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%
112.014649364648444652854650204649814650130.04
212.064642334643344642840.02
单位质量响应值RSD%判断
38718.8238497.840.41数据可信
加速6月-供试品溶液-2024082721批-氢氯噻嗪-pH6.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1361628-36162867.23872.977.7567.2472.977.75
2441802-44180282.14482.14
3363078-36307867.50767.51
4410589-41058976.34176.34
5391726-39172672.83472.83
6386055-38605571.77971.78
10min1472898-47289887.92690.983.1688.0491.103.17
2515403-51540395.82995.97
3481792-48179289.58089.69
4499642-49964292.89993.03
5482278-48227889.67089.79
6483977-48397789.98690.11
15min1498836-49883692.74994.341.8693.0194.611.86
2524418-52441897.50597.80
3500283-50028393.01893.28
4511057-51105795.02195.30
5503996-50399693.70893.98
6505659-50565994.01794.29
20min1505570-50557094.00194.951.5294.4195.381.53
2524310-52431097.48597.94
3502311-50231193.39593.81
4513466-51346695.46995.91
5510921-51092194.99695.42
6507549-50754994.36994.80
30min1510363-51036394.89295.501.2995.4696.081.30
2523536-52353697.34197.96
3503573-50357393.62994.20
4515922-51592295.92696.53
5514909-51490995.73796.32
6513386-51338695.45496.04
45min1513765-51376595.52495.631.1196.2596.381.12
2522108-52210897.07697.86
3504502-50450293.80294.53
4516146-51614695.96796.73
5515383-51538395.82596.57
6514042-51404295.57696.32
60min1513742-51374295.52095.481.1596.4196.381.15
2521748-52174897.00997.95
3503450-50345093.60794.49
4514675-51467595.69496.61
5514544-51454495.66996.57
6512981-51298195.37996.28
极限1534967-53496799.46799.920.50100.51100.990.51
2539766-539766100.359101.47
3533987-53398799.284100.33
4540644-540644100.522101.60
5536840-53684099.815100.88
6538280-538280100.083101.14
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%
116.521537751537231538901538551538381538160.05
216.491537311537661537480.02
单位质量响应值RSD%判断
9310.909323.710.10数据可信
加速6月-供试品溶液-2024082721批-坎地沙坦酯-pH6.8
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
10min1-0.0000.15244.950.000.14244.95
21445-14450.8710.87
3-0.0000.00
4-0.0000.00
5-0.0000.00
6-0.0000.00
15min12906-29061.7511.7415.421.751.7415.40
23140-31401.8921.89
33303-33031.9901.99
43227-32271.9441.94
52689-26891.6201.62
62110-21101.2711.27
20min13707-37072.2332.328.412.242.328.33
24299-42992.5902.59
34146-41462.4982.50
43637-36372.1912.19
53826-38262.3052.31
63443-34432.0742.08
30min14257-42572.5652.947.072.572.957.06
24964-49642.9913.00
35304-53043.1963.20
44934-49342.9732.98
54835-48352.9132.92
65002-50023.0143.02
45min15668-56683.4153.505.833.433.525.83
25509-55093.3193.33
35709-57093.4403.45
45527-55273.3303.34
56164-61643.7143.73
66307-63073.8003.81
60min16873-68734.1414.018.734.164.038.70
27053-70534.2494.27
37200-72004.3384.36
45778-57783.4813.50
56077-60773.6613.68
66929-69294.1754.19
极限16737-67374.0594.045.424.084.065.40
27022-70224.2314.26
36727-67274.0534.08
47098-70984.2774.30
56100-61003.6753.70
66520-65203.9283.95
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%
112.014633264632974632524632964637884633920.05
212.064620114619484619800.01
单位质量响应值RSD%判断
38583.8538306.800.51数据可信
加速6月-供试品溶液-2024082721批-氢氯噻嗪-pH6.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1378529-37852970.67961.289.4170.6861.289.42
2343886-34388664.21064.21
3333930-33393062.35162.35
4300150-30015056.04456.04
5296050-29605055.27855.28
6316578-31657859.11159.11
10min1500070-50007093.37387.793.8993.4987.893.90
2482042-48204290.00790.11
3465603-46560386.93787.04
4450148-45014884.05184.14
5456002-45600285.14485.24
6467035-46703587.20587.30
15min1514863-51486396.13594.721.2996.4194.971.30
2516198-51619896.38496.64
3504198-50419894.14494.39
4503895-50389594.08794.32
5500849-50084993.51893.75
6503700-50370094.05194.29
20min1519969-51996997.08896.580.8597.5296.990.86
2524518-52451897.93898.36
3514442-51444296.05696.46
4516682-51668296.47596.86
5515672-51567296.28696.68
6512281-51228195.65396.05
30min1523787-52378797.80198.091.0098.4098.661.00
2534705-53470599.840100.42
3519976-51997697.09097.66
4527797-52779798.55099.10
5523358-52335897.72198.27
6522402-52240297.54398.10
45min1523627-52362797.77199.141.1798.5399.871.16
2540210-540210100.868101.62
3530036-53003698.96899.70
4536294-536294100.137100.85
5526861-52686198.37599.09
6528744-52874498.72799.45
60min1519481-51948196.99799.321.3997.92100.221.37
2541342-541342101.079101.99
3531190-53119099.184100.08
4536917-536917100.253101.14
5531053-53105399.158100.04
6531518-53151899.245100.13
极限1537729-537729100.405100.010.68101.49101.070.69
2540094-540094100.846101.93
3537600-537600100.380101.44
4535650-535650100.016101.07
5531233-53123399.192100.23
6531377-53137799.218100.27
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%
116.521534721535211534821535531537471535550.08
216.491535071534711534890.02
单位质量响应值RSD%判断
9295.109308.000.10数据可信
加速6月-供试品溶液-2024082721批-坎地沙坦酯-pH6.8
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
10min1-0.0000.26155.350.000.26155.39
2-0.0000.00
31390-13900.8390.84
4-0.0000.00
5-0.0000.00
61231-12310.7430.74
15min12267-22671.3681.6411.691.371.6411.75
22724-27241.6441.64
33225-32251.9461.95
42863-28631.7281.73
52606-26061.5731.57
62617-26171.5791.58
20min14100-41002.4742.316.522.482.316.63
23642-36422.1982.20
33794-37942.2902.29
43644-36442.1992.20
53597-35972.1712.17
64166-41662.5142.52
30min14879-48792.9452.895.882.952.905.89
24289-42892.5892.59
34842-48422.9222.93
45150-51503.1083.11
54844-48442.9232.93
64737-47372.8592.87
45min15524-55243.3343.347.423.353.357.48
25141-51413.1033.11
35486-54863.3113.32
45941-59413.5863.60
55025-50253.0333.04
66043-60433.6473.66
60min15901-59013.5613.817.683.583.837.59
26667-66674.0244.04
35882-58823.5503.57
45837-58373.5233.54
56770-67704.0864.10
66820-68204.1164.13
极限16126-61263.6973.999.303.724.019.20
27341-73414.4314.45
35921-59213.5733.60
46299-62993.8023.83
56619-66193.9954.02
67348-73484.4354.46
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%
112.014620334620064622234621564618864620610.03
212.064618164617584617870.01
单位质量响应值RSD%判断
38473.0238290.800.34数据可信
中间条件6月-供试品溶液-2024082721批-氢氯噻嗪-pH6.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1326590-32659061.08161.639.3961.0861.629.39
2364203-36420368.11668.12
3313607-31360758.65358.65
4282208-28220852.78052.78
5362356-36235667.77067.77
6328037-32803761.35261.35
10min1453763-45376384.86686.343.0184.9786.443.02
2475498-47549888.93189.04
3450110-45011084.18384.28
4444021-44402183.04483.13
5473700-47370088.59588.71
6472651-47265188.39888.50
15min1490042-49004291.65192.851.2991.8993.101.29
2499216-49921693.36793.63
3490487-49048791.73491.97
4499406-49940693.40293.63
5493088-49308892.22192.48
6506447-50644794.71994.97
20min1496131-49613192.79094.361.5493.1994.761.53
2505807-50580794.59995.02
3499303-49930393.38393.77
4513511-51351196.04096.42
5498691-49869193.26993.68
6513857-51385796.10596.51
30min1506160-50616094.66595.772.0395.2296.332.01
2511231-51123195.61496.19
3504363-50436394.32994.88
4528323-52832398.81099.35
5501783-50178393.84794.42
6520455-52045597.33997.91
45min1511168-51116895.60296.372.2996.3197.092.27
2510294-51029495.43996.17
3509701-50970195.32896.03
4531310-53131099.369100.08
5501153-50115393.72994.46
6528044-52804498.75899.49
60min1504781-50478194.40896.372.5895.2897.252.55
2511955-51195595.74996.64
3508416-50841695.08795.95
4535200-535200100.097100.97
5503205-50320594.11395.00
6528191-52819198.78699.68
极限1523825-52382597.96998.800.8398.9999.840.82
2529698-52969899.068100.12
3531923-53192399.484100.50
4533415-53341599.763100.80
5522433-52243397.70998.75
6528248-52824898.79699.86
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%
116.521537451538101539191538551537721538200.05
216.491542491540671541580.09
单位质量响应值RSD%判断
9311.149348.570.29数据可信
中间条件6月-供试品溶液-2024082721批-坎地沙坦酯-pH6.8
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
10min12278-22781.3711.2612.641.371.2612.64
22048-20481.2321.23
31764-17641.0611.06
41809-18091.0881.09
52352-23521.4151.42
62333-23331.4041.40
15min14022-40222.4202.346.142.422.346.17
24136-41362.4892.49
33895-38952.3442.35
43967-39672.3872.39
53901-39012.3472.35
63442-34422.0712.07
20min14362-43622.6252.8412.542.632.8412.50
25623-56233.3833.39
34387-43872.6402.65
44495-44952.7052.71
54146-41462.4952.50
65281-52813.1783.18
30min16190-61903.7253.673.333.743.693.32
26289-62893.7843.80
35826-58263.5063.52
46184-61843.7213.73
56275-62753.7763.79
65875-58753.5353.55
45min17118-71184.2834.205.714.304.215.69
26829-68294.1094.13
37008-70084.2174.23
46259-62593.7663.78
57249-72494.3624.38
67375-73754.4384.45
60min16529-65293.9284.209.833.954.229.82
27754-77544.6664.69
35883-58833.5403.56
46996-69964.2094.23
57535-75354.5344.56
67162-71624.3094.33
极限17822-78224.7064.626.274.744.656.19
27929-79294.7714.80
37366-73664.4324.46
48346-83465.0225.05
56956-69564.1854.22
67602-76024.5744.61
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%
112.014608124608644609074608074610924608960.03
212.064606744604214605480.04
单位质量响应值RSD%判断
38376.0238188.060.35数据可信
中间条件6月-供试品溶液-2024082721批-氢氯噻嗪-pH6.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1370403-37040369.45663.8310.6269.4663.8410.62
2335494-33549462.91062.91
3292023-29202354.75954.76
4389770-38977073.08873.09
5343102-34310264.33764.34
6311759-31175958.45958.46
10min1501260-50126093.99488.435.2394.1188.535.24
2460060-46006086.26886.37
3451437-45143784.65184.74
4496414-49641493.08593.21
5479286-47928689.87389.98
6440941-44094182.68382.78
15min1522258-52225897.93194.752.3198.2095.002.32
2494794-49479492.78193.03
3507756-50775695.21295.44
4509468-50946895.53395.81
5508032-50803295.26395.52
6489471-48947191.78392.02
20min1523898-52389898.23996.311.7198.6796.721.71
2500541-50054193.85994.26
3519326-51932697.38197.77
4510912-51091295.80396.24
5519307-51930797.37897.79
6507732-50773295.20795.60
30min1524774-52477498.40397.371.5599.0097.941.54
2508563-50856395.36395.92
3527077-52707798.83599.39
4511161-51116195.85096.45
5526102-52610298.65299.23
6517927-51792797.11997.67
45min1520361-52036197.57598.041.8498.3498.771.83
2514231-51423196.42697.14
3535305-535305100.378101.10
4511607-51160795.93496.69
5532877-53287799.922100.66
6522511-52251197.97898.69
60min1524499-52449998.35198.111.9399.2899.001.91
2513803-51380396.34697.22
3535985-535985100.505101.39
4509921-50992195.61896.53
5531959-53195999.750100.66
6522959-52295998.06298.93
极限1536004-536004100.50999.001.94101.60100.061.93
2507943-50794395.24796.29
3533420-533420100.024101.08
4527625-52762598.937100.01
5531535-53153599.671100.75
6531308-53130899.628100.66
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%
116.521536391536681536901536991537691536930.04
216.491541541540171540860.07
单位质量响应值RSD%判断
9303.459344.210.31数据可信
中间条件6月-供试品溶液-2024082721批-坎地沙坦酯-pH6.8
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
10min11698-16981.0221.2415.291.021.2415.32
22203-22031.3261.33
31950-19501.1741.17
41757-17571.0581.06
52481-24811.4941.49
62318-23181.3961.40
15min13946-39462.3762.326.952.382.326.84
24287-42872.5812.58
33852-38522.3192.32
43883-38832.3382.34
53513-35132.1152.12
63643-36432.1932.20
20min14862-48622.9273.032.512.933.032.52
25210-52103.1373.14
35041-50413.0353.04
45056-50563.0443.05
54908-49082.9552.96
65083-50833.0603.07
30min16160-61603.7093.4611.693.723.4811.65
26273-62733.7773.79
35817-58173.5023.51
44465-44652.6882.70
55670-56703.4143.42
66143-61433.6993.71
45min16335-63353.8144.124.203.834.144.20
26704-67044.0364.05
36940-69404.1784.20
46978-69784.2014.22
57064-70644.2534.27
67086-70864.2664.28
60min16690-66904.0284.497.584.054.527.56
27511-75114.5224.55
37977-79774.8034.83
47316-73164.4054.43
58195-81954.9344.96
67046-70464.2424.27
极限17498-74984.5144.516.764.544.546.66
26568-65683.9553.99
37385-73854.4464.48
47583-75834.5664.60
57972-79724.8004.83
67909-79094.7624.79
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