拉莫三嗪片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)0
对照品批号100775-201902对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.7对照品水分(%)0对照品稀释倍数200
标示量(mg)50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%
111.325852575853525847455855465854795852760.06
211.305860405858015859200.03
单位质量响应值RSD%判断
51702.8351851.330.21数据可信
长期24月-供试品溶液-pH1.0
批号样品(片)A1A2A平均溶出量(%)平均(%)RSD%置信区间
2024030121156003756006156004997.0698.211.2796.91%～99.51%
257261557278957270299.25
355737655729655733696.59
456631556608456620098.12
556807356800156803798.44
657592557606057599299.82
2024030221156951956990956971498.7398.771.9096.81%～100.74%
257095457097057096298.95
3589469590018589744102.20
455853355857755855596.80
556201756237356219597.43
656842656865056853898.53
2024030321157579657562557571099.7799.601.7197.81%～101.38%
256111056097756104497.23
3587241587343587292101.78
456525556538556532097.97
5580706580852580779100.65
6578148577834577991100.17
拉莫三嗪片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)0
对照品批号100775-201902对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.7对照品水分(%)0对照品稀释倍数200
标示量(mg)50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%
111.325857515853375856035853465854525854980.04
211.305848305845335846820.04
单位质量响应值RSD%判断
51722.4451741.770.03数据可信
中间条件24月-供试品溶液-pH1.0
批号样品(片)A1A2A平均溶出量(%)平均(%)RSD%置信区间
20240301211580425580450580438100.6898.871.4797.35%～100.39%
255943255959455951397.05
356479756495556487697.98
4577289577736577512100.17
557350157340457345299.47
656412456419556416097.85
2024030221156262056258556260297.5897.781.3396.43%～99.14%
256952857004056978498.83
356064756032456048697.22
457239157215857227499.26
556590256612056601198.18
655159855124455142195.64
20240303211579010579066579038100.4399.641.7397.84%～101.45%
257054557027457041098.94
3588913589092589002102.16
457653957617057635499.97
555906455895155900896.96
657330557291857311299.41
拉莫三嗪片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)0
对照品批号100775-201902对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.7对照品水分(%)0对照品稀释倍数200
标示量(mg)50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%
111.321164695116430611643691164407116472111645000.02
211.301163495116397511637350.03
单位质量响应值RSD%判断
102871.02102985.400.08数据可信
长期24月-供试品溶液-pH1.0
批号样品(片)A1A2A平均溶出量(%)平均(%)RSD%置信区间
20240301211115398011537201153850100.59101.331.13100.14%～102.52%
2115196811520531152010100.43
3115855911585291158544101.00
4117630511765081176406102.56
5115180711525531152180100.44
6118116311812451181204102.97
2024030221111183081118723111851697.5199.641.3498.24%～101.04%
211339851134300113414298.87
3115519311550181155106100.70
4115947711594471159462101.08
511396181139625113962299.35
6115098411510801151032100.34
2024030321111375311137338113743499.1699.741.1798.51%～100.96%
211309311131230113108098.60
311309891131007113099898.60
4115549411565591156026100.78
511456711145683114567799.88
6116300211631011163052101.39
拉莫三嗪片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)0
对照品批号100775-201902对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.7对照品水分(%)0对照品稀释倍数200
标示量(mg)50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%
111.321164747116550111660651165865116572311655800.05
211.301164584116513911648620.04
单位质量响应值RSD%判断
102966.43103085.130.09数据可信
中间条件24月-供试品溶液-pH1.0
批号样品(片)A1A2A平均溶出量(%)平均(%)RSD%置信区间
2024030121111481611147923114804299.99100.320.5299.78%～100.86%
211438591143526114369299.61
3114851411481421148328100.01
4115630011562741156287100.71
5115813711584011158269100.88
6115615711562961156226100.70
2024030221111366801136620113665099.00100.010.9699.01%～101.01%
2115139111511411151266100.27
3115191011518181151864100.32
4116635311671301166742101.62
511389351139079113900799.20
611442731144351114431299.66
20240303211115207811517111151894100.3299.841.3098.49%～101.20%
2116582311654051165614101.52
311326551132837113274698.66
411389701138609113879099.18
5115999811591881159593100.99
611294931129754112962498.38
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