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%
19.834071240708407124056040674406730.17
29.894080540779407920.05
单位质量响应值RSD%判断
4137.644124.570.23数据可信
长期9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%
5min143194-4319489.20996.754.2189.2196.754.21
246585-4658596.21396.21
348056-4805699.25199.25
446556-4655696.15396.15
548202-4820299.55299.55
648471-48471100.108100.11
10min146848-4684896.75699.221.6997.75100.301.70
248624-48624100.424101.49
348222-4822299.593100.70
447297-4729797.68398.75
548298-4829899.750100.86
648959-48959101.116102.23
15min147195-4719597.47297.900.8899.54100.080.89
247565-4756598.237100.42
347115-4711597.30799.52
446926-4692696.91799.07
547536-4753698.177100.39
648077-4807799.294101.53
20min145688-4568894.36097.041.9197.51100.301.91
247540-4754098.185101.46
347346-4734697.784101.07
446119-4611995.25098.48
547190-4719097.462100.77
648022-4802299.180102.52
30min145806-4580694.60495.781.3898.80100.131.39
246739-4673996.531100.90
346363-4636395.754100.13
445455-4545593.87998.17
547133-4713397.344101.73
646767-4676796.588101.03
45min144497-4449791.90093.341.4297.1598.751.41
245991-4599194.986100.43
345781-4578194.55299.99
444752-4475292.42797.76
544654-4465492.22497.69
645502-4550293.97699.49
极限145093-4509393.13192.542.1399.4098.991.99
245518-4551894.009100.50
343058-4305888.92895.42
444912-4491292.75799.12
544563-4456392.03798.53
645705-4570594.395100.95
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%
114.088316383181830808299582938830710.13
214.088305683080830680.03
单位质量响应值RSD%判断
5899.935899.720.01数据可信
长期9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%
5min180446-8044688.39195.383.9388.3995.383.93
285812-8581294.28794.29
389870-8987098.74698.75
487546-8754696.19296.19
588214-8821496.92696.93
688949-8894997.73497.73
10min186468-8646895.00897.901.7195.9998.961.73
290060-9006098.955100.00
390396-9039699.324100.42
488092-8809296.79297.86
589751-8975198.61599.69
689860-8986098.73599.82
15min187276-8727695.89696.750.5797.9398.900.61
288362-8836297.08999.24
388341-8834197.06699.27
487555-8755596.20298.35
588451-8845197.18799.36
688316-8831697.03899.22
20min184183-8418392.49795.862.0695.6099.082.05
288233-8823396.947100.17
388923-8892397.705100.98
485989-8598994.48297.69
587951-8795196.63799.89
688155-8815596.862100.12
30min184805-8480593.18194.261.4897.3198.551.44
286729-8672995.29599.60
384724-8472493.09297.46
484662-8466293.02497.29
587679-8767996.339100.66
686142-8614294.65098.99
45min181595-8159589.65492.021.8894.8297.351.84
285387-8538793.82099.18
385701-8570194.16599.56
483019-8301991.21896.51
582944-8294491.13696.53
683830-8383092.10997.50
极限179908-7990887.80090.912.3093.9697.272.21
284574-8457492.92799.33
380919-8091988.91195.36
483901-8390192.18798.50
583016-8301691.21597.62
684114-8411492.42198.83
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%
19.834081440839407874080940859408220.07
29.894075540736407460.04
单位质量响应值RSD%判断
4152.804119.920.57数据可信
长期9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%
5min149174-49174101.43298.122.90101.4398.122.90
247724-4772498.44198.44
345196-4519693.22793.23
448641-48641100.333100.33
547354-4735497.67897.68
647317-4731797.60297.60
10min148445-4844599.928100.060.77101.06101.150.77
248224-4822499.472100.57
348367-4836799.767100.80
449130-49130101.341102.46
548136-4813699.291100.38
648751-48751100.559101.64
15min147482-4748297.942101.746.77100.18103.946.63
256082-56082115.681117.88
347573-4757398.130100.27
448666-48666100.384102.62
548031-4803199.074101.26
648110-4811099.237101.44
20min147127-4712797.21098.110.92100.54101.440.91
247718-4771898.429101.91
347905-4790598.814102.05
448169-4816999.359102.72
547358-4735897.686100.98
647099-4709997.152100.46
30min147684-4768498.35996.381.31102.76100.801.23
246030-4603094.94799.52
346626-4662696.176100.51
447040-4704097.030101.49
546136-4613695.16599.54
646829-4682996.595100.98
45min145957-4595794.79695.271.12100.29100.771.05
245860-4586094.596100.23
346403-4640395.716101.12
446799-4679996.533102.07
545463-4546393.77799.21
646649-4664996.224101.68
极限145189-4518993.21298.5512.2899.76105.1011.47
244969-4496992.75899.44
359712-59712123.169129.63
446238-4623895.376101.99
545285-4528593.41099.88
645274-4527493.38799.91
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%
114.088343283292832898320583297833030.10
214.088304983019830340.03
单位质量响应值RSD%判断
5916.415897.300.23数据可信
长期9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%
5min187353-8735395.86693.592.1795.8793.592.17
284263-8426392.47592.48
382419-8241990.45190.45
487134-8713495.62695.63
585412-8541293.73693.74
685075-8507593.36693.37
10min187844-8784496.40595.891.3997.4796.931.38
285070-8507093.36194.39
387694-8769496.24197.25
488586-8858697.21998.28
587227-8722795.72896.77
687831-8783196.39197.43
15min185301-8530193.61494.741.6295.7596.841.60
284243-8424392.45394.52
386144-8614494.53996.61
487999-8799996.57598.72
587417-8741795.93798.04
686841-8684195.30497.41
20min185408-8540893.73294.151.1396.9197.311.12
284493-8449392.72895.82
386802-8680295.26298.39
486845-8684595.30998.52
586159-8615994.55697.73
685035-8503593.32296.49
30min186157-8615794.55492.531.7898.7796.741.74
281657-8165789.61593.74
384728-8472892.98597.17
485041-8504193.32997.60
584024-8402492.21396.43
684282-8428292.49696.70
45min183119-8311991.22091.461.6196.4996.691.57
281106-8110689.01094.13
384329-8432992.54897.76
484668-8466892.92098.23
582643-8264390.69795.94
684144-8414492.34597.58
极限181868-8186889.84789.811.5696.1396.061.53
279570-7957087.32593.43
382800-8280090.87097.11
483237-8323791.34997.69
581862-8186289.84096.09
681681-8168189.64295.90
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%
19.834056940539405774052640568405560.06
29.894070840645406760.11
单位质量响应值RSD%判断
4125.744112.840.23数据可信
长期9月-供试品溶液-2022081501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%
5min146306-4630695.91195.281.7095.9195.281.70
245012-4501293.23093.23
347281-4728197.93097.93
445481-4548194.20294.20
545793-4579394.84894.85
646140-4614095.56795.57
10min147974-4797499.36598.990.96100.43100.050.96
247183-4718397.72798.76
348255-4825599.947101.04
447745-4774598.89199.94
548257-4825799.952101.01
647337-4733798.04699.11
15min147751-4775198.90497.971.20101.07100.121.20
246521-4652196.35698.48
348053-4805399.529101.73
447019-4701997.38799.53
547474-4747498.330100.49
646971-4697197.28899.44
20min147233-4723397.83197.191.17101.10100.441.16
246535-4653596.38599.58
347280-4728097.928101.23
446760-4676096.851100.08
547608-4760898.607101.86
646132-4613295.55098.78
30min146784-4678496.90196.601.10101.26100.921.10
246076-4607695.43499.70
347214-4721497.791102.18
446452-4645296.213100.52
547196-4719697.754102.11
646099-4609995.48299.78
45min146217-4621795.72694.860.89101.16100.260.89
245297-4529793.82199.14
345838-4583894.941100.42
445742-4574294.742100.12
546292-4629295.882101.32
645412-4541294.05999.41
极限145783-4578394.82794.070.91101.32100.520.91
245158-4515893.53399.90
345752-4575294.763101.30
444909-4490993.01799.44
545817-4581794.898101.40
645078-4507893.36799.77
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%
114.088275282874828398286982851828370.06
214.088285382936828940.08
单位质量响应值RSD%判断
5883.315887.360.05数据可信
长期9月-供试品溶液-2022081501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%
5min183906-8390692.42091.351.8992.4291.351.89
280214-8021488.35388.35
384577-8457793.15993.16
483859-8385992.36892.37
582647-8264791.03391.03
682418-8241890.78190.78
10min188461-8846197.43796.061.4798.4697.081.47
285252-8525293.90294.88
387462-8746296.33797.37
488239-8823997.19398.22
587804-8780496.71397.72
686071-8607194.80595.81
15min188584-8858497.57395.361.5999.6897.451.58
284525-8452593.10295.13
387132-8713295.97398.08
486944-8694495.76697.87
586549-8654995.33197.42
685737-8573794.43796.50
20min187501-8750196.38094.581.5299.5797.721.51
284533-8453393.11096.17
385691-8569194.38697.56
486420-8642095.18998.36
586845-8684595.65798.80
684218-8421892.76495.87
30min186724-8672495.52494.081.3999.7998.271.39
283752-8375292.25096.34
385603-8560394.28998.51
486121-8612194.86099.09
586083-8608394.81899.03
684184-8418492.72696.87
45min184866-8486693.47792.181.2798.8097.421.27
282182-8218290.52195.64
382954-8295491.37196.64
484294-8429492.84798.13
584598-8459893.18298.44
683224-8322491.66996.84
极限184548-8454893.12791.491.1499.4997.761.14
281941-8194190.25596.38
382686-8268691.07697.36
483109-8310991.54297.86
583684-8368492.17598.47
682414-8241490.77696.97
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