普瑞巴林口崩片项目信息
介质体积(ml)900取样体积(ml)0补液体积(ml)0
对照品批号101106-202003对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.4对照品水分(%)0对照品稀释倍数200
标示量(mg)75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%
116.635515655371554025500455477552820.36
216.665548255459554700.03
单位质量响应值RSD%判断
3324.233329.530.12数据可信
加速6月-供试品溶液-2024121221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%
2min150952-5095291.34091.761.7691.3491.761.75
251057-5105791.52891.53
351098-5109891.60291.60
451192-5119291.77091.77
550030-5003089.68789.69
652798-5279894.64994.65
5min156460-56460101.214100.630.63101.21100.630.63
256052-56052100.483100.48
356039-56039100.459100.46
456469-56469101.230101.23
555529-5552999.54599.55
656245-56245100.829100.83
10min156959-56959102.109101.210.64102.11101.210.63
256655-56655101.564101.56
356434-56434101.168101.17
456297-56297100.922100.92
555898-55898100.207100.21
656516-56516101.315101.31
15min157021-57021102.220101.150.88102.22101.150.88
256682-56682101.612101.61
356074-56074100.522100.52
456884-56884101.974101.97
556034-56034100.450100.45
655859-55859100.137100.14
30min156843-56843101.901101.150.61101.90101.150.61
256834-56834101.885101.88
356235-56235100.811100.81
456417-56417101.137101.14
556084-56084100.540100.54
656122-56122100.608100.61
普瑞巴林口崩片项目信息
介质体积(ml)900取样体积(ml)0补液体积(ml)0
对照品批号101106-202003对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.4对照品水分(%)0对照品稀释倍数200
标示量(mg)75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%
116.635537455548550995513655123552560.36
216.665501554980549980.05
单位质量响应值RSD%判断
3322.673301.200.46数据可信
长期6月-供试品溶液-2024121221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%
2min151741-5174193.17492.441.8993.1792.441.89
250877-5087791.61891.62
351468-5146892.68292.68
450995-5099591.83191.83
552901-5290195.26395.26
650017-5001790.07090.07
5min155051-5505199.135101.551.3399.13101.541.34
256661-56661102.034102.03
357099-57099102.823102.82
456698-56698102.101102.10
555999-55999100.842100.84
656830-56830102.338102.34
10min155301-5530199.585101.821.2599.58101.821.25
256613-56613101.947101.95
357091-57091102.808102.81
457019-57019102.679102.68
556167-56167101.144101.14
657056-57056102.745102.75
15min155860-55860100.592101.540.68100.59101.540.68
256299-56299101.382101.38
356560-56560101.852101.85
456875-56875102.419102.42
556070-56070100.970100.97
656640-56640101.996102.00
30min155721-55721100.341101.720.98100.34101.720.98
256519-56519101.778101.78
357203-57203103.010103.01
456728-56728102.155102.15
555962-55962100.775100.78
656796-56796102.277102.28
普瑞巴林口崩片项目信息
介质体积(ml)900取样体积(ml)0补液体积(ml)0
对照品批号101106-202003对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.4对照品水分(%)0对照品稀释倍数200
标示量(mg)75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%
116.635502954982551655505255068550590.13
216.665487954883548810.01
单位质量响应值RSD%判断
3310.823294.180.36数据可信
中间条件6月-供试品溶液-2024121221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%
2min152169-5216994.21391.042.9894.2191.042.98
250878-5087891.88191.88
351240-5124092.53592.54
450923-5092391.96391.96
549185-4918588.82488.82
648067-4806786.80586.80
5min154975-5497599.28099.900.6699.2899.900.66
255245-5524599.76899.77
354990-5499099.30799.31
455837-55837100.837100.84
555178-5517899.64799.65
655686-55686100.564100.56
10min155619-55619100.443100.430.42100.44100.430.42
255480-55480100.192100.19
355244-5524499.76699.77
455681-55681100.555100.56
555723-55723100.631100.63
655927-55927100.999101.00
15min155338-5533899.936100.490.3599.94100.500.35
255846-55846100.853100.85
355517-55517100.259100.26
455670-55670100.535100.54
555688-55688100.568100.57
655826-55826100.817100.82
30min155581-55581100.375100.250.30100.37100.250.30
255579-55579100.371100.37
355385-55385100.021100.02
455777-55777100.729100.73
555359-5535999.97499.97
655406-55406100.059100.06
普瑞巴林口崩片项目信息
介质体积(ml)900取样体积(ml)0补液体积(ml)0
对照品批号101106-202003对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.4对照品水分(%)0对照品稀释倍数200
标示量(mg)75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%
116.631772917676177391778917648177160.32
216.661786917989179290.48
单位质量响应值RSD%判断
1065.301076.170.72数据可信
中间条件6月-供试品溶液-2024121521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%
2min115979-1597989.00588.623.1189.0188.623.11
215835-1583588.20388.20
315739-1573987.66887.67
415845-1584588.25988.26
515273-1527385.07385.07
616789-1678993.51793.52
5min118322-18322102.056104.221.90102.06104.221.90
218604-18604103.627103.63
319085-19085106.306106.31
418879-18879105.159105.16
518298-18298101.922101.92
619071-19071106.228106.23
10min118448-18448102.758104.151.50102.76104.151.50
218623-18623103.733103.73
318972-18972105.677105.68
418688-18688104.095104.09
518378-18378102.368102.37
619079-19079106.273106.27
15min118486-18486102.970104.411.74102.97104.411.74
218663-18663103.955103.96
318927-18927105.426105.43
418888-18888105.209105.21
518305-18305101.961101.96
619199-19199106.941106.94
30min118530-18530103.215104.821.54103.21104.821.54
218624-18624103.738103.74
319069-19069106.217106.22
419011-19011105.894105.89
518524-18524103.181103.18
619150-19150106.668106.67
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