缬沙坦左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4000
标示量(mg)2.5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%
114.071138801136461137931136151138731137610.11
214.091143771147421145600.23
单位质量响应值RSD%判断
8085.368130.590.40数据可信
供试品溶液-2024081921批-左氨氯地平-pH2.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min181541-8154163.49863.232.0263.5063.232.02
279805-7980562.14662.15
381261-8126163.28063.28
484231-8423165.59265.59
580328-8032862.55362.55
680026-8002662.31862.32
10min187923-8792368.46768.651.7868.5768.761.78
286163-8616367.09767.20
388485-8848568.90569.01
490946-9094670.82270.93
587747-8774768.33068.43
687687-8768768.28468.39
15min191594-9159471.32671.691.5971.5571.911.59
290295-9029570.31570.53
392203-9220371.80072.02
494694-9469473.74073.97
592064-9206471.69271.91
691499-9149971.25271.47
20min194149-9414973.31673.721.8173.6574.061.81
292613-9261372.12072.45
394601-9460173.66874.01
497729-9772976.10476.45
595013-9501373.98974.33
693898-9389873.12073.46
30min197863-9786376.20876.801.6576.6777.261.65
296679-9667975.28675.74
398313-9831376.55877.02
4101539-10153979.07179.55
598982-9898277.07977.54
698383-9838376.61377.07
45min1102058-10205879.47579.741.7780.0680.331.77
2100508-10050878.26878.85
3101980-10198079.41480.00
4105534-10553482.18182.79
5103268-10326880.41781.01
6101042-10104278.68379.27
60min1104753-10475381.57382.191.7282.2982.911.72
2104050-10405081.02681.73
3104407-10440781.30482.03
4108673-10867384.62685.37
5106768-10676883.14283.87
6104606-10460681.45982.18
90min1109114-10911484.96985.331.5085.8386.191.50
2108022-10802284.11984.96
3109012-10901284.89085.75
4112515-11251587.61888.50
5110349-11034985.93186.79
6108454-10845484.45585.31
120min1111132-11113286.54187.601.7387.5488.601.72
2110798-11079886.28187.26
3111944-11194487.17388.17
4115730-11573090.12191.15
5113938-11393888.72689.73
6111419-11141986.76487.76
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1113624-11362488.48188.841.7089.6289.991.70
2112376-11237687.51088.64
3113404-11340488.31089.46
4117190-11719091.25892.44
5115612-11561290.02991.18
6112297-11229787.44888.59
缬沙坦左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%
115.94 4576245456858145745564565728457766045725540.12
215.954606837461804646124420.18
单位质量响应值RSD%判断
286860.35289181.320.57数据可信
供试品溶液-2024081921批-缬沙坦-pH2.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1321444-3214446.2216.371.756.226.371.74
2332335-3323356.4326.43
3328959-3289596.3676.37
4337552-3375526.5336.53
5331194-3311946.4106.41
6324611-3246116.2836.28
10min1563162-56316210.90011.261.9910.9111.271.99
2581871-58187111.26211.27
3576635-57663511.16011.17
4588185-58818511.38411.39
5597705-59770511.56811.58
6582460-58246011.27311.28
15min1760002-76000214.70915.312.5114.7415.342.51
2787636-78763615.24415.27
3782787-78278715.15015.18
4802497-80249715.53215.56
5818719-81871915.84615.88
6794859-79485915.38415.41
20min1933371-93337118.06518.802.6618.1218.852.65
2963559-96355918.64918.70
3957183-95718318.52618.58
4985912-98591219.08219.14
51007913-100791319.50819.56
6979187-97918718.95219.01
30min11207800-120780023.37624.473.0923.4624.553.09
21250550-125055024.20424.29
31241722-124172224.03324.12
41283851-128385124.84824.94
51319568-131956825.53925.63
61280880-128088024.79124.88
45min11550307-155030730.00531.273.0630.1331.403.06
21596952-159695230.90831.03
31585233-158523330.68130.81
41640324-164032431.74731.88
51692511-169251132.75832.89
61627850-162785031.50631.63
60min11821819-182181935.26036.702.9835.4336.882.98
21884770-188477036.47936.66
31859409-185940935.98836.16
41923347-192334737.22537.41
51986073-198607338.43938.63
61902434-190243436.82037.00
90min12241176-224117643.37745.072.7343.6145.302.72
22306757-230675744.64644.88
32296936-229693644.45644.69
42365235-236523545.77846.02
52426409-242640946.96247.21
62333995-233399545.17345.41
120min12564438-256443849.63351.352.6549.9451.672.65
22624518-262451850.79651.11
32623409-262340950.77451.09
42691528-269152852.09352.41
52769338-276933853.59953.93
62646530-264653051.22251.54
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12781435-278143553.83355.632.3254.2256.032.32
22853862-285386255.23555.63
32843072-284307255.02655.42
42926441-292644156.63957.05
52970776-297077657.49857.92
62869956-286995655.54655.95
缬沙坦左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4000
标示量(mg)2.5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%
114.071133141134791131871135951133371133820.14
214.091149551149351149450.02
单位质量响应值RSD%判断
8058.428157.910.87数据可信
供试品溶液-2024082021批-左氨氯地平-pH2.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min182028-8202863.87764.023.6563.8864.023.65
276817-7681759.81959.82
382190-8219064.00364.00
482350-8235064.12864.13
584207-8420765.57465.57
685651-8565166.69966.70
10min188927-8892769.25067.892.8069.3668.002.80
283865-8386565.30865.41
388780-8878069.13569.24
484311-8431165.65565.76
587956-8795668.49468.60
689252-8925269.50369.61
15min194017-9401773.21371.821.9873.4472.041.99
288704-8870469.07669.28
392493-9249372.02772.25
492583-9258372.09772.31
592538-9253872.06272.29
693066-9306672.47372.70
20min195617-9561774.45973.641.6574.8073.981.65
291460-9146071.22271.55
395196-9519674.13274.47
495217-9521774.14874.48
595339-9533974.24374.59
694568-9456873.64273.99
30min1100275-10027578.08776.481.8278.5576.941.82
295130-9513074.08074.52
398160-9816076.44076.91
499035-9903577.12177.58
597513-9751375.93676.40
699168-9916877.22577.70
45min1104591-10459181.44879.981.7082.0580.571.70
299423-9942377.42377.99
3102761-10276180.02380.62
4103471-10347180.57581.16
5102966-10296680.18280.78
6103031-10303180.23380.83
60min1107762-10776283.91781.951.5384.6582.671.53
2103082-10308280.27380.97
3104872-10487281.66682.39
4105616-10561682.24682.97
5104167-10416781.11781.84
6105882-10588282.45383.19
90min1111386-11138686.73985.301.3387.6186.161.33
2107178-10717883.46284.29
3109948-10994885.61986.48
4110511-11051186.05886.92
5109194-10919485.03285.89
6109012-10901284.89085.76
120min1114810-11481089.40587.281.5190.4288.281.51
2109828-10982885.52686.49
3111979-11197987.20188.21
4113002-11300287.99889.00
5111369-11136986.72687.73
6111466-11146686.80187.81
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1116359-11635990.61288.941.2791.7890.091.28
2111948-11194887.17788.29
3114253-11425388.97290.12
4114954-11495489.51890.67
5113811-11381188.62789.78
6113949-11394988.73589.89
缬沙坦左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%
115.94 4560170456806345569844570508456321645637880.13
215.954637609463418046358940.06
单位质量响应值RSD%判断
286310.41290651.661.07数据可信
供试品溶液-2024082021批-缬沙坦-pH2.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1293514-2935145.6725.633.965.675.633.97
2308444-3084445.9605.96
3297742-2977425.7545.75
4286151-2861515.5305.53
5274414-2744145.3035.30
6287704-2877045.5605.56
10min1529343-52934310.2299.896.6310.249.906.64
2468380-4683809.0519.06
3525592-52559210.15710.17
4562887-56288710.87710.89
5493001-4930019.5279.54
6491740-4917409.5039.51
15min1742549-74254914.34913.646.3214.3813.676.31
2654575-65457512.64912.67
3725899-72589914.02714.05
4765150-76515014.78614.81
5678618-67861813.11413.14
6669648-66964812.94012.97
20min1927256-92725617.91916.745.1117.9716.805.09
2817576-81757615.79915.85
3903119-90311917.45217.50
4881339-88133917.03117.08
5843494-84349416.30016.35
6826371-82637115.96916.02
30min11233450-123345023.83622.125.3223.9222.205.32
21081470-108147020.89920.97
31190480-119048023.00523.08
41162983-116298322.47422.55
51108825-110882521.42721.50
61090557-109055721.07421.15
45min11590720-159072030.74028.575.0230.8628.695.02
21401992-140199227.09227.20
31529406-152940629.55529.67
41498613-149861328.96029.08
51441767-144176727.86127.97
61409665-140966527.24127.35
60min11869969-186996936.13633.944.4136.3134.114.41
21687234-168723432.60532.76
31807684-180768434.93235.10
41782261-178226134.44134.61
51724874-172487433.33233.49
61667114-166711432.21632.37
90min12298575-229857544.41842.014.1044.6542.234.11
22095661-209566140.49740.70
32240967-224096743.30543.53
42211359-221135942.73342.96
52119476-211947640.95741.17
62078512-207851240.16640.37
120min12648460-264846051.18048.323.9451.4948.613.95
22413155-241315546.63346.91
32566317-256631749.59249.89
42533764-253376448.96349.26
52441991-244199147.19047.47
62400082-240008246.38046.65
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12871588-287158855.49152.953.1455.8853.323.15
22662964-266296451.46051.81
32798536-279853654.08054.46
42762230-276223053.37853.75
52693269-269326952.04652.40
62652467-265246751.25751.61
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