缬沙坦氨氯地平片项目信息
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100374-202106对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.9对照品水分(%)0对照品稀释倍数2000
标示量(mg)5供试品稀释倍数1系数0.7210
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
113.872437452432142432702428522429722432110.15
213.942462402457492459940.15
单位质量响应值RSD%判断
17535.0417646.630.45数据可信
加速6月-供试品溶液-BDJL7批-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%
5min123287-232878.5827.984.748.587.984.73
221424-214247.8957.90
320142-201427.4237.42
422011-220118.1118.11
521327-213277.8597.86
621739-217398.0118.01
10min135156-3515612.95613.296.7212.9713.306.72
235213-3521312.97712.99
336430-3643013.42513.44
439244-3924414.46214.48
532325-3232511.91211.93
637944-3794413.98314.00
15min149338-4933818.18218.816.0918.2218.846.09
249812-4981218.35718.39
351013-5101318.79918.83
455583-5558320.48320.52
546934-4693417.29617.33
653562-5356219.73919.78
20min161442-6144222.64323.595.8722.7123.665.87
262060-6206022.87022.94
363791-6379123.50823.57
469503-6950325.61325.69
559817-5981722.04422.11
667525-6752524.88424.95
30min183637-8363730.82231.634.1230.9331.744.13
283688-8368830.84130.94
386389-8638931.83631.94
490454-9045433.33433.45
581473-8147330.02430.12
689341-8934132.92433.03
45min1112032-11203241.28614.17146.1141.4414.33144.45
22216-22160.8170.97
32353-23530.8671.03
42146-21460.7910.96
5109948-10994840.51840.67
62045-20450.7540.92
60min12405-24050.8861.008.091.111.185.09
22850-28501.0501.21
33052-30521.1251.28
42619-26190.9651.14
52675-26750.9861.20
62683-26830.9891.16
90min14478-44781.6501.716.111.881.894.48
24806-48061.7711.93
35078-50781.8712.03
44675-46751.7231.90
54290-42901.5811.80
64464-44641.6451.81
120min16019-60192.2182.357.352.452.535.93
26826-68262.5162.68
36974-69742.5702.73
46494-64942.3932.57
55855-58552.1582.38
66030-60302.2222.39
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
极限18682-86823.1993.6513.423.433.8412.28
29926-99263.6583.82
310788-107883.9764.14
411985-119854.4174.60
58463-84633.1193.34
69550-95503.5193.69
缬沙坦氨氯地平片项目信息
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100651-202307对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.1对照品水分(%)0对照品稀释倍数200
标示量(mg)80供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
116.014727430472374847200624719607471859347218880.08
216.004777547476844947729980.14
单位质量响应值RSD%判断
294933.67298312.380.81数据可信
加速6月-供试品溶液-BDJL7批-缬沙坦-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
10min1-0.0000.00-0.000.00-
2-0.0000.00
3-0.0000.00
4-0.0000.00
5-0.0000.00
6-0.0000.00
15min1-0.0000.00-0.000.00-
2-0.0000.00
3-0.0000.00
4-0.0000.00
5-0.0000.00
6-0.0000.00
20min1-0.0000.00-0.000.00-
2-0.0000.00
3-0.0000.00
4-0.0000.00
5-0.0000.00
6-0.0000.00
30min1-0.0000.00-0.000.00-
2-0.0000.00
3-0.0000.00
4-0.0000.00
5-0.0000.00
6-0.0000.00
45min1-0.0001.4677.480.001.4677.48
2114864-1148642.1592.16
3118080-1180802.2192.22
4117227-1172272.2032.20
5-0.0000.00
6116333-1163332.1862.19
60min1138134-1381342.5962.662.152.602.662.16
2142529-1425292.6792.68
3146822-1468222.7592.76
4141767-1417672.6642.67
5139141-1391412.6152.61
6141490-1414902.6592.66
90min1189013-1890133.5523.612.463.563.622.50
2194176-1941763.6493.66
3200459-2004593.7673.78
4193494-1934943.6363.64
5188409-1884093.5413.55
6188502-1885023.5433.55
120min1239168-2391684.4954.623.304.514.633.34
2252268-2522684.7414.76
3257772-2577724.8444.86
4247350-2473504.6494.66
5238506-2385064.4824.49
6239284-2392844.4974.51
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
极限1291299-2912995.4745.948.475.495.968.47
2322539-3225396.0626.08
3330372-3303726.2096.23
4358999-3589996.7476.77
5287821-2878215.4095.43
6306839-3068395.7675.79
缬沙坦氨氯地平片项目信息
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100374-202106对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.9对照品水分(%)0对照品稀释倍数2000
标示量(mg)5供试品稀释倍数1系数0.7210
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
113.872443862440662441522442052440942441810.06
213.942451352448902450120.08
单位质量响应值RSD%判断
17604.9717576.180.12数据可信
加速6月-供试品溶液-BDJL7批-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%
5min117629-176296.4978.0110.706.508.0210.68
223206-232068.5528.55
323900-239008.8088.81
422164-221648.1688.17
523047-230478.4938.49
620545-205457.5717.57
10min131820-3182011.72613.216.9811.7413.226.97
238339-3833914.12914.14
333966-3396612.51712.53
437864-3786413.95413.97
536169-3616913.32913.34
636892-3689213.59613.61
15min145866-4586616.90318.625.9416.9318.655.95
253529-5352919.72719.76
348282-4828217.79317.83
453210-5321019.60919.65
550303-5030318.53818.57
651913-5191319.13119.17
20min158395-5839521.52023.274.9821.5823.344.98
265533-6553324.15024.22
360771-6077122.39522.46
466621-6662124.55124.62
562627-6262723.07923.15
664904-6490423.91923.99
30min179576-7957629.32631.394.2029.4231.504.20
285840-8584031.63431.74
384055-8405530.97631.08
490224-9022433.25033.36
584169-8416931.01831.12
687221-8722132.14332.25
45min1108112-10811239.84227.5875.1339.9827.7374.69
2112362-11236241.40841.57
3112466-11246641.44641.60
42288-22880.8431.01
5111490-11149041.08741.24
62288-22880.8431.00
60min12658-26580.9800.977.461.191.173.84
22381-23810.8771.11
32611-26110.9621.19
42826-28261.0411.21
52430-24300.8961.12
62854-28541.0521.21
90min14612-46121.7001.652.361.911.852.26
24410-44101.6251.86
34424-44241.6301.86
44374-43741.6121.78
54391-43911.6181.85
64585-45851.6901.85
120min16574-65742.4232.333.312.642.533.33
26358-63582.3432.58
36393-63932.3562.58
46088-60882.2442.42
56031-60312.2232.45
66422-64222.3672.53
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
极限111444-114444.2173.7210.234.443.9310.13
210951-109514.0364.28
38800-88003.2433.47
49695-96953.5733.75
510499-104993.8694.10
69210-92103.3943.56
缬沙坦氨氯地平片项目信息
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100651-202307对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.1对照品水分(%)0对照品稀释倍数200
标示量(mg)80供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
116.014736624473247847334504736257473776647353150.05
216.004769565477175247706580.04
单位质量响应值RSD%判断
295772.33298166.120.57数据可信
加速6月-供试品溶液-BDJL7批-缬沙坦-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
10min1-0.0000.00-0.000.00-
2-0.0000.00
3-0.0000.00
4-0.0000.00
5-0.0000.00
6-0.0000.00
15min1-0.0000.00-0.000.00-
2-0.0000.00
3-0.0000.00
4-0.0000.00
5-0.0000.00
6-0.0000.00
20min1-0.0000.00-0.000.00-
2-0.0000.00
3-0.0000.00
4-0.0000.00
5-0.0000.00
6-0.0000.00
30min1-0.0000.00-0.000.00-
2-0.0000.00
3-0.0000.00
4-0.0000.00
5-0.0000.00
6-0.0000.00
45min1-0.0000.74154.920.000.74154.92
2-0.0000.00
3-0.0000.00
4118152-1181522.2182.22
5-0.0000.00
6117632-1176322.2082.21
60min1137435-1374352.5802.622.272.582.622.30
2137213-1372132.5762.58
3138401-1384012.5982.60
4143160-1431602.6872.69
5137302-1373022.5772.58
6144085-1440852.7052.71
90min1191325-1913253.5913.561.183.603.571.25
2187776-1877763.5253.53
3187528-1875283.5203.52
4190820-1908203.5823.59
5188337-1883373.5353.54
6193000-1930003.6233.63
120min1249357-2493574.6814.561.404.694.571.39
2241921-2419214.5414.55
3241002-2410024.5244.53
4240102-2401024.5074.52
5241602-2416024.5354.55
6244078-2440784.5824.60
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
极限1355489-3554896.6736.007.496.696.027.45
2331316-3313166.2196.24
3290508-2905085.4535.47
4310529-3105295.8295.85
5331256-3312566.2186.24
6300199-3001995.6355.66
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