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%
1 14.042515802517192507982505122514402512100.21
214.142510032517442513740.21
单位质量响应值RSD%判断
17892.4517777.510.46数据可信
供试品溶液-APCE853批-氨氯地平-pH3.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min110899-108993.9624.0312.863.964.0312.87
28752-87523.1813.18
310742-107423.9043.90
412824-128244.6614.66
511043-110434.0144.01
612332-123324.4824.48
10min121744-217447.9038.2311.227.918.2311.21
219011-190116.9106.92
321171-211717.6957.70
426138-261389.5019.51
523194-231948.4308.44
624521-245218.9138.92
15min132415-3241511.78211.957.4811.8011.977.50
229099-2909910.57710.59
331874-3187411.58511.60
436454-3645413.25013.27
533278-3327812.09612.12
634209-3420912.43412.46
20min142346-4234615.39215.405.6415.4315.445.64
238354-3835413.94113.98
341235-4123514.98815.03
445289-4528916.46116.51
543573-4357315.83815.88
643445-4344515.79115.83
30min158530-5853021.27421.103.5521.3421.163.57
254659-5465919.86719.92
356976-5697620.70920.77
460752-6075222.08222.15
559023-5902321.45321.52
658358-5835821.21221.28
45min178258-7825828.44527.852.7128.5527.952.73
273707-7370726.79126.88
375564-7556427.46627.56
479395-7939528.85828.97
577227-7722728.07028.17
675551-7555127.46127.57
60min193002-9300233.80433.032.5233.9533.182.53
287483-8748331.79831.93
389908-8990832.67932.82
493056-9305633.82433.98
592353-9235333.56833.72
689418-8941832.50132.65
90min1114094-11409441.47040.611.9741.6740.811.97
2109456-10945639.78539.97
3109475-10947539.79139.99
4114147-11414741.49041.70
5112696-11269640.96241.17
6110520-11052040.17140.38
120min1129559-12955947.09246.161.7547.3646.431.75
2123969-12396945.06045.31
3126694-12669446.05046.31
4129062-12906246.91147.19
5127722-12772246.42446.70
6125025-12502545.44445.72
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1142249-14224951.70451.091.5552.0651.441.56
2137490-13749049.97450.30
3140690-14069051.13751.48
4143116-14311652.01952.38
5141280-14128051.35251.70
6138510-13851050.34550.69
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%
1 16.099226062923341592019629203434922331592176380.16
2 15.999232405925039192413980.14
单位质量响应值RSD%判断
572879.93577948.590.63数据可信
供试品溶液-APCE853批-缬沙坦-pH3.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1296745-2967452.8753.0014.292.873.0014.29
2264323-2643232.5612.56
3266206-2662062.5792.58
4371064-3710643.5953.59
5308805-3088052.9922.99
6353655-3536553.4263.43
10min1651660-6516606.3136.6716.056.326.6816.06
2587411-5874115.6915.69
3576378-5763785.5845.59
4869477-8694778.4238.43
5695004-6950046.7336.74
6753099-7530997.2967.30
15min11009005-10090059.7759.868.639.799.878.62
2918086-9180868.8948.91
3918368-9183688.8978.91
41135835-113583511.00411.02
51042336-104233610.09810.11
61081306-108130610.47510.49
20min11343411-134341113.01513.016.5813.0513.046.60
21233913-123391311.95411.98
31242067-124206712.03312.06
41450312-145031214.05014.09
51381930-138193013.38813.42
61405076-140507613.61213.65
30min11899110-189911018.39818.305.3418.4518.365.35
21771197-177119717.15917.21
31778694-177869417.23217.28
42037316-203731619.73719.80
51930455-193045518.70218.76
61918955-191895518.59018.65
45min12599637-259963725.18524.623.2025.2724.703.21
22439444-243944423.63323.71
32449914-244991423.73423.81
42633053-263305325.50825.60
52590653-259065325.09825.18
62536128-253612824.56924.66
60min13167756-316775630.68929.962.6830.8130.082.69
22989684-298968428.96329.08
33006969-300696929.13129.25
43175624-317562430.76530.90
53147111-314711130.48830.62
63065167-306516729.69529.82
90min13974933-397493338.50837.712.0938.6937.882.10
23804408-380440836.85637.02
33787666-378766636.69436.86
43969235-396923538.45338.64
53930002-393000238.07338.25
63887910-388791037.66537.84
120min14564912-456491244.22443.521.3744.4743.761.38
24438690-443869043.00143.23
34455884-445588443.16843.39
44555337-455533744.13144.38
54514135-451413543.73243.97
64422612-442261242.84543.09
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15015617-501561748.59048.111.7848.9148.421.79
24853919-485391947.02447.32
34907774-490777447.54547.84
45032942-503294248.75849.08
55078328-507832849.19849.51
64907463-490746347.54247.86
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%
1 14.042526012522492531352519182529792525760.20
214.142543132541322542220.06
单位质量响应值RSD%判断
17989.7417978.930.05数据可信
供试品溶液-25010701批-氨氯地平-pH3.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min154217-5421719.54319.733.8619.5419.733.87
251659-5165918.62118.62
354556-5455619.66519.66
454450-5445019.62719.63
555415-5541519.97519.97
658197-5819720.97720.98
10min175576-7557627.24227.364.0627.2727.394.06
271020-7102025.59925.63
375492-7549227.21127.24
476005-7600527.39627.43
576691-7669127.64427.68
680655-8065529.07229.11
15min189586-8958632.29232.562.8132.3732.642.82
286446-8644631.16031.23
389643-8964332.31232.39
490574-9057432.64832.73
591590-9159033.01433.09
694123-9412333.92734.01
20min1100581-10058136.25536.413.7236.3936.543.72
297902-9790235.28935.41
3100740-10074036.31236.44
496585-9658534.81434.95
5103165-10316537.18637.32
6107030-10703038.57938.72
30min1118151-11815142.58843.622.9242.7843.812.93
2117568-11756842.37842.56
3118774-11877442.81243.00
4122427-12242744.12944.32
5122374-12237444.11044.31
6126790-12679045.70245.91
45min1138111-13811149.78351.322.3650.0551.582.35
2139962-13996250.45050.70
3140832-14083250.76351.03
4144105-14410551.94352.21
5143840-14384051.84852.12
6147323-14732353.10353.38
60min1153165-15316555.20956.982.0855.5557.332.09
2157492-15749256.76957.11
3156385-15638556.36956.72
4159499-15949957.49257.84
5158966-15896657.30057.66
6162955-16295558.73859.11
90min1175300-17530063.18765.241.8963.6365.691.89
2181050-18105065.26065.69
3179938-17993864.85965.30
4182464-18246465.77066.22
5181550-18155065.44065.89
6185691-18569166.93367.40
120min1192153-19215369.26270.851.2069.8171.401.20
2197937-19793771.34771.89
3196290-19629070.75371.30
4197759-19775971.28371.84
5196382-19638270.78771.35
6198756-19875671.64272.22
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1203042-20304273.18774.631.1073.8575.301.10
2208507-20850775.15775.82
3206860-20686074.56375.23
4207975-20797574.96575.64
5206325-20632574.37175.05
6209489-20948975.51176.21
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%
1 16.099268069926069592964059253972928226992722820.19
2 15.999324843932274593237940.02
单位质量响应值RSD%判断
576276.07583101.560.84数据可信
供试品溶液-25010701批-缬沙坦-pH3.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1265240-2652402.5512.683.622.552.683.66
2281030-2810302.7032.70
3284369-2843692.7352.73
4266298-2662982.5612.56
5284519-2845192.7362.74
6288813-2888132.7772.78
10min1574756-5747565.5275.243.295.535.253.28
2527385-5273855.0725.08
3543161-5431615.2235.23
4528182-5281825.0795.08
5542861-5428615.2205.22
6555972-5559725.3465.35
15min1748729-7487297.2007.515.177.217.525.18
2769183-7691837.3977.41
3768813-7688137.3937.41
4758786-7587867.2977.31
5778538-7785387.4877.50
6860262-8602628.2738.29
20min1948139-9481399.1189.504.269.149.524.26
2951042-9510429.1469.17
3967360-9673609.3039.33
41059063-105906310.18410.21
5991077-9910779.5319.56
61008392-10083929.6979.72
30min11281967-128196712.32812.872.8912.3712.912.89
21301828-130182812.51912.56
31376375-137637513.23613.28
41341748-134174812.90312.94
51351697-135169712.99913.04
61374626-137462613.21913.26
45min11677377-167737716.13016.933.3416.1916.993.33
21742869-174286916.76016.82
31726550-172655016.60316.67
41781855-178185517.13517.20
51786024-178602417.17517.24
61848275-184827517.77417.84
60min12007885-200788519.30920.353.4519.4020.443.43
22104882-210488220.24220.33
32093642-209364220.13320.22
42124890-212489020.43420.53
52134122-213412220.52320.61
62233516-223351621.47921.57
90min12526161-252616124.29325.402.4824.4125.522.48
22661999-266199925.59925.72
32604306-260430625.04425.17
42677602-267760225.74925.88
52667600-266760025.65325.78
62707179-270717926.03426.16
120min12941017-294101728.28229.261.8528.4429.421.85
23073145-307314529.55329.72
33016249-301624929.00629.17
43090270-309027029.71829.89
53054717-305471729.37629.54
63079087-307908729.61029.78
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13190573-319057330.68231.611.6330.8931.831.63
23320188-332018831.92932.14
33263304-326330431.38231.60
43324340-332434031.96832.19
53294307-329430731.68031.90
63329572-332957232.01932.24
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%
1 14.042551402551632552872551312547262550890.09
214.142549322549412549360.01
单位质量响应值RSD%判断
18168.7318029.420.55数据可信
供试品溶液-25010702批-氨氯地平-pH3.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min160264-6026421.58521.693.1521.5821.693.15
259977-5997721.48221.48
364158-6415822.98022.98
459244-5924421.22021.22
558862-5886221.08321.08
660890-6089021.80921.81
10min188306-8830631.62931.952.7131.6631.992.71
288232-8823231.60231.64
393503-9350333.49033.53
487396-8739631.30331.34
587261-8726131.25531.29
690583-9058332.44432.48
15min1104710-10471037.50438.062.4437.5938.152.45
2105401-10540137.75237.84
3111432-11143239.91240.01
4105898-10589837.93038.02
5104489-10448937.42537.51
6105624-10562437.83237.92
20min1117672-11767242.14742.822.4442.3042.982.44
2117289-11728942.01042.16
3124275-12427544.51244.67
4118467-11846742.43242.58
5117578-11757842.11342.26
6122082-12208243.72743.88
30min1135109-13510948.39249.122.3148.6149.342.31
2135480-13548048.52548.75
3142421-14242151.01151.25
4135876-13587648.66748.89
5134365-13436548.12648.35
6139569-13956949.99050.22
45min1154501-15450155.33856.091.7555.6456.401.76
2155180-15518055.58155.88
3161904-16190457.99058.31
4155412-15541255.66455.97
5155486-15548655.69155.99
6157101-15710156.26956.58
60min1168524-16852460.36160.851.5060.7661.251.51
2169091-16909160.56460.96
3175061-17506162.70263.12
4168635-16863560.40160.80
5168940-16894060.51060.90
6169093-16909360.56560.97
90min1186528-18652866.80967.031.2067.3067.531.21
2185801-18580166.54967.04
3191427-19142768.56469.09
4186619-18661966.84267.34
5185148-18514866.31566.81
6187338-18733867.09967.60
120min1196936-19693670.53770.990.9671.1471.600.96
2197179-19717970.62471.23
3201968-20196872.34072.97
4197875-19787570.87471.48
5197268-19726870.65671.26
6197980-19798070.91171.53
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1202848-20284872.65573.041.0473.3873.771.05
2201702-20170272.24472.97
3207708-20770874.39575.15
4204232-20423273.15073.88
5202663-20266372.58873.31
6204407-20440773.21373.95
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%
1 16.099362725936731793733099370882935915793666780.07
2 15.999352219935397793530980.02
单位质量响应值RSD%判断
582142.82584934.210.34数据可信
供试品溶液-25010702批-缬沙坦-pH3.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1866708-8667088.2797.982.268.287.982.27
2825978-8259787.8907.89
3827114-8271147.9017.90
4841213-8412138.0368.04
5811402-8114027.7517.75
6841043-8410438.0348.03
10min11602580-160258015.30915.152.4415.3215.162.43
21540570-154057014.71714.73
31569444-156944414.99315.01
41646421-164642115.72815.74
51554521-155452114.85014.86
61599418-159941815.27915.29
15min12164549-216454920.67720.523.7520.7220.563.76
22073931-207393119.81219.85
32115678-211567820.21120.25
42144958-214495820.49020.53
52091011-209101119.97520.01
62297503-229750321.94821.99
20min12580169-258016924.64824.521.7724.7224.601.77
22500732-250073223.88923.96
32566458-256645824.51724.59
42578997-257899724.63724.71
52540799-254079924.27224.34
62636399-263639925.18525.26
30min13239370-323937030.94530.951.2431.0631.061.24
23175247-317524730.33230.44
33245802-324580231.00631.12
43235526-323552630.90831.02
53243591-324359130.98531.10
63301184-330118431.53531.65
45min13982441-398244138.04338.060.8038.2138.230.80
23928403-392840337.52737.69
34003570-400357038.24538.41
43978216-397821638.00338.17
53994191-399419138.15638.32
64021295-402129538.41438.58
60min14550231-455023143.46743.441.0443.7043.671.04
24489481-448948142.88743.11
34550016-455001643.46543.69
44524108-452410843.21843.45
54540602-454060243.37543.60
64631321-463132144.24244.48
90min15319763-531976350.81850.810.3751.1251.110.36
25352236-535223651.12951.42
35297352-529735250.60450.90
45317761-531776150.79951.10
55302903-530290350.65750.96
65323865-532386550.85851.17
120min15831229-583122955.70455.680.4656.0956.060.46
25784549-578454955.25855.64
35823718-582371855.63356.02
45837439-583743955.76456.15
55866887-586688756.04556.43
65827445-582744555.66856.06
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16105463-610546358.32458.100.7058.8058.580.70
26005560-600556057.37057.84
36060030-606003057.89058.37
46113132-611313258.39758.88
56091288-609128858.18958.67
66115113-611511358.41658.90
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