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%
115.182641662642552617562633422615362630110.50
215.002636312633252634780.09
单位质量响应值RSD%判断
17326.1517565.200.97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%
5min181312-8131230.21629.563.0230.2229.563.02
279473-7947329.53229.53
376003-7600328.24328.24
477356-7735628.74528.75
581214-8121430.17930.18
681875-8187530.42530.42
10min1141017-14101752.40252.222.9852.4552.262.98
2137143-13714350.96251.01
3137374-13737451.04851.10
4136528-13652850.73450.78
5145517-14551754.07454.12
6145517-14551754.07454.12
15min1170730-17073063.44363.512.6363.5863.642.63
2166523-16652361.88062.01
3168049-16804962.44762.58
4167878-16787862.38362.52
5178310-17831066.26066.40
6173939-17393964.63664.78
20min1189573-18957370.44570.973.7470.6971.213.74
2190157-19015770.66270.90
3178853-17885366.46266.70
4190920-19092070.94671.18
5197758-19775873.48773.74
6198651-19865173.81974.07
30min1211485-21148578.58879.643.1578.9580.003.14
2215140-21514079.94680.30
3207535-20753577.12077.47
4207915-20791577.26177.62
5224718-22471883.50583.88
6219088-21908881.41381.78
45min1224301-22430183.35085.403.7583.8485.903.74
2227607-22760784.57985.07
3226378-22637884.12284.60
4221685-22168582.37882.86
5245376-24537691.18291.69
6233612-23361286.81087.32
60min1239001-23900188.81389.902.7589.4490.542.75
2239528-23952889.00989.64
3235436-23543687.48888.10
4240099-24009989.22189.84
5254574-25457494.60095.26
6242978-24297890.29190.94
极限1250298-25029893.01191.992.1093.7992.782.10
2238172-23817288.50589.28
3248345-24834592.28593.05
4245301-24530191.15491.92
5252097-25209793.67994.50
6251105-25110593.31194.11
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%
116.694703494469947546959544684465468353946933850.20
216.674723292472249647228940.02
单位质量响应值RSD%判断
281209.41283316.980.53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%
5min13642390-364239071.93471.183.1971.9371.183.19
23563623-356362370.37870.38
33510610-351061069.33169.33
43452049-345204968.17568.17
53727587-372758773.61773.62
63729470-372947073.65473.65
10min14313134-431313485.18185.982.6185.3086.102.61
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
44734972-473497293.51293.92
54939888-493988897.55897.99
64886419-488641996.50396.93
30min14801627-480162794.82896.812.8495.3997.382.84
24865592-486559296.09196.66
34739443-473944393.60094.15
44885280-488528096.48097.04
55125037-5125037101.215101.81
64994836-499483698.64499.23
45min14877275-487727596.32298.172.4997.0598.902.49
24929823-492982397.36098.09
34830446-483044695.39796.11
44974208-497420898.23698.96
55174202-5174202102.186102.95
65037842-503784299.493100.25
60min14918262-491826297.13198.582.1298.0299.482.13
24934725-493472597.45798.35
34877560-487756096.32897.20
45002907-500290798.80399.69
55167879-5167879102.061102.99
65047783-504778399.689100.61
极限15079467-5079467100.31599.791.52101.36100.841.52
24927686-492768697.31898.37
35010633-501063398.95699.98
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%
115.182628642630712628482622392618092625660.21
215.002618062621952620000.11
单位质量响应值RSD%判断
17296.8417466.670.70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%
5min180170-8017029.90027.378.2129.9027.378.21
275036-7503627.98527.99
371321-7132126.60026.60
476062-7606228.36828.37
562524-6252423.31923.32
675185-7518528.04128.04
10min1137272-13727251.19748.675.6851.2548.725.68
2133684-13368449.85949.91
3134020-13402049.98450.03
4130793-13079348.78048.83
5116179-11617943.33043.37
6131064-13106448.88148.93
15min1165508-16550861.72859.224.4161.8659.354.42
2161295-16129560.15660.29
3163640-16364061.03161.16
4158478-15847859.10659.23
5145789-14578954.37354.48
6158046-15804658.94559.07
20min1185030-18503069.00866.494.1369.2566.724.13
2175704-17570465.53065.76
3183185-18318568.32068.55
4182095-18209567.91468.14
5164884-16488461.49561.70
6178768-17876866.67366.90
30min1203618-20361875.94173.823.3576.2974.153.35
2199493-19949374.40374.74
3204607-20460776.31076.65
4190498-19049871.04871.39
5189011-18901170.49370.80
6200281-20028174.69675.03
45min1220167-22016782.11379.233.5282.5979.693.51
2204073-20407376.11176.57
3220473-22047382.22782.70
4216462-21646280.73181.19
5205559-20555976.66577.09
6207910-20791077.54278.00
60min1224960-22496083.90182.981.3284.5283.571.33
2219314-21931481.79582.39
3226337-22633784.41485.02
4223502-22350283.35783.95
5219405-21940581.82982.38
6221357-22135782.55783.15
极限1246283-24628391.85390.403.9092.6191.133.87
2242330-24233090.37991.11
3245402-24540291.52592.27
4223815-22381583.47484.21
5246031-24603191.75992.45
6250378-25037893.38194.11
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%
116.694722195471984547136144705121469422047109990.25
216.674672499467699746747480.07
单位质量响应值RSD%判断
282264.77280428.790.47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%
5min13677950-367795072.87367.346.5572.8767.346.55
23449458-344945868.34568.35
33449152-344915268.33968.34
43329319-332931965.96565.97
53007727-300772759.59359.59
63479461-347946168.94068.94
10min14310959-431095985.41581.164.8985.5481.274.89
24141076-414107682.04982.16
34198253-419825383.18283.30
44059198-405919880.42680.54
53724974-372497473.80473.90
64143135-414313582.09082.20
15min14581494-458149490.77586.814.3491.0487.064.35
24416451-441645187.50587.76
34482194-448219488.80789.06
44378838-437883886.76087.00
54022707-402270779.70379.93
64406701-440670187.31287.56
20min14690578-469057892.93689.613.8193.3590.003.82
24559614-455961490.34190.74
34618907-461890791.51691.92
44539769-453976989.94890.34
54192292-419229283.06483.42
64534589-453458989.84690.24
30min14789964-478996494.90592.312.8995.4892.862.90
24691077-469107792.94693.49
34743056-474305693.97694.53
44669117-466911792.51193.05
54403721-440372187.25387.75
64657932-465793292.28992.84
45min14864019-486401996.37394.082.1797.1094.782.18
24758175-475817594.27694.98
34806549-480654995.23495.94
44744994-474499494.01494.71
54559472-455947290.33990.98
64757921-475792194.27194.97
60min14886877-488687796.82694.861.5997.7195.721.61
24785742-478574294.82295.68
34834217-483421795.78296.65
44781627-478162794.74095.59
54657837-465783792.28893.08
64781199-478119994.73295.59
极限15101158-5101158101.071100.670.77102.12101.680.76
25042685-504268599.913100.93
35063165-5063165100.318101.35
45052478-5052478100.107101.11
55077483-5077483100.602101.55
65147802-5147802101.995103.01
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%
115.182641082645942644852649492652402646750.17
215.002582042583742582890.05
单位质量响应值RSD%判断
17435.7717219.270.89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%
5min174197-7419727.75926.244.6727.7626.244.67
270165-7016526.25126.25
364792-6479224.24124.24
472362-7236227.07327.07
568398-6839825.59025.59
670875-7087526.51726.52
10min1132399-13239949.53548.362.5649.5848.402.56
2128926-12892648.23548.28
3129863-12986348.58648.63
4131332-13133249.13549.18
5122971-12297146.00746.05
6129989-12998948.63348.68
15min1160361-16036159.99659.681.8060.1259.801.80
2159489-15948959.67059.79
3157000-15700058.73958.86
4162653-16265360.85460.98
5155407-15540758.14358.26
6162180-16218060.67760.80
20min1184831-18483169.15167.291.5569.3867.521.55
2178196-17819666.66966.89
3180260-18026067.44167.66
4179965-17996567.33167.56
5176572-17657266.06166.28
6179375-17937567.11067.34
30min1207049-20704977.46376.001.3877.8176.331.39
2201116-20111675.24475.58
3202611-20261175.80376.13
4203168-20316876.01176.35
5199385-19938574.59674.92
6205478-20547876.87677.21
45min1227237-22723785.01682.003.5685.4982.463.54
2213232-21323279.77780.24
3206666-20666677.32077.78
4220834-22083482.62183.09
5221933-22193383.03283.48
6225151-22515184.23684.70
60min1235179-23517987.98885.523.7888.6086.113.75
2225720-22572084.44985.04
3222820-22282083.36483.95
4215849-21584980.75681.36
5233089-23308987.20687.79
6238786-23878689.33789.94
极限1254161-25416195.09092.362.0495.8593.112.04
2243706-24370691.17891.91
3241251-24125190.26090.99
4242824-24282490.84891.59
5249695-24969593.41994.15
6249630-24963093.39494.15
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%
116.694711854471826447240524730538473397047237360.20
216.674644137464646046452980.04
单位质量响应值RSD%判断
283027.92278662.151.10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%
5min13555172-355517270.56968.082.4270.5768.082.42
23364535-336453566.78566.79
33471886-347188668.91668.92
43425419-342541967.99467.99
53318263-331826365.86765.87
63444276-344427668.36868.37
10min14263288-426328884.62583.111.8584.7483.221.85
24092825-409282581.24281.35
34217975-421797583.72683.84
44176547-417654782.90483.02
54100611-410061181.39681.51
64268996-426899684.73984.85
15min14554718-455471890.41088.751.8790.6789.001.87
24357427-435742786.49486.74
34478054-447805488.88889.14
44443291-444329188.19888.45
54417074-441707487.67887.92
64576505-457650590.84391.10
20min14688175-468817593.05991.441.7693.4791.841.76
24488905-448890589.10489.49
34600214-460021491.31391.72
44572761-457276190.76891.17
54581298-458129890.93891.33
64708831-470883193.46993.88
30min14829760-482976095.87094.281.9296.4394.831.92
24618113-461811391.66992.21
34710932-471093293.51194.07
44702699-470269993.34893.90
54769549-476954994.67495.22
64866795-486679596.60597.17
45min14902104-490210497.30695.762.0298.0396.472.01
24687406-468740693.04493.74
34762789-476278994.54095.25
44775109-477510994.78595.49
54878276-487827696.83397.53
64939884-493988498.05698.78
60min14926909-492690997.79896.312.0598.6897.182.04
24720444-472044493.70094.55
34777929-477792994.84195.71
44799451-479945195.26896.13
54920642-492064297.67498.54
64967317-496731798.60099.49
极限15106756-5106756101.36899.511.83102.42100.541.83
24917828-491782897.61898.62
34933743-493374397.93498.96
44938167-493816798.02299.04
55093035-5093035101.096102.12
65088069-5088069100.997102.05
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