氢氯噻嗪美阿沙坦钾片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号H220807-2对照品来源原料对照品使用方法直接使用
对照品含量(%)100对照品水分(%)0.07对照品稀释倍数1000
标示量(mg)12.5供试品稀释倍数2系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
112.231184111185881185091184521184871184890.06
212.261181381181881181630.03
单位质量响应值RSD%判断
9688.399638.090.37数据可信
供试品溶液-25090901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%
5min153064-5306479.02083.185.0579.0283.185.05
252427-5242778.07278.07
354650-5465081.38281.38
458199-5819986.66786.67
558750-5875087.48887.49
658057-5805786.45686.46
10min156745-5674584.50291.485.1285.3892.405.12
260257-6025789.73290.60
359448-5944888.52789.43
463998-6399895.30396.27
564987-6498796.77597.75
663133-6313394.01594.98
15min157304-5730485.33491.905.3387.1593.845.32
260569-6056990.19692.06
359035-5903587.91289.80
464218-6421895.63097.65
565867-6586798.086100.13
663294-6329494.25496.26
20min156676-5667684.39990.845.4487.1693.805.43
259843-5984389.11591.98
358141-5814186.58189.45
462996-6299693.81196.89
565343-6534397.306100.44
662989-6298993.80096.85
30min156064-5606483.48889.834.9087.1993.804.90
259434-5943488.50692.36
358234-5823486.71990.55
462187-6218792.60696.73
564087-6408795.43599.65
661940-6194092.23896.33
45min155616-5561682.82189.285.6887.4594.255.65
258100-5810086.52091.36
357488-5748885.60890.40
461661-6166191.82296.98
564548-6454896.122101.40
662318-6231892.80197.92
60min154870-5487081.71088.626.1187.2694.586.05
257173-5717385.13990.94
356902-5690284.73690.48
462940-6294093.72799.90
563446-6344694.481100.83
661735-6173591.93398.08
极限154479-5447981.12787.805.2287.5994.745.22
257467-5746785.57792.32
357737-5773785.97992.66
460171-6017189.60496.82
563402-6340294.415101.81
660485-6048590.07197.24
氢氯噻嗪美阿沙坦钾片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号D211-4R701-2402002对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.5对照品水分(%)0对照品稀释倍数500
标示量(mg)40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%
110.831139751141511141181140241140391140610.07
210.851139721140601140160.06
单位质量响应值RSD%判断
10531.9510508.390.16数据可信
供试品溶液-25090901批-美阿沙坦钾-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%
5min15708-57082.4292.208.742.432.208.72
24987-49872.1232.12
34917-49172.0932.09
45758-57582.4512.45
54738-47382.0172.02
64857-48572.0672.07
10min16287-62872.6762.4110.432.702.4410.36
25647-56472.4032.43
35203-52032.2142.24
46463-64632.7512.78
55020-50202.1372.16
65366-53662.2842.31
15min16542-65422.7842.4810.292.842.5310.19
25701-57012.4262.48
35214-52142.2192.27
46618-66182.8172.87
55436-54362.3142.36
65483-54832.3342.38
20min17316-73163.1142.7110.473.202.7910.42
26271-62712.6692.75
35754-57542.4492.52
47054-70543.0023.09
55867-58672.4972.57
65908-59082.5152.59
30min17313-73133.1122.848.543.232.948.58
26617-66172.8162.92
36212-62122.6442.74
47427-74273.1613.28
56141-61412.6142.71
66295-62952.6792.78
45min18052-80523.4273.137.573.583.277.64
27176-71763.0543.19
36880-68802.9283.06
48077-80773.4383.60
56905-69052.9393.07
67070-70703.0093.14
60min18701-87013.7033.427.333.903.597.45
27854-78543.3433.51
37487-74873.1873.35
48843-88433.7643.96
57568-75683.2213.38
67747-77473.2973.46
极限19513-95134.0493.667.084.283.887.14
28636-86363.6763.88
38090-80903.4433.64
49163-91633.9004.14
58084-80843.4413.64
68179-81793.4813.68
氢氯噻嗪美阿沙坦钾片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号H220807-2对照品来源原料对照品使用方法直接使用
对照品含量(%)100对照品水分(%)0.07对照品稀释倍数1000
标示量(mg)12.5供试品稀释倍数2系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
112.231175381175821176321175711175991175840.03
212.261185551185661185600.01
单位质量响应值RSD%判断
9614.399670.470.42数据可信
供试品溶液-25090901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%
5min151997-5199777.59983.846.2877.6083.846.28
255884-5588483.39983.40
351900-5190077.45477.45
459686-5968689.07389.07
558581-5858187.42487.42
659030-5903088.09488.09
10min160499-6049990.28792.902.9991.1593.833.00
259420-5942088.67689.60
362792-6279293.70994.57
464171-6417195.76796.76
563268-6326894.41995.39
663355-6335594.54995.53
15min160235-6023589.89392.913.2191.7694.873.20
259719-5971989.12391.03
363197-6319794.31396.21
465117-6511797.17899.23
562585-6258593.40095.42
662692-6269293.55995.59
20min160613-6061390.45792.772.8393.3295.762.83
259603-5960388.95091.85
363312-6331294.48597.43
464363-6436396.05399.19
562630-6263093.46796.53
662437-6243793.17996.25
30min159705-5970589.10291.483.3792.9795.513.36
258399-5839987.15391.04
361927-6192792.41896.42
464406-6440696.117100.32
561765-6176592.17696.27
661589-6158991.91396.02
45min159031-5903188.09690.483.4092.9695.523.39
257577-5757785.92690.78
361423-6142391.66696.69
463496-6349694.759100.03
561262-6126291.42596.55
660966-6096690.98496.11
60min158070-5807086.66289.163.0592.5095.203.05
257342-5734285.57591.39
360554-6055490.36996.41
462393-6239393.11399.43
559863-5986389.33895.47
660233-6023389.89096.03
极限157460-5746085.75188.883.3192.5595.923.29
257372-5737285.62092.38
360374-6037490.10097.15
462628-6262893.464100.82
559648-5964889.01796.15
659854-5985489.32496.46
氢氯噻嗪美阿沙坦钾片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号D211-4R701-2402002对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.5对照品水分(%)0对照品稀释倍数500
标示量(mg)40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%
110.831132741132641133381132551132961132850.03
210.851139331138841139080.04
单位质量响应值RSD%判断
10460.3010498.430.26数据可信
供试品溶液-25090901批-美阿沙坦钾-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%
5min13230-32301.3801.556.681.381.556.68
23441-34411.4701.47
33627-36271.5501.55
43825-38251.6341.63
53832-38321.6371.64
63763-37631.6081.61
10min13459-34591.4781.637.661.491.657.74
23578-35781.5291.55
33634-36341.5531.57
44114-41141.7581.78
54091-40911.7481.77
64031-40311.7221.74
15min13676-36761.5711.667.791.601.707.91
23532-35321.5091.54
33665-36651.5661.60
44211-42111.7991.84
54188-41881.7891.83
64100-41001.7521.79
20min13752-37521.6031.686.601.651.736.62
23548-35481.5161.57
33814-38141.6301.68
44239-42391.8111.87
54097-40971.7511.81
64074-40741.7411.80
30min13760-37601.6071.748.281.671.818.23
23700-37001.5811.65
33860-38601.6491.72
44427-44271.8921.97
54294-42941.8351.91
64406-44061.8831.96
45min13725-37251.5921.757.801.681.847.77
23774-37741.6131.70
33938-39381.6831.77
44464-44641.9072.01
54387-43871.8741.97
64256-42561.8181.92
60min13901-39011.6671.787.271.771.897.34
23819-38191.6321.73
33992-39921.7061.81
44492-44921.9192.04
54481-44811.9152.03
64351-43511.8591.98
极限13828-38281.6361.787.511.761.927.45
23894-38941.6641.78
33959-39591.6921.82
44501-45011.9232.06
54466-44661.9082.05
64411-44111.8852.02
氢氯噻嗪美阿沙坦钾片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号H220807-2对照品来源原料对照品使用方法直接使用
对照品含量(%)100对照品水分(%)0.07对照品稀释倍数1000
标示量(mg)12.5供试品稀释倍数2系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
112.231149771139871145651142701145491144700.33
212.261151831149891150860.12
单位质量响应值RSD%判断
9359.779387.110.21数据可信
供试品溶液-25090901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%
5min160274-6027492.53291.423.3792.5391.423.37
258008-5800889.05389.05
361972-6197295.13895.14
461656-6165694.65394.65
557804-5780488.74088.74
657604-5760488.43388.43
10min164309-6430998.72698.643.1399.7599.663.13
261915-6191595.05196.04
367512-67512103.643104.70
465316-65316100.272101.32
562574-6257496.06397.05
663901-6390198.10099.08
15min163629-6362997.68297.643.7799.8199.763.76
261280-6128094.07696.12
367692-67692103.920106.13
464904-6490499.640101.81
562296-6229695.63697.69
661824-6182494.91196.98
20min163549-6354997.55997.796.57100.77100.986.45
259845-5984591.87394.96
366320-66320101.813105.18
470732-70732108.587111.86
561265-6126594.05397.17
660478-6047892.84595.97
30min161768-6176894.82595.683.5499.1299.963.54
259890-5989091.94296.05
365930-65930101.215105.71
463679-6367997.759102.24
562107-6210795.34699.51
660563-6056392.97597.13
45min161799-6179994.87395.123.61100.22100.463.61
260633-6063393.08398.22
365529-65529100.599106.22
463514-6351497.506103.07
560951-6095193.57198.79
659328-5932891.07996.27
60min161435-6143594.31493.713.76100.72100.113.76
259134-5913490.78296.95
364840-6484099.541106.28
462331-6233195.690102.34
559330-5933091.08297.34
659167-5916790.83297.04
极限159361-5936191.13093.073.7898.58100.523.73
260736-6073693.241100.42
364331-6433198.760106.60
461948-6194895.102102.81
559591-5959191.48398.76
657794-5779488.72495.94
氢氯噻嗪美阿沙坦钾片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号D211-4R701-2402002对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.5对照品水分(%)0对照品稀释倍数500
标示量(mg)40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%
110.831121961121271120561115701117301119360.25
210.851107261106281106770.07
单位质量响应值RSD%判断
10335.7310200.650.94数据可信
供试品溶液-25090901批-美阿沙坦钾-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%
5min13994-39941.7421.846.321.741.846.38
24531-45311.9761.98
33901-39011.7011.70
44477-44771.9521.95
54053-40531.7671.77
64325-43251.8861.89
10min14402-44021.9202.1712.841.942.1912.74
25122-51222.2342.26
34517-45171.9701.99
45081-50812.2162.24
54577-45771.9962.02
66119-61192.6682.69
15min14652-46522.0292.247.542.072.297.59
25474-54742.3872.43
34852-48522.1162.16
45501-55012.3992.45
54887-48872.1312.17
65495-54952.3962.45
20min14909-49092.1412.5826.062.202.6525.55
25670-56702.4732.55
35102-51022.2252.29
48999-89993.9244.00
55127-51272.2362.30
65716-57162.4932.57
30min15283-52832.3042.547.182.392.647.28
26170-61702.6912.79
35524-55242.4092.50
46135-61352.6752.79
55553-55532.4222.51
66275-62752.7362.84
45min15638-56382.4592.717.052.572.847.17
26582-65822.8703.00
35935-59352.5882.70
46571-65712.8653.01
55912-59122.5782.70
66657-66572.9033.04
60min15966-59662.6022.857.022.743.017.19
26918-69183.0173.18
36238-62382.7202.86
46957-69573.0343.21
56202-62022.7052.85
66989-69893.0483.22
极限16119-61192.6683.0211.432.843.2010.95
28365-83653.6483.84
36504-65042.8363.01
46613-66132.8843.10
56713-67132.9273.10
67208-72083.1433.34
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