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%
112.174564364561594561864562064561224562220.03
212.154534964533694534320.02
单位质量响应值RSD%判断
37487.4337319.510.32数据可信
供试品溶液-24050801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%
5min1344494-34449466.11568.2019.2066.1168.2019.20
2387349-38734974.34074.34
3387527-38752774.37474.37
4453116-45311686.96286.96
5288106-28810655.29355.29
6271635-27163552.13252.13
10min1458751-45875188.04387.617.8188.1587.737.82
2456912-45691287.69087.81
3475744-47574491.30491.43
4511166-51116698.10298.25
5423325-42332581.24481.34
6413148-41314879.29179.38
15min1482047-48204792.51493.283.5292.7793.543.55
2476923-47692391.53191.80
3487956-48795693.64893.92
4519220-51922099.64899.96
5478264-47826491.78892.02
6471913-47191390.56990.79
20min1488956-48895693.84094.972.6294.2595.392.64
2486497-48649793.36893.79
3490863-49086394.20694.64
4520586-52058699.910100.38
5494879-49487994.97795.36
6487401-48740193.54293.91
30min1493899-49389994.78996.212.1895.3696.782.18
2494530-49453094.91095.49
3492070-49207094.43895.03
4520784-52078499.948100.59
5506382-50638297.18497.72
6500036-50003695.96696.49
45min1494869-49486994.97597.252.3395.7097.992.32
2501611-50161196.26997.01
3493068-49306894.62995.38
4520053-52005399.808100.62
5517969-51796999.408100.11
6512882-51288298.43299.12
60min1496203-49620395.23197.922.8896.1198.822.85
2503803-50380396.68997.59
3492397-49239794.50095.40
4518879-51887999.583100.56
5525988-525988100.947101.81
6524174-524174100.599101.45
极限1526898-526898101.122101.981.31102.16103.041.30
2527422-527422101.222102.28
3522324-522324100.244101.31
4538170-538170103.285104.42
5533486-533486102.386103.42
6539856-539856103.609104.63
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%
116.081610711599231586951588281587531594540.65
216.021565391560171562780.24
单位质量响应值RSD%判断
9916.299755.181.16数据可信
供试品溶液-24050801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
10min12046-20461.1681.6625.941.171.6625.80
23208-32081.8311.83
33665-36652.0922.09
43822-38222.1822.18
52309-23091.3181.32
62410-24101.3761.38
15min15347-53473.0523.167.553.053.167.56
25785-57853.3023.31
35719-57193.2643.27
46079-60793.4703.47
54897-48972.7952.80
65347-53473.0523.05
20min16345-63453.6223.684.883.633.694.89
26579-65793.7553.76
37003-70033.9974.01
46185-61853.5303.54
56150-61503.5103.52
66431-64313.6713.68
30min17278-72784.1544.216.034.174.236.01
27271-72714.1504.17
37663-76634.3744.39
48023-80234.5794.59
56693-66933.8203.83
67370-73704.2074.22
45min17688-76884.3884.663.404.414.683.40
28468-84684.8334.86
38392-83924.7904.81
48224-82244.6944.72
58168-81684.6624.68
68067-80674.6054.63
60min18109-81094.6294.782.314.664.812.27
28487-84874.8444.87
38678-86784.9534.98
48357-83574.7704.80
58338-83384.7594.79
68274-82744.7234.75
极限18468-84684.8334.935.634.874.975.64
29113-91135.2025.24
38972-89725.1215.16
49069-90695.1765.22
57968-79684.5484.58
68216-82164.6904.73
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%
112.174545424545684545744542434543004544450.04
212.154536024535404535710.01
单位质量响应值RSD%判断
37341.4137330.950.02数据可信
供试品溶液-24050802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%
5min1320278-32027861.57868.528.0461.5868.528.04
2386127-38612774.23874.24
3393872-39387275.72775.73
4336099-33609964.62064.62
5355220-35522068.29668.30
6346826-34682666.68266.68
10min1463753-46375389.16392.162.6389.2792.282.64
2500402-50040296.20996.33
3485861-48586193.41493.54
4472677-47267790.87990.99
5474831-47483191.29391.41
6478530-47853092.00492.12
15min1497135-49713595.58196.921.7395.8397.191.73
2518807-51880799.748100.03
3504289-50428996.95797.24
4503331-50333196.77297.03
5494007-49400794.98095.25
6507108-50710897.49997.76
20min1508120-50812097.69398.541.6098.1098.971.60
2523548-523548100.659101.11
3510372-51037298.12698.57
4516050-51605099.21899.64
5500086-50008696.14896.57
6517134-51713499.42699.85
30min1518047-51804799.60299.821.73100.18100.411.72
2529161-529161101.739102.36
3513715-51371598.76999.38
4526129-526129101.156101.74
5504834-50483497.06197.65
6523144-523144100.582101.17
45min1523372-523372100.626100.351.95101.36101.111.95
2530542-530542102.004102.79
3514710-51471098.96099.73
4532051-532051102.294103.05
5505427-50542797.17597.92
6525662-525662101.066101.83
60min1524413-524413100.826100.372.00101.73101.301.99
2530056-530056101.911102.87
3514112-51411298.84599.78
4532781-532781102.435103.36
5505321-50532197.15598.06
6525610-525610101.056101.98
极限1523582-523582100.666101.421.09101.74102.511.07
2527902-527902101.497102.62
3520842-520842100.139101.24
4530962-530962102.085103.18
5536762-536762103.200104.27
6524957-524957100.930102.03
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%
116.081569761569861568881562471563091566810.24
216.021565791566441566120.03
单位质量响应值RSD%判断
9743.849776.030.24数据可信
供试品溶液-24050802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
10min12462-24621.4161.5011.221.421.5011.21
23148-31481.8111.81
32371-23711.3641.36
42695-26951.5501.55
52537-25371.4591.46
62400-24001.3801.38
15min15540-55403.1873.114.143.193.124.09
25757-57573.3113.31
35091-50912.9282.93
45342-53423.0733.08
55327-53273.0643.07
65398-53983.1053.11
20min16683-66833.8443.863.143.853.863.19
26774-67743.8963.90
37074-70744.0694.08
46645-66453.8223.83
56458-64583.7153.72
66582-65823.7863.79
30min17940-79404.5674.313.824.584.333.79
27199-71994.1414.16
37574-75744.3564.37
47492-74924.3094.32
57626-76264.3864.40
67178-71784.1294.14
45min18658-86584.9804.658.425.004.678.39
26748-67483.8813.90
38078-80784.6464.67
48297-82974.7724.79
58298-82984.7734.79
68407-84074.8364.86
60min19122-91225.2475.094.615.285.124.59
29322-93225.3625.39
38913-89135.1275.16
48968-89685.1585.19
58577-85774.9334.96
68187-81874.7094.74
极限19132-91325.2535.233.725.295.273.73
29176-91765.2785.32
39112-91125.2415.28
48494-84944.8864.92
59123-91235.2475.28
69545-95455.4905.53
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