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%
113.824680494685864686054689054703134688920.19
213.884740224713604726910.40
单位质量响应值RSD%判断
33928.5134055.550.27数据可信
加速6月-供试品溶液-2024041121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%
2min1189462-18946235.27837.1815.2835.2837.1815.28
2232164-23216443.22943.23
3217564-21756440.51140.51
4227881-22788142.43242.43
5170612-17061231.76831.77
6160502-16050229.88629.89
5min1308853-30885357.50959.524.6457.5159.524.65
2332534-33253461.91861.92
3327128-32712860.91260.91
4334886-33488662.35662.36
5317799-31779959.17459.17
6296743-29674355.25455.25
10min1320928-32092859.75763.123.7859.7663.123.78
2345797-34579764.38864.39
3331326-33132661.69361.69
4358355-35835566.72666.73
5341419-34141963.57363.57
6336222-33622262.60562.60
15min1327263-32726360.93761.894.0260.9461.894.02
2346607-34660764.53964.54
3333420-33342062.08362.08
4340248-34024863.35463.35
5338119-33811962.95862.96
6308615-30861557.46457.46
20min1331288-33128861.68662.385.0461.6962.385.04
2330031-33003161.45261.45
3341727-34172763.63063.63
4362434-36243467.48667.49
5333612-33361262.11962.12
6310851-31085157.88157.88
30min1333857-33385762.16461.565.5562.1661.565.55
2349126-34912665.00865.01
3331827-33182761.78661.79
4347907-34790764.78164.78
5320697-32069759.71459.71
6300164-30016455.89155.89
45min1312736-31273658.23260.225.1458.2360.225.14
2326914-32691460.87260.87
3338276-33827662.98762.99
4343548-34354863.96963.97
5320658-32065859.70759.71
6298486-29848655.57855.58
极限1329350-32935061.32561.273.0261.3361.283.02
2343409-34340963.94363.94
3333293-33329362.05962.06
4332805-33280561.96961.97
5317389-31738959.09859.10
6318220-31822059.25359.25
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%
113.824667994689554682604681794691214682630.20
213.884721224717864719540.06
单位质量响应值RSD%判断
33883.0034002.450.25数据可信
加速6月-供试品溶液-2024041221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%
2min1222013-22201341.39938.9514.8341.4038.9514.84
2232091-23209143.27843.28
3247487-24748746.14946.15
4205766-20576638.36938.37
5174196-17419632.48332.48
6171688-17168832.01532.01
5min1273323-27332350.96755.687.1950.9755.687.19
2294646-29464654.94354.94
3280119-28011952.23452.23
4333626-33362662.21262.21
5305430-30543056.95456.95
6304339-30433956.75156.75
10min1325240-32524060.64863.814.0360.6563.824.03
2346799-34679964.66864.67
3352605-35260565.75165.75
4345167-34516764.36464.36
5357888-35788866.73666.74
6325618-32561860.71860.72
15min1311030-31103057.99861.596.6058.0061.596.60
2346299-34629964.57564.57
3321055-32105559.86859.87
4330810-33081061.68761.69
5364438-36443867.95767.96
6308081-30808157.44857.45
20min1308451-30845157.51763.076.2757.5263.076.27
2324173-32417360.44960.45
3336560-33656062.75962.76
4337836-33783662.99763.00
5368424-36842468.70168.70
6353915-35391565.99566.00
30min1330439-33043961.61762.234.4861.6262.244.48
2337848-33784862.99963.00
3323951-32395160.40860.41
4337332-33733262.90362.90
5358389-35838966.82966.83
6314508-31450858.64758.65
45min1337100-33710062.85962.864.5162.8662.864.51
2323500-32350060.32360.32
3322957-32295760.22260.22
4330240-33024061.58061.58
5362213-36221367.54267.54
6346709-34670964.65164.65
极限1318537-31853759.39862.515.2559.4062.515.25
2331193-33119361.75861.76
3331172-33117261.75461.75
4319907-31990759.65359.65
5345387-34538764.40564.40
6365167-36516768.09368.09
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