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%
117.035588955975558565609756230560090.28
217.105659256370564810.28
单位质量响应值RSD%判断
3288.843302.980.31数据可信
中间条件36月-供试品溶液-2022100911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%
2min150746-5074691.82690.483.8291.8390.483.82
250004-5000490.48390.48
349378-4937889.35189.35
449646-4964689.83689.84
547195-4719585.40085.40
653045-5304595.98695.99
5min154626-5462698.84797.972.0798.8597.972.07
254247-5424798.16198.16
353846-5384697.43697.44
453354-5335496.54596.55
552772-5277295.49295.49
655989-55989101.313101.31
10min155098-5509899.70199.151.5799.7099.151.57
254965-5496599.46099.46
354421-5442198.47698.48
454176-5417698.03398.03
553848-5384897.43997.44
656261-56261101.806101.81
15min155190-5519099.86899.561.4699.8799.561.46
255040-5504099.59699.60
354829-5482999.21499.21
454424-5442498.48198.48
554177-5417798.03498.03
656465-56465102.175102.17
30min155444-55444100.32799.981.23100.3399.981.23
255358-55358100.172100.17
354806-5480699.17399.17
454828-5482899.21299.21
554612-5461298.82298.82
656453-56453102.153102.15
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%
117.035619456419561725619556465562890.26
217.105607256447562600.48
单位质量响应值RSD%判断
3305.283290.060.33数据可信
中间条件36月-供试品溶液-2022101011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%
2min151102-5110292.42190.352.1792.4290.352.17
250225-5022590.83590.83
349833-4983390.12690.13
450820-5082091.91191.91
548046-4804686.89486.89
649719-4971989.92089.92
5min154714-5471498.95398.211.4298.9598.201.42
254199-5419998.02298.02
354277-5427798.16398.16
453813-5381397.32497.32
553281-5328196.36296.36
655519-55519100.409100.41
10min155403-55403100.20098.940.81100.2098.940.81
254792-5479299.09599.09
354261-5426198.13498.13
454380-5438098.34998.35
554423-5442398.42798.43
654992-5499299.45699.46
15min155499-55499100.37399.100.80100.3799.100.80
254971-5497199.41899.42
354685-5468598.90198.90
454466-5446698.50598.50
554255-5425598.12398.12
654901-5490199.29299.29
30min155555-55555100.47499.141.02100.4799.141.01
254881-5488199.25599.26
354282-5428298.17298.17
454501-5450198.56898.57
554289-5428998.18598.18
655382-55382100.162100.16
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%
117.035614255956562535608856070561020.20
217.105639256223563080.22
单位质量响应值RSD%判断
3294.303292.870.04数据可信
中间条件36月-供试品溶液-2022101111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%
2min151076-5107692.48889.553.7792.4989.553.77
250100-5010090.72190.72
348712-4871288.20788.21
451628-5162893.48893.49
548636-4863688.07088.07
646564-4656484.31884.32
5min155219-5521999.99098.531.8499.9998.531.84
254664-5466498.98598.99
354733-5473399.11099.11
455476-55476100.456100.46
553314-5331496.54196.54
653056-5305696.07396.07
10min155848-55848101.129100.752.13101.13100.752.13
255839-55839101.113101.11
355773-55773100.993100.99
457570-57570104.247104.25
554598-5459898.86698.87
654194-5419498.13498.13
15min156509-56509102.326101.021.76102.33101.021.76
256062-56062101.517101.52
356176-56176101.723101.72
456808-56808102.868102.87
554850-5485099.32299.32
654337-5433798.39398.39
30min156609-56609102.507101.401.56102.51101.401.57
256391-56391102.112102.11
356113-56113101.609101.61
456971-56971103.163103.16
555202-5520299.95999.96
654697-5469799.04599.04
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