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125
标示量(mg)100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%
116.279208599205159209599225939217549213360.10
216.259215179212189213680.03
单位质量响应值RSD%判断
56627.9056699.570.09数据可信
供试品溶液-24070502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%
5min1612844-61284454.76451.797.0354.7651.797.03
2599531-59953153.57453.57
3602946-60294653.87953.88
4501726-50172644.83444.83
5570850-57085051.01151.01
6589490-58949052.67752.68
10min1615341-61534154.98753.592.6055.0853.672.61
2596595-59659553.31253.40
3616632-61663255.10255.19
4573968-57396851.29051.36
5597673-59767353.40853.49
6597841-59784153.42353.51
15min1586941-58694152.44953.541.9152.6353.711.91
2612161-61216154.70354.88
3609989-60998954.50954.69
4588739-58873952.61052.77
5605802-60580254.13454.31
6591123-59112352.82353.00
20min1625213-62521355.86953.642.6156.1453.912.60
2595398-59539853.20553.47
3606726-60672654.21754.49
4587377-58737752.48852.74
5581706-58170651.98152.25
6605291-60529154.08954.35
30min1609454-60945454.46152.512.4754.8252.872.45
2566137-56613750.59050.95
3593714-59371453.05453.42
4580152-58015251.84252.18
5590978-59097852.81053.16
6585588-58558852.32852.68
45min1609887-60988754.49952.602.5754.9553.042.56
2593163-59316353.00553.45
3579493-57949351.78352.23
4569113-56911350.85651.28
5580103-58010351.83852.28
6600179-60017953.63254.07
极限1559691-55969150.01448.751.8450.5649.281.85
2548035-54803548.97249.50
3543314-54331448.55049.09
4532060-53206047.54548.05
5537662-53766248.04548.57
6552488-55248849.37049.90
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125
标示量(mg)100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%
116.279221319214829217709219029206649215900.07
216.259212099202349207220.08
单位质量响应值RSD%判断
56643.5256659.820.03数据可信
供试品溶液-24070502批-水
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min1785243-78524370.18467.459.0970.1867.469.09
2783380-78338070.01870.02
3615229-61522954.98854.99
4788438-78843870.47070.47
5784039-78403970.07770.08
6771863-77186368.98868.99
10min1868547-86854777.63077.440.8877.7577.560.88
2864011-86401177.22477.34
3862446-86244677.08477.18
4879966-87996678.65078.77
5857641-85764176.65576.77
6866036-86603677.40577.52
15min1898378-89837880.29680.310.9780.5480.550.96
2892895-89289579.80680.05
3900575-90057580.49280.71
4914038-91403881.69681.94
5889004-88900479.45879.70
6896199-89619980.10180.35
20min1919908-91990882.22081.930.7682.6082.300.76
2912666-91266681.57381.95
3915554-91555481.83182.19
4928989-92898983.03283.42
5909809-90980981.31881.69
6913038-91303881.60681.98
30min1938083-93808383.84583.570.7184.3684.080.71
2925367-92536782.70883.22
3934935-93493583.56384.05
4945258-94525884.48685.01
5933085-93308583.39883.91
6933001-93300183.39183.90
45min1934669-93466983.54084.170.6884.2084.820.68
2939593-93959383.98084.63
3941967-94196784.19284.82
4953677-95367785.23985.90
5939637-93963783.98484.64
6940976-94097684.10384.76
极限1958234-95823485.64684.850.5486.4485.640.53
2944476-94447684.41685.21
3949177-94917784.83685.61
4949476-94947684.86385.67
5944407-94440784.41085.20
6950046-95004684.91485.71
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125
标示量(mg)100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%
116.279389839396329388729383959382869388340.06
216.259211849204239208040.06
单位质量响应值RSD%判断
57703.3856664.861.29数据可信
供试品溶液-24070502批-pH6.8(内含1%CTAB)
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min1924973-92497381.91074.3114.4981.9174.3114.49
2914785-91478581.00881.01
3927168-92716882.10482.10
4850527-85052775.31775.32
5805972-80597271.37271.37
6611443-61144354.14654.15
10min1969098-96909885.81784.231.9385.9584.361.95
2951583-95158384.26684.40
3967831-96783185.70585.84
4955995-95599584.65784.78
5943327-94332783.53583.65
6919535-91953581.42881.52
15min1975637-97563786.39685.591.1886.6885.861.20
2959933-95993385.00685.28
3975794-97579486.41086.69
4973640-97364086.22086.49
5967350-96735085.66385.92
6947058-94705883.86684.09
20min1980264-98026486.80685.981.1887.2386.391.19
2967314-96731485.65986.08
3982563-98256387.01087.43
4979184-97918486.71187.12
5961175-96117585.11685.52
6955137-95513784.58184.95
30min1989166-98916687.59587.061.0688.1687.611.08
2977499-97749986.56187.12
3993179-99317987.95088.52
4987918-98791887.48488.04
5986407-98640787.35087.89
6964722-96472285.43085.94
45min1994177-99417788.03887.481.0888.7588.181.09
2981879-98187986.94987.65
3999071-99907188.47289.19
4997937-99793788.37189.07
5980967-98096786.86887.56
6973299-97329986.18986.84
极限11064204-106420494.23992.571.7095.1093.411.71
21052671-105267193.21894.07
31055932-105593293.50794.37
41051807-105180793.14293.99
51029874-102987491.19992.03
61017736-101773690.12590.92
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