伐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%
111.733752033752873764003754833754703755690.13
211.813770713769583770140.03
单位质量响应值RSD%判断
32017.8231923.290.21数据可信
供试品溶液-2023120621批-pH1.0盐酸溶液
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
2min1400233-40023394.88988.526.4394.8988.526.43
2341955-34195581.07381.07
3379033-37903389.86389.86
4373721-37372188.60488.60
5348760-34876082.68682.69
6396463-39646393.99694.00
5min1436900-436900103.583100.042.10103.58100.042.10
2412719-41271997.85097.85
3424582-424582100.662100.66
4417106-41710698.89098.89
5415370-41537098.47898.48
6425035-425035100.770100.77
10min1439396-439396104.174100.622.08104.17100.622.08
2414003-41400398.15498.15
3423863-423863100.492100.49
4419837-41983799.53799.54
5420520-42052099.69999.70
6428830-428830101.669101.67
15min1438707-438707104.011100.632.08104.01100.632.08
2415812-41581298.58398.58
3427590-427590101.375101.38
4416509-41650998.74898.75
5419688-41968899.50299.50
6428303-428303101.544101.54
20min1438949-438949104.068100.662.08104.07100.662.08
2416280-41628098.69498.69
3427585-427585101.374101.37
4417821-41782199.05999.06
5418228-41822899.15699.16
6428633-428633101.623101.62
30min1439107-439107104.106100.512.11104.11100.522.12
2414415-41441598.25298.25
3424440-424440100.629100.63
4418033-41803399.11099.11
5419155-41915599.37699.38
6428559-428559101.605101.61
45min1439036-439036104.089100.612.02104.09100.612.03
2417293-41729398.93498.93
3425187-425187100.806100.81
4418641-41864199.25499.25
5417379-41737998.95598.95
6428753-428753101.651101.65
极限1438342-438342103.925100.651.93103.92100.651.92
2417768-41776899.04799.05
3425577-425577100.898100.90
4418798-41879899.29199.29
5417898-41789899.07899.08
6428790-428790101.660101.66
伐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%
111.733788993776103789643778733790723784840.19
211.813783233777243780240.12
单位质量响应值RSD%判断
32266.3332008.810.57数据可信
供试品溶液-2305004056批
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
2min1130774-13077430.84438.5239.9430.8438.5239.94
2116551-11655127.48927.49
3121728-12172828.71028.71
4126731-12673129.89029.89
5277813-27781365.52465.52
6206350-20635048.66948.67
5min1346545-34654581.73586.696.4681.7386.696.46
2367200-36720086.60786.61
3357971-35797184.43084.43
4346429-34642981.70881.71
5378125-37812589.18389.18
6409083-40908396.48596.48
10min1415831-41583198.07798.351.0098.0898.350.99
2415906-41590698.09498.09
3414793-41479397.83297.83
4411719-41171997.10797.11
5420528-42052899.18499.18
6423145-42314599.80299.80
15min1426252-426252100.53499.411.09100.5399.421.09
2418304-41830498.66098.66
3421382-42138299.38699.39
4414687-41468797.80797.81
5421773-42177399.47899.48
6426614-426614100.620100.62
20min1424004-424004100.00499.341.23100.0099.341.23
2418999-41899998.82498.82
3422557-42255799.66399.66
4414184-41418497.68897.69
5418284-41828498.65598.66
6429038-429038101.191101.19
30min1424008-424008100.00599.460.97100.0199.460.97
2422043-42204399.54299.54
3420106-42010699.08599.08
4415797-41579798.06898.07
5420367-42036799.14699.15
6427939-427939100.932100.93
45min1423918-42391899.98499.321.3599.9899.321.36
2419842-41984299.02399.02
3426128-426128100.505100.51
4411626-41162697.08597.08
5418493-41849398.70498.70
6426569-426569100.609100.61
极限1426007-426007100.47799.271.05100.4899.271.05
2419408-41940898.92098.92
3420254-42025499.12099.12
4414856-41485697.84797.85
5418664-41866498.74598.74
6426110-426110100.501100.50
伐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%
111.733773823767553757673761883766603765500.17
211.813743713762553753130.36
单位质量响应值RSD%判断
32101.4531779.250.72数据可信
供试品溶液-2023120621批
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
2min1379737-37973790.11791.624.1790.1291.634.17
2372230-37223088.33688.34
3416522-41652298.84798.85
4377638-37763889.61989.62
5390801-39080192.74392.74
6379612-37961290.08890.09
5min1421397-421397100.004101.131.80100.00101.131.79
2430263-430263102.108102.11
3438748-438748104.122104.12
4419985-41998599.66999.67
5427528-427528101.459101.46
6418883-41888399.40799.41
10min1419372-41937299.523101.411.5499.52101.401.54
2431761-431761102.463102.46
3437693-437693103.871103.87
4423493-423493100.501100.50
5427133-427133101.365101.37
6424373-424373100.710100.71
15min1419111-41911199.461101.281.9199.46101.281.91
2433910-433910102.973102.97
3439236-439236104.237104.24
4420620-42062099.82099.82
5426272-426272101.161101.16
6421538-421538100.037100.04
20min1421139-42113999.943101.301.7399.94101.301.73
2431458-431458102.392102.39
3439344-439344104.263104.26
4420068-42006899.68999.69
5426145-426145101.131101.13
6423098-423098100.408100.41
30min1421049-42104999.921101.381.5499.92101.381.53
2434034-434034103.003103.00
3436596-436596103.611103.61
4421776-421776100.094100.09
5425091-425091100.881100.88
6424564-424564100.755100.76
45min1419292-41929299.504100.981.6699.50100.981.66
2431213-431213102.333102.33
3436838-436838103.668103.67
4419379-41937999.52599.52
5423123-423123100.414100.41
6423254-423254100.445100.44
极限1418305-41830599.270101.041.6299.27101.041.62
2431265-431265102.346102.35
3436206-436206103.518103.52
4419529-41952999.56199.56
5424847-424847100.823100.82
6424351-424351100.705100.70
伐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%
111.733772193743633748793758353742733753140.33
211.813760343766353763340.12
单位质量响应值RSD%判断
31996.0831865.710.29数据可信
供试品溶液-2305004056批
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
2min1163946-16394638.91832.8914.7138.9232.9014.71
2163782-16378238.87938.88
3130901-13090131.07331.07
4115678-11567827.46027.46
5126085-12608529.93029.93
6131051-13105131.10931.11
5min1387019-38701991.87185.206.7391.8785.206.73
2386745-38674591.80691.81
3336437-33643779.86479.86
4365106-36510686.66986.67
5342204-34220481.23381.23
6335942-33594279.74679.75
10min1411357-41135797.64898.922.2197.6598.922.21
2428918-428918101.817101.82
3426877-426877101.332101.33
4415422-41542298.61398.61
5406049-40604996.38896.39
6411716-41171697.73397.73
15min1429265-429265101.899100.381.53101.90100.381.53
2430763-430763102.255102.25
3422126-422126100.204100.20
4418333-41833399.30499.30
5413718-41371898.20998.21
6422940-422940100.398100.40
20min1429867-429867102.042100.541.58102.04100.541.58
2431275-431275102.376102.38
3424487-424487100.765100.76
4416102-41610298.77498.77
5415453-41545398.62098.62
6423971-423971100.642100.64
30min1433962-433962103.014100.751.97103.01100.751.97
2433035-433035102.794102.79
3425272-425272100.951100.95
4416131-41613198.78198.78
5413794-41379498.22798.23
6424309-424309100.723100.72
45min1429989-429989102.071100.641.71102.07100.641.71
2433053-433053102.798102.80
3422751-422751100.353100.35
4418762-41876299.40699.41
5413434-41343498.14198.14
6425650-425650101.041101.04
极限1429579-429579101.974100.521.63101.97100.521.63
2432149-432149102.584102.58
3423509-423509100.533100.53
4419394-41939499.55699.56
5413141-41314198.07298.07
6423051-423051100.424100.42
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