苯磺酸左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%
113.991192631188831189711189441187861189690.16
213.391194131197131195630.18
单位质量响应值RSD%判断
8503.868929.283.46数据不可信!(响应值差异过大,请重新称样测定!)
供试品溶液-2023051321批-苯磺酸左氨氯地平-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%
15min1460079-460079333.454347.2014.83333.45347.2014.83
2570199-570199413.267413.27
3457668-457668331.707331.71
4413246-413246299.511299.51
5562835-562835407.929407.93
6410251-410251297.340297.34
5min1113039-11303981.92880.523.3882.4881.093.26
2105216-10521676.25876.95
3114120-11412082.71183.26
4112483-11248381.52582.02
5107611-10761177.99478.67
6114074-11407482.67883.17
10min1118671-11867186.01084.414.4186.7085.124.29
2108981-10898178.98779.80
3120342-12034287.22187.91
4119265-11926586.44087.08
5110919-11091980.39181.20
6120618-12061887.42188.05
20min1119595-11959586.68084.505.3387.5285.365.20
2111210-11121080.60281.55
3119964-11996486.94787.78
4119971-11997186.95287.73
5106579-10657977.24678.19
6122231-12223188.59089.37
30min1119800-11980086.82883.785.4387.8184.785.29
2105945-10594576.78677.87
3115276-11527683.54984.53
4119413-11941386.54887.47
5110694-11069480.22881.30
6122462-12246288.75889.68
45min1116081-11608184.13384.324.8785.2685.454.73
2107313-10731377.77878.99
3119316-11931686.47787.60
4120727-12072787.50088.57
5112376-11237681.44782.65
6122216-12221688.57989.65
60min1119405-11940586.54284.633.8487.8185.913.72
2109812-10981279.58980.93
3117330-11733085.03886.30
4119943-11994386.93288.15
5112925-11292581.84583.19
6121220-12122087.85789.08
90min1109327-10932779.23883.764.9880.6585.174.85
2110337-11033779.97081.44
3120012-12001286.98288.39
4120440-12044087.29288.65
5111488-11148880.80482.28
6121780-12178088.26389.63
120min1120050-12005087.00984.414.2588.5585.974.12
2110367-11036779.99181.60
3117955-11795585.49187.04
4121004-12100487.70189.21
5110070-11007079.77681.39
6119333-11933386.49088.01
苯磺酸左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%
115.974661379466289146610044652926465002746576450.13
215.974671097467018146706390.02
单位质量响应值RSD%判断
291649.66292463.310.20数据可信
供试品溶液-2023051321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%
15min14226829-422682980.67674.9116.5580.6874.9116.56
24679272-467927289.31289.31
33689636-368963670.42370.42
43731557-373155771.22371.22
54371065-437106583.42983.43
62849342-284934254.38454.38
5min14075869-407586977.79576.199.5577.9376.319.52
23285572-328557262.71162.86
34184361-418436179.86679.98
44103242-410324278.31778.44
53904055-390405574.51574.65
64396139-439613983.90884.00
10min14271802-427180281.53480.8110.8081.8081.0610.75
23432408-343240865.51365.77
34441360-444136084.77185.02
44389354-438935483.77884.03
54077354-407735477.82378.09
64789301-478930191.41291.64
20min14310100-431010082.26581.6511.0782.6782.0411.03
23465086-346508666.13766.50
34482782-448278285.56185.95
44435662-443566284.66285.05
54097006-409700678.19878.59
64876884-487688493.08393.47
30min14313396-431339682.32881.8111.0882.8782.3311.04
23477218-347721866.36966.84
34491037-449103785.71986.25
44447607-444760784.89085.42
54095109-409510978.16278.69
64892073-489207393.37393.91
45min14321882-432188282.49081.9511.0383.1682.6110.99
23488056-348805666.57567.16
34498337-449833785.85886.54
44467061-446706185.26185.93
54094131-409413178.14378.80
64893163-489316393.39494.09
60min14326796-432679682.58482.1011.1383.4082.9011.08
23487673-348767366.56867.26
34504503-450450385.97686.80
44481875-448187585.54486.36
54101190-410119078.27879.06
64907802-490780293.67494.52
90min14334491-433449182.73182.1711.1383.6883.1011.09
23489922-348992266.61167.42
34504748-450474885.98186.94
44487717-448771785.65686.61
54102477-410247778.30379.22
64911713-491171393.74894.75
120min14338564-433856482.80982.1611.1383.9083.2311.08
23488450-348845066.58367.50
34505717-450571785.99987.11
44488450-448845085.67086.77
54098969-409896978.23679.28
64906652-490665293.65294.81
苯磺酸左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%
113.991185721185741184001187621185671185750.11
213.391196241191861194050.26
单位质量响应值RSD%判断
8475.708917.483.60数据不可信!(响应值差异过大,请重新称样测定!)
供试品溶液-2023051321批-苯磺酸左氨氯地平-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%
15min1876273-876273636.592663.9217.74636.59663.9217.74
2796833-796833578.881578.88
31207653-1207653877.333877.33
4818946-818946594.946594.95
5991493-991493720.297720.30
6792115-792115575.454575.45
5min1251587-251587182.772175.963.78183.83177.063.76
2248999-248999180.892181.86
3246584-246584179.138180.60
4244374-244374177.532178.52
5231427-231427168.126169.33
6230250-230250167.271168.23
10min1255287-255287185.460180.662.60186.83182.062.61
2253914-253914184.463185.73
3252648-252648183.543185.30
4248424-248424180.474181.76
5241333-241333175.323176.80
6240458-240458174.687175.93
20min1258578-258578187.851180.922.97189.53182.622.96
2255706-255706185.765187.34
3251362-251362182.609184.68
4246259-246259178.902180.49
5240860-240860174.979176.75
6241441-241441175.401176.93
30min1256328-256328186.216180.232.78188.20182.232.76
2254884-254884185.167187.05
3249496-249496181.253183.62
4246867-246867179.343181.23
5241800-241800175.662177.73
6239168-239168173.750175.57
45min1255085-255085185.313179.832.92187.61182.132.92
2252693-252693183.576185.77
3252992-252992183.793186.47
4246081-246081178.772180.96
5237467-237467172.514174.87
6240897-240897175.006177.12
60min1255895-255895185.902179.733.10188.51182.333.10
2254117-254117184.610187.11
3250680-250680182.113185.09
4246526-246526179.096181.58
5240801-240801174.936177.58
6236369-236369171.717174.12
90min1255878-255878185.890178.403.19188.81181.303.21
2242891-242891176.455179.26
3251598-251598182.780186.06
4247537-247537179.830182.61
5241572-241572175.497178.43
6233899-233899169.922172.61
120min1252763-252763183.627178.512.30186.85181.702.29
2251329-251329182.585185.68
3246884-246884179.356182.94
4243875-243875177.170180.25
5240394-240394174.641177.87
6239040-239040173.657176.63
苯磺酸左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%
115.974727623472074847218364730467472603547253420.09
215.974751128475379247524600.04
单位质量响应值RSD%判断
295888.67297586.730.41数据可信
供试品溶液-2023051321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%
15min11508517-150851728.33937.2619.6128.3437.2619.61
22174438-217443840.84840.85
32079755-207975539.07039.07
42566604-256660448.21548.22
51603214-160321430.11730.12
61968464-196846436.97936.98
5min13048919-304891957.27652.156.4957.3252.226.47
22608452-260845249.00249.07
32792603-279260352.46152.53
42584646-258464648.55448.63
52912198-291219854.70854.76
62710455-271045550.91850.98
10min13926667-392666773.76569.036.0973.9169.186.07
23522893-352289366.18066.33
33785269-378526971.10971.26
43309856-330985662.17862.34
53808625-380862571.54871.69
63693475-369347569.38469.53
20min14304743-430474380.86875.726.1881.1375.986.16
23862496-386249672.56072.82
34149458-414945877.95078.22
43613964-361396467.89168.16
54142631-414263177.82278.08
64111770-411177077.24277.50
30min14447403-444740383.54878.226.3583.9578.616.33
23979995-397999574.76775.15
34302199-430219980.82081.22
43722507-372250769.93070.31
54267295-426729580.16480.55
64263906-426390680.10080.49
45min14552695-455269585.52580.056.3886.0780.576.36
24070486-407048676.46776.97
34394423-439442382.55283.09
43808200-380820071.54072.03
54358824-435882481.88382.41
64382194-438219482.32382.85
60min14615202-461520286.70081.316.1987.3881.976.17
24132397-413239777.63078.26
34457621-445762183.73984.41
43885849-388584972.99873.61
54426112-442611283.14883.81
64453767-445376783.66784.33
90min14670102-467010287.73182.336.2288.5683.126.20
24173940-417394078.41079.17
34524890-452489085.00385.82
43936830-393683073.95674.69
54482428-448242884.20585.00
64506457-450645784.65785.46
120min14759798-475979889.41684.046.1490.3984.966.12
24245785-424578579.76080.65
34603527-460352786.48087.43
44033279-403327975.76876.63
54583958-458395886.11387.05
64614889-461488986.69487.64
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