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23060010771B对照品来源自制对照品使用方法直接使用
对照品含量(%)99.97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0.8437
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
112.293914263929703914833913103913203917020.19
212.323910753905193907970.11
单位质量响应值RSD%判断
31871.6031720.540.34数据可信
供试品溶液-1批-pH1.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1418390-41839099.88799.751.8199.8999.751.81
2423428-423428101.090101.09
3421509-421509100.632100.63
4408551-40855197.53897.54
5408775-40877597.59297.59
6426285-426285101.772101.77
10min1424984-424984101.462100.891.61101.63101.061.61
2427183-427183101.987102.16
3427394-427394102.037102.20
4413125-41312598.63098.79
5414894-41489499.05399.22
6428060-428060102.196102.37
15min1424551-424551101.358100.781.57101.69101.111.57
2428144-428144102.216102.55
3424513-424513101.349101.69
4412837-41283798.56298.89
5414948-41494899.06699.39
6427730-427730102.117102.46
20min1424441-424441101.332100.671.55101.84101.171.56
2425475-425475101.579102.09
3424696-424696101.393101.90
4412706-41270698.53099.02
5414211-41421198.89099.38
6428454-428454102.290102.80
30min1424075-424075101.245100.521.49101.92101.191.48
2425013-425013101.469102.15
3424034-424034101.235101.91
4411627-41162798.27398.93
5414708-41470899.00899.67
6426659-426659101.862102.54
45min1425022-425022101.471100.601.53102.31101.441.53
2425998-425998101.704102.55
3425519-425519101.589102.43
4411704-41170498.29199.11
5414708-41470899.00899.83
6425423-425423101.566102.42
60min1425177-425177101.508100.461.65102.52101.461.65
2424862-424862101.433102.45
3423526-423526101.114102.13
4410986-41098698.12099.10
5412973-41297398.59499.58
6427132-427132101.974102.99
极限1422594-422594100.891100.161.31102.07101.331.32
2423059-423059101.002102.19
3421456-421456100.619101.80
4412428-41242898.46499.61
5412747-41274798.54099.69
6424842-424842101.428102.62
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23060010771B对照品来源自制对照品使用方法直接使用
对照品含量(%)99.97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0.8437
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
112.297814817818817828827828767875447833330.32
212.327816217815357815780.01
单位质量响应值RSD%判断
63737.4363439.770.34数据可信
供试品溶液-2批-pH1.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1824165-82416598.38799.551.4498.3999.551.44
2830529-83052999.14799.15
3856433-856433102.239102.24
4837879-837879100.024100.02
5826880-82688098.71198.71
6827473-82747398.78298.78
10min1837587-83758799.989100.941.57100.15101.111.57
2841594-841594100.468100.63
3869764-869764103.830104.00
4850217-850217101.497101.66
5841991-841991100.515100.68
6832311-83231199.35999.52
15min1836342-83634299.841101.051.55100.17101.381.55
2844434-844434100.807101.14
3869069-869069103.747104.09
4852909-852909101.818102.15
5843251-843251100.665101.00
6832839-83283999.42299.75
20min1832771-83277199.414100.981.6199.91101.481.61
2841469-841469100.453100.95
3869410-869410103.788104.30
4850783-850783101.565102.07
5847149-847149101.131101.63
6833538-83353899.506100.00
30min1833753-83375399.532100.821.53100.19101.491.54
2840212-840212100.303100.97
3863697-863697103.106103.80
4856838-856838102.287102.96
5841412-841412100.446101.11
6831434-83143499.25599.92
45min1838018-838018100.041101.181.56100.87102.021.56
2842944-842944100.629101.46
3868517-868517103.682104.54
4855131-855131102.084102.93
5849267-849267101.384102.22
6831399-83139999.251100.08
60min1833151-83315199.460100.721.54100.46101.731.54
2846843-846843101.094102.10
3863831-863831103.122104.16
4850163-850163101.491102.51
5840747-840747100.366101.37
6827656-82765698.80499.80
极限1831541-83154199.267100.421.26100.43101.591.26
2837936-837936100.031101.20
3857167-857167102.327103.53
4849628-849628101.427102.61
5840705-840705100.361101.53
6829943-82994399.077100.23
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23060010771B对照品来源自制对照品使用方法直接使用
对照品含量(%)99.97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0.8437
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
112.293903683903233905593911393901983905170.10
212.323909633911453910540.04
单位质量响应值RSD%判断
31775.1831741.400.08数据可信
供试品溶液-1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%
5min1152478-15247836.44640.636.4036.4540.636.40
2173916-17391641.57041.57
3167096-16709639.94039.94
4180561-18056143.15943.16
5181020-18102043.26843.27
6164782-16478239.38739.39
10min1219290-21929052.41655.353.6152.4855.423.62
2232254-23225455.51555.58
3232447-23244755.56155.63
4242499-24249957.96358.04
5237665-23766556.80856.88
6225217-22521753.83253.90
15min1270642-27064264.69066.253.4564.8466.413.45
2277258-27725866.27266.43
3281825-28182567.36367.52
4287640-28764068.75368.92
5283854-28385467.84868.01
6261793-26179362.57562.73
20min1302551-30255172.31774.372.3372.5774.642.33
2309443-30944373.96574.24
3317543-31754375.90176.17
4318277-31827776.07676.36
5316040-31604075.54175.82
6302890-30289072.39872.66
30min1343321-34332182.06283.532.2182.4483.922.21
2346157-34615782.74083.14
3360490-36049086.16686.56
4355360-35536084.94085.35
5351398-35139883.99384.40
6340008-34000881.27081.65
45min1365914-36591487.46389.361.5987.9889.901.60
2373961-37396189.38689.92
3383262-38326291.60992.15
4376245-37624589.93290.48
5374271-37427189.46090.01
6369503-36950388.32088.84
60min1380703-38070390.99892.291.3391.6692.981.33
2383035-38303591.55592.24
3395592-39559294.55695.25
4386671-38667192.42493.13
5386182-38618292.30793.00
6384535-38453591.91392.58
极限1397182-39718294.93695.681.0095.7596.521.00
2396687-39668794.81895.65
3407514-40751497.40698.26
4399688-39968895.53596.39
5401764-40176496.03296.88
6399009-39900995.37396.19
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23060010771B对照品来源自制对照品使用方法直接使用
对照品含量(%)99.97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0.8437
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
112.297828517827687823897825957826667826540.03
212.327830327826927828620.04
单位质量响应值RSD%判断
63682.1863543.990.16数据可信
供试品溶液-2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%
5min1300482-30048235.85732.8016.2635.8632.8016.27
2274635-27463532.77332.77
3308293-30829336.78936.79
4323207-32320738.56938.57
5228379-22837927.25327.25
6213956-21395625.53225.53
10min1404139-40413948.22646.988.8048.2947.048.81
2385770-38577046.03446.09
3425823-42582350.81450.88
4435614-43561451.98252.05
5363058-36305843.32443.37
6347936-34793641.52041.56
15min1489308-48930858.39056.907.5158.5357.047.51
2463895-46389555.35755.49
3509779-50977960.83360.98
4521522-52152262.23462.38
5440871-44087152.61052.73
6435646-43564651.98652.10
20min1552689-55268965.95363.946.4966.1964.176.50
2526324-52632462.80763.03
3565412-56541267.47167.72
4577303-57730368.89069.14
5495413-49541359.11859.32
6497941-49794159.42059.62
30min1640891-64089176.47873.225.9476.8373.565.95
2600673-60067371.67972.01
3643773-64377376.82277.18
4650984-65098477.68378.05
5578085-57808568.98469.29
6567335-56733567.70168.00
45min1687919-68791982.09079.245.2282.5779.705.24
2642072-64207276.61977.07
3691139-69113982.47582.96
4704822-70482284.10784.61
5636362-63636275.93876.36
6621828-62182874.20474.61
60min1717536-71753685.62483.214.6286.2483.804.63
2678861-67886181.00981.58
3723028-72302886.28086.91
4734001-73400187.58988.23
5678260-67826080.93881.48
6652068-65206877.81278.35
极限1750305-75030589.53587.983.4190.2988.703.44
2732048-73204887.35688.07
3750832-75083289.59890.37
4770007-77000791.88692.67
5720811-72081186.01586.70
6699462-69946283.46884.13
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