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%
116.081732531735631730401729261732551732070.15
216.121733271733501733380.01
单位质量响应值RSD%判断
10771.5810752.980.13数据可信
供试品溶液-2024042711批-pH6.5(内含0.35%Tween)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min157533-5753330.01027.5510.2230.0127.5510.22
245790-4579023.88523.88
360142-6014231.37131.37
450305-5030526.24026.24
549250-4925025.68925.69
653873-5387328.10128.10
10min1109633-10963357.18656.931.7357.5257.241.76
2105528-10552855.04555.31
3111049-11104957.92558.27
4109666-10966657.20357.49
5109120-10912056.91957.20
6109863-10986357.30657.62
15min1139741-13974172.89171.762.0073.8672.702.00
2132821-13282169.28170.16
3136232-13623271.06172.05
4138070-13807072.01972.95
5140426-14042673.24874.17
6138090-13809072.03072.98
20min1154169-15416980.41779.751.7282.2081.491.69
2150702-15070278.60880.26
3148884-14888477.66079.44
4154523-15452380.60182.33
5155923-15592381.33283.06
6153199-15319979.91181.66
30min1165853-16585386.51185.931.0789.1888.551.07
2162852-16285284.94687.47
3163869-16386985.47688.12
4166192-16619286.68889.31
5162880-16288084.96087.60
6166797-16679787.00489.64
45min1173143-17314390.31490.260.4393.9593.840.45
2172261-17226189.85493.32
3172726-17272690.09693.69
4173929-17392990.72494.31
5172284-17228489.86693.45
6173864-17386490.69094.29
60min1172237-17223789.84190.390.7794.4894.960.74
2172536-17253689.99794.46
3174931-17493191.24695.84
4174989-17498991.27795.87
5172171-17217189.80794.38
6172822-17282290.14694.76
极限1173427-17342790.46289.991.0396.1095.581.02
2170386-17038688.87694.34
3171441-17144189.42695.04
4174740-17474091.14796.76
5171102-17110289.24994.82
6174025-17402590.77496.39
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%
116.081733511735161734521734751733991734390.04
216.121735141735681735410.03
单位质量响应值RSD%判断
10786.0110765.570.14数据可信
供试品溶液-2024042711批-pH6.5(内含0.35%Tween)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min159027-5902730.75132.927.3230.7532.927.32
265938-6593834.35134.35
366691-6669134.74334.74
464780-6478033.74833.75
566853-6685334.82834.83
655859-5585929.10029.10
10min1117103-11710361.00662.611.9861.3562.971.98
2118022-11802261.48561.87
3121110-12111063.09363.48
4123767-12376764.47864.85
5120306-12030662.67563.06
6120742-12074262.90263.23
15min1143632-14363274.82775.690.9775.8576.760.98
2143997-14399775.01776.08
3145770-14577075.94077.03
4147145-14714576.65777.75
5144704-14470475.38576.47
6146514-14651476.32877.35
20min1156801-15680181.68781.782.0083.5483.681.95
2153169-15316979.79581.69
3157875-15787582.24784.18
4159505-15950583.09685.04
5153545-15354579.99181.91
6160923-16092383.83485.70
30min1167600-16760087.31386.742.3590.0789.562.29
2162387-16238784.59787.38
3168695-16869587.88390.73
4167533-16753387.27890.14
5161303-16130384.03286.84
6171542-17154289.36792.17
45min1173989-17398990.64189.581.8794.3793.361.82
2169689-16968988.40192.13
3173636-17363690.45794.28
4172277-17227789.74993.59
5166716-16671686.85290.60
6175406-17540691.38095.17
60min1172379-17237989.80389.241.5694.5494.011.53
2168374-16837487.71692.42
3172028-17202889.62094.45
4172377-17237789.80294.63
5167828-16782887.43292.14
6174796-17479691.06295.87
极限1169314-16931488.20688.661.7693.9494.421.72
2168664-16866487.86793.55
3173772-17377290.52896.35
4169955-16995588.54094.37
5165922-16592286.43992.12
6173435-17343590.35396.17
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%
116.081733391732571732231732041730411732130.07
216.121752281750171751220.09
单位质量响应值RSD%判断
10771.9510863.650.60数据可信
供试品溶液-2024042711批-pH6.5(内含0.35%Tween)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min176151-7615139.51841.414.8439.5241.414.83
282191-8219142.65342.65
374661-7466138.74538.75
482090-8209042.60042.60
584608-8460843.90743.91
679096-7909641.04741.05
10min1136850-13685071.01870.830.7971.4671.290.81
2138176-13817671.70672.18
3134834-13483469.97270.40
4136218-13621870.69071.16
5136467-13646770.81971.31
6136381-13638170.77471.23
15min1157908-15790881.94681.850.7083.1783.100.68
2158698-15869882.35683.63
3158614-15861482.31283.52
4157383-15738381.67382.93
5155720-15572080.81082.08
6158034-15803482.01183.25
20min1164521-16452185.37785.771.1987.5287.931.15
2167493-16749386.92089.11
3167286-16728686.81288.93
4163918-16391885.06587.23
5162566-16256684.36386.54
6165861-16586186.07388.23
30min1171307-17130788.89989.011.0891.9992.121.05
2173328-17332889.94893.10
3172953-17295389.75392.84
4169805-16980588.12091.23
5168899-16889987.64990.76
6172839-17283989.69492.80
45min1172541-17254189.53989.400.8793.6193.500.82
2171425-17142588.96093.11
3174698-17469890.65994.74
4170731-17073188.60092.69
5171151-17115188.81892.90
6173100-17310089.82993.94
60min1170600-17060088.53289.191.2093.6094.281.15
2172104-17210489.31394.45
3174235-17423590.41995.51
4169530-16953087.97793.05
5170407-17040788.43293.50
6174364-17436490.48595.59
极限1171238-17123888.86388.521.2894.9294.601.21
2170120-17012088.28394.41
3173309-17330989.93896.03
4169418-16941887.91993.97
5167189-16718986.76292.82
6172190-17219089.35795.47
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%
116.081747581744421746331744331744941745520.09
216.121736811736601736700.01
单位质量响应值RSD%判断
10855.2210773.570.54数据可信
供试品溶液-2024042711批-pH6.5(内含0.35%Tween)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min158173-5817330.19833.598.3930.2033.598.39
261182-6118231.76031.76
368888-6888835.76035.76
471113-7111336.91536.92
560350-6035031.32831.33
668498-6849835.55835.56
10min1106876-10687655.48057.683.2155.8258.063.24
2108497-10849756.32256.67
3112869-11286958.59158.99
4115817-11581760.12160.53
5108753-10875356.45456.80
6113889-11388959.12159.52
15min1135492-13549270.33570.732.3371.2971.742.35
2131028-13102868.01869.00
3139004-13900472.15873.21
4139142-13914272.23073.31
5134661-13466169.90370.88
6138180-13818071.73072.78
20min1150539-15053978.14678.832.8879.8880.622.88
2144047-14404774.77676.51
3154097-15409779.99381.84
4154273-15427380.08481.96
5151599-15159978.69680.45
6156540-15654081.26183.11
30min1165497-16549785.91186.801.8388.5189.481.87
2163361-16336184.80287.37
3169695-16969588.09090.83
4170410-17041088.46191.23
5164657-16465785.47588.10
6169635-16963588.05990.81
45min1175664-17566491.18890.391.3494.7494.031.37
2170102-17010288.30191.81
3174598-17459890.63594.35
4176801-17680191.77995.53
5173150-17315089.88393.46
6174484-17448490.57694.31
60min1173275-17327589.94890.801.6394.5295.451.67
2170253-17025388.38092.87
3178044-17804492.42497.15
4176832-17683291.79596.57
5174558-17455890.61495.19
6176535-17653591.64196.38
极限1173379-17337990.00290.471.3995.5796.121.43
2169815-16981588.15293.62
3175255-17525590.97696.73
4176422-17642291.58297.38
5175129-17512990.91196.49
6175704-17570491.20996.96
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