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%
113.872422542429892425292423982423752425090.12
213.942429682428572429120.04
单位质量响应值RSD%判断
17484.4317425.540.24数据可信
长期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%
5min130096-3009611.17711.857.8311.1811.857.84
231784-3178411.80411.80
329320-2932010.88910.89
436446-3644613.53613.54
531355-3135511.64511.64
632425-3242512.04212.04
10min168970-6897025.61426.135.0525.6326.155.05
271584-7158426.58526.60
364373-6437323.90723.93
474955-7495527.83727.86
572008-7200826.74326.76
670282-7028226.10226.12
15min198972-9897236.75738.573.9136.8238.633.91
2102542-10254238.08338.15
3105536-10553639.19539.25
4110666-11066641.10041.17
5104285-10428538.73038.79
6101132-10113237.55937.62
20min1121257-12125745.03347.333.2145.1647.463.21
2126672-12667247.04447.17
3127008-12700847.16947.29
4133453-13345349.56349.70
5130037-13003748.29448.42
6126227-12622746.87947.01
30min1147625-14762554.82659.834.7955.0260.034.79
2162063-16206360.18860.39
3164837-16483761.21861.42
4170964-17096463.49463.71
5161788-16178860.08660.29
6159291-15929159.15859.36
45min1187918-18791869.79073.153.7370.0873.463.72
2196276-19627672.89473.20
3199570-19957074.11774.42
4205109-20510976.17576.50
5203959-20395975.74776.06
6188954-18895470.17570.48
60min1213996-21399679.47581.562.2679.8881.992.26
2217638-21763880.82881.26
3223739-22373983.09383.52
4223592-22359283.03983.49
5224598-22459883.41283.85
6214169-21416979.53979.96
90min1232255-23225586.25689.032.5086.7989.602.50
2239436-23943688.92389.49
3243841-24384190.55991.13
4244823-24482390.92491.51
5245261-24526191.08691.66
6232741-23274186.43786.99
120min1241034-24103489.51792.042.1390.2092.762.13
2246799-24679991.65892.37
3253582-25358294.17794.89
4249850-24985092.79193.53
5253113-25311394.00394.73
6242659-24265990.12090.82
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1251017-25101793.22495.391.8994.0596.261.90
2256012-25601295.07995.94
3263032-26303297.68698.56
4259395-25939596.33697.23
5260101-26010196.59897.48
6251588-25158893.43694.28
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%
116.014638045465313946470704645429464559746458560.12
216.004648991464980846494000.02
单位质量响应值RSD%判断
290184.63290587.500.10数据可信
长期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%
5min11261670-126167024.22025.525.2724.2225.525.26
21314377-131437725.23125.23
31291693-129169324.79624.80
41460773-146077328.04228.04
51302236-130223624.99825.00
61345254-134525425.82425.82
10min12203721-220372142.30443.673.5742.3443.713.56
22267339-226733943.52543.57
32279438-227943843.75743.80
42412851-241285146.31846.36
52300384-230038444.15944.20
62185558-218555841.95542.00
15min12783263-278326353.42955.102.6853.5455.222.68
22839120-283912054.50154.62
32882495-288249555.33455.45
42997387-299738757.53957.66
52907240-290724055.80955.92
62813578-281357854.01154.12
20min13233891-323389162.07962.992.2362.2863.202.23
23234685-323468562.09462.30
33301691-330169163.38163.59
43394666-339466665.16565.39
53325739-332573963.84264.05
63198216-319821661.39461.60
30min13693155-369315570.89573.142.5571.2073.452.56
23764293-376429372.26172.57
33869042-386904274.27274.58
43934425-393442575.52775.86
53877314-387731474.43174.75
63720945-372094571.42971.73
45min14178433-417843380.21182.382.4080.6382.822.40
24245062-424506281.49081.92
34367249-436724983.83684.27
44405492-440549284.57085.02
54372721-437272183.94184.38
64179994-417999480.24180.67
60min14453705-445370585.49587.572.2986.0588.142.29
24504509-450450986.47187.04
34659398-465939889.44490.02
44660628-466062889.46790.06
54644730-464473089.16289.74
64446892-444689285.36485.92
90min14704188-470418890.30492.462.0591.0093.172.05
24762582-476258291.42592.13
34925234-492523494.54795.27
44890994-489099493.89094.63
54895076-489507693.96894.70
64719943-471994390.60691.31
120min14793975-479397592.02794.082.2492.8894.962.23
24853967-485396793.17994.04
35041461-504146196.77897.66
44959937-495993795.21396.11
54983767-498376795.67196.55
64773684-477368491.63892.49
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14928218-492821894.60496.372.3595.6197.402.34
24967242-496724295.35396.37
35172748-517274899.298100.34
45085099-508509997.61698.68
55101918-510191897.93998.98
64866181-486618193.41394.42
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%
113.872430662431422432132434942436592433150.11
213.942429022427422428220.05
单位质量响应值RSD%判断
17542.5417419.080.50数据可信
长期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%
5min131861-3186111.81511.7310.3711.8211.7310.39
236266-3626613.44913.45
331688-3168811.75111.75
428379-2837910.52410.52
527599-2759910.23510.23
633947-3394712.58912.59
10min172767-7276726.98526.684.3727.0026.704.36
275168-7516827.87527.90
372935-7293527.04727.07
467705-6770525.10825.13
568498-6849825.40225.42
674651-7465127.68427.70
15min1105838-10583839.24938.143.1939.3138.203.19
2104218-10421838.64838.72
3102216-10221637.90637.97
498712-9871236.60636.67
599485-9948536.89336.95
6106586-10658639.52639.59
20min1132223-13222349.03447.283.0649.1647.403.06
2130145-13014548.26348.40
3126819-12681947.03047.16
4122745-12274545.51945.64
5123205-12320545.68945.81
6129752-12975248.11748.25
30min1168679-16867962.55360.182.7262.7660.392.71
2158347-15834758.72158.94
3159749-15974959.24159.45
4158608-15860858.81859.01
5161541-16154159.90660.10
6166780-16678061.84962.06
45min1204818-20481875.95573.012.5576.2773.312.55
2193450-19345071.73972.05
3194627-19462772.17672.48
4193434-19343471.73372.03
5193384-19338471.71572.01
6201490-20149074.72175.04
60min1224364-22436483.20380.811.8383.6581.241.83
2216298-21629880.21280.64
3217815-21781580.77581.20
4212085-21208578.65079.06
5218171-21817180.90781.32
6218700-21870081.10381.54
90min1240199-24019989.07688.100.9589.6688.660.94
2235253-23525387.24187.81
3238675-23867588.51089.07
4237658-23765888.13388.68
5239086-23908688.66389.21
6234475-23447586.95387.53
120min1251883-25188393.40891.391.5494.1492.101.54
2244219-24421990.56691.28
3244569-24456990.69691.40
4241534-24153489.57190.26
5247043-24704391.61492.31
6249383-24938392.48193.20
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1258974-25897496.03894.371.2696.9295.231.26
2251722-25172293.34994.21
3256151-25615194.99195.85
4250022-25002292.71893.56
5254907-25490794.53095.38
6255011-25501194.56895.44
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%
116.014704003470691947095884714396471922547108260.13
216.004707130470690547070180.01
单位质量响应值RSD%判断
294242.72294188.620.02数据可信
长期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%
5min11341454-134145425.41625.066.7525.4225.066.74
21451978-145197827.51027.51
31307362-130736224.77024.77
41225817-122581723.22523.23
51225944-122594423.22723.23
61383876-138387626.22026.22
10min12314426-231442643.85042.763.4043.8942.803.40
22328748-232874844.12244.17
32258429-225842942.78942.83
42152404-215240440.78140.82
52174473-217447341.19941.24
62313843-231384343.83943.88
15min12921155-292115555.34653.752.4755.4653.862.47
22885740-288574054.67554.79
32812671-281267153.29053.40
42746528-274652852.03752.14
52772087-277208752.52252.63
62881971-288197154.60354.72
20min13338924-333892463.26161.462.1163.4761.662.11
23271089-327108961.97662.19
33214378-321437860.90161.10
43155616-315561659.78859.98
53191615-319161560.47060.67
63290009-329000962.33462.54
30min13888248-388824873.66971.651.8473.9871.961.85
23781467-378146771.64671.96
33748889-374888971.02971.33
43698234-369823470.06970.36
53738611-373861170.83471.13
63835447-383544772.66972.98
45min14367228-436722882.74480.671.6483.1881.091.65
24231317-423131780.16980.60
34226715-422671580.08280.50
44178127-417812779.16179.57
54227209-422720980.09180.50
64316099-431609981.77582.21
60min14637331-463733187.86185.671.5788.4486.231.58
24485976-448597684.99485.56
34497862-449786285.21985.77
44436396-443639684.05484.60
54503024-450302485.31785.86
64569071-456907186.56887.14
90min14879243-487924392.44590.601.1993.1791.301.19
24741904-474190489.84390.55
34769716-476971690.37091.07
44716257-471625789.35790.04
54779869-477986990.56291.25
64804227-480422791.02491.74
120min14980045-498004594.35592.171.3095.2393.021.31
24823019-482301991.38092.24
34861592-486159292.11092.96
44797136-479713690.88991.72
54850126-485012691.89392.73
64876348-487634892.39093.26
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15032045-503204595.34093.731.0496.3794.731.04
24913259-491325993.08994.10
34958814-495881493.95294.95
44884601-488460192.54693.53
54929307-492930793.39394.39
64963297-496329794.03795.06
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