坎地沙坦酯氢氯噻嗪片项目信息
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%
111.834548424550304549124549324546974548830.03
211.944541664540064540860.03
单位质量响应值RSD%判断
38451.6538030.650.78数据可信
供试品溶液-2024082321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%
5min1368840-36884069.23965.908.0369.2465.908.04
2331909-33190962.30662.31
3394052-39405273.97173.97
4359874-35987467.55567.56
5318954-31895459.87459.87
6332809-33280962.47562.47
10min1461811-46181186.69188.394.0286.8188.504.02
2445876-44587683.70083.80
3498024-49802493.48993.61
4483887-48388790.83590.95
5459060-45906086.17586.27
6476534-47653489.45589.56
15min1490045-49004591.99193.332.1092.2593.592.10
2482878-48287890.64690.89
3512015-51201596.11596.39
4498627-49862793.60293.87
5494792-49479292.88293.13
6504758-50475894.75395.01
20min1501039-50103994.05594.681.4394.4795.101.44
2494700-49470092.86593.26
3514740-51474096.62797.07
4501965-50196594.22994.65
5503219-50321994.46494.86
6510706-51070695.87096.28
30min1508611-50861195.47695.801.0296.0596.371.02
2505581-50558194.90895.46
3518528-51852897.33897.94
4506175-50617595.01995.60
5508289-50828995.41695.97
6514702-51470296.62097.19
45min1511262-51126295.97496.170.9196.7096.900.92
2508372-50837295.43196.14
3520102-52010297.63398.40
4509156-50915695.57996.31
5509334-50933495.61296.33
6515649-51564996.79797.53
60min1510442-51044295.82096.140.8596.7197.030.86
2508676-50867695.48996.35
3519865-51986597.58998.51
4509383-50938395.62196.52
5509777-50977795.69596.57
6514706-51470696.62097.51
极限1525498-52549898.64699.471.0499.70100.521.03
2533558-533558100.159101.18
3536079-536079100.633101.72
4522854-52285498.15099.20
5534475-534475100.331101.37
6526829-52682998.89699.95
坎地沙坦酯氢氯噻嗪片项目信息
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%
116.171528601530501529641531901531671530460.10
216.221531401530361530880.05
单位质量响应值RSD%判断
9464.819438.220.20数据可信
供试品溶液-2024082321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
10min1-0.0000.00-0.000.00-
2-0.0000.00
3-0.0000.00
4-0.0000.00
5-0.0000.00
6-0.0000.00
15min1-0.0000.94154.930.000.94154.93
2-0.0000.00
34708-47082.7962.80
44773-47732.8352.83
5-0.0000.00
6-0.0000.00
20min15990-59903.5583.407.803.563.407.78
25534-55343.2873.29
36095-60953.6203.62
45830-58303.4633.47
54913-49132.9182.92
66012-60123.5713.57
30min16517-65173.8713.905.043.883.915.09
26103-61033.6253.63
36720-67203.9914.00
46977-69774.1444.15
56280-62803.7303.73
66802-68024.0404.05
45min17071-70714.2004.0910.974.214.1010.96
27997-79974.7504.76
37187-71874.2694.29
46589-65893.9143.93
55711-57113.3923.40
66747-67474.0074.02
60min17276-72764.3224.406.714.344.426.67
28311-83114.9364.96
36892-68924.0944.12
47336-73364.3574.38
57583-75834.5044.52
67085-70854.2084.23
极限18608-86085.1134.943.365.144.963.39
28669-86695.1495.18
38101-81014.8124.84
48236-82364.8924.92
57961-79614.7284.75
68287-82874.9224.95
坎地沙坦酯氢氯噻嗪片项目信息
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%
111.834526284524424521694527114526524525200.05
211.944517254511234514240.10
单位质量响应值RSD%判断
38251.9037807.710.83数据可信
供试品溶液-2024082321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%
5min1343879-34387964.91263.168.0464.9163.168.03
2361536-36153668.24568.24
3348056-34805665.70065.70
4284316-28431653.66953.67
5328189-32818961.95061.95
6341552-34155264.47364.47
10min1459646-45964686.76487.703.1186.8787.803.11
2475563-47556389.76989.88
3460212-46021286.87186.98
4443540-44354083.72483.81
5463288-46328887.45287.56
6485318-48531891.61091.72
15min1494317-49431793.30994.651.5293.5694.911.52
2504470-50447095.22695.49
3496035-49603593.63393.89
4497704-49770493.94894.18
5501115-50111594.59294.84
6515021-51502197.21797.48
20min1506294-50629495.57096.541.0995.9896.951.09
2515271-51527197.26497.69
3506750-50675095.65696.07
4508035-50803595.89996.28
5511902-51190296.62897.04
6520325-52032598.21898.64
30min1516658-51665897.52698.210.8598.0998.780.86
2524422-52442298.99299.58
3515799-51579997.36497.93
4516680-51668097.53098.08
5522438-52243898.61799.19
6525680-52568099.22999.82
45min1525143-52514399.12899.400.6299.86100.130.62
2530496-530496100.138100.89
3522878-52287898.70099.43
4524076-52407698.92799.63
5530392-530392100.119100.85
6526430-52643099.371100.12
60min1528205-52820599.70699.600.58100.60100.500.59
2531046-531046100.242101.16
3523996-52399698.91199.81
4525187-52518799.136100.01
5531318-531318100.294101.19
6526243-52624399.336100.25
极限1526480-52648099.38099.350.62100.44100.410.62
2529191-52919199.892100.98
3522613-52261398.65099.71
4524668-52466899.038100.08
5530932-530932100.221101.29
6523908-52390898.89599.98
坎地沙坦酯氢氯噻嗪片项目信息
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%
116.171530021531311531621532701532371531600.07
216.221527351526471526910.05
单位质量响应值RSD%判断
9471.869413.750.44数据可信
供试品溶液-2024082321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
10min1-0.0001.36109.850.001.36109.85
24392-43922.6112.61
3-0.0000.00
44918-49182.9242.92
54428-44282.6322.63
6-0.0000.00
15min15393-53933.2062.7249.573.212.7349.57
24960-49602.9492.95
35931-59313.5263.53
45807-58073.4523.46
55404-54043.2133.22
6-0.0000.00
20min17070-70704.2033.826.604.213.826.61
26618-66183.9343.94
36421-64213.8173.82
46327-63273.7613.77
56293-62933.7413.75
65780-57803.4363.44
30min17297-72974.3384.403.084.354.423.13
27758-77584.6124.63
37093-70934.2174.23
47381-73814.3884.40
57558-75584.4934.51
67358-73584.3744.38
45min18066-80664.7954.614.064.814.634.09
27826-78264.6534.68
37891-78914.6914.71
48041-80414.7804.80
57436-74364.4214.44
67315-73154.3494.36
60min18844-88445.2585.185.235.295.215.25
29290-92905.5235.55
37951-79514.7274.75
49009-90095.3565.39
58642-86425.1385.17
68589-85895.1065.13
极限18348-83484.9635.222.965.005.252.92
29025-90255.3655.41
38914-89145.2995.33
48937-89375.3135.35
58572-85725.0965.14
68841-88415.2565.28
坎地沙坦酯氢氯噻嗪片项目信息
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%
111.834504894506894506594507384507724506690.03
211.944497104494024495560.05
单位质量响应值RSD%判断
38095.4437651.260.83数据可信
供试品溶液-2024082521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%
5min1305425-30542557.89158.203.7357.8958.203.74
2301018-30101857.05657.06
3317632-31763260.20560.21
4323541-32354161.32561.33
5292720-29272055.48355.48
6301886-30188657.22157.22
10min1464398-46439888.02486.802.5588.1286.902.55
2436073-43607382.65582.75
3466269-46626988.37888.48
4465428-46542888.21988.32
5453639-45363985.98486.08
6461922-46192287.55487.65
15min1506373-50637395.98096.011.8896.2296.251.88
2491359-49135993.13493.37
3518043-51804398.19298.44
4515261-51526197.66497.91
5503510-50351095.43795.67
6504596-50459695.64395.88
20min1518217-51821798.22598.321.5998.6398.721.60
2506646-50664696.03196.42
3529405-529405100.345100.76
4525978-52597899.696100.11
5513627-51362797.35597.75
6518306-51830698.24298.64
30min1525313-52531399.57099.951.24100.14100.521.24
2518880-51888098.35098.90
3536074-536074101.609102.19
4533491-533491101.120101.70
5522738-52273899.08299.64
6527431-52743199.971100.54
45min1530438-530438100.541100.831.20101.27101.571.21
2524809-52480999.474100.19
3539861-539861102.327103.08
4539626-539626102.283103.03
5526988-52698899.887100.61
6530187-530187100.494101.22
60min1530121-530121100.481100.901.06101.38101.801.06
2526784-52678499.848100.73
3538613-538613102.091103.01
4540074-540074102.368103.28
5528548-528548100.183101.07
6529709-529709100.403101.30
极限1529728-529728100.407100.670.96101.47101.740.97
2526403-52640399.776100.82
3536965-536965101.778102.87
4537926-537926101.960103.05
5526927-52692799.876100.93
6528666-528666100.205101.27
坎地沙坦酯氢氯噻嗪片项目信息
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%
116.171524521527031525281524941527561525870.09
216.221523791522941523360.04
单位质量响应值RSD%判断
9436.439391.860.34数据可信
供试品溶液-2024082521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
10min14331-43312.5830.43244.952.580.43244.95
2-0.0000.00
3-0.0000.00
4-0.0000.00
5-0.0000.00
6-0.0000.00
15min14997-49972.9803.296.542.983.296.53
25814-58143.4673.47
35911-59113.5253.52
45355-53553.1933.19
55285-52853.1523.15
65757-57573.4333.43
20min15731-57313.4173.868.483.433.878.44
27234-72344.3144.32
36862-68624.0924.10
46610-66103.9423.95
56384-63843.8073.81
66029-60293.5953.60
30min17031-70314.1934.288.304.214.298.25
27981-79814.7594.77
37800-78004.6514.66
46586-65863.9273.94
57048-70484.2034.21
66586-65863.9273.94
45min16584-65843.9264.6110.313.954.6410.22
28615-86155.1375.16
38123-81234.8444.86
48242-82424.9154.93
56940-69404.1384.16
67931-79314.7294.75
60min17398-73984.4125.047.484.445.067.42
29261-92615.5225.55
38419-84195.0205.05
48816-88165.2575.28
58611-86115.1355.16
68187-81874.8824.91
极限18004-80044.7735.265.464.815.305.44
29236-92365.5085.55
38594-85945.1255.16
49224-92245.5005.54
58748-87485.2175.25
69139-91395.4505.48
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