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%
111.913749693746183746513749693754153749240.09
211.913752743746403749570.12
单位质量响应值RSD%判断
31479.7631482.540.01数据可信
供试品溶液-2024072521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%
5min1170767-17076741.11652.4210.7041.1252.4210.69
2222789-22278953.64153.64
3224230-22423053.98853.99
4232672-23267256.02156.02
5226581-22658154.55454.55
6229368-22936855.22555.23
10min1205075-20507549.37661.679.8749.4461.759.88
2261351-26135162.92663.02
3262729-26272963.25763.35
4270713-27071365.18065.27
5267832-26783264.48664.58
6269012-26901264.77064.86
15min1230141-23014155.41168.099.2555.5668.289.26
2288491-28849169.46069.65
3289456-28945669.69369.89
4300549-30054972.36372.57
5293937-29393770.77170.97
6294173-29417370.82871.03
20min1251794-25179460.62573.128.5060.8773.438.50
2312396-31239675.21675.53
3309694-30969474.56574.88
4322278-32227877.59577.92
5312660-31266075.27975.60
6313425-31342575.46475.78
30min1281889-28188967.87179.627.4068.2180.047.42
2338207-33820781.43081.87
3338007-33800781.38281.82
4350712-35071284.44184.89
5336323-33632380.97781.42
6338995-33899581.62082.06
45min1310174-31017474.68185.526.4275.1486.086.44
2362736-36273687.33687.91
3361873-36187387.12887.70
4374744-37474490.22790.82
5357413-35741386.05586.63
6364194-36419487.68788.27
60min1335004-33500480.65989.184.8581.2489.884.88
2377152-37715290.80791.52
3375097-37509790.31291.03
4386206-38620692.98793.73
5372555-37255589.70090.42
6376373-37637390.62091.35
90min1367809-36780988.55892.932.5889.2793.782.62
2389975-38997593.89594.76
3386547-38654793.06993.94
4397595-39759595.72996.63
5384666-38466692.61693.49
6389105-38910593.68594.56
120min1383891-38389192.43094.511.8493.2995.511.88
2394735-39473595.04196.07
3388378-38837893.51094.53
4403904-40390497.24898.31
5388024-38802493.42594.45
6396149-39614995.38196.41
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1397366-39736695.67496.441.0096.6997.601.03
2402435-40243596.89598.08
3401309-40130996.62397.80
4407274-40727498.06099.28
5396916-39691695.56696.75
6398007-39800795.82897.02
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%
111.913755013753413753443754543753913754060.02
211.913763123759663761390.07
单位质量响应值RSD%判断
31520.2431581.780.14数据可信
供试品溶液-2024072522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%
5min1248291-24829159.64949.6728.8759.6549.6828.87
2223439-22343953.67853.68
3217714-21771452.30352.30
4184054-18405444.21744.22
5267520-26752064.26864.27
699591-9959123.92623.93
10min1280043-28004367.27757.1824.0767.3857.2624.07
2246389-24638959.19259.28
3256211-25621161.55261.64
4225592-22559254.19654.27
5288979-28897969.42469.53
6130860-13086031.43831.48
15min1306404-30640473.61063.7621.2773.8263.9321.28
2267714-26771464.31564.50
3286975-28697568.94269.13
4257767-25776761.92562.09
5314406-31440675.53275.76
6159042-15904238.20838.30
20min1324052-32405277.85069.0117.8878.1869.3017.90
2287577-28757769.08769.38
3309779-30977974.42174.73
4281776-28177667.69367.96
5330261-33026179.34179.69
6190109-19010945.67145.83
30min1347752-34775283.54376.8213.0184.0177.2213.06
2317009-31700976.15876.57
3342248-34224882.22182.65
4319874-31987476.84677.23
5351546-35154684.45584.94
6240126-24012657.68757.92
45min1367596-36759688.31083.948.7088.9184.478.77
2343111-34311182.42882.97
3369560-36956088.78289.35
4352030-35203084.57185.08
5372253-37225389.42990.05
6291851-29185170.11470.44
60min1376264-37626490.39387.826.0891.1488.496.16
2361811-36181186.92187.60
3384223-38422392.30593.02
4367854-36785488.37289.02
5379811-37981191.24592.02
6323375-32337577.68778.13
90min1384987-38498792.48891.723.3093.3992.543.40
2377187-37718790.61591.43
3397311-39731195.44996.32
4381219-38121991.58392.38
5389700-38970093.62194.54
6360393-36039386.58087.15
120min1384903-38490392.46893.182.1493.5294.142.20
2380842-38084291.49392.46
3401984-40198496.57297.60
4388111-38811193.23994.19
5391840-39184094.13595.21
6379497-37949791.17091.89
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1393530-39353094.54195.041.7995.7596.161.82
2388161-38816193.25194.37
3408873-40887398.22799.41
4396211-39621195.18596.29
5394677-39467794.81696.05
6392099-39209994.19795.07
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%
111.913762233761323766003762623757563761950.09
211.913762973763703763340.02
单位质量响应值RSD%判断
31586.4831598.150.03数据可信
供试品溶液-2024072522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%
5min1264946-26494663.56749.7721.2963.5749.7721.29
2215712-21571251.75451.75
3142076-14207634.08734.09
4187123-18712344.89544.90
5190082-19008245.60545.61
6244643-24464358.69658.70
10min1301753-30175372.39858.3618.7272.5058.4418.72
2249189-24918959.78659.87
3171657-17165741.18541.24
4227411-22741154.56154.64
5229576-22957655.08155.16
6279886-27988667.15167.25
15min1324185-32418577.78064.5616.2378.0164.7416.24
2275532-27553266.10766.29
3199865-19986547.95248.08
4256654-25665461.57761.74
5253574-25357460.83861.01
6304709-30470973.10773.32
20min1339458-33945881.44469.7813.4681.8070.0713.48
2297421-29742171.35871.65
3227867-22786754.67154.88
4280864-28086467.38667.65
5277116-27711666.48766.76
6322397-32239777.35177.68
30min1363854-36385487.29777.689.8487.7978.089.88
2331236-33123679.47179.89
3272631-27263165.41165.71
4318151-31815176.33276.71
5309351-30935174.22174.60
6347294-34729483.32483.78
45min1382003-38200391.65184.616.8792.2985.146.92
2358923-35892386.11486.66
3314006-31400675.33775.74
4351495-35149584.33284.84
5338479-33847981.20981.71
6370957-37095789.00189.60
60min1393206-39320694.33988.655.0095.1389.335.07
2375598-37559890.11590.81
3341065-34106581.82982.36
4368507-36850788.41389.06
5357150-35715085.68986.33
6381497-38149791.53092.28
90min1401406-40140696.30792.333.0797.2593.163.14
2387496-38749692.96993.81
3367799-36779988.24488.91
4387192-38719292.89693.69
5375240-37524090.02990.81
6389969-38996993.56394.46
120min1407825-40782597.84794.062.6398.9595.032.69
2395588-39558894.91195.91
3379234-37923490.98791.80
4395043-39504394.78095.73
5382365-38236591.73892.67
6392134-39213494.08295.14
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1406628-40662897.56095.472.0198.8396.602.07
2400828-40082896.16897.32
3388088-38808893.11194.08
4404761-40476197.11298.22
5388451-38845193.19894.28
6398667-39866795.65096.86
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