比索洛尔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%
19.878282083089828228296982775828950.16
29.828274282737827400.01
单位质量响应值RSD%判断
8398.688425.660.23数据可信
供试品溶液-2024022021批-5mg/5mg规格-比索洛尔-0.005mol/L盐酸
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min187887-8788793.84198.072.3893.8498.072.38
291807-9180798.02698.03
392194-9219498.43998.44
491663-9166397.87297.87
593248-9324899.56599.56
694313-94313100.702100.70
10min190541-9054196.674100.002.0196.83100.172.02
292837-9283799.12699.29
393304-9330499.62599.79
495615-95615102.092102.26
594265-94265100.651100.82
695390-95390101.852102.02
15min190566-9056696.70199.861.9197.02100.181.91
292885-9288599.17799.51
393040-9304099.34399.67
495467-95467101.934102.27
594096-94096100.470100.80
695065-95065101.505101.84
20min190399-9039996.52399.741.9597.00100.231.95
292776-9277699.06199.55
393006-9300699.30699.80
495321-95321101.778102.28
593823-93823100.179100.68
695135-95135101.580102.09
30min190033-9003396.13299.042.3796.7799.712.37
292335-9233598.59099.25
390453-9045396.58097.24
495129-95129101.573102.25
593730-93730100.079100.75
694883-94883101.310101.99
45min189910-8991096.00199.311.9896.80100.141.98
292399-9239998.65899.48
392548-9254898.81799.64
494876-94876101.303102.15
593655-9365599.999100.83
694677-94677101.091101.94
极限189731-8973195.80999.162.0096.77100.152.00
292199-9219998.44599.43
392585-9258598.85799.84
494796-94796101.218102.23
593376-9337699.701100.70
694535-94535100.939101.95
比索洛尔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%
19.878261682713826858270882597826640.07
29.828254482549825460.01
单位质量响应值RSD%判断
8375.288405.910.26数据可信
供试品溶液-2024022021批-5mg/5mg规格-比索洛尔-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%
5min189740-8974096.06695.181.6096.0795.181.60
288802-8880295.06195.06
389506-8950695.81595.82
490495-9049596.87496.87
588546-8854694.78794.79
686398-8639892.48892.49
10min191039-9103997.45696.361.8397.6296.511.83
289272-8927295.56595.72
390580-9058096.96597.12
492117-9211798.61098.77
589689-8968996.01196.17
687365-8736593.52393.68
15min190820-9082097.22296.141.9497.5496.461.94
289172-8917295.45895.78
390458-9045896.83497.16
492066-9206698.55698.88
589352-8935295.65095.97
687002-8700293.13593.44
20min190418-9041896.79195.771.9197.2896.251.91
288557-8855794.79995.28
390238-9023896.59997.08
491707-9170798.17198.66
589021-8902195.29695.77
686820-8682092.94093.41
30min189843-8984396.17695.351.9196.8295.991.91
288577-8857794.82195.46
389724-8972496.04896.69
491340-9134097.77898.43
588689-8868994.94195.58
686273-8627392.35492.97
45min189432-8943295.73694.891.8496.5495.691.84
288011-8801194.21595.01
389308-8930895.60396.41
490783-9078397.18298.00
588306-8830694.53195.33
685994-8599492.05692.83
极限188996-8899695.26994.391.7096.2395.351.69
287651-8765193.82994.78
388744-8874494.99995.96
490113-9011396.46597.44
587823-8782394.01394.97
685735-8573591.77892.71
比索洛尔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%
19.878266882629825908268482681826500.05
29.828269882671826840.03
单位质量响应值RSD%判断
8373.868419.960.39数据可信
供试品溶液-2024022021批-5mg/5mg规格-比索洛尔-pH4.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min195791-95791102.46699.233.86102.4799.233.86
288017-8801794.15194.15
397490-97490104.284104.28
491455-9145597.82897.83
593751-93751100.284100.28
690079-9007996.35696.36
10min196778-96778103.522100.493.87103.69100.653.87
289289-8928995.51195.67
398722-98722105.602105.78
492715-9271599.17699.34
595330-95330101.973102.14
690801-9080197.12997.29
15min196759-96759103.502100.343.91103.85100.673.91
289021-8902195.22595.54
398616-98616105.488105.84
492585-9258599.03799.37
595053-95053101.677102.01
690775-9077597.10197.42
20min196543-96543103.271100.044.00103.79100.544.00
288812-8881295.00195.48
398381-98381105.237105.76
492250-9225098.67999.17
594941-94941101.557102.06
690185-9018596.47096.95
30min196751-96751103.493100.063.97104.18100.733.97
288685-8868594.86595.50
398392-98392105.249105.95
492353-9235398.78999.45
594539-94539101.127101.80
690538-9053896.84797.49
45min195946-95946102.63299.793.89103.49100.623.89
288494-8849494.66195.45
398090-98090104.926105.80
492026-9202698.43999.26
594835-94835101.444102.29
690358-9035896.65597.46
极限195841-95841102.52099.494.01103.55100.494.01
288185-8818594.33095.28
398030-98030104.861105.91
491762-9176298.15799.14
594315-94315100.888101.90
689921-8992196.18797.15
比索洛尔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%
19.878268982790827378255382548826630.14
29.828300483004830040.00
单位质量响应值RSD%判断
8375.188452.550.66数据可信
供试品溶液-2024022021批-5mg/5mg规格-比索洛尔-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%
5min190145-9014596.23496.361.2896.2396.361.29
290982-9098297.12897.13
391365-9136597.53697.54
488722-8872294.71594.71
589056-8905695.07195.07
691305-9130597.47297.47
10min191522-9152297.70497.991.1697.8698.151.16
292071-9207198.29098.45
393397-9339799.70699.87
490835-9083596.97197.13
590528-9052896.64396.80
692409-9240998.65198.81
15min191785-9178597.98598.171.2698.3198.501.26
291964-9196498.17698.50
393703-93703100.032100.36
491075-9107597.22797.55
590484-9048496.59696.92
692748-9274899.01399.34
20min191634-9163497.82498.151.3498.3198.641.34
292125-9212598.34898.84
393970-93970100.317100.81
490838-9083896.97497.46
590592-9059296.71197.19
692462-9246298.70799.20
30min191327-9132797.49698.101.3998.1598.751.39
292066-9206698.28598.94
393904-93904100.247100.91
490755-9075596.88597.53
590577-9057796.69597.34
692705-9270598.96799.62
45min189744-8974495.80697.821.7996.6298.641.78
292073-9207398.29299.11
394048-94048100.401101.23
490554-9055496.67197.48
590546-9054696.66297.46
692840-9284099.11199.93
极限191464-9146497.64297.671.3698.6198.651.36
291859-9185998.06499.04
393313-9331399.616100.61
490252-9025296.34897.31
589969-8996996.04697.01
692094-9209498.31599.30
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