比拉斯汀片项目信息
介质体积(ml)900取样体积(ml)0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%
111.023815733816023815973816343817803816370.03
211.033823543824043823790.01
单位质量响应值RSD%判断
34631.3134667.180.08数据可信
供试品溶液-24090901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%
5min1246699-24669963.82363.411.6063.8263.411.60
2238805-23880561.78161.78
3243852-24385263.08663.09
4243711-24371163.05063.05
5250071-25007164.69564.70
6247519-24751964.03564.03
10min1310667-31066780.37280.811.8380.3780.811.84
2303466-30346678.50978.51
3311820-31182080.67080.67
4314392-31439281.33581.34
5321129-32112983.07883.08
6312704-31270480.89980.90
15min1336440-33644087.03987.782.5087.0487.782.49
2326379-32637984.43784.44
3336082-33608286.94786.95
4345618-34561889.41489.41
5350716-35071690.73390.73
6340576-34057688.10988.11
20min1346799-34679989.71991.082.0889.7291.082.08
2344807-34480789.20489.20
3347676-34767689.94689.95
4355668-35566892.01492.01
5364463-36446394.28994.29
6352906-35290691.29991.30
30min1356947-35694792.34592.742.2392.3492.742.23
2345025-34502589.26089.26
3356000-35600092.10092.10
4364170-36417094.21394.21
5368074-36807495.22395.22
6360686-36068693.31293.31
45min1360928-36092893.37593.601.9793.3793.601.97
2349491-34949190.41690.42
3359329-35932992.96192.96
4367940-36794095.18995.19
5369065-36906595.48095.48
6364026-36402694.17694.18
极限1372644-37264496.40696.170.7296.4196.170.72
2370795-37079595.92795.93
3375564-37556497.16197.16
4372687-37268796.41796.42
5371109-37110996.00996.01
6367520-36752095.08095.08
比拉斯汀片项目信息
介质体积(ml)900取样体积(ml)0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%
111.023830983826433823403820283819563824130.13
211.033823833826423825120.05
单位质量响应值RSD%判断
34701.7234679.240.05数据可信
供试品溶液-24090902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%
5min1213082-21308255.06055.914.3055.0655.914.30
2218052-21805256.34556.34
3213594-21359455.19355.19
4205616-20561653.13153.13
5233418-23341860.31560.32
6214401-21440155.40155.40
10min1292669-29266975.62676.223.4475.6376.223.44
2291181-29118175.24175.24
3293020-29302075.71675.72
4284973-28497373.63773.64
5314629-31462981.30081.30
6293287-29328775.78575.79
15min1328901-32890184.98884.572.8484.9984.572.84
2321192-32119282.99683.00
3325385-32538584.07984.08
4317699-31769982.09382.09
5344447-34444789.00589.00
6326044-32604484.25084.25
20min1344875-34487589.11688.182.4889.1288.182.48
2334576-33457686.45486.45
3338510-33851087.47187.47
4332698-33269885.96985.97
5356005-35600591.99191.99
6340962-34096288.10488.10
30min1357056-35705692.26390.792.3092.2690.792.30
2344390-34439088.99088.99
3347425-34742589.77489.77
4344066-34406688.90688.91
5364557-36455794.20194.20
6350637-35063790.60490.60
45min1360247-36024793.08891.852.0093.0991.852.00
2348896-34889690.15590.15
3353689-35368991.39391.39
4347715-34771589.84989.85
5366523-36652394.70994.71
6355777-35577791.93391.93
极限1361011-36101193.28593.401.3593.2993.401.35
2361322-36132293.36593.37
3366166-36616694.61794.62
4353724-35372491.40291.40
5367083-36708394.85494.85
6359431-35943192.87792.88
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