比拉斯汀口崩片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)0
对照品批号D1BSF0200923对照品来源自制对照品使用方法直接使用
对照品含量(%)99.6对照品水分(%)0对照品稀释倍数500
标示量(mg)20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%
111.083765673772463764423773413777073770610.15
211.003773133775563774340.05
单位质量响应值RSD%判断
34030.7834312.180.59数据可信
加速2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
1批119143419104819124150.1750.521.5749.69%～51.35%
219252019324919288450.60
319143819133619138750.21
419788819811519800251.94
519279519300319289950.60
618890018911218900649.58
1批119504419511019507751.1750.121.7049.22%～51.01%
218989918990218990049.82
319299719304319302050.63
418712818711618712249.09
518785418772818779149.26
619326619346819336750.73
1批118562318668618615448.8350.021.3449.32%～50.72%
219233019227619230350.45
319011418996619004049.85
419093819121519107650.12
519358819354119356450.78
619094219083619088950.08
比拉斯汀口崩片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)0
对照品批号D1BSF0200923对照品来源自制对照品使用方法直接使用
对照品含量(%)99.6对照品水分(%)0对照品稀释倍数500
标示量(mg)20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%
111.083780163779423779443782553787823781880.10
211.003781093789283785180.16
单位质量响应值RSD%判断
34132.4934410.730.58数据可信
中间条件9月-供试品溶液
批号样品(片)A1A2A平均溶出量(%)平均(%)RSD%置信区间
1批137682937698737690898.58100.401.5398.80%～102.00%
2383600383867383734100.37
3386851386368386610101.12
437762737771137766998.78
5385876385762385819100.92
6392196392438392317102.62
1批1387985387643387814101.44100.271.3298.89%～101.66%
2388528387872388200101.54
3382336383171382754100.11
4382834382547382690100.10
5384340384521384430100.55
637413337447237430297.90
1批138083338054638069099.57100.651.8498.70%～102.59%
2394768394845394806103.27
3389369389742389556101.89
437983738032238008099.41
537596337580437588498.32
6388941386555387748101.42
比拉斯汀口崩片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)0
对照品批号D1BSF0200923对照品来源自制对照品使用方法直接使用
对照品含量(%)99.6对照品水分(%)0对照品稀释倍数500
标示量(mg)20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%
111.083783493783363783573782813781123782870.03
211.003797773795223796500.05
单位质量响应值RSD%判断
34141.4334513.640.77数据可信
加速2月-供试品溶液
批号样品(片)A1A2A平均溶出量(%)平均(%)RSD%置信区间
1批119091719106619099249.8850.231.5249.44%～51.03%
219289519326419308050.42
319156419146819151650.01
419785719746519766151.62
519176019190319183250.09
618915318906318910849.38
1批119425919460619443250.7749.841.5549.04%～50.65%
219012119026619019449.67
319250219287219268750.32
418672518664718668648.75
518836418851518844049.21
619281619276719279250.35
1批118698618694418696548.8249.690.9849.19%～50.20%
219109919128419119249.93
318970818993518982249.57
419098719098419098649.87
519238219241019239650.24
619034619047819041249.72
比拉斯汀口崩片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)0
对照品批号D1BSF0200923对照品来源自制对照品使用方法直接使用
对照品含量(%)99.6对照品水分(%)0对照品稀释倍数500
标示量(mg)20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%
111.083792023785363772703796523792973787910.25
211.003702513664803683660.73
单位质量响应值RSD%判断
34186.9133487.821.47数据可信
中间条件9月-供试品溶液
批号样品(片)A1A2A平均溶出量(%)平均(%)RSD%置信区间
1批137409837430037419999.14101.531.5799.86%～103.20%
2381585381924381754101.14
3386842386712386777102.47
4379016379339379178100.46
5386723386929386826102.49
6390596390646390621103.49
1批1386814387111386962102.52101.361.3399.95%～102.76%
2387205387727387466102.66
3383351382980383166101.52
4380725380496380610100.84
5383623383438383530101.61
637368637367437368099.00
1批1381319381692381506101.08101.911.52100.29%～103.54%
2393519393762393640104.29
3389294389432389363103.16
4380588380939380764100.88
5378235378073378154100.19
6384619384437384528101.88
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