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%
110.601812021814031815631814921811091813540.11
210.671806421812381809400.24
单位质量响应值RSD%判断
17108.8716957.830.63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%
5min1106219-10621955.90056.731.5155.9056.731.51
2108655-10865557.18257.18
3106849-10684956.23256.23
4110496-11049658.15158.15
5106493-10649356.04456.04
6108098-10809856.88956.89
10min1146380-14638077.03676.991.1877.1377.081.18
2147268-14726877.50377.60
3146009-14600976.84076.93
4148801-14880178.31078.41
5143652-14365275.60075.69
6145596-14559676.62376.72
15min1162996-16299685.78085.841.3686.0086.061.36
2165613-16561387.15887.38
3162637-16263785.59185.81
4165610-16561087.15687.38
5159894-15989484.14884.37
6161888-16188885.19785.42
20min1170785-17078589.87990.441.4490.2490.811.45
2174606-17460691.89092.26
3171678-17167890.34990.71
4174670-17467091.92492.30
5168170-16817088.50388.86
6171248-17124890.12390.49
30min1178129-17812993.74494.581.3794.2695.101.36
2182662-18266296.13096.65
3179197-17919794.30694.82
4182752-18275296.17796.70
5176850-17685093.07193.58
6178710-17871094.05094.56
45min1182055-18205595.81096.771.3996.4897.441.39
2187126-18712698.47999.16
3183381-18338196.50897.18
4186804-18680498.31099.00
5180875-18087595.18995.85
6183000-18300096.30896.98
60min1184650-18465097.17697.561.2098.0198.401.20
2188539-18853999.223100.07
3184381-18438197.03597.87
4187452-18745298.65199.50
5182517-18251796.05496.87
6184748-18474897.22898.06
极限1185853-18585397.80997.861.1998.8098.851.18
2189678-18967899.822100.83
3184648-18464897.17598.17
4187250-18725098.54499.56
5183916-18391696.79097.77
6184312-18431296.99897.99
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%
110.601810061811551813521810901810261811260.08
210.671807341806941807140.02
单位质量响应值RSD%判断
17087.3616936.640.63数据可信
供试品溶液-3208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%
5min194220-9422049.64855.305.7949.6555.305.79
2107078-10707856.42356.42
3102333-10233353.92353.92
4105592-10559255.64055.64
5111123-11112358.55458.55
6109368-10936857.63057.63
10min1129646-12964668.31572.914.4368.4073.004.43
2141129-14112974.36574.46
3132684-13268469.91670.01
4138073-13807372.75572.85
5144965-14496576.38776.48
6143667-14366775.70375.80
15min1151480-15148079.82083.193.4080.0283.403.40
2160750-16075084.70484.92
3150991-15099179.56279.77
4158814-15881483.68483.90
5163410-16341086.10686.33
6161793-16179385.25485.48
20min1163289-16328986.04289.142.9886.3789.492.98
2173460-17346091.40291.76
3162356-16235685.55185.89
4170723-17072389.95990.31
5173448-17344891.39591.76
6171743-17174390.49790.86
30min1173839-17383991.60194.492.6292.0794.992.63
2183640-18364096.76697.28
3172866-17286691.08991.57
4181350-18135095.55996.06
5182220-18222096.01896.54
6181972-18197295.88796.40
45min1178442-17844294.02797.032.7294.6597.692.72
2188150-18815099.14299.82
3177148-17714893.34593.98
4187814-18781498.96599.63
5186046-18604698.03498.71
6187297-18729798.69399.37
60min1180235-18023594.97298.033.0195.7598.853.01
2190333-190333100.293101.13
3177957-17795793.77194.56
4190167-190167100.205101.03
5186919-18691998.49499.34
6190615-190615100.441101.28
极限1180099-18009994.90098.553.2195.8499.533.20
2191276-191276100.790101.79
3179082-17908294.36495.31
4192003-192003101.173102.17
5187636-18763698.87199.88
6192017-192017101.180102.19
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