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%
114.074543874542204535924537564536814539270.08
214.074524894522284523580.05
单位质量响应值RSD%判断
32262.0532150.530.25数据可信
长期12月-供试品溶液-2023041621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%
5min1344537-34453775.04978.018.7175.0578.008.71
2328603-32860371.57871.58
3369099-36909980.39980.40
4400607-40060787.26287.26
5322746-32274670.30270.30
6383077-38307783.44483.44
10min1437818-43781895.36895.731.7495.5995.961.74
2430135-43013593.69493.91
3446885-44688597.34397.58
4448382-44838297.66997.93
5441880-44188096.25396.46
6431717-43171794.03994.29
15min1445139-44513996.96396.861.5197.4797.381.51
2434555-43455594.65795.15
3448873-44887397.77698.31
4452273-45227398.51799.07
5448084-44808497.60498.10
6438943-43894395.61396.15
20min1446850-44685097.33597.261.6698.1498.071.66
2436739-43673995.13395.91
3455237-45523799.16299.99
4453456-45345698.77499.62
5447432-44743297.46298.25
6439336-43933695.69996.52
30min1448058-44805897.59897.162.3898.6998.262.38
2427770-42777093.17994.24
3456392-45639299.414100.54
4454184-45418498.933100.08
5449776-44977697.97399.06
6440010-44001095.84596.95
45min1450105-45010598.04497.821.4799.4399.211.48
2439147-43914795.65797.00
3456472-45647299.431100.85
4454680-45468099.041100.48
5450389-45038998.10699.48
6443698-44369896.64998.04
60min1449719-44971997.96097.731.6599.6499.421.66
2438153-43815395.44197.07
3457016-45701699.550101.27
4455025-45502599.116100.86
5450295-45029598.08699.76
6441722-44172296.21897.90
极限1448087-44808797.60597.681.4799.5899.661.47
2438924-43892495.60997.53
3456566-45656699.452101.47
4453482-45348298.780100.82
5450426-45042698.114100.08
6443086-44308696.51598.49
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%
110.008448978453768437138435278441728443370.10
210.008416688411058413860.05
单位质量响应值RSD%判断
84433.7084138.600.25数据可信
长期12月-供试品溶液-2023041621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%
5min199787-9978711.74419.3092.7111.7419.3092.70
2-0.0000.00
3174542-17454220.54320.54
4450444-45044453.01553.01
5124193-12419314.61714.62
6135169-13516915.90915.91
10min1833846-83384698.13997.680.6098.1797.740.62
2828784-82878497.54397.54
3832082-83208297.93297.99
4835305-83530598.31198.47
5828110-82811097.46497.51
6821746-82174696.71596.76
15min1845001-84500199.45298.880.6399.7899.230.62
2845345-84534599.49399.79
3840567-84056798.93099.29
4839268-83926898.77799.23
5839952-83995298.85899.19
6830740-83074097.77498.11
20min1842234-84223499.12698.460.6899.7599.100.65
2843282-84328299.25099.84
3837507-83750798.57099.22
4831306-83130697.84098.59
5835808-83580898.37099.00
6829127-82912797.58498.22
30min1838916-83891698.73698.260.5399.6699.200.52
2839458-83945898.80099.69
3835479-83547998.33199.28
4833557-83355798.10599.15
5834634-83463498.23299.16
6827304-82730497.36998.29
45min1831725-83172597.89097.840.5099.1199.080.47
2838037-83803798.63299.82
3831810-83181097.90099.14
4829723-82972397.65498.99
5831294-83129497.83999.06
6825357-82535797.14098.36
60min1839393-83939398.79297.600.87100.3199.140.85
2835077-83507798.28499.77
3829009-82900997.57099.11
4826170-82617097.23698.87
5827200-82720097.35798.87
6818909-81890996.38197.89
极限1828421-82842197.50197.130.5899.3198.950.55
2831885-83188597.90899.68
3824873-82487397.08398.91
4822513-82251396.80598.73
5825755-82575597.18799.00
6818148-81814896.29298.09
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%
114.074543084544954543864543594542794543650.02
214.074558434551914555170.11
单位质量响应值RSD%判断
32293.1832375.050.18数据可信
长期12月-供试品溶液-2023041621批-左氨氯地平-水
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1118792-11879225.77428.3521.2225.7728.3521.22
2150297-15029732.60932.61
3162209-16220935.19435.19
4136946-13694629.71229.71
582948-8294817.99718.00
6132751-13275128.80228.80
10min1392894-39289485.24486.821.7785.3286.901.77
2409339-40933988.81288.91
3394046-39404685.49485.60
4406329-40632988.15988.25
5403231-40323187.48787.54
6394979-39497985.69685.78
15min1409939-40993988.94290.412.0489.2890.762.02
2413637-41363789.74490.11
3405436-40543687.96588.33
4424427-42442792.08592.44
5427047-42704792.65492.97
6419834-41983491.08991.43
20min1419441-41944191.00490.314.0791.6090.934.04
2404488-40448887.75988.39
3415525-41552590.15490.78
4429676-42967693.22493.85
5437607-43760794.94595.54
6390774-39077484.78485.40
30min1412547-41254789.50890.923.3590.3891.813.33
2412416-41241689.47990.38
3424212-42421292.03992.94
4429196-42919693.12094.03
5437546-43754694.93295.81
6398438-39843886.44787.32
45min1424072-42407292.00890.943.5293.1592.103.48
2402307-40230787.28688.45
3424384-42438492.07693.25
4419014-41901490.91192.10
5441687-44168795.83096.99
6403503-40350387.54688.68
60min1419245-41924590.96193.322.5592.3894.752.52
2417974-41797490.68592.11
3428490-42849092.96794.42
4434656-43465694.30595.77
5447497-44749797.09198.54
6432787-43278793.89995.29
极限1429919-42991993.27793.272.8994.9794.982.85
2421796-42179691.51593.21
3412996-41299689.60591.33
4434623-43462394.29896.04
5449837-44983797.59899.34
6430156-43015693.32895.00
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%
110.008443918442468440318444078433948440940.05
210.008467318462908465100.04
单位质量响应值RSD%判断
84409.4084651.000.21数据可信
长期12月-供试品溶液-2023041621批- 贝那普利-水
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min122835-228352.6801.49172.542.681.49172.55
2-0.0000.00
353316-533166.2576.26
4-0.0000.00
5-0.0000.00
6-0.0000.00
10min1815193-81519395.66795.310.8795.6795.310.88
2801148-80114894.01994.02
3815281-81528195.67795.70
4814491-81449195.58495.58
5806227-80622794.61594.61
6820433-82043396.28296.28
15min1841076-84107698.70499.180.9399.0099.470.93
2835070-83507097.99998.28
3858048-858048100.696101.00
4846286-84628699.31699.60
5848036-84803699.52199.80
6842304-84230498.84899.14
20min1840235-84023598.60698.920.7199.2099.500.72
2834958-83495897.98698.56
3852589-852589100.055100.66
4844953-84495399.15999.74
5844417-84441799.09699.68
6840203-84020398.60299.19
30min1834695-83469597.95598.510.8698.8499.390.87
2830378-83037897.44998.32
3849605-84960599.705100.61
4843627-84362799.00499.89
5843194-84319498.95399.83
6834911-83491197.98198.86
45min1834621-83462197.94798.160.6099.1399.340.60
2831081-83108197.53198.69
3845416-84541699.214100.42
4835459-83545998.04599.22
5837976-83797698.34099.52
6833899-83389997.86299.04
60min1826004-82600496.93597.620.9398.4199.100.93
2822377-82237796.51097.96
3844333-84433399.086100.59
4833381-83338197.80199.27
5835149-83514998.00999.48
6829951-82995197.39998.87
极限1829126-82912697.30297.330.8399.0799.090.84
2819457-81945796.16797.91
3839343-83934398.501100.30
4830342-83034297.44599.21
5833154-83315497.77599.54
6824550-82455096.76598.53
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%
114.074532884532934528674532724532234531890.05
214.074549574547104548340.04
单位质量响应值RSD%判断
32209.5932326.510.26数据可信
长期12月-供试品溶液-2023041621批-左氨氯地平-醋酸盐缓冲液(pH4.5)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1273613-27361359.48657.3216.2259.4957.3216.21
2251305-25130554.63654.64
3268073-26807358.28158.28
4313670-31367068.19568.19
5187575-18757540.78040.78
6287542-28754262.51462.51
10min1402389-40238987.48388.962.4087.6689.142.41
2406538-40653888.38588.55
3407500-40750088.59488.77
4428877-42887793.24293.45
5405289-40528988.11388.24
6404614-40461487.96788.15
15min1406927-40692788.46991.522.4488.9191.962.45
2417501-41750190.76891.20
3423166-42316692.00092.44
4438417-43841795.31695.80
5421395-42139591.61592.00
6418268-41826890.93591.39
20min1419413-41941391.18492.791.4791.8993.501.48
2427626-42762692.97093.67
3425563-42556392.52193.24
4438076-43807695.24296.01
5426448-42644892.71393.37
6423547-42354792.08392.81
30min1423027-42302791.97093.801.7092.9594.791.71
2435554-43555494.69395.67
3430555-43055593.60694.60
4443717-44371796.46897.52
5426538-42653892.73393.67
6429184-42918493.30894.31
45min1426387-42638792.70094.791.8293.9696.061.83
2442035-44203596.10297.37
3431208-43120893.74895.02
4448419-44841997.49098.84
5434401-43440194.44395.66
6433548-43354894.25795.54
60min1424842-42484292.36494.921.9493.9096.481.94
2443254-44325496.36797.92
3433065-43306594.15295.71
4448967-44896797.60999.25
5433798-43379894.31195.81
6435625-43562594.70996.27
极限1426260-42626092.67394.871.7694.4896.721.77
2440398-44039895.74697.59
3437867-43786795.19697.03
4447661-44766197.32599.26
5429738-42973893.42995.21
6436384-43638494.87496.72
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%
110.008422658424398414558423148422368421420.05
210.008453848454148453990.01
单位质量响应值RSD%判断
84214.2084539.900.28数据可信
长期12月-供试品溶液-2023041621批- 贝那普利-醋酸盐缓冲液(pH4.5)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min166115-661157.77310.1964.717.7710.2064.72
2124941-12494114.68914.69
3159122-15912218.70818.71
4108345-10834512.73812.74
561748-617487.2607.26
6-0.0000.00
10min1809129-80912995.12896.911.8095.1596.941.81
2825847-82584797.09397.14
3829852-82985297.56497.62
4836352-83635298.32898.37
5840535-84053598.82098.84
6803835-80383594.50594.51
15min1835279-83527998.20299.891.2398.51100.211.23
2846124-84612499.47799.81
3848005-84800599.698100.05
4863176-863176101.482101.82
5860298-860298101.143101.46
6844939-84493999.33899.62
20min1831929-83192997.80899.641.3698.41100.261.37
2845261-84526199.376100.01
3844593-84459399.29799.94
4863793-863793101.554102.19
5857670-857670100.835101.46
6841568-84156898.94199.52
30min1827983-82798397.34499.311.2498.24100.231.24
2844369-84436999.271100.20
3840743-84074398.84499.79
4856836-856836100.736101.68
5854581-854581100.471101.40
6843692-84369299.191100.07
45min1826734-82673497.19798.861.1598.39100.081.15
2840803-84080398.851100.08
3837804-83780498.49999.74
4851756-851756100.139101.38
5851658-851658100.128101.35
6836626-83662698.36099.54
60min1817395-81739596.09998.321.4397.5899.831.43
2836886-83688698.39199.92
3831387-83138797.74499.28
4852001-852001100.168101.71
5845168-84516899.365100.89
6834708-83470898.13599.61
极限1815588-81558895.88797.851.2697.6699.661.26
2830839-83083997.68099.50
3830433-83043397.63299.46
4844083-84408399.237101.08
5842936-84293699.102100.93
6829702-82970297.54699.31
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%
114.074566304561484560224557564554454560000.10
214.074548194545744546960.04
单位质量响应值RSD%判断
32409.3832316.700.21数据可信
长期12月-供试品溶液-2023041621批-左氨氯地平-磷酸盐缓冲液(pH6.8)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1270301-27030158.59348.8013.1358.5948.8013.12
2253778-25377855.01255.01
3210168-21016845.55845.56
4196606-19660642.61842.62
5210006-21000645.52345.52
6209804-20980445.47945.48
10min1358439-35843977.69973.724.1677.8773.864.16
2324643-32464370.37370.54
3343349-34334974.42874.56
4321836-32183669.76469.89
5347880-34788075.41075.55
6344355-34435574.64674.78
15min1382923-38292383.00680.553.1883.4280.923.18
2354873-35487376.92677.30
3374754-37475481.23681.60
4358812-35881277.78078.12
5379554-37955482.27682.64
6378676-37867682.08682.45
20min1388471-38847184.20982.423.4484.8783.033.43
2357986-35798677.60178.21
3387194-38719483.93284.54
4370511-37051180.31680.89
5390620-39062084.67585.28
6386452-38645283.77184.38
30min1385026-38502683.46283.452.9784.3784.302.95
2369170-36917080.02580.86
3395050-39505085.63586.49
4381508-38150882.70083.51
5378318-37831882.00882.87
6400621-40062186.84387.70
45min1405816-40581687.96986.882.4189.1387.992.40
2384675-38467583.38684.47
3399446-39944686.58887.70
4395833-39583385.80586.86
5410175-41017588.91490.02
6408805-40880588.61789.74
60min1408930-40893088.64488.112.0590.0789.472.05
2393409-39340985.27986.61
3405644-40564487.93289.30
4401130-40113086.95388.27
5413737-41373789.68691.06
6415834-41583490.14091.52
极限1421369-42136991.34090.402.2993.0392.032.28
2404037-40403787.58389.17
3414570-41457089.86691.50
4408668-40866888.58790.16
5426045-42604592.35494.00
6427382-42738292.64494.30
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%
110.008478098465338461288456998450198462380.13
210.008447148442158444640.05
单位质量响应值RSD%判断
84623.8084446.400.15数据可信
长期12月-供试品溶液-2023041621批- 贝那普利-磷酸盐缓冲液(pH6.8)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1299943-29994335.19813.65133.2135.2013.65133.19
221206-212062.4882.49
3-0.0000.00
421453-214532.5172.52
5331228-33122838.86938.87
624014-240142.8182.82
10min1826051-82605196.93596.430.5197.0496.470.54
2818738-81873896.07796.08
3827279-82727997.07997.08
4818082-81808296.00096.01
5822442-82244296.51296.63
6817846-81784695.97295.98
15min1835637-83563798.06098.130.7898.4698.460.75
2840019-84001998.57498.87
3846603-84660399.34799.64
4835561-83556198.05198.35
5830088-83008897.40997.82
6829315-82931597.31897.61
20min1835121-83512198.00097.780.7298.6998.410.70
2837169-83716998.24098.83
3841747-84174798.77799.37
4832245-83224597.66298.25
5827055-82705597.05397.75
6826355-82635596.97197.56
30min1831508-83150897.57697.490.6898.5698.410.66
2835286-83528698.01998.91
3838847-83884798.43799.32
4829191-82919197.30498.19
5825105-82510596.82497.81
6824635-82463596.76997.65
45min1828253-82825397.19497.100.7098.4798.310.67
2830486-83048697.45698.64
3836509-83650998.16399.34
4826673-82667397.00898.18
5821217-82121796.36897.65
6821629-82162996.41697.59
60min1824097-82409796.70696.680.6898.2798.180.66
2827840-82784097.14598.62
3832375-83237597.67799.15
4822652-82265296.53698.00
5817973-81797395.98797.56
6818163-81816396.01097.47
极限1822266-82226696.49196.230.7498.3598.020.73
2823533-82353396.64098.40
3829086-82908697.29199.06
4818019-81801995.99397.75
5813683-81368395.48497.34
6813684-81368495.48497.23
点击查看处理图标(人工保存)
 
原始图谱下载图谱(姜进硙 于 2024-05-05 15:16:23 完成)
生成报告数据部分下载报告(孙文新 于 2024-05-07 16:15:20 完成)
Current page cost:527 ms