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)1.5
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%
111.161893921892291901191902441897141897400.24
211.171896711896101896400.03
单位质量响应值RSD%判断
17001.7916977.620.11数据可信
供试品溶液-2025073121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%
5min1134580-13458071.00672.303.0571.0172.303.04
2135285-13528571.37871.38
3135504-13550471.49471.49
4135818-13581871.65971.66
5145492-14549276.76476.76
6135495-13549571.48971.49
10min1174985-17498592.32592.821.6992.4492.941.69
2175055-17505592.36192.48
3176217-17621792.97593.09
4173753-17375391.67491.79
5181665-18166595.84995.98
6173835-17383591.71891.84
15min1184982-18498297.59998.181.3197.8798.461.32
2185472-18547297.85898.13
3186661-18666198.48598.76
4185279-18527997.75698.03
5190604-190604100.565100.85
6183500-18350096.81797.09
20min1187506-18750698.93199.681.4599.37100.121.45
2188643-18864399.53199.97
3191074-191074100.813101.25
4188486-18848699.44899.88
5192796-192796101.722102.18
6185026-18502697.62298.06
30min1189517-18951799.992100.441.34100.59101.041.34
2189779-189779100.130100.73
3190950-190950100.748101.35
4189974-189974100.233100.83
5194825-194825102.792103.42
6187103-18710398.71899.31
极限1189338-18933899.897100.481.17100.66101.251.17
2189971-189971100.231101.00
3192221-192221101.418102.19
4189774-189774100.127100.90
5193808-193808102.256103.05
6187561-18756198.96099.72
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)1.5
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%
111.161932091931121918291912921916171922120.47
211.171908671909841909260.05
单位质量响应值RSD%判断
17223.3017092.750.54数据可信
供试品溶液-2025073121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%
5min1137774-13777471.97971.342.3571.9871.342.35
2138338-13833872.27472.27
3141295-14129573.81973.82
4133795-13379569.90169.90
5135421-13542170.75070.75
6132635-13263569.29569.29
10min1178852-17885293.44091.162.2693.5691.282.26
2174892-17489291.37291.49
3178252-17825293.12793.25
4169782-16978288.70288.82
5175277-17527791.57391.69
6169868-16986888.74788.86
15min1186784-18678497.58495.941.7497.8696.211.74
2183406-18340695.82096.09
3186946-18694697.66997.95
4178208-17820893.10493.37
5183524-18352495.88196.15
6182979-18297995.59795.86
20min1190438-19043899.49397.602.1099.9398.042.10
2187226-18722697.81598.25
3188717-18871798.59499.04
4179206-17920693.62594.04
5187440-18744097.92798.36
6187897-18789798.16698.59
30min1194536-194536101.63498.072.52102.2498.662.51
2188428-18842898.44399.04
3188063-18806398.25398.86
4179701-17970193.88494.46
5187713-18771398.07098.66
6187801-18780198.11698.70
极限1191961-191961100.28998.021.98101.0698.781.97
2189298-18929898.89899.66
3187968-18796898.20398.97
4180810-18081094.46395.20
5187544-18754497.98198.74
6188095-18809598.26999.02
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)1.5
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%
111.161909371910091908621908131907001908640.07
211.171911991906261909120.22
单位质量响应值RSD%判断
17102.5117091.500.05数据可信
供试品溶液-2025080121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%
5min1143845-14384575.41879.843.4675.4279.843.46
2159508-15950883.63083.63
3153103-15310380.27280.27
4151734-15173479.55579.55
5150163-15016378.73178.73
6155353-15535381.45281.45
10min1178803-17880393.74796.692.0893.8796.822.08
2189144-18914499.16999.31
3186125-18612597.58697.72
4181294-18129495.05395.19
5184106-18410696.52796.66
6186988-18698898.03898.17
15min1188176-18817698.661100.902.1298.94101.192.12
2196354-196354102.949103.25
3193236-193236101.314101.61
4188790-18879098.98399.27
5190158-19015899.70099.99
6197937-197937103.779104.08
20min1191140-191140100.215102.371.90100.66102.831.90
2200446-200446105.094105.57
3195582-195582102.544103.01
4192396-192396100.874101.33
5193217-193217101.304101.76
6198733-198733104.196104.67
30min1192694-192694101.030102.682.07101.64103.312.07
2201051-201051105.412106.06
3197986-197986103.805104.44
4191522-191522100.415101.04
5192583-192583100.972101.60
6199152-199152104.416105.06
极限1189698-18969899.459103.122.60100.24103.932.60
2204390-204390107.162107.99
3196931-196931103.251104.06
4193707-193707101.561102.35
5195311-195311102.402103.20
6200096-200096104.911105.73
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)1.5
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%
111.161910991908411906131906161904531907240.14
211.171905251900831903040.17
单位质量响应值RSD%判断
17089.9617037.060.22数据可信
供试品溶液-2025080121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%
5min1148946-14894678.24678.102.8978.2578.102.89
2144787-14478776.06176.06
3148380-14838077.94977.95
4152832-15283280.28880.29
5153951-15395180.87580.88
6143057-14305775.15375.15
10min1182727-18272795.99295.671.5096.1295.801.51
2179516-17951694.30694.43
3182214-18221495.72395.85
4182608-18260895.93096.06
5186607-18660798.03198.17
6179003-17900394.03694.16
15min1189282-18928299.436100.312.3199.73100.602.31
2189872-18987299.746100.03
3188086-18808698.80899.10
4193788-193788101.803102.10
5198333-198333104.191104.49
6186268-18626897.85398.13
20min1190536-190536100.095100.871.31100.55101.331.32
2190332-19033299.988100.44
3191962-191962100.844101.30
4192949-192949101.362101.83
5196550-196550103.254103.73
6189756-18975699.685100.13
30min1192750-192750101.258101.451.99101.88102.081.98
2188859-18885999.21499.83
3195716-195716102.816103.44
4195411-195411102.656103.29
5197622-197622103.817104.46
6188365-18836598.95499.57
极限1193851-193851101.836101.451.23102.63102.251.23
2193381-193381101.589102.37
3192182-192182100.959101.75
4194499-194499102.177102.98
5195830-195830102.876103.69
6188983-18898399.279100.06
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)1.5
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%
111.161911231905531908711903601904401906690.17
211.171918011914291916150.14
单位质量响应值RSD%判断
17085.0417154.430.29数据可信
供试品溶液-2025080122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%
5min1153791-15379180.52681.212.4380.5381.212.42
2156297-15629781.83881.84
3151671-15167179.41679.42
4154230-15423080.75680.76
5152542-15254279.87279.87
6162044-16204484.84884.85
10min1185213-18521396.97997.481.7697.1197.611.76
2186387-18638797.59497.73
3184752-18475296.73896.87
4185914-18591497.34697.48
5182490-18249095.55395.69
6192213-192213100.644100.79
15min1190576-19057699.787100.211.38100.08100.501.38
2194862-194862102.031102.33
3193429-193429101.281101.57
4190911-19091199.963100.26
5187213-18721398.02698.32
6191263-191263100.147100.46
20min1192017-192017100.542100.911.45101.00101.371.45
2195684-195684102.462102.93
3191325-191325100.179100.64
4193192-193192101.157101.62
5188416-18841698.65699.11
6195661-195661102.450102.93
30min1197486-197486103.405101.051.34104.04101.681.34
2193106-193106101.112101.75
3190468-19046899.731100.36
4192773-192773100.938101.57
5190477-19047799.735100.36
6193584-193584101.362102.01
极限1194232-194232101.702102.351.46102.50103.161.45
2200812-200812105.147105.96
3194723-194723101.959102.75
4196173-196173102.718103.52
5192733-192733100.917101.70
6194192-194192101.681102.50
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)1.5
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%
111.161921411905661901431895471901741905140.52
211.171911901913251912580.05
单位质量响应值RSD%判断
17071.1517122.470.22数据可信
供试品溶液-2025080122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%
5min1156794-15679482.20980.963.0082.2180.963.00
2148441-14844177.82977.83
3155898-15589881.73981.74
4154246-15424680.87380.87
5150049-15004978.67278.67
6161072-16107284.45284.45
10min1187856-18785698.49597.891.8098.6398.021.80
2184048-18404896.49896.63
3189663-18966399.44299.58
4184803-18480396.89497.03
5182715-18271595.79995.93
6191102-191102100.197100.34
15min1193828-193828101.626101.141.47101.93101.441.48
2190144-19014499.69499.98
3195549-195549102.528102.83
4191211-191211100.254100.55
5190052-19005299.64699.94
6196608-196608103.083103.39
20min1199434-199434104.565102.651.39105.04103.121.39
2191277-191277100.288100.75
3196808-196808103.188103.66
4194586-194586102.023102.49
5195924-195924102.725103.18
6196613-196613103.086103.57
30min1195180-195180102.335102.121.52102.98102.761.51
2190110-19011099.676100.30
3194741-194741102.105102.75
4193186-193186101.289101.92
5196812-196812103.190103.82
6198608-198608104.132104.78
极限1194439-194439101.946102.171.08102.76102.981.08
2192048-192048100.693101.48
3194671-194671102.068102.88
4193489-193489101.448102.25
5197099-197099103.341104.14
6197479-197479103.540104.37
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