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%
116.279352329346139348549344049338909345990.06
216.259308089307019307540.01
单位质量响应值RSD%判断
57443.0957277.170.21数据可信
供试品溶液-24070501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%
5min1577276-57727650.95952.959.8650.9652.959.86
2632703-63270355.85255.85
3490511-49051143.30043.30
4620255-62025554.75354.75
5653549-65354957.69257.69
6624993-62499355.17155.17
10min1608226-60822653.69154.383.7253.7854.463.73
2639858-63985856.48456.58
3574677-57467750.73050.80
4620931-62093154.81354.90
5631140-63114055.71455.81
6621157-62115754.83354.92
15min1608710-60871053.73454.783.4053.9154.963.41
2636958-63695856.22856.41
3584042-58404251.55651.71
4624966-62496655.16955.35
5640592-64059256.54856.74
6628172-62817255.45255.64
20min1608807-60880753.74254.163.1654.0154.433.17
2628768-62876855.50555.79
3578378-57837851.05651.30
4619529-61952954.68954.96
5632218-63221855.80956.09
6613470-61347054.15454.43
30min1591974-59197452.25753.263.2552.6153.623.26
2615679-61567954.34954.72
3568720-56872050.20450.53
4611438-61143853.97554.34
5620389-62038954.76555.14
6612015-61201554.02654.39
45min1583519-58351951.51052.192.8051.9552.642.82
2604060-60406053.32353.79
3563112-56311249.70950.12
4591953-59195352.25552.71
5609583-60958353.81154.28
6595068-59506852.53052.99
极限1542936-54293647.92848.212.3448.4548.752.33
2559980-55998049.43249.99
3534047-53404747.14347.64
4552428-55242848.76649.31
5529362-52936246.72947.29
6558182-55818249.27449.82
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%
116.279313839308959311129304099297339307060.07
216.259300549303919302220.03
单位质量响应值RSD%判断
57203.8157244.430.06数据可信
供试品溶液-24070501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%
5min1819381-81938172.50370.213.6672.5070.213.66
2800410-80041070.82470.82
3801561-80156170.92670.93
4736080-73608065.13265.13
5802890-80289071.04471.04
6800420-80042070.82570.82
10min1892895-89289579.00877.701.7179.1377.821.71
2860838-86083876.17176.29
3868041-86804176.80876.93
4899378-89937879.58179.69
5871062-87106277.07677.19
6876530-87653077.56077.68
15min1923257-92325781.69480.481.6081.9580.731.60
2897108-89710879.38079.63
3903513-90351379.94780.19
4932189-93218982.48482.73
5900641-90064179.69379.94
6900542-90054279.68479.93
20min1937312-93731282.93881.082.4583.3381.462.44
2914316-91431680.90381.28
3921020-92102081.49681.88
4941479-94147983.30783.69
5881659-88165978.01378.39
6901971-90197179.81180.19
30min1952731-95273184.30283.451.5084.8383.961.50
2937179-93717982.92683.44
3937553-93755382.95983.47
4967321-96732185.59386.11
5931993-93199382.46782.98
6931802-93180282.45082.96
45min1960610-96061084.99984.321.2485.6784.981.23
2947748-94774883.86184.51
3940560-94056083.22583.88
4972836-97283686.08186.74
5949941-94994184.05584.70
6946147-94614783.72084.37
极限1968477-96847785.69584.901.0086.5085.701.00
2954108-95410884.42485.21
3950093-95009384.06984.86
4974079-97407986.19186.99
5953095-95309584.33485.12
6957200-95720084.69885.49
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%
116.279258939258929261489255939262879259630.03
216.259274269273889274070.01
单位质量响应值RSD%判断
56912.2957071.200.20数据可信
供试品溶液-24070501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%
5min1896539-89653979.65480.841.3879.6580.841.38
2902499-90249980.18380.18
3910140-91014080.86280.86
4902710-90271080.20280.20
5931405-93140582.75182.75
6916091-91609181.39181.39
10min1948847-94884784.30185.081.1284.4385.211.12
2953263-95326384.69384.83
3953812-95381284.74284.88
4952742-95274284.64784.78
5978579-97857986.94387.08
6958106-95810685.12485.26
15min1959189-95918985.22085.691.2585.4985.961.25
2950441-95044184.44384.72
3962883-96288385.54885.82
4962425-96242585.50785.78
5986476-98647687.64487.93
6965281-96528185.76186.04
20min1962781-96278185.53986.101.3485.9586.511.34
2952608-95260884.63585.05
3968697-96869786.06586.48
4968036-96803686.00686.42
5991865-99186588.12388.55
6970266-97026686.20486.62
30min1975838-97583886.69987.021.1987.2687.581.19
2964567-96456785.69886.25
3980398-98039887.10487.67
4979208-97920886.99887.56
51000106-100010688.85589.43
6976606-97660686.76787.33
45min1983465-98346587.37787.921.1788.0888.631.16
2977311-97731186.83087.53
3985715-98571587.57788.28
41001721-100172188.99989.70
51006067-100606789.38590.11
6983431-98343187.37488.08
极限11040286-104028692.42592.960.6693.2793.820.66
21043386-104338692.70093.54
31044677-104467792.81593.67
41048774-104877493.17994.03
51059026-105902694.09094.96
61041910-104191092.56993.42
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