阿齐沙坦氨氯地平片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号68522100802对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.70对照品水分(%)0对照品稀释倍数1000
标示量(mg)20供试品稀释倍数2系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.302868932871412869162870062871072870130.04
210.332865972865182865580.02
单位质量响应值RSD%判断
27865.3427740.370.32数据可信
供试品溶液-2024010621批-阿齐沙坦-pH5.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min19366-93663.0233.5946.053.023.5846.12
212593-125934.0644.06
35651-56511.8241.82
420358-203586.5706.57
510791-107913.4833.48
67909-79092.5532.55
10min145019-4501914.52923.6122.5814.5523.6322.58
280714-8071426.04926.07
365045-6504520.99321.00
493260-9326030.09930.14
575472-7547224.35824.38
679444-7944425.64025.65
15min1111159-11115935.87542.998.7435.9743.148.78
2139970-13997045.17445.34
3129057-12905741.65241.78
4140686-14068645.40545.61
5139239-13923944.93845.09
6139099-13909944.89345.05
20min1144284-14428446.56652.456.3646.8652.846.40
2169083-16908354.57054.99
3157453-15745350.81651.17
4163047-16304752.62253.08
5171191-17119155.25055.65
6170096-17009654.89655.30
30min1177019-17701957.13161.816.1157.6962.496.10
2194340-19434062.72163.44
3186611-18661160.22760.87
4185422-18542259.84360.59
5211413-21141368.23168.94
6194229-19422962.68563.40
45min1189587-18958761.18765.855.6562.0666.875.65
2208323-20832367.23468.30
3200611-20061164.74565.72
4195719-19571963.16664.25
5222591-22259171.83972.93
6207352-20735266.92067.98
60min1193354-19335462.40367.876.3263.6269.266.31
2214349-21434969.17970.62
3207690-20769067.03068.36
4200783-20078364.80066.23
5231970-23197074.86676.36
6213596-21359668.93670.37
极限1223995-22399572.29276.273.3373.8578.043.40
2238717-23871777.04378.87
3236505-23650576.32978.04
4232136-23213674.91976.71
5247578-24757879.90381.81
6238941-23894177.11578.93
阿齐沙坦氨氯地平片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)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4000
标示量(mg)5供试品稀释倍数2系数0.7211
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
114.937230172136723027215572023721830.17
214.987226272167722140.10
单位质量响应值RSD%判断
4834.764820.690.21数据可信
供试品溶液-2024010621批-氨氯地平-pH5.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1-0.00021.5184.690.0021.5184.69
229345-2934539.40939.41
315417-1541720.70420.70
421065-2106528.28928.29
5-0.0000.00
630276-3027640.65940.66
10min152476-5247670.47373.0410.8270.4773.1610.88
263389-6338985.12985.35
346313-4631362.19662.31
457663-5766377.43977.60
551049-5104968.55768.56
655433-5543374.44474.67
15min162433-6243383.84587.514.8084.2488.034.86
270488-7048894.66295.35
361778-6177882.96583.43
464819-6481987.04987.64
566358-6635889.11689.50
665083-6508387.40488.04
20min165597-6559788.09492.164.6088.9593.174.63
273377-7337798.54299.76
365755-6575588.30689.23
467284-6728490.35991.43
571408-7140895.89896.77
668322-6832291.75392.88
30min169276-6927693.03594.143.6094.3895.673.58
273006-7300698.04499.81
367786-6778691.03492.45
468940-6894092.58394.16
573535-7353598.754100.16
668074-6807491.42093.06
45min168430-6843091.89892.673.4693.7694.723.47
272498-7249897.36299.67
366562-6656289.39091.31
467783-6778391.03093.12
571392-7139295.87697.83
667367-6736790.47192.61
60min167743-6774390.97692.473.2593.3595.033.29
272369-7236997.188100.04
366440-6644089.22691.64
468263-6826391.67494.27
570735-7073594.99497.48
667584-6758490.76293.41
极限169328-6932893.10494.172.6895.9897.252.71
272946-7294697.963101.35
368712-6871292.27795.19
470649-7064994.87897.98
571296-7129695.74798.77
667818-6781891.07794.23
阿齐沙坦氨氯地平片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号68522100802对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.70对照品水分(%)0对照品稀释倍数1000
标示量(mg)20供试品稀释倍数2系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.302852542855182852502851222852082852700.06
210.332859392858232858810.03
单位质量响应值RSD%判断
27696.1227674.830.06数据可信
供试品溶液-2024010621批-阿齐沙坦-pH5.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min122009-220097.1335.0435.437.135.0435.39
25641-56411.8281.83
316165-161655.2395.24
417191-171915.5725.57
514148-141484.5854.59
618147-181475.8825.88
10min1100655-10065532.62328.5210.7932.6628.5510.81
271861-7186123.29123.30
390343-9034329.28129.31
484465-8446527.37627.41
589927-8992729.14629.17
690799-9079929.42829.46
15min1149414-14941448.42646.644.9248.6546.824.94
2133421-13342143.24243.38
3150758-15075848.86149.05
4137434-13743444.54344.73
5148482-14848248.12448.31
6143853-14385346.62346.82
20min1173039-17303956.08354.983.5156.5755.433.53
2164283-16428353.24553.62
3178396-17839657.81958.28
4161931-16193152.48352.91
5169921-16992155.07255.53
6170284-17028455.19055.65
30min1196784-19678463.77963.354.8264.5864.104.80
2192370-19237062.34863.02
3211784-21178468.64069.42
4182663-18266359.20259.92
5194277-19427762.96663.73
6194959-19495963.18763.95
45min1209541-20954167.91367.305.4869.0768.405.44
2207937-20793767.39368.42
3227904-22790473.86575.03
4193636-19363662.75863.81
5203176-20317665.85066.96
6203620-20362065.99467.11
60min1215123-21512369.72269.255.5171.2670.735.47
2214720-21472069.59270.99
3234009-23400975.84377.42
4198000-19800064.17365.57
5208904-20890467.70769.18
6211223-21122368.45869.94
极限1241162-24116278.16276.714.5180.0878.574.51
2232123-23212375.23277.02
3254315-25431582.42584.42
4222157-22215772.00273.76
5234842-23484276.11377.97
6235478-23547876.32078.18
阿齐沙坦氨氯地平片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)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4000
标示量(mg)5供试品稀释倍数2系数0.7211
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
114.937180571683717637178171711717490.08
214.987182171923718720.11
单位质量响应值RSD%判断
4805.694797.860.12数据可信
供试品溶液-2024010621批-氨氯地平-pH5.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min123114-2311431.20925.7348.1431.2125.7348.16
25173-51736.9856.98
319508-1950826.34026.34
416554-1655422.35122.35
533193-3319344.81844.82
616785-1678522.66322.66
10min160270-6027081.37776.996.8181.5577.136.88
251934-5193470.12270.16
358301-5830178.71978.86
453536-5353672.28572.41
561941-6194183.63383.88
656132-5613275.79075.92
15min166067-6606789.20488.783.0589.8389.353.11
264639-6463987.27687.70
367778-6777891.51592.10
463708-6370886.01986.55
568404-6840492.36093.07
663913-6391386.29686.84
20min168259-6825992.16491.542.2093.2992.602.19
269120-6912093.32794.24
369257-6925793.51294.60
465481-6548188.41389.42
568091-6809191.93793.16
666563-6656389.87490.90
30min168939-6893993.08292.922.1694.7294.502.16
269662-6966294.05895.49
370701-7070195.46197.07
466275-6627589.48590.98
569040-6904093.21994.96
668318-6831892.24493.77
45min168674-6867492.72492.011.9794.8794.101.93
269441-6944193.76095.71
369804-6980494.25096.39
466619-6661989.95091.94
567262-6726290.81893.07
667080-6708090.57292.61
60min167187-6718790.71791.481.5293.3894.081.49
269043-6904393.22395.70
368671-6867192.72095.39
466211-6621189.39991.89
567822-6782291.57494.33
667587-6758791.25793.80
极限170153-7015394.72192.861.4897.8995.961.52
268460-6846092.43595.43
369583-6958393.95297.13
467708-6770891.42094.41
569082-6908293.27596.54
667643-6764391.33294.38
阿齐沙坦氨氯地平片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号68522100802对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.70对照品水分(%)0对照品稀释倍数1000
标示量(mg)20供试品稀释倍数2系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.302856082855172855432855722856542855790.02
210.332843842845282844560.04
单位质量响应值RSD%判断
27726.1227536.880.49数据可信
供试品溶液-2024010721批-阿齐沙坦-pH5.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min14438-44381.4414.8048.931.444.8048.98
221357-213576.9366.94
314237-142374.6234.62
418881-188816.1316.13
58049-80492.6142.61
621797-217977.0787.08
10min157091-5709118.54026.0417.9918.5526.0618.02
295939-9593931.15531.19
376998-7699825.00425.03
485355-8535527.71827.75
572638-7263823.58923.60
693023-9302330.20830.25
15min1125147-12514740.64045.756.6240.7545.936.68
2152904-15290449.65449.87
3139344-13934445.25145.42
4143494-14349446.59946.79
5138424-13842444.95245.10
6146052-14605247.42947.64
20min1157483-15748351.14154.794.4951.4855.214.55
2178492-17849257.96458.45
3163959-16395953.24453.66
4169765-16976555.13055.58
5167510-16751054.39854.79
6175017-17501756.83557.31
30min1186623-18662360.60463.663.2661.2364.393.32
2204239-20423966.32567.13
3190618-19061861.90262.61
4197838-19783864.24665.00
5197129-19712964.01664.71
6199788-19978864.88065.67
45min1202920-20292065.89769.674.3366.8570.754.36
2228585-22858574.23175.41
3207994-20799467.54468.60
4210484-21048468.35369.46
5220465-22046571.59472.65
6216720-21672070.37871.52
60min1213441-21344169.31372.053.7870.6473.523.80
2233049-23304975.68177.27
3212633-21263369.05170.48
4218881-21888171.08072.57
5229428-22942874.50575.96
6223820-22382072.68474.22
极限1236697-23669776.86579.343.0978.5781.213.13
2256858-25685883.41385.42
3237076-23707676.98978.80
4242586-24258678.77880.66
5248026-24802680.54482.41
6244616-24461679.43781.38
阿齐沙坦氨氯地平片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)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4000
标示量(mg)5供试品稀释倍数2系数0.7211
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
114.937168771683717017162471639716670.05
214.987166271819717400.16
单位质量响应值RSD%判断
4800.204789.050.17数据可信
供试品溶液-2024010721批-氨氯地平-pH5.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min116759-1675922.66230.0420.2122.6630.0420.22
224428-2442833.03233.03
324185-2418532.70432.70
419865-1986526.86226.86
519031-1903125.73425.73
629038-2903839.26639.27
10min152678-5267871.23373.566.8271.3673.736.84
255477-5547775.01775.20
357411-5741177.63377.81
454784-5478474.08074.23
547940-4794064.82664.97
658105-5810578.57178.79
15min164652-6465287.42488.302.9087.9588.882.91
265578-6557888.67689.28
368652-6865292.83393.45
465497-6549788.56789.13
562976-6297685.15885.66
664465-6446587.17187.83
20min169394-6939493.83692.022.0894.8493.082.05
267664-6766491.49792.59
370073-7007394.75595.88
467501-6750191.27792.33
567404-6740491.14592.12
666253-6625389.58990.73
30min170905-7090595.88094.192.2997.4195.772.26
267976-6797691.91993.52
371997-7199797.35699.01
469988-6998894.64096.20
568816-6881693.05594.54
668244-6824492.28193.92
45min171190-7119096.26595.042.2398.3397.142.18
269890-6989094.50796.62
372302-7230297.76999.96
468634-6863492.80994.89
571269-7126996.37298.37
668421-6842192.52194.67
60min172351-7235197.83594.742.64100.4397.372.55
267757-6775791.62394.26
371388-7138896.53399.27
469450-6945093.91296.51
571138-7113896.19598.73
668291-6829192.34595.01
极限170002-7000294.65994.442.0697.8097.602.04
269824-6982494.41897.56
372378-7237897.871101.15
469369-6936993.80396.93
569536-6953694.02897.10
667954-6795491.88995.07
阿齐沙坦氨氯地平片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号68522100802对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.70对照品水分(%)0对照品稀释倍数1000
标示量(mg)20供试品稀释倍数2系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.302888762888282890492889302889932889350.04
210.332856482854722855600.05
单位质量响应值RSD%判断
28051.9427643.761.04数据可信
供试品溶液-2024010721批-阿齐沙坦-pH5.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min117884-178845.7633.9164.975.763.9064.98
24381-43811.4121.41
317701-177015.7045.70
421808-218087.0277.03
54120-41201.3281.33
66829-68292.2012.20
10min182342-8234226.53324.5816.8626.5724.6016.90
272200-7220023.26523.27
383946-8394627.05027.08
493235-9323530.04330.08
556974-5697418.35918.37
668905-6890522.20322.22
15min1144137-14413746.44644.265.9746.6344.426.03
2135201-13520143.56643.70
3143379-14337946.20146.38
4145211-14521146.79247.00
5125290-12529040.37340.48
6130909-13090942.18342.32
20min1171011-17101155.10553.283.9755.5453.684.02
2167034-16703453.82454.20
3169844-16984454.72955.17
4170048-17004854.79555.26
5157376-15737650.71251.05
6156761-15676150.51350.88
30min1198911-19891164.09662.772.5964.8463.482.64
2195019-19501962.84163.52
3200191-20019164.50865.25
4197110-19711063.51564.29
5190103-19010361.25761.87
6187519-18751960.42561.08
45min1215547-21554769.45667.933.7270.5668.983.75
2211984-21198468.30869.34
3219152-21915270.61871.72
4215896-21589669.56970.69
5201658-20165864.98165.94
6200631-20063164.65065.64
60min1225812-22581272.76471.374.7174.2572.794.72
2220374-22037471.01272.42
3238354-23835476.80578.30
4223041-22304171.87173.38
5211322-21132268.09569.41
6209935-20993567.64868.99
极限1247711-24771179.82178.463.0381.7180.283.06
2241144-24114477.70479.51
3243852-24385278.57780.50
4255512-25551282.33484.24
5235474-23547475.87777.57
6237243-23724376.44778.17
阿齐沙坦氨氯地平片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)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4000
标示量(mg)5供试品稀释倍数2系数0.7211
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
114.937275172643726767276172621726900.09
214.987184271687717640.16
单位质量响应值RSD%判断
4868.724790.651.15数据可信
供试品溶液-2024010721批-氨氯地平-pH5.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min113498-1349818.12132.6647.0118.1232.6647.02
240170-4017053.92853.93
328159-2815937.80337.80
434041-3404145.70045.70
516516-1651622.17322.17
613579-1357918.23018.23
10min149262-4926266.13476.118.8366.2376.308.91
263004-6300484.58384.88
360229-6022980.85781.07
458706-5870678.81379.07
553093-5309371.27771.40
655885-5588575.02575.13
15min162022-6202283.26488.403.6683.7389.003.72
267434-6743490.53091.30
368633-6863392.13992.80
465525-6552587.96788.66
564340-6434086.37686.90
667113-6711390.09990.62
20min165624-6562488.10091.542.1789.0392.642.21
268495-6849591.95493.23
369714-6971493.59194.76
467356-6735690.42591.61
569024-6902492.66493.66
668918-6891892.52293.54
30min168644-6864492.15494.492.4893.5796.092.42
269372-6937293.13294.91
371410-7141095.86897.56
468514-6851491.98093.66
572470-7247097.29198.80
671893-7189396.51698.05
45min168789-6878992.34994.091.6994.2896.221.67
269343-6934393.09395.39
371193-7119395.57697.80
468916-6891692.51994.71
571120-7112095.47897.53
671143-7114395.50997.58
60min169765-6976593.65994.554.4496.1097.204.32
268915-6891592.51895.34
375086-75086100.803103.56
465845-6584588.39791.10
572228-7222896.96699.55
670721-7072194.94397.54
极限169042-6904292.68994.041.9895.6597.211.93
268159-6815991.50394.84
370878-7087895.15398.47
472075-7207596.76099.96
569752-6975293.64296.77
670367-7036794.46797.59
阿齐沙坦氨氯地平片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号68522100802对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.70对照品水分(%)0对照品稀释倍数1000
标示量(mg)20供试品稀释倍数2系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.302865782868552867872868342869922868090.06
210.332887292887672887480.01
单位质量响应值RSD%判断
27845.5327952.370.28数据可信
供试品溶液-2024010921批-阿齐沙坦-pH5.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min110538-105383.3894.7045.083.394.7045.11
26811-68112.1912.19
318250-182505.8705.87
415144-151444.8714.87
525392-253928.1678.17
611518-115183.7043.70
10min178003-7800325.08825.2217.4225.1125.2417.42
273884-7388423.76323.78
361549-6154919.79619.83
479896-7989625.69725.72
5103013-10301333.13233.18
674045-7404523.81523.84
15min1141227-14122745.42244.555.9745.5844.726.02
2136828-13682844.00744.15
3128880-12888041.45141.59
4135897-13589743.70843.88
5153304-15330449.30749.54
6134949-13494943.40343.56
20min1175574-17557456.46953.364.2356.8853.774.25
2166153-16615353.43953.83
3160060-16006051.47951.85
4158183-15818350.87651.29
5172814-17281455.58256.08
6162642-16264252.31052.70
30min1192835-19283562.02160.712.5662.7561.422.60
2189192-18919260.84961.53
3186662-18666260.03560.69
4181784-18178458.46659.16
5195261-19526162.80163.61
6186798-18679860.07960.76
45min1211090-21109067.89265.643.8368.9666.693.80
2206505-20650566.41767.44
3202229-20222965.04266.03
4189278-18927860.87761.90
5207044-20704466.59167.75
6208442-20844267.04068.06
60min1215574-21557469.33467.313.2170.7868.723.19
2211351-21135167.97669.37
3207521-20752166.74468.10
4196694-19669463.26264.62
5211363-21136367.98069.51
6213204-21320468.57269.96
极限1242058-24205877.85275.663.1279.6877.443.11
2238320-23832076.65078.42
3232959-23295974.92676.65
4221506-22150671.24272.95
5237821-23782176.48978.40
6238770-23877076.79578.57
阿齐沙坦氨氯地平片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)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4000
标示量(mg)5供试品稀释倍数2系数0.7211
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
114.937227771936721267231971953721220.25
214.987257772525725510.06
单位质量响应值RSD%判断
4830.684843.190.19数据可信
供试品溶液-2024010921批-氨氯地平-pH5.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min121057-2105728.22522.0968.3428.2222.0968.34
29276-927612.43412.43
3-0.0000.00
412284-1228416.46516.47
527591-2759136.98336.98
628672-2867238.43238.43
10min151277-5127768.73271.947.3968.8972.077.45
249869-4986966.84466.91
352026-5202669.73669.74
452579-5257970.47770.57
560824-6082481.52881.73
655463-5546374.34374.56
15min162869-6286984.27087.322.8684.8187.842.92
264988-6498887.11087.55
363254-6325484.78685.17
465773-6577388.16288.65
567788-6778890.86391.52
666184-6618488.71389.34
20min168043-6804391.20590.951.4792.2191.951.49
268890-6889092.34093.26
366533-6653389.18190.04
467363-6736390.29391.27
567227-6722790.11191.27
669046-6904692.54993.67
30min166125-6612588.63490.981.7890.1592.491.81
267654-6765490.68392.12
367116-6711689.96291.32
468919-6891992.37993.85
567997-6799791.14392.81
669438-6943893.07594.71
45min166524-6652489.16991.572.6191.1793.592.59
269693-6969393.41695.36
367479-6747990.44992.30
468099-6809991.28093.27
566935-6693589.72091.89
671155-7115595.37697.53
60min166425-6642589.03691.422.2591.5493.942.22
269666-6966693.38095.84
367276-6727690.17792.53
469044-6904492.54795.04
566849-6684989.60492.27
669954-6995493.76696.45
极限167505-6750590.48493.342.5393.4896.382.50
271832-7183296.28499.26
367807-6780790.88893.75
470824-7082494.93297.94
569143-6914392.67995.85
670705-7070594.77397.97
阿齐沙坦氨氯地平片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号68522100802对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.70对照品水分(%)0对照品稀释倍数1000
标示量(mg)20供试品稀释倍数2系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.302879692881132878632876742880652879370.07
210.332870042870952870500.03
单位质量响应值RSD%判断
27955.0527788.000.43数据可信
供试品溶液-2024010921批-阿齐沙坦-pH5.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min12864-28640.9224.2055.700.924.2055.70
24686-46861.5091.51
318367-183675.9135.91
418453-184535.9415.94
515827-158275.0955.10
618015-180155.8005.80
10min150706-5070616.32525.3319.4416.3325.3519.47
272770-7277023.42823.44
387918-8791828.30528.34
489598-8959828.84628.88
580322-8032225.85925.89
690698-9069829.20029.23
15min1115366-11536637.14143.898.1837.2444.068.23
2134744-13474443.38043.52
3144554-14455446.53846.73
4142707-14270745.94446.14
5135960-13596043.77243.94
6144707-14470746.58846.78
20min1149828-14982848.23652.394.1048.5452.804.18
2161133-16113351.87652.26
3167230-16723053.83954.29
4166032-16603253.45353.90
5165792-16579253.37653.79
6166333-16633353.55054.00
30min1180772-18077258.19960.373.0458.7761.073.10
2186055-18605559.89960.57
3192447-19244761.95762.70
4194489-19448962.61563.36
5181486-18148658.42859.14
6189855-18985561.12361.87
45min1198538-19853863.91864.612.3164.8165.652.34
2198561-19856163.92664.93
3202745-20274565.27366.36
4199810-19981064.32865.42
5195616-19561662.97764.01
6208906-20890667.25668.35
60min1207399-20739966.77166.261.2668.0267.651.26
2203735-20373565.59166.95
3206161-20616166.37267.83
4206543-20654366.49567.95
5201924-20192465.00866.39
6209085-20908567.31468.78
极限1232700-23270074.91675.071.2976.5476.831.31
2233416-23341675.14776.87
3233519-23351975.18077.00
4235214-23521475.72677.55
5227748-22774873.32275.07
6236432-23643276.11877.96
阿齐沙坦氨氯地平片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)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4000
标示量(mg)5供试品稀释倍数2系数0.7211
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
114.937242572458727367298772320725850.38
214.987218572382722840.20
单位质量响应值RSD%判断
4861.694825.370.54数据可信
供试品溶液-2024010921批-氨氯地平-pH5.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min119656-1965626.31125.2636.8126.3125.2636.81
225514-2551434.15334.15
318794-1879425.15725.16
419069-1906925.52625.53
55932-59327.9417.94
624254-2425432.46632.47
10min143362-4336258.04472.5311.8258.1972.6711.83
259379-5937979.48479.67
355729-5572974.59874.74
456635-5663575.81175.95
549955-4995566.86966.91
660057-6005780.39280.57
15min157413-5741376.85385.035.9777.3285.586.02
266155-6615588.55489.19
364981-6498186.98387.54
464372-6437286.16886.73
560652-6065281.18881.60
667568-6756890.44691.07
20min164734-6473486.65288.952.2787.5589.962.35
267809-6780990.76991.89
366128-6612888.51889.56
465512-6551287.69488.74
565787-6578788.06288.93
668713-6871391.97993.11
30min168696-6869691.95691.262.8993.3392.772.93
268896-6889692.22493.85
367733-6773390.66792.20
469157-6915792.57394.10
564477-6447786.30887.66
670092-7009293.82595.46
45min169584-6958493.14590.883.8495.0392.893.83
268023-6802391.05593.19
366873-6687389.51691.55
466179-6617988.58790.63
564696-6469686.60188.44
671987-7198796.36198.52
60min169884-6988493.54690.593.0295.9593.113.03
268100-6810091.15893.80
366835-6683589.46591.99
466468-6646888.97391.51
564788-6478886.72589.04
669983-6998393.67996.38
极限169015-6901592.38392.991.4495.3196.011.55
269836-6983693.48296.63
369658-6965893.24496.27
469925-6992593.60196.63
567732-6773290.66593.46
670647-7064794.56797.78
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