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%
113.922461872459372463592462162459162461230.08
214.042450652446922448780.11
单位质量响应值RSD%判断
17681.2517441.450.97数据可信
供试品溶液-25010701批-氨氯地平-pH6.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1110888-11088840.93540.134.3540.9340.134.35
2115826-11582642.75742.76
3103294-10329438.13138.13
4109236-10923640.32540.32
5103622-10362238.25238.25
6109396-10939640.38440.38
10min1175366-17536664.73764.671.8664.8064.741.87
2178286-17828665.81565.89
3170042-17004262.77162.83
4172978-17297863.85563.92
5175922-17592264.94265.01
6178558-17855865.91565.98
15min1199528-19952873.65673.722.0973.8373.902.09
2200484-20048474.00974.19
3192105-19210570.91671.08
4199535-19953573.65973.83
5204366-20436675.44275.61
6202246-20224674.66074.84
20min1207179-20717976.48177.711.8876.7878.011.88
2214390-21439079.14379.45
3205580-20558075.89076.18
4208778-20877877.07177.37
5215297-21529779.47779.78
6211850-21185078.20578.51
30min1229623-22962384.76682.702.2085.1983.132.19
2226707-22670783.68984.13
3215393-21539379.51379.93
4222602-22260282.17482.60
5226360-22636083.56183.99
6223475-22347582.49682.93
45min1229919-22991984.87585.201.3985.4485.771.39
2233099-23309986.04986.62
3225777-22577783.34683.89
4228873-22887384.48985.05
5233464-23346486.18486.75
6233742-23374286.28686.86
60min1232671-23267185.89186.351.2586.6087.061.25
2238208-23820887.93588.65
3231759-23175985.55486.24
4234447-23444786.54787.25
5236066-23606687.14487.86
6230301-23030185.01685.73
极限1236508-23650887.30790.182.6388.1691.032.62
2249995-24999592.28693.15
3236012-23601287.12487.95
4245538-24553890.64191.49
5248002-24800291.55192.41
6249645-24964592.15793.01
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%
115.759222274921836692228989225631922292292224180.03
215.779225105921870392219040.05
单位质量响应值RSD%判断
585550.35584775.140.10数据可信
供试品溶液-25010701批-缬沙坦-pH6.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min14503695-450369542.90343.202.0042.9043.202.00
24676667-467666744.55144.55
34402110-440211041.93541.94
44509287-450928742.95642.96
54573613-457361343.56943.57
64545310-454531043.30043.30
10min14980984-498098447.45048.061.7947.5248.131.79
25155133-515513349.10949.18
34928739-492873946.95247.02
44998481-499848147.61747.69
55133734-513373448.90548.98
65072818-507281848.32548.40
15min15011723-501172347.74348.471.8147.8948.621.81
25193714-519371449.47649.63
34975496-497549647.39847.55
45046354-504635448.07348.22
55188880-518888049.43049.58
65114389-511438948.72148.87
20min15000453-500045347.63548.481.8747.8748.711.86
25196661-519666149.50449.74
34978004-497800447.42147.65
45048246-504824648.09148.32
55192296-519229649.46349.70
65117870-511787048.75448.99
30min15132237-513223748.89148.731.6749.2049.041.67
25198265-519826549.52049.84
34984203-498420347.48147.79
45050073-505007348.10848.42
55202135-520213549.55749.88
65122734-512273448.80049.12
45min14993772-499377247.57248.692.1647.9649.082.15
25211442-521144249.64550.05
34993182-499318247.56647.95
45051051-505105148.11748.51
55203694-520369449.57149.97
65213764-521376449.66750.06
60min14987921-498792147.51648.641.8047.9949.121.79
25217048-521704849.69950.18
35051934-505193448.12648.59
45049712-504971248.10548.58
55201625-520162549.55250.04
65128159-512815948.85249.33
极限14979842-497984247.43948.952.2547.9949.512.25
25257636-525763650.08550.65
35049084-504908448.09948.64
45091294-509129448.50149.05
55253871-525387150.04950.62
65200628-520062849.54250.10
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%
113.922446512444602450932445902457052449000.21
214.042452112449662450880.08
单位质量响应值RSD%判断
17593.3917456.410.56数据可信
供试品溶液-25010702批-氨氯地平-pH6.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1121762-12176245.04145.102.3445.0445.102.34
2122618-12261845.35745.36
3119227-11922744.10344.10
4123296-12329645.60845.61
5126259-12625946.70446.70
6118431-11843143.80943.81
10min1193617-19361771.62168.663.7971.7068.743.79
2189575-18957570.12570.20
3180245-18024566.67466.75
4177744-17774465.74965.83
5192430-19243071.18171.26
6180147-18014766.63866.71
15min1199267-19926773.71177.363.1773.9077.553.16
2213221-21322178.87279.06
3203371-20337175.22975.41
4208860-20886077.25977.44
5214463-21446379.33279.53
6215684-21568479.78379.97
20min1223230-22323082.57581.212.3982.8981.532.38
2218027-21802780.65080.97
3212195-21219578.49378.80
4215036-21503679.54479.86
5224341-22434182.98683.31
6224413-22441383.01283.33
30min1242862-24286289.83785.433.5090.2985.893.49
2228938-22893884.68685.14
3222744-22274482.39582.84
4221840-22184082.06182.51
5235574-23557487.14187.61
6233813-23381386.48986.94
45min1239547-23954788.61087.022.6689.2287.622.66
2233911-23391186.52687.13
3228917-22891784.67885.26
4227322-22732284.08884.67
5242941-24294189.86690.48
6238852-23885288.35388.95
60min1231845-23184585.76186.403.5686.5187.143.54
2237202-23720287.74388.49
3225249-22524983.32284.04
4222957-22295782.47483.20
5243147-24314789.94290.70
6240962-24096289.13489.88
极限1249891-24989192.43793.552.6493.3394.442.63
2257561-25756195.27496.16
3242746-24274689.79490.65
4250023-25002392.48693.35
5261282-26128296.65097.56
6255928-25592894.67095.57
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%
115.759212617922019392230559226393922903392222580.07
215.779229727922534192275340.04
单位质量响应值RSD%判断
585540.19585132.150.05数据可信
供试品溶液-25010702批-缬沙坦-pH6.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min18786194-878619483.67483.801.9783.6783.801.97
28896845-889684584.72884.73
38520299-852029981.14281.14
48699868-869986882.85282.85
59014064-901406485.84485.84
68879825-887982584.56684.57
10min19648489-964848991.88691.322.4992.0391.462.49
29760316-976031692.95193.09
39239654-923965487.99388.13
49362368-936236889.16189.30
59854565-985456593.84993.99
69671095-967109592.10192.24
15min19755956-975595692.91092.112.5493.2092.402.54
29806475-980647593.39193.69
39316471-931647188.72489.01
49439696-943969689.89890.18
59974515-997451594.99195.29
69740433-974043392.76293.06
20min19827393-982739393.59092.252.5094.0492.702.50
29824469-982446993.56294.01
39331095-933109588.86489.29
49447236-944723689.97090.41
59940851-994085194.67095.13
69749794-974979492.85193.30
30min19961742-996174294.86992.662.5895.4793.262.58
29842181-984218193.73194.34
39362865-936286589.16689.74
49475635-947563590.24090.83
59940650-994065094.66995.28
69793930-979393093.27193.88
45min19957229-995722994.82693.002.5495.5993.752.54
29896514-989651494.24895.01
39398908-939890889.50990.24
49514357-951435790.60991.35
59991093-999109395.14995.92
69833371-983337193.64794.41
60min110000357-1000035795.23793.182.5596.1694.082.55
29913843-991384394.41395.33
39422284-942228489.73290.61
49529438-952943890.75291.64
510006761-1000676195.29896.23
69830946-983094693.62494.54
极限110220308-1022030897.33295.941.8698.4197.011.87
210232325-1023232597.44698.52
39840854-984085493.71894.74
49845352-984535293.76194.80
510222761-1022276197.35598.45
610085720-1008572096.05097.12
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%
113.922513052513902512172511332517212513530.10
214.042549482551242550360.05
单位质量响应值RSD%判断
18056.9718164.960.43数据可信
供试品溶液-APCE853批-氨氯地平-pH6.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1112756-11275640.35940.653.8040.3640.653.80
2115834-11583441.46141.46
3110726-11072639.63339.63
4120142-12014243.00343.00
5107624-10762438.52338.52
6114302-11430240.91340.91
10min1191317-19131768.47969.411.5868.5569.481.58
2193768-19376869.35769.43
3197194-19719470.58370.65
4197611-19761170.73270.80
5189988-18998868.00468.07
6193592-19359269.29469.36
15min1218843-21884378.33279.561.5578.5179.751.55
2222386-22238679.60079.78
3228306-22830681.71981.90
4223355-22335579.94780.14
5219283-21928378.48978.67
6221556-22155679.30379.49
20min1233697-23369783.64984.481.5983.9684.801.58
2232811-23281183.33183.65
3241478-24147886.43486.75
4239992-23999285.90286.22
5233421-23342183.55083.86
6234784-23478484.03884.35
30min1236065-23606584.49686.072.2384.9586.532.22
2241018-24101886.26986.73
3246977-24697788.40288.87
4245693-24569387.94288.41
5239789-23978985.82986.28
6233177-23317783.46283.92
45min1243230-24323087.06187.631.7887.6588.231.78
2243521-24352187.16587.77
3251593-25159390.05490.67
4248656-24865689.00389.62
5240973-24097386.25386.84
6240962-24096286.24986.84
60min1243931-24393187.31287.981.8688.0588.721.86
2241961-24196186.60787.35
3254493-25449391.09291.85
4246827-24682788.34889.11
5242967-24296786.96787.70
6244553-24455387.53488.27
极限1246535-24653588.24491.192.5389.1392.092.52
2254575-25457591.12292.01
3263646-26364694.36895.28
4260625-26062593.28794.20
5249914-24991489.45390.33
6253373-25337390.69191.58
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%
115.759282483928637892889989291172929383892885740.05
215.779409062942070394148820.09
单位质量响应值RSD%判断
589750.73597012.180.87数据可信
供试品溶液-APCE853批-缬沙坦-pH6.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min18175640-817564076.80778.052.2376.8178.052.24
28305327-830532778.02578.03
38434150-843415079.23579.24
48558955-855895580.40880.41
58035942-803594275.49475.49
68337155-833715578.32478.32
10min19861678-986167892.64793.421.6492.7793.541.64
29843103-984310392.47292.60
310188265-1018826595.71595.85
410110997-1011099794.98995.12
59841437-984143792.45692.58
69815740-981574092.21592.35
15min110020183-1002018394.13694.951.5694.4295.241.55
210008842-1000884294.02994.31
310377394-1037739497.49297.78
410208039-1020803995.90096.19
510066533-1006653394.57194.85
69962643-996264393.59593.88
20min110032175-1003217594.24895.131.5894.6995.581.58
210015267-1001526794.08994.53
310399051-1039905197.69598.15
410232597-1023259796.13196.58
510088658-1008865894.77995.22
69989250-998925093.84594.29
30min110057961-1005796194.49195.431.5695.0996.031.56
210077370-1007737094.67395.27
310433464-1043346498.01898.64
410248584-1024858496.28196.89
510122233-1012223395.09495.69
610006280-1000628094.00594.60
45min110050903-1005090394.42495.321.5695.1896.081.56
210043323-1004332394.35395.11
310423000-1042300097.92098.70
410236336-1023633696.16696.94
510115955-1011595595.03595.79
610008057-1000805794.02294.78
60min110078141-1007814194.68095.351.5395.5996.281.54
210029797-1002979794.22695.14
310421436-1042143697.90598.85
410242441-1024244196.22497.16
510107984-1010798494.96195.87
610019808-1001980894.13295.04
极限110129019-1012901995.15896.261.6796.2397.341.66
210122235-1012223595.09496.16
310545167-1054516799.068100.17
410328156-1032815697.02998.12
510248666-1024866696.28297.35
610104711-1010471194.93096.00
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