玛巴洛沙韦干混悬剂项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号DQTL-4125-250109对照品来源自制对照品使用方法直接使用
对照品含量(%)99.77对照品水分(%)0对照品稀释倍数2500
标示量(mg)40供试品稀释倍数10系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.079613896181962639627296413962530.11
211.069646396442964520.02
单位质量响应值RSD%判断
8694.948720.800.21数据可信
影响因素5天-供试品溶液-pH6.8(内含0.16%CTAB)
批号样品(片)A1A2A平均溶出量(%)平均(%)RSD%置信区间
2025090921批180041800008002082.5189.724.4985.50%～93.95%
285659855538560688.27
387527871488733890.06
490232903169027493.09
590834904459064093.47
687985883968819090.94
2025090921批188828885958871291.4892.592.2990.37%～94.80%
287255874198733790.06
389005891218906391.84
491138909689105393.89
589330894228937692.16
693192931859318896.09
2025090921批186196864968634689.0493.982.6891.34%～96.62%
293152929289304095.94
391112913189121594.06
492641926469264495.53
591682915069159494.45
692172918289200094.87
玛巴洛沙韦干混悬剂项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号DQTL-4125-250109对照品来源自制对照品使用方法直接使用
对照品含量(%)99.77对照品水分(%)0对照品稀释倍数2500
标示量(mg)40供试品稀释倍数10系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.079615496259961779634496205962280.08
211.069658896312964500.21
单位质量响应值RSD%判断
8692.688720.610.23数据可信
影响因素10天-供试品溶液-pH6.8(内含0.16%CTAB)
批号样品(片)A1A2A平均溶出量(%)平均(%)RSD%置信区间
2025090921批186954869628695889.6890.981.6589.41%～92.54%
287029873658719789.93
388035877108787290.62
490379899189014892.97
587176871658717089.90
690146897288993792.75
2025090921批188030882288812990.8993.772.7791.05%～96.48%
288129880918811090.87
390936907969086693.71
491795917599177794.65
594681946409466097.62
691945920189198294.86
2025090921批189168888858902691.8193.612.9290.75%～96.47%
287576870418730890.04
389442893768940992.21
491723914469158494.45
593419926099301495.93
694053945069428097.23
玛巴洛沙韦干混悬剂项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号DQTL-4125-250109对照品来源自制对照品使用方法直接使用
对照品含量(%)99.77对照品水分(%)0对照品稀释倍数2500
标示量(mg)40供试品稀释倍数10系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.079702997191968719708496646969640.22
211.069682896486966570.26
单位质量响应值RSD%判断
8759.178739.330.17数据可信
影响因素5天-供试品溶液-pH6.8(内含0.16%CTAB)
批号样品(片)A1A2A平均溶出量(%)平均(%)RSD%置信区间
2025090921批191629911719140093.8096.682.0094.65%～98.71%
295116949419502897.53
392851927889282095.26
496293957909604298.57
593610940079380896.27
696019962519613598.66
2025090921批195221955149536897.8897.852.5795.22%～100.48%
291195915569137693.78
396107962459617698.70
497449973369739299.95
593732938599379696.26
6978639803897950100.53
2025090921批192028919879200894.4397.772.0595.67%～99.86%
295108954869529797.80
3975769760997592100.16
496713963449652899.07
594225943649429496.77
695662960469585498.37
玛巴洛沙韦干混悬剂项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号DQTL-4125-250109对照品来源自制对照品使用方法直接使用
对照品含量(%)99.77对照品水分(%)0对照品稀释倍数2500
标示量(mg)40供试品稀释倍数10系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.079618996669963919675996700965420.26
211.069629296279962860.01
单位质量响应值RSD%判断
8721.058705.790.13数据可信
影响因素10天-供试品溶液-pH6.8(内含0.16%CTAB)
批号样品(片)A1A2A平均溶出量(%)平均(%)RSD%置信区间
2025090921批195990955319576098.6897.281.3695.89%～98.66%
293351933849336896.22
394246943319428897.17
496076958019593898.87
592507928919269995.53
694318943339432697.20
2025090921批192062918919197694.7899.432.7196.60%～102.25%
295485958189565298.57
396577966779662799.58
496634965259658099.53
5989899862698808101.82
6991759933499254102.28
2025090921批196726965199662299.57100.471.3299.09%～101.86%
296182958789603098.96
3980609802598042101.03
4987809854998664101.67
596603964309651699.46
6991289911499121102.15
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