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%
113.96 1156111149101149821150261148711150800.27
214.051147741152351150040.29
单位质量响应值RSD%判断
8243.558185.340.51数据可信
供试品溶液-2024082121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%
5min177448-7744859.52961.233.0559.5361.233.05
276266-7626658.62058.62
382857-8285763.68663.69
480259-8025961.69061.69
579928-7992861.43561.44
681214-8121462.42462.42
10min183408-8340864.11066.942.5264.2167.042.52
285606-8560665.79965.90
387385-8738567.16767.27
488533-8853368.04968.15
588516-8851668.03668.14
689098-8909868.48368.59
15min192228-9222870.88970.662.3371.1070.872.33
288290-8829067.86268.07
394749-9474972.82773.05
491235-9123570.12670.34
592042-9204270.74670.96
693003-9300371.48571.70
20min196315-9631574.03173.581.4474.3573.911.44
293820-9382072.11372.43
397921-9792175.26575.60
495604-9560473.48473.82
594928-9492872.96573.30
695793-9579373.62973.97
30min199107-9910776.17776.431.7176.6276.881.71
296706-9670674.33174.77
3101830-10183078.27078.73
4100022-10002276.88077.34
598839-9883975.97176.43
6100078-10007876.92377.38
45min1102900-10290079.09279.131.7679.6779.711.76
299742-9974276.66577.23
3105220-10522080.87581.47
4103698-10369879.70580.29
5102671-10267178.91679.50
6103469-10346979.52980.12
60min1103878-10387879.84480.421.6080.5581.141.60
2101986-10198678.39079.08
3106835-10683582.11782.85
4105087-10508780.77381.49
5104287-10428780.15880.87
6105708-10570881.25081.97
90min1108224-10822483.18483.741.4284.0284.581.42
2106519-10651981.87482.70
3110904-11090485.24486.11
4109757-10975784.36385.21
5108465-10846583.37084.22
6109799-10979984.39585.25
120min1111693-11169385.85186.291.3586.8387.281.36
2110015-11001584.56185.52
3114504-11450488.01189.02
4112922-11292286.79587.79
5111682-11168285.84286.83
6112757-11275786.66987.67
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1112818-11281886.71587.221.0887.8488.361.08
2111422-11142285.64286.74
3114312-11431287.86489.02
4114544-11454488.04289.18
5113362-11336287.13488.26
6114428-11442887.95389.09
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%
115.844588792458919945892124586497458915545885710.03
215.774599452459899745992240.01
单位质量响应值RSD%判断
289682.51291643.880.48数据可信
供试品溶液-2024082121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%
5min1389217-3892177.4656.895.557.466.895.52
2334514-3345146.4156.42
3374720-3747207.1877.19
4356969-3569696.8466.85
5344324-3443246.6046.60
6356823-3568236.8436.84
10min1711021-71102113.63612.963.6613.6512.973.66
2639732-63973212.26912.28
3693547-69354713.30113.31
4674599-67459912.93812.95
5662076-66207612.69812.71
6673602-67360212.91912.93
15min1971621-97162118.63417.903.2818.6717.943.29
2885011-88501116.97317.00
3959335-95933518.39818.43
4930425-93042517.84417.88
5919438-91943817.63317.67
6935570-93557017.94317.98
20min11173487-117348722.50622.091.5422.5722.151.54
21149629-114962922.04822.11
31170037-117003722.43922.50
41146306-114630621.98422.05
51125766-112576621.59021.65
61145287-114528721.96522.03
30min11533834-153383429.41628.303.8129.5228.403.80
21381521-138152126.49526.59
31493605-149360528.64528.75
41524133-152413329.23029.33
51447432-144743227.75927.86
61472887-147288728.24828.35
45min11851847-185184735.51534.932.8635.6735.072.87
21719852-171985232.98433.12
31857923-185792335.63235.78
41840981-184098135.30735.46
51812095-181209534.75334.90
61843942-184394235.36435.51
60min12142440-214244041.08840.372.7541.3040.582.75
21991827-199182738.20038.40
32139932-213993241.04041.25
42124732-212473240.74940.96
52097734-209773440.23140.43
62134329-213432940.93341.14
90min12550306-255030648.91148.172.4949.1948.442.50
22391283-239128345.86146.12
32554038-255403848.98249.26
42538823-253882348.69048.97
52495235-249523547.85448.12
62539292-253929248.69948.97
120min12861470-286147054.87854.042.3355.2454.402.33
22693236-269323651.65251.99
32866345-286634554.97255.33
42845411-284541154.57054.93
52799361-279936153.68754.04
62841369-284136954.49354.85
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13046122-304612258.42057.782.0758.8758.232.07
22897305-289730555.56655.99
33068789-306878958.85459.31
43043123-304312358.36258.81
52991288-299128857.36857.81
63030784-303078458.12558.57
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%
113.96 1142311144671145621142501140861143190.17
214.051153711151941152820.11
单位质量响应值RSD%判断
8189.048205.120.14数据可信
供试品溶液-2024082121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%
5min179948-7994861.58060.784.3461.5860.784.34
272159-7215955.58055.58
379651-7965161.35161.35
479234-7923461.03061.03
580706-8070662.16462.16
681732-8173262.95462.95
10min188879-8887968.45969.002.7468.5669.112.73
294365-9436572.68572.78
388827-8882768.41968.52
487211-8721167.17467.28
589106-8910668.63468.74
689133-8913368.65568.76
15min191315-9131570.33571.732.1270.5571.952.11
296795-9679574.55674.77
391698-9169870.63070.85
492454-9245471.21371.43
593091-9309171.70371.92
693440-9344071.97272.19
20min194342-9434272.66773.771.5373.0074.111.53
298502-9850275.87176.21
394941-9494173.12873.46
495077-9507773.23373.57
595815-9581573.80274.14
695994-9599473.93974.28
30min198081-9808175.54776.891.1276.0077.341.12
2101305-10130578.03078.49
399213-9921376.41976.87
499669-9966976.77077.22
5100263-10026377.22877.69
6100408-10040877.33977.80
45min1101376-10137678.08579.431.3178.6780.021.31
2105123-10512380.97181.57
3102439-10243978.90479.49
4103231-10323179.51480.10
5102411-10241178.88279.47
6104164-10416480.23280.82
60min1102992-10299279.33081.011.2980.0481.731.29
2106301-10630181.87882.61
3104585-10458580.55781.27
4104619-10461980.58381.30
5106508-10650882.03882.76
6106025-10602581.66682.39
90min1107258-10725882.61584.191.2683.4685.041.26
2110607-11060785.19586.06
3108659-10865983.69584.54
4108822-10882283.82084.67
5109425-10942584.28585.14
6111007-11100785.50386.36
120min1110647-11064785.22686.671.1986.2187.671.19
2113727-11372787.59888.61
3111638-11163885.98986.98
4111949-11194986.22987.22
5114123-11412387.90388.90
6113047-11304787.07488.08
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1112144-11214486.37987.871.0587.5089.011.05
2114854-11485488.46689.62
3113418-11341887.36088.49
4113923-11392387.74988.88
5115474-11547488.94490.09
6114690-11469088.34089.49
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%
115.844577856457862645806634576437457767545782510.04
215.774622565462569046241280.05
单位质量响应值RSD%判断
289031.00293223.081.02数据可信
供试品溶液-2024082121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%
5min1338924-3389246.4906.523.896.496.523.91
2321904-3219046.1646.16
3351514-3515146.7316.73
4329202-3292026.3046.30
5346372-3463726.6336.63
6356100-3561006.8196.82
10min1646029-64602912.37112.593.3512.3812.613.37
2630461-63046112.07212.08
3667946-66794612.79012.80
4641024-64102412.27512.29
5688530-68853013.18413.20
6672399-67239912.87512.89
15min1895612-89561217.15017.713.7617.1817.743.75
2884441-88444116.93616.97
3920948-92094817.63517.67
4982742-98274218.81818.85
5937510-93751017.95217.98
6928854-92885417.78617.82
20min11098832-109883221.04121.431.8021.1021.501.80
21097636-109763621.01821.08
31131476-113147621.66621.73
41109569-110956921.24721.31
51146170-114617021.94822.01
61132234-113223421.68121.74
30min11405632-140563226.91627.692.2127.0127.792.21
21412953-141295327.05627.15
31459102-145910227.94028.04
41445046-144504627.67127.77
51488931-148893128.51128.61
61464893-146489328.05128.15
45min11762702-176270233.75334.712.2633.8934.852.26
21779176-177917634.06934.21
31833021-183302135.10035.24
41795682-179568234.38534.53
51873519-187351935.87536.02
61831786-183178635.07635.22
60min12038074-203807439.02640.232.2439.2240.432.24
22069208-206920839.62239.82
32125743-212574340.70540.91
42079534-207953439.82040.02
52167006-216700641.49541.70
62125111-212511140.69340.90
90min12449873-244987346.91248.161.8847.1748.431.89
22488555-248855547.65247.91
32540007-254000748.63748.91
42494327-249432747.76348.03
52584329-258432949.48649.76
62534155-253415548.52548.80
120min12763360-276336052.91454.091.6053.2554.441.60
22802699-280269953.66854.01
32846263-284626354.50254.85
42803155-280315553.67654.02
52892947-289294755.39655.75
62841622-284162254.41354.77
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12958200-295820056.64557.741.4557.0758.181.46
22996664-299666457.38257.81
33033683-303368358.09158.53
42993719-299371957.32557.76
53086300-308630059.09859.55
63024126-302412657.90858.35
点击查看处理图标(人工保存)
 
原始图谱下载图谱(姜进硙 于 2024-09-10 16:59:59 完成)
生成报告数据部分(等待生成报告)
Current page cost:68 ms