富马酸比索洛尔片项目信息
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对照品来源中检所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%
110.108541285312853458529985414853560.07
210.058480684831848180.03
单位质量响应值RSD%判断
8451.098439.600.10数据可信
供试品溶液-2025120521批-pH6.8
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min196709-96709102.854102.901.05102.85102.901.05
298352-98352104.602104.60
397016-97016103.181103.18
495587-95587101.661101.66
597097-97097103.267103.27
695755-95755101.840101.84
10min196452-96452102.581102.031.23102.75102.211.23
297703-97703103.912104.09
396245-96245102.361102.53
494927-94927100.959101.13
595931-95931102.027102.20
694371-94371100.368100.54
15min196324-96324102.445101.711.29102.79102.051.29
297333-97333103.518103.87
395881-95881101.974102.32
494823-94823100.849101.19
595653-95653101.731102.07
693776-9377699.735100.07
20min195960-95960102.058101.571.36102.57102.081.36
297394-97394103.583104.10
396042-96042102.145102.66
494411-94411100.410100.92
595457-95457101.523102.03
693750-9375099.707100.21
30min195570-95570101.643101.511.31102.33102.191.31
297363-97363103.550104.24
395991-95991102.091102.77
494299-94299100.291100.96
595593-95593101.667102.35
693876-9387699.841100.51
45min195808-95808101.896101.131.33102.75101.981.33
296745-96745102.893103.76
395463-95463101.529102.38
494327-94327100.321101.16
595051-95051101.091101.94
693110-9311099.02799.86
极限195698-95698101.779101.061.28102.80102.081.29
296829-96829102.982104.02
395371-95371101.431102.45
493863-9386399.828100.83
594843-94843100.870101.89
693548-9354899.492100.49
富马酸比索洛尔片项目信息
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对照品来源中检所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%
110.108500384836849478542985578851590.39
210.058442684558844920.12
单位质量响应值RSD%判断
8431.588407.160.21数据可信
供试品溶液-2025120522批-pH6.8
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min193949-93949100.227101.981.66100.23101.981.66
294290-94290100.591100.59
397204-97204103.700103.70
494259-94259100.558100.56
597188-97188103.683103.68
696677-96677103.138103.14
10min193150-9315099.375101.361.6799.54101.531.67
293666-9366699.925100.09
397206-97206103.702103.87
494585-94585100.906101.07
594946-94946101.291101.46
696511-96511102.961103.13
15min193921-93921100.197101.141.52100.53101.471.52
293166-9316699.39299.73
397248-97248103.747104.09
494332-94332100.636100.97
594569-94569100.889101.23
695565-95565101.951102.29
20min193547-9354799.799101.081.48100.30101.581.48
293071-9307199.29199.79
396949-96949103.428103.95
494465-94465100.778101.28
594981-94981101.328101.84
695450-95450101.829102.34
30min193524-9352499.774100.791.36100.44101.471.36
293119-9311999.342100.01
396666-96666103.126103.82
494219-94219100.515101.19
594205-94205100.500101.18
695149-95149101.508102.19
45min193576-9357699.829100.621.30100.66101.461.30
292856-9285699.06199.89
396354-96354102.793103.66
494013-94013100.296101.13
594115-94115100.404101.25
695002-95002101.351102.20
极限194095-94095100.383100.581.31101.38101.591.31
292611-9261198.80099.80
396268-96268102.701103.74
493852-93852100.124101.13
593923-93923100.200101.21
694938-94938101.282102.30
富马酸比索洛尔片项目信息
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对照品来源中检所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%
110.108479885030848038498684865848960.13
210.058363383725836790.08
单位质量响应值RSD%判断
8405.548326.270.68数据可信
供试品溶液-2025120621批-pH6.8
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min194522-94522101.485100.302.13101.49100.302.13
295129-95129102.137102.14
392099-9209998.88498.88
494775-94775101.757101.76
590001-9000196.63196.63
693960-93960100.882100.88
10min195113-95113102.120100.922.01102.29101.092.01
295371-95371102.397102.57
392860-9286099.70199.87
495816-95816102.875103.04
590827-9082797.51897.68
693990-93990100.914101.08
15min195270-95270102.288101.092.16102.63101.422.16
295730-95730102.782103.12
393027-9302799.880100.21
496042-96042103.117103.46
590679-9067997.35997.68
694153-94153101.089101.43
20min195020-95020102.020100.942.22102.53101.442.21
295570-95570102.610103.12
393018-9301899.870100.37
495959-95959103.028103.54
590354-9035497.01097.50
694143-94143101.078101.58
30min195064-95064102.067100.702.21102.75101.382.21
295414-95414102.443103.13
392740-9274099.572100.24
495666-95666102.713103.40
590269-9026996.91997.57
693593-93593100.488101.16
45min194525-94525101.488100.472.15102.34101.312.15
295268-95268102.286103.14
392593-9259399.414100.24
495470-95470102.503103.36
590153-9015396.79497.60
693434-93434100.317101.16
极限194409-94409101.364100.212.22102.38101.222.22
294775-94775101.757102.78
392353-9235399.156100.15
495352-95352102.376103.40
589709-8970996.31897.29
693429-93429100.312101.32
富马酸比索洛尔片项目信息
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对照品来源中检所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%
110.108496884936848688505584968849590.08
210.058416684194841800.03
单位质量响应值RSD%判断
8411.788376.120.31数据可信
供试品溶液-G02PSP批-pH6.8
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min159614-5961463.79165.6111.9363.7965.6111.93
253982-5398257.76457.76
363803-6380368.27368.27
474650-7465079.88079.88
556599-5659960.56460.56
659249-5924963.40063.40
10min180441-8044186.07783.596.9486.1883.706.94
273979-7397979.16279.26
378125-7812583.59983.71
487744-8774493.89194.02
574944-7494480.19580.30
673484-7348478.63278.74
15min187818-8781893.97192.554.2494.2292.804.24
286698-8669892.77293.00
384193-8419390.09290.34
492878-9287899.38599.67
584933-8493390.88491.12
682414-8241488.18888.42
20min190511-9051196.85296.582.9897.2696.982.99
291998-9199898.44398.83
386947-8694793.03993.44
494301-94301100.908101.36
589919-8991996.21996.60
687881-8788194.03894.42
30min191251-9125197.64498.702.3398.2199.262.33
294730-94730101.367101.91
389446-8944695.71396.27
494818-94818101.461102.08
592120-9212098.57499.12
691037-9103797.41597.96
45min190905-9090597.27498.912.3498.0099.642.34
295396-95396102.080102.80
389642-8964295.92296.64
494448-94448101.065101.86
592452-9245298.92999.64
691787-9178798.21898.92
极限190575-9057596.92198.742.3197.8199.632.31
295323-95323102.001102.89
389699-8969995.98396.86
494151-94151100.747101.71
592211-9221198.67199.55
691675-9167598.09898.96
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