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(%)99.70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%
111.784490244484134482614477754481054483160.11
211.784464744465494465120.02
单位质量响应值RSD%判断
38057.3937904.240.29数据可信
中间条件6月-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%
5min1310733-31073358.72964.748.8158.7364.748.81
2333414-33341463.01663.02
3337549-33754963.79763.80
4318912-31891260.27560.27
5362255-36225568.46768.47
6392335-39233574.15274.15
10min1481975-48197591.09489.172.6491.1989.282.64
2482238-48223891.14491.25
3466325-46632588.13688.24
4451719-45171985.37685.48
5466612-46661288.19088.30
6481874-48187491.07591.20
15min1516642-51664297.64695.342.0397.9095.602.02
2515221-51522197.37897.63
3497726-49772694.07194.32
4491330-49133092.86293.10
5498872-49887294.28894.55
6506922-50692295.80996.08
20min1521475-52147598.56096.871.2798.9797.291.27
2519161-51916198.12298.54
3508778-50877896.16096.57
4504412-50441295.33595.73
5510282-51028296.44496.86
6511173-51117396.61297.05
30min1526748-52674899.55698.070.84100.1398.650.84
2520132-52013298.30698.89
3519123-51912398.11598.69
4515168-51516897.36897.92
5516945-51694597.70398.28
6515220-51522097.37797.97
45min1528730-52873099.93198.430.85100.6799.170.85
2519465-51946598.18098.93
3522915-52291598.83299.57
4516582-51658297.63598.35
5518657-51865798.02798.77
6518282-51828297.95698.71
60min1530502-530502100.26698.500.94101.1799.410.93
2519450-51945098.17799.09
3522204-52220498.69799.60
4517132-51713297.73998.62
5519215-51921598.13299.04
6518521-51852198.00198.92
极限1532088-532088100.56599.911.05101.64100.981.05
2530751-530751100.313101.39
3522227-52222798.70299.76
4525880-52588099.392100.44
5523982-52398299.033100.10
6536769-536769101.450102.54
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(%)99.80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%
115.642956352958602963662961412964532960910.12
215.602960372958282959320.05
单位质量响应值RSD%判断
18931.6518970.000.15数据可信
中间条件6月-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
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(%)99.70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%
111.784457404456384455194454484450154454720.07
211.784451944454274453100.04
单位质量响应值RSD%判断
37815.9637802.210.03数据可信
中间条件6月-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%
5min1354025-35402567.21564.204.9167.2164.204.91
2321685-32168561.07561.07
3326219-32621961.93661.94
4322779-32277961.28361.28
5358684-35868468.09968.10
6345505-34550565.59765.60
10min1487090-48709092.47890.202.0992.5990.312.09
2460827-46082787.49287.59
3470744-47074489.37589.48
4474960-47496090.17590.28
5485627-48562792.20192.31
6471374-47137489.49589.60
15min1516730-51673098.10697.270.7998.3797.520.78
2513508-51350897.49497.74
3506088-50608896.08596.34
4516125-51612597.99198.24
5511223-51122397.06097.33
6510153-51015396.85797.12
20min1521325-52132598.97899.020.6399.4199.440.62
2525970-52597099.860100.27
3519438-51943898.62099.03
4525095-52509599.694100.11
5518647-51864798.47098.90
6518823-51882398.50398.92
30min1524009-52400999.48899.470.68100.08100.050.67
2528928-528928100.422101.00
3522726-52272699.24499.82
4526989-526989100.054100.64
5520114-52011498.74899.34
6520573-52057398.83699.42
45min1524229-52422999.53099.530.70100.29100.280.69
2528579-528579100.356101.10
3524062-52406299.498100.24
4528008-528008100.247101.00
5520767-52076798.87299.63
6519692-51969298.66899.42
60min1524340-52434099.55199.550.98100.48100.470.97
2532892-532892101.174102.09
3523786-52378699.446100.35
4526546-52654699.970100.89
5519804-51980498.69099.61
6518770-51877098.49399.41
极限1524415-52441599.56599.340.70100.66100.420.69
2527078-527078100.071101.15
3523444-52344499.381100.45
4526648-52664899.989101.07
5519033-51903398.54399.63
6518796-51879698.49899.58
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(%)99.80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%
115.642962152963962960392961812959042961470.07
215.602974462973732974100.02
单位质量响应值RSD%判断
18935.2319064.740.49数据可信
中间条件6月-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
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(%)99.70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%
111.784431294431664425174423584427294427800.09
211.784418304419974419140.03
单位质量响应值RSD%判断
37587.4437513.920.14数据可信
中间条件6月-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%
5min1337811-33781164.57862.2611.7964.5862.2611.79
2301575-30157557.65157.65
3341185-34118565.22365.22
4289599-28959955.36155.36
5294118-29411856.22556.23
6389707-38970774.49974.50
10min1479513-47951391.66789.234.9091.7789.334.90
2465331-46533188.95589.05
3454868-45486886.95587.06
4457886-45788687.53287.62
5438538-43853883.83383.93
6504520-50452096.44796.57
15min1517948-51794899.01496.122.7899.2796.372.79
2511102-51110297.70597.95
3490342-49034293.73793.99
4496797-49679794.97195.21
5484903-48490392.69792.93
6515619-51561998.56998.85
20min1521959-52195999.78198.242.03100.2198.652.04
2523692-523692100.112100.52
3503685-50368596.28796.70
4515137-51513798.47798.87
5498530-49853095.30295.69
6520266-52026699.45799.91
30min1524899-524899100.34399.491.13100.93100.071.14
2526224-526224100.596101.17
3520323-52032399.468100.04
4519896-51989699.38699.95
5509618-50961897.42297.97
6521785-52178599.747100.36
45min1524971-524971100.35799.780.91101.12100.520.93
2526520-526520100.653101.39
3521043-52104399.606100.34
4520236-52023699.451100.18
5513726-51372698.20798.92
6525275-525275100.415101.20
60min1524110-524110100.19299.770.61101.12100.680.63
2525871-525871100.529101.44
3522536-52253699.891100.79
4519548-51954899.320100.21
5517033-51703398.83999.71
6522414-52241499.868100.82
极限1523067-52306799.99399.900.39101.09100.970.38
2524560-524560100.278101.35
3519277-51927799.268100.34
4521833-52183399.757100.81
5524616-524616100.289101.33
6522016-52201699.792100.91
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(%)99.80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%
115.642964862964542959502962652964392963190.08
215.602962512969262965880.17
单位质量响应值RSD%判断
18946.2319012.050.25数据可信
中间条件6月-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
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(%)99.70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%
111.784413604414064413224413484410444412960.04
211.784397984401364399670.06
单位质量响应值RSD%判断
37461.4637348.640.22数据可信
中间条件6月-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%
5min1316399-31639960.72063.3111.5760.7263.3111.56
2334358-33435864.16764.17
3327595-32759562.86962.87
4271525-27152552.10852.11
5340045-34004565.25865.26
6389530-38953074.75574.75
10min1463752-46375288.99989.233.4389.1089.333.44
2461228-46122888.51488.62
3453918-45391887.11287.22
4444097-44409785.22785.31
5479906-47990692.09992.21
6486722-48672293.40793.53
15min1507302-50730297.35796.682.0797.6196.942.07
2504047-50404796.73296.99
3488568-48856893.76194.01
4494586-49458694.91695.15
5513878-51387898.61998.88
6514263-51426398.69298.97
20min1517071-51707199.23199.051.7299.6499.471.73
2515158-51515898.86499.28
3501282-50128296.20196.61
4514077-51407798.65799.04
5521377-521377100.058100.48
6527906-527906101.311101.76
30min1520119-52011999.816100.060.63100.39100.640.64
2520573-52057399.903100.48
3516110-51611099.04799.61
4522184-522184100.213100.76
5523932-523932100.548101.14
6525350-525350100.820101.43
45min1520301-52030199.851100.470.77100.59101.210.78
2522081-522081100.193100.94
3517985-51798599.407100.14
4525411-525411100.832101.55
5527069-527069101.150101.91
6528210-528210101.369102.15
60min1519271-51927199.653100.150.69100.56101.060.69
2521341-521341100.051100.96
3516289-51628999.08199.98
4525052-525052100.763101.65
5524398-524398100.637101.57
6524811-524811100.717101.67
极限1517800-51780099.37199.860.74100.45100.950.75
2519803-51980399.756100.84
3514980-51498098.83099.89
4522544-522544100.282101.34
5521099-521099100.004101.10
6525991-525991100.943102.06
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(%)99.80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%
115.642956482962712964482966182964032962780.13
215.602953272958592955930.13
单位质量响应值RSD%判断
18943.6118948.270.02数据可信
中间条件6月-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
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