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%
110.214168241669417054165341718416850.07
210.164166041713416860.09
单位质量响应值RSD%判断
4082.764102.950.35数据可信
供试品溶液-2022081001批-培哚普利-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%
5min146625-4662597.19598.031.0097.2098.031.00
246511-4651196.95896.96
347267-4726798.53498.53
446858-4685897.68197.68
547792-4779299.62899.63
647092-4709298.16998.17
10min148443-48443100.985100.201.01102.07101.291.00
247322-4732298.64899.73
347683-4768399.401100.50
448551-48551101.210102.30
548355-48355100.802101.91
648044-48044100.153101.24
15min148097-48097100.26499.581.01102.47101.781.00
246929-4692997.829100.00
347871-4787199.793101.99
447720-4772099.478101.69
547658-4765899.349101.58
648328-48328100.746102.95
20min146075-4607596.04995.960.9299.3699.270.91
245382-4538294.60497.86
346291-4629196.49999.81
445670-4567095.20598.52
546370-4637096.66499.99
646412-4641296.751100.07
30min146305-4630596.52895.451.30100.9199.821.25
245347-4534794.53198.84
345183-4518394.18998.57
446315-4631596.549100.92
546358-4635896.639101.04
645214-4521494.25498.65
45min146041-4604195.97894.771.08101.43100.201.04
245092-4509294.00099.36
345310-4531094.45499.88
444756-4475693.29998.75
545749-4574995.369100.85
645821-4582195.519100.96
极限145024-4502493.85894.251.11100.38100.741.07
244538-4453892.84599.25
344851-4485193.49799.97
445528-4552894.909101.39
545903-4590395.690102.23
645418-4541894.679101.19
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2000
标示量(mg)10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%
114.121663401664141661631662401665931663500.10
214.121661281659901660590.06
单位质量响应值RSD%判断
11781.1611760.550.13数据可信
供试品溶液-2022081001批-氨氯地平-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%
5min187772-8777248.33851.753.9648.3451.753.96
292873-9287351.14851.15
398657-9865754.33354.33
496522-9652253.15753.16
594706-9470652.15752.16
693302-9330251.38451.38
10min1132626-13262673.04174.331.3173.5874.901.32
2133317-13331773.42173.99
3136185-13618575.00175.60
4137121-13712175.51676.11
5134598-13459874.12774.71
6135949-13594974.87175.44
15min1153270-15327084.41085.891.5285.7687.291.53
2153227-15322784.38685.77
3158682-15868287.39088.83
4156936-15693686.42987.86
5155475-15547585.62487.03
6158141-15814187.09288.50
20min1153221-15322184.38386.621.5586.6788.981.56
2155748-15574885.77488.10
3159830-15983088.02390.43
4157449-15744986.71189.10
5158538-15853887.31189.67
6158914-15891487.51889.89
30min1158576-15857687.33288.151.2290.5691.471.20
2159017-15901787.57590.85
3159185-15918587.66791.05
4163029-16302989.78493.14
5162030-16203089.23492.56
6158558-15855887.32290.66
45min1160769-16076988.54089.511.4592.7393.801.38
2165540-16554091.16795.41
3162006-16200689.22193.58
4159570-15957087.87992.23
5165046-16504690.89595.21
6162233-16223389.34693.66
极限1160232-16023288.24489.931.3793.4295.221.35
2161280-16128088.82194.08
3163662-16366290.13395.48
4163913-16391390.27195.60
5166457-16645791.67297.00
6164198-16419890.42895.73
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%
110.214169541862416784164041507416760.31
210.164173441740417370.02
单位质量响应值RSD%判断
4081.884107.970.46数据可信
供试品溶液-2022081101批-培哚普利-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%
5min146763-4676397.43497.692.0197.4397.682.01
246113-4611396.08096.08
347076-4707698.08698.09
447244-4724498.43698.44
548394-48394100.833100.83
645711-4571195.24295.24
10min147823-4782399.64398.851.68100.7399.941.68
246642-4664297.18298.25
347207-4720798.35999.45
447903-4790399.809100.90
548561-48561101.180102.30
646521-4652196.93097.99
15min147038-4703898.00797.941.75100.20100.121.75
246845-4684597.60599.75
346399-4639996.67698.86
447598-4759899.174101.38
548225-48225100.480102.72
645935-4593595.70997.84
20min146735-4673597.37697.710.98100.65100.981.00
246632-4663297.161100.39
346916-4691697.753101.01
447362-4736298.682101.99
547463-4746398.893102.25
646260-4626096.38699.58
30min146106-4610696.06595.231.02100.4399.581.03
245322-4532294.43298.74
345794-4579495.41599.76
445920-4592095.678100.08
546114-4611496.082100.54
644966-4496693.69097.96
45min145431-4543194.65994.261.47100.0999.681.46
244715-4471593.16798.53
345410-4541094.615100.02
445430-4543094.657100.12
546175-4617596.209101.74
644268-4426892.23697.55
极限145044-4504493.85393.361.95100.3399.821.91
243856-4385691.37797.77
344606-4460692.94099.39
445013-4501393.788100.30
546278-4627896.424103.02
644034-4403491.74898.08
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2000
标示量(mg)10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%
114.121666151661831661561657471661351661670.19
214.121663951663091663520.04
单位质量响应值RSD%判断
11768.2011781.300.08数据可信
供试品溶液-2022081101批-氨氯地平-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%
5min192840-9284051.11253.002.2651.1153.002.26
295057-9505752.33352.33
395548-9554852.60352.60
497918-9791853.90853.91
597766-9776653.82453.82
698449-9844954.20054.20
10min1131939-13193972.63873.401.6673.2173.991.65
2131592-13159272.44773.03
3131734-13173472.52573.11
4136492-13649275.14575.74
5135763-13576374.74375.34
6132430-13243072.90873.51
15min1150232-15023282.70983.931.8884.0885.331.87
2152247-15224783.81985.21
3149719-14971982.42783.82
4156171-15617185.97987.41
5155782-15578285.76587.19
6150539-15053982.87884.29
20min1154994-15499485.33187.341.2587.6289.681.25
2158826-15882687.44189.76
3159061-15906187.57089.88
4160665-16066588.45390.84
5159968-15996888.06990.45
6158396-15839687.20489.54
30min1156649-15664986.24287.621.2489.4890.931.24
2158333-15833387.16990.46
3159855-15985588.00791.29
4161999-16199989.18792.56
5160410-16041088.31391.67
6157681-15768186.81090.11
45min1157340-15734086.62387.711.5190.8291.991.49
2157643-15764386.78991.05
3160981-16098188.62792.88
4162310-16231089.35993.72
5161023-16102388.65092.99
6156566-15656686.19690.46
极限1159236-15923687.66688.442.0092.8393.701.95
2156101-15610185.94091.16
3160758-16075888.50493.75
4163365-16336589.94095.30
5165079-16507990.88396.21
6159303-15930387.70392.93
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%
110.214173641698416794175541800417340.12
210.164170541765417350.11
单位质量响应值RSD%判断
4087.564107.780.35数据可信
供试品溶液-2022081201批-培哚普利-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%
5min147132-4713298.13797.650.5298.1497.650.52
247016-4701697.89597.90
346800-4680097.44697.45
447038-4703897.94197.94
546931-4693197.71897.72
646463-4646396.74496.74
10min147088-4708898.04598.141.7099.1499.221.68
246782-4678297.40898.50
347698-4769899.315100.40
448416-48416100.810101.90
546274-4627496.35097.44
646534-4653496.89297.97
15min146891-4689197.63597.741.4599.8199.921.43
246544-4654496.91399.08
347172-4717298.220100.41
448041-48041100.030102.24
546012-4601295.80597.96
646987-4698797.83599.99
20min146057-4605795.89996.612.1999.1699.872.14
246538-4653896.900100.15
345498-4549894.73598.01
448346-48346100.665103.98
545875-4587595.52098.74
646076-4607695.93899.18
30min146604-4660497.03895.741.56101.37100.071.53
246062-4606295.909100.23
345843-4584395.45399.78
446700-4670097.237101.68
544709-4470993.09297.37
645958-4595895.692100.00
45min145394-4539494.51894.271.6399.9399.671.61
245238-4523894.19399.58
345186-4518694.08599.48
446605-4660597.040102.56
544785-4478593.25098.57
644451-4445192.55597.92
极限145103-4510393.91293.361.94100.3799.811.90
244472-4447292.59899.03
345172-4517294.056100.49
446279-4627996.361102.96
544022-4402291.66198.01
643989-4398991.59397.99
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2000
标示量(mg)10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%
114.121660691665191660601664301658581661870.17
214.121666001661921663960.18
单位质量响应值RSD%判断
11769.6211784.420.09数据可信
供试品溶液-2022081201批-氨氯地平-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%
5min191372-9137250.29552.664.0550.2952.664.05
2101128-10112855.66555.66
395463-9546352.54652.55
491701-9170150.47650.48
598950-9895054.46654.47
695438-9543852.53352.53
10min1125442-12544269.04871.712.0569.6172.292.05
2131631-13163172.45573.07
3132733-13273373.06173.65
4131913-13191372.61073.17
5130827-13082772.01272.62
6129093-12909371.05871.64
15min1146024-14602480.37782.971.6381.7084.361.63
2150871-15087183.04584.47
3151283-15128383.27284.67
4152951-15295184.19085.56
5150921-15092183.07384.48
6152373-15237383.87285.25
20min1151855-15185583.58786.032.6685.8188.342.61
2157136-15713686.49488.84
3151269-15126983.26485.59
4162319-16231989.34691.65
5157001-15700186.41988.75
6158194-15819487.07689.38
30min1157410-15741086.64487.881.2489.7991.141.24
2159647-15964787.87691.18
3158610-15861087.30590.55
4162292-16229289.33292.63
5158247-15824787.10590.39
6161767-16176789.04392.32
45min1156067-15606785.90587.781.5590.0292.011.54
2158917-15891787.47491.76
3158639-15863987.32191.54
4163560-16356090.03094.32
5160506-16050688.34992.60
6159108-15910887.57991.84
极限1158509-15850987.24988.381.2992.3193.591.27
2159612-15961287.85693.11
3161044-16104488.64593.83
4164356-16435690.46895.76
5160500-16050088.34593.58
6159343-15934387.70892.94
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%
110.214176141857418184151241775417450.33
210.164168342072418780.66
单位质量响应值RSD%判断
4088.644121.850.58数据可信
供试品溶液-697902批-培哚普利-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%
5min147786-4778699.31699.400.8099.3299.400.80
248471-48471100.740100.74
348008-4800899.77799.78
447491-4749198.70398.70
547425-4742598.56698.57
647785-4778599.31499.31
10min148390-48390100.571101.200.72101.67102.300.72
249307-49307102.477103.60
348839-48839101.505102.61
448600-48600101.008102.10
548378-48378100.546101.64
648642-48642101.095102.20
15min148022-4802299.80799.450.92102.03101.680.91
248146-48146100.064102.32
348135-48135100.041102.28
448209-48209100.195102.41
547381-4738198.474100.69
647206-4720698.111100.34
20min147587-4758798.90298.290.33102.23101.620.32
247322-4732298.352101.72
347179-4717998.055101.40
447191-4719198.079101.41
547212-4721298.123101.43
647264-4726498.231101.55
30min147442-4744298.60197.940.84103.03102.360.81
247312-4731298.331102.79
347237-4723798.175102.61
446563-4656396.774101.20
546694-4669497.047101.44
647487-4748798.695103.10
45min146050-4605095.70896.510.63101.23102.030.61
246597-4659796.845102.40
346882-4688297.437102.97
446346-4634696.323101.82
546256-4625696.136101.61
646494-4649496.631102.14
极限145200-4520093.94194.490.92100.53101.080.87
245931-4593195.461102.09
345232-4523294.008100.62
446005-4600595.615102.18
544995-4499593.515100.06
645424-4542494.407100.99
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2000
标示量(mg)10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%
114.121660411663731664961663281665341663540.12
214.121662181662561662370.02
单位质量响应值RSD%判断
11781.4411773.160.05数据可信
供试品溶液-697902批-氨氯地平-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%
5min1135701-13570174.69374.752.0974.6974.752.09
2134612-13461274.09474.09
3141231-14123177.73777.74
4133524-13352473.49573.49
5133814-13381473.65473.65
6135976-13597674.84474.84
10min1162582-16258289.48990.180.9290.3291.010.93
2163956-16395690.24591.07
3166540-16654091.66892.53
4163441-16344189.96290.78
5162380-16238089.37890.20
6164118-16411890.33591.17
15min1168229-16822992.59792.740.5594.4294.570.55
2167431-16743192.15893.98
3169130-16913093.09394.98
4169899-16989993.51795.33
5167699-16769992.30694.12
6168555-16855592.77794.61
20min1169758-16975893.43992.691.0996.2995.551.04
2166025-16602591.38494.23
3166090-16609091.42094.34
4169809-16980993.46796.32
5169661-16966193.38696.22
6169041-16904193.04495.91
30min1168019-16801992.48292.011.2096.3795.901.16
2167058-16705891.95395.82
3166742-16674291.77995.71
4166848-16684891.83795.73
5164068-16406890.30794.18
6170217-17021793.69297.59
45min1164672-16467290.63991.410.8095.5696.320.77
2164791-16479190.70595.59
3165530-16553091.11296.06
4166694-16669491.75296.67
5166623-16662391.71396.59
6168126-16812692.54197.48
极限1161772-16177289.04390.281.2094.9796.211.12
2164839-16483990.73196.63
3161525-16152588.90794.87
4166405-16640591.59397.53
5164334-16433490.45396.35
6165217-16521790.93996.91
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%
110.214182141731416354179341906417770.25
210.164194141726418340.37
单位质量响应值RSD%判断
4091.774117.520.45数据可信
供试品溶液-719406批-培哚普利-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%
5min147904-4790499.575101.111.8899.58101.111.87
248124-48124100.032100.03
348779-48779101.394101.39
448092-4809299.96699.97
548591-48591101.003101.00
650376-50376104.714104.71
10min148591-48591101.003101.121.37102.11102.241.35
248054-4805499.887101.00
348272-48272100.340101.47
448442-48442100.694101.80
549931-49931103.789104.91
648592-48592101.005102.17
15min147933-4793399.635100.442.21101.86102.682.18
247173-4717398.056100.28
349310-49310102.498104.74
447234-4723498.183100.41
549740-49740103.392105.67
648520-48520100.856103.14
20min149171-49171102.209100.561.45105.54103.921.41
248092-4809299.966103.28
348959-48959101.768105.15
447572-4757298.885102.21
548824-48824101.488104.91
647642-4764299.031102.44
30min147171-4717198.05299.101.79102.52103.581.76
246586-4658696.836101.26
348720-48720101.271105.78
447343-4734398.409102.83
548662-48662101.151105.70
647577-4757798.895103.40
45min146230-4623096.09697.912.06101.66103.492.01
245896-4589695.401100.90
347901-4790199.569105.21
446738-4673897.152102.66
548351-48351100.504106.18
647491-4749198.717104.32
极限146069-4606995.76196.811.21102.39103.481.21
246046-4604695.713102.27
347465-4746598.663105.41
446321-4632196.285102.88
547006-4700697.709104.50
646523-4652396.705103.41
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2000
标示量(mg)10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%
114.121665671666951667271666201666641666550.04
214.121664461666901665680.11
单位质量响应值RSD%判断
11802.7611796.600.04数据可信
供试品溶液-719406批-氨氯地平-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%
5min1132663-13266372.88273.131.0372.8873.131.02
2132011-13201172.52472.52
3131449-13144972.21572.22
4134742-13474274.02574.02
5133195-13319573.17573.17
6134665-13466573.98273.98
10min1164898-16489890.59289.441.2991.4090.251.28
2161863-16186388.92489.73
3159850-15985087.81888.62
4163482-16348289.81490.64
5165182-16518290.74891.56
6161500-16150088.72589.55
15min1170769-17076993.81793.660.7395.6395.470.71
2168382-16838292.50694.30
3171288-17128894.10295.88
4169670-16967093.21395.03
5171319-17131994.11995.94
6171507-17150794.22396.03
20min1176594-17659497.01794.231.5499.8897.081.50
2171039-17103993.96596.79
3171943-17194394.46297.29
4169608-16960893.17996.04
5170371-17037193.59896.47
6169588-16958893.16896.02
30min1171177-17117794.04193.351.2597.9897.241.21
2166555-16655591.50295.37
3172541-17254194.79198.66
4169128-16912892.91696.81
5171040-17104093.96697.87
6169042-16904292.86896.76
45min1167825-16782592.20092.381.1397.1897.311.08
2166016-16601691.20696.09
3170426-17042693.62998.56
4166700-16670091.58296.51
5167418-16741891.97696.93
6170504-17050493.67298.59
极限1169671-16967193.21492.680.7999.2298.640.75
2168582-16858292.61698.51
3170669-17066993.76299.73
4167723-16772392.14498.09
5166982-16698291.73797.71
6168559-16855992.60398.57
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