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4000
标示量(mg)2.5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%
110.428802988198878468863987251879930.58
210.358883388038884360.64
单位质量响应值RSD%判断
8444.638544.540.84数据可信
供试品溶液-2025070921批-pH1.2
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min195826-95826101.32899.681.87101.3399.691.87
295332-95332100.806100.81
395381-95381100.857100.86
491373-9137396.61996.62
592886-9288698.21998.22
694832-94832100.277100.28
10min196138-96138101.658100.312.25101.83100.482.25
295766-95766101.265101.43
396452-96452101.990102.16
491263-9126396.50396.66
593253-9325398.60798.77
696306-96306101.836102.00
15min197615-97615103.220100.722.74103.56101.062.74
296352-96352101.884102.22
396816-96816102.375102.71
490942-9094296.16496.49
593191-9319198.54298.87
696615-96615102.162102.50
20min196334-96334101.865100.292.31102.38100.792.31
295967-95967101.477101.98
396759-96759102.315102.82
491055-9105596.28396.77
593438-9343898.80399.30
695498-95498100.981101.49
30min195298-95298100.77099.712.25101.45100.382.25
295310-95310100.782101.46
395622-95622101.112101.79
490558-9055895.75896.40
592994-9299498.33398.99
696003-96003101.515102.19
45min195588-95588101.07699.482.32101.92100.312.32
295161-95161100.625101.47
395804-95804101.305102.15
490501-9050195.69796.50
592247-9224797.54398.36
695162-95162100.626101.47
极限194984-94984100.43899.052.57101.45100.052.56
294947-94947100.399101.41
395387-95387100.864101.88
489262-8926294.38795.35
592495-9249597.80698.79
694978-94978100.431101.44
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4000
标示量(mg)2.5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%
110.428782288348882638821288494882280.29
210.358858488942887630.29
单位质量响应值RSD%判断
8467.188576.140.91数据可信
供试品溶液-G01TD1批-pH1.2
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min158438-5843861.59763.5412.5561.6063.5412.55
257383-5738360.48560.49
369419-6941973.17273.17
466317-6631769.90269.90
547998-4799850.59350.59
662130-6213065.48965.49
10min180802-8080285.17084.094.9485.2784.194.95
276868-7686881.02481.12
385529-8552990.15390.27
482388-8238886.84286.96
574664-7466478.70178.78
678409-7840982.64882.76
15min189509-8950994.34892.772.8094.5993.022.80
287548-8754892.28192.52
392210-9221097.19597.47
486736-8673691.42591.69
586583-8658391.26491.48
685473-8547390.09490.34
20min192434-9243497.43195.812.9097.8396.212.89
293208-9320898.24798.64
393989-9398999.07099.50
489196-8919694.01894.43
588838-8883893.64194.01
687710-8771092.45292.85
30min191470-9147096.41597.232.2396.9897.792.22
295388-95388100.545101.10
394189-9418999.28199.88
490978-9097895.89796.47
590245-9024595.12495.65
691193-9119396.12396.67
45min190972-9097295.89097.051.7896.6297.771.78
294901-94901100.032100.75
393163-9316398.20098.96
491385-9138596.32697.06
590663-9066395.56596.25
691337-9133796.27596.99
极限191109-9110996.03596.952.3496.9297.842.33
295825-95825101.006101.89
393157-9315798.19399.12
490937-9093795.85396.74
590060-9006094.92995.77
690801-9080195.71096.58
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4000
标示量(mg)2.5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%
110.428854588485891748792687879884020.60
210.358830188024881620.23
单位质量响应值RSD%判断
8483.888518.070.29数据可信
供试品溶液-G01TD1批-pH1.2
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min168996-6899672.90062.9113.9472.9062.9113.94
249420-4942052.21752.22
350016-5001652.84652.85
461747-6174765.24165.24
559990-5999063.38563.38
667063-6706370.85870.86
10min187185-8718592.11985.007.2792.2485.107.28
273884-7388478.06578.15
373824-7382478.00278.09
479810-7981084.32684.44
581437-8143786.04586.15
686539-8653991.43691.55
15min189749-8974994.82892.892.9795.1093.142.99
285466-8546690.30290.52
384311-8431189.08289.30
487858-8785892.83093.08
588969-8896994.00494.25
691148-9114896.30696.58
20min191309-9130996.47696.121.5696.9196.521.58
289822-8982294.90595.27
389252-8925294.30394.67
490817-9081795.95696.36
591324-9132496.49296.90
693296-9329698.57699.01
30min191804-9180496.99996.861.1597.5997.421.17
291752-9175296.94497.47
389971-8997195.06295.59
491201-9120196.36296.93
592175-9217597.39197.96
693132-9313298.40299.00
45min190908-9090896.05296.621.3796.8197.351.38
291034-9103496.18696.87
390028-9002895.12395.80
490946-9094696.09396.82
592218-9221897.43798.17
693553-9355398.84799.61
极限191210-9121096.37295.920.8997.2996.810.90
290321-9032195.43296.28
390063-9006395.16096.00
489860-8986094.94595.83
591678-9167896.86697.76
691574-9157496.75697.68
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4000
标示量(mg)2.5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%
110.421754081753561753661745951751971751840.20
210.351751001754751752880.16
单位质量响应值RSD%判断
16812.2816936.040.52数据可信
供试品溶液-2025070922批-pH1.2
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1183276-18327697.55898.321.0997.5698.321.09
2185440-18544098.71098.71
3185771-18577198.88698.89
4186913-18691399.49499.49
5181425-18142596.57396.57
6185458-18545898.71998.72
10min1185364-18536498.66999.530.9898.8399.700.98
2188147-188147100.151100.32
3187343-18734399.72399.89
4189713-189713100.984101.15
5184783-18478398.36098.52
6186559-18655999.30599.47
15min1182699-18269997.25198.811.4097.5899.141.40
2187809-18780999.971100.30
3185996-18599699.00699.34
4189154-189154100.687101.02
5182865-18286597.33997.66
6185291-18529198.63098.96
20min1182230-18223097.00198.591.1997.4999.091.19
2187062-18706299.573100.07
3186426-18642699.23599.73
4187514-18751499.814100.32
5183020-18302097.42297.91
6185083-18508398.52099.01
30min1181666-18166696.70198.461.3397.3599.121.32
2187200-18720099.647100.31
3185844-18584498.92599.59
4187541-18754199.828100.50
5182411-18241197.09797.75
6185109-18510998.53499.19
45min1180257-18025795.95197.801.4596.7698.621.45
2185737-18573798.86899.70
3184595-18459598.26099.09
4186331-18633199.184100.02
5180534-18053496.09896.91
6184938-18493898.44399.27
极限1180788-18078896.23497.281.0097.2198.271.00
2184115-18411598.00499.00
3182379-18237997.08098.07
4185197-18519798.58099.58
5180691-18069196.18297.15
6183377-18337797.61298.60
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