富马酸比索洛尔左氨氯地平片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号100711-202203对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.8对照品水分(%)0对照品稀释倍数2000
标示量(mg)5供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.078486184841848588483384865848520.02
210.088463784609846230.03
单位质量响应值RSD%判断
8426.228395.140.27数据可信
长期3月-供试品溶液-2023101321批-富马酸比索洛尔-pH6.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min195100-95100101.56099.751.72101.5699.751.72
294555-94555100.978100.98
391225-9122597.42297.42
494440-94440100.855100.86
593388-9338899.73299.73
691736-9173697.96897.97
10min196127-96127102.657100.571.61102.83100.741.61
294929-94929101.378101.55
392332-9233298.60498.77
495119-95119101.581101.75
594029-94029100.417100.58
692523-9252398.80898.97
15min195891-95891102.405100.241.71102.75100.581.71
294711-94711101.145101.48
391877-9187798.11898.45
494929-94929101.378101.72
593578-9357899.935100.27
692193-9219398.45698.78
20min195669-95669102.168100.141.57102.68100.641.57
294493-94493100.912101.42
392026-9202698.27798.77
494562-94562100.986101.49
593801-93801100.173100.67
692060-9206098.31498.81
30min195700-95700102.201100.131.64102.88100.801.64
294503-94503100.923101.60
391951-9195198.19798.85
494667-94667101.098101.77
593821-93821100.194100.86
691948-9194898.19498.85
45min195328-95328101.80499.871.63102.66100.701.63
294358-94358100.768101.61
391653-9165397.87998.70
494594-94594101.020101.86
593347-9334799.688100.52
691812-9181298.04998.87
极限195252-95252101.72399.671.68102.74100.661.68
294094-94094100.486101.50
391189-9118997.38498.36
494268-94268100.672101.68
593399-9339999.744100.74
691753-9175397.98698.97
富马酸比索洛尔左氨氯地平片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
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4000
标示量(mg)2.5供试品稀释倍数1系数0.7210
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
114.705300452885529505292352892529310.10
214.695264752603526250.06
单位质量响应值RSD%判断
3600.753582.370.37数据可信
长期3月-供试品溶液-2023101321批-左氨氯地平-pH6.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min140378-4037870.98371.631.6670.9871.631.67
241000-4100072.07772.08
340586-4058671.34971.35
441558-4155873.05873.06
541266-4126672.54472.54
639684-3968469.76369.76
10min150705-5070589.13888.380.8089.2688.500.80
249873-4987387.67587.80
349810-4981087.56487.68
450535-5053588.83988.96
550096-5009688.06788.19
650642-5064289.02789.14
15min153164-5316493.46191.171.9993.7391.441.99
252011-5201191.43491.70
350064-5006488.01188.28
451847-5184791.14591.42
552432-5243292.17492.44
651662-5166290.82091.08
20min154103-5410395.11193.631.5495.5394.051.54
252809-5280992.83693.26
351896-5189691.23191.64
453882-5388294.72395.14
553695-5369594.39494.82
653180-5318093.48993.90
30min154195-5419595.27394.251.4295.8594.821.42
253560-5356094.15794.73
352178-5217891.72792.29
454281-5428195.42496.00
553750-5375094.49195.07
653722-5372294.44195.01
45min154838-5483896.40394.541.7697.1495.271.76
253693-5369394.39095.12
352119-5211991.62392.34
454526-5452695.85596.59
553861-5386194.68695.42
653621-5362194.26494.99
极限155167-5516796.98294.452.3197.8895.342.30
253093-5309393.33694.22
351629-5162990.76291.63
454537-5453795.87496.77
553979-5397994.89395.79
653945-5394594.83395.72
富马酸比索洛尔左氨氯地平片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号100711-202203对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.8对照品水分(%)0对照品稀释倍数2000
标示量(mg)5供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.078444484453844328451784497844690.05
210.088481284864848380.05
单位质量响应值RSD%判断
8388.188416.470.24数据可信
长期3月-供试品溶液-2023101322批-富马酸比索洛尔-pH6.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min193373-9337399.815100.091.6599.82100.091.65
292259-9225998.62498.62
396154-96154102.788102.79
492471-9247198.85198.85
594798-94798101.338101.34
692739-9273999.13799.14
10min194166-94166100.663100.881.54100.83101.051.54
292783-9278399.18499.35
396783-96783103.460103.63
493585-93585100.042100.21
595292-95292101.866102.04
693611-93611100.069100.23
15min194310-94310100.817100.661.50101.15100.991.50
292432-9243298.80999.14
396358-96358103.006103.35
493507-9350799.958100.29
595073-95073101.632101.97
693279-9327999.715100.05
20min194033-94033100.521100.541.65101.02101.041.65
292297-9229798.66599.16
396560-96560103.222103.74
493202-9320299.632100.13
595053-95053101.611102.12
693157-9315799.584100.08
30min194226-94226100.727101.001.50101.40101.671.50
292728-9272899.12699.78
396657-96657103.326104.01
493700-93700100.165100.83
595592-95592102.187102.86
693988-93988100.472101.14
45min194249-94249100.752101.031.64101.59101.871.64
292720-9272099.11799.94
397057-97057103.753104.61
493793-93793100.264101.10
595509-95509102.098102.95
693718-93718100.184101.02
极限193956-93956100.438100.761.59101.44101.761.59
292504-9250498.88699.88
396701-96701103.373104.41
493583-93583100.040101.04
595245-95245101.816102.83
693528-9352899.981100.98
富马酸比索洛尔左氨氯地平片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
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4000
标示量(mg)2.5供试品稀释倍数1系数0.7210
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
114.705257552553525105241252569525240.13
214.695266652695526800.04
单位质量响应值RSD%判断
3573.063586.110.26数据可信
长期3月-供试品溶液-2023101322批-左氨氯地平-pH6.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min144428-4442878.36479.441.9678.3679.441.96
244715-4471578.87078.87
345580-4558080.39680.40
443824-4382477.29977.30
546244-4624481.56781.57
645438-4543880.14580.15
10min151007-5100789.96889.831.1690.1089.961.16
250582-5058289.21989.35
351012-5101289.97790.11
450592-5059289.23689.37
550357-5035788.82288.96
652006-5200691.73091.86
15min153323-5332394.05393.011.0894.3393.291.07
252435-5243592.48792.77
352685-5268592.92893.21
452491-5249192.58692.86
553465-5346594.30494.59
651978-5197891.68191.97
20min153639-5363994.61194.291.1395.0594.721.12
253018-5301893.51593.95
353961-5396195.17995.62
452482-5248292.57093.00
553583-5358394.51294.95
654048-5404895.33295.77
30min154029-5402995.29894.041.4495.8994.631.44
252640-5264092.84993.44
354298-5429895.77396.37
452521-5252192.63993.22
553621-5362194.57995.18
652784-5278493.10393.70
45min153524-5352494.40894.840.7095.1695.590.70
253432-5343294.24594.99
354450-5445096.04196.80
453534-5353494.42595.17
553826-5382694.94095.70
653843-5384394.97095.72
极限154191-5419195.58494.760.8496.5095.670.84
253419-5341994.22395.12
354162-5416295.53396.45
453045-5304593.56394.46
553900-5390095.07195.99
653623-5362394.58295.49
富马酸比索洛尔左氨氯地平片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号100711-202203对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.8对照品水分(%)0对照品稀释倍数2000
标示量(mg)5供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.078526285142852158518085130851860.07
210.088442584333843790.08
单位质量响应值RSD%判断
8459.388370.930.75数据可信
长期3月-供试品溶液-2023101323批-富马酸比索洛尔-pH6.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min194429-94429100.79299.271.31100.7999.281.31
291812-9181297.99998.00
392821-9282199.07699.08
492194-9219498.40798.41
592192-9219298.40598.40
694593-94593100.968100.97
10min195376-95376101.80399.981.46101.97100.141.46
291921-9192198.11598.28
392992-9299299.25999.42
493434-9343499.73099.89
593050-9305099.32199.48
695234-95234101.652101.82
15min195270-95270101.69099.911.28102.03100.241.28
292210-9221098.42498.75
393155-9315599.43399.76
493055-9305599.32699.66
593062-9306299.33399.66
694862-94862101.255101.59
20min195026-95026101.43099.861.22101.94100.361.22
292115-9211598.32398.81
392995-9299599.26299.76
493345-9334599.635100.13
593045-9304599.31599.81
694801-94801101.190101.70
30min194835-94835101.22699.611.22101.90100.281.22
291984-9198498.18398.84
392345-9234598.56899.23
493212-9321299.493100.16
593089-9308999.362100.02
694484-94484100.851101.53
45min194822-94822101.21299.521.35102.06100.351.35
291874-9187498.06598.88
392612-9261298.85399.68
492446-9244698.67699.50
592914-9291499.175100.00
694766-94766101.152102.00
极限194144-94144100.48899.341.05101.50100.341.06
291778-9177897.96398.94
392384-9238498.61099.60
493033-9303399.302100.29
592817-9281799.072100.06
694259-94259100.611101.62
富马酸比索洛尔左氨氯地平片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
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4000
标示量(mg)2.5供试品稀释倍数1系数0.7210
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
114.705298953017529535302253052530070.08
214.695228152431523560.21
单位质量响应值RSD%判断
3605.923564.060.83数据可信
长期3月-供试品溶液-2023101323批-左氨氯地平-pH6.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min144637-4463778.61676.562.1378.6276.562.13
243736-4373677.02977.03
341869-4186973.74173.74
443843-4384377.21877.22
543140-4314075.98075.98
643586-4358676.76576.77
10min151316-5131690.38088.331.3890.5188.461.38
249465-4946587.12087.25
350249-5024988.50088.62
449721-4972187.57087.70
549659-4965987.46187.59
650500-5050088.94289.07
15min149812-4981287.73190.191.4688.0190.461.45
251678-5167891.01791.29
351884-5188491.38091.65
451557-5155790.80491.08
551267-5126790.29390.57
651038-5103889.89090.17
20min153727-5372794.62690.602.9395.0591.022.92
252330-5233092.16692.59
351678-5167891.01791.44
449979-4997988.02588.45
549690-4969087.51687.94
651230-5123090.22890.65
30min154192-5419295.44592.291.9396.0392.861.92
251227-5122790.22390.80
352207-5220791.94992.52
452755-5275592.91493.49
551869-5186991.35491.92
652144-5214491.83892.41
45min153978-5397895.06892.732.0795.8193.462.05
252996-5299693.33994.07
351827-5182791.28092.01
450933-5093389.70590.43
553118-5311893.55394.27
653055-5305593.44294.17
极限153855-5385594.85192.342.4195.7593.222.39
252654-5265492.73693.62
352306-5230692.12393.00
452892-5289293.15594.03
552796-5279692.98693.86
650084-5008488.21089.09
富马酸比索洛尔左氨氯地平片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号100711-202203对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.8对照品水分(%)0对照品稀释倍数2000
标示量(mg)5供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.078486484790848378480784789848170.04
210.088465984613846360.04
单位质量响应值RSD%判断
8422.748396.430.23数据可信
长期3月-供试品溶液-2024010421批-富马酸比索洛尔-pH6.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min195318-95318101.80699.461.96101.8199.461.96
293936-93936100.330100.33
393143-9314399.48399.48
489861-8986195.97895.98
592760-9276099.07499.07
693710-93710100.089100.09
10min195695-95695102.209100.121.81102.38100.281.81
294523-94523100.957101.12
393270-9327099.61999.78
490729-9072996.90597.06
593725-93725100.105100.27
694484-94484100.915101.08
15min195462-95462101.960100.171.80102.30100.501.80
294323-94323100.744101.08
393606-9360699.978100.31
490621-9062196.79097.11
593896-93896100.287100.62
694783-94783101.235101.57
20min195391-95391101.88499.961.79102.39100.461.79
294352-94352100.775101.28
393197-9319799.541100.04
490527-9052796.68997.17
593701-93701100.079100.58
694378-94378100.802101.31
30min195215-95215101.69699.801.82102.38100.471.82
294156-94156100.565101.24
393350-9335099.704100.37
490277-9027796.42297.07
593368-9336899.724100.39
694264-94264100.681101.35
45min194752-94752101.20299.561.79102.05100.401.79
293917-93917100.310101.15
393147-9314799.487100.32
490067-9006796.19897.00
593204-9320499.548100.38
694215-94215100.628101.47
极限194983-94983101.44899.371.95102.47100.371.95
293732-93732100.112101.12
392806-9280699.123100.12
489707-8970795.81396.78
592973-9297399.302100.30
694004-94004100.403101.41
富马酸比索洛尔左氨氯地平片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
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4000
标示量(mg)2.5供试品稀释倍数1系数0.7210
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
114.705250652714527605260852606526390.19
214.695256552564525640.01
单位质量响应值RSD%判断
3580.883578.220.06数据可信
长期3月-供试品溶液-2024010421批-左氨氯地平-pH6.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min146278-4627881.62878.362.9281.6378.362.92
244549-4454978.57878.58
342755-4275575.41475.41
443450-4345076.63976.64
544048-4404877.69477.69
645458-4545880.18180.18
10min151456-5145690.76188.663.2390.9088.803.22
251061-5106190.06490.20
347325-4732583.47483.60
451077-5107790.09290.22
549408-4940887.14887.28
651271-5127190.43490.57
15min153825-5382594.93992.981.6895.2393.261.69
253073-5307393.61393.89
351466-5146690.77891.04
452758-5275893.05793.34
551892-5189291.53091.80
653268-5326893.95794.24
20min153905-5390595.08092.652.0395.5393.082.03
252931-5293193.36293.80
351579-5157990.97891.39
452919-5291993.34193.77
550969-5096989.90290.33
652844-5284493.20993.65
30min155180-5518097.32994.082.6897.9394.662.68
253558-5355894.46895.06
350814-5081489.62890.20
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45min154607-5460796.31993.582.9097.0894.322.89
253355-5335594.11094.86
352484-5248492.57493.29
451535-5153590.90091.65
551354-5135490.58191.31
654998-5499897.00897.76
极限155108-5510897.20294.062.0798.1394.962.07
254152-5415295.51696.42
352835-5283593.19394.06
452070-5207091.84492.74
552783-5278393.10193.99
653002-5300293.48894.40
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