枸橼酸西地那非口崩片项目信息
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%
113.824749164718054730424737154736534734260.24
213.884761214744844753020.25
单位质量响应值RSD%判断
34256.5834243.660.03数据可信
供试品溶液-2024041321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%
2min1167909-16790931.02934.5112.6631.0334.5112.65
2199194-19919436.81036.81
3163078-16307830.13630.14
4171290-17129031.65431.65
5224410-22441041.47041.47
6194726-19472635.98535.98
5min1294109-29410954.35158.526.7554.3558.526.75
2328771-32877160.75660.76
3298682-29868255.19655.20
4306305-30630556.60456.60
5350993-35099364.86364.86
6321110-32111059.34059.34
10min1327840-32784060.58460.512.7660.5860.512.76
2331430-33143061.24761.25
3339469-33946962.73362.73
4327994-32799460.61260.61
5311785-31178557.61757.62
6326253-32625360.29160.29
15min1323344-32334459.75359.821.9659.7559.821.95
2331125-33112561.19161.19
3315131-31513158.23558.24
4329508-32950860.89260.89
5317838-31783858.73658.74
6325418-32541860.13660.14
20min1308330-30833056.97956.822.6256.9856.822.61
2308925-30892557.08857.09
3317747-31774758.71958.72
4307658-30765856.85456.85
5292959-29295954.13854.14
6309207-30920757.14157.14
30min1307452-30745256.81656.001.6956.8256.001.69
2301746-30174655.76255.76
3306033-30603356.55456.55
4307348-30734856.79756.80
5294178-29417854.36354.36
6301428-30142855.70355.70
45min1294159-29415954.36054.341.1854.3654.341.18
2297599-29759954.99555.00
3297289-29728954.93854.94
4288105-28810553.24153.24
5293894-29389454.31154.31
6293136-29313654.17154.17
极限1283149-28314952.32552.181.3952.3352.181.39
2279521-27952151.65551.65
3286786-28678652.99753.00
4276100-27610051.02251.02
5284869-28486952.64352.64
6283833-28383352.45252.45
枸橼酸西地那非口崩片项目信息
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%
113.824723824753604742094774064771484753010.45
213.884746344750774748560.07
单位质量响应值RSD%判断
34392.2634211.530.38数据可信
供试品溶液-2024041321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%
2min1248243-24824345.80639.748.6945.8139.748.70
2209587-20958738.67338.67
3196737-19673736.30236.30
4224099-22409941.35141.35
5201056-20105637.09937.10
6212530-21253039.21639.22
5min1295942-29594254.60753.376.8354.6153.386.84
2315989-31598958.30658.31
3304722-30472256.22756.23
4263304-26330448.58548.58
5274921-27492150.72850.73
6280689-28068951.79351.79
10min1286098-28609852.79155.644.9652.7955.644.96
2322426-32242659.49459.49
3316353-31635358.37358.37
4287489-28748953.04753.05
5296657-29665754.73954.74
6300054-30005455.36655.37
15min1299638-29963855.28954.614.2655.2954.614.26
2314584-31458458.04758.05
3299979-29997955.35255.35
4277980-27798051.29351.29
5297219-29721954.84354.84
6286452-28645252.85652.86
20min1284647-28464752.52351.993.6852.5251.993.68
2285764-28576452.72952.73
3293008-29300854.06654.07
4280932-28093251.83751.84
5262283-26228348.39648.40
6283968-28396852.39852.40
30min1280978-28097851.84651.612.9051.8551.612.90
2289914-28991453.49553.49
3283099-28309952.23752.24
4274023-27402350.56350.56
5266873-26687349.24349.24
6283451-28345152.30252.30
45min1288290-28829053.19550.843.3553.2050.843.35
2283223-28322352.26052.26
3278676-27867651.42151.42
4269276-26927649.68749.69
5267409-26740949.34249.34
6266130-26613049.10649.11
极限1274837-27483750.71349.954.0350.7149.954.03
2283849-28384952.37652.38
3275304-27530450.79950.80
4252663-25266346.62146.62
5263764-26376448.67048.67
6273663-27366350.49650.50
枸橼酸西地那非口崩片项目信息
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%
113.824734344733624713964722564761644733220.38
213.884745334735044740180.16
单位质量响应值RSD%判断
34249.0634151.150.21数据可信
供试品溶液-2024041321批-pH2.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
2min1383919-38391971.05170.6412.1871.0570.6412.18
2320351-32035159.28759.29
3395763-39576373.24373.24
4436850-43685080.84780.85
5419913-41991377.71277.71
6333465-33346561.71461.71
5min1537058-53705899.39299.801.2999.3999.801.29
2545541-545541100.962100.96
3531507-53150798.36598.36
4546496-546496101.139101.14
5543790-543790100.638100.64
6531337-53133798.33398.33
10min1541386-541386100.193101.010.98100.19101.000.98
2554884-554884102.691102.69
3541175-541175100.154100.15
4546229-546229101.089101.09
5548478-548478101.506101.51
6542505-542505100.400100.40
15min1541420-541420100.199101.291.05100.20101.281.05
2554823-554823102.680102.68
3543918-543918100.662100.66
4553607-553607102.455102.45
5547338-547338101.295101.29
6542686-542686100.434100.43
20min1542146-542146100.334101.380.84100.33101.380.84
2554284-554284102.580102.58
3545964-545964101.040101.04
4549675-549675101.727101.73
5550833-550833101.941101.94
6543921-543921100.662100.66
30min1540406-540406100.012101.451.09100.01101.451.09
2557403-557403103.157103.16
3544901-544901100.844100.84
4551038-551038101.979101.98
5550131-550131101.812101.81
6545159-545159100.891100.89
45min1542854-542854100.465101.350.96100.46101.340.96
2555029-555029102.718102.72
3546581-546581101.155101.15
4550106-550106101.807101.81
5550218-550218101.828101.83
6540885-540885100.100100.10
极限1542301-542301100.362101.440.83100.36101.440.83
2554572-554572102.633102.63
3550076-550076101.801101.80
4549535-549535101.701101.70
5548719-548719101.550101.55
6543486-543486100.582100.58
枸橼酸西地那非口崩片项目信息
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%
113.824726114725664736374734034744034733240.17
213.884745874704424725140.63
单位质量响应值RSD%判断
34249.2034042.800.43数据可信
供试品溶液-2024041321批-pH2.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
2min1410349-41034976.06374.045.3076.0674.045.30
2392792-39279272.80972.81
3371721-37172168.90368.90
4384053-38405371.18971.19
5431388-43138879.96379.96
6406388-40638875.32975.33
5min1525344-52534497.37996.642.6897.3896.642.68
2538494-53849499.81799.82
3499939-49993992.67092.67
4512187-51218794.94094.94
5532266-53226698.66298.66
6519758-51975896.34496.34
10min1533430-53343098.87899.961.1198.8899.961.11
2550264-550264101.998102.00
3538989-53898999.90899.91
4534960-53496099.16199.16
5540228-540228100.138100.14
6537737-53773799.67699.68
15min1531530-53153098.526100.291.4798.53100.301.47
2555542-555542102.977102.98
3540182-540182100.129100.13
4538345-53834599.78999.79
5541637-541637100.399100.40
6539152-53915299.93899.94
20min1533909-53390998.967100.141.5698.97100.141.56
2554649-554649102.811102.81
3539609-539609100.023100.02
4531396-53139698.50198.50
5544490-544490100.928100.93
6537246-53724699.58599.59
30min1532108-53210898.633100.331.4898.63100.331.48
2554618-554618102.805102.81
3545691-545691101.151101.15
4536385-53638599.42699.43
5540697-540697100.225100.22
6537977-53797799.72199.72
45min1533321-53332198.858100.301.4298.86100.301.42
2554752-554752102.830102.83
3543055-543055100.662100.66
4535881-53588199.33299.33
5542291-542291100.520100.52
6537310-53731099.59799.60
极限1534960-53496099.161100.251.3299.16100.251.32
2553330-553330102.567102.57
3539760-539760100.051100.05
4535836-53583699.32499.32
5544760-544760100.978100.98
6536293-53629399.40999.41
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