盐酸伐地那非口崩片项目信息
介质体积(ml)900取样体积(ml)2补液体积(ml)2
对照品批号2.0对照品来源中检院对照品使用方法直接使用
对照品含量(%)90.5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%
112.308366783681836508365583691836690.03
212.278263382642826380.01
单位质量响应值RSD%判断
6802.366734.960.71数据可信
加速6月-供试品溶液-2024050521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%
5min111363-1136312.72514.4414.1012.7214.4414.12
212957-1295714.51014.51
313046-1304614.61014.61
411644-1164413.04013.04
512010-1201013.44913.45
616330-1633018.28718.29
10min135396-3539639.63840.557.1739.6740.587.17
234577-3457738.72138.75
335967-3596740.27840.31
433064-3306437.02737.06
537817-3781742.35042.38
640424-4042445.26945.31
15min154803-5480361.37161.735.0661.4961.865.07
253106-5310659.47159.59
356167-5616762.89963.02
451124-5112457.25257.36
556463-5646363.23063.35
659102-5910266.18666.33
20min165110-6511072.91473.604.0073.1773.864.00
263757-6375771.39971.65
369415-6941577.73578.00
462750-6275070.27170.51
564939-6493972.72272.99
668382-6838276.57876.87
30min172198-7219880.85181.873.0081.2782.293.00
272050-7205080.68681.09
377151-7715186.39886.83
471370-7137079.92480.32
571784-7178480.38880.81
674093-7409382.97383.43
45min173983-7398382.85084.352.1283.4484.952.13
274840-7484083.81084.40
377624-7762486.92887.55
474184-7418483.07583.65
574250-7425083.14983.75
677035-7703586.26886.91
60min175246-7524684.26585.771.1285.0486.571.14
276146-7614685.27386.05
377747-7774787.06587.89
476595-7659585.77586.53
576677-7667785.86786.66
677145-7714586.39187.23
极限178820-7882088.26788.501.3989.2389.481.37
278044-7804487.39888.36
377873-7787387.20788.22
479209-7920988.70389.65
580915-8091590.61391.59
679289-7928988.79289.82
盐酸伐地那非口崩片项目信息
介质体积(ml)900取样体积(ml)2补液体积(ml)2
对照品批号2.0对照品来源中检院对照品使用方法直接使用
对照品含量(%)90.5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%
112.308260282342823038223982227823430.19
212.278207682092820840.02
单位质量响应值RSD%判断
6694.556689.810.06数据可信
加速6月-供试品溶液-2024050521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%
5min113724-1372415.54413.0312.2415.5413.0312.25
29937-993711.25511.25
311356-1135612.86212.86
410922-1092212.37112.37
512580-1258014.24814.25
610499-1049911.89111.89
10min134412-3441238.97637.1810.6539.0137.2010.64
233581-3358138.03538.06
330327-3032734.34934.38
430043-3004334.02734.05
538744-3874443.88243.91
629837-2983733.79433.82
15min154257-5425761.45359.078.6461.5759.188.64
255128-5512862.43962.55
347765-4776554.10054.20
447871-4787154.22054.32
558647-5864766.42566.55
649272-4927255.80755.91
20min168256-6825677.30874.256.5177.5774.506.52
267719-6771976.70076.95
360378-6037868.38668.61
461533-6153369.69469.92
571380-7138080.84781.12
664084-6408472.58372.81
30min177716-7771688.02386.562.4988.4586.962.50
277963-7796388.30388.72
373254-7325482.96983.35
475137-7513785.10285.48
576513-7651386.66187.12
677948-7794888.28688.67
45min178961-7896189.43389.661.3590.0690.261.31
279166-7916689.66590.28
379454-7945489.99290.55
479238-7923889.74790.31
577417-7741787.68488.33
680743-8074391.45292.03
60min179316-7931689.83590.071.2990.6690.871.25
279415-7941589.94790.76
380075-8007590.69591.46
479672-7967290.23991.01
577793-7779388.11088.95
680867-8086791.59292.38
极限180320-8032090.97291.161.2592.0092.161.21
280050-8005090.66791.68
381402-8140292.19893.16
480889-8088991.61792.58
578799-7879989.25090.29
681474-8147492.28093.27
盐酸伐地那非口崩片项目信息
介质体积(ml)900取样体积(ml)2补液体积(ml)2
对照品批号2.0对照品来源中检院对照品使用方法直接使用
对照品含量(%)90.5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%
112.308259082579825668257382609825830.03
212.278243782464824500.03
单位质量响应值RSD%判断
6714.076719.640.06数据可信
加速6月-供试品溶液-2024050521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%
5min113353-1335315.06812.6620.4815.0712.6620.48
29214-921410.39810.40
314808-1480816.71016.71
49635-963510.87310.87
510409-1040911.74611.75
69892-989211.16311.16
10min136393-3639341.06837.4610.7941.1037.4910.80
229811-2981133.64133.66
338587-3858743.54443.58
431600-3160035.66035.68
532874-3287437.09737.12
629925-2992533.76933.79
15min156653-5665363.93160.376.7964.0660.486.80
250049-5004956.47956.58
358895-5889566.46166.59
453087-5308759.90760.01
552479-5247959.22159.33
649795-4979556.19256.29
20min168662-6866277.48375.313.0977.7575.553.11
264180-6418072.42572.65
369359-6935978.26978.55
467417-6741776.07876.31
565313-6531373.70373.94
665465-6546573.87574.10
30min178351-7835188.41687.481.2888.8687.891.30
277317-7731787.25087.63
378626-7862688.72789.18
478050-7805088.07788.48
576179-7617985.96586.37
676612-7661286.45486.84
45min180990-8099091.39489.930.8592.0390.530.86
279439-7943989.64490.22
379307-7930789.49590.15
479605-7960589.83290.43
579089-7908989.24989.84
679699-7969989.93890.52
60min181066-8106691.48090.320.7492.3291.130.74
279605-7960589.83290.61
379371-7937189.56790.42
479944-7994490.21491.02
580010-8001090.28991.08
680225-8022590.53191.31
极限182106-8210692.65491.291.0193.7092.301.01
280401-8040190.73091.71
380030-8003090.31191.36
480342-8034290.66391.66
580840-8084091.22592.22
681646-8164692.13593.12
盐酸伐地那非口崩片项目信息
介质体积(ml)900取样体积(ml)2补液体积(ml)2
对照品批号2.0对照品来源中检院对照品使用方法直接使用
对照品含量(%)90.5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%
112.308238482501824438237782388824190.07
212.278238782458824220.07
单位质量响应值RSD%判断
6700.736717.360.18数据可信
加速6月-供试品溶液-2024050521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%
5min110830-1083012.23616.2517.2712.2416.2517.26
214001-1400115.81815.82
317564-1756419.84319.84
416761-1676118.93618.94
512882-1288214.55414.55
614240-1424016.08816.09
10min133902-3390238.30244.5510.6938.3344.5810.69
240257-4025745.48245.52
344478-4447850.25050.29
442567-4256748.09148.13
534844-3484439.36639.40
640540-4054045.80145.84
15min155894-5589463.14865.875.5763.2666.005.58
258040-5804065.57265.71
363847-6384772.13372.29
459539-5953967.26667.41
554513-5451361.58861.71
657982-5798265.50765.64
20min168690-6869077.60578.083.4877.8678.363.49
268151-6815176.99677.28
373153-7315382.64782.96
469766-6976678.82079.12
565810-6581074.35174.61
669082-6908278.04778.33
30min179982-7998290.36287.022.1090.7987.482.08
275154-7515484.90885.36
377041-7704187.03987.54
476145-7614586.02786.50
576832-7683286.80387.23
676996-7699686.98987.45
45min180812-8081291.30089.091.4791.9389.741.45
277671-7767187.75188.39
378302-7830288.46489.16
478121-7812188.26088.92
579619-7961989.95290.57
678635-7863588.84089.49
60min181047-8104791.56590.031.2692.3990.871.23
279172-7917289.44790.28
379028-7902889.28490.17
478820-7882089.04989.91
580875-8087591.37192.19
679171-7917189.44690.29
极限181666-8166692.26591.921.0293.3092.970.99
282255-8225592.93093.97
381317-8131791.87092.96
480436-8043690.87591.93
582146-8214692.80793.82
680353-8035390.78191.83
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