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%
110.464396144175441484420444256441490.26
210.474427844184442310.16
单位质量响应值RSD%判断
4220.754224.550.07数据可信
供试品溶液-322765批-培哚普利-pH1.2
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min130917-3091762.46987.2614.4262.4787.2614.42
245277-4527791.48491.48
347901-4790196.78696.79
446299-4629993.54993.55
542904-4290486.68986.69
645835-4583592.61192.61
10min147727-4772796.43498.821.9397.1399.792.01
249669-49669100.358101.37
349673-49673100.366101.44
449893-49893100.811101.85
548335-4833597.66398.63
648155-4815597.29998.33
15min149201-4920199.41298.161.43101.18100.231.35
248703-4870398.406100.54
347947-4794796.87999.07
449487-4948799.990102.15
548447-4844797.88999.94
647711-4771196.40298.51
20min149289-4928999.59097.711.72102.46100.871.61
248453-4845397.901101.13
347771-4777196.52399.79
449298-4929899.608102.88
548098-4809897.184100.32
647236-4723695.44298.62
30min149132-4913299.27397.541.47103.25101.791.37
247556-4755696.089100.40
348298-4829897.588101.93
449094-4909499.196103.57
548008-4800897.002101.22
647567-4756796.111100.35
45min148503-4850398.00296.761.30103.08102.091.18
247308-4730895.587100.97
347218-4721895.406100.83
448378-4837897.749103.23
548472-4847297.939103.23
647450-4745095.874101.18
极限148951-4895198.90796.701.36105.08103.101.22
247639-4763996.256102.70
347351-4735195.674102.16
448229-4822997.448104.01
547820-4782096.622103.00
647169-4716995.307101.68
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%
113.818258583498822068268582349826650.61
213.898256382741826520.16
单位质量响应值RSD%判断
5985.885950.470.42数据可信
供试品溶液-322765批-氨氯地平-pH1.2
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min159847-5984765.00583.8111.4765.0183.8111.47
279463-7946386.31286.31
382644-8264489.76789.77
481944-8194489.00789.01
576197-7619782.76482.76
682874-8287490.01790.02
10min185725-8572593.11494.211.6293.8495.141.67
287915-8791595.49296.45
387223-8722394.74195.74
488485-8848596.11197.10
584740-8474092.04492.96
686319-8631993.75994.76
15min186127-8612793.55092.491.2995.3194.461.23
285489-8548992.85794.88
383641-8364190.85092.90
486480-8648093.93495.99
584240-8424091.50193.44
684910-8491092.22894.27
20min186004-8600493.41791.991.3796.2195.001.29
284602-8460291.89494.95
383326-8332690.50893.57
486053-8605393.47096.57
583601-8360190.80793.77
684557-8455791.84594.91
30min185203-8520392.54791.031.3596.3895.061.27
282475-8247589.58393.66
383543-8354390.74494.81
485110-8511092.44696.58
582871-8287190.01493.98
683659-8365990.87094.96
45min183350-8335090.53489.711.4795.4094.751.39
281654-8165488.69293.76
380756-8075687.71692.79
484090-8409091.33896.50
583132-8313290.29795.27
682544-8254489.65894.76
极限183793-8379391.01589.221.7396.8895.251.60
280373-8037387.30093.35
380526-8052687.46693.51
482925-8292590.07296.25
582113-8211389.19095.16
683099-8309990.26196.35
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%
110.464410944016438264399944015439930.24
210.474404843913439800.22
单位质量响应值RSD%判断
4205.834200.570.09数据可信
供试品溶液-2021561批-培哚普利-pH1.2
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min146281-4628193.94588.3811.9393.9488.3811.93
235029-3502971.10571.10
349601-49601100.684100.68
444781-4478190.90090.90
545549-4554992.45992.46
639988-3998881.17181.17
10min149250-4925099.97298.983.51101.0299.963.57
245569-4556992.50093.29
350454-50454102.416103.53
449298-49298100.069101.08
548312-4831298.06899.09
649683-49683100.851101.75
15min149472-49472100.42299.672.57102.58101.762.64
246841-4684195.08296.90
350306-50306102.115104.37
449666-49666100.816102.94
548501-4850198.451100.57
649832-49832101.153103.18
20min149587-49587100.65699.602.14103.93102.792.20
247607-4760796.63799.51
350026-50026101.547104.94
449234-4923499.939103.18
547946-4794697.325100.54
650007-50007101.508104.65
30min148871-4887199.20298.202.55103.59102.492.58
246478-4647894.34598.29
349340-49340100.154104.67
448397-4839798.240102.59
547425-4742596.267100.56
649746-49746100.978105.25
45min148694-4869498.84398.491.65104.33103.881.72
247753-4775396.933101.93
349576-49576100.633106.27
448704-4870498.863104.31
547420-4742096.257101.62
648987-4898799.438104.83
极限148681-4868198.81798.311.75105.41104.791.83
247388-4738896.192102.27
349633-49633100.749107.50
448641-4864198.735105.28
547516-4751696.452102.88
648732-4873298.920105.42
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%
113.818286982711827368289182505827420.19
213.898266882921827940.22
单位质量响应值RSD%判断
5991.465960.690.37数据可信
供试品溶液-2021561批-氨氯地平-pH1.2
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min177652-7765284.23379.6910.5584.2379.6910.56
260182-6018265.28365.28
381047-8104787.91687.92
475870-7587082.30082.30
577642-7764284.22284.22
668397-6839774.19474.19
10min183264-8326490.32189.762.9091.2690.642.96
277933-7793384.53885.26
384291-8429191.43592.41
484100-8410091.22892.14
583243-8324390.29891.23
683631-8363190.71991.54
15min183505-8350590.58290.122.2792.5292.002.33
279459-7945986.19387.86
383364-8336490.42992.42
484887-8488792.08194.01
583099-8309990.14292.08
684135-8413591.26693.10
20min183753-8375390.85189.712.2693.8092.592.29
279432-7943286.16488.79
382820-8282089.83992.84
483716-8371690.81193.76
581816-8181688.75091.69
684648-8464891.82294.67
30min182148-8214889.11087.982.0693.0791.862.05
279019-7901985.71689.30
381028-8102887.89591.89
480188-8018886.98490.94
580446-8044687.26491.19
683787-8378790.88894.75
45min181229-8122988.11386.762.5193.0691.622.36
280452-8045287.27091.80
378636-7863685.30190.27
481075-8107587.94692.87
576582-7658283.07287.97
681930-8193088.87493.75
极限180981-8098187.84488.320.9793.7794.140.96
281105-8110587.97993.48
381126-8112688.00293.92
481943-8194388.88894.79
580609-8060987.44193.26
682752-8275289.76595.63
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%
110.464368643873437954393944034438650.31
210.474400343847439250.26
单位质量响应值RSD%判断
4193.594195.320.03数据可信
供试品溶液-697902批-培哚普利-pH1.2
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min146724-4672495.04297.494.0495.0497.494.04
247342-4734296.29996.30
349278-49278100.237100.24
449976-49976101.657101.66
544933-4493391.39991.40
649316-49316100.314100.31
10min148680-4868099.021101.451.76100.08102.541.74
249128-4912899.932101.00
349953-49953101.610102.72
450394-50394102.507103.64
551120-51120103.984105.00
649979-49979101.663102.78
15min146498-4649894.58299.142.8696.74101.352.82
247954-4795497.54499.72
349194-49194100.066102.31
450109-50109101.927104.20
550124-50124101.958104.13
648561-4856198.779101.02
20min146306-4630694.19298.323.4697.40101.633.39
246836-4683695.27098.53
347954-4795497.544100.90
449243-49243100.166103.57
550855-50855103.445106.75
648814-4881499.293102.63
30min146487-4648794.56098.082.4598.81102.482.43
247304-4730496.222100.54
348433-4843398.518102.96
449255-49255100.190104.70
549628-49628100.949105.40
648206-4820698.056102.50
45min145805-4580593.17396.712.7498.48102.202.70
246438-4643894.46099.85
347351-4735196.317101.85
448730-4873099.122104.75
549193-49193100.064105.64
647743-4774397.115102.65
极限145971-4597193.51096.342.2799.85102.912.26
246485-4648594.556101.00
347247-4724796.106102.71
448319-4831998.286105.01
548810-4881099.285105.97
647337-4733796.289102.90
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%
113.811632241632191633171631141639921633730.22
213.891637331629341633340.35
单位质量响应值RSD%判断
11830.0511759.110.43数据可信
供试品溶液-697902批-氨氯地平-pH1.2
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1160873-16087388.41990.274.1988.4290.274.19
2163062-16306289.62389.62
3168830-16883092.79392.79
4170776-17077693.86293.86
5152653-15265383.90283.90
6169259-16925993.02993.03
10min1169911-16991193.38795.561.3294.3796.561.34
2173904-17390495.58296.58
3174343-17434395.82396.85
4176218-17621896.85397.90
5172964-17296495.06596.00
6175852-17585296.65297.69
15min1161707-16170788.87893.132.4490.9095.192.41
2168619-16861992.67794.73
3169776-16977693.31395.41
4173218-17321895.20597.32
5172241-17224194.66896.66
6171085-17108594.03296.14
20min1157195-15719586.39891.203.2789.4194.303.21
2161931-16193189.00192.09
3166163-16616391.32794.46
4171072-17107294.02597.20
5169926-16992693.39596.44
6169345-16934593.07696.23
30min1162154-16215489.12492.002.1093.0996.112.07
2165815-16581591.13695.21
3166493-16649391.50895.66
4170850-17085093.90398.12
5171738-17173894.39198.47
6167267-16726791.93496.12
45min1158063-15806386.87589.223.0491.8394.352.94
2157239-15723986.42291.51
3163052-16305289.61794.78
4168739-16873992.74398.01
5167483-16748392.05297.18
6159380-15938087.59992.81
极限1160508-16050888.21989.841.4794.1495.961.45
2163110-16311089.64995.70
3161056-16105688.52094.68
4163883-16388390.07496.37
5166073-16607391.27897.43
6166092-16609291.28897.47
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%
110.464381644069442604401743942440210.38
210.474413344328442300.32
单位质量响应值RSD%判断
4208.514224.450.27数据可信
供试品溶液-719406批-培哚普利-pH1.2
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min147063-4706395.23295.385.7295.2395.385.71
246843-4684394.78794.79
342194-4219485.37985.38
449379-4937999.91899.92
549664-49664100.495100.49
647670-4767096.46096.46
10min148677-4867798.498101.112.0799.56102.172.08
249102-4910299.358100.41
349476-49476100.114101.06
451087-51087103.374104.48
550355-50355101.893103.01
651102-51102103.405104.48
15min148285-4828597.705100.201.8899.86102.391.84
248708-4870898.560100.72
350704-50704102.599104.66
450204-50204101.588103.85
549966-49966101.106103.35
649250-4925099.657101.88
20min147642-4764296.40399.211.5899.64102.501.55
248653-4865398.449101.70
349694-49694100.556103.76
449174-4917499.503102.89
549531-49531100.226103.60
649467-49467100.096103.42
30min146945-4694594.99398.442.0999.30102.842.05
247980-4798097.087101.43
349325-4932599.809104.13
448841-4884198.830103.32
549115-4911599.384103.87
649681-49681100.529104.97
45min146247-4624793.58197.482.0598.95102.971.99
248974-4897499.099104.52
348360-4836097.856103.28
448435-4843598.008103.60
548803-4880398.753104.34
648230-4823097.593103.15
极限146189-4618993.46396.061.6699.87102.641.62
247100-4710095.307101.83
348296-4829697.727104.24
447875-4787596.875103.56
547252-4725295.614102.30
648126-4812697.383104.02
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%
113.811645381636051634061638891637781638430.27
213.891651321644591647960.29
单位质量响应值RSD%判断
11864.0811864.360.01数据可信
供试品溶液-719406批-氨氯地平-pH1.2
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1163102-16310289.11887.345.2989.1287.345.29
2158599-15859986.65786.66
3143766-14376678.55378.55
4166608-16660891.03391.03
5166161-16616190.78990.79
6160893-16089387.91187.91
10min1172734-17273494.38095.391.9095.3796.361.91
2171674-17167493.80194.76
3171377-17137793.63994.51
4177492-17749296.98097.99
5174704-17470495.45796.47
6179468-17946898.06099.04
15min1167740-16774091.65293.811.7493.6995.841.71
2168422-16842292.02494.03
3173900-17390095.01796.93
4173468-17346894.78196.87
5171776-17177693.85795.93
6174885-17488595.55697.62
20min1167742-16774291.65393.411.5694.7196.491.55
2168169-16816991.88694.91
3171441-17144193.67496.64
4172412-17241294.20497.35
5171246-17124693.56796.68
6174788-17478895.50398.63
30min1165927-16592790.66192.192.2394.7496.302.18
2163244-16324489.19593.24
3169999-16999992.88696.90
4168703-16870392.17896.37
5170379-17037993.09497.25
6174059-17405995.10499.29
45min1164012-16401289.61591.281.1594.7096.421.14
2166133-16613390.77495.81
3167889-16788991.73396.78
4166527-16652790.98996.20
5169303-16930392.50697.69
6168523-16852392.08097.33
极限1162430-16243088.75089.491.8194.8395.641.63
2165419-16541990.38496.43
3167222-16722291.36997.43
4165272-16527290.30396.53
5163588-16358889.38395.60
6158794-15879486.76493.03
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