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%
112.174417244415204414984419164418664417050.05
212.154413604418494416040.08
单位质量响应值RSD%判断
36294.5836346.010.11数据可信
供试品溶液-2批-氢氯噻嗪-0.35tw20
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1282048-28204855.74454.897.1455.7454.897.14
2280186-28018655.37655.38
3301085-30108559.50759.51
4289218-28921857.16257.16
5270916-27091653.54453.54
6242899-24289948.00748.01
10min1385772-38577276.24576.754.8776.3476.844.87
2372239-37223973.57073.66
3418699-41869982.75282.85
4403557-40355779.76079.85
5375996-37599674.31274.40
6373788-37378873.87673.96
15min1422529-42252983.50984.413.1883.7384.633.18
2406250-40625080.29280.51
3446312-44631288.21088.45
4427125-42712584.41884.65
5423824-42382483.76583.98
6436358-43635886.24386.45
20min1439645-43964586.89287.663.1187.2588.023.10
2421915-42191583.38883.74
3459652-45965290.84691.23
4436997-43699786.36986.74
5447197-44719788.38588.74
6455822-45582290.08990.44
30min1454579-45457989.84490.682.7890.3591.182.78
2441854-44185487.32987.82
3473060-47306093.49694.03
4447533-44753388.45188.96
5465439-46543991.99092.49
6470326-47032692.95693.45
45min1468176-46817692.53193.822.7893.1894.482.77
2462445-46244591.39892.03
3489390-48939096.72497.42
4458853-45885390.68891.35
5483021-48302195.46596.12
6486405-48640596.13496.79
60min1479227-47922794.71596.292.9395.5297.112.92
2479322-47932294.73495.52
3500079-50007998.83699.69
4466485-46648592.19793.01
5496632-49663298.15598.97
6501498-50149899.11799.93
极限1513520-513520101.493102.031.53102.46103.011.54
2504936-50493699.796100.74
3525415-525415103.844104.86
4513930-513930101.574102.54
5514325-514325101.652102.63
6525346-525346103.830104.81
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%
116.081524151521291523401523341523971523230.08
216.021524401526091525240.08
单位质量响应值RSD%判断
9472.829520.850.36数据可信
供试品溶液-2批-坎地沙坦酯-0.35tw20
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min162313-6231336.83536.655.5336.8336.645.54
263252-6325237.39037.39
365684-6568438.82738.83
463341-6334137.44237.44
561836-6183636.55336.55
655546-5554632.83432.83
10min1102716-10271660.71862.683.7960.7862.743.79
2104502-10450261.77361.84
3112015-11201566.21466.28
4110021-11002165.03665.10
5102427-10242760.54760.61
6104490-10449061.76661.82
15min1125404-12540474.12976.092.8974.2976.262.88
2124367-12436773.51673.68
3133118-13311878.68978.86
4130103-13010376.90777.08
5126871-12687174.99675.16
6132481-13248178.31278.47
20min1138115-13811581.64383.302.8381.9383.602.82
2135505-13550580.10080.39
3144493-14449385.41385.72
4139944-13994482.72483.02
5141273-14127383.51083.80
6146218-14621886.43386.72
30min1149955-14995588.64289.892.3389.0690.322.33
2148577-14857787.82788.25
3154471-15447191.31191.76
4148953-14895388.04988.49
5152886-15288690.37490.80
6157530-15753093.11993.55
45min1155173-15517391.72692.862.2692.3093.442.25
2154702-15470291.44892.02
3159332-15933294.18594.79
4152667-15266790.24590.83
5158403-15840393.63594.21
6162285-16228595.93096.52
60min1156330-15633092.41093.752.4193.1394.492.41
2156202-15620292.33493.05
3160679-16067994.98195.74
4153920-15392090.98591.72
5160067-16006794.61995.35
6164408-16440897.18597.93
极限1161770-16177095.62695.921.3096.5096.811.30
2159982-15998294.56995.44
3163216-16321696.48197.40
4160657-16065794.96895.85
5162099-16209995.82096.71
6165867-16586798.04898.96
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%
112.174371984370874370824369124369814370520.03
212.154378604378504378550.01
单位质量响应值RSD%判断
35912.2436037.450.25数据可信
供试品溶液-2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%
5min1301059-30105960.07362.639.3860.0762.639.38
2300951-30095160.05260.05
3305257-30525760.91160.91
4332040-33204066.25566.26
5280281-28028155.92755.93
6363520-36352072.53772.54
10min1433940-43394086.58887.893.6086.6987.993.61
2438652-43865287.52987.63
3429413-42941385.68585.79
4450145-45014589.82289.93
5423497-42349784.50584.60
6467022-46702293.19093.31
15min1474652-47465294.71294.572.2494.9694.822.24
2468181-46818193.42193.67
3459961-45996191.78192.02
4487708-48770897.31797.58
5468594-46859493.50393.74
6484557-48455796.68996.96
20min1489476-48947697.67096.612.0298.0797.022.02
2478696-47869695.51995.92
3471159-47115994.01594.41
4498564-49856499.48399.91
5479209-47920995.62196.01
6488013-48801397.37897.82
30min1502787-502787100.32698.812.00100.8999.382.00
2489722-48972297.71998.28
3483384-48338496.45497.01
4510542-510542101.874102.46
5490048-49004897.78498.33
6494724-49472498.71799.32
45min1514554-514554102.674101.032.11103.41101.772.10
2501656-501656100.100100.82
3494472-49447298.66799.38
4523346-523346104.428105.19
5503887-503887100.546101.26
6500005-50000599.771100.54
60min1519121-519121103.585102.092.26104.49102.992.25
2508845-508845101.535102.43
3500494-50049499.869100.75
4530470-530470105.850106.78
5510144-510144101.794102.67
6500682-50068299.906100.84
极限1528901-528901105.537105.201.92106.61106.271.92
2513983-513983102.560103.62
3524886-524886104.736105.78
4539162-539162107.584108.69
5518643-518643103.490104.54
6537586-537586107.270108.37
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%
116.081566411566191566391564631563001565320.10
216.021535331535211535270.01
单位质量响应值RSD%判断
9734.589583.461.11数据可信
供试品溶液-2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
15min14369-43692.5390.88155.092.540.88155.09
2-0.0000.00
3-0.0000.00
4-0.0000.00
5-0.0000.00
64713-47132.7392.74
20min15215-52153.0313.084.503.043.084.45
25208-52083.0273.03
35202-52023.0243.02
45392-53923.1343.13
55016-50162.9152.92
65711-57113.3193.32
30min15737-57373.3353.514.603.343.524.58
25771-57713.3543.36
35955-59553.4613.47
46346-63463.6883.69
56030-60303.5053.51
66389-63893.7133.72
45min17303-73034.2454.074.434.264.094.45
27225-72254.1994.21
36908-69084.0154.03
46485-64853.7693.78
56899-68994.0104.02
67235-72354.2054.22
60min17453-74534.3324.411.464.354.421.47
27604-76044.4204.44
37525-75254.3744.39
47591-75914.4124.43
57536-75364.3804.40
67778-77784.5214.54
极限17954-79544.6234.704.734.654.724.72
27462-74624.3374.36
38411-84114.8894.91
47927-79274.6074.63
58297-82974.8224.85
68469-84694.9224.95
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