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%
110.108567285471852098552985376854510.21
210.058553985051852950.41
单位质量响应值RSD%判断
8460.508487.060.23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%
5min196334-96334102.112102.261.50102.11102.261.50
297194-97194103.024103.02
395534-95534101.264101.26
497782-97782103.647103.65
594156-9415699.80399.80
697845-97845103.714103.71
10min195488-95488101.215101.731.21101.39101.901.21
297248-97248103.081103.25
395389-95389101.110101.28
497007-97007102.825103.00
594202-9420299.852100.02
696495-96495102.283102.46
15min195174-95174100.882101.241.20101.22101.581.20
297050-97050102.871103.21
395153-95153100.860101.20
496046-96046101.807102.15
593660-9366099.27899.61
695985-95985101.742102.09
20min194832-94832100.520101.420.93101.03101.930.93
297136-97136102.962103.48
395058-95058100.759101.26
496293-96293102.068102.58
595129-95129100.835101.33
695648-95648101.385101.90
30min195316-95316101.033101.180.92101.71101.860.92
296686-96686102.485103.17
394950-94950100.645101.32
495751-95751101.494102.18
594134-9413499.780100.45
695866-95866101.616102.30
45min195086-95086100.789101.001.14101.63101.851.14
296932-96932102.746103.60
394452-94452100.117100.96
495709-95709101.449102.30
593862-9386299.492100.32
695682-95682101.421102.27
极限194708-94708100.388101.180.82101.40102.190.82
296481-96481102.268103.30
395554-95554101.285102.29
495628-95628101.364102.39
594386-94386100.047101.05
695944-95944101.699102.72
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%
110.108618686247859188592086057860660.18
210.058545485565855100.10
单位质量响应值RSD%判断
8521.398508.460.11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%
5min199111-99111104.548103.072.03104.55103.072.03
298070-98070103.450103.45
3100621-100621106.141106.14
495451-95451100.687100.69
595793-95793101.048101.05
697187-97187102.518102.52
10min198614-98614104.023102.721.06104.20102.901.07
298113-98113103.495103.67
397757-97757103.119103.30
495756-95756101.009101.18
597360-97360102.701102.87
696689-96689101.993102.16
15min198217-98217103.605102.421.10103.95102.761.10
297852-97852103.220103.56
397496-97496102.844103.19
495261-95261100.487100.82
597179-97179102.510102.85
696554-96554101.850102.19
20min197881-97881103.250102.331.03103.77102.841.03
297671-97671103.029103.55
397496-97496102.844103.36
495270-95270100.496101.00
597332-97332102.671103.18
696375-96375101.662102.17
30min198101-98101103.482102.231.05104.17102.911.04
297712-97712103.072103.76
397363-97363102.704103.40
495367-95367100.598101.27
596591-96591101.889102.57
696336-96336101.620102.30
45min197656-97656103.013101.751.21103.88102.601.21
297154-97154102.483103.34
397350-97350102.690103.55
494778-9477899.977100.82
596468-96468101.760102.61
695336-95336100.566101.42
极限197620-97620102.975101.751.28104.01102.771.27
296944-96944102.262103.29
397709-97709103.069104.10
494559-9455999.746100.75
596286-96286101.568102.59
695611-95611100.856101.87
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%
110.108527585246849648532985091851810.18
210.058461584799847070.16
单位质量响应值RSD%判断
8433.768428.560.05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%
5min192994-9299499.07099.121.3999.0799.121.39
293436-9343699.54199.54
392289-9228998.31998.32
494754-94754100.945100.94
593745-9374599.87099.87
691000-9100096.94596.95
10min193442-9344299.54799.521.4899.7199.691.48
294039-94039100.183100.35
393172-9317299.25999.42
494840-94840101.036101.20
594158-94158100.310100.48
690865-9086596.80296.96
15min193743-9374399.868100.081.49100.20100.401.49
294300-94300100.461100.79
393702-9370299.824100.15
495570-95570101.814102.15
594833-94833101.029101.36
691481-9148197.45897.78
20min193953-93953100.09199.881.45100.59100.381.45
294579-94579100.758101.26
393276-9327699.37099.87
495116-95116101.330101.84
594324-94324100.487100.99
691290-9129097.25497.74
30min193135-9313599.22099.651.4599.88100.321.45
294315-94315100.477101.15
392980-9298099.05599.72
495099-95099101.312101.99
594380-94380100.546101.22
691316-9131697.28297.93
45min193328-9332899.42599.361.72100.26100.191.71
294579-94579100.758101.59
392437-9243798.47699.30
494879-94879101.078101.92
593835-9383599.966100.80
690548-9054896.46497.27
极限192916-9291698.98799.231.5199.98100.231.51
293467-9346799.574100.58
392582-9258298.63199.62
494530-94530100.706101.72
594574-94574100.753101.76
690821-9082196.75597.73
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%
110.108574685950861448601685981859670.17
210.058501185449852300.37
单位质量响应值RSD%判断
8511.588480.600.26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%
5min157706-5770661.00770.1813.4461.0170.1813.44
279821-7982184.38684.39
357097-5709760.36360.36
465985-6598569.75969.76
573502-7350277.70677.71
664179-6417967.85067.85
10min182863-8286387.60288.056.0487.7088.176.05
290459-9045995.63395.77
375200-7520079.50179.60
481985-8198586.67486.79
586056-8605690.97891.11
683170-8317087.92788.04
15min191288-9128896.50994.753.6496.7695.013.65
292882-9288298.19498.49
383635-8363588.41988.65
488442-8844293.50093.76
590690-9069095.87796.16
690797-9079795.99096.25
20min193696-9369699.05598.102.2299.4698.522.23
292783-9278398.09098.55
390260-9026095.42295.80
490441-9044195.61496.03
594291-9429199.684100.12
695280-95280100.730101.15
30min194792-94792100.214100.092.52100.79100.672.50
292884-9288498.19798.82
395886-95886101.370101.91
490952-9095296.15496.73
596000-96000101.491102.10
697517-97517103.095103.68
45min195303-95303100.754100.643.15101.49101.393.12
292974-9297498.29299.08
398152-98152103.766104.47
490680-9068095.86796.60
595603-95603101.071101.85
698454-98454104.085104.84
极限195138-95138100.579100.693.33101.49101.613.29
292700-9270098.00298.96
398993-98993104.655105.54
490733-9073395.92396.82
595633-95633101.103102.05
698240-98240103.859104.79
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