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%
19.988431284386845868455884601844890.16
29.958406084119840900.05
单位质量响应值RSD%判断
8465.838451.260.13数据可信
供试品溶液-2024010421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%
5min189978-8997847.77348.561.9147.7748.561.91
292221-9222148.96448.96
390740-9074048.17848.18
492612-9261249.17249.17
593873-9387349.84149.84
689288-8928847.40747.41
10min191524-9152448.59449.571.4648.6749.651.46
294560-9456050.20650.29
392137-9213748.91949.00
493281-9328149.52749.61
595052-9505250.46750.55
693612-9361249.70349.78
15min191764-9176448.72149.641.5348.8849.801.53
294819-9481950.34350.51
392022-9202248.85849.02
493053-9305349.40649.57
595038-9503850.46050.63
694273-9427350.05450.22
20min191743-9174348.71049.581.8248.9549.821.82
295300-9530050.59950.85
391126-9112648.38348.63
493031-9303149.39449.64
594843-9484350.35650.61
694206-9420650.01850.26
30min191711-9171148.69349.561.6849.0249.881.67
295058-9505850.47050.80
391568-9156848.61748.94
492713-9271349.22549.55
594923-9492350.39950.73
694058-9405849.93950.27
45min191601-9160148.63549.411.8349.0449.821.83
295206-9520650.54950.97
391038-9103848.33648.74
492369-9236949.04349.45
594836-9483650.35250.77
693278-9327849.52549.94
极限191266-9126648.45749.351.8748.9449.841.87
295081-9508150.48350.98
390741-9074148.17848.66
492535-9253549.13149.62
594422-9442250.13350.64
693598-9359849.69550.19
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%
114.104886549058491054847048811488620.52
214.144891649002489590.13
单位质量响应值RSD%判断
3465.393462.450.07数据可信
供试品溶液-2024010421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%
5min154469-5446999.28299.512.9999.2899.513.00
255491-55491101.145101.15
354990-54990100.232100.23
452093-5209394.95294.95
553653-5365397.79597.80
656875-56875103.668103.67
10min154534-5453499.401100.772.7099.57100.942.71
255778-55778101.668101.84
356607-56607103.179103.35
453230-5323097.02497.18
554391-5439199.14099.30
657173-57173104.211104.38
15min155496-55496101.154101.912.19101.49102.242.18
255267-55267100.737101.07
356845-56845103.613103.95
455166-55166100.553100.87
554757-5475799.807100.14
657932-57932105.595105.94
20min154658-5465899.627101.532.16100.13102.032.16
255357-55357100.901101.41
356469-56469102.928103.44
455919-55919101.925102.41
554279-5427998.93699.43
657527-57527104.856105.38
30min155300-55300100.797101.821.74101.46102.491.74
255356-55356100.899101.57
356715-56715103.376104.06
455967-55967102.013102.67
554609-5460999.538100.20
657210-57210104.279104.98
45min154672-5467299.652101.081.55100.49101.921.55
254891-54891100.052100.89
355548-55548101.249102.10
456421-56421102.840103.67
554658-5465899.627100.45
656537-56537103.052103.92
极限154288-5428898.953100.501.3299.95101.511.31
254744-5474499.784100.79
355774-55774101.661102.69
456105-56105102.264103.26
554544-5454499.419100.41
655379-55379100.941101.98
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%
19.988420584359842608425784246842650.07
29.958457984499845390.07
单位质量响应值RSD%判断
8443.398496.380.45数据可信
供试品溶液-2024010421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%
5min194180-9418049.93850.121.5249.9450.121.52
293431-9343149.54149.54
394259-9425949.98049.98
492829-9282949.22149.22
596157-9615750.98650.99
696341-9634151.08451.08
10min194809-9480950.27150.521.7350.3550.601.72
294020-9402049.85349.94
395408-9540850.58950.67
493136-9313649.38449.47
597164-9716451.52051.60
697155-9715551.51551.60
15min194476-9447650.09550.441.8150.2650.611.81
293984-9398449.83450.00
395006-9500650.37650.54
492984-9298449.30449.47
596875-9687551.36751.54
697429-9742951.66051.83
20min194104-9410449.89750.351.8550.1550.601.84
294000-9400049.84250.09
395063-9506350.40650.66
492617-9261749.10949.36
596793-9679351.32351.58
697153-9715351.51451.77
30min194128-9412849.91050.291.8750.2450.631.86
293542-9354249.59949.93
394951-9495150.34750.68
492674-9267449.13949.47
596690-9669051.26951.61
697130-9713051.50251.84
45min193599-9359949.63050.201.8550.0550.621.85
293721-9372149.69450.11
394966-9496650.35450.77
492413-9241349.00149.41
596372-9637251.10051.53
696938-9693851.40051.83
极限192304-9230448.94349.962.0649.4450.472.05
293428-9342849.53950.04
394504-9450450.10950.61
492211-9221148.89449.39
596198-9619851.00851.52
696743-9674351.29751.81
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%
114.104906148902491544900049027490290.19
214.144932049279493000.06
单位质量响应值RSD%判断
3477.233486.560.19数据可信
供试品溶液-2024010421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%
5min153348-5334896.737101.022.7596.74101.022.75
255902-55902101.368101.37
357194-57194103.711103.71
455026-5502699.78099.78
555270-55270100.222100.22
657505-57505104.275104.28
10min155936-55936101.430102.840.96101.59103.000.96
256664-56664102.750102.92
357548-57548104.353104.53
456600-56600102.634102.80
556497-56497102.447102.61
657022-57022103.399103.57
15min155359-55359100.384102.831.59100.71103.171.59
256023-56023101.588101.93
357745-57745104.710105.06
456598-56598102.630102.97
557156-57156103.642103.98
657371-57371104.032104.38
20min155583-55583100.790102.180.98101.29102.690.98
256558-56558102.558103.07
356973-56973103.310103.83
455842-55842101.260101.77
556829-56829103.049103.56
656300-56300102.090102.61
30min156194-56194101.898103.230.80102.56103.910.81
256727-56727102.864103.54
357269-57269103.847104.54
457118-57118103.573104.25
556803-56803103.002103.68
657462-57462104.197104.89
45min153593-5359397.181100.651.8498.02101.511.83
255561-55561100.750101.60
355667-55667100.942101.81
455658-55658100.926101.78
555913-55913101.388102.24
656655-56655102.734103.60
极限154782-5478299.337101.801.43100.33102.821.43
256125-56125101.773102.79
356408-56408102.286103.32
456089-56089101.708102.73
556163-56163101.842102.86
657270-57270103.849104.88
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