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%
115.202641662642552617562633422615362630110.50
215.182636312633252634780.09
单位质量响应值RSD%判断
17303.3617356.920.22数据可信
长期24月-供试品溶液-2023112221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%
5min181312-8131230.41629.753.0230.4229.763.02
279473-7947329.72829.73
376003-7600328.43028.43
477356-7735628.93628.94
581214-8121430.37930.38
681875-8187530.62630.63
10min1141017-14101752.74952.562.9852.8052.612.98
2137143-13714351.30051.35
3137374-13737451.38651.43
4136528-13652851.07051.12
5145517-14551754.43254.48
6145517-14551754.43254.48
15min1170730-17073063.86363.932.6364.0064.062.63
2166523-16652362.29062.42
3168049-16804962.86162.99
4167878-16787862.79762.93
5178310-17831066.69966.84
6173939-17393965.06465.21
20min1189573-18957370.91271.443.7471.1671.683.74
2190157-19015771.13071.37
3178853-17885366.90267.14
4190920-19092071.41671.65
5197758-19775873.97474.23
6198651-19865174.30874.56
30min1211485-21148579.10880.173.1579.4780.533.14
2215140-21514080.47580.83
3207535-20753577.63177.98
4207915-20791577.77378.13
5224718-22471884.05884.43
6219088-21908881.95282.33
45min1224301-22430183.90285.973.7584.4086.473.74
2227607-22760785.13985.63
3226378-22637884.67985.16
4221685-22168582.92483.41
5245376-24537691.78692.30
6233612-23361287.38587.90
60min1239001-23900189.40190.502.7590.0491.142.75
2239528-23952889.59890.23
3235436-23543688.06788.69
4240099-24009989.81290.44
5254574-25457495.22695.90
6242978-24297890.88991.54
极限1250298-25029893.62792.602.1094.4193.392.10
2238172-23817289.09189.87
3248345-24834592.89693.66
4245301-24530191.75892.53
5252097-25209794.30095.13
6251105-25110593.92994.74
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%
116.674703494469947546959544684465468353946933850.20
216.694723292472249647228940.02
单位质量响应值RSD%判断
281546.79282977.470.36数据可信
长期24月-供试品溶液-2023112221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%
5min13642390-364239071.93471.183.1971.9371.183.19
23563623-356362370.37870.38
33510610-351061069.33169.33
43452049-345204968.17568.17
53727587-372758773.61673.62
63729470-372947073.65473.65
10min14313134-431313485.18085.982.6185.3086.102.61
24326931-432693185.45385.57
34221816-422181683.37783.49
44275749-427574984.44284.56
54500149-450014988.87489.00
64484090-448409088.55788.68
15min14568909-456890990.23291.392.6290.4991.652.62
24601921-460192190.88491.14
34467536-446753688.23088.48
44584617-458461790.54290.80
54787058-478705894.54094.81
64754454-475445493.89694.17
20min14686444-468644492.55394.052.7492.9794.472.74
24738409-473840993.57993.99
34587462-458746290.59891.00
44734972-473497293.51193.92
54939888-493988897.55897.99
64886419-488641996.50296.93
30min14801627-480162794.82896.812.8495.3997.382.84
24865592-486559296.09196.66
34739443-473944393.60094.15
44885280-488528096.48097.04
55125037-5125037101.215101.81
64994836-499483698.64399.23
45min14877275-487727596.32298.172.4997.0598.902.48
24929823-492982397.35998.09
34830446-483044695.39796.11
44974208-497420898.23698.96
55174202-5174202102.186102.95
65037842-503784299.493100.24
60min14918262-491826297.13198.582.1298.0299.482.13
24934725-493472597.45698.35
34877560-487756096.32797.19
45002907-500290798.80399.69
55167879-5167879102.061102.99
65047783-504778399.689100.61
极限15079467-5079467100.31599.791.52101.36100.841.52
24927686-492768697.31798.37
35010633-501063398.95599.98
45090213-5090213100.527101.58
55151845-5151845101.744102.84
65056229-505622999.856100.94
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%
115.202628642630712628482622392618092625660.21
215.182618062621952620000.11
单位质量响应值RSD%判断
17274.0817259.550.06数据可信
长期24月-供试品溶液-2023112221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%
5min180170-8017030.09827.558.2130.1027.558.22
275036-7503628.17128.17
371321-7132126.77626.78
476062-7606228.55628.56
562524-6252423.47323.47
675185-7518528.22728.23
10min1137272-13727251.53648.995.6851.5949.045.68
2133684-13368450.18950.24
3134020-13402050.31550.36
4130793-13079349.10449.15
5116179-11617943.61743.66
6131064-13106449.20649.25
15min1165508-16550862.13759.624.4162.2759.744.41
2161295-16129560.55560.69
3163640-16364061.43661.56
4158478-15847859.49859.63
5145789-14578954.73454.85
6158046-15804659.33559.46
20min1185030-18503069.46666.934.1369.7167.164.13
2175704-17570465.96566.20
3183185-18318568.77369.00
4182095-18209568.36468.59
5164884-16488461.90362.11
6178768-17876867.11567.34
30min1203618-20361876.44574.303.3576.8074.643.35
2199493-19949374.89675.24
3204607-20460776.81677.16
4190498-19049871.51971.86
5189011-18901170.96171.27
6200281-20028175.19275.53
45min1220167-22016782.65879.763.5283.1480.223.51
2204073-20407376.61577.08
3220473-22047382.77383.25
4216462-21646281.26781.73
5205559-20555977.17377.60
6207910-20791078.05678.52
60min1224960-22496084.45783.531.3285.0884.121.34
2219314-21931482.33782.93
3226337-22633784.97485.59
4223502-22350283.91084.51
5219405-21940582.37282.92
6221357-22135783.10483.70
极限1246283-24628392.46290.993.9093.2291.733.87
2242330-24233090.97891.71
3245402-24540292.13292.88
4223815-22381584.02784.76
5246031-24603192.36893.06
6250378-25037894.00094.73
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%
116.674722195471984547136144705121469422047109990.25
216.694672499467699746747480.07
单位质量响应值RSD%判断
282603.42280092.750.64数据可信
长期24月-供试品溶液-2023112221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%
5min13677950-367795072.87367.346.5572.8767.346.55
23449458-344945868.34668.35
33449152-344915268.34068.34
43329319-332931965.96565.97
53007727-300772759.59459.59
63479461-347946168.94068.94
10min14310959-431095985.41581.164.8985.5481.274.89
24141076-414107682.04982.16
34198253-419825383.18283.30
44059198-405919880.42780.54
53724974-372497473.80573.90
64143135-414313582.09082.20
15min14581494-458149490.77586.814.3491.0487.064.35
24416451-441645187.50587.76
34482194-448219488.80889.06
44378838-437883886.76087.00
54022707-402270779.70479.93
64406701-440670187.31287.56
20min14690578-469057892.93789.613.8193.3590.003.82
24559614-455961490.34290.74
34618907-461890791.51791.92
44539769-453976989.94990.34
54192292-419229283.06483.42
64534589-453458989.84690.24
30min14789964-478996494.90692.312.8995.4892.862.90
24691077-469107792.94793.49
34743056-474305693.97694.53
44669117-466911792.51193.05
54403721-440372187.25387.75
64657932-465793292.29092.84
45min14864019-486401996.37394.082.1797.1094.782.18
24758175-475817594.27694.98
34806549-480654995.23495.94
44744994-474499494.01594.71
54559472-455947290.33990.98
64757921-475792194.27194.97
60min14886877-488687796.82694.871.5997.7195.721.61
24785742-478574294.82295.68
34834217-483421795.78396.65
44781627-478162794.74195.59
54657837-465783792.28893.08
64781199-478119994.73295.59
极限15101158-5101158101.072100.670.77102.12101.680.76
25042685-504268599.913100.93
35063165-5063165100.319101.35
45052478-5052478100.107101.11
55077483-5077483100.603101.55
65147802-5147802101.996103.01
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%
115.202641082645942644852649492652402646750.17
215.182582042583742582890.05
单位质量响应值RSD%判断
17412.8317015.091.64数据可信
长期24月-供试品溶液-2023112421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%
5min174197-7419727.94526.414.6727.9526.414.68
270165-7016526.42726.43
364792-6479224.40324.40
472362-7236227.25427.25
568398-6839825.76125.76
670875-7087526.69426.69
10min1132399-13239949.86648.682.5649.9148.722.56
2128926-12892648.55848.60
3129863-12986348.91148.95
4131332-13133249.46449.51
5122971-12297146.31546.36
6129989-12998948.95849.00
15min1160361-16036160.39850.2448.0160.5350.3747.90
22805-28051.0561.18
3157000-15700059.13259.25
4162653-16265361.26161.39
5155407-15540758.53258.65
6162180-16218061.08361.21
20min1184831-18483169.61467.741.5569.8467.951.57
2178196-17819667.11567.24
3180260-18026067.89268.11
4179965-17996567.78168.01
5176572-17657266.50366.72
6179375-17937567.55967.79
30min1207049-20704977.98276.511.3878.3376.831.41
2201116-20111675.74775.99
3202611-20261176.31076.64
4203168-20316876.52076.86
5199385-19938575.09575.42
6205478-20547877.39077.73
45min1227237-22723785.58582.553.5686.0683.003.56
2213232-21323280.31180.68
3206666-20666677.83878.30
4220834-22083483.17483.64
5221933-22193383.58884.04
6225151-22515184.80085.27
60min1235179-23517988.57786.093.7889.2086.683.76
2225720-22572085.01485.51
3222820-22282083.92284.51
4215849-21584981.29681.91
5233089-23308987.78988.38
6238786-23878689.93590.55
极限1254161-25416195.72692.982.0496.4993.712.05
2243706-24370691.78892.43
3241251-24125190.86491.59
4242824-24282491.45692.20
5249695-24969594.04494.78
6249630-24963094.01994.78
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%
116.674711854471826447240524730538473397047237360.20
216.694644137464646046452980.04
单位质量响应值RSD%判断
283367.49278328.221.27数据可信
长期24月-供试品溶液-2023112421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%
5min13555172-355517270.57068.082.4270.5768.082.42
23364535-336453566.78666.79
33471886-347188668.91768.92
43425419-342541967.99467.99
53318263-331826365.86765.87
63444276-344427668.36968.37
10min14263288-426328884.62683.111.8584.7483.221.85
24092825-409282581.24281.35
34217975-421797583.72783.84
44176547-417654782.90483.02
54100611-410061181.39781.51
64268996-426899684.73984.85
15min14554718-455471890.41174.8646.9590.6775.1246.80
2159489-1594893.1663.41
34478054-447805488.88989.14
44443291-444329188.19988.45
54417074-441707487.67987.92
64576505-457650590.84491.10
20min14688175-468817593.06091.441.7693.4791.821.81
24488905-448890589.10589.36
34600214-460021491.31491.72
44572761-457276190.76991.17
54581298-458129890.93991.33
64708831-470883193.47093.88
30min14829760-482976095.87194.281.9296.4494.811.97
24618113-461811391.66992.07
34710932-471093293.51294.07
44702699-470269993.34893.90
54769549-476954994.67595.22
64866795-486679596.60697.17
45min14902104-490210497.30795.762.0298.0396.452.06
24687406-468740693.04593.60
34762789-476278994.54195.25
44775109-477510994.78695.49
54878276-487827696.83497.53
64939884-493988498.05798.78
60min14926909-492690997.79996.312.0598.6997.162.08
24720444-472044493.70194.41
34777929-477792994.84295.71
44799451-479945195.26996.13
54920642-492064297.67598.54
64967317-496731798.60199.49
极限15106756-5106756101.36999.511.83102.42100.511.86
24917828-491782897.61998.48
34933743-493374397.93598.96
44938167-493816798.02399.04
55093035-5093035101.097102.12
65088069-5088069100.998102.05
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