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%
19.744102541194414474121341492412740.47
29.784115341255412040.18
单位质量响应值RSD%判断
4237.584213.090.41数据可信
长期18月-供试品溶液-2022081302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%
5min148303-4830397.53798.752.1497.5498.762.14
249383-4938399.71799.72
350363-50363101.696101.70
448476-4847697.88697.89
547416-4741695.74695.75
649496-4949699.94699.95
10min148446-4844697.82599.521.4698.91100.611.45
248657-4865798.25199.36
349612-49612100.180101.31
449196-4919699.340100.43
549344-4934499.639100.70
650442-50442101.856102.97
15min148815-4881598.57099.121.04100.74101.331.05
248982-4898298.908101.11
349740-49740100.438102.68
448766-4876698.472100.66
548533-4853398.001100.17
649701-49701100.360102.60
20min148323-4832397.57797.910.78100.84101.220.79
248125-4812597.177100.48
349072-4907299.089102.45
448216-4821697.361100.65
548378-4837897.688100.95
648825-4882598.591101.95
30min146900-4690094.70495.901.5999.05100.291.56
246837-4683794.57698.95
347882-4788296.687101.15
447301-4730195.51399.88
547212-4721295.33499.68
648828-4882898.597103.05
45min146275-4627593.44294.691.5598.84100.151.53
246405-4640593.70499.13
347420-4742095.754101.29
446457-4645793.80999.24
546687-4668794.27399.68
648110-4811097.147102.70
极限146022-4602292.93193.971.6799.37100.481.59
245403-4540391.68198.15
347022-4702294.950101.55
446442-4644293.779100.25
547614-4761496.145102.60
646729-4672994.358100.99
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%
114.178423684073844128421184340842540.16
214.188440284360843810.04
单位质量响应值RSD%判断
5945.945950.710.06数据可信
长期18月-供试品溶液-2022081302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%
5min188961-8896196.95097.152.0396.9597.152.03
289699-8969997.75497.75
391672-9167299.90599.90
488793-8879396.76796.77
586110-8611093.84393.84
689624-8962497.67397.67
10min189757-8975797.81897.861.5798.8998.941.57
289485-8948597.52198.61
390673-9067398.81699.93
490351-9035198.46599.54
587235-8723595.06996.11
691248-9124899.443100.53
15min190557-9055798.68998.231.42100.85100.401.42
289494-8949497.53199.70
392033-92033100.298102.51
490061-9006198.149100.32
588186-8818696.10698.20
690479-9047998.604100.79
20min189320-8932097.34196.811.29100.60100.071.28
287543-8754395.40598.66
390710-9071098.856102.18
488901-8890196.885100.14
587814-8781495.70098.87
688726-8872696.69499.98
30min187531-8753195.39294.831.3199.7399.161.31
285694-8569493.39097.70
388008-8800895.912100.33
486926-8692694.73299.07
585651-8565193.34397.57
688270-8827096.197100.56
45min184799-8479992.41492.871.8697.8298.261.82
283490-8349090.98896.34
387233-8723395.067100.55
484434-8443492.01797.41
584225-8422591.78997.06
687144-8714494.970100.40
极限184868-8486892.49092.051.5298.9298.471.48
282016-8201689.38195.74
385813-8581393.519100.06
484863-8486392.48498.90
584508-8450892.09798.38
684734-8473492.34498.83
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%
19.744125941226410794126041191412030.19
29.784128241446413640.29
单位质量响应值RSD%判断
4230.294229.450.02数据可信
长期18月-供试品溶液-2022081302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%
5min147717-4771796.24996.050.9696.2596.050.96
248077-4807796.97596.98
347077-4707794.95894.96
447341-4734195.49195.49
547300-4730095.40895.41
648205-4820597.23497.23
10min148545-4854597.91997.501.0498.9998.571.03
248214-4821497.25298.33
348957-4895798.75099.81
447569-4756995.95197.01
548706-4870698.24499.30
648034-4803496.88997.97
15min147751-4775196.31896.410.7998.4898.560.78
247496-4749695.80397.96
347808-4780896.43398.59
447294-4729495.39697.52
548289-4828997.40399.55
648131-4813197.08499.24
20min147345-4734595.49995.401.1598.7398.621.13
247026-4702694.85598.08
347122-4712295.04998.27
446558-4655893.91197.10
548156-4815697.135100.37
647571-4757195.95599.19
30min146510-4651093.81593.581.0398.1097.861.01
246355-4635593.50297.78
346140-4614093.06897.35
445624-4562492.02796.26
546899-4689994.59998.91
646838-4683894.47698.78
45min146326-4632693.44393.121.5398.7798.441.47
247016-4701694.835100.15
345760-4576092.30297.62
445199-4519991.17096.42
545817-4581792.41797.78
646883-4688394.56799.92
极限145869-4586992.52292.080.9898.8998.440.97
245779-4577992.34098.71
345336-4533691.44797.79
444901-4490190.56996.84
545911-4591192.60699.00
646099-4609992.98699.39
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%
114.178445884218846278444584455844410.18
214.188442184869846450.38
单位质量响应值RSD%判断
5959.145969.320.13数据可信
长期18月-供试品溶液-2022081302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%
5min186205-8620593.69691.951.4993.7091.961.49
284375-8437591.70791.71
383028-8302890.24390.24
484693-8469392.05392.05
583490-8349090.74590.75
685827-8582793.28593.29
10min188920-8892096.64795.161.3297.6996.181.31
286109-8610993.59294.61
388827-8882796.54697.55
486575-8657594.09895.12
587256-8725694.83895.85
687639-8763995.25596.29
15min186859-8685994.40793.851.3896.5295.931.37
284588-8458891.93994.00
387152-8715294.72596.80
485308-8530892.72194.79
586418-8641893.92895.99
687758-8775895.38497.48
20min186448-8644893.96093.191.0597.1296.311.05
284344-8434491.67394.75
385629-8562993.07096.20
485052-8505292.44395.54
586387-8638793.89497.00
686567-8656794.09097.24
30min184449-8444991.78891.130.9696.0095.280.96
282767-8276789.95994.06
383814-8381491.09795.26
483063-8306390.28194.41
584091-8409191.39895.55
684856-8485692.23096.43
45min183916-8391691.20890.111.2196.4495.281.18
283052-8305290.26995.37
383124-8312490.34795.52
481934-8193489.05494.18
581494-8149488.57693.74
683902-8390291.19396.42
极限183077-8307790.29689.310.9296.5495.480.92
281426-8142688.50294.60
381981-8198189.10595.28
481609-8160988.70194.82
581795-8179588.90395.05
683140-8314090.36596.60
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%
19.744126241400411694124341295412740.21
29.784150641483414940.04
单位质量响应值RSD%判断
4237.584242.740.09数据可信
长期18月-供试品溶液-2022081401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%
5min147862-4786296.30796.541.0096.3196.541.00
247890-4789096.36496.36
348550-4855097.69297.69
448291-4829197.17197.17
548121-4812196.82996.83
647163-4716394.90194.90
10min148318-4831897.22598.850.9398.3099.920.91
249276-4927699.153100.22
349242-4924299.084100.17
449040-4904098.67899.76
549173-4917398.945100.02
649698-49698100.002101.06
15min147340-4734095.25797.001.1897.4199.171.15
248529-4852997.65099.82
348055-4805596.69698.88
448816-4881698.227100.40
547843-4784396.26998.44
648665-4866597.923100.09
20min146645-4664593.85995.871.5197.0799.121.47
247657-4765795.89599.15
346999-4699994.57197.83
447776-4777696.13499.40
548444-4844497.479100.72
648349-4834997.287100.54
30min146658-4665893.88595.251.1498.1499.561.11
247309-4730995.19599.52
347634-4763495.849100.16
446826-4682694.22398.56
548121-4812196.829101.16
647464-4746495.50799.84
45min145869-4586992.29794.621.3197.5999.991.27
247105-4710594.784100.16
347711-4771196.004101.38
447248-4724895.072100.45
547053-4705394.680100.08
647158-4715894.891100.29
极限145882-4588292.32393.761.6798.64100.181.59
246203-4620392.96999.40
346945-4694594.462100.91
448008-4800896.601103.04
546184-4618492.93199.39
646347-4634793.25999.71
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%
114.178458684822848238475784574847120.15
214.188490185015849580.10
单位质量响应值RSD%判断
5978.265991.400.16数据可信
长期18月-供试品溶液-2022081401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%
5min185065-8506592.13992.370.9992.1492.370.99
286502-8650293.69593.70
386073-8607393.23193.23
484929-8492991.99291.99
584859-8485991.91691.92
684258-8425891.26591.26
10min187159-8715994.40795.981.1795.4397.011.16
289415-8941596.85197.89
389451-8945196.89097.93
487575-8757594.85895.88
588583-8858395.94996.97
689483-8948396.92497.94
15min185369-8536992.46894.171.2794.5496.261.25
287702-8770294.99597.11
387227-8722794.48196.59
487429-8742994.69996.78
585801-8580192.93695.02
688106-8810695.43397.52
20min184016-8401691.00393.361.7194.1096.501.67
286787-8678794.00497.18
385275-8527592.36695.53
485856-8585692.99696.12
587030-8703094.26797.39
688192-8819295.52698.68
30min183230-8323090.15192.071.3994.2696.241.37
285262-8526292.35296.57
386012-8601293.16597.35
483835-8383590.80794.97
585895-8589593.03897.21
685763-8576392.89597.11
45min182198-8219889.03391.261.6294.1596.461.58
284810-8481091.86397.11
385937-8593793.08398.31
483761-8376190.72695.90
583496-8349690.43995.64
685297-8529792.39097.64
极限181798-8179888.60090.621.8394.7096.841.73
283558-8355890.50796.77
384807-8480791.85998.12
485884-8588493.02699.20
582297-8229789.14195.35
683642-8364290.59896.87
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%
19.744109641336412424134041480412990.35
29.784149241402414470.16
单位质量响应值RSD%判断
4240.144237.930.04数据可信
长期18月-供试品溶液-2022081401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%
5min147703-4770396.01397.891.4696.0197.901.47
249463-4946399.55599.56
348123-4812396.85896.86
449462-4946299.55399.55
548547-4854797.71297.71
648529-4852997.67597.68
10min148405-4840597.42698.350.8498.4999.440.84
248844-4884498.30999.42
348901-4890198.42499.50
449583-4958399.797100.90
548550-4855097.71898.80
648916-4891698.45499.54
15min148413-4841397.44297.780.6299.5999.960.62
248490-4849097.59799.80
348125-4812596.86299.03
448816-4881698.253100.47
548947-4894798.517100.69
648683-4868397.985100.16
20min147546-4754695.69795.890.3598.9399.150.34
247512-4751295.62898.91
347487-4748795.57898.82
447683-4768395.97399.28
547918-4791896.44699.71
647699-4769996.00599.27
30min146484-4648493.55994.580.7397.8598.910.71
247509-4750995.62299.97
346909-4690994.41598.72
446934-4693494.46598.84
546917-4691794.43198.77
647182-4718294.96499.30
45min146070-4607092.72694.191.3098.0699.581.24
246367-4636793.32498.73
346864-4686494.32499.68
447112-4711294.823100.25
547782-4778296.172101.56
646592-4659293.77799.17
极限145926-4592692.43693.271.2498.8099.701.19
246487-4648793.565100.01
345667-4566791.91598.32
447313-4731395.228101.70
546482-4648293.555100.01
646176-4617692.93999.37
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%
114.178421384253847668446584653844700.29
214.188487984678847780.17
单位质量响应值RSD%判断
5961.195978.700.21数据可信
长期18月-供试品溶液-2022081401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%
5min187377-8737794.87994.631.2294.8894.631.23
288529-8852996.13096.13
386009-8600993.39493.39
488131-8813195.69895.70
586823-8682394.27894.28
686000-8600093.38493.38
10min189448-8944897.12896.050.8998.1897.100.89
288244-8824495.82196.89
387547-8754795.06496.10
489369-8936997.04298.11
587894-8789495.44196.49
688231-8823195.80796.84
15min189850-8985097.56595.701.3799.7097.821.35
288003-8800395.55997.69
386267-8626793.67495.77
488123-8812395.68997.83
588891-8889196.52398.63
687667-8766795.19497.30
20min187828-8782895.36993.701.1698.5996.881.15
286218-8621893.62196.82
384752-8475292.02995.16
485920-8592093.29796.50
586623-8662394.06097.24
686408-8640893.82796.99
30min185259-8525992.57992.151.0896.8696.381.05
286311-8631193.72297.96
383952-8395291.16095.32
484829-8482992.11296.35
583841-8384191.04095.27
685001-8500192.29996.50
45min184576-8457691.83891.551.3097.1496.801.25
283566-8356690.74196.02
383034-8303490.16395.33
484608-8460891.87297.14
586175-8617593.57498.81
683900-8390091.10496.33
极限184646-8464691.91490.901.4598.2497.161.40
284072-8407291.29097.57
381751-8175188.77094.94
485133-8513392.44398.73
583603-8360390.78197.06
683080-8308090.21396.45
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