阿齐沙坦左氨氯地平片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号100546-202105 对照品来源中检院对照品使用方法直接使用
对照品含量(%)97.3对照品水分(%)0对照品稀释倍数6250
标示量(mg)2.5供试品稀释倍数2系数0.7210
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
112.284936649193490564927849250492290.24
212.294931049056491830.37
单位质量响应值RSD%判断
4008.884001.870.13数据可信
供试品溶液-24050703批-左氨氯地平-pH4.5
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min113517-1351727.27358.8453.2627.2758.8453.26
245810-4581092.43192.43
324736-2473649.91049.91
418624-1862437.57837.58
521046-2104642.46542.46
651242-51242103.391103.39
10min132334-3233465.24191.2114.9665.3991.5415.05
249393-4939399.661100.17
346475-4647593.77394.05
445748-4574892.30692.51
545506-4550691.81892.05
651780-51780104.477105.05
15min149007-4900798.88298.143.2899.4098.973.42
249690-49690100.260101.33
347527-4752795.89696.69
446861-4686194.55295.27
547646-4764696.13696.88
651101-51101103.107104.26
20min149790-49790100.46298.443.89101.5299.823.98
249668-49668100.215101.84
347096-4709695.02696.36
446901-4690194.63295.88
547591-4759196.02597.30
651674-51674104.263105.99
30min149088-4908899.04597.853.27100.6799.783.35
248193-4819397.23999.42
349043-4904398.954100.81
446154-4615493.12594.90
547631-4763196.10597.92
650861-50861102.623104.93
45min147230-4723095.29696.722.8197.4799.192.95
247716-4771696.27799.00
348848-4884898.561100.97
446627-4662794.08096.37
546995-4699594.82297.17
650187-50187101.263104.14
60min147448-4744895.73697.322.4598.44100.332.59
247833-4783396.51399.77
349156-4915699.182102.14
447326-4732695.49098.30
547441-4744195.72298.60
650206-50206101.301104.74
极限146944-4694494.71997.251.9297.95100.802.09
248151-4815197.155100.95
348670-4867098.202101.71
448399-4839997.655101.00
547455-4745595.75099.16
649571-49571100.020104.02
阿齐沙坦左氨氯地平片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号68522100802对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.7对照品水分(%)0对照品稀释倍数1000
标示量(mg)20供试品稀释倍数2系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.843777873781813777243775433780293778530.07
210.963783913783323783620.02
单位质量响应值RSD%判断
34857.2934522.080.69数据可信
供试品溶液-24050703批-阿齐沙坦-pH4.5
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min1-0.0000.00-0.000.00-
2-0.0000.00
3-0.0000.00
4-0.0000.00
5-0.0000.00
6-0.0000.00
10min13115-31150.8061.7232.030.811.7232.03
25347-53471.3831.38
38373-83732.1662.17
48607-86072.2262.23
57964-79642.0602.06
66530-65301.6891.69
15min111918-119183.0833.8114.633.093.8214.65
212768-127683.3033.31
316943-169434.3834.39
416796-167964.3454.36
516009-160094.1414.15
613938-139383.6053.61
20min120832-208325.3895.798.625.415.828.68
219704-197045.0975.12
324445-244456.3236.36
424420-244206.3176.35
522945-229455.9355.97
621849-218495.6525.68
30min131265-312658.0878.315.088.148.375.14
230383-303837.8597.91
334777-347778.9969.07
433368-333688.6318.70
531562-315628.1648.23
631333-313338.1058.17
45min138713-3871310.01410.404.1210.1110.514.20
238797-3879710.03610.13
342858-4285811.08611.21
441433-4143310.71810.84
540295-4029510.42310.54
639222-3922210.14610.25
60min144424-4442411.49111.732.4811.6411.892.54
244360-4436011.47511.63
347163-4716312.20012.38
446206-4620611.95212.13
544737-4473711.57211.74
645121-4512111.67111.83
极限146255-4625511.96512.442.1612.1812.672.21
248155-4815512.45612.67
349147-4914712.71312.96
449005-4900512.67612.92
547833-4783312.37312.61
648142-4814212.45312.68
阿齐沙坦左氨氯地平片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号100546-202105 对照品来源中检院对照品使用方法直接使用
对照品含量(%)97.3对照品水分(%)0对照品稀释倍数6250
标示量(mg)2.5供试品稀释倍数2系数0.7210
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
112.284915549108493304936149186492280.23
212.294899849172490850.26
单位质量响应值RSD%判断
4008.793993.900.27数据可信
供试品溶液-24050703批-左氨氯地平-pH4.5
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min121921-2192144.27557.9048.0244.2757.9048.02
220910-2091042.23342.23
313427-1342727.11927.12
443330-4333087.51587.52
524356-2435649.19349.19
648048-4804897.04597.04
10min146948-4694894.82394.219.5795.0794.549.65
247613-4761396.16696.40
337790-3779076.32676.48
449839-49839100.662101.15
548514-4851497.98698.26
649177-4917799.32599.86
15min148097-4809797.14499.141.5497.9299.991.69
248644-4864498.24899.02
348569-4856998.09798.67
449972-49972100.931101.98
549458-4945899.892100.71
649778-49778100.539101.63
20min149389-4938999.753101.401.30101.07102.801.41
249466-4946699.909101.22
350213-50213101.417102.54
450828-50828102.659104.27
550496-50496101.989103.36
650849-50849102.702104.35
30min150541-50541102.080101.341.62103.95103.301.65
248822-4882298.608100.48
350331-50331101.656103.34
451248-51248103.508105.68
550309-50309101.611103.55
649795-49795100.573102.79
45min147883-4788396.71196.981.0599.1599.511.15
247129-4712995.18897.61
348034-4803497.01699.26
448623-4862398.206100.96
548255-4825597.46399.97
648183-4818397.317100.10
60min148593-4859398.14596.760.97101.1299.831.03
247555-4755596.04999.00
347672-4767296.28599.07
448239-4823997.430100.73
547363-4736395.66198.71
648030-4803097.008100.33
极限148114-4811497.17896.021.06100.6999.621.10
247254-4725495.44198.92
346946-4694694.81998.14
447103-4710395.13698.97
547819-4781996.582100.16
648002-4800296.952100.81
阿齐沙坦左氨氯地平片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号68522100802对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.7对照品水分(%)0对照品稀释倍数1000
标示量(mg)20供试品稀释倍数2系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.843782903781853779543784453777683781280.08
210.963833173831063832120.04
单位质量响应值RSD%判断
34882.6634964.600.17数据可信
供试品溶液-24050703批-阿齐沙坦-pH4.5
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min14188-41881.0761.038.431.081.038.35
23613-36130.9280.93
33617-36170.9290.93
44357-43571.1191.12
54331-43311.1131.11
63959-39591.0171.02
10min19229-92292.3712.349.662.382.349.69
29858-98582.5332.54
38123-81232.0872.09
410133-101332.6032.61
59271-92712.3822.39
67993-79932.0542.06
15min116693-166934.2894.226.704.314.246.66
216963-169634.3584.38
316161-161614.1524.17
417196-171964.4184.44
517297-172974.4444.46
614357-143573.6893.71
20min124739-247396.3566.215.276.406.255.26
224121-241216.1976.24
324879-248796.3926.43
424632-246326.3296.37
525020-250206.4286.47
621653-216535.5635.60
30min135421-354219.1018.794.389.188.864.39
236134-361349.2849.36
334138-341388.7718.85
433680-336808.6538.73
533983-339838.7318.81
631823-318238.1768.24
45min138984-3898410.01610.262.4110.1510.382.42
239784-3978410.22210.35
340100-4010010.30310.43
440667-4066710.44910.58
541255-4125510.60010.73
638768-387689.96110.07
60min145045-4504511.57411.510.8211.7611.690.87
244800-4480011.51111.70
344944-4494411.54811.73
445141-4514111.59811.78
544788-4478811.50711.69
644111-4411111.33411.50
极限147271-4727112.14512.141.3912.3912.391.36
247592-4759212.22812.48
346593-4659311.97112.22
446644-4664411.98412.24
548346-4834612.42212.67
647114-4711412.10512.34
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