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%
110.048409284641845548408184308843350.31
210.068426484517843900.22
单位质量响应值RSD%判断
8399.908388.670.10数据可信
加速6月-供试品溶液-2024110221批-富马酸比索洛尔-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%
5min192954-9295499.46298.990.6199.4698.990.61
293143-9314399.66499.66
392974-9297499.48499.48
491894-9189498.32898.33
592111-9211198.56098.56
692024-9202498.46798.47
10min194299-94299100.901100.030.90101.07100.200.90
294640-94640101.266101.43
393492-93492100.038100.20
492867-9286799.36999.53
593142-9314299.66399.83
692482-9248298.95799.12
15min193720-93720100.28299.900.53100.62100.240.54
294084-94084100.671101.01
393375-9337599.913100.25
492852-9285299.35399.68
593364-9336499.901100.23
692804-9280499.30299.63
20min193937-93937100.51499.660.86101.02100.160.86
294033-94033100.617101.12
393551-93551100.101100.60
492574-9257499.05699.55
592228-9222898.68599.18
692506-9250698.98399.48
30min193728-93728100.29099.580.70100.96100.240.70
293841-93841100.411101.08
393191-9319199.716100.38
492578-9257899.06099.72
592223-9222398.68099.34
692813-9281399.31199.97
45min192934-9293499.44199.300.67100.28100.130.67
293866-93866100.438101.28
392781-9278199.277100.11
492846-9284699.347100.17
592162-9216298.61599.44
692226-9222698.68399.51
极限193220-9322099.74798.871.00100.7599.861.00
293746-93746100.310101.31
392506-9250698.98399.98
491746-9174698.17099.16
591521-9152197.92998.92
691652-9165298.06999.06
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%
114.064921349240492584916149296492340.11
214.064938749374493800.02
单位质量响应值RSD%判断
3501.713512.090.21数据可信
加速6月-供试品溶液-2024110221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%
5min151436-5143692.60589.312.8092.6189.312.81
250436-5043690.80590.80
348142-4814286.67586.67
449719-4971989.51489.51
550099-5009990.19890.20
647817-4781786.09086.09
10min152490-5249094.50394.063.7794.6694.213.77
254399-5439997.94098.09
349772-4977289.60989.75
452587-5258794.67794.83
554156-5415697.50297.65
650064-5006490.13590.28
15min153699-5369996.68094.113.9896.9994.423.98
253597-5359796.49696.81
349334-4933488.82189.11
452887-5288795.21895.52
554149-5414997.49097.80
649976-4997689.97790.27
20min151577-5157792.85990.623.4993.3391.083.49
251384-5138492.51292.99
347339-4733985.22985.67
451176-5117692.13792.60
551501-5150192.72293.20
649029-4902988.27288.72
30min152701-5270194.88392.742.1895.5193.362.17
250327-5032790.60991.24
350269-5026990.50491.09
452577-5257794.65995.28
552209-5220993.99794.63
650986-5098691.79592.39
45min152148-5214893.88792.272.3794.6793.042.36
251737-5173793.14793.93
351445-5144592.62193.36
449427-4942788.98889.77
552581-5258194.66795.45
650159-5015990.30691.05
极限152163-5216393.91492.273.9594.8693.193.94
252829-5282995.11396.05
349870-4987089.78690.67
451063-5106391.93492.86
553497-5349796.31697.26
648066-4806686.53887.43
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%
110.048433884586841218449283883842840.34
210.068374684181839640.37
单位质量响应值RSD%判断
8394.828346.320.41数据可信
加速6月-供试品溶液-2024110321批-富马酸比索洛尔-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%
5min195476-95476102.451100.311.40102.45100.311.39
292626-9262699.39399.39
394656-94656101.571101.57
493309-93309100.126100.13
592433-9243399.18699.19
692371-9237199.11999.12
10min196018-96018103.033101.371.27103.20101.541.27
294176-94176101.056101.22
395490-95490102.466102.64
494813-94813101.739101.91
593241-93241100.053100.22
693079-9307999.879100.04
15min195890-95890102.895101.851.28103.24102.191.28
295683-95683102.673103.01
396127-96127103.149103.49
494934-94934101.869102.21
593459-93459100.287100.62
693423-93423100.248100.58
20min195461-95461102.435101.301.18102.95101.801.19
294130-94130101.007101.51
395675-95675102.664103.18
494831-94831101.759102.27
592945-9294599.735100.23
693369-93369100.190100.69
30min195671-95671102.660101.051.59103.34101.721.59
293233-93233100.044100.72
396064-96064103.082103.76
494613-94613101.525102.20
592786-9278699.564100.23
692641-9264199.409100.07
45min195345-95345102.310100.891.51103.17101.731.51
293296-93296100.112100.95
395769-95769102.765103.62
494554-94554101.462102.31
592863-9286399.647100.48
692282-9228299.02499.85
极限195067-95067102.012100.791.33103.04101.801.33
292824-9282499.605100.61
395613-95613102.598103.62
494298-94298101.187102.20
592759-9275999.535100.53
692982-9298299.775100.77
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%
114.064940549585500635012349464497280.69
214.064959149080493360.74
单位质量响应值RSD%判断
3536.843508.960.56数据可信
加速6月-供试品溶液-2024110321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%
5min148603-4860387.10890.092.9687.1190.092.96
251142-5114291.65991.66
348274-4827486.51986.52
450440-5044090.40190.40
551325-5132591.98791.99
651810-5181092.85692.86
10min153040-5304095.06194.572.1595.2194.722.15
253452-5345295.79995.95
352102-5210293.37993.52
452516-5251694.12194.27
551109-5110991.60091.75
654376-5437697.45597.61
15min151274-5127491.89581.1136.4992.2081.4236.36
254358-5435897.42397.74
350221-5022190.00890.31
450860-5086091.15391.46
511696-1169620.96221.27
653143-5314395.24595.56
20min152861-5286194.74094.540.9795.2094.980.92
252220-5222093.59194.07
353142-5314295.24395.69
452450-5245094.00394.46
553498-5349895.88196.22
652313-5231393.75894.23
30min151570-5157092.42692.571.5493.0493.171.52
252822-5282294.67095.30
350569-5056990.63291.24
451544-5154492.37993.00
552243-5224393.63294.13
651151-5115191.67592.31
45min153983-5398396.75193.442.2597.5294.202.24
253021-5302195.02795.82
351615-5161592.50793.27
450965-5096591.34292.11
552117-5211793.40694.06
651130-5113091.63792.42
极限152779-5277994.59381.4636.6095.5282.3636.20
252349-5234993.82294.77
311513-1151320.63421.55
451423-5142392.16393.08
551849-5184992.92693.74
652779-5277994.59395.53
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%
110.048427484097842308418783549840670.36
210.068417384510843420.29
单位质量响应值RSD%判断
8373.218383.900.10数据可信
加速6月-供试品溶液-2024110421批-富马酸比索洛尔-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%
5min193613-93613100.35599.200.69100.3699.200.69
291995-9199598.62198.62
392412-9241299.06899.07
492942-9294299.63699.64
592106-9210698.74098.74
692123-9212398.75898.76
10min195523-95523102.403100.601.09102.57100.771.09
294466-94466101.270101.43
392929-9292999.62299.79
493962-93962100.729100.90
593052-9305299.75499.92
693129-9312999.836100.00
15min195629-95629102.517100.571.05102.85100.901.05
293802-93802100.558100.89
393116-9311699.823100.15
494006-94006100.777101.11
593406-93406100.133100.46
692907-9290799.59899.93
20min194342-94342101.137100.230.51101.65100.730.51
293630-93630100.374100.87
393206-9320699.919100.42
493400-93400100.127100.63
593409-93409100.137100.63
692979-9297999.676100.17
30min194739-94739101.562100.320.79102.24100.990.79
294026-94026100.798101.47
392960-9296099.655100.32
493727-93727100.478101.15
593214-9321499.928100.59
692806-9280699.490100.15
45min194645-94645101.462100.400.90102.31101.240.90
293889-93889100.651101.49
392771-9277199.453100.28
494602-94602101.416102.25
593020-9302099.720100.55
693003-9300399.701100.53
极限195466-95466102.342100.101.13103.36101.101.13
293248-9324899.964100.97
392609-9260999.279100.27
493172-9317299.883100.89
592775-9277599.457100.45
692979-9297999.676100.67
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%
114.064925849233496064970549684494970.48
214.065009949425497620.96
单位质量响应值RSD%判断
3520.413539.260.38数据可信
加速6月-供试品溶液-2024110421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%
5min150659-5065990.61490.891.4290.6190.891.42
250856-5085690.96690.97
350451-5045190.24290.24
450260-5026089.90089.90
550432-5043290.20890.21
652219-5221993.40493.40
10min150593-5059390.49691.171.9890.6591.321.97
250710-5071090.70590.86
350167-5016789.73489.88
451646-5164692.38092.53
552658-5265894.19094.34
650029-5002989.48789.64
15min150665-5066590.62591.771.5990.9392.081.58
251741-5174192.54992.85
350068-5006889.55789.86
452118-5211893.22493.53
552016-5201693.04193.35
651230-5123091.63591.94
20min150908-5090891.05991.541.5491.5192.001.53
250473-5047390.28190.74
351873-5187392.78693.23
452418-5241893.76094.22
550636-5063690.57391.04
650748-5074890.77391.23
30min152456-5245693.82892.061.9994.4392.671.97
251585-5158592.27092.88
350255-5025589.89190.50
450479-5047990.29290.91
551253-5125391.67792.29
652785-5278594.41795.03
45min150938-5093891.11390.951.6091.8791.721.58
250050-5005089.52590.29
351788-5178892.63493.39
449705-4970588.90889.67
551430-5143091.99392.76
651181-5118191.54892.31
极限150398-5039890.14789.520.9291.0690.430.91
249262-4926288.11589.03
349916-4991689.28590.19
450217-5021789.82390.74
550538-5053890.39891.32
649942-4994289.33290.25
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