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%
111.161918741914701914971913611913581915120.12
211.171908031906921907480.05
单位质量响应值RSD%判断
17160.5717076.810.35数据可信
供试品溶液-2025073121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%
5min1123754-12375464.80365.001.1364.8065.001.13
2126478-12647866.22966.23
3124108-12410864.98864.99
4122353-12235364.06964.07
5123354-12335464.59364.59
6124722-12472265.31065.31
10min1160223-16022383.89984.290.8784.0184.400.87
2163644-16364485.69185.80
3160932-16093284.27184.38
4159610-15961083.57883.69
5160690-16069084.14484.25
6160715-16071584.15784.27
15min1177056-17705692.71493.210.6392.9693.450.64
2179925-17992594.21694.47
3178157-17815793.29093.54
4177551-17755192.97393.22
5176865-17686592.61492.86
6178412-17841293.42493.67
20min1185515-18551597.14397.691.3797.5598.101.37
2191473-191473100.263100.67
3186366-18636697.58997.99
4184509-18450996.61797.02
5184809-18480996.77497.18
6186719-18671997.77498.18
30min1191413-191413100.232100.380.64100.80100.950.64
2193546-193546101.349101.93
3191558-191558100.308100.87
4190104-19010499.546100.11
5190943-19094399.986100.55
6192608-192608100.857101.43
极限1193583-193583101.368101.451.55102.10102.181.54
2199471-199471104.451105.20
3192779-192779100.947101.68
4191065-191065100.050100.78
5191803-191803100.436101.17
6193723-193723101.441102.18
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%
111.161907121909411909811906801909451908520.08
211.171908861907261908060.06
单位质量响应值RSD%判断
17101.4317082.010.09数据可信
供试品溶液-2025073121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%
5min1123095-12309564.55965.653.8864.5665.653.88
2123848-12384864.95464.95
3126630-12663066.41366.41
4120825-12082563.36863.37
5134264-13426470.41770.42
6122381-12238164.18564.18
10min1158930-15893083.35384.853.2183.4684.963.21
2159175-15917583.48283.59
3164503-16450386.27686.39
4157668-15766882.69182.80
5171206-17120689.79189.91
6159266-15926683.52983.64
15min1175730-17573092.16493.762.8192.4194.012.82
2177337-17733793.00793.25
3183759-18375996.37596.63
4172638-17263890.54390.79
5185846-18584697.47097.74
6177290-17729092.98293.23
20min1183706-18370696.34797.992.4996.7598.402.49
2186129-18612997.61898.02
3192050-192050100.723101.14
4180844-18084494.84695.24
5192603-192603101.013101.44
6185684-18568497.38597.79
30min1189502-18950299.387101.092.6399.95101.662.63
2191901-191901100.645101.21
3197166-197166103.407103.99
4186143-18614397.62598.18
5200004-200004104.895105.49
6191804-191804100.594101.16
极限1190457-19045799.888101.282.13100.61102.022.14
2193281-193281101.369102.10
3198463-198463104.087104.84
4187330-18733098.24898.96
5196933-196933103.284104.06
6192254-192254100.830101.56
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%
111.161907191911041915181914241915421912610.19
211.171916081915981916030.01
单位质量响应值RSD%判断
17138.0817153.360.07数据可信
供试品溶液-2025080121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%
5min1123570-12357064.60467.773.4764.6067.773.47
2130046-13004667.99067.99
3134357-13435770.24470.24
4127316-12731666.56266.56
5135179-13517970.67370.67
6127306-12730666.55766.56
10min1158263-15826382.74286.282.9582.8586.402.95
2165840-16584086.70386.82
3170506-17050689.14389.26
4162259-16225984.83184.94
5170470-17047089.12489.24
6162886-16288685.15985.27
15min1173291-17329190.59994.112.3390.8494.372.33
2180427-18042794.33094.59
3184045-18404596.22196.49
4178091-17809193.10893.36
5184693-18469396.56096.83
6179484-17948493.83794.09
20min1180235-18023594.22997.622.1894.6398.042.18
2186941-18694197.73598.15
3190790-19079099.747100.17
4184044-18404496.22196.63
5190686-19068699.693100.12
6187653-18765398.10798.52
30min1184137-18413796.26999.962.1496.82100.532.14
2191691-191691100.219100.80
3193927-193927101.388101.98
4189103-18910398.86599.43
5195573-195573102.248102.84
6192703-192703100.748101.32
极限1185694-18569497.083100.542.0797.80101.282.07
2192031-192031100.396101.14
3195883-195883102.410103.17
4190087-19008799.380100.11
5196121-196121102.535103.30
6194019-194019101.436102.18
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%
111.161915631910421910181911521914161912380.13
211.171905831907931906880.08
单位质量响应值RSD%判断
17136.0217071.440.27数据可信
供试品溶液-2025080121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%
5min1130224-13022468.25069.092.0768.2569.092.07
2132288-13228869.33269.33
3133776-13377670.11270.11
4135829-13582971.18871.19
5130696-13069668.49868.50
6128189-12818967.18467.18
10min1166204-16620487.10787.931.3687.2288.041.37
2167300-16730087.68287.80
3168362-16836288.23888.36
4172104-17210490.19990.32
5166434-16643487.22887.34
6166232-16623287.12287.23
15min1181107-18110794.91895.561.5495.1895.821.54
2184272-18427296.57796.84
3182330-18233095.55995.82
4186476-18647697.73298.00
5181556-18155695.15395.41
6178285-17828593.43993.70
20min1187127-18712798.07398.631.2898.4999.051.28
2189157-18915799.13799.56
3188458-18845898.77099.19
4192073-192073100.665101.10
5187362-18736298.19698.61
6184920-18492096.91697.33
30min1191779-191779100.511101.011.06101.09101.591.06
2193866-193866101.605102.19
3192213-192213100.738101.33
4196017-196017102.732103.33
5192407-192407100.840101.42
6190057-19005799.608100.18
极限1191884-191884100.566101.210.93101.31101.960.93
2193845-193845101.594102.35
3192777-192777101.034101.79
4196350-196350102.907103.68
5192279-192279100.773101.52
6191514-191514100.372101.11
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%
111.161941461938531938511936481942941939580.14
211.171911221910641910930.03
单位质量响应值RSD%判断
17379.7517107.701.12数据可信
供试品溶液-2025080122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%
5min1135893-13589370.64769.072.7670.6569.072.76
2138331-13833171.91571.91
3131460-13146068.34368.34
4128425-12842566.76566.76
5132683-13268368.97868.98
6130379-13037967.78167.78
10min1170473-17047388.62487.042.6588.7487.152.66
2173953-17395390.43490.55
3166592-16659286.60786.72
4161218-16121883.81383.92
5167540-16754087.10087.21
6164729-16472985.63885.75
15min1185413-18541396.39194.412.5096.6694.672.50
2187771-18777197.61797.89
3180457-18045793.81594.07
4174939-17493990.94691.20
5181473-18147394.34394.60
6179594-17959493.36693.62
20min1191315-19131599.46097.542.2599.8997.962.25
2193309-193309100.496100.93
3186656-18665697.03897.45
4181529-18152994.37294.77
5187415-18741597.43297.85
6185498-18549896.43696.85
30min1194863-194863101.30499.482.13101.90100.062.14
2196454-196454102.131102.73
3190611-19061199.09499.67
4184915-18491596.13296.69
5191544-19154499.579100.16
6189731-18973198.63699.21
极限1196788-196788102.30599.762.28103.07100.512.28
2196290-196290102.046102.82
3190644-19064499.11199.85
4184908-18490896.12996.85
5192090-19209099.863100.61
6190661-19066199.12099.86
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%
111.161913201913231910321913851913811912880.08
211.171912311913651912980.05
单位质量响应值RSD%判断
17140.5017126.050.06数据可信
供试品溶液-2025080122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%
5min1135510-13551070.89869.511.4070.9069.511.40
2133391-13339169.78969.79
3133421-13342169.80569.80
4132410-13241069.27669.28
5129815-12981567.91867.92
6132630-13263069.39169.39
10min1169143-16914388.49487.520.8388.6187.640.84
2167321-16732187.54187.66
3168200-16820088.00188.12
4166098-16609886.90187.02
5165333-16533386.50186.61
6167627-16762787.70187.82
15min1181858-18185895.14794.670.6795.4194.930.67
2180363-18036394.36594.63
3182408-18240895.43495.70
4179632-17963293.98294.24
5179712-17971294.02494.28
6181729-18172995.07995.34
20min1186598-18659897.62798.570.6198.0598.980.61
2189261-18926199.02099.44
3188827-18882798.79399.21
4189457-18945799.12299.54
5187354-18735498.02298.44
6188854-18885498.80799.23
30min1190664-19066499.75499.920.71100.34100.500.71
2190115-19011599.467100.05
3192716-192716100.828101.41
4189234-18923499.00699.59
5190733-19073399.790100.37
6192433-192433100.679101.26
极限1190039-19003999.427100.150.97100.18100.900.97
2190447-19044799.640100.39
3193378-193378101.174101.93
4189932-18993299.371100.12
5190561-19056199.700100.44
6194163-194163101.585102.34
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