氢氯噻嗪坎地沙坦酯片项目信息
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(%)99.7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%
112.014665144663284656874655694652064658610.12
212.064640704642304641500.03
单位质量响应值RSD%判断
38789.4338486.730.56数据可信
加速6月-供试品溶液-2024082721批-氢氯噻嗪-pH1.2
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1353509-35350965.67869.9512.8665.6869.9512.86
2309308-30930857.46657.47
3428745-42874579.65679.66
4354516-35451665.86565.86
5435206-43520680.85680.86
6377692-37769270.17170.17
10min1502467-50246793.35391.995.6793.4692.115.68
2439891-43989181.72781.82
3511432-51143295.01895.15
4505413-50541393.90094.01
5516479-51647995.95696.09
6495172-49517291.99792.11
15min1522451-52245197.06596.883.2797.3397.153.28
2488248-48824890.71190.94
3524942-52494297.52897.82
4535048-53504899.40699.67
5524903-52490397.52197.82
6533052-53305299.03599.31
20min1524634-52463497.47198.102.0097.9098.542.01
2510376-51037694.82295.21
3527848-52784898.06898.52
4539625-539625100.256100.69
5527778-52777898.05598.51
6537924-53792499.940100.38
30min1527805-52780598.06098.921.1098.6599.521.10
2529330-52933098.34398.88
3528535-52853598.19698.81
4540295-540295100.381100.98
5529157-52915798.31198.93
6539537-539537100.240100.84
45min1527625-52762598.02799.101.2498.7899.861.22
2535373-53537399.466100.17
3528420-52842098.17498.96
4542625-542625100.813101.58
5527343-52734397.97498.76
6539136-539136100.165100.93
60min1528536-52853698.19699.201.2899.11100.131.26
2539477-539477100.229101.10
3527521-52752198.00798.95
4542241-542241100.742101.68
5527410-52741097.98798.93
6538512-538512100.049100.99
极限1533061-53306199.03799.761.16100.12100.851.14
2543677-543677101.009102.05
3532709-53270998.971100.08
4542681-542681100.824101.93
5528713-52871398.22999.34
6540767-540767100.468101.57
氢氯噻嗪坎地沙坦酯片项目信息
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(%)99.8对照品水分(%)0对照品稀释倍数2000
标示量(mg)8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%
116.521541681543121542521542981543001542660.04
216.491541291541951541620.04
单位质量响应值RSD%判断
9338.149348.820.09数据可信
加速6月-供试品溶液-2024082721批-坎地沙坦酯-pH1.2
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
氢氯噻嗪坎地沙坦酯片项目信息
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(%)99.7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%
112.014632324632294635304636154636654634540.05
212.064638664639084638870.01
单位质量响应值RSD%判断
38589.0138464.930.23数据可信
加速6月-供试品溶液-2024082721批-氢氯噻嗪-pH1.2
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1348261-34826164.88970.5510.1764.8970.5510.17
2442904-44290482.52382.52
3387381-38738172.17872.18
4373660-37366069.62169.62
5387560-38756072.21172.21
6331980-33198061.85561.86
10min1466032-46603286.83291.284.4986.9491.394.49
2514733-51473395.90696.04
3501962-50196293.52793.65
4496807-49680792.56692.68
5500259-50025993.20993.33
6459502-45950285.61585.72
15min1500127-50012793.18596.622.7493.4496.892.75
2527997-52799798.37798.67
3530651-53065198.87299.15
4521069-52106997.08797.36
5530010-53001098.75299.03
6501484-50148493.43793.68
20min1515108-51510895.97698.051.7196.3898.481.72
2532671-53267199.24899.71
3535967-53596799.862100.30
4523667-52366797.57198.00
5533111-53311199.33099.77
6516855-51685596.30196.70
30min1534279-53427999.54899.530.68100.12100.130.69
2534615-53461599.610100.24
3537908-537908100.224100.83
4532194-53219499.15999.75
5537834-537834100.210100.82
6528423-52842398.45799.02
45min1537402-537402100.13099.820.64100.86100.580.65
2535967-53596799.862100.66
3538338-538338100.304101.08
4531173-53117398.96999.73
5539607-539607100.541101.31
6532102-53210299.14299.87
60min1537196-537196100.09199.650.69100.99100.580.68
2530420-53042098.82999.79
3537768-537768100.198101.14
4531509-53150999.03299.96
5539180-539180100.461101.40
6532918-53291899.294100.19
极限1539496-539496100.52099.780.71101.59100.880.71
2535708-53570899.814100.94
3539137-539137100.453101.56
4532461-53246199.209100.30
5536525-53652599.966101.07
6529908-52990898.73399.79
氢氯噻嗪坎地沙坦酯片项目信息
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(%)99.8对照品水分(%)0对照品稀释倍数2000
标示量(mg)8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%
116.521538081538531539541539211539871539050.05
216.491546471545911546190.03
单位质量响应值RSD%判断
9316.289376.530.46数据可信
加速6月-供试品溶液-2024082721批-坎地沙坦酯-pH1.2
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
氢氯噻嗪坎地沙坦酯片项目信息
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(%)99.7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%
112.014619074616864625044636954639084627400.22
212.064616904618014617460.02
单位质量响应值RSD%判断
38529.5638287.400.45数据可信
中间条件6月-供试品溶液-2024082721批-氢氯噻嗪-pH1.2
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1347150-34715064.88264.9610.5164.8864.9610.51
2374983-37498370.08470.08
3384194-38419471.80571.81
4333959-33395962.41662.42
5362095-36209567.67567.67
6282994-28299452.89152.89
10min1473645-47364588.52391.043.3288.6391.143.32
2472070-47207088.22988.35
3497501-49750192.98293.10
4502360-50236093.89093.99
5505047-50504794.39294.51
6471933-47193388.20388.29
15min1513108-51310895.89996.262.2196.1596.522.21
2507088-50708894.77495.04
3520686-52068697.31597.59
4503405-50340594.08594.35
5534881-53488199.968100.24
6510932-51093295.49295.73
20min1524533-52453398.03498.601.0998.4599.021.09
2519946-51994697.17797.60
3530393-53039399.12999.57
4524863-52486398.09698.51
5536391-536391100.250100.69
6529247-52924798.91599.31
30min1529915-52991599.040100.040.7899.62100.620.78
2532565-53256599.535100.12
3536144-536144100.204100.81
4539207-539207100.777101.36
5540656-540656101.048101.65
6533052-53305299.626100.19
45min1530854-53085499.216100.170.7399.96100.920.74
2533272-53327299.668100.42
3537277-537277100.416101.19
4539607-539607100.852101.60
5540740-540740101.063101.84
6533855-53385599.776100.50
60min1520747-52074797.32799.501.2998.24100.421.29
2529105-52910598.88999.80
3533761-53376199.759100.70
4538354-538354100.617101.53
5539495-539495100.831101.77
6532943-53294399.606100.50
极限1529347-52934798.93499.810.74100.01100.900.74
2531952-53195299.421100.50
3534076-53407699.818100.92
4536836-536836100.334101.42
5540162-540162100.955102.06
6531937-53193799.418100.48
氢氯噻嗪坎地沙坦酯片项目信息
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(%)99.8对照品水分(%)0对照品稀释倍数2000
标示量(mg)8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%
116.521544081543501546151548101549651546300.17
216.491541121541611541360.03
单位质量响应值RSD%判断
9360.179347.240.10数据可信
中间条件6月-供试品溶液-2024082721批-坎地沙坦酯-pH1.2
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
氢氯噻嗪坎地沙坦酯片项目信息
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(%)99.7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%
112.014618034618354618104618134617114617940.02
212.064604904605084604990.01
单位质量响应值RSD%判断
38450.7938184.000.50数据可信
中间条件6月-供试品溶液-2024082721批-氢氯噻嗪-pH1.2
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1381186-38118671.41266.026.7371.4166.026.73
2363653-36365368.12868.13
3356958-35695866.87466.87
4322150-32215060.35260.35
5325122-32512260.90960.91
6365419-36541968.45968.46
10min1511765-51176595.87590.713.5195.9990.823.52
2498396-49839693.37193.48
3477779-47777989.50889.62
4470282-47028288.10488.20
5470676-47067688.17888.28
6476174-47617489.20889.32
15min1525423-52542398.43496.351.2498.7196.611.24
2515219-51521996.52396.79
3507083-50708394.99895.26
4514524-51452496.39296.64
5509269-50926995.40895.66
6514193-51419396.33096.59
20min1524427-52442798.24897.800.4298.6998.230.42
2521132-52113297.63098.06
3518745-51874597.18397.60
4524343-52434398.23298.64
5521416-52141697.68498.09
6522323-52232397.85398.28
30min1527150-52715098.75899.110.8099.3699.690.79
2531945-53194599.656100.25
3527624-52762498.84799.43
4532146-53214699.694100.27
5522148-52214897.82198.39
6533079-53307999.869100.45
45min1526650-52665098.66499.680.7499.44100.430.73
2531854-53185499.639100.40
3530751-53075199.432100.18
4535478-535478100.318101.06
5530036-53003699.298100.03
6537527-537527100.702101.45
60min1523306-52330698.03899.470.9898.97100.390.97
2530035-53003599.298100.22
3530058-53005899.303100.21
4535282-535282100.281101.19
5528970-52897099.099100.00
6538169-538169100.822101.74
极限1531166-53116699.510100.780.78100.61101.860.77
2538017-538017100.794101.88
3536837-536837100.573101.65
4537403-537403100.679101.75
5540314-540314101.224102.29
6543838-543838101.884102.97
氢氯噻嗪坎地沙坦酯片项目信息
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(%)99.8对照品水分(%)0对照品稀释倍数2000
标示量(mg)8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%
116.521546411546121546221546601546041546280.02
216.491544071543401543740.04
单位质量响应值RSD%判断
9360.059361.670.02数据可信
中间条件6月-供试品溶液-2024082721批-坎地沙坦酯-pH1.2
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
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