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4000
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%
110.474433644274443724416343799441890.53
210.344453844186443620.57
单位质量响应值RSD%判断
4220.534290.331.16数据可信
供试品溶液-介质不脱气-2024010321批-比索洛尔-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%
5min144412-4441246.87447.602.1946.8747.602.19
243660-4366046.08046.08
344796-4479647.27947.28
445811-4581148.35048.35
546297-4629748.86348.86
645612-4561248.14048.14
10min144795-4479547.27847.901.9947.3647.981.99
244196-4419646.64646.72
344910-4491047.39947.48
445978-4597848.52648.61
546616-4661649.20049.28
645829-4582948.36948.45
15min144640-4464047.11447.761.8547.2747.921.86
244128-4412846.57446.73
344902-4490247.39147.55
445969-4596948.51748.68
546315-4631548.88249.05
645566-4556648.09248.25
20min144585-4458547.05647.701.7847.2947.941.78
244218-4421846.66946.90
344745-4474547.22547.46
445863-4586348.40548.65
546264-4626448.82849.07
645510-4551048.03348.27
30min144469-4446946.93447.651.9547.2547.971.95
244005-4400546.44446.75
344742-4474247.22247.54
445881-4588148.42448.75
546270-4627048.83549.16
645513-4551348.03648.36
45min144470-4447046.93547.511.7547.3347.911.75
243867-4386746.29846.69
344738-4473847.21847.61
445595-4559548.12248.53
545935-4593548.48148.89
645478-4547847.99948.40
极限144194-4419446.64447.291.7847.1147.771.78
243759-4375946.18446.65
344445-4444546.90847.38
445453-4545347.97248.46
545784-4578448.32248.81
645219-4521947.72548.21
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%
113.554762748287479874853048265481390.72
213.654852148789486550.39
单位质量响应值RSD%判断
3552.693564.470.24数据可信
供试品溶液-介质不脱气-2024010321批-左氨氯地平-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%
5min155617-5561798.67895.601.8398.6895.601.83
252933-5293393.91693.92
353678-5367895.23895.24
452975-5297593.99193.99
553918-5391895.66495.66
654167-5416796.10696.11
10min155773-5577398.95598.621.0999.1298.781.09
254772-5477297.17997.34
356590-56590100.405100.56
455477-5547798.43098.59
555635-5563598.71098.87
655256-5525698.03898.20
15min155781-5578198.96998.051.5199.3098.381.51
253757-5375795.37895.70
356181-5618199.679100.01
455085-5508597.73598.06
555493-5549398.45898.78
655277-5527798.07598.40
20min155715-5571598.85297.331.4499.3597.821.44
253910-5391095.65096.13
355334-5533498.17698.67
455373-5537398.24698.73
553874-5387495.58696.07
654933-5493397.46597.95
30min154843-5484397.30597.791.3897.9698.441.38
254114-5411496.01296.65
356363-56363100.002100.66
455499-5549998.46999.12
554838-5483897.29697.94
655032-5503297.64198.29
45min155015-5501597.61097.160.9498.4397.970.94
254272-5427296.29297.09
355255-5525598.03698.86
455093-5509397.74998.56
553980-5398095.77496.58
654957-5495797.50798.32
极限154609-5460996.89096.650.8697.8797.620.86
253777-5377795.41496.37
354014-5401495.83496.82
454717-5471797.08298.06
554795-5479597.22098.19
654936-5493697.47098.44
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4000
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%
110.474416944083444684443044078442460.43
210.344451044753446320.39
单位质量响应值RSD%判断
4225.984316.441.50数据可信
供试品溶液-桨法100转-2024010321批-比索洛尔-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%
5min145725-4572548.08347.642.2548.0847.642.24
245552-4555247.90147.90
345290-4529047.62647.63
445127-4512747.45447.45
543522-4352245.76745.77
646610-4661049.01449.01
10min145925-4592548.29447.962.3048.3748.042.31
245795-4579548.15748.24
345593-4559347.94548.02
445583-4558347.93448.01
543759-4375946.01646.09
647000-4700049.42449.51
15min145957-4595748.32747.902.5348.4948.062.54
245817-4581748.18048.34
345526-4552647.87448.03
445400-4540047.74247.90
543523-4352345.76845.92
647056-4705649.48349.65
20min145888-4588848.25547.812.2348.5048.062.23
245748-4574848.10848.35
345411-4541147.75347.99
445226-4522647.55947.80
543734-4373445.99046.22
646807-4680749.22149.47
30min145551-4555147.90047.712.0748.2248.022.08
245506-4550647.85348.17
345400-4540047.74248.06
445372-4537247.71248.03
543720-4372045.97546.28
646648-4664849.05449.38
45min145433-4543347.77647.552.2548.1847.952.25
245450-4545047.79448.19
345391-4539147.73248.13
445002-4500247.32347.72
543447-4344745.68846.07
646580-4658048.98249.39
极限145419-4541947.76247.432.1848.2447.912.18
245202-4520247.53348.01
345111-4511147.43847.92
445050-4505047.37447.85
543408-4340845.64746.11
646459-4645948.85549.35
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%
113.554845748585485294849648729485590.22
213.654848148536485080.09
单位质量响应值RSD%判断
3583.693553.700.60数据可信
供试品溶液-桨法100转-2024010321批-左氨氯地平-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%
5min153988-5398895.51896.981.6595.5296.981.65
254705-5470596.78796.79
353858-5385895.28895.29
454765-5476596.89396.89
555270-5527097.78697.79
656313-5631399.63299.63
10min154750-5475096.86697.280.4197.0397.440.41
255102-5510297.48997.65
355296-5529697.83297.99
454746-5474696.85997.02
555123-5512397.52697.69
654890-5489097.11497.28
15min154330-5433096.12396.981.5296.4497.311.52
254992-5499297.29597.62
354988-5498897.28797.61
455633-5563398.42998.75
553410-5341094.49694.82
655544-5554498.27198.60
20min154209-5420995.90996.881.0096.3997.370.99
254318-5431896.10296.59
355254-5525497.75898.24
454679-5467996.74197.23
554514-5451496.44996.93
655574-5557498.32498.82
30min154218-5421895.92596.970.9996.5797.610.98
255770-5577098.67199.32
354959-5495997.23697.88
454831-5483197.01097.66
554523-5452396.46597.11
654535-5453596.48697.14
45min153346-5334694.38295.560.8295.1896.370.82
254185-5418595.86796.68
353698-5369895.00595.81
454021-5402195.57796.39
554212-5421295.91596.72
654604-5460496.60897.42
极限153425-5342594.52295.581.0195.4896.541.00
253420-5342094.51395.48
353860-5386095.29296.26
454705-5470596.78797.76
554243-5424395.96996.93
654468-5446896.36797.34
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4000
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%
110.474443144018442674441644608443480.50
210.344422944217442230.02
单位质量响应值RSD%判断
4235.724276.890.69数据可信
供试品溶液-36℃-2024010321批-比索洛尔-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%
5min147152-4715249.75348.961.6449.7548.961.65
247222-4722249.82749.83
346870-4687049.45649.46
445614-4561448.13048.13
545931-4593148.46548.46
645634-4563448.15148.15
10min146342-4634248.89849.231.3548.9849.311.34
247424-4742450.04050.12
347302-4730249.91149.99
446341-4634148.89748.98
546739-4673949.31749.40
645792-4579248.31848.40
15min146438-4643849.00049.311.2149.1649.471.21
247404-4740450.01950.19
347443-4744350.06050.23
446346-4634648.90349.06
546637-4663749.21049.37
646122-4612248.66648.83
20min146109-4610948.65349.241.4048.9049.491.40
247431-4743150.04850.30
347361-4736149.97450.22
446420-4642048.98149.22
546827-4682749.41049.66
645855-4585548.38548.63
30min146138-4613848.68349.291.2649.0149.621.26
247591-4759150.21650.55
347124-4712449.72450.06
446056-4605648.59748.92
546640-4664049.21349.54
646737-4673749.31549.64
45min146074-4607448.61649.031.4949.0249.441.49
247200-4720049.80450.22
347316-4731649.92650.34
445953-4595348.48848.89
546621-4662149.19349.60
645648-4564848.16648.57
极限145909-4590948.44248.841.4748.9349.341.47
247128-4712849.72850.23
346978-4697849.57050.07
445818-4581848.34648.83
546470-4647049.03449.52
645439-4543947.94648.43
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%
113.554845348465484534817748235483570.29
213.654889648724488100.25
单位质量响应值RSD%判断
3568.783575.820.14数据可信
供试品溶液-36℃-2024010321批-左氨氯地平-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%
5min152203-5220392.26592.221.0492.2792.221.04
252975-5297593.63093.63
352177-5217792.21992.22
451284-5128490.64190.64
552331-5233192.49192.49
652100-5210092.08392.08
10min153989-5398995.42292.334.1795.5892.484.17
248182-4818285.15885.31
352892-5289293.48393.64
451457-5145790.94791.10
553773-5377395.04095.19
653139-5313993.92094.07
15min154107-5410795.63092.752.0495.9493.062.04
253313-5331394.22794.53
351293-5129390.65790.97
452554-5255492.88693.19
551907-5190791.74292.05
651679-5167991.33991.65
20min153327-5332794.25293.181.2394.7293.641.22
253693-5369394.89995.35
352070-5207092.03092.49
452280-5228092.40192.86
552392-5239292.59993.06
652545-5254592.87093.33
30min153467-5346794.49993.481.6195.1394.101.60
253739-5373994.98095.59
352416-5241692.64293.26
451414-5141490.87191.48
553198-5319894.02494.64
653117-5311793.88194.50
45min153618-5361894.76693.550.9995.5594.320.99
253449-5344994.46795.24
352311-5231192.45693.22
452509-5250992.80693.57
552695-5269593.13593.91
652986-5298693.64994.42
极限151140-5114090.38691.911.9091.3392.841.88
252786-5278693.29694.22
352563-5256392.90293.82
451921-5192191.76792.68
553051-5305193.76494.70
650559-5055989.36090.29
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4000
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%
110.474462244586444724459344574445690.13
210.344431444476443950.26
单位质量响应值RSD%判断
4256.834293.520.61数据可信
供试品溶液-38℃-2024010321批-比索洛尔-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%
5min144834-4483447.09847.512.7047.1047.512.70
246538-4653848.88848.89
344040-4404046.26446.26
446744-4674449.10549.10
543867-4386746.08246.08
645345-4534547.63547.64
10min145036-4503647.31047.942.6847.3948.022.69
247219-4721949.60449.69
344576-4457646.82746.90
447076-4707649.45349.54
544472-4447246.71846.79
645433-4543347.72747.81
15min144990-4499047.26247.912.5947.4248.072.59
247267-4726749.65449.82
344686-4468646.94347.10
446842-4684249.20849.37
544413-4441346.65646.81
645454-4545447.75047.91
20min144966-4496647.23747.872.5547.4748.102.55
247139-4713949.52049.77
344629-4462946.88347.12
446776-4677649.13849.38
544330-4433046.56946.80
645549-4554947.84948.09
30min144521-4452146.76947.622.6847.0847.942.68
246856-4685649.22249.55
344347-4434746.58746.90
446686-4668649.04449.37
544090-4409046.31746.63
645465-4546547.76148.08
45min144621-4462146.87447.492.4747.2747.892.47
246759-4675949.12049.53
344492-4449246.73947.13
446392-4639248.73549.14
543976-4397646.19746.58
645005-4500547.27847.68
极限144730-4473046.98947.482.4747.4647.962.48
246646-4664649.00249.50
344227-4422746.46146.93
446465-4646548.81249.30
544036-4403646.26046.72
645091-4509147.36847.84
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%
113.554926949463488514862048992490390.69
213.654848748588485380.15
单位质量响应值RSD%判断
3619.113555.901.25数据可信
供试品溶液-38℃-2024010321批-左氨氯地平-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%
5min149805-4980587.66189.552.1887.6689.552.18
251678-5167890.95790.96
349283-4928386.74286.74
451013-5101389.78789.79
551382-5138290.43690.44
652102-5210291.70491.70
10min152119-5211991.73392.171.2491.8892.321.24
252898-5289893.10593.26
352486-5248692.37992.52
452827-5282792.98093.13
552701-5270192.75892.91
651176-5117690.07490.23
15min152623-5262392.62192.591.5592.9292.901.54
253591-5359194.32494.63
352802-5280292.93693.23
451114-5111489.96590.27
552710-5271092.77493.08
652805-5280592.94193.24
20min152614-5261492.60592.540.6193.0693.000.61
253062-5306293.39393.86
352320-5232092.08792.54
452483-5248392.37492.83
552197-5219791.87192.33
652782-5278292.90093.36
30min151261-5126190.22391.931.3190.8392.541.30
252770-5277092.87993.50
352167-5216791.81892.42
452707-5270792.76893.38
551584-5158490.79291.40
652896-5289693.10193.71
45min152920-5292093.14391.881.1693.9092.641.15
251933-5193391.40692.18
351163-5116390.05190.81
452419-5241992.26193.02
552541-5254192.47693.24
652244-5224491.95392.72
极限152511-5251192.42391.651.3593.3492.571.33
252494-5249492.39393.32
352451-5245192.31893.23
450747-5074789.31990.24
551818-5181891.20492.12
652401-5240192.23093.15
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