缬沙坦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%
113.922573412573312570492570512570462571640.07
214.042559752560172559960.02
单位质量响应值RSD%判断
18474.4318233.330.93数据可信
供试品溶液-25010701批-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%
5min140107-4010714.16615.014.6714.1715.004.66
245389-4538916.03216.03
341893-4189314.79714.80
443148-4314815.24015.24
540667-4066714.36414.36
643694-4369415.43315.43
10min184853-8485329.97130.111.8229.9930.131.81
287862-8786231.03431.06
383079-8307929.34429.37
484977-8497730.01530.04
585587-8558730.23030.25
685094-8509430.05630.08
15min1121075-12107542.76542.541.2342.8442.611.24
2122574-12257443.29443.37
3118054-11805441.69841.77
4120711-12071142.63642.71
5120025-12002542.39442.47
6120180-12018042.44942.52
20min1148889-14888952.58952.491.0852.7352.631.08
2149093-14909352.66152.81
3145598-14559851.42751.57
4149620-14962052.84752.99
5150141-15014153.03153.18
6148277-14827752.37352.52
30min1188641-18864166.63065.960.9066.8666.200.89
2186147-18614765.74965.99
3183881-18388164.94965.18
4187985-18798566.39866.63
5187203-18720366.12266.36
6186678-18667865.93766.17
45min1218708-21870877.25077.591.0577.5977.931.05
2217492-21749276.82177.17
3217443-21744376.80377.14
4219406-21940677.49777.84
5222890-22289078.72779.07
6222011-22201178.41778.76
60min1235651-23565183.23583.451.3683.7183.921.35
2231751-23175181.85782.33
3234720-23472082.90683.37
4236204-23620483.43083.90
5241245-24124585.21085.69
6238004-23800484.06684.54
90min1250211-25021188.37788.361.1088.9988.971.09
2248019-24801987.60388.22
3247860-24786087.54788.15
4247984-24798487.59188.20
5254201-25420189.78790.40
6252736-25273689.26989.88
120min1253751-25375189.62889.701.1290.3990.461.11
2250103-25010388.33989.10
3253030-25303089.37390.12
4252463-25246389.17389.93
5257978-25797891.12191.89
6256364-25636490.55191.31
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1253564-25356489.56289.561.1790.4790.461.17
2251339-25133988.77689.68
3250332-25033288.42089.32
4251885-25188588.96989.88
5257673-25767391.01391.93
6256492-25649290.59691.51
缬沙坦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100
标示量(mg)160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%
115.758935884892546489268108925969892576289279780.05
215.778919056892336889212120.04
单位质量响应值RSD%判断
566855.75565707.800.15数据可信
供试品溶液-25010701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%
5min11512668-151266814.89015.302.0714.8915.302.06
21603008-160300815.78015.78
31533042-153304215.09115.09
41563546-156354615.39115.39
51541034-154103415.17015.17
61571801-157180115.47315.47
10min12253101-225310122.17922.381.7522.2022.411.75
22349213-234921323.12523.15
32237206-223720622.02322.05
42279746-227974622.44122.47
52256707-225670722.21522.24
62265667-226566722.30322.33
15min12780716-278071627.37327.370.7327.4327.430.73
22788727-278872727.45227.52
32743543-274354327.00727.07
42791859-279185927.48327.55
52801327-280132727.57627.64
62776113-277611327.32827.39
20min13182004-318200431.32331.250.6531.4331.360.65
23166369-316636931.16931.28
33137187-313718730.88230.99
43186766-318676631.37031.48
53194943-319494331.45031.56
63179579-317957931.29931.41
30min13750820-375082036.92236.760.7537.0836.920.75
23708093-370809336.50236.66
33696409-369640936.38736.55
43735174-373517436.76836.93
53771735-377173537.12837.29
63742552-374255236.84137.00
45min14254271-425427141.87841.870.9442.1042.100.94
24207308-420730841.41641.64
34218334-421833441.52541.74
44250312-425031241.83942.06
54317920-431792042.50542.73
64274144-427414442.07442.30
60min14559032-455903244.87844.850.9045.1745.140.90
24510517-451051744.40144.69
34523104-452310444.52544.81
44545257-454525744.74345.03
54622950-462295045.50845.80
64577919-457791945.06445.36
90min14824574-482457447.49247.480.9047.8647.840.90
24773076-477307646.98547.35
34794956-479495647.20147.56
44800354-480035447.25447.62
54889224-488922448.12948.50
64857348-485734847.81548.18
120min14967379-496737948.89848.401.0649.3448.841.06
24854203-485420347.78448.23
34877633-487763348.01548.46
44880154-488015448.03948.48
54975401-497540148.97749.43
64944452-494445248.67249.12
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14907265-490726548.30648.420.8648.8348.950.86
24876235-487623548.00148.53
34896761-489676148.20348.72
44893847-489384748.17448.70
54985277-498527749.07449.61
64955787-495578748.78449.31
缬沙坦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%
113.922582082585652588362585022583012584820.10
214.042569122563892566500.15
单位质量响应值RSD%判断
18569.1118279.911.11数据可信
供试品溶液-25010702批-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%
5min157706-5770620.30520.164.9120.3020.164.91
258834-5883420.70220.70
353475-5347518.81618.82
460851-6085121.41121.41
558476-5847620.57620.58
654399-5439919.14119.14
10min1103837-10383736.53637.763.7436.5737.793.74
2112379-11237939.54239.58
3102662-10266236.12336.15
4111007-11100739.05939.09
5108865-10886538.30638.34
6105113-10511336.98537.02
15min1142493-14249350.13850.401.8950.2350.501.89
2144093-14409350.70150.80
3139307-13930749.01749.11
4147336-14733651.84251.94
5144297-14429750.77350.87
6141955-14195549.94950.04
20min1171869-17186960.47459.492.2560.6559.682.25
2173794-17379461.15261.34
3164709-16470957.95558.13
4165422-16542258.20658.39
5171523-17152360.35360.54
6167179-16717958.82459.00
30min1209895-20989573.85472.411.6374.1372.691.63
2208494-20849473.36173.65
3200506-20050670.55170.82
4205490-20549072.30472.59
5206436-20643672.63772.92
6203999-20399971.78072.05
45min1239111-23911184.13482.411.4184.5482.811.41
2235461-23546182.85083.26
3229068-22906880.60180.99
4233831-23383182.27782.68
5234828-23482882.62783.03
6232952-23295281.96782.36
60min1252932-25293288.99787.551.1989.5488.091.18
2245360-24536086.33386.88
3245504-24550486.38486.91
4250492-25049288.13988.68
5249107-24910787.65288.19
6249498-24949887.78988.32
90min1261254-26125491.92691.021.0292.6291.711.01
2257843-25784390.72591.42
3255738-25573889.98590.65
4255960-25596090.06390.75
5259429-25942991.28491.97
6261885-26188592.14892.83
120min1264076-26407692.91991.840.8393.7692.670.84
2259738-25973891.39292.23
3258019-25801990.78791.60
4261969-26196992.17793.02
5259992-25999291.48292.32
6262246-26224692.27593.11
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1267732-26773294.20592.561.0495.2093.541.03
2261709-26170992.08693.08
3260346-26034691.60692.57
4262532-26253292.37593.37
5261293-26129391.93992.93
6264659-26465993.12494.11
缬沙坦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100
标示量(mg)160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%
115.759001465901648990192529009445901202790117360.08
215.778956587895378989551880.03
单位质量响应值RSD%判断
572173.71567862.270.54数据可信
供试品溶液-25010702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%
5min13830194-383019437.45737.463.2437.4637.463.24
23907368-390736838.21238.21
33675997-367599735.94935.95
44010073-401007339.21639.22
53848633-384863337.63737.64
63710585-371058536.28736.29
10min15312258-531225851.95152.962.4152.0153.022.41
25553360-555336054.30954.37
35230586-523058651.15251.21
45544874-554487454.22654.29
55471303-547130353.50653.57
65379668-537966852.61052.67
15min16330182-633018261.90662.511.9062.0562.661.91
26501503-650150363.58163.74
36187425-618742560.51060.65
46489479-648947963.46363.62
56468199-646819963.25563.41
66375888-637588862.35362.50
20min17123095-712309569.66069.371.6369.9169.621.63
27189035-718903570.30570.56
36868268-686826867.16867.41
47146688-714668869.89170.15
57143212-714321269.85770.11
67089397-708939769.33069.58
30min18126754-812675479.47578.361.4279.8478.731.42
28074145-807414578.96179.34
37798458-779845876.26576.62
48032672-803267278.55578.93
58044394-804439478.67079.04
67999336-799933678.22978.60
45min18921336-892133687.24685.871.2187.7586.361.21
28797330-879733086.03386.54
38596346-859634684.06784.55
48780760-878076085.87186.38
58822510-882251086.27986.78
68762898-876289885.69686.19
60min19298835-929883590.93789.761.0591.5890.401.06
29162914-916291489.60890.26
39008260-900826088.09688.72
49181422-918142289.78990.44
59230257-923025790.26790.92
69186214-918621489.83690.48
90min19598200-959820093.86592.910.9894.6693.700.98
29504878-950487892.95293.75
39327667-932766791.21991.99
49492349-949234992.83093.63
59543249-954324993.32894.13
69534368-953436893.24194.03
120min19649691-964969194.36993.740.8395.3294.690.83
29584539-958453993.73194.69
39434561-943456192.26593.19
49581555-958155593.70294.66
59632108-963210894.19795.15
69629886-962988694.17595.12
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19689985-968998594.76393.940.8095.8795.040.80
29616738-961673894.04695.16
39462663-946266392.54093.62
49604213-960421393.92495.04
59612765-961276594.00795.12
69646797-964679794.34095.44
缬沙坦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%
113.922554362561582553642555622557382556520.13
214.042589012581072585040.22
单位质量响应值RSD%判断
18365.8018411.970.18数据可信
供试品溶液-APCE853批-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%
5min131468-3146811.09310.855.0811.0910.855.08
231077-3107710.95510.96
330074-3007410.60210.60
433274-3327411.73011.73
530149-3014910.62810.63
628654-2865410.10110.10
10min163937-6393722.53922.384.1422.5622.404.14
263878-6387822.51922.54
363129-6312922.25422.27
467036-6703623.63223.65
564024-6402422.57022.59
658902-5890220.76420.78
15min189001-8900131.37531.503.3331.4331.553.33
287725-8772530.92530.98
389427-8942731.52531.58
493819-9381933.07333.13
591055-9105532.09932.15
685036-8503629.97730.03
20min1109542-10954238.61639.212.7338.7239.322.74
2110028-11002838.78738.89
3111159-11115939.18639.29
4115803-11580340.82340.94
5113559-11355940.03240.14
6107315-10731537.83137.93
30min1142947-14294750.39251.112.0850.5651.282.09
2144195-14419550.83251.00
3144719-14471951.01751.19
4149672-14967252.76352.95
5147121-14712151.86452.04
6141255-14125549.79649.96
45min1182451-18245164.31864.672.6564.5864.932.65
2180713-18071363.70663.96
3184328-18432864.98065.24
4189818-18981866.91567.19
5187186-18718665.98866.25
6176133-17613362.09162.34
60min1200576-20057670.70873.452.7371.0773.822.73
2207294-20729473.07673.44
3209729-20972973.93474.30
4216406-21640676.28876.67
5212117-21211774.77675.15
6204013-20401371.91972.27
90min1235821-23582183.13383.821.8783.6184.311.88
2239236-23923684.33684.82
3238272-23827283.99784.49
4244750-24475086.28086.79
5237334-23733483.66684.16
6231180-23118081.49681.97
120min1252185-25218588.90189.311.8689.5289.941.86
2254736-25473689.80190.43
3251261-25126188.57689.20
4260243-26024391.74292.39
5255415-25541590.04090.68
6246223-24622386.79987.41
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1260094-26009491.68991.281.8692.4692.061.86
2262649-26264992.59093.36
3255795-25579590.17490.95
4265558-26555893.61694.42
5257146-25714690.65091.44
6252360-25236088.96389.71
缬沙坦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100
标示量(mg)160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%
115.758924766893228189364648936876893234489325460.06
215.779050458903358190420200.14
单位质量响应值RSD%判断
567145.78573368.420.78数据可信
供试品溶液-APCE853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%
5min12677627-267762726.17526.123.9726.1826.123.98
22714278-271427826.53326.53
32633696-263369625.74625.75
42843757-284375727.79927.80
52641477-264147725.82225.82
62522124-252212424.65524.65
10min14208136-420813641.13741.292.9241.1841.342.92
24259076-425907641.63541.68
34201744-420174441.07441.12
44389551-438955142.91042.96
54272005-427200541.76141.80
64014432-401443239.24339.28
15min15167954-516795450.51950.742.5650.6350.852.57
25183946-518394650.67650.79
35190698-519069850.74250.85
45388180-538818052.67252.79
55238528-523852851.20951.32
64975529-497552948.63848.74
20min15900602-590060257.68157.992.2357.8858.192.23
25917809-591780957.84958.05
35926636-592663657.93658.13
46135590-613559059.97860.18
55985412-598541258.51058.71
65728061-572806155.99556.18
30min16932992-693299267.77368.241.9668.0768.531.96
26966753-696675368.10368.40
36987518-698751868.30668.60
47185673-718567370.24370.55
57041972-704197268.83969.13
66768750-676875066.16866.45
45min17983895-798389578.04678.462.0178.4578.872.01
28003599-800359978.23978.65
38020361-802036178.40378.81
48271092-827109280.85481.28
58099598-809959879.17879.59
67778703-777870376.04176.43
60min18620093-862009384.26684.751.8784.8085.291.87
28675199-867519984.80485.34
38647520-864752084.53485.07
48926912-892691287.26587.82
58721811-872181185.26085.80
68427450-842745082.38282.90
90min19272473-927247390.64390.961.6291.3291.641.62
29376611-937661191.66192.34
39279441-927944190.71191.39
49520223-952022393.06593.77
59316390-931639091.07291.76
69061704-906170488.58389.24
120min19575012-957501293.60093.821.7194.4394.651.71
29672584-967258494.55495.39
39554736-955473693.40294.23
49834426-983442696.13696.99
59610789-961078993.95094.79
69334380-933438091.24892.05
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19716485-971648594.98395.031.5995.9796.021.59
29823380-982338096.02897.02
39677977-967797794.60795.59
49933022-993302297.10098.12
59702190-970219094.84495.84
69474060-947406092.61493.57
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