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%
115.971725291724741732041727761727961727560.17
215.951735621736821736220.05
单位质量响应值RSD%判断
10817.5310885.390.45数据可信
影响因素30天-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%
5min156261-5626129.10627.6013.6029.1127.6013.61
265732-6573234.00534.01
346051-4605123.82423.82
453283-5328327.56527.56
552328-5232827.07127.07
646484-4648424.04824.05
10min1107453-10745355.58956.695.6455.9157.005.67
2119681-11968161.91562.29
3103907-10390753.75454.02
4106635-10663555.16655.47
5114536-11453659.25359.55
6105280-10528054.46554.73
15min1137368-13736871.06571.093.9672.0172.023.99
2144587-14458774.79975.87
3134081-13408169.36470.23
4129189-12918966.83467.75
5141621-14162173.26574.22
6137598-13759871.18472.06
20min1154027-15402779.68380.502.3281.4182.222.37
2161970-16197083.79285.69
3151023-15102378.12979.76
4155960-15596080.68382.34
5154875-15487580.12281.89
6155784-15578480.59282.26
30min1169580-16958087.72988.031.5890.3590.651.63
2173607-17360789.81292.64
3166007-16600785.88188.38
4169117-16911787.49090.05
5170247-17024788.07490.74
6172429-17242989.20391.76
45min1172926-17292689.46089.571.8193.0593.171.85
2176909-17690991.52195.35
3167833-16783386.82590.28
4172587-17258789.28592.82
5172967-17296789.48193.12
6175649-17564990.86994.42
60min1172550-17255089.26690.011.3193.8594.601.33
2177228-17722891.68696.53
3172545-17254589.26393.68
4173862-17386289.94494.47
5171513-17151388.72993.37
6176181-17618191.14495.70
极限1172883-17288389.43889.211.1295.0194.801.05
2173570-17357089.79395.65
3175187-17518790.63096.04
4170571-17057188.24293.76
5169969-16996987.93093.55
6172455-17245589.21694.79
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%
115.971732181735301738061738531738421736500.16
215.951702831702171702500.03
单位质量响应值RSD%判断
10873.5110673.981.31数据可信
影响因素30天-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%
5min144101-4410122.98125.0111.8122.9825.0111.80
253780-5378028.02528.02
353491-5349127.87427.87
442407-4240722.09822.10
542167-4216721.97321.97
652046-5204627.12127.12
10min1105083-10508354.75956.653.2455.0156.933.27
2110974-11097457.82958.14
3109533-10953357.07857.39
4104710-10471054.56554.81
5108127-10812756.34556.59
6113871-11387159.33959.64
15min1134187-13418769.92571.722.4770.7972.622.47
2134191-13419169.92770.88
3139714-13971472.80573.75
4137116-13711671.45272.30
5137513-13751371.65872.53
6143044-14304474.54175.50
20min1150283-15028378.31380.072.0779.9581.772.07
2152088-15208879.25480.98
3152196-15219679.31081.06
4152950-15295079.70381.35
5155100-15510080.82382.49
6159305-15930583.01484.80
30min1164281-16428185.60786.651.0388.1289.241.03
2164882-16488285.92088.53
3165137-16513786.05388.69
4167336-16733687.19989.73
5168228-16822887.66490.23
6167840-16784087.46290.17
45min1171405-17140589.32089.760.6892.7893.320.72
2171128-17112889.17592.74
3172016-17201689.63893.23
4171740-17174089.49492.99
5172994-17299490.14893.69
6174246-17424690.80094.48
60min1171374-17137489.30389.581.4593.7694.131.43
2168037-16803787.56592.12
3171131-17113189.17793.76
4172278-17227889.77594.27
5172932-17293290.11594.66
6175648-17564891.53196.22
极限1170942-17094289.07889.390.9294.5394.940.87
2171043-17104389.13194.66
3169004-16900488.06893.65
4173438-17343890.37995.87
5172644-17264489.96595.51
6172212-17221289.74095.45
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%
115.971735211735731734401735901734701735190.04
215.951736981734251735620.12
单位质量响应值RSD%判断
10865.3110881.630.11数据可信
影响因素30天-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%
5min158453-5845330.17830.719.7330.1830.719.73
268117-6811735.16735.17
356222-5622229.02629.03
451068-5106826.36526.37
562523-6252332.27932.28
660520-6052031.24531.25
10min1117373-11737360.59762.352.8460.9362.702.87
2125721-12572164.90765.30
3118228-11822861.03961.36
4118067-11806760.95661.25
5121652-12165262.80663.17
6123601-12360163.81364.16
15min1146446-14644675.60776.791.7576.6277.831.78
2151628-15162878.28279.39
3148114-14811476.46877.47
4145756-14575675.25176.22
5148484-14848476.65977.72
6152021-15202178.48579.54
20min1159899-15989982.55383.511.4184.4085.401.44
2165590-16559085.49187.47
3159951-15995182.57984.43
4161342-16134283.29885.10
5160411-16041182.81784.73
6163303-16330384.31086.24
30min1170436-17043687.99388.510.9690.7691.330.99
2172064-17206488.83391.76
3170295-17029587.92090.69
4169588-16958887.55590.29
5172326-17232688.96891.80
6173975-17397589.82092.68
45min1174115-17411589.89290.320.8493.6494.120.89
2176767-17676791.26195.18
3173806-17380689.73393.48
4173194-17319489.41793.12
5175287-17528790.49794.31
6176445-17644591.09594.96
60min1170392-17039287.97089.110.8792.7193.910.88
2172429-17242989.02293.95
3171917-17191788.75793.50
4172248-17224888.92893.63
5174160-17416089.91594.74
6174420-17442090.05094.92
极限1171621-17162188.60489.231.0094.3295.021.01
2175631-17563190.67596.60
3170631-17063188.09393.82
4172917-17291789.27494.96
5173561-17356189.60695.43
6172598-17259889.10994.98
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%
115.971726241725691726691727521726811726590.04
215.951757891758051757970.01
单位质量响应值RSD%判断
10811.4611021.761.37数据可信
影响因素30天-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%
5min170278-7027836.14334.067.1036.1434.067.10
269168-6916835.57235.57
360925-6092531.33331.33
471693-7169336.87136.87
563474-6347432.64432.64
661793-6179331.77931.78
10min1125411-12541164.49764.021.2964.9064.401.33
2125767-12576764.68065.08
3122298-12229862.89663.24
4126198-12619864.90265.31
5124303-12430363.92764.29
6122878-12287863.19563.55
15min1148054-14805476.14277.681.3477.2678.771.32
2154078-15407879.24080.35
3152161-15216178.25479.30
4151272-15127277.79778.93
5150461-15046177.38078.45
6150274-15027477.28478.34
20min1160919-16091982.75982.810.4484.7284.760.45
2161127-16112782.86684.86
3161367-16136782.98984.91
4161866-16186683.24685.24
5159759-15975982.16284.09
6161066-16106682.83484.75
30min1168558-16855886.68788.081.0589.5790.951.03
2173846-17384689.40792.32
3170181-17018187.52290.36
4171791-17179188.35091.27
5171929-17192988.42191.27
6171236-17123688.06490.90
45min1172453-17245388.69088.940.5392.5492.790.51
2173211-17321189.08092.99
3173222-17322289.08692.90
4173039-17303988.99292.89
5171470-17147088.18592.01
6174212-17421289.59593.41
60min1173257-17325789.10488.690.8093.9493.520.77
2173843-17384389.40594.30
3172382-17238288.65493.45
4171432-17143288.16593.06
5170276-17027687.57192.38
6173476-17347689.21694.02
极限1169605-16960587.22687.681.0793.0593.501.03
2171499-17149988.20094.09
3167680-16768086.23692.02
4171888-17188888.40094.27
5169718-16971887.28493.06
6172547-17254788.73994.54
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