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%
19.743968739850397073979939815397720.18
29.783991939816398680.19
单位质量响应值RSD%判断
4083.374076.480.12数据可信
长期18月-供试品溶液-培哚普利-pH2.0
批号样品(片)A1A2A平均溶出量(%)平均(%)RSD%置信区间
2024030121147076472244715098.6098.840.9797.84%～99.84%
247266472224724498.80
347562474974753099.40
447521473034741299.15
547815477594778799.93
646530463804645597.15
2024030221147814478174781699.9999.151.3897.72%～100.58%
247250473374729498.90
347436474014741899.16
447639476294763499.61
5480664813248099100.59
646239462064622296.66
2024030321147276473254730098.9199.670.7698.88%～100.47%
247729477594774499.84
347557476284759299.53
447316472444728098.87
5477484789847823100.01
6481864829948242100.88
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%
114.171661451663511664421663261664851663500.08
214.181662961665241664100.10
单位质量响应值RSD%判断
11739.5911735.540.03数据可信
长期18月-供试品溶液-氨氯地平-pH2.0
批号样品(片)A1A2A平均溶出量(%)平均(%)RSD%置信区间
2024030121117505117500317502796.6797.520.7996.72%～98.32%
217750817726817738897.97
317777117760217768698.13
417666417697417681997.65
517794217775717785098.22
617475817460517468296.47
2024030221117580017582117581097.1096.590.9595.64%～97.55%
217355217342117348695.81
317555617533717544696.90
417644317645917645197.45
517596717588117592497.16
617240617214317227495.14
2024030321117379617322717351295.8397.251.0296.22%～98.28%
217670717673817672297.60
317871517848917860298.64
417496417506317501496.66
517557517551217554496.95
617698317723717711097.82
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%
19.743993439953400523993939966399690.13
29.783978339964398740.33
单位质量响应值RSD%判断
4103.594077.100.46数据可信
长期18月-供试品溶液-培哚普利-pH2.0
批号样品(片)A1A2A平均溶出量(%)平均(%)RSD%置信区间
2024030121147445474104742898.9399.111.3397.74%～100.48%
246804468464682597.67
3481684799048079100.29
447043469364699098.02
5484674841348440101.04
647310473374732498.71
20240302211494364944449440103.1399.681.8497.77%～101.60%
247160472164718898.43
3480684799548032100.19
447217472514723498.53
547645476464764699.39
647166472144719098.43
20240303211480374793847988100.10101.301.3599.87%～102.74%
2489434851248728101.64
3497454957049658103.58
4487614891948840101.88
547913479104791299.94
6483244821548270100.69
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%
114.178362983783834678343383451835530.19
214.188333883498834180.14
单位质量响应值RSD%判断
5896.475882.790.17数据可信
长期18月-供试品溶液-氨氯地平-pH2.0
批号样品(片)A1A2A平均溶出量(%)平均(%)RSD%置信区间
2024030121187517877368762696.4596.491.4795.01%～97.98%
285378853358535693.95
388724886008866297.59
487314873378732696.12
588936889598894897.90
688093880748808496.95
20240302211912059147291338100.5396.832.1394.67%～98.99%
287794878798783696.68
387857876378774796.58
486614865108656295.28
588219885258837297.27
686007859458597694.63
2024030321187158870568710795.8898.421.5296.86%～99.98%
289120890838910298.07
389935896488979298.83
4911759115591165100.34
589142893088922598.21
690240899719010699.18
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%
19.742008219958199772007320057200290.29
29.782018620113201500.26
单位质量响应值RSD%判断
2056.372060.330.14数据可信
长期18月-供试品溶液-培哚普利-pH2.0
批号样品(片)A1A2A平均溶出量(%)平均(%)RSD%置信区间
2024030121123465233292339796.9898.551.3297.18%～99.91%
223866238222384498.84
323598236952364698.01
4243132435024332100.86
523717235882365298.04
623716238312377498.55
2024030221123471235722352297.5098.562.1296.37%～100.75%
223294231912324296.34
3246942475724726102.49
423759237362374898.44
523624237252367498.13
623823236872375598.47
2024030321123787236902373898.4097.391.6395.73%～99.05%
223978239342395699.30
323699237202371098.28
422944228852291494.98
523254232352324496.35
623480233402341097.04
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%
114.171663051660881661721661471660511661530.06
214.181675211674061674640.05
单位质量响应值RSD%判断
11725.6911809.870.51数据可信
长期18月-供试品溶液-氨氯地平-pH2.0
批号样品(片)A1A2A平均溶出量(%)平均(%)RSD%置信区间
2024030121117311917319517315795.3997.821.4396.35%～99.28%
217797017800517798898.05
317835517867217851498.34
418052518027518040099.38
517895917898317897198.59
617627817638717633297.14
2024030221117771317785717778597.9497.760.6997.05%～98.46%
217630017666117648097.22
317945117987517966398.97
417749017701717725497.65
517618017641317629697.12
617739417705217722397.63
2024030321117935217921717928498.7697.091.6095.47%～98.71%
217694317682517688497.44
317887317858517872998.46
417165917137817151894.49
517519017504717511896.47
617595417595317595496.93
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%
19.741987720056200622005819931199970.44
29.782025520176202160.28
单位质量响应值RSD%判断
2053.082067.080.49数据可信
长期18月-供试品溶液-培哚普利-pH2.0
批号样品(片)A1A2A平均溶出量(%)平均(%)RSD%置信区间
2024030121123571236332360297.7598.733.6294.98%～102.48%
2244032431224358100.88
3252372545025344104.97
423521233682344497.10
523183230802313295.80
623233230722315295.89
2024030221123059230942307695.5798.102.1795.88%～100.33%
222992230602302695.37
324028240412403499.54
424035240752405599.63
523791237062374898.36
6242292413024180100.14
2024030321123298233322331596.5698.663.1095.45%～101.86%
223540234642350297.34
324019240482403499.54
4250992527225186104.31
523706237582373298.29
623173231402315695.90
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%
114.178316883161833558339283335832820.14
214.188376183355835580.35
单位质量响应值RSD%判断
5877.355892.670.19数据可信
长期18月-供试品溶液-氨氯地平-pH2.0
批号样品(片)A1A2A平均溶出量(%)平均(%)RSD%置信区间
2024030121187273870918718296.0396.463.5692.87%～100.06%
289166891448915598.21
3929779318793082102.53
485678860578586894.59
585224851298517693.82
684900850648498293.61
2024030221185135849138502493.6695.282.1093.18%～97.38%
284077840918408492.62
387441876988757096.46
487392875788748596.37
585674860708587294.59
688936889438894097.97
2024030321185097849698503393.6796.583.2293.33%～99.84%
286838867128677595.59
388770889468885897.88
4926419282192731102.15
587193870658712995.98
685362857138553894.22
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