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250
标示量(mg)50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%
117.064610074608514619964622964608684614040.15
216.984613814609964611880.06
单位质量响应值RSD%判断
27045.9627160.660.30数据可信
供试品溶液-2024051712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%
5min1549640-549640102.685101.291.37102.68101.291.37
2534491-53449199.85499.85
3535024-53502499.95499.95
4548611-548611102.492102.49
5548413-548413102.455102.46
6536941-536941100.312100.31
10min1536949-536949100.314100.320.88100.48100.490.88
2529065-52906598.84199.01
3542899-542899101.425101.59
4536478-536478100.226100.40
5535891-535891100.116100.29
6540523-540523100.981101.15
15min1537134-537134100.348100.110.59100.69100.450.60
2531148-53114899.23099.56
3534848-53484899.921100.26
4535392-535392100.023100.36
5535786-535786100.096100.43
6540841-540841101.041101.38
20min1534494-53449499.85599.970.49100.36100.470.49
2531018-53101899.20699.70
3535127-53512799.973100.48
4535828-535828100.104100.61
5535012-53501299.952100.46
6539153-539153100.725101.23
30min1534733-53473399.90099.830.60100.57100.500.60
2529400-52940098.90399.57
3533171-53317199.608100.28
4535621-535621100.066100.74
5534130-53413099.787100.46
6539211-539211100.736101.41
45min1533711-53371199.70999.580.62100.55100.420.62
2528834-52883498.79899.62
3531570-53157099.309100.14
4533464-53346499.663100.50
5532021-53202199.393100.23
6538646-538646100.631101.47
极限1532601-53260199.50199.300.52100.51100.300.52
2527265-52726598.50499.50
3529543-52954398.93099.93
4533427-53342799.656100.66
5531559-53155999.307100.31
6534749-53474999.903100.91
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250
标示量(mg)50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%
117.064609504606254609484609064607584608370.04
216.984604504608064606280.06
单位质量响应值RSD%判断
27012.7227127.680.31数据可信
供试品溶液-2024051712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%
5min1538542-538542100.73496.422.75100.7396.422.75
2524432-52443298.09598.10
3497546-49754693.06693.07
4511633-51163395.70195.70
5510438-51043895.47795.48
6510227-51022795.43895.44
10min1547838-547838102.47397.992.30102.6498.152.30
2521280-52128097.50597.67
3516237-51623796.56296.72
4517781-51778196.85197.01
5517356-51735696.77196.93
6522627-52262797.75797.92
15min1546221-546221102.17198.022.18102.5198.342.18
2521291-52129197.50897.83
3515914-51591496.50296.82
4515845-51584596.48996.81
5519947-51994797.25697.58
6524814-52481498.16798.49
20min1546101-546101102.14898.042.22102.6698.522.22
2519053-51905397.08997.58
3516540-51654096.61997.10
4515734-51573496.46896.95
5519261-51926197.12897.61
6528008-52800898.76499.25
30min1545370-545370102.01298.052.22102.6998.702.22
2520163-52016397.29797.95
3516195-51619596.55497.19
4514720-51472096.27896.92
5518989-51898997.07797.72
6529645-52964599.07099.72
45min1555177-555177103.84698.222.96104.7099.042.96
2519121-51912197.10297.91
3515047-51504796.34097.14
4516589-51658996.62897.43
5516142-51614296.54497.35
6528555-52855598.86699.68
极限1544656-544656101.87897.702.28102.9098.682.28
2517300-51730096.76197.74
3514827-51482796.29897.26
4513592-51359296.06797.03
5516725-51672596.65397.62
6526865-52686598.55099.53
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250
标示量(mg)50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%
117.064606734605644609684607764607524607470.04
216.984591064595564593310.07
单位质量响应值RSD%判断
27007.4427051.300.12数据可信
供试品溶液-2024051713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%
5min1525291-52529198.40496.941.1798.4096.941.17
2511269-51126995.77795.78
3524887-52488798.32898.33
4514873-51487396.45296.45
5514329-51432996.35096.35
6514167-51416796.32096.32
10min1531222-53122299.51598.231.1499.6898.401.14
2521478-52147897.68997.85
3532595-53259599.77299.94
4518323-51832397.09897.26
5521483-52148397.69097.85
6521158-52115897.63097.79
15min1543524-543524101.81998.971.70102.1599.301.70
2531621-53162199.59099.91
3530089-53008999.30399.63
4518001-51800197.03897.36
5524018-52401898.16598.49
6522665-52266597.91298.24
20min1534739-534739100.17499.061.25100.6799.541.25
2533935-533935100.023100.51
3533723-53372399.983100.48
4519810-51981097.37797.86
5528653-52865399.03499.52
6521776-52177697.74598.23
30min1534576-534576100.14399.231.09100.8199.881.09
2534822-534822100.189100.84
3533100-53310099.867100.53
4523754-52375498.11698.76
5530431-53043199.367100.02
6521562-52156297.70598.35
45min1534691-534691100.16599.530.65101.00100.350.65
2533738-53373899.986100.81
3531833-53183399.629100.46
4524976-52497698.34599.15
5530660-53066099.410100.23
6531897-53189799.641100.45
极限1533819-533819100.00199.751.37101.00100.731.36
2532122-53212299.683100.67
3545719-545719102.231103.23
4524458-52445898.24899.22
5528591-52859199.022100.01
6530005-53000599.287100.27
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250
标示量(mg)50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%
117.064601554601994614864604194601624604840.13
216.984599134593754596440.09
单位质量响应值RSD%判断
26992.0327069.730.21数据可信
供试品溶液-2024051713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%
5min1515757-51575796.61295.691.3796.6195.691.37
2505986-50598694.78294.78
3513992-51399296.28296.28
4515347-51534796.53696.54
5498756-49875693.42893.43
6515038-51503896.47896.48
10min1527661-52766198.84298.061.6799.0098.221.67
2533892-533892100.010100.17
3527489-52748998.81098.97
4525552-52555298.44798.61
5509967-50996795.52895.68
6516285-51628596.71196.87
15min1530452-53045299.36598.361.6499.6998.691.63
2525982-52598298.52898.85
3536232-536232100.448100.77
4527979-52797998.90299.23
5514042-51404296.29196.61
6515928-51592896.64596.97
20min1528153-52815398.93598.551.9099.4399.041.90
2526708-52670898.66499.15
3541509-541509101.436101.93
4529982-52998299.27799.77
5515496-51549696.56497.04
6514771-51477196.42896.91
30min1532257-53225799.70399.092.05100.3699.742.05
2528476-52847698.99599.65
3545589-545589102.201102.86
4533002-53300299.843100.50
5519422-51942297.29997.94
6515074-51507496.48597.13
45min1532251-53225199.70299.242.18100.52100.062.17
2529574-52957499.201100.02
3548747-548747102.792103.62
4532369-53236999.724100.55
5520152-52015297.43698.23
6515734-51573496.60897.41
极限1530309-53030999.33899.232.02100.33100.212.01
2528700-52870099.037100.02
3548599-548599102.765103.77
4531414-53141499.545100.53
5518714-51871497.16698.13
6520494-52049497.50098.47
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