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%
115.202519922507932519912521802501212514150.37
215.182538262514342526300.67
单位质量响应值RSD%判断
16540.4616642.290.44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%
5min176311-7631129.81627.594.9529.8227.604.95
269072-6907226.98826.99
371274-7127427.84827.85
471984-7198428.12628.13
565963-6596325.77325.77
669148-6914827.01727.02
10min1133824-13382452.28849.205.4752.3449.255.47
2134345-13434552.49152.54
3124658-12465848.70648.75
4125119-12511948.88648.93
5118457-11845746.28346.33
6119162-11916246.55946.60
15min1168110-16811065.68460.268.8965.8260.388.88
2169298-16929866.14866.28
3151660-15166059.25659.38
4154778-15477860.47560.60
5132142-13214251.63051.75
6149326-14932658.34558.47
20min1182054-18205471.13267.726.4271.3867.956.41
2189876-18987674.18874.43
3163366-16336663.83064.06
4175308-17530868.49668.73
5162049-16204963.31663.52
6167233-16723365.34165.56
30min1209336-20933681.79276.964.9782.1677.304.98
2207329-20732981.00781.37
3188841-18884173.78474.12
4198946-19894677.73278.08
5186392-18639272.82773.14
6190903-19090374.58974.92
45min1220841-22084186.28784.164.0186.7984.634.02
2229366-22936689.61890.12
3209130-20913081.71182.17
4216767-21676784.69585.17
5207438-20743881.05081.48
6208897-20889781.62082.07
60min1222054-22205486.76186.335.0287.4186.945.02
2241430-24143094.33194.98
3208815-20881581.58882.18
4220840-22084086.28686.90
5217679-21767985.05185.62
6214928-21492883.97784.57
极限1239760-23976093.67994.303.1594.4795.053.16
2250451-25045197.85698.66
3242125-24212594.60395.33
4247234-24723496.59997.36
5228454-22845489.26189.97
6240013-24001393.77894.51
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%
116.674793564479686047980164798841480219447978950.07
216.694836677484255948396180.09
单位质量响应值RSD%判断
287816.14289971.120.53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%
5min13750969-375096972.37867.835.6472.3867.845.64
23596915-359691569.40669.41
33468566-346856666.92966.93
43676315-367631570.93870.94
53219568-321956862.12462.12
63380737-338073765.23465.23
10min14555123-455512387.89583.306.1288.0283.426.12
24635549-463554989.44789.56
34194799-419479980.94281.05
44431050-443105085.50185.62
53964006-396400676.48976.59
64122753-412275379.55279.66
15min14826958-482695893.14089.445.4793.4189.705.47
24985063-498506396.19196.46
34503357-450335786.89687.14
44725337-472533791.17991.44
54310402-431040283.17383.40
64461280-446128086.08486.33
20min14947782-494778295.47292.444.9295.8992.844.92
25131865-513186599.02499.45
34664707-466470790.01090.40
44876479-487647994.09694.51
54502157-450215786.87387.24
64619483-461948389.13789.52
30min15070372-507037297.83795.424.1998.4295.984.20
25263168-5263168101.557102.15
34810446-481044692.82293.36
45018812-501881296.84297.41
54727580-472758091.22391.74
64781059-478105992.25592.79
45min15120444-512044498.80397.173.5199.5597.893.52
25325442-5325442102.759103.52
34911291-491129194.76895.46
45090917-509091798.23498.96
54879768-487976894.15994.83
64888167-488816794.32195.01
60min15131975-513197599.02697.773.1199.9498.643.12
25327259-5327259102.794103.72
34956370-495637095.63796.49
45122340-512234098.84099.73
54939069-493906995.30496.13
64923919-492391995.01195.86
极限15215989-5215989100.647101.461.52101.72102.501.53
25363958-5363958103.502104.60
35216905-5216905100.665101.68
45338520-5338520103.011104.07
55259527-5259527101.487102.47
65154819-515481999.467100.47
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%
115.202496402499592501852501072505312500840.14
215.182514052514022514040.01
单位质量响应值RSD%判断
16452.8916561.530.47数据可信
长期24月-供试品溶液-2023112521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%
5min183331-8333132.72530.688.3632.7330.688.36
271968-7196828.26328.26
388161-8816134.62234.62
478738-7873830.92130.92
573253-7325328.76728.77
673316-7331628.79228.79
10min1129986-12998651.04749.942.9351.1049.992.93
2124623-12462348.94148.99
3130745-13074551.34551.40
4130825-13082551.37751.43
5123824-12382448.62748.68
6122990-12299048.30048.35
15min1156968-15696861.64359.904.4361.7860.044.43
2144437-14443756.72256.85
3161227-16122763.31663.46
4156652-15665261.51961.66
5149952-14995258.88859.02
6145930-14593057.30857.44
20min1173244-17324468.03567.561.3768.2867.791.37
2171856-17185667.49067.71
3171601-17160167.39067.64
4175645-17564568.97869.22
5168552-16855266.19266.42
6171252-17125267.25367.48
30min1196204-19620477.05277.002.2477.4177.352.23
2199254-19925478.24978.59
3201302-20130279.05479.41
4197934-19793477.73178.09
5190390-19039074.76875.11
6191338-19133875.14175.48
45min1209613-20961382.31883.062.6082.8083.542.59
2218670-21867085.87486.34
3217921-21792185.58086.07
4210158-21015882.53283.02
5206425-20642581.06681.53
6206281-20628181.00981.47
60min1208202-20820281.76386.253.3082.3886.873.28
2226264-22626488.85789.47
3225870-22587088.70289.34
4224471-22447188.15288.77
5217999-21799985.61186.21
6214995-21499584.43185.03
极限1239304-23930493.97894.051.6294.7494.801.61
2245727-24572796.50097.26
3238804-23880493.78194.56
4240513-24051394.45295.22
5233670-23367091.76592.50
6238867-23886793.80694.54
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%
116.674801832480324148100344806687481270048068990.10
216.694815398482097748181880.09
单位质量响应值RSD%判断
288356.27288687.120.09数据可信
长期24月-供试品溶液-2023112521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%
5min13583692-358369269.23968.343.4869.2468.343.48
23412401-341240165.92965.93
33720636-372063671.88471.88
43614668-361466869.83769.84
53474153-347415367.12267.12
63417841-341784166.03466.03
10min14262791-426279182.35981.872.1782.4781.992.17
24198415-419841581.11581.23
34374581-437458184.51984.64
44298470-429847083.04883.16
54129460-412946079.78379.90
64161701-416170180.40680.52
15min14536045-453604587.63987.501.8887.8987.741.88
24527385-452738587.47187.72
34646394-464639489.77190.03
44590661-459066188.69488.95
54412708-441270885.25685.50
64458488-445848886.14086.38
20min14684400-468440090.50590.421.9790.9090.811.97
24753615-475361591.84292.23
34775960-477596092.27492.68
44727122-472712291.33091.73
54548520-454852087.88088.27
64589449-458944988.67089.06
30min14837701-483770193.46793.362.0394.0293.902.03
24949907-494990795.63596.18
34900128-490012894.67395.24
44868279-486827994.05794.61
54685957-468595790.53591.07
64750093-475009391.77492.31
45min14929776-492977695.24695.051.9395.9595.751.93
25048954-504895497.54898.25
34970805-497080596.03896.76
44938805-493880595.42096.13
54776200-477620092.27892.96
64853550-485355093.77394.46
60min14947494-494749495.58895.561.8796.4596.421.87
25076694-507669498.08498.95
34993383-499338396.47597.36
44968871-496887196.00196.87
54811340-481134092.95793.80
64877255-487725594.23195.08
极限15120625-512062598.93399.761.0499.96100.781.03
25259344-5259344101.613102.64
35158080-515808099.657100.70
45145350-514535099.411100.44
55114020-511402098.80599.80
65183083-5183083100.140101.14
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%
115.202501572505162508352510192508502506750.14
215.182519312518122518720.04
单位质量响应值RSD%判断
16491.7816592.360.43数据可信
长期24月-供试品溶液-2023112521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%
5min179886-7988631.30628.1112.7031.3128.1112.70
279016-7901630.96530.97
366941-6694126.23326.23
463694-6369424.96124.96
580511-8051131.55131.55
660312-6031223.63523.64
10min1130106-13010650.98647.548.5251.0447.598.52
2129111-12911150.59750.65
3113736-11373644.57144.62
4104995-10499541.14641.19
5129712-12971250.83250.88
6120215-12021547.11047.15
15min1157300-15730061.64360.573.9361.7860.703.94
2162851-16285163.81963.95
3144878-14487856.77556.89
4151510-15151059.37459.48
5156726-15672661.41861.56
6154121-15412160.39860.52
20min1173063-17306367.82165.805.6368.0666.025.61
2171780-17178067.31867.56
3153921-15392160.31960.53
4168298-16829865.95366.16
5160227-16022762.79063.03
6180132-18013270.59170.81
30min1195817-19581776.73877.335.4677.0977.665.45
2200331-20033178.50778.86
3178395-17839569.91070.22
4207187-20718781.19381.51
5194585-19458576.25576.60
6207591-20759181.35281.69
45min1213431-21343183.64082.658.0284.1283.117.99
2209830-20983082.22982.71
3179136-17913670.20170.63
4227041-22704188.97489.43
5212844-21284483.41083.88
6223106-22310687.43287.90
60min1213548-21354883.68686.028.3184.3186.638.28
2228079-22807989.38190.00
3185951-18595172.87173.42
4236156-23615692.54693.15
5221749-22174986.90087.51
6231574-23157490.75091.37
极限1233616-23361691.55092.435.8392.3193.185.82
2245300-24530096.12996.90
3210040-21004082.31182.98
4243777-24377795.53296.29
5235677-23567792.35893.11
6246758-24675896.70197.47
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%
116.674796747480758648156354818997481681748111560.19
216.694822337482187948221080.01
单位质量响应值RSD%判断
288611.64288921.990.08数据可信
长期24月-供试品溶液-2023112521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%
5min13599641-359964169.48865.189.5069.4965.189.49
23609604-360960469.68069.68
33542386-354238668.38268.38
42927710-292771056.51756.52
53578220-357822069.07469.07
63002389-300238957.95857.96
10min14267816-426781682.38680.933.9182.5081.043.91
24319666-431966683.38783.50
34169716-416971680.49380.61
43878809-387880974.87774.97
54306150-430615083.12683.24
64212756-421275681.32381.42
15min14523153-452315387.31588.702.1387.5788.942.12
24632373-463237389.42489.68
34443903-444390385.78586.03
44662810-466281090.01190.23
54594191-459419188.68788.94
64712801-471280190.97691.21
20min14654027-465402789.84291.833.2790.2492.223.25
24756689-475668991.82392.23
34539014-453901487.62188.01
44938930-493893095.34195.71
54728749-472874991.28491.69
64925494-492549495.08295.47
30min14799260-479926092.64594.853.5993.1995.393.57
24886287-488628794.32594.88
34680081-468008190.34590.88
45126546-512654698.96399.49
54874152-487415294.09194.64
65114174-511417498.72499.27
45min14881036-488103694.22496.133.5494.9396.833.52
24957861-495786195.70796.42
34736555-473655591.43592.12
45197117-5197117100.326101.02
54935034-493503495.26695.98
65170506-517050699.812100.52
60min14918516-491851694.94796.553.3895.8197.413.36
24980142-498014296.13797.01
34759946-475994691.88692.73
45210627-5210627100.586101.45
54961406-496140695.77596.64
65178582-517858299.968100.84
极限15060120-506012097.68198.701.8398.7099.731.82
25156936-515693699.550100.58
34977729-497772996.09097.08
45212455-5212455100.622101.65
55067083-506708397.81598.84
65204725-5204725100.472101.51
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