培哚普利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DJ468-220103对照品来源中检院对照品使用方法直接使用
对照品含量(%)94.8对照品水分(%)0对照品稀释倍数2000
标示量(mg)10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%
19.834007839911399994008040150400440.23
29.894026540234402500.06
单位质量响应值RSD%判断
4073.654069.770.07数据可信
长期9月-供试品溶液-2022081001批-培哚普利-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%
5min145064-4506494.42995.823.3894.4395.833.38
244170-4417092.55592.56
343954-4395492.10392.10
446830-4683098.12998.13
547649-4764999.84599.85
646715-4671597.88897.89
10min147278-4727899.068100.111.43100.12101.181.44
246772-4677298.00899.04
347564-4756499.667100.69
448189-48189100.977102.07
548398-48398101.415102.52
648447-48447101.518102.61
15min147079-4707998.65199.430.85100.80101.610.86
246899-4689998.274100.39
347861-47861100.290102.42
447366-4736699.252101.46
547750-47750100.057102.29
647760-47760100.078102.29
20min147133-4713398.76498.691.19102.01101.971.20
246175-4617596.75799.97
346797-4679798.060101.31
447347-4734799.213102.53
547809-47809100.181103.53
647311-4731199.137102.46
30min146607-4660797.66297.561.16102.01101.941.17
245577-4557795.50499.79
346553-4655397.549101.88
446719-4671997.897102.31
547234-4723498.976103.44
646651-4665197.754102.18
45min144570-4457093.39494.691.3498.82100.151.27
245209-4520994.733100.08
345846-4584696.067101.49
445793-4579395.956101.46
545312-4531294.948100.51
644399-4439993.03598.55
极限144527-4452793.30393.751.3299.77100.261.29
244310-4431092.84999.25
343945-4394592.08498.57
445476-4547695.292101.86
545282-4528294.885101.50
644894-4489494.072100.62
培哚普利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4000
标示量(mg)5供试品稀释倍数2系数0.721
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
114.081646821646991647681647411648411647460.04
214.081645061646211645640.05
单位质量响应值RSD%判断
11700.7111687.780.08数据可信
长期9月-供试品溶液-2022081001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%
5min1165029-16502991.48193.422.9391.4893.422.93
2165865-16586591.94591.94
3162403-16240390.02590.03
4171087-17108794.83994.84
5175773-17577397.43797.44
6170970-17097094.77494.77
10min1175024-17502497.02298.310.9998.0499.351.00
2177143-17714398.19699.22
3175518-17551897.29698.30
4178594-17859499.001100.05
5179101-17910199.282100.36
6178687-17868799.052100.11
15min1175894-17589497.50497.990.5999.60100.120.57
2178553-17855398.978101.09
3176792-17679298.002100.08
4175681-17568197.38699.54
5177114-17711498.180100.37
6176602-17660297.896100.05
20min1175331-17533197.19297.210.73100.37100.430.74
2176231-17623197.691100.90
3173621-17362196.24499.41
4174804-17480496.900100.14
5177319-17731998.294101.57
6174858-17485896.930100.17
30min1172559-17255995.65596.270.7099.91100.560.71
2174092-17409296.505100.80
3172952-17295295.873100.11
4173111-17311195.961100.27
5175899-17589997.507101.88
6173370-17337096.105100.42
45min1165175-16517591.56293.121.9396.8898.491.83
2172212-17221295.463100.83
3169270-16927093.83299.14
4169712-16971294.07799.46
5168258-16825893.27198.72
6163319-16331990.53395.92
极限1165868-16586891.94692.341.4298.2898.741.38
2168797-16879793.570100.00
3162581-16258190.12496.47
4168363-16836393.32999.75
5168146-16814693.20999.70
6165677-16567791.84098.23
培哚普利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DJ468-220103对照品来源中检院对照品使用方法直接使用
对照品含量(%)94.8对照品水分(%)0对照品稀释倍数2000
标示量(mg)10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%
19.834017440154401094011240034401170.14
29.894013240062400970.13
单位质量响应值RSD%判断
4081.084054.300.47数据可信
长期9月-供试品溶液-2022081101批-培哚普利-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%
5min145095-4509594.58894.452.1894.5994.452.18
245013-4501394.41694.42
345874-4587496.22296.22
444630-4463093.61393.61
546153-4615396.80796.81
643405-4340591.04391.04
10min147145-4714598.88899.242.3199.94100.292.29
245991-4599196.46797.52
349217-49217103.234104.30
447515-4751599.664100.70
546600-4660097.74598.82
647413-4741399.450100.46
15min146528-4652897.59497.951.8799.74100.111.86
246782-4678298.127100.25
348347-48347101.409103.63
446170-4617096.84398.99
545829-4582996.12898.29
646543-4654397.62599.74
20min146373-4637397.26997.591.42100.50100.831.42
246711-4671197.978101.19
347661-4766199.970103.31
446494-4649497.523100.75
545657-4565795.76799.00
646251-4625197.013100.21
30min145839-4583996.14996.001.51100.46100.331.50
245929-4592996.337100.64
347022-4702298.630103.08
445131-4513194.66498.97
545307-4530795.03399.33
645387-4538795.20199.48
45min145175-4517594.75694.920.73100.14100.320.76
245110-4511094.62099.99
345857-4585796.186101.74
445384-4538495.194100.55
545022-4502294.43599.78
644983-4498394.35399.69
极限144558-4455893.46293.751.3499.90100.191.33
244985-4498594.357100.78
345770-4577096.004102.62
444235-4423592.78499.20
544239-4423992.79399.19
644372-4437293.07299.46
培哚普利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4000
标示量(mg)5供试品稀释倍数2系数0.721
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
114.081640641645271646401643821641061643440.16
214.081646521647191646860.03
单位质量响应值RSD%判断
11672.1611696.450.15数据可信
长期9月-供试品溶液-2022081101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%
5min1164739-16473991.39891.582.3591.4091.582.35
2165540-16554091.84391.84
3168449-16844993.45693.46
4162686-16268690.25990.26
5169799-16979994.20594.21
6159149-15914988.29788.30
10min1174110-17411096.59797.261.5797.6198.281.56
2175197-17519797.20098.22
3180658-180658100.230101.27
4174158-17415896.62497.63
5172853-17285395.90096.95
6174858-17485897.01297.99
15min1171789-17178995.31095.661.9197.4097.761.90
2172442-17244295.67297.77
3178602-17860299.089101.24
4169229-16922993.88995.97
5170099-17009994.37296.48
6172333-17233395.61197.67
20min1170205-17020594.43195.221.5497.5898.381.53
2172473-17247395.68998.85
3176549-17654997.950101.20
4170416-17041694.54897.67
5169228-16922893.88997.05
6170904-17090494.81997.94
30min1168506-16850693.48893.741.5497.6997.961.53
2169713-16971394.15898.38
3173539-17353996.280100.62
4165746-16574691.95796.13
5168187-16818793.31197.52
6168080-16808093.25297.43
45min1166014-16601492.10692.700.8397.3497.960.86
2166897-16689792.59597.87
3169730-16973094.16799.58
4167134-16713492.72797.92
5166693-16669392.48297.72
6166006-16600692.10197.31
极限1163595-16359590.76391.601.4597.0297.891.44
2166596-16659692.42898.73
3169117-16911793.827100.28
4162637-16263790.23296.45
5164822-16482291.44497.71
6163864-16386490.91397.15
培哚普利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DJ468-220103对照品来源中检院对照品使用方法直接使用
对照品含量(%)94.8对照品水分(%)0对照品稀释倍数2000
标示量(mg)10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%
19.834001339945399173987440017399530.16
29.893993639976399560.08
单位质量响应值RSD%判断
4064.394040.040.43数据可信
长期9月-供试品溶液-2022081201批-培哚普利-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%
5min145264-4526495.30596.062.3095.3096.062.30
247071-4707199.11099.11
343888-4388892.40892.41
446034-4603496.92696.93
545544-4554495.89495.89
645926-4592696.69996.70
10min147301-4730199.59499.541.00100.65100.611.00
248050-48050101.171102.27
346933-4693398.81999.85
446847-4684798.63899.71
546945-4694598.84499.91
647578-47578100.177101.25
15min146533-4653397.97798.731.07100.14100.901.07
247397-4739799.796102.02
346379-4637997.65399.78
446422-4642297.74399.92
547145-4714599.265101.43
647455-4745599.918102.11
20min146110-4611097.08697.151.22100.34100.421.22
246730-4673098.392101.73
345505-4550595.81299.02
445728-4572896.28299.54
545874-4587496.58999.86
646901-4690198.752102.05
30min145963-4596396.77796.551.25101.11100.901.25
246340-4634097.570102.00
344934-4493494.61098.88
445489-4548995.779100.11
545909-4590996.663101.00
646491-4649197.888102.28
45min145299-4529995.37995.821.67100.79101.241.64
246064-4606496.989102.50
344903-4490394.54599.87
445071-4507194.898100.29
544923-4492394.587100.00
646783-4678398.503103.99
极限144777-4477794.27994.611.64100.75101.101.61
245775-4577596.381102.97
344285-4428593.24499.62
444646-4464694.004100.45
544216-4421693.09899.56
645899-4589996.642103.22
培哚普利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4000
标示量(mg)5供试品稀释倍数2系数0.721
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
114.081640001640661638761639821642181640280.08
214.081643641639981641810.16
单位质量响应值RSD%判断
11649.7211660.580.07数据可信
长期9月-供试品溶液-2022081201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%
5min1165820-16582092.22892.502.2092.2392.502.20
2171519-17151995.39895.40
3160532-16053289.28789.29
4168519-16851993.72993.73
5165399-16539991.99491.99
6166111-16611192.39092.39
10min1177002-17700298.44797.081.2399.4798.111.23
2176766-17676698.31699.38
3172917-17291796.17597.17
4173615-17361596.56397.60
5171725-17172595.51296.53
6175280-17528097.49098.52
15min1174561-17456197.09096.560.8999.2198.660.90
2175035-17503597.35399.51
3171297-17129795.27497.33
4173192-17319296.32898.44
5172481-17248195.93398.02
6175063-17506397.36999.48
20min1172504-17250495.94695.031.3299.1498.211.31
2173022-17302296.23499.47
3168283-16828393.59896.72
4169828-16982894.45797.64
5168539-16853993.74096.89
6173012-17301296.22899.42
30min1172124-17212495.73494.451.39100.0098.691.38
2171369-17136995.31499.62
3166493-16649392.60296.76
4168811-16881193.89198.13
5168126-16812693.51197.70
6172018-17201895.67599.94
45min1167864-16786493.36593.421.7598.6998.701.70
2169995-16999594.55099.91
3166591-16659192.65797.84
4166843-16684392.79798.07
5164046-16404691.24196.47
6172459-17245995.920101.24
极限1167716-16771693.28292.461.7799.6598.781.74
2169170-16917094.091100.50
3164144-16414491.29697.51
4165468-16546892.03298.34
5161828-16182890.00896.25
6169075-16907594.038100.43
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