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%
111.917521317526157523797529297519867524080.06
211.917523367518137520740.05
单位质量响应值RSD%判断
63174.4863146.430.04数据可信
供试品溶液-2024072721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%
5min1401902-40190248.23147.787.0848.2347.787.09
2358916-35891643.07343.07
3391956-39195647.03847.04
4401386-40138648.16948.17
5388971-38897146.67946.68
6445945-44594553.51753.52
10min1474358-47435856.92756.055.8457.0156.135.84
2426295-42629551.15951.23
3465364-46536455.84755.93
4469432-46943256.33556.42
5456455-45645554.77854.86
6510343-51034361.24561.33
15min1531958-53195863.83962.325.3464.0162.495.35
2476930-47693057.23557.39
3518592-51859262.23562.41
4519673-51967362.36562.54
5507595-50759560.91561.08
6561125-56112567.33967.53
20min1565784-56578467.89866.984.6168.1867.264.62
2522153-52215362.66262.91
3557947-55794766.95867.23
4557644-55764466.92267.20
5545021-54502165.40765.68
6600279-60027972.03872.34
30min1621064-62106474.53273.353.7074.9373.743.71
2577292-57729269.27969.64
3615784-61578473.89974.29
4608305-60830573.00173.39
5599578-59957871.95472.33
6645006-64500677.40677.83
45min1664109-66410979.69879.063.1780.2279.573.18
2632172-63217275.86576.34
3661823-66182379.42479.93
4657641-65764178.92279.43
5643543-64354377.23077.73
6693297-69329783.20183.75
60min1693267-69326783.19782.332.9283.8582.972.93
2664148-66414879.70380.30
3691423-69142382.97683.62
4682640-68264081.92282.56
5666329-66632979.96580.59
6718250-71825086.19586.89
90min1721475-72147586.58385.572.4887.3786.352.49
2697522-69752283.70884.44
3717855-71785586.14886.93
4710608-71060885.27886.06
5690782-69078282.89983.66
6739930-73993088.79789.63
120min1732292-73229287.88187.342.3088.8288.262.32
2716244-71624485.95586.83
3735616-73561688.28089.20
4726636-72663687.20288.12
5703730-70373084.45385.35
6752307-75230790.28391.27
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
极限1755737-75573790.69489.842.3891.7890.912.39
2738881-73888188.67189.69
3763460-76346091.62192.69
4737668-73766888.52689.59
5724602-72460286.95888.00
6771378-77137892.57193.70
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%
111.917525667544177529167541977530057534200.12
211.917546837527237537030.19
单位质量响应值RSD%判断
63259.4563283.210.03数据可信
供试品溶液-2024072921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%
5min1295252-29525235.37044.7118.6935.3744.7118.69
2402617-40261748.23248.23
3373457-37345744.73944.74
4377958-37795845.27845.28
5304499-30449936.47836.48
6485619-48561958.17658.18
10min1381606-38160645.71552.3613.2645.7752.4413.27
2449039-44903953.79453.87
3422553-42255350.62150.70
4449048-44904853.79553.87
5382227-38222745.79045.85
6538063-53806364.45964.56
15min1444371-44437153.23458.5910.4753.3758.7610.49
2487462-48746258.39758.57
3468958-46895856.18056.34
4503977-50397760.37560.54
5447276-44727653.58253.72
6582513-58251369.78469.99
20min1496512-49651259.48163.608.3259.7063.868.34
2529615-52961563.44663.71
3511579-51157961.28661.54
4545371-54537165.33465.60
5491327-49132758.86059.09
6610913-61091373.18673.51
30min1566693-56669367.88870.876.2168.2171.246.24
2587695-58769570.40470.78
3577083-57708369.13369.49
4608620-60862072.91173.29
5553489-55348966.30766.63
6655990-65599078.58679.03
45min1631076-63107675.60177.494.5676.0477.984.60
2648098-64809877.64078.13
3634478-63447876.00976.48
4658968-65896878.94379.44
5611347-61134773.23873.67
6697170-69717083.51984.09
60min1662107-66210779.31981.303.8879.8881.913.92
2681374-68137481.62782.25
3672887-67288780.61081.21
4687735-68773582.38983.02
5645035-64503577.27377.83
6722530-72253086.55787.27
90min1707265-70726584.72885.533.1485.4286.273.18
2720570-72057086.32287.08
3714789-71478985.63086.36
4720119-72011986.26887.03
5676067-67606780.99181.68
6744695-74469589.21290.07
120min1731184-73118487.59487.792.8888.4388.682.92
2740984-74098488.76889.67
3734126-73412687.94688.82
4734221-73422187.95888.87
5695671-69567183.34084.16
6760569-76056991.11492.12
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
极限1752795-75279590.18390.282.2491.1691.322.28
2760678-76067891.12792.17
3750321-75032189.88690.91
4760090-76009091.05792.11
5723817-72381786.71187.67
6774141-77414192.74093.90
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%
111.917579947609257556327552337580197575610.31
211.917544417544687544540.01
单位质量响应值RSD%判断
63607.1463346.260.30数据可信
供试品溶液-2024072921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%
5min1328890-32889039.27343.5318.3739.2743.5318.37
2425360-42536050.79250.79
3344446-34444641.13041.13
4417448-41744849.84849.85
5414804-41480449.53249.53
6256340-25634030.61030.61
10min1384414-38441445.90351.3315.1245.9751.4015.12
2483662-48366257.75457.84
3409117-40911748.85348.92
4484231-48423157.82257.91
5485788-48578858.00858.09
6331793-33179339.61939.67
15min1435138-43513851.96057.5312.5652.1057.6912.57
2531363-53136363.45063.63
3457682-45768254.65254.80
4535411-53541163.93464.11
5535135-53513563.90164.08
6396008-39600847.28747.40
20min1484729-48472957.88262.5210.3358.1162.7710.35
2565074-56507467.47667.76
3493747-49374758.95859.20
4574316-57431668.57968.87
5573483-57348368.48068.77
6449988-44998853.73353.93
30min1535571-53557163.95369.318.2864.2869.678.31
2617166-61716673.69674.10
3554524-55452466.21666.56
4626790-62679074.84575.25
5625642-62564274.70875.11
6522915-52291562.44162.73
45min1602328-60232871.92476.115.9872.3676.596.01
2662688-66268879.13279.65
3611811-61181173.05773.51
4678173-67817380.98181.51
5673795-67379580.45880.98
6595740-59574071.13771.53
60min1642197-64219776.68580.065.2277.2480.665.26
2695693-69569383.07383.73
3646772-64677277.23177.80
4708950-70895084.65685.32
5700353-70035383.62984.29
6628841-62884175.09075.60
90min1674676-67467680.56383.624.4281.2484.354.46
2726665-72666586.77187.56
3676803-67680380.81781.52
4736225-73622587.91388.71
5720895-72089586.08286.88
6666370-66637079.57180.20
120min1692577-69257782.70185.653.9583.5186.524.00
2742630-74263088.67889.61
3695996-69599683.10983.94
4750932-75093289.66990.62
5734160-73416087.66688.61
6687535-68753582.09982.86
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
极限1721819-72181986.19388.423.3487.1489.443.39
2760314-76031490.78991.87
3726348-72634886.73387.71
4773315-77331592.34293.44
5750986-75098689.67590.76
6710128-71012884.79785.70
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