奥美沙坦酯片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号100864-201904对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.2对照品水分(%)0对照品稀释倍数3333.33
标示量(mg)20供试品稀释倍数5系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
115.092537542536862536082534692532042535440.09
215.062541752546122543940.13
单位质量响应值RSD%判断
16802.1216892.030.38数据可信
长期36月-供试品溶液-20210216批-shui(内含0.1%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min187955-8795534.95934.2811.1734.9634.2811.16
269663-6966327.68827.69
395985-9598538.15038.15
482891-8289132.94632.95
585875-8587534.13234.13
695163-9516337.82437.82
10min1142579-14257956.67055.562.9856.8655.753.00
2132749-13274952.76352.92
3143619-14361957.08357.29
4136808-13680854.37654.56
5141563-14156356.26656.46
6141354-14135456.18356.39
15min1157465-15746562.58663.752.2663.1064.252.28
2156059-15605962.02762.47
3165208-16520865.66466.19
4158313-15831362.92363.41
5163044-16304464.80465.31
6162302-16230264.50965.03
20min1172572-17257268.59169.181.0569.4570.041.07
2172285-17228568.47769.27
3173328-17332868.89169.78
4173481-17348168.95269.79
5176296-17629670.07170.93
6176381-17638170.10570.99
30min1182735-18273572.63075.462.1773.8776.702.16
2187565-18756574.55075.72
3193503-19350376.91078.19
4190212-19021275.60276.82
5192199-19219976.39277.64
6192902-19290276.67177.94
45min1198995-19899579.09380.511.4780.7382.161.49
2199734-19973479.38680.97
3206908-20690882.23883.94
4201754-20175480.18981.83
5204173-20417381.15182.83
6203753-20375380.98482.68
60min1205403-20540381.64082.822.0283.7284.932.01
2207864-20786482.61884.64
3215032-21503285.46787.63
4203417-20341780.85082.93
5211401-21140184.02486.15
6207179-20717982.34684.49
极限1208444-20844482.84885.152.0885.3887.712.06
2213392-21339284.81587.30
3221371-22137187.98690.62
4214675-21467585.32587.86
5216303-21630385.97288.57
6211198-21119883.94386.55
奥美沙坦酯片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号100864-201904对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.2对照品水分(%)0对照品稀释倍数3333.33
标示量(mg)20供试品稀释倍数5系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
115.092550292550702552662547222549682550110.08
215.062527282534502530890.21
单位质量响应值RSD%判断
16899.3416805.380.40数据可信
长期36月-供试品溶液-20210217批-shui(内含0.1%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min190451-9045135.93931.7917.5135.9431.7917.50
257960-5796023.03023.03
389699-8969935.64135.64
470987-7098728.20628.21
576788-7678830.51130.51
694127-9412737.40037.40
10min1140105-14010555.66953.285.6255.8753.465.66
2120289-12028947.79547.92
3140314-14031455.75255.95
4131905-13190552.41152.57
5134184-13418453.31653.49
6137788-13778854.74854.96
15min1164235-16423565.25762.773.5365.7763.243.58
2148608-14860859.04759.44
3159613-15961363.42063.93
4157100-15710062.42262.87
5155859-15585961.92862.39
6162465-16246564.55365.07
20min1174509-17450969.33969.050.4270.2169.870.49
2172570-17257068.56869.29
3174424-17442469.30570.17
4174079-17407969.16869.96
5173611-17361168.98269.79
6173435-17343568.91269.78
30min1191176-19117675.96175.440.5677.2276.640.58
2189370-18937075.24476.35
3190267-19026775.60076.85
4190651-19065175.75376.93
5188278-18827874.81076.00
6189401-18940175.25676.51
45min1202547-20254780.47979.890.8282.1681.510.85
2200238-20023879.56281.08
3200672-20067279.73481.40
4200772-20077279.77481.37
5198801-19880178.99180.60
6203329-20332980.79082.46
60min1204639-20463981.31182.521.2083.4484.591.17
2208352-20835282.78684.75
3211388-21138883.99286.10
4208456-20845682.82784.87
5205128-20512881.50583.55
6208156-20815682.70884.83
极限1204407-20440781.21882.872.0583.8085.401.92
2215756-21575685.72888.15
3206647-20664782.10884.68
4210967-21096783.82586.33
5208662-20866282.90985.41
6204999-20499981.45484.03
奥美沙坦酯片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号100864-201904对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.2对照品水分(%)0对照品稀释倍数3333.33
标示量(mg)20供试品稀释倍数5系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
115.092541842545532545512544322547452544930.09
215.062561502569502565500.23
单位质量响应值RSD%判断
16865.0117035.190.71数据可信
长期36月-供试品溶液-20210218批-shui(内含0.1%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min177695-7769530.69431.6417.3530.6931.6417.34
294071-9407137.16337.16
392062-9206236.36936.37
474629-7462929.48229.48
556440-5644022.29722.30
685667-8566733.84333.84
10min1133253-13325352.64254.242.4852.8154.422.52
2141356-14135655.84356.05
3141068-14106855.72955.93
4135390-13539053.48653.65
5134731-13473153.22653.35
6138058-13805854.54054.73
15min1157477-15747762.21261.773.8462.6762.253.87
2163988-16398864.78465.30
3157305-15730562.14462.66
4155834-15583461.56362.02
5145554-14555457.50157.92
6158003-15800362.41962.91
20min1173904-17390468.70168.642.1569.5169.462.18
2174686-17468669.01069.89
3176358-17635869.67170.53
4177138-17713869.97970.78
5166651-16665165.83666.57
6173803-17380368.66169.50
30min1182200-18220071.97975.002.3773.1776.202.37
2191059-19105975.47876.74
3192872-19287276.19577.44
4193450-19345076.42377.61
5186660-18666073.74074.85
6192803-19280376.16777.39
45min1200014-20001479.01680.281.3980.6181.901.41
2207240-20724081.87183.55
3204083-20408380.62382.29
4205429-20542981.15582.77
5201572-20157279.63181.15
6200979-20097979.39781.04
60min1203194-20319480.27282.161.3182.3084.221.32
2209967-20996782.94885.08
3207650-20765082.03384.15
4209094-20909482.60384.67
5207137-20713781.83083.79
6210762-21076283.26285.35
极限1206618-20661881.62584.352.2284.1086.872.13
2208987-20898782.56185.16
3214070-21407084.56987.14
4215962-21596285.31687.84
5218589-21858986.35488.77
6216869-21686985.67588.22
奥美沙坦酯片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号100864-201904对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.2对照品水分(%)0对照品稀释倍数3333.33
标示量(mg)20供试品稀释倍数5系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
115.092543382543572544152542502540722542860.06
215.062533742539632536680.17
单位质量响应值RSD%判断
16851.2916843.820.04数据可信
长期36月-供试品溶液-SX026YA批-shui(内含0.1%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min189006-8900635.37532.936.8535.3832.936.85
282378-8237832.74132.74
385801-8580134.10134.10
472287-7228728.73028.73
583328-8332833.11833.12
684342-8434233.52133.52
10min1141621-14162156.28753.973.6556.4854.153.66
2136038-13603854.06854.25
3138440-13844055.02355.21
4127013-12701350.48150.64
5137305-13730554.57154.76
6134304-13430453.37953.56
15min1159473-15947363.38262.953.2163.8963.443.21
2159357-15935763.33663.82
3164900-16490065.53966.03
4149363-14936359.36459.80
5159770-15977063.50063.99
6157523-15752362.60763.09
20min1171971-17197168.34968.390.3469.2169.220.34
2171010-17101067.96768.80
3172169-17216968.42869.29
4172109-17210968.40469.17
5172672-17267268.62869.47
6172501-17250168.56069.39
30min1185244-18524473.62574.222.0874.8775.432.05
2190318-19031875.64176.85
3190253-19025375.61576.85
4187944-18794474.69875.85
5186696-18669674.20275.42
6179923-17992371.51072.72
45min1196553-19655378.11978.771.0779.7780.401.05
2197869-19786978.64280.27
3201823-20182380.21481.87
4199339-19933979.22780.79
5196105-19610577.94179.57
6197502-19750278.49780.11
60min1202198-20219880.36381.001.5482.4583.061.48
2199344-19934479.22981.30
3204930-20493081.44983.55
4208605-20860582.90984.91
5204903-20490381.43883.50
6202833-20283380.61582.66
极限1213640-21364084.91182.761.6187.4485.271.57
2203353-20335380.82283.33
3207143-20714382.32884.89
4208514-20851482.87385.34
5209233-20923383.15985.68
6207433-20743382.44484.94
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