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%
110.078496384997851008486284866849580.12
210.088498085104850420.11
单位质量响应值RSD%判断
8436.748436.710.01数据可信
中间条件3月-供试品溶液-2023101321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%
5min193941-93941100.01398.461.04100.0198.461.04
291859-9185997.79697.80
393148-9314899.16899.17
491284-9128497.18497.18
592572-9257298.55598.56
692090-9209098.04298.04
10min194402-94402100.50399.110.94100.6799.270.94
292305-9230598.27198.43
393881-9388199.949100.11
492270-9227098.23498.40
593017-9301799.02999.19
692678-9267898.66898.83
15min194480-94480100.58698.971.03100.9299.291.03
292366-9236698.33698.66
393778-9377899.839100.17
492082-9208298.03398.36
592663-9266398.65298.98
692375-9237598.34598.67
20min194291-94291100.38598.681.07100.8999.171.07
291864-9186497.80198.29
393440-9344099.47999.98
491783-9178397.71598.20
592385-9238598.35698.85
692363-9236398.33398.82
30min194334-94334100.43198.561.22101.1099.221.22
291804-9180497.73798.39
393536-9353699.581100.25
491500-9150097.41498.07
592407-9240798.37999.04
691860-9186097.79798.45
45min193944-93944100.01698.331.13100.8599.161.13
291399-9139997.30698.12
393257-9325799.284100.11
491559-9155997.47798.29
592375-9237598.34599.17
691652-9165297.57698.39
极限193739-9373999.79798.191.01100.8099.181.02
291389-9138997.29698.27
392877-9287798.88099.88
491318-9131897.22098.20
592136-9213698.09199.08
691922-9192297.86398.84
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%
114.715434054225541875430554115542340.17
214.695435454263543080.12
单位质量响应值RSD%判断
3686.883696.940.20数据可信
中间条件3月-供试品溶液-2023101321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%
5min156702-5670296.97095.031.6396.9795.031.63
256162-5616296.04796.05
354873-5487393.84293.84
455234-5523494.46094.46
556118-5611895.97295.97
654323-5432392.90292.90
10min158186-5818699.50896.831.9399.6796.991.93
256586-5658696.77296.93
354983-5498394.03194.19
457172-5717297.77497.93
556836-5683697.20097.36
655950-5595095.68495.84
15min157950-5795099.10597.241.8099.4397.561.80
257870-5787098.96899.29
355954-5595495.69196.00
457007-5700797.49297.81
556966-5696697.42297.74
655402-5540294.74795.06
20min156394-5639496.44496.421.5996.9496.901.59
257692-5769298.66399.15
355252-5525294.49194.96
455994-5599495.76096.24
557129-5712997.70198.18
655823-5582395.46795.94
30min158047-5804799.27197.041.5899.9297.681.58
256898-5689897.30697.96
356170-5617096.06196.69
457082-5708297.62098.26
556859-5685997.23997.89
655389-5538994.72595.36
45min157968-5796899.13597.161.4799.9597.961.47
257189-5718997.80398.62
355897-5589795.59496.38
456887-5688797.28798.09
557128-5712897.69998.51
655800-5580095.42896.22
极限157802-5780298.85297.311.3999.8498.271.39
257461-5746198.26899.24
355769-5576995.37596.32
456888-5688897.28898.26
557305-5730598.00298.97
656162-5616296.04797.00
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%
110.078495884903849768501884843849400.09
210.088493384803848680.11
单位质量响应值RSD%判断
8434.968419.440.14数据可信
中间条件3月-供试品溶液-2023101322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%
5min189882-8988295.79998.412.1295.8098.412.12
292815-9281598.92698.93
391042-9104297.03697.04
491873-9187397.92197.92
595613-95613101.908101.91
692757-9275798.86498.86
10min190746-9074696.72099.012.2096.8899.182.20
293087-9308799.21599.38
391274-9127497.28397.44
492542-9254298.63598.80
596534-96534102.889103.06
693194-9319499.32999.49
15min190576-9057696.53998.832.1896.8699.162.18
292975-9297599.09699.43
391040-9104097.03497.36
492266-9226698.34098.67
596228-96228102.563102.90
693290-9329099.43299.76
20min190417-9041796.37098.772.1496.8599.262.14
292762-9276298.86999.36
391079-9107997.07597.56
492392-9239298.47598.97
596069-96069102.394102.91
693274-9327499.41599.91
30min190466-9046696.42298.562.0397.0699.222.04
292425-9242598.51099.17
391002-9100296.99397.64
492162-9216298.23098.89
595796-95796102.103102.79
692994-9299499.11699.78
45min190257-9025796.19998.272.1097.0099.102.09
292337-9233798.41699.24
390583-9058396.54797.36
491808-9180897.85298.67
595645-95645101.942102.79
692591-9259198.68799.51
极限190065-9006595.99498.081.9696.9699.061.96
292194-9219498.26499.25
390259-9025996.20197.17
491831-9183197.87798.86
594957-94957101.209102.23
692798-9279898.90799.90
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%
114.715417754099542205413554116541490.10
214.695408654234541600.20
单位质量响应值RSD%判断
3681.103686.860.12数据可信
中间条件3月-供试品溶液-2023101322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%
5min155803-5580395.63894.971.2695.6494.971.26
256254-5625496.41196.41
355958-5595895.90495.90
455020-5502094.29694.30
554990-5499094.24594.24
654453-5445393.32493.32
10min157939-5793999.29997.741.3799.4697.901.37
256807-5680797.35997.52
357837-5783799.12499.28
456809-5680997.36297.52
556957-5695797.61697.77
655822-5582295.67195.83
15min157879-5787999.19697.231.2699.5297.551.26
256225-5622596.36196.68
357376-5737698.33498.66
456280-5628096.45696.78
556296-5629696.48396.80
656332-5633296.54596.86
20min156849-5684997.43197.420.9697.9297.900.96
256869-5686997.46597.95
357883-5788399.20399.69
456525-5652596.87697.36
556573-5657396.95897.44
656363-5636396.59897.07
30min157854-5785499.15397.451.1199.8198.101.11
256735-5673597.23597.88
357362-5736298.31098.96
456221-5622196.35497.00
556366-5636696.60397.25
656617-5661797.03397.67
45min157525-5752598.58996.731.6599.4197.541.64
255626-5562695.33596.14
357319-5731998.23699.05
455832-5583295.68896.49
556933-5693397.57598.38
655400-5540094.94795.75
极限157609-5760998.73397.071.4299.7298.041.42
256811-5681197.36698.33
357543-5754398.62099.60
456002-5600295.97996.94
556087-5608796.12597.09
655793-5579395.62196.58
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%
110.078509785182851128498984935850630.12
210.088503785084850600.04
单位质量响应值RSD%判断
8447.178438.490.08数据可信
中间条件3月-供试品溶液-2023101323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%
5min194206-94206100.22297.781.68100.2297.781.68
289889-8988995.62995.63
392862-9286298.79298.79
490811-9081196.61096.61
591450-9145097.29097.29
692249-9224998.14098.14
10min194870-94870100.92998.611.67101.1098.771.68
290341-9034196.11096.27
393505-9350599.47699.64
492071-9207197.95198.11
592099-9209997.98198.14
693233-9323399.18799.35
15min194899-94899100.95998.641.80101.2998.971.80
290113-9011395.86896.19
393864-9386499.858100.19
492121-9212198.00498.33
592096-9209697.97798.30
693215-9321599.16899.50
20min194871-94871100.93098.351.89101.4398.841.89
289940-8994095.68496.16
393625-9362599.604100.10
491569-9156997.41797.90
591697-9169797.55398.04
692982-9298298.92099.41
30min194512-94512100.54898.231.71101.2298.891.71
289972-8997295.71896.36
393417-9341799.383100.05
491510-9151097.35498.00
592035-9203597.91298.56
692573-9257398.48599.14
45min194522-94522100.55898.251.59101.4099.081.59
290319-9031996.08796.89
393250-9325099.205100.03
491632-9163297.48498.30
591732-9173297.59098.40
692683-9268398.60299.43
极限194498-94498100.53398.061.85101.5499.041.85
289724-8972495.45496.41
393241-9324199.196100.19
491490-9149097.33398.31
591187-9118797.01097.99
692891-9289198.82399.81
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%
114.715393554141539585404154035540220.16
214.695427354154542140.16
单位质量响应值RSD%判断
3672.473690.540.35数据可信
中间条件3月-供试品溶液-2023101323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%
5min155144-5514494.57395.030.9894.5795.030.98
255862-5586295.80495.80
356299-5629996.55496.55
455073-5507394.45194.45
555157-5515794.59594.60
654945-5494594.23294.23
10min156373-5637396.68197.401.2296.8497.561.22
256245-5624596.46196.62
358053-5805399.56299.72
456561-5656197.00397.16
556400-5640096.72796.88
657123-5712397.96798.12
15min156542-5654296.97097.471.1897.2997.791.18
257156-5715698.02398.34
358018-5801899.50299.83
456715-5671597.26797.59
556374-5637496.68297.00
656192-5619296.37096.69
20min156209-5620996.39997.221.5696.8897.701.55
255589-5558995.33695.82
358167-5816799.757100.25
456751-5675197.32997.81
557045-5704597.83398.31
656360-5636096.65897.14
30min155607-5560795.36797.591.3296.0198.241.32
256771-5677197.36398.01
357844-5784499.20399.86
456991-5699197.74098.38
556829-5682997.46398.11
657372-5737298.39499.04
45min155516-5551695.21196.101.3396.0196.911.32
256207-5620796.39697.20
357279-5727998.23499.06
455091-5509194.48295.29
556107-5610796.22497.03
656020-5602096.07596.88
极限155653-5565395.44695.591.3796.4096.561.36
254310-5431093.14394.11
355752-5575295.61696.60
456026-5602696.08597.05
556492-5649296.88597.85
656180-5618096.35097.32
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%
110.078513385057849478505685172850730.11
210.088493784837848870.09
单位质量响应值RSD%判断
8448.168421.330.23数据可信
中间条件3月-供试品溶液-2024010421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%
5min193015-9301599.05099.200.5299.0599.200.52
292887-9288798.91498.91
393845-9384599.93499.93
493686-9368699.76599.76
592856-9285698.88198.88
692673-9267398.68698.69
10min193552-9355299.62299.520.7099.7999.690.70
293312-9331299.36699.53
394018-94018100.118100.28
494354-94354100.476100.64
592765-9276598.78498.95
692756-9275698.77498.94
15min193656-9365699.73399.720.76100.06100.050.75
293071-9307199.11099.44
394258-94258100.374100.71
494703-94703100.848101.18
593181-9318199.22799.56
692992-9299299.02699.35
20min193363-9336399.42199.450.8899.9299.950.88
293092-9309299.13299.63
393937-93937100.032100.53
494494-94494100.625101.13
593374-9337499.43299.93
692080-9208098.05498.55
30min193182-9318299.22899.020.5899.8999.680.59
292424-9242498.42199.08
393675-9367599.753100.42
493372-9337299.430100.10
592988-9298899.02199.68
692296-9229698.28498.94
45min193110-9311099.15199.240.6599.98100.060.65
292785-9278598.80599.63
393946-93946100.042100.88
493755-9375599.838100.67
593217-9321799.265100.09
692332-9233298.32399.14
极限193111-9311199.15298.990.50100.1599.980.50
292775-9277598.79599.78
392827-9282798.85099.85
493708-9370899.788100.79
592984-9298499.017100.01
692325-9232598.31599.30
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%
114.715408554297541875424554254542140.16
214.695412254033540780.12
单位质量响应值RSD%判断
3685.523681.280.09数据可信
中间条件3月-供试品溶液-2024010421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%
5min156098-5609896.15994.301.7596.1694.301.75
254937-5493794.16994.17
354624-5462493.63293.63
455692-5569295.46395.46
553370-5337091.48391.48
655349-5534994.87594.87
10min155923-5592395.85996.311.8296.0296.471.82
256376-5637696.63596.79
356110-5611096.17996.34
457033-5703397.76297.92
554402-5440293.25293.40
657277-5727798.18098.34
15min157293-5729398.20796.102.7098.5396.422.69
255954-5595495.91296.23
355749-5574995.56195.88
456264-5626496.44396.77
553418-5341891.56591.87
657712-5771298.92599.25
20min156847-5684797.44396.631.7597.9397.101.75
256168-5616896.27996.76
356202-5620296.33796.81
457235-5723598.10898.59
554592-5459293.57794.04
657181-5718198.01598.50
30min157191-5719198.03295.732.1898.6896.372.17
256012-5601296.01196.65
355396-5539694.95695.59
455737-5573795.54096.19
553814-5381492.24492.86
656930-5693097.58598.23
45min155916-5591695.84794.731.7896.6695.531.78
255287-5528794.76995.57
355151-5515194.53695.33
455330-5533094.84295.65
553508-5350891.71992.49
656404-5640496.68397.50
极限154392-5439293.23593.353.3294.2094.313.31
254107-5410792.74693.70
355083-5508394.41995.37
456205-5620596.34297.31
551153-5115387.68388.61
655820-5582095.68296.66
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