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100374-202106对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.9对照品水分(%)0对照品稀释倍数1000
标示量(mg)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%
113.989088399096109093349087849086949090520.05
213.999084239099469091840.12
单位质量响应值RSD%判断
65025.1864988.130.05数据可信
长期12月-供试品溶液-MU5570批-氨氯地平-pH2.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1803125-80312588.98784.999.1888.9984.999.18
2676697-67669774.97974.98
3804196-80419689.10689.11
4837531-83753192.79992.80
5679087-67908775.24375.24
6801769-80176988.83788.84
10min1843982-84398293.51494.993.0393.7895.253.03
2858725-85872595.14795.37
3844529-84452993.57593.84
4891462-89146298.77599.05
5822653-82265391.15191.38
6882699-88269997.80498.07
15min1845358-84535893.66695.672.5194.2196.212.52
2862840-86284095.60396.11
3846338-84633893.77594.32
4896037-89603799.28299.86
5847040-84704093.85394.35
6883194-88319497.85998.42
20min1841412-84141293.22995.432.4694.0696.262.46
2858725-85872595.14795.94
3841964-84196493.29094.12
4892178-89217898.85499.73
5851972-85197294.39995.18
6881631-88163197.68598.54
30min1838235-83823592.87795.062.3693.9996.172.36
2854832-85483294.71695.80
3840350-84035093.11194.22
4888123-88812398.40599.57
5849425-84942594.11795.18
6876445-87644597.11198.26
45min1832934-83293492.29094.512.3293.6895.902.33
2850691-85069194.25795.62
3837328-83732892.77794.17
4882196-88219697.74899.21
5842938-84293893.39894.74
6871573-87157396.57198.01
60min1828553-82855391.80494.032.2993.4795.712.29
2847813-84781393.93895.59
3832807-83280792.27693.94
4877581-87758197.23798.99
5839004-83900492.96294.59
6865825-86582595.93497.66
极限1825828-82582891.50293.752.4393.4495.722.43
2844715-84471593.59595.53
3827769-82776991.71793.66
4877020-87702097.17599.22
5837377-83737792.78294.69
6863983-86398395.73097.75
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%
19.948186578177628182758177598171838179270.07
29.968166228182238174220.14
单位质量响应值RSD%判断
82286.4282070.480.19数据可信
长期12月-供试品溶液-MU5570批-贝那普利-pH2.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1464675-46467556.09266.5949.2956.0966.5849.29
2568263-56826368.59768.60
3683421-68342182.49882.50
4751071-75107190.66490.66
5788831-78883195.22295.22
653339-533396.4396.44
10min1820642-82064299.06297.881.3399.2398.081.35
2796079-79607996.09796.30
3801243-80124396.72196.97
4820922-82092299.09699.37
5818424-81842498.79599.08
6808022-80802297.53997.56
15min1824467-82446799.52498.131.4599.9998.621.42
2796668-79666896.16896.66
3799783-79978396.54497.08
4819191-81919198.88799.46
5816008-81600898.50399.08
6821462-82146299.16199.47
20min1821721-82172199.19397.861.4499.9698.651.41
2794685-79468595.92996.71
3797496-79749696.26897.10
4817367-81736798.66799.53
5813753-81375398.23199.11
6819107-81910798.87799.49
30min1820811-82081199.08397.641.49100.1498.721.46
2791877-79187795.59096.66
3795990-79599096.08697.20
4816792-81679298.59899.76
5811894-81189498.00699.18
6815747-81574798.47199.38
45min1815842-81584298.48397.221.3999.8498.591.36
2789630-78963095.31996.68
3793195-79319595.74997.15
4811158-81115897.91799.38
5808308-80830897.57399.04
6813957-81395798.25599.46
60min1814995-81499598.38196.951.37100.0398.621.34
2788359-78835995.16596.81
3790901-79090195.47297.16
4810274-81027497.81199.56
5805703-80570397.25999.02
6808834-80883497.63799.13
极限1810026-81002697.78196.581.4299.7398.541.39
2784402-78440294.68896.62
3786966-78696694.99796.98
4807222-80722297.44299.49
5804329-80432997.09399.14
6807769-80776997.50899.30
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100374-202106对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.9对照品水分(%)0对照品稀释倍数1000
标示量(mg)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%
113.989083779073489074909067949068119073640.08
213.999045549053959049740.07
单位质量响应值RSD%判断
64904.4364687.210.24数据可信
中间条件12月-供试品溶液-MU5570批-氨氯地平-pH2.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1817951-81795190.92580.2610.1490.9280.2610.14
2718732-71873279.89579.90
3801094-80109489.05189.05
4672541-67254174.76174.76
5687705-68770576.44676.45
6634307-63430770.51170.51
10min1839553-83955393.32692.085.1593.6092.325.15
2888280-88828098.74398.98
3826388-82638891.86392.13
4840490-84049093.43093.65
5818516-81851690.98891.22
6756747-75674784.12184.33
15min1838418-83841893.20093.563.9993.7594.083.98
2902404-902404100.313100.85
3826979-82697991.92892.47
4845578-84557893.99694.50
5835478-83547892.87393.38
6801125-80112589.05489.52
20min1836263-83626392.96093.363.7493.7994.153.73
2898360-89836099.863100.70
3822028-82202891.37892.20
4841865-84186593.58394.37
5833999-83399992.70993.49
6806403-80640389.64190.37
30min1832208-83220892.51093.233.5093.6294.313.49
2895727-89572799.570100.71
3818076-81807690.93992.03
4839866-83986693.36194.43
5829625-82962592.22293.28
6816547-81654790.76991.77
45min1827294-82729491.96392.753.4293.3594.113.41
2890057-89005798.940100.38
3814489-81448990.54091.91
4833737-83373792.68094.03
5827528-82752891.98993.33
6812956-81295690.37091.64
60min1822624-82262491.44492.343.3993.1193.973.39
2885181-88518198.398100.13
3811246-81124690.17991.82
4833561-83356192.66094.29
5822157-82215791.39293.00
6809170-80917089.94991.49
极限1821054-82105491.27091.983.4493.2193.893.43
2882981-88298198.154100.18
3809154-80915489.94791.85
4826875-82687591.91793.82
5819383-81938391.08492.97
6805006-80500689.48691.30
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%
19.948183218166288168158163588161908168620.11
29.968148528146768147640.02
单位质量响应值RSD%判断
82179.2881803.610.33数据可信
中间条件12月-供试品溶液-MU5570批-贝那普利-pH2.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1680426-68042682.32439.7283.2082.3239.7283.20
2470831-47083156.96556.97
3556706-55670667.35567.36
450696-506966.1346.13
5104389-10438912.63012.63
6106470-10647012.88212.88
10min1787508-78750895.28097.171.5895.5397.291.58
2826265-82626599.969100.14
3801699-80169996.99797.20
4803001-80300197.15497.17
5801666-80166696.99397.03
6798753-79875396.64096.68
15min1786997-78699795.21898.141.8995.7598.561.84
2831938-831938100.655101.13
3804617-80461797.35097.84
4820382-82038299.25799.57
5808081-80808197.76998.10
6815109-81510998.61998.95
20min1786449-78644995.15297.831.7695.9798.531.71
2826826-826826100.037100.81
3802099-80209997.04597.83
4819606-81960699.16399.77
5804943-80494397.38998.01
6811468-81146898.17998.80
30min1783665-78366594.81597.591.8395.9298.591.78
2825994-82599499.936101.01
3800201-80020196.81597.89
4816983-81698398.84699.75
5802329-80232997.07397.99
6810675-81067598.08399.00
45min1781330-78133094.53297.251.8195.9298.541.76
2823573-82357399.643101.02
3796762-79676296.39997.77
4812515-81251598.30599.51
5800636-80063696.86898.07
6807815-80781597.73798.95
60min1775869-77586993.87296.931.9695.5498.511.90
2820585-82058599.282100.95
3794515-79451596.12797.78
4812686-81268698.32699.82
5797593-79759396.50098.00
6805626-80562697.47298.98
极限1775382-77538293.81396.681.8795.7798.561.81
2817719-81771998.935100.90
3792732-79273295.91297.86
4810429-81042998.05399.84
5795034-79503496.19097.98
6803308-80330897.19198.99
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100374-202106对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.9对照品水分(%)0对照品稀释倍数1000
标示量(mg)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%
113.989035259036749042979032729021889033910.09
213.999048199055989052080.07
单位质量响应值RSD%判断
64620.2464703.930.10数据可信
中间条件12月-供试品溶液-2023102021批-氨氯地平-pH2.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1700953-70095378.08079.263.9378.0879.263.93
2754242-75424284.01684.02
3715605-71560579.71279.71
4719945-71994580.19680.20
5710317-71031779.12379.12
6668226-66822674.43574.43
10min1867864-86786496.67296.232.1896.9196.472.18
2833366-83336692.83093.08
3868373-86837396.72996.97
4889744-88974499.11099.35
5870034-87003496.91497.15
6853997-85399795.12895.35
15min1872587-87258797.19996.552.2797.7297.082.26
2834493-83449392.95593.49
3873769-87376997.33097.86
4890400-89040099.18399.72
5875673-87567397.54298.07
6853863-85386395.11395.62
20min1868351-86835196.72796.472.1797.5497.282.16
2835388-83538893.05593.86
3872147-87214797.15097.97
4889266-88926699.05699.89
5876384-87638497.62298.44
6854668-85466895.20396.00
30min1866116-86611696.47896.132.1497.5897.242.13
2831530-83153092.62593.71
3868189-86818996.70997.82
4884482-88448298.52499.66
5874096-87409697.36798.48
6853750-85375095.10096.18
45min1859247-85924795.71395.632.1297.1197.032.12
2829503-82950392.39993.77
3861858-86185896.00397.41
4883134-88313498.37399.80
5868612-86861296.75698.16
6848841-84884194.55395.92
60min1861034-86103495.91295.352.1797.5997.032.16
2826200-82620092.03193.68
3861480-86148095.96197.65
4878326-87832697.83899.56
5866251-86625196.49398.19
6842746-84274693.87595.52
极限1862139-86213996.03595.272.1098.0197.242.09
2827796-82779692.20994.13
3857790-85779095.55097.53
4877128-87712897.70499.72
5865770-86577096.43998.42
6840987-84098793.67995.61
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%
19.948124728123758127168132288126188126820.05
29.968142628139228140920.03
单位质量响应值RSD%判断
81758.7581736.140.02数据可信
中间条件12月-供试品溶液-2023102021批-贝那普利-pH2.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1404576-40457649.09519.8893.3049.1019.8993.29
2186861-18686122.67522.68
3159673-15967319.37619.38
4232051-23205128.15928.16
5-0.0000.00
6-0.0000.00
10min1827201-827201100.380100.880.91100.53100.940.91
2841536-841536102.120102.19
3840429-840429101.986102.04
4826143-826143100.252100.34
5826931-826931100.348100.35
6825777-825777100.208100.21
15min1832132-832132100.979101.731.11101.43102.091.10
2850016-850016103.149103.52
3850137-850137103.164103.53
4830604-830604100.793101.18
5834836-834836101.307101.61
6832008-832008100.964101.26
20min1828015-828015100.479101.631.21101.23102.301.20
2851607-851607103.342104.03
3848636-848636102.981103.66
4829311-829311100.636101.32
5832749-832749101.054101.66
6834713-834713101.292101.90
30min1825455-825455100.168101.241.17101.22102.211.16
2847013-847013102.784103.78
3845488-845488102.599103.58
4824931-824931100.105101.09
5830673-830673100.802101.71
6832099-832099100.975101.88
45min1822616-82261699.824100.801.20101.18102.081.20
2845505-845505102.601103.90
3840770-840770102.027103.32
4822226-82222699.777101.07
5825514-825514100.176101.39
6827191-827191100.379101.59
60min1822366-82236699.794100.421.28101.45102.001.28
2842178-842178102.198103.81
3839813-839813101.911103.51
4817732-81773299.231100.82
5821413-82141399.678101.19
6821715-82171599.715101.23
极限1819382-81938299.431100.271.18101.38102.141.18
2841984-841984102.174104.09
3834934-834934101.319103.22
4819373-81937399.430101.32
5821073-82107399.637101.45
6820797-82079799.603101.41
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100374-202106对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.9对照品水分(%)0对照品稀释倍数1000
标示量(mg)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%
113.989017679013419015739014509013489014960.02
213.998910028922958916480.11
单位质量响应值RSD%判断
64484.6963734.670.83数据可信
中间条件12月-供试品溶液-2023102121批-氨氯地平-pH2.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1743137-74313783.49584.966.2183.5084.966.21
2685663-68566377.03877.04
3729089-72908981.91781.92
4769210-76921086.42586.42
5794572-79457289.27489.27
6815293-81529391.60291.60
10min1808228-80822890.80895.583.9791.0695.833.97
2820483-82048392.18592.42
3849928-84992895.49495.74
4847924-84792495.26895.53
5882611-88261199.16699.43
6894817-894817100.537100.81
15min1810992-81099291.11996.094.1691.6496.634.17
2822448-82244892.40692.91
3854036-85403695.95596.49
4854359-85435995.99196.54
5885748-88574899.518100.08
6903756-903756101.541102.12
20min1810694-81069491.08595.914.2591.8896.744.25
2818068-81806891.91492.70
3851654-85165495.68796.51
4852284-85228495.75896.59
5887181-88718199.679100.54
6901819-901819101.324102.20
30min1807003-80700390.67195.494.0491.7496.614.05
2817828-81782891.88792.95
3849505-84950595.44696.55
4849100-84910095.40196.52
5880317-88031798.908100.07
6895714-895714100.638101.82
45min1804043-80404390.33895.194.2691.6896.604.26
2812598-81259891.29992.64
3845671-84567195.01596.41
4845107-84510794.95296.36
5880544-88054498.933100.39
6895432-895432100.606102.09
60min1798549-79854989.72194.634.1291.3396.324.13
2810864-81086491.10592.71
3839086-83908694.27595.95
4842357-84235794.64396.33
5876274-87627498.454100.21
6886405-88640599.592101.38
极限1798272-79827289.69094.514.4291.5796.484.41
2805635-80563590.51792.40
3837492-83749294.09696.06
4839064-83906494.27396.25
5873004-87300498.086100.14
6893618-893618100.402102.49
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%
19.948109348115398106758106478123368112260.09
29.968022618013918018260.08
单位质量响应值RSD%判断
81612.2780504.620.97数据可信
中间条件12月-供试品溶液-2023102121批-贝那普利-pH2.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1726900-72690088.96336.7090.0188.9636.7090.01
2123143-12314315.07115.07
344749-447495.4775.48
4493815-49381560.43660.44
582659-8265910.11610.12
6327988-32798840.14140.14
10min1832642-832642101.904101.781.24102.17101.891.21
2820370-820370100.402100.45
3840839-840839102.907102.92
4828762-828762101.429101.61
5845870-845870103.523103.55
6821521-821521100.543100.66
15min1833603-833603102.022102.851.29102.59103.261.23
2831132-831132101.719102.07
3854986-854986104.639104.96
4834262-834262102.102102.59
5853513-853513104.459104.80
6834745-834745102.162102.58
20min1833449-833449102.003102.751.45102.88103.481.40
2828055-828055101.343101.99
3854820-854820104.618105.26
4834470-834470102.128102.92
5855186-855186104.663105.32
6831413-831413101.754102.48
30min1830283-830283101.615102.341.42102.80103.371.36
2826487-826487101.151102.11
3852008-852008104.274105.23
4830332-830332101.621102.72
5850697-850697104.114105.08
6827414-827414101.264102.30
45min1826545-826545101.158101.941.49102.65103.281.43
2821664-821664100.561101.82
3849486-849486103.966105.23
4825234-825234100.998102.40
5847959-847959103.779105.06
6826602-826602101.165102.50
60min1821949-821949100.595101.421.43102.39103.061.37
2821246-821246100.509102.07
3842638-842638103.128104.71
4823405-823405100.774102.48
5844736-844736103.384104.98
6817949-817949100.106101.75
极限1819847-819847100.338101.061.39102.43103.011.34
2814898-81489899.733101.59
3838746-838746102.651104.54
4817337-817337100.031102.04
5841614-841614103.002104.90
6822268-822268100.635102.58
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