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%
117.035703856699570645686656895569120.26
217.105666156637566490.03
单位质量响应值RSD%判断
3341.873312.810.62数据可信
中间条件36月-供试品溶液-2022100911批-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%
2min154863-5486398.34096.922.3298.3496.922.32
254164-5416497.08797.09
353136-5313695.24495.24
455454-5545499.39999.40
552085-5208593.36093.36
654734-5473498.10898.11
5min157253-57253102.624102.321.62102.62102.321.62
257204-57204102.536102.54
357272-57272102.658102.66
458115-58115104.169104.17
555333-5533399.18299.18
657320-57320102.744102.74
10min157379-57379102.849102.891.66102.85102.881.66
257588-57588103.224103.22
357688-57688103.403103.40
458711-58711105.237105.24
555774-5577499.97399.97
657255-57255102.627102.63
15min157302-57302102.711102.641.38102.71102.641.38
257563-57563103.179103.18
357315-57315102.735102.73
458330-58330104.554104.55
555895-55895100.189100.19
657171-57171102.477102.48
30min156818-56818101.844102.321.49101.84102.321.49
257248-57248102.615102.61
357545-57545103.147103.15
458265-58265104.438104.44
555715-5571599.86799.87
656896-56896101.984101.98
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%
117.035674456870564915658256794566960.28
217.105707456929570020.18
单位质量响应值RSD%判断
3329.183333.450.10数据可信
中间条件36月-供试品溶液-2022101011批-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%
2min153826-5382696.36494.801.7996.3694.801.79
253048-5304894.97194.97
352233-5223393.51293.51
452347-5234793.71693.72
551947-5194793.00093.00
654301-5430197.21497.21
5min156866-56866101.80699.701.37101.8199.701.38
256162-56162100.546100.55
355396-5539699.17599.17
454887-5488798.26398.26
554955-5495598.38598.39
655870-55870100.023100.02
10min156583-56583101.300100.111.02101.30100.111.02
256433-56433101.031101.03
355838-5583899.96699.97
455254-5525498.92098.92
555280-5528098.96798.97
656119-56119100.469100.47
15min156513-56513101.174100.110.95101.17100.110.95
256413-56413100.995101.00
355676-5567699.67699.68
455289-5528998.98398.98
555413-5541399.20599.20
656215-56215100.641100.64
30min156662-56662101.441100.361.18101.44100.361.18
256274-56274100.746100.75
355829-5582999.95099.95
455362-5536299.11499.11
555324-5532499.04699.05
656885-56885101.840101.84
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%
117.035676656831567835681856720567840.08
217.105675656787567720.04
单位质量响应值RSD%判断
3334.353320.000.31数据可信
中间条件36月-供试品溶液-2022101111批-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%
2min154244-5424497.23395.422.3097.2395.422.30
253142-5314295.25895.26
351188-5118891.75591.76
452581-5258194.25294.25
554477-5447797.65197.65
653760-5376096.36696.37
5min156536-56536101.342100.701.29101.34100.701.29
255882-55882100.170100.17
355230-5523099.00199.00
455919-55919100.236100.24
557367-57367102.831102.83
656138-56138100.628100.63
10min156560-56560101.385101.051.05101.38101.041.05
256162-56162100.671100.67
355536-5553699.54999.55
456237-56237100.806100.81
557341-57341102.785102.78
656388-56388101.077101.08
15min156821-56821101.853101.210.81101.85101.200.81
256119-56119100.594100.59
355844-55844100.101100.10
456480-56480101.242101.24
557098-57098102.349102.35
656397-56397101.093101.09
30min156498-56498101.274101.140.74101.27101.140.74
256227-56227100.788100.79
355851-55851100.114100.11
456283-56283100.888100.89
557087-57087102.330102.33
656597-56597101.451101.45
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