富马酸伏诺拉生片项目信息
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430030-202302对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.7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0.7485
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
114.992460512465802463672460832465972463360.11
214.992450252448572449410.05
单位质量响应值RSD%判断
16433.3616340.290.41数据可信
供试品溶液-12561861批-pH1.0
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min1212253-21225386.99583.8614.2386.9983.8614.23
2191137-19113778.34078.34
3180697-18069774.06174.06
4169120-16912069.31669.32
5241472-24147298.97098.97
6232996-23299695.49695.50
10min1248084-248084101.68098.954.66101.8399.104.67
2236075-23607596.75896.89
3232719-23271995.38395.51
4226395-22639592.79192.91
5251304-251304103.000103.17
6254006-254006104.108104.27
15min1250180-250180102.539100.682.51102.85100.982.53
2242221-24222199.27799.57
3240191-24019198.44598.73
4238222-23822297.63897.91
5250225-250225102.558102.89
6252826-252826103.624103.96
20min1251653-251653103.143101.381.71103.63101.851.73
2245174-245174100.488100.94
3244101-244101100.048100.49
4241857-24185799.12899.56
5249463-249463102.246102.75
6251877-251877103.235103.74
30min1249584-249584102.295101.271.27102.95101.911.30
2244177-244177100.079100.70
3245065-245065100.443101.06
4243676-24367699.874100.47
5248971-248971102.044102.72
6250960-250960102.859103.54
45min1248565-248565101.877100.981.25102.71101.791.28
2243688-24368899.879100.67
3244432-244432100.184100.96
4242921-24292199.564100.33
5248314-248314101.775102.62
6250362-250362102.614103.46
60min1247752-247752101.544100.871.30102.54101.851.33
2243594-24359499.840100.80
3243359-24335999.744100.69
4243158-24315899.661100.59
5248033-248033101.659102.68
6250780-250780102.785103.81
极限1248211-248211101.732100.651.30102.90101.801.32
2242616-24261699.439100.56
3242869-24286999.543100.66
4242877-24287799.546100.64
5246995-246995101.234102.42
6249871-249871102.413103.60
富马酸伏诺拉生片项目信息
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430030-202302对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.7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0.7485
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
114.992458342457192458642451512446642454460.22
214.992451762458482455120.20
单位质量响应值RSD%判断
16373.9816378.390.02数据可信
供试品溶液-12561861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%
5min1153407-15340762.91671.2915.0962.9271.2915.10
2130460-13046053.50553.50
3182707-18270774.93374.93
4196087-19608780.42080.42
5185956-18595676.26576.27
6194336-19433679.70279.70
10min1222802-22280291.37793.946.1791.4894.066.18
2204937-20493784.05084.14
3226455-22645592.87593.00
4238408-23840897.77797.91
5241943-24194399.22799.35
6239815-23981598.35498.49
15min1236599-23659997.03598.432.8597.2998.712.87
2228073-22807393.53993.77
3240295-24029598.55198.83
4243822-24382299.998100.29
5246443-246443101.073101.37
6244834-244834100.413100.71
20min1241712-24171299.13299.791.5099.55100.231.52
2236647-23664797.05597.44
3244889-244889100.435100.88
4245271-245271100.592101.06
5246381-246381101.047101.51
6245048-245048100.500100.96
30min1243952-243952100.051100.521.20100.64101.121.23
2239966-23996698.41698.96
3246119-246119100.940101.55
4248449-248449101.895102.53
5246918-246918101.267101.90
6245145-245145100.540101.17
45min1244281-244281100.186100.840.96100.94101.620.98
2242244-24224499.350100.06
3246799-246799101.219102.00
4248894-248894102.078102.88
5247233-247233101.397102.19
6245831-245831100.822101.62
60min1245031-245031100.493100.880.97101.41101.820.99
2242701-24270199.538100.41
3246376-246376101.045101.99
4249468-249468102.313103.28
5247590-247590101.543102.51
6244675-244675100.347101.31
极限1244327-244327100.205100.980.91101.29102.090.93
2244131-244131100.124101.17
3246682-246682101.171102.29
4249416-249416102.292103.43
5248213-248213101.798102.93
6244576-244576100.307101.44
富马酸伏诺拉生片项目信息
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430030-202302对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.7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0.7485
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
114.992447962450392450512449622444252448550.11
214.992437662440222438940.08
单位质量响应值RSD%判断
16334.5616270.450.28数据可信
供试品溶液-12561861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%
5min1222429-22242991.63670.9623.6091.6470.9623.60
2171357-17135770.59670.60
3132839-13283954.72754.73
4121305-12130549.97549.98
5212095-21209587.37987.38
6173382-17338271.43071.43
10min1243446-243446100.29593.497.19100.4593.617.21
2232959-23295995.97596.09
3218871-21887190.17190.26
4198675-19867581.85081.93
5239347-23934798.60698.75
6228332-22833294.06894.19
15min1246213-246213101.43598.703.32101.7598.973.35
2244279-244279100.638100.92
3236527-23652797.44597.69
4224965-22496592.68192.90
5244578-244578100.761101.07
6240850-24085099.22699.50
20min1247283-247283101.876100.461.44102.36100.901.47
2246042-246042101.365101.81
3241900-24190099.658100.06
4237751-23775197.94998.32
5245556-245556101.164101.64
6244564-244564100.756101.20
30min1247974-247974102.161101.360.70102.82101.960.74
2247151-247151101.821102.44
3246063-246063101.373101.94
4242916-242916100.077100.61
5246091-246091101.385102.03
6245933-245933101.320101.93
45min1248214-248214102.259101.770.54103.09102.540.56
2247617-247617102.013102.80
3248477-248477102.368103.11
4245023-245023100.945101.65
5246194-246194101.427102.24
6246626-246626101.605102.38
60min1247886-247886102.124101.650.59103.12102.600.59
2247025-247025101.770102.72
3248714-248714102.465103.37
4245054-245054100.958101.83
5245233-245233101.031102.02
6246528-246528101.565102.51
极限1248344-248344102.313101.590.53103.48102.700.54
2246675-246675101.625102.75
3247837-247837102.104103.18
4245326-245326101.070102.11
5245327-245327101.070102.22
6245960-245960101.331102.45
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