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%
111.814749147489474904747647525474940.04
211.874756547585475750.03
单位质量响应值RSD%判断
4021.514008.000.24数据可信
供试品溶液-24042903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%
5min150218-50218101.089101.204.10101.09101.204.10
247683-4768395.98695.99
349177-4917798.99398.99
452370-52370105.421105.42
553040-53040106.769106.77
649144-4914498.92798.93
10min153134-53134106.958104.584.04107.52105.144.03
248855-4885598.34598.88
351717-51717104.106104.66
452968-52968106.624107.21
554668-54668110.046110.64
650376-50376101.407101.96
15min151761-51761104.195103.863.23105.35105.013.24
249330-4933099.301100.38
351164-51164102.993104.12
453158-53158107.007108.18
553751-53751108.201109.41
650415-50415101.485102.60
20min152170-52170105.018103.343.94106.75105.063.93
248338-4833897.30498.94
350623-50623101.904103.60
452576-52576105.835107.61
554062-54062108.827110.63
650237-50237101.127102.80
30min151484-51484103.637103.703.86105.96105.993.86
248490-4849097.61099.78
351092-51092102.848105.11
453086-53086106.862109.22
554214-54214109.133111.54
650726-50726102.111104.35
45min151921-51921104.517102.664.10107.41105.534.09
247978-4797896.57999.29
350273-50273101.199104.04
452225-52225105.129108.08
553868-53868108.436111.45
649730-49730100.106102.91
60min151854-51854104.382101.754.17107.86105.194.15
247449-4744995.51598.77
350139-50139100.930104.33
451390-51390103.448106.99
553348-53348107.389111.01
649095-4909598.828102.19
极限152542-52542105.767104.113.66109.82108.123.66
248418-4841897.465101.25
350987-50987102.637106.60
452769-52769106.224110.34
553875-53875108.450112.67
651737-51737104.146108.06
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(%)99.70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%
110.963829293830113829423829533830433829760.02
210.983840133840083840100.01
单位质量响应值RSD%判断
34943.0734973.590.07数据可信
供试品溶液-24042903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%
5min110138-101382.6022.3211.522.602.3211.47
29161-91612.3512.35
38086-80862.0752.08
410038-100382.5772.58
59345-93452.3992.40
67554-75541.9391.94
10min120377-203775.2304.905.555.244.925.55
218726-187264.8074.82
318145-181454.6574.67
419710-197105.0595.07
519933-199335.1165.13
617731-177314.5514.56
15min126712-267126.8566.653.406.906.693.40
225849-258496.6356.67
324737-247376.3496.39
426420-264206.7816.82
526708-267086.8556.90
624942-249426.4026.44
20min131860-318608.1787.903.268.267.983.27
230535-305357.8387.91
329356-293567.5357.61
431044-310447.9688.05
531872-318728.1818.26
630064-300647.7177.79
30min138460-384609.8729.822.0810.009.952.08
238280-382809.8269.95
336864-368649.4629.58
438330-383309.8389.96
539328-3932810.09510.22
638387-383879.8539.97
45min146502-4650211.93611.692.1512.1211.872.16
246457-4645711.92412.10
344118-4411811.32411.49
444847-4484711.51111.69
546159-4615911.84812.03
645213-4521311.60511.77
60min151411-5141113.19612.991.5513.4413.231.55
251392-5139213.19113.43
349667-4966712.74812.98
450084-5008412.85513.10
551142-5114213.12713.37
650004-5000412.83513.07
极限158865-5886515.10915.051.3415.4315.361.32
259177-5917715.18915.50
357685-5768514.80615.11
457754-5775414.82415.14
558665-5866515.05815.38
659653-5965315.31215.62
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%
111.814763047567475734756347589475840.06
211.874735247409473800.09
单位质量响应值RSD%判断
4029.133991.580.67数据可信
供试品溶液-24042903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%
5min149377-4937799.507101.011.8599.51101.011.85
249346-4934699.44499.44
349754-49754100.266100.27
451850-51850104.490104.49
550223-50223101.212101.21
650197-50197101.159101.16
10min152187-52187105.170105.132.07105.72105.692.07
251817-51817104.424104.98
350707-50707102.187102.74
454044-54044108.912109.49
552245-52245105.286105.85
652004-52004104.801105.36
15min151978-51978104.748104.591.78105.89105.731.78
251579-51579103.944105.08
350493-50493101.756102.88
453318-53318107.449108.63
551770-51770104.329105.48
652248-52248105.292106.44
20min151182-51182103.144104.292.16104.86106.022.15
251878-51878104.547106.26
350176-50176101.117102.81
453510-53510107.836109.62
551520-51520103.825105.55
652236-52236105.268107.00
30min151553-51553103.892103.441.83106.18105.751.83
251085-51085102.949105.24
350128-50128101.020103.27
452956-52956106.719109.10
550913-50913102.602104.91
651344-51344103.471105.78
45min150776-50776102.326102.851.61105.20105.731.60
250400-50400101.568104.43
350699-50699102.171104.98
452639-52639106.080109.05
550615-50615102.002104.88
651082-51082102.943105.83
60min150850-50850102.475102.152.18105.91105.602.16
250948-50948102.673106.10
348907-4890798.560101.94
452345-52345105.488109.05
550607-50607101.985105.43
650462-50462101.693105.15
极限150907-50907102.590103.362.34106.60107.382.32
251288-51288103.358107.36
350159-50159101.083105.01
453568-53568107.953112.10
550539-50539101.848105.86
651274-51274103.330107.36
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(%)99.70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%
110.963840713840183839623839953838873839870.02
210.983821473825103823280.07
单位质量响应值RSD%判断
35035.3134820.400.44数据可信
供试品溶液-24042903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%
5min18263-82632.1232.139.012.122.138.95
28416-84162.1622.16
38450-84502.1712.17
47527-75271.9341.93
59552-95522.4542.45
67535-75351.9361.94
10min118928-189284.8634.814.284.874.824.31
219152-191524.9204.93
318444-184444.7384.75
417939-179394.6094.62
519938-199385.1225.14
617822-178224.5794.59
15min126358-263586.7716.622.796.816.662.82
226156-261566.7206.76
325595-255956.5756.61
424955-249556.4116.45
526611-266116.8366.88
624938-249386.4076.44
20min131475-314758.0867.932.068.168.012.05
231384-313848.0638.14
330731-307317.8957.97
430222-302227.7647.84
531418-314188.0718.15
630071-300717.7257.80
30min139832-3983210.2339.802.6310.359.922.59
238423-384239.8719.99
338341-383419.8509.97
437256-372569.5719.69
538048-380489.7759.90
637023-370239.5119.63
45min146893-4689312.04711.722.3012.2311.892.30
245597-4559711.71411.89
346836-4683612.03212.21
444811-4481111.51211.68
545045-4504511.57211.75
644446-4444611.41811.59
60min152387-5238713.45813.002.2613.7013.242.25
251226-5122613.16013.40
350666-5066613.01613.26
450294-5029412.92113.15
550043-5004312.85613.10
649005-4900512.59012.82
极限159057-5905715.17214.951.7715.4915.261.74
258576-5857615.04815.36
358863-5886315.12215.43
458913-5891315.13515.44
557145-5714514.68115.00
656665-5666514.55714.86
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