盐酸伐地那非片项目信息
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2.0对照品来源中检所对照品使用方法直接使用
对照品含量(%)90.50对照品水分(%)0对照品稀释倍数1000
标示量(mg)10供试品稀释倍数1系数0.9306
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.913765653768023762163758643764393763770.10
211.913746883741463744170.11
单位质量响应值RSD%判断
31601.7631437.200.37数据可信
供试品溶液-2024072521批-pH6.8(内含0.5%吐温80)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1219656-21965652.82347.4919.3952.8247.4919.39
2219611-21961152.81252.81
3248529-24852959.76659.77
4185528-18552844.61644.62
5148166-14816635.63135.63
6163331-16333139.27839.28
10min1276556-27655666.50662.1111.4966.5962.1911.50
2274330-27433065.97166.06
3299213-29921371.95572.05
4221366-22136653.23453.31
5243284-24328458.50558.56
6234888-23488856.48656.55
15min1306070-30607073.60469.288.8673.8069.468.87
2293426-29342670.56370.76
3322292-32229277.50577.72
4248385-24838559.73259.89
5278416-27841666.95367.11
6280039-28003967.34467.50
20min1317457-31745776.34274.097.4876.6674.397.49
2319666-31966676.87377.19
3335696-33569680.72881.08
4268084-26808464.46964.73
5300021-30002172.14972.42
6307641-30764173.98174.25
30min1334412-33441280.41978.606.4380.8779.026.44
2325118-32511878.18478.63
3350487-35048784.28584.77
4289382-28938269.59069.96
5322239-32223977.49277.88
6339529-33952981.65082.04
45min1355666-35566685.53083.775.2286.1184.325.23
2346459-34645983.31683.89
3361484-36148486.92987.55
4316761-31676176.17576.66
5341789-34178982.19382.71
6367862-36786288.46388.99
60min1379697-37969791.30986.635.5292.0387.325.52
2356913-35691385.83086.54
3368055-36805588.51089.28
4328558-32855879.01179.62
5348460-34846083.79784.45
6379698-37969891.31091.99
极限1404033-40403397.16296.511.6598.0497.351.66
2399131-39913195.98396.84
3406308-40630897.70998.62
4403656-40365697.07197.82
5388913-38891393.52694.32
6405979-40597997.63098.46
盐酸伐地那非片项目信息
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2.0对照品来源中检所对照品使用方法直接使用
对照品含量(%)90.50对照品水分(%)0对照品稀释倍数1000
标示量(mg)10供试品稀释倍数1系数0.9306
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.917502607490957534577505447496537506020.23
211.917530497525507528000.05
单位质量响应值RSD%判断
63022.8463207.390.21数据可信
供试品溶液-2024073021批
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1374762-37476245.00747.2710.2445.0147.2710.24
2354732-35473242.60142.60
3458789-45878955.09855.10
4422587-42258750.75050.75
5359718-35971843.20043.20
6390886-39088646.94346.94
10min1462402-46240255.53257.318.0355.6157.398.03
2437523-43752352.54452.61
3526286-52628663.20463.30
4522728-52272862.77762.86
5446042-44604253.56753.64
6468222-46822256.23156.31
15min1503068-50306860.41662.187.1860.5862.367.18
2478665-47866557.48557.64
3563160-56316067.63267.83
4565590-56559067.92468.11
5494187-49418759.34959.51
6502085-50208560.29760.47
20min1530117-53011763.66465.236.7363.9365.516.73
2507264-50726460.91961.17
3585884-58588470.36170.67
4592615-59261571.17071.47
5522722-52272262.77663.04
6520363-52036362.49362.76
30min1566847-56684768.07569.196.0068.4569.576.01
2539941-53994164.84465.20
3613040-61304073.62274.05
4624069-62406974.94775.37
5564202-56420267.75768.12
6548499-54849965.87166.25
45min1598004-59800471.81772.815.1872.3073.315.20
2577938-57793869.40769.87
3640092-64009276.87177.42
4650075-65007578.07078.62
5594194-59419471.35971.84
6577167-57716769.31469.80
60min1625287-62528775.09375.194.4375.7075.824.44
2593855-59385571.31871.90
3651246-65124678.21178.89
4666327-66632780.02280.70
5612901-61290173.60674.20
6607006-60700672.89873.50
极限1724229-72422986.97687.045.4287.7187.795.42
2687256-68725682.53583.23
3756216-75621690.81791.63
4774597-77459793.02593.83
5734066-73406688.15788.88
6672351-67235180.74581.47
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