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%
111.904698874698634699624697894695204698040.04
212.024655094653044654060.04
单位质量响应值RSD%判断
39479.3338719.301.38数据可信
供试品溶液-2024052221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%
5min1327303-32730360.09767.639.5860.1067.639.57
2349694-34969464.20864.21
3390869-39086971.76871.77
4341303-34130362.66762.67
5379400-37940069.66269.66
6421448-42144877.38377.38
10min1452608-45260883.10486.883.4183.2086.993.42
2456382-45638283.79783.90
3488484-48848489.69189.81
4473456-47345686.93287.04
5476293-47629387.45387.57
6491837-49183790.30790.44
15min1492056-49205690.34793.281.6890.5993.541.69
2506647-50664793.02693.27
3512127-51212794.03294.30
4513671-51367194.31694.57
5508243-50824393.31993.58
6515588-51558894.66894.95
20min1515774-51577494.70295.540.7595.0995.950.75
2519913-51991395.46295.86
3518036-51803695.11795.54
4519813-51981395.44495.85
5527214-52721496.80297.22
6521201-52120195.69896.14
30min1528094-52809496.96497.050.9297.5197.620.91
2530856-53085697.47198.03
3523259-52325996.07696.66
4531515-53151597.59298.16
5534965-53496598.22698.80
6522667-52266795.96896.56
45min1527348-52734896.82797.661.2597.5498.391.23
2535144-53514498.25998.98
3523357-52335796.09496.84
4540720-54072099.282100.01
5536525-53652598.51299.25
6528113-52811396.96897.72
60min1535428-53542898.31198.041.4499.1898.941.42
2536330-53633098.47699.36
3523565-52356596.13297.04
4542083-54208399.533100.43
5540618-54061899.264100.17
6525691-52569196.52397.44
极限1559370-559370102.707100.281.49103.74101.341.46
2542292-54229299.571100.62
3537797-53779798.74699.81
4546948-546948100.426101.49
5539555-53955599.068100.14
6551098-551098101.188102.27
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%
115.921531411527951527581528641526731528460.12
215.961517371516441516900.05
单位质量响应值RSD%判断
9600.889504.390.72数据可信
供试品溶液-2024052221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
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%
111.904632694639404637384635854634704636000.06
212.024604874604204604540.02
单位质量响应值RSD%判断
38957.9838307.321.20数据可信
供试品溶液-2024052221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%
5min1394707-39470773.34672.5313.9673.3572.5313.96
2455977-45597784.73284.73
3333775-33377562.02462.02
4321662-32166259.77359.77
5441018-44101881.95281.95
6394871-39487173.37773.38
10min1530433-53043398.56892.097.6598.6992.217.66
2530200-53020098.52498.67
3445981-44598182.87482.98
4454125-45412584.38884.49
5519736-51973696.58096.72
6492988-49298891.60991.73
15min1537173-53717399.82096.583.89100.1196.853.91
2536782-53678299.747100.05
3487799-48779990.64590.89
4503017-50301793.47393.71
5531571-53157198.77999.08
6521965-52196596.99497.27
20min1536060-53606099.61398.102.52100.0798.542.54
2535376-53537699.48699.96
3502704-50270493.41593.81
4525622-52562297.67498.07
5538834-538834100.129100.59
6529030-52903098.30798.74
30min1542877-542877100.88099.572.59101.50100.172.59
2536304-53630499.659100.30
3508205-50820594.43794.99
4542142-542142100.743101.30
5540478-540478100.434101.06
6545074-545074101.288101.89
45min1545296-545296101.330100.111.62102.12100.881.64
2535321-53532199.476100.28
3522980-52298097.18397.89
4540238-540238100.390101.12
5541665-541665100.655101.45
6546892-546892101.626102.40
60min1543658-543658101.025100.011.35101.98100.941.36
2535434-53543499.497100.47
3525946-52594697.73498.60
4540823-540823100.498101.39
5537137-53713799.813100.78
6546294-546294101.515102.45
极限1554875-554875103.110101.971.04104.23103.061.04
2540077-540077100.360101.49
3546982-546982101.643102.67
4545276-545276101.326102.39
5551396-551396102.463103.59
6553819-553819102.913104.02
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%
115.921517661520881518651520521520021519550.09
215.961512761516381514570.17
单位质量响应值RSD%判断
9544.919489.790.41数据可信
供试品溶液-2024052221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
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%
111.904644014611204617664643024629704629120.32
212.024605924601184603550.08
单位质量响应值RSD%判断
38900.1738299.081.11数据可信
供试品溶液-2024052221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%
5min1329714-32971461.32160.037.4161.3260.047.41
2298831-29883155.57755.58
3301850-30185056.13956.14
4342665-34266563.73063.73
5356701-35670166.34066.34
6307020-30702057.10057.10
10min1485307-48530790.25885.755.6290.3685.855.62
2430522-43052280.06980.16
3427739-42773979.55279.65
4483356-48335689.89690.00
5475986-47598688.52588.64
6463472-46347286.19786.29
15min1535476-53547699.58996.063.5599.8496.303.56
2497641-49764192.55292.78
3490078-49007891.14691.37
4525613-52561397.75598.01
5520764-52076496.85397.11
6529315-52931598.44398.68
20min1547565-547565101.83799.771.43102.26100.171.44
2534618-53461899.42999.81
3525511-52551197.73698.11
4534470-53447099.40299.82
5534000-53400099.31499.73
6542434-542434100.883101.29
30min1556178-556178103.439101.611.08104.03102.181.08
2545099-545099101.379101.92
3549881-549881102.268102.81
4539440-539440100.326100.91
5543113-543113101.009101.59
6544307-544307101.231101.80
45min1550223-550223102.332101.561.36103.09102.301.34
2546547-546547101.648102.36
3551453-551453102.560103.27
4531414-53141498.83399.59
5549403-549403102.179102.93
6547528-547528101.830102.57
60min1555703-555703103.351101.331.35104.28102.241.34
2538747-538747100.197101.08
3549816-549816102.256103.14
4535919-53591999.671100.59
5546464-546464101.632102.56
6542475-542475100.891101.80
极限1555526-555526103.318101.331.33104.42102.411.32
2544065-544065101.186102.24
3546503-546503101.640102.69
4533051-53305199.138100.22
5546283-546283101.599102.69
6543712-543712101.121102.20
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%
115.921525581519141518661530141523141523330.32
215.961515421518231516820.14
单位质量响应值RSD%判断
9568.669503.880.49数据可信
供试品溶液-2024052221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%
111.904586344588734587544586344588924587570.03
212.024581304585024583160.06
单位质量响应值RSD%判断
38551.0138129.450.78数据可信
供试品溶液-2024052221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%
5min1371597-37159769.57663.017.5769.5863.017.57
2311851-31185158.38958.39
3335456-33545662.80962.81
4325709-32570960.98460.98
5311976-31197658.41358.41
6362588-36258867.88967.89
10min1503180-50318094.21390.564.2494.3390.664.24
2466913-46691387.42287.52
3462368-46236886.57186.68
4472896-47289688.54288.64
5483449-48344990.51890.62
6513143-51314396.07896.19
15min1532427-53242799.68998.511.7499.9698.771.74
2516700-51670096.74496.99
3522271-52227197.78798.04
4516100-51610096.63296.88
5531228-53122899.46499.71
6538200-538200100.770101.04
20min1539026-539026100.924101.270.62101.36101.690.62
2541651-541651101.416101.82
3544562-544562101.961102.37
4535567-535567100.277100.69
5540531-540531101.206101.62
6543962-543962101.848102.29
30min1541817-541817101.447101.750.61102.05102.340.60
2543227-543227101.711102.28
3549521-549521102.889103.47
4542886-542886101.647102.22
5543518-543518101.765102.35
6539680-539680101.047101.66
45min1537479-537479100.635101.981.08101.41102.731.06
2546334-546334102.293103.04
3553663-553663103.665104.42
4547317-547317102.477103.22
5539488-539488101.011101.76
6543552-543552101.772102.55
60min1541001-541001101.294101.830.96102.24102.760.94
2544007-544007101.857102.77
3551551-551551103.269104.20
4548452-548452102.689103.61
5539465-539465101.007101.93
6538761-538761100.875101.82
极限1539675-539675101.046101.920.76102.16103.020.75
2544961-544961102.036103.12
3550351-550351103.045104.14
4547555-547555102.521103.61
5540628-540628101.224102.31
6542889-542889101.648102.76
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%
115.921510911510951512361511641510051511180.06
215.961509511511591510550.10
单位质量响应值RSD%判断
9492.349464.600.21数据可信
供试品溶液-2024052221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
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