坎地沙坦酯左氨氯地平片项目信息
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4000
标示量(mg)8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%
116.081753701762821760291753741756841757480.23
216.121765871762161764020.15
单位质量响应值RSD%判断
10929.6010943.050.09数据可信
供试品溶液-2024042711批-pH1.2(内含0.05%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min172124-7212437.02242.2710.5737.0242.2710.57
272762-7276237.35037.35
393853-9385348.17648.18
482122-8212242.15442.15
589173-8917345.77445.77
684034-8403443.13643.14
10min1131443-13144367.47170.003.1467.8870.463.15
2134886-13488669.23969.65
3134156-13415668.86469.40
4140004-14000471.86672.33
5143012-14301273.41073.92
6134679-13467969.13269.61
15min1152252-15225278.15379.322.4479.3180.572.46
2151807-15180777.92479.11
3157274-15727480.73182.03
4158471-15847181.34582.61
5157803-15780381.00282.33
6149560-14956076.77178.02
20min1153649-15364978.87081.532.2880.9083.662.28
2156973-15697380.57682.63
3158281-15828181.24883.45
4158200-15820081.20683.38
5163477-16347783.91586.14
6162355-16235583.33985.44
30min1164365-16436584.37186.332.2187.2889.362.20
2167050-16705085.74988.69
3172079-17207988.33091.43
4173220-17322088.91691.99
5167688-16768886.07689.23
6164689-16468984.53787.56
45min1168130-16813086.30385.672.2290.1589.672.17
2159975-15997582.11786.02
3169980-16998087.25391.33
4169487-16948787.00091.06
5165774-16577485.09489.21
6168067-16806786.27190.24
60min1161463-16146382.88184.231.5987.6889.181.60
2161314-16131482.80487.62
3162720-16272083.52688.58
4167337-16733785.89690.92
5166382-16638285.40690.46
6165355-16535584.87989.80
极限1158016-15801681.11282.151.7486.8388.041.72
2158342-15834281.27987.01
3165256-16525684.82890.81
4160459-16045982.36688.35
5160181-16018182.22388.23
6158031-15803181.11986.99
坎地沙坦酯左氨氯地平片项目信息
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4000
标示量(mg)8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%
116.081764461761011759611759101757811760400.15
216.121758221757811758020.02
单位质量响应值RSD%判断
10947.7610905.830.28数据可信
供试品溶液-12235763批-pH1.2(内含0.05%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min130117-3011715.47315.463.7015.4715.463.70
230920-3092015.88615.89
330953-3095315.90215.90
430892-3089215.87115.87
528164-2816414.47014.47
629468-2946815.14015.14
10min167654-6765434.75835.151.9334.9335.321.92
271037-7103736.49636.67
368053-6805334.96335.14
468022-6802234.94735.12
568280-6828035.08035.24
667477-6747734.66734.84
15min1111768-11176857.42255.412.8157.9855.972.80
2108623-10862355.80656.39
3110313-11031356.67557.24
4107547-10754755.25455.82
5104193-10419353.53054.08
6104622-10462253.75154.30
20min1134924-13492469.31970.742.7270.5171.922.68
2138057-13805770.92872.13
3139598-13959871.72072.92
4138925-13892571.37472.55
5132003-13200367.81868.96
6142636-14263673.28174.43
30min1156935-15693580.62785.593.4582.5987.553.39
2172364-17236488.55490.54
3168863-16886386.75588.75
4167477-16747786.04388.01
5162988-16298883.73785.64
6170926-17092687.81589.78
45min1166380-16638085.48087.143.7888.3490.053.72
2174184-17418489.48992.46
3173344-17334489.05892.01
4175315-17531590.07093.00
5158323-15832381.34084.17
6170084-17008487.38390.32
60min1173606-17360689.19287.821.2293.0091.701.10
2168658-16865886.65090.62
3171960-17196088.34692.29
4168472-16847286.55490.48
5172330-17233088.53792.27
6170543-17054387.61891.53
极限1168541-16854186.59085.911.1191.3990.761.05
2167449-16744986.02990.96
3167669-16766986.14291.07
4168624-16862486.63391.52
5167394-16739486.00190.72
6163586-16358684.04488.93
坎地沙坦酯左氨氯地平片项目信息
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4000
标示量(mg)8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%
116.081765371760401762401760001757671761170.17
216.121763151759751761450.14
单位质量响应值RSD%判断
10952.5510927.110.17数据可信
供试品溶液-12407637批-pH1.2(内含0.05%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min131869-3186916.35416.306.2916.3516.306.27
233898-3389817.39517.39
333621-3362117.25317.25
428423-2842314.58514.59
530903-3090315.85815.86
631897-3189716.36816.37
10min161297-6129731.45432.917.7331.6433.097.71
271017-7101736.44236.64
364507-6450733.10233.29
459882-5988230.72830.89
559081-5908130.31730.49
668971-6897135.39235.57
15min196427-9642749.48153.276.2050.0153.826.18
2106582-10658254.69255.29
3112408-11240857.68258.24
495878-9587849.20049.70
5105736-10573654.25854.77
6105881-10588154.33354.91
20min1124210-12421063.73868.635.6464.8269.775.64
2138584-13858471.11472.32
3140123-14012371.90473.10
4124124-12412463.69464.74
5136141-13614169.86170.98
6139323-13932371.49372.67
30min1158619-15861981.39583.423.2683.1885.323.30
2164214-16421484.26686.26
3168940-16894086.69188.69
4154156-15415679.10580.86
5165441-16544184.89686.79
6164045-16404584.17986.15
45min1176712-17671290.68088.662.7293.3791.482.69
2169247-16924786.84989.78
3179075-17907591.89294.85
4166294-16629485.33487.97
5172907-17290788.72791.56
6172408-17240888.47191.38
60min1175794-17579490.20887.412.1993.9191.222.09
2164828-16482884.58188.48
3172629-17262988.58492.57
4168454-16845486.44290.03
5170644-17064487.56691.39
6169661-16966187.06190.95
极限1160476-16047682.34884.181.9987.0588.962.00
2164687-16468784.50989.35
3169795-16979587.13092.10
4163204-16320483.74888.29
5161598-16159882.92487.72
6164458-16445884.39189.25
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