枸橼酸西地那非片项目信息
介质体积(ml)900取样体积(ml)0补液体积(ml)0
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200
标示量(mg)50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%
114.164881394888874878154872404884204881000.13
214.074908234904814906520.05
单位质量响应值RSD%判断
34470.3434872.210.82数据可信
供试品溶液-2024041221批-pH4.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
2min1296166-29616654.06863.2010.4054.0763.2010.40
2388898-38889870.99771.00
3342446-34244662.51662.52
4318299-31829958.10858.11
5382954-38295469.91269.91
6348431-34843163.60963.61
5min1502630-50263091.75994.233.4391.7694.233.42
2529156-52915696.60296.60
3526945-52694596.19896.20
4486611-48661188.83588.84
5529665-52966596.69596.69
6522098-52209895.31395.31
10min1527826-52782696.35998.050.8896.3698.050.88
2540413-54041398.65798.66
3539284-53928498.45198.45
4536879-53687998.01298.01
5539778-53977898.54198.54
6538346-53834698.28098.28
15min1527361-52736196.27498.691.2396.2798.691.23
2543294-54329499.18399.18
3543501-54350199.22199.22
4544709-54470999.44199.44
5540976-54097698.76098.76
6543858-54385899.28699.29
20min1530265-53026596.80498.861.1096.8098.861.11
2541760-54176098.90398.90
3546619-54661999.79099.79
4545013-54501399.49799.50
5540503-54050398.67398.67
6544867-54486799.47099.47
30min1527862-52786296.36698.691.2196.3798.681.21
2541419-54141998.84198.84
3543354-54335499.19499.19
4545956-54595699.66999.67
5540436-54043698.66198.66
6544388-54438899.38399.38
45min1528294-52829496.44599.071.3396.4499.071.34
2545644-54564499.61299.61
3547214-54721499.89999.90
4547158-54715899.88899.89
5543219-54321999.16999.17
6544444-54444499.39399.39
极限1528819-52881996.54098.621.1596.5498.621.15
2543565-54356599.23299.23
3543662-54366299.25099.25
4545610-54561099.60699.61
5537857-53785798.19098.19
6541807-54180798.91298.91
枸橼酸西地那非片项目信息
介质体积(ml)900取样体积(ml)0补液体积(ml)0
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200
标示量(mg)50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%
114.164867524859364863304855044853444859730.12
214.074874774882314878540.11
单位质量响应值RSD%判断
34320.1334673.350.73数据可信
供试品溶液-2024041221批-pH4.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
2min1318154-31815458.37559.2811.9158.3859.2911.91
2319331-31933158.59158.59
3366061-36606167.16567.17
4327370-32737060.06660.07
5352649-35264964.70464.70
6255100-25510046.80646.81
5min1523779-52377996.10392.015.3396.1092.005.34
2503322-50332292.35092.35
3516952-51695294.85194.85
4511941-51194193.93193.93
5503386-50338692.36292.36
6449337-44933782.44582.44
10min1550242-550242100.95998.751.36100.9698.751.36
2539962-53996299.07399.07
3535557-53555798.26498.26
4533115-53311597.81697.82
5540965-54096599.25799.26
6529466-52946697.14797.15
15min1553368-553368101.53299.531.19101.5399.531.19
2543758-54375899.76999.77
3539214-53921498.93598.94
4536239-53623998.39098.39
5545102-545102100.016100.02
6537059-53705998.54098.54
20min1555348-555348101.89699.831.24101.9099.841.24
2547471-547471100.450100.45
3538919-53891998.88198.88
4536720-53672098.47898.48
5544389-54438999.88599.88
6541846-54184699.41899.42
30min1555487-555487101.92199.911.21101.9299.911.21
2542015-54201599.44999.45
3540447-54044799.16299.16
4536502-53650298.43898.44
5546044-546044100.189100.19
6546679-546679100.305100.31
45min1557546-557546102.29999.981.51102.3099.981.51
2546029-546029100.186100.19
3538809-53880998.86198.86
4533608-53360897.90797.91
5545464-545464100.082100.08
6548024-548024100.552100.55
极限1556552-556552102.117100.311.23102.12100.311.23
2546355-546355100.246100.25
3539358-53935898.96298.96
4539272-53927298.94698.95
5547959-547959100.540100.54
6550705-550705101.044101.04
枸橼酸西地那非片项目信息
介质体积(ml)900取样体积(ml)0补液体积(ml)0
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200
标示量(mg)50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%
114.164891414898684897554885664889914892640.12
214.074885284891084888180.09
单位质量响应值RSD%判断
34552.5434741.860.39数据可信
供试品溶液-B736402批-pH4.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
2min1345128-34512863.04863.377.5263.0563.377.52
2371126-37112667.79867.80
3343857-34385762.81662.82
4321202-32120258.67758.68
5382543-38254369.88369.88
6317422-31742257.98757.99
5min1526923-52692396.25995.191.0196.2695.201.01
2513714-51371493.84693.85
3521291-52129195.23095.23
4515934-51593494.25194.25
5523596-52359695.65195.65
6525134-52513495.93295.93
10min1542962-54296299.18998.640.7399.1998.640.74
2534795-53479597.69797.70
3535442-53544297.81597.81
4544157-54415799.40799.41
5540374-54037498.71698.72
6541857-54185798.98798.99
15min1538176-53817698.31498.801.6198.3198.801.62
2534335-53433597.61397.61
3530426-53042696.89996.90
4555207-555207101.426101.43
5544086-54408699.39499.39
6542913-54291399.18099.18
20min1541474-54147498.91798.920.7798.9298.920.77
2535423-53542397.81197.81
3538544-53854498.38298.38
4547446-547446100.008100.01
5542662-54266299.13499.13
6543481-54348199.28399.28
30min1545052-54505299.57098.870.7099.5798.870.70
2536921-53692198.08598.09
3538080-53808098.29798.30
4546095-54609599.76199.76
5541925-54192598.99999.00
6539305-53930598.52198.52
45min1542822-54282299.16398.790.4999.1698.790.48
2536651-53665198.03698.04
3538932-53893298.45298.45
4543745-54374599.33299.33
5541154-54115498.85898.86
6541296-54129698.88498.88
极限1542564-54256499.11698.810.6399.1298.810.63
2535356-53535697.79997.80
3538851-53885198.43898.44
4541513-54151398.92498.92
5545242-54524299.60599.61
6541797-54179798.97698.98
枸橼酸西地那非片项目信息
介质体积(ml)900取样体积(ml)0补液体积(ml)0
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200
标示量(mg)50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%
114.164870144879324875074878274878594876280.08
214.074883324883164883240.01
单位质量响应值RSD%判断
34437.0134706.750.56数据可信
供试品溶液-B736402批-pH4.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
2min1319072-31907258.41663.288.0658.4263.288.06
2338898-33889862.04562.05
3343936-34393662.96862.97
4346643-34664363.46363.46
5327049-32704959.87659.88
6398349-39834972.93072.93
5min1515922-51592294.45594.492.3794.4694.492.37
2515972-51597294.46494.46
3511644-51164493.67293.67
4518447-51844794.91794.92
5498430-49843091.25391.25
6536222-53622298.17298.17
10min1535398-53539898.02198.161.0598.0298.161.05
2540721-54072198.99599.00
3530666-53066697.15497.15
4532264-53226497.44797.45
5532934-53293497.57097.57
6545015-54501599.78199.78
15min1536501-53650198.22398.681.1098.2298.681.10
2543599-54359999.52299.52
3534362-53436297.83197.83
4535435-53543598.02798.03
5535239-53523997.99297.99
6548867-548867100.487100.49
20min1535737-53573798.08398.491.3198.0898.491.31
2541462-54146299.13199.13
3527830-52783096.63596.64
4537895-53789598.47898.48
5535783-53578398.09198.09
6549006-549006100.512100.51
30min1538625-53862598.61298.730.8998.6198.730.89
2541561-54156199.14999.15
3533929-53392997.75297.75
4538711-53871198.62798.63
5535377-53537798.01798.02
6547320-547320100.203100.20
45min1537388-53738898.38598.511.0198.3998.511.01
2541919-54191999.21599.21
3532483-53248397.48797.49
4532594-53259497.50797.51
5537683-53768398.43998.44
6546361-546361100.028100.03
极限1539834-53983498.83398.711.1298.8398.711.12
2542625-54262599.34499.34
3529873-52987397.00997.01
4540017-54001798.86698.87
5535370-53537098.01698.02
6547367-547367100.212100.21
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