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%
114.001176021174681171991174241174031174190.13
214.161199511198521199020.06
单位质量响应值RSD%判断
8387.078467.660.68数据可信
供试品溶液-2024082121批-左氨氯地平-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%
5min123790-2379017.82418.446.7217.8218.446.73
223216-2321617.39417.39
324405-2440518.28518.28
423221-2322117.39817.40
525614-2561419.19019.19
627449-2744920.56520.57
10min135160-3516026.34328.385.9526.3728.415.95
236727-3672727.51727.55
337852-3785228.35928.39
436824-3682427.58927.62
539061-3906129.26529.30
641639-4163931.19731.23
15min148107-4810736.04337.675.0936.1237.755.09
249173-4917336.84136.92
350103-5010337.53837.62
449265-4926536.91036.99
549674-4967437.21737.30
655314-5531441.44241.53
20min158754-5875444.02045.754.2044.1545.884.20
260885-6088545.61645.75
359958-5995844.92245.06
459760-5976044.77344.91
560974-6097445.68345.83
666014-6601449.45949.61
30min174434-7443455.76758.304.2055.9758.514.20
278286-7828658.65358.87
377856-7785658.33158.55
475349-7534956.45356.66
577183-7718357.82758.05
683740-8374062.74062.98
45min194002-9400270.42872.363.1270.7372.683.12
296968-9696872.65072.96
396541-9654172.33072.64
495565-9556571.59971.90
594206-9420670.58170.90
6102209-10220976.57776.92
60min1105296-10529678.89081.552.9379.3181.982.93
2110875-11087583.07083.50
3108648-10864881.40181.83
4108565-10856581.33981.76
5105863-10586379.31579.75
6113830-11383085.28485.75
90min1118552-11855288.82190.841.9389.3791.411.94
2121402-12140290.95791.53
3122244-12224491.58892.16
4120818-12081890.51991.08
5119347-11934789.41789.98
6125132-12513293.75194.36
120min1124146-12414693.01394.381.2993.7195.101.30
2126118-12611894.49095.21
3126779-12677994.98595.71
4123991-12399192.89693.61
5126648-12664894.88795.60
6128148-12814896.01196.78
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1126654-12665494.89296.581.0595.7497.461.06
2128608-12860896.35697.23
3130020-13002097.41398.29
4128358-12835896.16897.03
5129477-12947797.00797.88
6130334-13033497.64998.58
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%
115.884615404461136846127664608595460977446115810.06
215.964659498465909546592960.01
单位质量响应值RSD%判断
290401.83291935.840.38数据可信
供试品溶液-2024082121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%
5min11173075-117307522.45823.396.0722.4623.396.07
21172101-117210122.44022.44
31223691-122369123.42823.43
41140812-114081221.84121.84
51297274-129727424.83624.84
61323565-132356525.34025.34
10min11811977-181197734.69036.264.7734.7336.304.76
21847928-184792835.37835.42
31886022-188602236.10836.15
41813079-181307934.71134.75
51970926-197092637.73337.77
62032833-203283338.91838.96
15min12344386-234438644.88346.684.0044.9846.784.00
22406261-240626146.06846.16
32425212-242521246.43146.53
42365569-236556945.28945.38
52475601-247560147.39547.50
62613388-261338850.03350.14
20min12774630-277463053.12054.983.7853.2955.163.79
22854695-285469554.65354.83
32850315-285031554.56954.75
42798524-279852453.57853.75
52873928-287392855.02155.20
63079953-307995358.96659.16
30min13422387-342238765.52167.002.9765.7867.272.98
23499708-349970867.00267.27
33474701-347470166.52366.79
43428684-342868465.64265.90
53468672-346867266.40866.68
63702704-370270470.88871.18
45min14016515-401651576.89678.622.4477.2679.002.45
24141899-414189979.29679.67
34081527-408152778.14178.52
44071028-407102877.94078.31
54038310-403831077.31377.70
64291532-429153282.16182.57
60min14414355-441435584.51385.931.9685.0186.441.96
24520614-452061486.54787.06
34464868-446486885.48085.99
44466217-446621785.50686.00
54414807-441480784.52185.04
64647939-464793988.98589.53
90min14815231-481523192.18793.381.2392.8294.041.23
24880181-488018193.43194.08
34879242-487924293.41394.06
44877305-487730593.37694.02
54828971-482897192.45093.11
64984729-498472995.43296.12
120min14982709-498270995.39496.571.0696.1897.381.07
25009641-500964195.90996.72
35116844-511684497.96298.77
45044689-504468996.58097.38
55013351-501335195.98096.79
65098935-509893597.61998.47
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15057938-505793896.83497.430.6497.7898.400.65
25062524-506252496.92297.89
35081436-508143697.28498.25
45109928-510992897.82998.79
55078688-507868897.23198.20
65142734-514273498.45799.47
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%
114.001170811169401167421167801167161168520.14
214.161207881205771206820.13
单位质量响应值RSD%判断
8346.578522.741.48数据可信
供试品溶液-2024082121批-左氨氯地平-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%
5min123561-2356117.63919.078.6317.6419.078.63
224214-2421418.12718.13
325065-2506518.76518.76
424200-2420018.11718.12
526265-2626519.66319.66
629532-2953222.10922.11
10min137744-3774428.25730.286.5828.2930.316.58
238424-3842428.76628.80
339831-3983129.81929.85
440285-4028530.15930.19
541106-4110630.77330.81
645258-4525833.88233.92
15min149906-4990637.36140.085.4037.4440.175.40
251105-5110538.25938.34
353303-5330339.90539.99
453977-5397740.40940.49
554880-5488041.08541.17
658078-5807843.47943.57
20min158917-5891744.10748.065.8244.2548.215.82
260924-6092445.61045.75
364920-6492048.60148.75
465820-6582049.27549.42
565236-6523648.83848.99
669373-6937351.93552.10
30min176499-7649957.27061.274.6557.4861.504.66
279718-7971859.68059.90
381758-8175861.20761.44
484375-8437563.16663.40
581145-8114560.74860.98
687534-8753465.53165.78
45min193819-9381970.23674.703.6570.5475.033.66
297915-9791573.30373.62
3101116-10111675.69976.03
4102394-10239476.65676.99
599385-9938574.40374.74
6104082-10408277.92078.28
60min1107246-10724680.28883.373.0280.7183.823.03
2108331-10833181.10081.54
3112314-11231484.08284.54
4115490-11549086.46086.92
5110152-11015282.46482.92
6114645-11464585.82786.32
90min1120567-12056790.26191.822.0790.8292.422.08
2119417-11941789.40089.97
3122947-12294792.04392.64
4126020-12602094.34394.95
5121983-12198391.32191.92
6124989-12498993.57194.21
120min1122720-12272091.87395.121.8292.5895.861.83
2127138-12713895.18095.90
3127755-12775595.64296.39
4128404-12840496.12896.89
5126918-12691895.01595.76
6129372-12937296.85397.64
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1125015-12501593.59196.531.8094.4597.441.81
2128757-12875796.39297.27
3130895-13089597.99398.90
4131192-13119298.21599.14
5127798-12779895.67496.58
6130025-13002597.34198.29
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%
115.884607492461159046126224613767461079746112540.06
215.964682161468281246824860.01
单位质量响应值RSD%判断
290381.23293388.850.73数据可信
供试品溶液-2024082121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%
5min11194273-119427322.80924.185.9722.8124.185.98
21191391-119139122.75422.75
31253644-125364423.94323.94
41288060-128806024.60024.60
51272450-127245024.30224.30
61396780-139678026.67626.68
10min11856425-185642535.45537.404.5235.4937.444.52
21884555-188455535.99236.03
31963210-196321037.49437.53
41955541-195554137.34837.39
51981184-198118437.83737.88
62108745-210874540.27440.32
15min12388526-238852645.61748.224.0145.7148.324.02
22443372-244337246.66446.76
32529188-252918848.30348.41
42554688-255468848.79048.89
52551282-255128248.72548.83
62680901-268090151.20151.31
20min12811468-281146853.69456.683.8953.8756.863.90
22864586-286458654.70954.88
32982462-298246256.96057.14
43036129-303612957.98558.17
52982794-298279456.96657.15
63130076-313007659.77959.98
30min13418391-341839165.28668.853.5865.5569.123.58
23508239-350823967.00267.27
33623188-362318869.19769.47
43718212-371821271.01271.29
53596062-359606268.67968.96
63765429-376542971.91372.21
45min14027142-402714276.91280.423.1077.2880.813.10
24118302-411830278.65379.03
34225871-422587180.70781.10
44351465-435146583.10683.51
54184015-418401579.90880.30
64358094-435809483.23283.65
60min14407933-440793384.18487.322.7084.6887.852.70
24479696-447969685.55586.06
34586112-458611287.58788.11
44720931-472093190.16290.70
54537872-453787286.66687.19
64701445-470144589.79090.34
90min14800395-480039591.68094.031.9892.3294.701.99
24856679-485667992.75593.41
34921985-492198594.00294.68
45054447-505444796.53297.22
54887213-488721393.33894.01
65020408-502040895.88296.59
120min14949038-494903894.51896.581.6795.3197.411.68
25006632-500663295.61896.43
35046049-504604996.37197.20
45178115-517811598.89399.74
55030795-503079596.08096.91
65132388-513238898.02098.88
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14999796-499979695.48897.571.6396.4498.561.64
25074811-507481196.92197.89
35086751-508675197.14998.14
45239171-5239171100.060101.07
55084473-508447397.10598.09
65166458-516645898.67199.70
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