枸橼酸西地那非片项目信息
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420012-202204对照品来源中检院对照品使用方法直接使用
对照品含量(%)98.8对照品水分(%)0对照品稀释倍数625
标示量(mg)20供试品稀释倍数1系数0.7118
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
117.621904021911161895401900251902491902660.31
217.851901941896571899260.20
单位质量响应值RSD%判断
10798.3010640.111.05数据可信
长期18月-供试品溶液-2022072301批-pH2.0
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min1215181-215181101.651101.601.06101.65101.601.06
2214327-214327101.248101.25
3211342-21134299.83899.84
4214930-214930101.533101.53
5216777-216777102.405102.41
6217932-217932102.951102.95
10min1215554-215554101.827102.541.08102.00102.711.08
2217366-217366102.683102.85
3213533-213533100.873101.04
4216832-216832102.431102.60
5219812-219812103.839104.01
6219275-219275103.585103.76
15min1215357-215357101.734102.921.97102.07103.261.96
2225309-225309106.436106.78
3213014-213014100.627100.96
4215860-215860101.972102.31
5218599-218599103.266103.61
6219113-219113103.509103.85
20min1215577-215577101.838102.191.08102.35102.701.08
2216305-216305102.182102.70
3212508-212508100.388100.89
4216039-216039102.056102.57
5218698-218698103.313103.83
6218830-218830103.375103.89
30min1215446-215446101.776101.911.17102.45102.591.17
2216635-216635102.338103.03
3211142-21114299.743100.41
4215327-215327101.720102.40
5217927-217927102.948103.64
6217889-217889102.930103.62
45min1214398-214398101.281101.761.28102.13102.611.27
2215263-215263101.690102.55
3211142-21114299.743100.58
4214966-214966101.550102.40
5217673-217673102.828103.69
6219010-219010103.460104.32
极限1214591-214591101.372101.751.21102.39102.771.21
2216057-216057102.065103.09
3211525-21152599.924100.93
4213925-213925101.058102.08
5217510-217510102.751103.78
6218734-218734103.330104.36
枸橼酸西地那非片项目信息
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420012-202204对照品来源中检院对照品使用方法直接使用
对照品含量(%)98.8对照品水分(%)0对照品稀释倍数625
标示量(mg)20供试品稀释倍数1系数0.7118
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
117.621900181906251902401906171902991903600.14
217.851902291903961903120.07
单位质量响应值RSD%判断
10803.6310661.740.94数据可信
长期18月-供试品溶液-2022072401批-pH2.0
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min1228054-228054107.596102.242.79107.60102.242.80
2214804-214804101.345101.34
3218094-218094102.897102.90
4213810-213810100.876100.88
5210667-21066799.39399.39
6214823-214823101.354101.35
10min1217490-217490102.612102.521.03102.79102.691.02
2217547-217547102.639102.81
3221348-221348104.432104.60
4216471-216471102.131102.30
5214944-214944101.411101.58
6215915-215915101.869102.04
15min1217852-217852102.783102.221.11103.13102.561.11
2217099-217099102.427102.77
3220484-220484104.024104.37
4215271-215271101.565101.90
5213525-213525100.741101.08
6215704-215704101.769102.11
20min1216558-216558102.172101.921.00102.69102.431.00
2216755-216755102.265102.78
3219491-219491103.556104.07
4215616-215616101.728102.24
5213323-213323100.646101.15
6214358-214358101.134101.64
30min1216489-216489102.140102.111.65102.83102.791.65
2216583-216583102.184102.87
3222984-222984105.204105.90
4215455-215455101.652102.33
5212440-212440100.229100.90
6214585-214585101.241101.92
45min1216589-216589102.187101.660.90103.05102.520.90
2215651-215651101.744102.60
3218369-218369103.027103.89
4215237-215237101.549102.40
5212800-212800100.399101.24
6214236-214236101.077101.92
极限1216167-216167101.988101.500.95103.02102.520.96
2215834-215834101.831102.85
3218158-218158102.927103.97
4213931-213931100.933101.95
5212292-212292100.159101.16
6214358-214358101.134102.15
枸橼酸西地那非片项目信息
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420012-202204对照品来源中检院对照品使用方法直接使用
对照品含量(%)98.8对照品水分(%)0对照品稀释倍数625
标示量(mg)20供试品稀释倍数1系数0.7118
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
117.621897531917891921841916421917671914270.51
217.851900361899461899910.04
单位质量响应值RSD%判断
10864.1910643.751.45数据可信
长期18月-供试品溶液-2022072501批-pH2.0
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min1217952-217952102.633101.761.45102.63101.761.45
2216638-216638102.014102.01
3214499-214499101.007101.01
4213442-213442100.509100.51
5221148-221148104.138104.14
6212957-212957100.280100.28
10min1221292-221292104.205103.491.35104.38103.661.35
2220069-220069103.629103.80
3216050-216050101.737101.91
4216327-216327101.867102.03
5221667-221667104.382104.56
6223240-223240105.123105.29
15min1220195-220195103.689102.791.26104.03103.131.25
2219049-219049103.149103.49
3216410-216410101.906102.24
4216623-216623102.007102.34
5222361-222361104.709105.06
6215107-215107101.293101.64
20min1220460-220460103.814102.481.38104.33103.001.38
2219487-219487103.355103.87
3215432-215432101.446101.95
4215340-215340101.403101.91
5220976-220976104.057104.58
6214122-214122100.829101.34
30min1219385-219385103.307101.881.46104.00102.571.46
2217819-217819102.570103.26
3213470-213470100.522101.20
4213241-213241100.414101.09
5220222-220222103.701104.40
6213996-213996100.770101.45
45min1219094-219094103.170101.941.22104.03102.801.22
2217599-217599102.466103.32
3214283-214283100.905101.75
4215306-215306101.387102.23
5219516-219516103.369104.24
6213114-213114100.354101.20
极限1218700-218700102.985101.611.50104.02102.641.49
2216865-216865102.121103.15
3213774-213774100.665101.68
4213164-213164100.378101.39
5220060-220060103.625104.67
6212176-21217699.913100.93
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