左氨氯地平贝那普利胶囊项目信息
介质体积(ml)500取样体积(ml)1.5补液体积(ml)1.5
对照品批号100546-202105对照品来源中检院对照品使用方法直接使用
对照品含量(%)97.3对照品水分(%)0对照品稀释倍数2000
标示量(mg)2.5供试品稀释倍数1系数0.7210
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
114.094498544497084497634496294494174496740.04
214.204471594469164470380.04
单位质量响应值RSD%判断
31914.4131481.550.97数据可信
加速6月-供试品溶液-2024071721批-左氨氯地平-pH2.0的盐酸溶液
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1278572-27857261.65663.2613.3061.6663.2613.30
2288196-28819663.78663.79
3241095-24109553.36153.36
4248605-24860555.02355.02
5330404-33040473.12873.13
6328171-32817172.63472.63
10min1391593-39159386.67190.105.0086.8690.294.98
2409003-40900390.52490.72
3423827-42382793.80593.96
4422364-42236493.48193.65
5373963-37396382.76982.99
6421717-42171793.33893.56
15min1409080-40908090.54193.052.3290.9993.512.31
2416357-41635792.15292.61
3431168-43116895.43095.87
4428555-42855594.85195.30
5410267-41026790.80491.27
6427096-42709694.52895.03
20min1409310-40931090.59293.112.3391.3193.852.32
2417102-41710292.31693.06
3431228-43122895.44396.17
4428566-42856694.85495.58
5410067-41006790.75991.50
6427797-42779794.68495.47
30min1411233-41123391.01793.142.1792.0194.162.16
2416661-41666192.21993.24
3431915-43191595.59596.61
4427548-42754894.62895.64
5410757-41075790.91291.92
6426857-42685794.47595.54
45min1412415-41241591.27993.062.1592.5494.362.14
2414225-41422591.68092.97
3431756-43175695.56096.86
4426784-42678494.45995.76
5410715-41071590.90392.19
6426836-42683694.47195.82
60min1411799-41179991.14392.962.0892.6894.542.07
2415867-41586792.04393.61
3430225-43022595.22196.81
4427271-42727194.56796.15
5409520-40952090.63892.20
6425452-42545294.16595.80
极限1411670-41167091.11492.792.0792.9294.642.06
2415524-41552491.96793.81
3430129-43012995.20097.07
4425865-42586594.25696.12
5408316-40831690.37292.20
6423964-42396493.83595.75
左氨氯地平贝那普利胶囊项目信息
介质体积(ml)500取样体积(ml)1.5补液体积(ml)1.5
对照品批号100768-202204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500
标示量(mg)10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%
110.088473808472038470128468408465428469950.04
210.078425268421718423480.03
单位质量响应值RSD%判断
84027.2883649.260.32数据可信
加速6月-供试品溶液-2024071721批-贝那普利-pH2.0的盐酸溶液
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min135798-357984.2363.3986.934.243.3986.92
264531-645317.6367.64
332843-328433.8863.89
4-0.0000.00
5-0.0000.00
638647-386474.5734.57
10min1814724-81472496.40197.041.8796.4197.051.87
2814010-81401096.31796.34
3827020-82702097.85697.87
4827218-82721897.87997.88
5796617-79661794.25994.26
6841301-84130199.54699.56
15min1826279-82627997.76899.121.2798.0799.421.27
2825528-82552897.67997.99
3839666-83966699.35299.66
4840108-84010899.40599.70
5840430-84043099.44399.73
6854131-854131101.064101.38
20min1822745-82274597.35098.761.3497.9599.361.33
2822285-82228597.29697.90
3836474-83647498.97599.58
4837284-83728499.07199.66
5837227-83722799.06499.64
6852121-852121100.826101.44
30min1819883-81988397.01298.331.2997.9099.221.29
2818959-81895996.90297.80
3833525-83352598.62699.53
4831983-83198398.44399.33
5833722-83372298.64999.53
6848026-848026100.342101.26
45min1817851-81785196.77197.921.3597.9599.111.34
2812960-81296096.19297.38
3829903-82990398.19799.39
4829613-82961398.16399.35
5830540-83054098.27399.45
6844647-84464799.942101.16
60min1814870-81487096.41897.641.3097.8999.131.30
2812629-81262996.15397.63
3826428-82642897.78699.28
4827100-82710097.86599.34
5827926-82792697.96399.43
6842448-84244899.682101.20
极限1811390-81139096.00797.281.2897.7699.061.28
2810547-81054795.90797.67
3824035-82403597.50399.29
4824070-82407097.50799.28
5823690-82369097.46299.22
6839122-83912299.288101.11
左氨氯地平贝那普利胶囊项目信息
介质体积(ml)500取样体积(ml)1.5补液体积(ml)1.5
对照品批号100546-202105对照品来源中检院对照品使用方法直接使用
对照品含量(%)97.3对照品水分(%)0对照品稀释倍数2000
标示量(mg)2.5供试品稀释倍数1系数0.7210
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
114.094477184480704479984480864477384479220.05
214.204478934483324481120.07
单位质量响应值RSD%判断
31790.0631557.180.52数据可信
加速6月-供试品溶液-2024071921批-左氨氯地平
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1385870-38587085.46772.0518.1085.4772.0618.10
2264284-26428458.53758.54
3314178-31417869.58869.59
4378705-37870583.88083.88
5359602-35960279.64979.65
6249214-24921455.19955.20
10min1431371-43137195.54595.521.3595.8095.741.36
2428821-42882194.98095.16
3430314-43031495.31195.52
4427849-42784994.76595.02
5442584-44258498.02898.27
6426668-42666894.50394.67
15min1435448-43544896.44896.381.3496.9996.881.34
2433793-43379396.08196.54
3434350-43435096.20596.70
4429367-42936795.10195.64
5446116-44611698.81199.34
6431687-43168795.61596.06
20min1434066-43406696.14296.341.1596.9797.131.16
2435358-43535896.42897.18
3432949-43294995.89496.68
4430536-43053695.36096.18
5444531-44453198.46099.29
6432189-43218995.72696.46
30min1426358-42635894.43495.921.6395.5697.011.62
2431993-43199395.68396.72
3433369-43336995.98797.06
4428534-42853494.91696.02
5446448-44644898.884100.01
6431829-43182995.64696.67
45min1435080-43508096.36696.281.1697.7797.641.17
2431560-43156095.58796.91
3433875-43387596.09997.46
4430184-43018495.28296.67
5444322-44432298.41399.83
6433080-43308095.92397.23
60min1432714-43271495.84295.891.6097.5497.551.60
2428836-42883694.98396.60
3432377-43237795.76897.41
4424967-42496794.12695.80
5445476-44547698.669100.39
6433150-43315095.93997.54
极限1431767-43176795.63395.871.5597.6197.821.55
2432842-43284295.87197.77
3429964-42996495.23397.17
4426251-42625194.41196.37
5445730-44573098.725100.74
6430521-43052195.35797.24
左氨氯地平贝那普利胶囊项目信息
介质体积(ml)500取样体积(ml)1.5补液体积(ml)1.5
对照品批号100768-202204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500
标示量(mg)10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%
110.088431018434298431768433038427718431560.03
210.078437618440218438910.03
单位质量响应值RSD%判断
83646.4383802.480.14数据可信
加速6月-供试品溶液-2024071921批-贝那普利
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min125948-259483.0741.57168.323.071.57168.37
2-0.0000.00
353492-534926.3386.34
4-0.0000.00
5-0.0000.00
6-0.0000.00
10min1831773-83177398.55297.601.7998.5697.601.79
2817249-81724996.83196.83
3830500-83050098.40198.42
4844922-844922100.110100.11
5813317-81331796.36596.37
6804417-80441795.31195.31
15min1848023-848023100.47798.971.67100.7899.271.67
2836417-83641799.10299.39
3840608-84060899.59999.91
4849557-849557100.659100.96
5821585-82158597.34597.63
6815713-81571396.64996.93
20min1842867-84286799.86698.621.71100.4799.221.71
2835794-83579499.02899.62
3836954-83695499.16699.78
4848384-848384100.520101.12
5816948-81694896.79597.38
6813203-81320396.35296.93
30min1841115-84111599.65998.271.67100.5699.161.67
2829688-82968898.30599.19
3834975-83497598.93199.84
4844607-844607100.072100.98
5816692-81669296.76597.64
6809479-80947995.91096.78
45min1839359-83935999.45197.981.69100.6699.161.69
2826423-82642397.91899.10
3832964-83296498.69399.90
4842007-84200799.764100.97
5811643-81164396.16797.33
6809077-80907795.86397.02
60min1835834-83583499.03397.701.51100.5499.181.52
2822785-82278597.48798.96
3830513-83051398.40399.91
4838118-83811899.304100.81
5812122-81212296.22397.67
6808110-80811095.74897.19
极限1833784-83378498.79097.431.44100.5999.201.45
2824930-82493097.74199.51
3824859-82485997.73399.53
4833960-83396098.811100.61
5811535-81153596.15497.89
6804973-80497395.37697.10
左氨氯地平贝那普利胶囊项目信息
介质体积(ml)500取样体积(ml)1.5补液体积(ml)1.5
对照品批号100546-202105对照品来源中检院对照品使用方法直接使用
对照品含量(%)97.3对照品水分(%)0对照品稀释倍数2000
标示量(mg)2.5供试品稀释倍数1系数0.7210
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
114.094450694448504447654448754449664449050.03
214.204432264431364431810.02
单位质量响应值RSD%判断
31575.9431209.930.83数据可信
加速6月-供试品溶液-2024072121批-左氨氯地平
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1258155-25815557.69168.9011.0957.6968.9011.08
2281538-28153862.91762.92
3354997-35499779.33379.33
4326972-32697273.07073.07
5316154-31615470.65370.65
6312082-31208269.74369.74
10min1410498-41049891.73694.662.3191.9194.862.32
2424355-42435594.83395.02
3425928-42592895.18595.42
4416875-41687593.16293.38
5424219-42421994.80395.01
6439561-43956198.23198.44
15min1416314-41631493.03695.302.1093.4895.802.11
2424931-42493194.96295.44
3428325-42832595.72096.24
4418453-41845393.51494.01
5429637-42963796.01496.51
6441139-44113998.58499.09
20min1415131-41513192.77293.473.4293.5094.253.39
2426110-42611095.22595.98
3399335-39933589.24290.05
4418104-41810493.43694.22
5409899-40989991.60392.39
6441043-44104398.56399.36
30min1414845-41484592.70895.011.8793.7196.061.88
2425435-42543595.07596.12
3425857-42585795.16996.25
4418595-41859593.54694.61
5428565-42856595.77496.83
6437538-43753897.77998.87
45min1414219-41421992.56894.512.5193.8595.852.50
2425581-42558195.10796.44
3410034-41003491.63393.00
4419930-41993093.84495.18
5428104-42810495.67197.02
6439588-43958898.23799.63
60min1412462-41246292.17594.572.0093.7496.202.00
2423760-42376094.70096.31
3423388-42338894.61796.26
4416607-41660793.10294.72
5425957-42595795.19196.82
6437002-43700297.65999.34
极限1412911-41291192.27694.752.1394.1196.662.14
2422602-42260294.44196.34
3424330-42433094.82896.75
4417883-41788393.38795.29
5426683-42668395.35397.27
6439428-43942898.202100.18
左氨氯地平贝那普利胶囊项目信息
介质体积(ml)500取样体积(ml)1.5补液体积(ml)1.5
对照品批号100768-202204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500
标示量(mg)10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%
110.088379978378388373078374738376068376440.04
210.078338518335708337100.03
单位质量响应值RSD%判断
83099.6082791.460.27数据可信
加速6月-供试品溶液-2024072121批-贝那普利
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min112562-125621.5024.53100.361.504.53100.37
2-0.0000.00
3-0.0000.00
484006-8400610.04710.05
571572-715728.5608.56
659184-591847.0787.08
10min1832344-83234499.54699.291.3399.5599.301.32
2847552-847552101.365101.36
3821203-82120398.21398.21
4818874-81887497.93597.96
5823848-82384898.53098.56
6837262-837262100.134100.16
15min1839663-839663100.421100.001.12100.72100.311.12
2851962-851962101.892102.20
3829684-82968499.22899.52
4825023-82502398.67098.99
5833306-83330699.66199.98
6837309-837309100.140100.46
20min1837865-837865100.20699.731.33100.81100.341.32
2853184-853184102.038102.65
3824385-82438598.59499.19
4822863-82286398.41299.03
5830758-83075899.35699.98
6834141-83414199.761100.38
30min1833303-83330399.66199.381.22100.57100.281.22
2849570-849570101.606102.52
3823477-82347798.48599.37
4821332-82133298.22999.14
5830199-83019999.289100.21
6827628-82762898.98299.90
45min1830557-83055799.33299.181.08100.54100.391.08
2846409-846409101.228102.45
3822003-82200398.30999.49
4823040-82304098.43399.64
5826454-82645498.841100.06
6827130-82713098.922100.14
60min1826541-82654198.85298.781.18100.35100.281.18
2843939-843939100.933102.46
3815975-81597597.58899.07
4819855-81985598.05299.56
5822596-82259698.38099.89
6826499-82649998.847100.36
极限1824851-82485198.65098.521.10100.45100.321.09
2840506-840506100.522102.35
3815803-81580397.56899.34
4816947-81694797.70499.50
5820134-82013498.08699.89
6824373-82437398.593100.40
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