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%
19.808257082667824598261182724826060.13
29.888261482426825200.17
单位质量响应值RSD%判断
8429.188352.230.65数据可信
供试品溶液-2024110221批-比索洛尔-pH4.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min191366-9136697.80798.700.9197.8198.700.91
292826-9282699.37099.37
393488-93488100.078100.08
492268-9226898.77298.77
591861-9186198.33798.34
691411-9141197.85597.85
10min191929-9192998.40999.690.8998.5799.850.89
293474-93474100.063100.23
394361-94361101.013101.18
493217-9321799.78899.95
593200-9320099.77099.93
692564-9256499.08999.25
15min191763-9176398.23299.580.9498.5699.910.94
293551-93551100.146100.48
394250-94250100.894101.23
493063-9306399.62399.95
593128-9312899.693100.02
692370-9237098.88199.21
20min191413-9141397.85799.410.9698.3599.910.96
293349-9334999.929100.43
393960-93960100.583101.09
492883-9288399.43199.93
593221-9322199.792100.29
692368-9236898.87999.37
30min191472-9147297.92099.180.9598.5799.840.95
292831-9283199.375100.04
394019-94019100.647101.32
492698-9269899.23399.90
592883-9288399.431100.09
691961-9196198.44499.10
45min191220-9122097.65099.150.9898.4799.980.98
293126-9312699.691100.52
393786-93786100.397101.24
492643-9264399.174100.00
592973-9297399.527100.36
691993-9199398.47899.30
极限191146-9114697.57198.960.9998.5599.950.99
292951-9295199.503100.50
393758-93758100.367101.37
492596-9259699.123100.12
592452-9245298.96999.96
691761-9176198.22999.22
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%
113.925049250042504575009050828503820.65
213.884987050432501510.80
单位质量响应值RSD%判断
3619.403613.180.13数据可信
供试品溶液-2024110221批-左氨氯地平-pH4.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min149663-4966386.70887.872.9786.7187.872.97
248396-4839684.49684.50
352507-5250791.67491.67
451007-5100789.05589.05
551131-5113189.27189.27
649266-4926686.01586.02
10min154390-5439094.96196.242.3895.1196.392.38
253102-5310292.71392.85
356810-5681099.18699.34
456153-5615398.03998.19
555243-5524396.45196.60
655047-5504796.10896.25
15min154892-5489295.83897.162.6296.1497.472.62
253437-5343793.29793.59
357719-57719100.774101.09
456528-5652898.69499.01
555498-5549896.89697.21
655836-5583697.48697.79
20min154628-5462895.37797.432.5595.8497.902.55
253609-5360993.59894.05
357525-57525100.435100.92
456359-5635998.39998.88
556222-5622298.16098.63
656468-5646898.58999.06
30min154823-5482395.71797.022.9496.3497.652.93
252850-5285092.27392.88
357449-57449100.302100.96
456540-5654098.71599.36
555308-5530896.56497.20
656442-5644298.54499.17
45min154656-5465695.42697.042.5896.2197.832.58
253554-5355493.50294.26
357505-57505100.400101.22
456796-5679699.16299.97
555274-5527496.50597.30
655688-5568897.22898.02
极限154609-5460995.34496.282.9696.2897.242.96
252680-5268091.97692.89
357433-57433100.274101.26
456020-5602097.80798.78
554398-5439894.97595.93
655736-5573697.31198.27
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%
19.808247482307824328244482414824140.08
29.888256282601825820.04
单位质量响应值RSD%判断
8409.598358.500.44数据可信
供试品溶液-2024110221批-比索洛尔-pH4.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min192938-9293899.56799.870.6699.5799.870.66
292898-9289899.52499.52
392638-9263899.24699.25
494370-94370101.101101.10
593288-9328899.94299.94
693206-9320699.85499.85
10min193118-9311899.760100.480.5899.93100.650.57
293470-93470100.137100.30
393578-93578100.253100.42
494664-94664101.416101.58
594018-94018100.724100.89
693915-93915100.614100.78
15min193330-9333099.987100.510.49100.32100.850.49
293386-93386100.047100.38
393620-93620100.298100.63
494523-94523101.265101.60
594053-94053100.762101.10
694007-94007100.713101.05
20min193300-9330099.955100.330.58100.45100.840.58
293219-9321999.868100.37
393348-93348100.007100.51
494603-94603101.351101.86
593969-93969100.672101.17
693480-93480100.148100.65
30min192945-9294599.575100.050.51100.24100.720.51
292848-9284899.471100.14
393340-9334099.998100.66
494158-94158100.874101.55
593577-93577100.252100.92
693469-93469100.136100.81
45min193119-9311999.76199.950.42100.59100.780.42
292735-9273599.350100.18
393180-9318099.827100.66
493900-93900100.598101.44
593358-93358100.017100.85
693476-93476100.144100.98
极限192676-9267699.28799.640.52100.28100.640.52
292508-9250899.107100.10
392779-9277999.397100.40
493848-93848100.542101.55
593107-9310799.748100.75
693134-9313499.777100.78
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%
113.925023250083497954987250166500300.38
213.885034150142502420.29
单位质量响应值RSD%判断
3594.113619.740.51数据可信
供试品溶液-2024110221批-左氨氯地平-pH4.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min150718-5071888.78188.852.3288.7888.862.32
250304-5030488.05788.06
350445-5044588.30388.30
453019-5301992.80992.81
550510-5051088.41788.42
649561-4956186.75686.76
10min155516-5551697.18096.121.7797.3396.261.78
254697-5469795.74695.89
354086-5408694.67794.82
456589-5658999.05899.21
554360-5436095.15695.30
654200-5420094.87695.02
15min155910-5591097.87096.590.9498.1896.900.94
254460-5446095.33295.64
355176-5517696.58596.89
455603-5560397.33297.65
554866-5486696.04296.35
655058-5505896.37896.68
20min154586-5458695.55296.521.0996.0397.001.09
255362-5536296.91097.38
354599-5459995.57596.04
456205-5620598.38698.87
555060-5506096.38296.85
655035-5503596.33896.80
30min156136-5613698.26597.080.9598.9097.710.95
255446-5544697.05897.68
355519-5551997.18597.81
455918-5591897.88498.53
554789-5478995.90796.53
654948-5494896.18696.81
45min156048-5604898.11196.471.3898.9197.271.38
255298-5529896.79897.59
354821-5482195.96396.75
455882-5588297.82198.63
554276-5427695.00995.80
654347-5434795.13495.92
极限155761-5576197.60997.032.3198.5797.982.30
254307-5430795.06496.01
354857-5485796.02696.97
456359-5635998.65699.63
553978-5397894.48895.43
657306-57306100.313101.26
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%
19.808251782615825838260282585825800.05
29.888262582612826180.02
单位质量响应值RSD%判断
8426.538362.150.55数据可信
供试品溶液-2024110321批-比索洛尔-pH4.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min191149-9114997.53197.712.8197.5397.702.80
295208-95208101.875101.87
392370-9237098.83898.84
489383-8938395.64295.64
587812-8781293.96193.96
691946-9194698.38498.38
10min192207-9220798.66499.301.4498.8399.471.44
293116-9311699.63699.81
394692-94692101.323101.49
490912-9091297.27897.44
592175-9217598.62998.79
693718-93718100.280100.44
15min192220-9222098.67799.321.3399.0099.651.33
293374-9337499.912100.25
394490-94490101.106101.44
491025-9102597.39997.72
592246-9224698.70599.03
693559-93559100.110100.44
20min192254-9225498.71499.431.3999.2199.921.39
293467-93467100.012100.51
394678-94678101.308101.81
491190-9119097.57598.06
592097-9209798.54699.03
693826-93826100.396100.89
30min192229-9222998.68799.521.4599.34100.181.45
293851-93851100.423101.09
394770-94770101.406102.08
491073-9107397.45098.10
592429-9242998.90199.55
693692-93692100.253100.92
45min192127-9212798.57899.321.4199.40100.141.42
293803-93803100.371101.21
394388-94388100.997101.84
490867-9086797.23098.04
592219-9221998.67699.49
693514-93514100.062100.89
极限191896-9189698.33199.853.0799.32100.843.05
293397-9339799.937100.94
398730-98730105.643106.65
490575-9057596.91797.89
591930-9193098.36799.35
693344-9334499.880100.88
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%
113.925029250162506084987350171502210.53
213.885052750190503580.48
单位质量响应值RSD%判断
3607.833628.100.40数据可信
供试品溶液-2024110321批-左氨氯地平-pH4.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min153949-5394994.14892.541.4694.1592.541.46
252233-5223391.15491.15
353059-5305992.59592.60
452010-5201090.76590.76
553660-5366093.64493.64
653257-5325792.94192.94
10min156303-5630398.25697.361.2498.4197.511.24
255251-5525196.42196.57
356198-5619898.07398.23
454706-5470695.47095.62
555778-5577897.34097.50
656491-5649198.58598.74
15min156142-5614297.97697.351.4998.3097.671.49
255623-5562397.07097.38
355693-5569397.19297.51
455361-5536196.61396.92
557176-5717699.780100.10
654715-5471595.48595.80
20min156616-5661698.80397.851.1099.2998.331.11
255170-5517096.27996.75
355976-5597697.68698.17
455602-5560297.03397.50
556800-5680099.12499.61
656249-5624998.16298.64
30min155413-5541396.70397.481.3397.3598.121.33
255190-5519096.31496.95
356096-5609697.89598.54
455269-5526996.45297.09
557148-5714899.731100.38
656041-5604197.79998.44
45min155198-5519896.32897.181.3197.1497.991.31
255959-5595997.65698.45
355607-5560797.04297.85
454589-5458995.26596.06
556661-5666198.88199.70
656108-5610897.91698.72
极限155253-5525396.42496.461.7297.3997.421.72
254606-5460695.29596.25
354756-5475695.55796.52
454539-5453995.17896.13
557070-5707099.595100.58
655400-5540096.68197.65
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%
19.808247182501825528248882584825190.06
29.888254282711826260.15
单位质量响应值RSD%判断
8420.318362.960.49数据可信
供试品溶液-2024110321批-比索洛尔-pH4.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min193202-9320299.760101.071.4999.76101.071.49
294978-94978101.661101.66
395426-95426102.141102.14
492182-9218298.66898.67
595096-95096101.787101.79
695678-95678102.410102.41
10min193734-93734100.330102.622.24100.50102.792.24
296725-96725103.531103.70
398415-98415105.340105.51
492815-9281599.34699.51
596400-96400103.183103.35
697163-97163104.000104.17
15min193887-93887100.493102.672.27100.83103.002.26
297079-97079103.910104.25
398367-98367105.289105.63
492646-9264699.16599.50
596755-96755103.563103.90
696766-96766103.575103.92
20min193756-93756100.353102.522.30100.85103.032.30
296396-96396103.179103.69
398631-98631105.571106.09
492597-9259799.11399.61
596649-96649103.450103.96
696646-96646103.446103.96
30min193983-93983100.596102.632.28101.26103.312.28
297065-97065103.895104.58
398495-98495105.426106.12
492577-9257799.09199.75
596621-96621103.420104.11
696579-96579103.375104.06
45min193478-93478100.056102.192.18100.89103.042.18
296523-96523103.315104.18
397890-97890104.778105.65
492418-9241898.92199.75
596147-96147102.912103.77
696359-96359103.139104.00
极限193283-9328399.847102.042.35100.85103.062.34
296091-96091102.852103.88
398149-98149105.055106.10
492063-9206398.54199.53
596357-96357103.137104.17
696023-96023102.780103.81
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%
113.925022649501505825001350003500650.79
213.884999150264501280.39
单位质量响应值RSD%判断
3596.623611.530.30数据可信
供试品溶液-2024110321批-左氨氯地平-pH4.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min153340-5334093.44493.270.8793.4493.270.87
253008-5300892.86292.86
353624-5362493.94293.94
453810-5381094.26794.27
553126-5312693.06993.07
652525-5252592.01692.02
10min154826-5482696.04797.421.5596.2097.581.55
255422-5542297.09197.25
355799-5579997.75297.91
457117-57117100.061100.22
554774-5477495.95696.11
655735-5573597.64097.79
15min155147-5514796.61097.531.1796.9397.851.17
254955-5495596.27396.59
356015-5601598.13098.45
456759-5675999.43499.76
555542-5554297.30297.62
655613-5561397.42697.74
20min155148-5514896.61197.631.0797.0998.111.07
255443-5544397.12897.61
355644-5564497.48097.96
456850-5685099.593100.08
555456-5545697.15197.63
655831-5583197.80898.29
30min155456-5545697.15197.501.0297.7998.141.02
256288-5628898.60999.25
355819-5581997.78798.43
456212-5621298.47599.13
554812-5481296.02396.66
655328-5532896.92797.57
45min155177-5517796.66297.071.2897.4697.871.27
255980-5598098.06998.87
355615-5561597.43098.24
456257-5625798.55499.37
554280-5428095.09195.89
655142-5514296.60197.40
极限155440-5544097.12396.851.5898.0897.821.58
255849-5584997.83998.81
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554445-5444595.38096.34
654107-5410794.78895.75
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