枸橼酸西地那非片项目信息
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250
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%
117.184689244684224687484689384687814687630.05
217.064682494682444682460.01
单位质量响应值RSD%判断
27285.3927447.010.42数据可信
供试品溶液-2024051711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%
5min1488052-48805290.30392.735.7590.3092.735.76
2461333-46133385.35985.36
3516231-51623195.51795.52
4531267-53126798.29998.30
5480255-48025588.86088.86
6529849-52984998.03798.04
10min1517191-51719195.69596.461.9795.8596.621.98
2505491-50549193.53093.67
3529740-52974098.01798.18
4533402-53340298.69498.86
5516586-51658695.58395.73
6525671-52567197.26497.43
15min1516390-51639095.54697.101.5695.8697.411.56
2514856-51485695.26395.56
3533087-53308798.63698.96
4533560-53356098.72399.05
5522584-52258496.69397.00
6528109-52810997.71598.04
20min1515401-51540195.36397.401.5395.8397.881.54
2519657-51965796.15196.61
3537072-53707299.37399.86
4532742-53274298.57299.06
5528023-52802397.69998.17
6525610-52561097.25297.74
30min1515810-51581095.43997.911.6396.0798.551.63
2526389-52638997.39798.01
3540324-54032499.975100.63
4533090-53309098.63699.29
5534365-53436598.87299.50
6525148-52514897.16797.82
45min1516797-51679795.62297.931.6896.4198.731.67
2529644-52964497.99998.78
3540429-54042999.994100.81
4527731-52773197.64598.47
5537850-53785099.517100.31
6523082-52308296.78597.60
极限1516952-51695295.65098.351.8996.6099.321.88
2528986-52898697.87798.82
3541652-541652100.221101.21
4529625-52962597.99598.98
5544299-544299100.710101.67
6527669-52766997.63398.61
枸橼酸西地那非片项目信息
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250
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%
117.184682144688794690074687704682654686270.08
217.064671284675794673540.07
单位质量响应值RSD%判断
27277.4727394.720.31数据可信
供试品溶液-2024051712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%
5min1510755-51075594.60796.071.0194.6196.071.01
2523135-52313596.90196.90
3520761-52076196.46196.46
4514626-51462695.32595.32
5518348-51834896.01496.01
6524317-52431797.12097.12
10min1518313-51831396.00797.941.5696.1798.111.56
2530797-53079798.32098.48
3530020-53002098.17698.34
4539202-53920299.877100.04
5519774-51977496.27896.44
6534508-53450899.00799.17
15min1519837-51983796.29097.971.4096.6198.301.40
2528191-52819197.83798.16
3530790-53079098.31998.64
4537675-53767599.59499.92
5521205-52120596.54396.86
6535901-53590199.26599.59
20min1522295-52229596.74598.361.9497.2298.841.93
2530418-53041898.25098.74
3532192-53219298.57899.07
4547331-547331101.382101.87
5518253-51825395.99696.48
6535470-53547099.18599.68
30min1521371-52137196.57497.941.4097.2198.591.40
2526627-52662797.54798.20
3528477-52847797.89098.54
4537905-53790599.636100.30
5520929-52092996.49297.13
6537063-53706399.481100.14
45min1519759-51975996.27597.741.3197.0898.551.31
2528274-52827497.85398.67
3528983-52898397.98498.80
4536540-53654099.384100.21
5519558-51955896.23897.04
6532845-53284598.69999.52
极限1520382-52038296.39197.861.3297.3598.841.32
2528927-52892797.97398.95
3526710-52671097.56398.54
4538635-53863599.772100.76
5521864-52186496.66597.63
6533517-53351798.82499.81
枸橼酸西地那非片项目信息
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250
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%
117.184693064692854698324695294697644695430.06
217.064730244732454731340.04
单位质量响应值RSD%判断
27330.7927733.531.04数据可信
供试品溶液-2024051713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%
5min1528719-52871997.24296.391.7497.2496.391.74
2528370-52837097.17897.18
3537338-53733898.82898.83
4520940-52094095.81295.81
5512755-51275594.30694.31
6516374-51637494.97294.97
10min1544056-544056100.06397.591.55100.2397.751.55
2523440-52344096.27196.43
3535491-53549198.48898.65
4529489-52948997.38497.54
5521805-52180595.97196.13
6529455-52945597.37897.54
15min1544679-544679100.17897.741.77100.5198.061.77
2524138-52413896.40096.72
3535134-53513498.42298.75
4529976-52997697.47497.80
5518324-51832495.33095.65
6536199-53619998.61898.94
20min1534971-53497198.39297.501.2998.8997.991.29
2523629-52362996.30696.79
3534597-53459798.32398.82
4532215-53221597.88598.37
5519604-51960495.56696.04
6535733-53573398.53299.02
30min1540047-54004799.32697.801.3399.9998.451.33
2528428-52842897.18997.83
3534791-53479198.35999.02
4530790-53079097.62398.27
5520031-52003195.64496.28
6536336-53633698.64399.29
45min1534623-53462398.32897.551.2499.1598.361.23
2526000-52600096.74297.55
3531908-53190897.82998.65
4528569-52856997.21598.03
5521383-52138395.89396.69
6539844-53984499.288100.10
极限1531475-53147597.74997.521.2098.7498.501.20
2534183-53418398.24799.21
3533183-53318398.06399.05
4529609-52960997.40698.38
5517904-51790495.25396.21
6535097-53509798.41599.39
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