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%
116.635186051969518085176151931518660.17
216.665141051670515400.36
单位质量响应值RSD%判断
3118.823093.640.58数据可信
中间条件36月-供试品溶液-2022100911批-水
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
2min151359-5135998.61294.333.3498.6194.333.34
248761-4876193.62393.62
349542-4954295.12395.12
449981-4998195.96695.97
546447-4644789.18089.18
648684-4868493.47593.48
5min153894-53894103.479101.351.60103.48101.361.60
253465-53465102.655102.66
352437-52437100.681100.68
452948-52948101.663101.66
552468-52468100.741100.74
651514-5151498.90998.91
10min153894-53894103.479102.301.05103.48102.301.05
253823-53823103.343103.34
353289-53289102.317102.32
453243-53243102.229102.23
553060-53060101.878101.88
652368-52368100.549100.55
15min154154-54154103.978102.551.07103.98102.551.07
253747-53747103.197103.20
353471-53471102.667102.67
453471-53471102.667102.67
553119-53119101.991101.99
652485-52485100.774100.77
30min154071-54071103.819102.731.00103.82102.731.00
254057-54057103.792103.79
353420-53420102.569102.57
453463-53463102.651102.65
553383-53383102.498102.50
652622-52622101.037101.04
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%
116.635180551641516285192451609517210.27
216.665175651635516960.17
单位质量响应值RSD%判断
3110.103103.000.17数据可信
中间条件36月-供试品溶液-2022101011批-水
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
2min149412-4941294.86293.532.3394.8693.532.33
249116-4911694.29494.29
349077-4907794.21994.22
448071-4807192.28792.29
549891-4989195.78295.78
646749-4674989.74989.75
5min152263-52263100.33599.590.66100.3499.590.66
251976-5197699.78499.78
352027-5202799.88299.88
451322-5132298.52998.53
552022-5202299.87399.87
651633-5163399.12699.13
10min152618-52618101.017100.560.49101.02100.560.50
252523-52523100.834100.83
352562-52562100.909100.91
451924-5192499.68599.68
552357-52357100.516100.52
652286-52286100.380100.38
15min152740-52740101.251100.770.71101.25100.770.71
252859-52859101.480101.48
352650-52650101.078101.08
451837-5183799.51899.52
552329-52329100.462100.46
652512-52512100.813100.81
30min152778-52778101.324100.940.59101.32100.940.59
252738-52738101.247101.25
352994-52994101.739101.74
452205-52205100.224100.22
552298-52298100.403100.40
652468-52468100.729100.73
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%
116.635126251376513395130951232513040.12
216.665146151494514780.05
单位质量响应值RSD%判断
3085.033089.920.12数据可信
中间条件36月-供试品溶液-2022101111批-水
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
2min148957-4895794.56992.252.1294.5792.252.12
248270-4827093.24293.24
347550-4755091.85191.85
446262-4626289.36389.36
547001-4700190.79190.79
648492-4849293.67193.67
5min151301-5130199.09798.441.1899.1098.441.18
251262-5126299.02299.02
351385-5138599.25999.26
450527-5052797.60297.60
549929-4992996.44796.45
651360-5136099.21199.21
10min151404-5140499.29699.461.0599.3099.461.05
251831-51831100.121100.12
352123-52123100.685100.68
451149-5114998.80398.80
550644-5064497.82897.83
651786-51786100.034100.03
15min151385-5138599.25999.581.0099.2699.581.00
251881-51881100.217100.22
352168-52168100.772100.77
451328-5132899.14999.15
550729-5072997.99297.99
651831-51831100.121100.12
30min151674-5167499.818100.200.8899.82100.200.88
251975-51975100.399100.40
352654-52654101.711101.71
451754-5175499.97299.97
551274-5127499.04599.04
651908-51908100.270100.27
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