苯磺酸氨氯地平缬沙坦片项目信息
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%
114.172394922398792395852396402395872396370.07
214.092408832408292408560.02
单位质量响应值RSD%判断
16911.5717094.110.76数据可信
长期9月-供试品溶液-BDJL7批-苯磺酸氨氯地平-pH6.8
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min1105941-10594140.39239.074.1740.3939.074.17
2104122-10412239.69939.70
3107932-10793241.15141.15
496909-9690936.94936.95
5101305-10130538.62538.62
698681-9868137.62437.62
10min1166658-16665863.54263.942.1463.6164.012.14
2167196-16719663.74763.81
3173372-17337266.10266.17
4164627-16462762.76862.83
5170406-17040664.97165.04
6164016-16401662.53562.60
15min1194275-19427574.07274.771.2374.2474.941.23
2194343-19434374.09774.27
3200390-20039076.40376.58
4194989-19498974.34474.51
5195142-19514274.40274.57
6197544-19754475.31875.48
20min1206070-20607078.56979.382.0178.8779.682.00
2206732-20673278.82179.12
3214131-21413181.64281.95
4206101-20610178.58078.87
5203559-20355977.61177.91
6212561-21256181.04381.34
30min1217292-21729282.84784.441.2083.2784.871.20
2220017-22001783.88684.31
3224309-22430985.52385.96
4220612-22061284.11384.53
5223126-22312685.07285.50
6223478-22347885.20685.63
45min1223304-22330485.13987.381.8485.7187.951.83
2229161-22916187.37387.94
3234005-23400589.21989.80
4227561-22756186.76387.32
5227053-22705386.56987.14
6233997-23399789.21689.79
60min1225840-22584086.10688.903.0286.8189.623.00
2228649-22864987.17787.89
3239604-23960491.35492.09
4231061-23106188.09788.80
5229947-22994787.67288.38
6243943-24394393.00893.73
极限1245353-24535393.54694.882.6394.4095.742.62
2254732-25473297.12297.98
3256326-25632697.73098.62
4238839-23883991.06291.92
5251276-25127695.80496.66
6246583-24658394.01594.89
苯磺酸氨氯地平缬沙坦片项目信息
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%
116.044658711466039446577274659134465902646589980.03
216.064687013468660946868110.01
单位质量响应值RSD%判断
290461.22291831.320.34数据可信
长期9月-供试品溶液-BDJL7批-缬沙坦-pH6.8
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min14329375-432937582.89282.192.2382.8982.192.23
24209451-420945180.59680.60
34421284-442128484.65284.65
44165360-416536079.75279.75
54272168-427216881.79781.80
64358205-435820583.44483.44
10min14856820-485682092.99194.242.4693.1394.382.46
24808897-480889792.07392.21
35017393-501739396.06596.21
44847969-484796992.82192.95
54881811-488181193.46993.61
65121138-512113898.05198.19
15min14915956-491595694.12395.662.5294.4295.952.53
24889926-488992693.62593.91
35071131-507113197.09497.40
44939975-493997594.58394.87
54940407-494040794.59194.88
65219016-521901699.925100.23
20min14924073-492407394.27895.962.3394.7396.422.33
24927876-492787694.35194.79
35084001-508400197.34097.80
44965960-496596095.08095.53
54952648-495264894.82595.28
65217101-521710199.889100.36
30min14950494-495049494.78496.522.1995.3997.132.19
24978118-497811895.31395.91
35113288-511328897.90198.53
45005723-500572395.84296.45
54966860-496686095.09895.71
65231871-5231871100.172100.81
45min14969348-496934895.14596.821.8495.9197.591.84
25018102-501810296.07996.84
35135976-513597698.33699.12
45032678-503267896.35897.12
54980868-498086895.36696.13
65202789-520278999.615100.42
60min14981254-498125495.37397.171.9896.3098.111.98
25040968-504096896.51697.44
35151800-515180098.63899.59
45047333-504733396.63897.56
54990751-499075195.55596.48
65238490-5238490100.298101.27
极限15090079-509007997.45799.651.5698.54100.751.55
25325246-5325246101.959103.04
35264388-5264388100.794101.91
45182226-518222699.221100.31
55174044-517404499.064100.15
65191175-519117599.392100.53
苯磺酸氨氯地平缬沙坦片项目信息
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%
114.172392862393062394432394162395872394080.06
214.092396592394902395740.05
单位质量响应值RSD%判断
16895.4117003.120.45数据可信
长期9月-供试品溶液-BDJL7批-苯磺酸氨氯地平-pH6.8
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min1107908-10790841.27238.564.5341.2738.564.53
298487-9848737.66837.67
395175-9517536.40236.40
4100786-10078638.54838.55
5104107-10410739.81839.82
698443-9844337.65137.65
10min1173340-17334066.29763.972.7466.3764.032.74
2166114-16611463.53463.60
3161072-16107261.60561.67
4169636-16963664.88164.94
5169937-16993764.99665.06
6163384-16338462.48962.55
15min1199181-19918176.18175.851.7676.3676.021.75
2194214-19421474.28174.45
3195017-19501774.58874.75
4198882-19888276.06676.24
5198647-19864775.97676.15
6203918-20391877.99278.16
20min1210495-21049580.50880.932.1080.8181.222.10
2207214-20721479.25379.55
3207347-20734779.30479.59
4212438-21243881.25181.55
5212883-21288381.42181.72
6219196-21919683.83684.13
30min1222433-22243385.07485.132.7585.5185.562.74
2219667-21966784.01684.44
3216196-21619682.68883.11
4221548-22154884.73585.17
5221386-22138684.67385.11
6234191-23419189.57190.01
45min1231543-23154388.55888.352.6589.1488.932.64
2224672-22467285.93086.49
3229118-22911887.63188.19
4227240-22724086.91287.49
5231117-23111788.39588.97
6242349-24234992.69193.28
60min1231910-23191088.69889.962.8689.4390.682.85
2230040-23004087.98388.69
3234773-23477389.79390.50
4235196-23519689.95590.68
5231011-23101188.35589.08
6248264-24826494.95395.69
极限1250237-25023795.70894.631.4496.5995.501.44
2244468-24446893.50294.36
3244463-24446393.50094.35
4245652-24565293.95494.82
5246419-24641994.24895.12
6253207-25320796.84497.74
苯磺酸氨氯地平缬沙坦片项目信息
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%
116.044656242465986746614714660784466370246604130.06
216.064671673466700746693400.08
单位质量响应值RSD%判断
290549.44290743.460.05数据可信
长期9月-供试品溶液-BDJL7批-缬沙坦-pH6.8
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min14390410-439041084.20581.682.9484.2081.682.94
24127224-412722479.15779.16
34116507-411650778.95178.95
44217765-421776580.89380.89
54302396-430239682.51782.52
64399844-439984484.38684.39
10min14973186-497318695.38294.402.7395.5294.542.73
24772775-477277591.53891.67
34826877-482687792.57692.71
44874435-487443593.48893.62
54932885-493288594.60994.75
65153241-515324198.83598.98
15min15103228-510322897.87696.252.9798.1896.542.97
24882070-488207093.63493.92
34911032-491103294.19094.48
44951480-495148094.96695.26
54982862-498286295.56795.86
65278865-5278865101.245101.55
20min15068729-506872997.21496.362.8897.6896.812.88
24871660-487166093.43593.88
34930040-493004094.55495.00
44970375-497037595.32895.78
55019195-501919596.26496.72
65283715-5283715101.338101.81
30min15080112-508011297.43396.572.6898.0697.182.68
24898297-489829793.94694.54
34951902-495190294.97495.57
44984880-498488095.60696.21
55014345-501434596.17196.79
65280736-5280736101.280101.92
45min15113397-511339798.07196.902.4798.8697.672.47
24916792-491679294.30095.05
34974831-497483195.41396.17
45002532-500253295.94596.71
55036288-503628896.59297.37
65268830-5268830101.052101.86
60min15122359-512235998.24397.062.3499.1998.002.34
24931309-493130994.57995.49
34990601-499060195.71696.63
45013432-501343296.15497.08
55040998-504099896.68297.62
65265308-5265308100.985101.96
极限15220390-5220390100.12398.142.09101.2499.242.09
25005905-500590596.00997.08
35026919-502691996.41297.49
45084726-508472697.52198.61
55092423-509242397.66998.77
65271722-5271722101.108102.26
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