-0.0000.00
4-0.0000.00
5-0.0000.00
6-0.0000.00
20min1-0.0000.00-0.000.00-
2-0.0000.00
3-0.0000.00
4-0.0000.00
5-0.0000.00
6-0.0000.00
30min1-0.0000.00-0.000.00-
2-0.0000.00
3-0.0000.00
4-0.0000.00
5-0.0000.00
6-0.0000.00
45min1-0.0000.00-0.000.00-
2-0.0000.00
3-0.0000.00
4-0.0000.00
5-0.0000.00
6-0.0000.00
60min1-0.0000.00-0.000.00-
2-0.0000.00
3-0.0000.00
4-0.0000.00
5-0.0000.00
6-0.0000.00
极限1-0.0000.00-0.000.00-
2-0.0000.00
3-0.0000.00
4-0.0000.00
5-0.0000.00
6-0.0000.00
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