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1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
114.131206491206151206031204261205211205630.08
214.081205151206111205630.06
单位质量响应值RSD%判断
8532.418562.710.26数据可信
供试品溶液-25040801批-左氨氯地平-pH1.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min179864-7986481.82185.563.0781.8285.563.07
285130-8513087.21687.22
381444-8144483.44083.44
487027-8702789.16089.16
583760-8376085.81385.81
683835-8383585.88985.89
10min187542-8754289.68792.962.8289.8293.102.82
292620-9262094.89095.04
387681-8768189.83089.97
493649-9364995.94496.09
591440-9144093.68193.82
691501-9150193.74393.89
15min190567-9056792.78694.902.7693.0795.202.76
292805-9280595.07995.38
390222-9022292.43392.72
496733-9673399.10499.41
594412-9441296.72697.02
691060-9106093.29193.59
20min191723-9172393.97196.862.6094.4197.322.60
294340-9434096.65297.11
391731-9173193.97994.42
497852-97852100.250100.72
595935-9593598.28698.75
695702-9570298.04798.50
30min195013-9501397.34199.552.5497.94100.162.54
296378-9637898.74099.36
394221-9422196.53097.13
4100882-100882103.354103.99
598632-98632101.049101.67
697863-97863100.261100.88
45min197315-9731599.700102.502.84100.46103.282.84
299989-99989102.439103.23
396569-9656998.93599.70
4104199-104199106.752107.57
5101887-101887104.384105.18
6100315-100315102.773103.56
60min199395-99395101.831104.682.68102.76105.632.68
2102419-102419104.929105.89
398766-98766101.186102.11
4106091-106091108.691109.68
5103696-103696106.237107.20
6102675-102675105.191106.15
90min1102507-102507105.019107.812.54106.11108.932.55
2105137-105137107.713108.85
3101873-101873104.369105.46
4108638-108638111.300112.47
5107502-107502110.136111.28
6105709-105709108.299109.43
120min1104194-104194106.747109.542.51108.02110.852.51
2106902-106902109.522110.83
3104084-104084106.635107.90
4111089-111089113.811115.17
5108609-108609111.271112.60
6106639-106639109.252110.56
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1105036-105036107.610110.802.86109.06112.302.85
2108251-108251110.904112.40
3104267-104267106.822108.27
4112105-112105114.852116.40
5110810-110810113.525115.04
6108453-108453111.111112.61
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%
115.964668006466645146680224666323466742646672460.02
215.954677620467780246777110.01
单位质量响应值RSD%判断
292433.96293273.420.21数据可信
供试品溶液-25040801批-缬沙坦-pH1.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1199602-1996023.7994.047.693.804.047.71
2244198-2441984.6484.65
3202787-2027873.8603.86
4209704-2097043.9923.99
5210246-2102464.0024.00
6205395-2053953.9103.91
10min1426061-4260618.1108.7313.608.128.7413.60
2584591-58459111.12811.14
3423022-4230228.0528.06
4442124-4421248.4168.42
5446174-4461748.4938.50
6430284-4302848.1908.20
15min1627880-62788011.95212.494.3611.9712.514.36
2687296-68729613.08213.11
3619870-61987011.79911.82
4651778-65177812.40612.43
5664640-66464012.65112.67
6686297-68629713.06313.08
20min1797042-79704215.17115.814.4015.2115.854.41
2868391-86839116.53016.58
3792406-79240615.08315.12
4864620-86462016.45816.50
5857064-85706416.31416.36
6802725-80272515.28015.32
30min11084727-108472720.64721.203.2820.7121.273.29
21162858-116285822.13522.21
31075317-107531720.46820.53
41121348-112134821.34521.41
51149564-114956421.88221.95
61089395-108939520.73620.80
45min11423300-142330027.09227.652.9527.1927.752.96
21507285-150728528.69128.80
31409820-140982026.83626.93
41467861-146786127.94028.04
51494292-149429228.44328.55
61413473-141347326.90527.01
60min11679360-167936031.96632.612.8332.1132.762.84
21774518-177451833.77733.94
31664162-166416231.67731.82
41728329-172832932.89833.05
51761196-176119633.52433.68
61670367-167036731.79531.94
90min12063939-206393939.28639.922.3639.4840.132.37
22162238-216223841.15841.37
32049053-204905339.00339.20
42104207-210420740.05340.26
52149777-214977740.92041.13
62055015-205501539.11739.32
120min12360954-236095444.94045.571.9845.2045.841.99
22463142-246314246.88547.17
32369030-236903045.09445.36
42387619-238761945.44845.72
52439421-243942146.43446.71
62342928-234292844.59744.86
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12549846-254984648.53649.152.0348.8749.502.04
22654732-265473250.53250.90
32530494-253049448.16748.50
42589317-258931749.28749.64
52631935-263193550.09850.45
62535909-253590948.27048.61
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1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
114.131199231202941203971202551202471202230.15
214.081208171209021208600.05
单位质量响应值RSD%判断
8508.358583.810.63数据可信
供试品溶液-25040102批-左氨氯地平-pH1.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min182832-8283284.87888.804.7584.8888.804.75
286982-8698289.13089.13
386422-8642288.55788.56
494307-9430796.63696.64
583371-8337185.43085.43
686050-8605088.17588.18
10min190754-9075492.99697.565.2493.1497.715.24
296005-9600598.37698.52
393970-9397096.29196.44
4104658-104658107.243107.40
591796-9179694.06394.21
694079-9407996.40396.55
15min193427-9342795.735100.475.2096.03100.785.20
298634-98634101.070101.38
396648-9664899.03599.34
4107690-107690110.350110.69
594503-9450396.83797.14
697414-9741499.820100.13
20min195174-9517497.525101.945.1897.98102.425.18
2100298-100298102.775103.26
398217-98217100.643101.12
4109232-109232111.930112.45
595571-9557197.93298.39
698400-98400100.831101.30
30min197325-9732599.729104.625.16100.35105.275.16
2102851-102851105.391106.04
3100654-100654103.140103.78
4112040-112040114.807115.52
598416-98416100.847101.47
6101296-101296103.798104.44
45min1100013-100013102.483106.835.08103.27107.655.08
2103122-103122105.669106.50
3102720-102720105.257106.07
4114566-114566117.396118.30
5100799-100799103.289104.08
6104302-104302106.878107.69
60min1102192-102192104.716109.164.90105.67110.164.90
2106515-106515109.146110.15
3105040-105040107.635108.62
4116585-116585119.465120.56
5102857-102857105.398106.36
6105956-105956108.573109.57
90min1104788-104788107.376112.104.68108.51113.284.68
2109718-109718112.428113.61
3107647-107647110.306111.47
4119150-119150122.093123.39
5106108-106108108.729109.87
6108983-108983111.675112.85
120min1105933-105933108.550113.134.51109.86114.504.52
2111358-111358114.109115.48
3108812-108812111.500112.85
4119675-119675122.631124.13
5106611-106611109.244110.57
6110056-110056112.774114.13
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1106277-106277108.902113.904.69110.39115.464.70
2112275-112275115.048116.61
3109414-109414112.117113.65
4120725-120725123.707125.41
5107141-107141109.787111.29
6111116-111116113.861115.41
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%
115.964672537467199246775284674705467332446740170.05
215.954695995469815446970740.04
单位质量响应值RSD%判断
292858.21294487.400.40数据可信
供试品溶液-25040102批-缬沙坦-pH1.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1181224-1812243.4403.675.433.443.675.38
2196561-1965613.7313.73
3193718-1937183.6773.68
4208779-2087793.9633.96
5198653-1986533.7713.77
6182088-1820883.4563.46
10min1396624-3966247.5298.023.677.538.033.71
2432636-4326368.2128.22
3419564-4195647.9647.97
4440407-4404078.3608.37
5430035-4300358.1638.17
6416135-4161357.8997.90
15min1600897-60089711.40612.032.9111.4212.052.91
2647733-64773312.29512.31
3629861-62986111.95611.98
4653292-65329212.40112.42
5638102-63810212.11212.13
6633960-63396012.03412.05
20min1780491-78049114.81515.582.7514.8515.622.76
2836468-83646815.87815.92
3811723-81172315.40815.45
4843787-84378716.01716.06
5823088-82308815.62415.66
6828252-82825215.72215.76
30min11081116-108111620.52121.342.3820.5821.412.38
21146653-114665321.76521.83
31109078-110907821.05221.12
41143524-114352421.70621.77
51118053-111805321.22321.29
61147971-114797121.79021.86
45min11426822-142682227.08428.273.3627.1828.373.36
21569917-156991729.80029.90
31460334-146033427.72027.82
41503277-150327728.53528.64
51464656-146465627.80227.90
61511151-151115128.68428.79
60min11684987-168498731.98433.132.3332.1333.282.32
21769577-176957733.59033.74
31725457-172545732.75232.90
41776355-177635533.71833.87
51723525-172352532.71532.86
61791600-179160034.00834.16
90min12072075-207207539.33240.502.0639.5340.702.07
22164613-216461341.08841.30
32113225-211322540.11340.31
42160564-216056441.01141.22
52103322-210332239.92540.13
62186797-218679741.50941.72
120min12364963-236496344.89146.112.0645.1546.382.06
22467908-246790846.84547.12
32411231-241123145.76946.04
42459202-245920246.68046.96
52382470-238247045.22345.49
62487840-248784047.22447.50
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12554698-255469848.49349.581.7248.8349.931.72
22636094-263609450.03850.39
32590428-259042849.17149.51
42644478-264447850.19750.55
52576457-257645748.90649.25
62670175-267017550.68551.04
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