培哚普利左氨氯地平项目信息
介质体积(ml)900取样体积(ml)0补液体积(ml)0
对照品批号DPAEA-2-05221204-B对照品来源中检院对照品使用方法直接使用
对照品含量(%)95.87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1.000
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
19.604030740313401694017440273402470.18
29.584063940567406030.13
单位质量响应值RSD%判断
4192.404238.310.78数据可信
加速3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
1批148170483574826498.7999.422.0597.28%～101.55%
248073481024808898.43
3500145014550080102.51
447105472424717496.56
548539486914861599.51
6492264916049193100.69
1批147742476494769697.6399.731.3998.28%～101.18%
248704484854859499.47
348517484334847599.23
4494484969849573101.47
5494254930849366101.05
648622486504863699.55
1批148064481404810298.4698.661.9596.65%～100.68%
247878481634802098.29
3489034912449014100.33
4488154911948967100.23
548638486024862099.52
646513464684649095.16
1批1497204985749788101.91101.750.83100.87%～102.63%
2501505004450097102.55
3499095007749993102.33
4498055001149908102.16
5493464955849452101.23
6490454896849006100.31
培哚普利左氨氯地平项目信息
介质体积(ml)900取样体积(ml)0补液体积(ml)0
对照品批号100546-202105对照品来源中检院对照品使用方法直接使用
对照品含量(%)97.3对照品水分(%)0对照品稀释倍数8000
标示量(mg)2.5 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%
113.693808138280385013784738102381620.64
213.653851238312384120.37
单位质量响应值RSD%判断
2787.582814.070.67数据可信
加速3月-供试品溶液-左氨氯地平-pH2.0
批号样品(片)A1A2A平均溶出量(%)平均(%)RSD%置信区间
1批142061418644196294.6097.602.5395.01%～100.19%
243517433824345097.95
343057429584300896.95
4452354533045282102.08
543058431794311897.20
643154427504295296.83
1批142690426264265896.1697.271.1896.06%～98.47%
242941429834296296.85
343083433024319297.37
443575433014343897.92
542884424264265596.16
643946440074397699.14
1批142191419184205494.8097.762.8694.83%～100.69%
243547436344359098.27
342386421464226695.28
443523432894340697.85
543350433624335697.74
6455724547945526102.63
1批1446364460344620100.5998.911.6397.22%～100.60%
243849437774381398.77
344051440744406299.33
443759437264374298.61
5442554457744416100.13
642485427084259696.02
培哚普利左氨氯地平项目信息
介质体积(ml)900取样体积(ml)0补液体积(ml)0
对照品批号DPAEA-2-05221204-B对照品来源中检院对照品使用方法直接使用
对照品含量(%)95.87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1.000
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
19.604018840441403964041939952402790.52
29.584024540341402930.17
单位质量响应值RSD%判断
4195.734205.950.18数据可信
长期3月-供试品溶液-培哚普利
批号样品(片)A1A2A平均溶出量(%)平均(%)RSD%置信区间
1批148023481704809698.79100.502.6797.68%～103.31%
2507555057250664104.06
3499854948549735102.15
4488194855548687100.00
546796471324696496.46
6493924946749430101.53
1批147725481524793898.4699.822.0597.68%～101.97%
2502225029950260103.23
348169481754817298.94
448003484654823499.07
5493854930049342101.35
647728475914766097.89
1批1492134955249382101.4399.212.9696.13%～102.29%
246332461884626095.02
3495764968249629101.94
4489674895548961100.56
5489234873448828100.29
646842466584675096.02
1批1489774876048868100.37100.900.35100.53%～101.26%
2491014901049056100.76
3492914919049240101.14
4493474937349360101.38
5490414908949065100.78
6490974918849142100.94
培哚普利左氨氯地平项目信息
介质体积(ml)900取样体积(ml)0补液体积(ml)0
对照品批号100546-202105对照品来源中检院对照品使用方法直接使用
对照品含量(%)97.3对照品水分(%)0对照品稀释倍数8000
标示量(mg)2.5 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%
113.693827738283381363792438060381360.40
213.653851838059382880.85
单位质量响应值RSD%判断
2785.682804.980.49数据可信
长期3月-供试品溶液-左氨氯地平
批号样品(片)A1A2A平均溶出量(%)平均(%)RSD%置信区间
1批142416427834260096.2298.612.7795.75%～101.47%
243488440044374698.81
343048432734316097.49
442884427514281896.71
5459494593845944103.77
643544438174368098.66
1批142202419024205294.9898.062.5495.45%～100.67%
244014438384392699.22
3452754524345259102.23
443010429104296097.03
543381434854343398.10
642970427354285296.79
1批142561428294269596.4498.713.6994.90%～102.52%
2468594692346891105.91
343505434554348098.21
443345434894341798.07
543229431774320397.58
642602424444252396.05
1批142448422874236895.7097.461.8295.60%～99.32%
243182432294320697.59
342649426604265496.34
442791429124285296.79
5446824453544608100.76
643252431604320697.59
培哚普利左氨氯地平项目信息
介质体积(ml)900取样体积(ml)0补液体积(ml)0
对照品批号DPAEA-2-05221204-B对照品来源中检院对照品使用方法直接使用
对照品含量(%)95.87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1.000
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
19.604001139821398744021939725399300.49
29.584066740448405580.39
单位质量响应值RSD%判断
4159.384233.611.26数据可信
中间条件3月-供试品溶液-培哚普利
批号样品(片)A1A2A平均溶出量(%)平均(%)RSD%置信区间
1批148405487154856099.8599.551.7597.73%～101.37%
248395481254826099.23
348478481254830299.32
446816470434693096.50
5490314951749274101.32
6492484906449156101.08
1批147612474714754297.7699.071.0498.00%～100.14%
2487704921048990100.73
347987478874793798.57
448184481604817299.05
548550483624845699.64
647994479734798498.67
1批145707458944580094.1898.162.5795.51%～100.80%
2493564964749502101.79
347239475374738897.44
448069480644806698.83
548144483964827099.25
647392473834738897.44
1批147970478094789098.47101.041.4999.47%～102.62%
2490634909249078100.92
3487674917048968100.69
4499545001849986102.78
5498534961749735102.27
6492444912949186101.14
培哚普利左氨氯地平项目信息
介质体积(ml)900取样体积(ml)0补液体积(ml)0
对照品批号100546-202105对照品来源中检院对照品使用方法直接使用
对照品含量(%)97.3对照品水分(%)0对照品稀释倍数8000
标示量(mg)2.5 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%
113.693794937988379983766838211379630.52
213.653777637886378310.21
单位质量响应值RSD%判断
2773.052771.500.04数据可信
中间条件3月-供试品溶液-左氨氯地平
批号样品(片)A1A2A平均溶出量(%)平均(%)RSD%置信区间
1批141846421714200895.6796.451.8294.61%～98.29%
241829418234182695.26
341949420994202495.71
443725432134346999.00
543103432204316298.30
641713415014160794.76
1批142373426474251096.8295.901.2494.65%～97.14%
242684423454251496.82
341715421214191895.47
442466424694246896.72
541145412194118293.79
642131419564204495.75
1批1462974628146289105.42100.862.4698.27%～103.46%
2440714448744279100.84
343579431224335098.73
443492432884339098.82
543989438124390099.98
6446614437644518101.39
1批142472427154259497.0199.292.0597.16%～101.42%
242818428834285097.59
3445564478844672101.74
4442344429944266100.81
5445714389944235100.74
642929430074296897.86
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