苯磺酸氨氯地平缬沙坦片项目信息
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%
114.172434322429802428032427652426742429310.13
214.092426432426382426400.01
单位质量响应值RSD%判断
17144.0417220.720.32数据可信
供试品溶液-2023112521批-苯磺酸氨氯地平-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%
5min142984-4298416.21716.297.2616.2216.297.26
243038-4303816.23716.24
337719-3771914.23114.23
443761-4376116.51016.51
544099-4409916.63816.64
647425-4742517.89217.89
10min177719-7771929.32229.253.7929.3529.273.79
277292-7729229.16129.19
372303-7230327.27827.30
478275-7827529.53129.56
578152-7815229.48529.51
681357-8135730.69430.72
15min199166-9916637.41337.883.1837.4937.963.19
2100284-10028437.83537.91
395058-9505835.86335.93
4102239-10223938.57338.65
5101233-10123338.19338.27
6104496-10449639.42439.51
20min1115238-11523843.47744.682.9043.6244.822.91
2117922-11792244.48944.63
3113616-11361642.86542.99
4120460-12046045.44745.59
5121308-12130845.76745.91
6122013-12201346.03346.18
30min1137635-13763551.92753.472.5252.1453.682.52
2142111-14211153.61553.83
3137426-13742651.84852.05
4145198-14519854.78055.00
5142229-14222953.66053.88
6145731-14573154.98155.20
45min1160844-16084460.68362.521.6460.9862.821.64
2164657-16465762.12262.42
3165705-16570562.51762.80
4167451-16745163.17663.48
5168031-16803163.39463.70
6167613-16761363.23763.55
60min1168286-16828663.49167.283.3863.8967.693.36
2178784-17878467.45167.86
3182443-18244368.83269.22
4184272-18427269.52269.94
5181880-18188068.61969.03
6174395-17439565.79566.22
90min1193377-19337772.95775.522.2573.4676.032.24
2198092-19809274.73675.25
3204717-20471777.23577.74
4205448-20544877.51178.04
5200583-20058375.67676.20
6198743-19874374.98175.51
120min1207170-20717078.16180.182.5678.7980.822.54
2207995-20799578.47279.11
3219740-21974082.90383.54
4218608-21860882.47683.13
5212009-21200979.98680.64
6209572-20957279.06779.72
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1224592-22459284.73485.461.8785.4986.231.85
2220193-22019383.07483.85
3231544-23154487.35788.13
4230882-23088287.10787.90
5225716-22571685.15885.94
6226100-22610085.30386.09
苯磺酸氨氯地平缬沙坦片项目信息
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%
116.044655030465779246549364653891465076746544830.06
216.064659003465880046589020.01
单位质量响应值RSD%判断
290179.74290093.520.03数据可信
供试品溶液-2023112521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%
5min11575995-157599530.27929.975.7030.2829.975.70
21544058-154405829.66629.67
31411153-141115327.11227.11
41555098-155509829.87829.88
51587231-158723130.49530.50
61686375-168637532.40032.40
10min12223823-222382342.72642.823.6142.7842.873.62
22180551-218055141.89541.94
32113546-211354640.60740.65
42272449-227244943.66043.71
52232840-223284042.89942.95
62350181-235018145.15445.21
15min12600751-260075149.96850.652.7850.0950.772.79
22583322-258332249.63349.75
32550380-255038049.00049.11
42698460-269846051.84551.97
52640177-264017750.72650.85
62743523-274352352.71152.84
20min12856139-285613954.87556.893.7455.0857.103.74
22877121-287712155.27855.48
32871971-287197155.17955.37
43002336-300233657.68457.89
53132230-313223060.17960.39
63026878-302687858.15558.37
30min13253886-325388662.51764.112.0962.8164.412.10
23278848-327884862.99663.29
33309409-330940963.58363.87
43420322-342032265.71466.02
53341492-334149264.20064.51
63415987-341598765.63165.95
45min13626348-362634869.67371.402.0070.0771.811.99
23639442-363944269.92470.32
33727708-372770871.62072.01
43814583-381458373.28973.70
53713942-371394271.35671.77
63776007-377600772.54872.97
60min13850226-385022673.97476.052.1774.4976.582.16
23869650-386965074.34774.86
33998664-399866476.82677.34
44066862-406686278.13678.67
53945898-394589875.81276.35
64017925-401792577.19677.74
90min14152037-415203779.77381.792.1980.4182.442.18
24155887-415588779.84780.49
34343425-434342583.45084.09
44370330-437033083.96784.63
54232359-423235981.31681.98
64287137-428713782.36883.04
120min14343149-434314983.44585.292.3684.2286.082.35
24314474-431447482.89483.67
34555097-455509787.51788.30
44562731-456273187.66388.47
54409183-440918384.71385.51
64451344-445134485.52386.33
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14640644-464064489.16090.001.7190.0790.941.70
24586212-458621288.11589.03
34798249-479824992.18893.11
44758460-475846091.42492.38
54642685-464268589.20090.14
64681226-468122689.94090.89
苯磺酸氨氯地平缬沙坦片项目信息
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%
114.172426992428672431612432052430302429920.09
214.092425952427862426900.06
单位质量响应值RSD%判断
17148.3417224.270.32数据可信
供试品溶液-2023112521批-苯磺酸氨氯地平
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min142673-4267316.09616.502.7716.1016.502.78
244251-4425116.69116.69
342399-4239915.99315.99
445470-4547017.15117.15
543109-4310916.26016.26
644606-4460616.82516.83
10min177102-7710229.08229.591.4029.1129.611.41
277748-7774829.32629.35
377964-7796429.40729.43
479775-7977530.09130.12
579747-7974730.08030.11
678289-7828929.53029.56
15min1102183-10218338.54338.401.2838.6238.481.29
2101275-10127538.20038.28
3100526-10052637.91837.99
4102344-10234438.60338.68
5103953-10395339.21039.29
6100574-10057437.93638.01
20min1118071-11807144.53545.033.8144.6845.183.80
2115163-11516343.43943.58
3119369-11936945.02545.16
4115804-11580443.68043.82
5120190-12019045.33545.48
6127762-12776248.19148.33
30min1143383-14338354.08353.531.1554.3053.751.14
2139327-13932752.55352.77
3142588-14258853.78354.00
4140614-14061453.03953.25
5143291-14329154.04854.27
6142374-14237453.70253.92
45min1166182-16618262.68362.500.9662.9962.800.96
2165312-16531262.35462.65
3166302-16630262.72863.03
4164527-16452762.05862.36
5168191-16819163.44063.75
6163638-16363861.72362.03
60min1182495-18249568.83668.791.3569.2469.201.34
2182078-18207868.67869.08
3184013-18401369.40869.82
4178443-17844367.30767.72
5185668-18566870.03370.45
6181471-18147168.44968.86
90min1204583-20458377.16776.071.9077.6976.591.88
2204074-20407476.97577.49
3204093-20409376.98277.51
4195858-19585873.87674.40
5203604-20360476.79877.33
6197779-19777974.60175.13
120min1216384-21638481.61881.061.0682.2781.711.06
2217150-21715081.90782.55
3215500-21550081.28581.94
4211766-21176679.87780.52
5216281-21628181.58082.24
6212361-21236180.10180.75
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1231864-23186487.45786.981.2888.2587.771.27
2235485-23548588.82389.61
3228322-22832286.12186.91
4227861-22786185.94786.72
5231469-23146987.30888.10
6228601-22860186.22787.01
苯磺酸氨氯地平缬沙坦片项目信息
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%
116.044656742466101846688564670909466874046652530.14
216.064653526465546646544960.03
单位质量响应值RSD%判断
290851.18289819.180.26数据可信
供试品溶液-2023112521批-缬沙坦
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min11606100-160610030.83730.711.3130.8430.711.31
21576601-157660130.27130.27
31577674-157767430.29130.29
41629993-162999331.29631.30
51594449-159444930.61330.61
61612603-161260330.96230.96
10min12284048-228404843.85343.691.5143.9043.741.51
22227110-222711042.76042.81
32259363-225936343.37943.43
42277627-227762743.73043.78
52331850-233185044.77144.82
62274022-227402243.66143.71
15min12695179-269517951.74751.531.4051.8751.661.40
22630659-263065950.50850.63
32669344-266934451.25151.37
42680934-268093451.47451.60
52746018-274601852.72352.85
62681839-268183951.49151.62
20min12978469-297846957.18659.7610.4557.4059.9710.41
22964835-296483556.92457.13
32973375-297337557.08857.30
42952298-295229856.68456.89
53031601-303160158.20658.42
63773371-377337172.44872.66
30min13393349-339334965.15264.851.2265.4665.161.22
23315737-331573763.66263.96
33381904-338190464.93265.24
43354542-335454264.40764.71
53439254-343925466.03366.34
63380640-338064064.90865.24
45min13816481-381648173.27672.531.1273.6972.951.11
23735680-373568071.72572.13
33783292-378329272.63973.05
43737968-373796871.76872.18
53836661-383666173.66374.08
63755795-375579572.11172.55
60min14044842-404484277.66077.290.9478.2077.840.93
24008846-400884676.96977.50
34033513-403351377.44377.98
43977258-397725876.36376.90
54085321-408532178.43878.98
64004977-400497776.89577.45
90min14360198-436019883.71583.151.0384.3883.821.02
24357014-435701483.65484.31
34337311-433731183.27683.94
44264217-426421781.87282.53
54376447-437644784.02784.70
64290051-429005182.36883.06
120min14538424-453842487.13786.660.9487.9487.470.93
24556717-455671787.48888.28
34512925-451292586.64787.45
44450154-445015485.44286.24
54546794-454679487.29888.11
64476887-447688785.95686.78
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14783025-478302591.83391.220.9092.7892.170.89
24807250-480725092.29893.24
34696444-469644490.17191.12
44713660-471366090.50291.44
54767361-476736191.53392.49
64738825-473882590.98591.95
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