比拉斯汀片项目信息
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%
110.983777943777393774413774433773103775450.06
211.063778503779703779100.03
单位质量响应值RSD%判断
34384.7934169.080.45数据可信
供试品溶液-24090201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%
5min1272192-27219271.18471.085.3871.1871.085.38
2286193-28619374.84574.85
3256986-25698667.20767.21
10min1327439-32743985.63284.814.5085.7584.934.50
2337034-33703488.14188.27
3308403-30840380.65380.77
15min1344376-34437690.06188.894.3090.3289.154.30
2351722-35172291.98292.25
3323572-32357284.62084.87
20min1351259-35125991.86190.434.0292.2790.844.02
2356079-35607993.12293.55
3329992-32999286.29986.69
30min1355971-35597193.09391.443.9893.6692.003.99
2359283-35928393.96094.54
3333701-33370187.26987.80
45min1361201-36120194.46192.403.9295.1893.113.92
2361453-36145394.52795.26
3337356-33735688.22588.90
极限1380704-38070499.56298.221.41100.4499.081.43
2375784-37578498.27599.17
3370182-37018296.81097.63
比拉斯汀片项目信息
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%
110.983772133765693766313766253771693768410.09
211.063771133767133769130.08
单位质量响应值RSD%判断
34320.6734078.930.50数据可信
供试品溶液-24090202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%
5min1277195-27719572.65669.643.8272.6669.643.82
2261850-26185068.63468.63
3258075-25807567.64467.64
10min1330321-33032186.58082.864.1786.7082.984.17
2313748-31374882.23782.35
3304315-30431579.76479.88
15min1347419-34741991.06287.114.2091.3387.374.21
2329800-32980086.44486.70
3319859-31985983.83884.08
20min1354503-35450392.91988.724.4393.3489.124.43
2336130-33613088.10388.50
3324805-32480585.13585.52
30min1362770-36277095.08690.195.1895.6690.745.17
2342233-34223389.70390.25
3327298-32729885.78886.32
45min1366060-36606095.94891.125.0696.6891.825.06
2345790-34579090.63591.33
3331053-33105386.77287.44
极限1374430-37443098.14298.061.7299.0398.911.72
2380369-38036999.699100.54
3367537-36753796.33597.15
比拉斯汀片项目信息
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%
110.983777243773193775223772363769613773520.08
211.063762993763453763220.01
单位质量响应值RSD%判断
34367.2134025.500.71数据可信
供试品溶液-24090203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%
5min1250409-25040965.64267.372.3565.6467.372.35
2262218-26221868.73868.74
3258403-25840367.73867.74
10min1311969-31196981.77982.961.2981.8983.071.28
2317583-31758383.25183.37
3319836-31983683.84283.95
15min1334413-33441387.66388.471.4787.9188.721.46
2334842-33484287.77588.03
3343171-34317189.95990.21
20min1343798-34379890.12390.822.1690.5191.222.16
2340709-34070989.31389.71
3354906-35490693.03593.44
30min1352908-35290892.51193.092.8293.0593.642.80
2346450-34645090.81891.37
3366036-36603695.95396.51
45min1360367-36036794.46794.703.0395.1695.403.02
2350772-35077291.95192.65
3372576-37257697.66798.38
极限1367571-36757196.35596.642.0897.2197.512.08
2361645-36164594.80295.65
3376810-37681098.77799.66
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