氨氯地平厄贝沙坦片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
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%
112.566557865665654646544265586655470.15
212.556564765679656630.04
单位质量响应值RSD%判断
5218.715232.110.19数据可信
供试品溶液-2025020311批-氨氯地平-pH4.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min123616-2361629.30251.8029.0229.3051.8029.02
250302-5030262.41262.41
330600-3060037.96737.97
442921-4292153.25453.25
554253-5425367.31467.31
648824-4882460.57860.58
10min167105-6710583.26091.565.7683.5992.145.90
277771-7777196.49497.19
370362-7036287.30287.72
474549-7454992.49793.09
575303-7530393.43294.18
677677-7767796.37897.05
15min173872-7387291.65794.222.4292.9195.822.55
276782-7678295.26797.03
374066-7406691.89793.29
477721-7772196.43298.05
575125-7512593.21195.00
678069-7806996.86498.61
20min173227-7322790.85693.942.5693.1396.582.70
276716-7671695.18598.01
374060-7406091.89094.30
476488-7648894.90297.59
575265-7526593.38596.21
678534-7853497.441100.26
30min174914-7491492.94993.972.1696.2397.662.29
276889-7688995.40099.28
373280-7328090.92294.36
476102-7610294.42398.17
575275-7527593.39797.26
677966-7796696.736100.64
45min175419-7541993.57693.081.6397.8997.811.66
275261-7526193.38098.32
373714-7371491.46195.90
475067-7506793.13997.93
573704-7370491.44896.35
676960-7696095.488100.47
60min174198-7419892.06192.422.2997.4198.182.36
274759-7475992.75798.74
371902-7190289.21294.67
475555-7555593.74599.57
573632-7363291.35997.27
676896-7689695.409101.45
极限174473-7447392.40291.842.2298.7898.632.25
274543-7454392.48999.50
371603-7160388.84195.29
473843-7384391.62198.49
573116-7311690.71997.65
676529-7652994.953102.05
氨氯地平厄贝沙坦片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号100607-202305对照品来源中检所对照品使用方法105℃烘干2小时
对照品含量(%)100对照品水分(%)0对照品稀释倍数200
标示量(mg)100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%
19.011355213135537613546191355711135424713550330.05
29.051361786135958513606860.12
单位质量响应值RSD%判断
150392.12150352.040.02数据可信
供试品溶液-2025020311批-厄贝沙坦-pH4.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min114673-146730.8781.6634.490.881.6634.53
233469-334692.0032.00
317116-171161.0241.02
429149-291491.7451.74
537535-375352.2472.25
634118-341182.0422.04
10min157872-578723.4644.4313.993.474.4514.12
280589-805894.8234.85
365951-659513.9473.96
473389-733894.3924.41
583964-839645.0255.05
682251-822514.9234.95
15min190884-908845.4405.905.495.495.975.64
2100590-1005906.0206.10
392907-929075.5615.62
4100269-1002696.0016.07
5103715-1037156.2086.29
6103228-1032286.1786.26
20min1105162-1051626.2946.684.316.406.814.47
2113830-1138306.8136.96
3106107-1061076.3516.47
4112689-1126896.7456.88
5115913-1159136.9387.09
6115930-1159306.9397.08
30min1125356-1253567.5037.612.147.687.822.30
2128837-1288377.7117.93
3122427-1224277.3277.52
4127922-1279227.6567.87
5129166-1291667.7317.96
6129074-1290747.7257.95
45min1138795-1387958.3078.300.868.578.591.02
2138598-1385988.2958.60
3136406-1364068.1648.43
4139010-1390108.3208.61
5139930-1399308.3758.69
6139090-1390908.3258.63
60min1144898-1448988.6728.661.409.039.041.47
2145395-1453958.7029.10
3140774-1407748.4268.79
4146741-1467418.7839.17
5145245-1452458.6939.10
6144804-1448048.6679.07
极限1150656-1506569.0178.941.219.479.431.27
2150243-1502438.9929.49
3146270-1462708.7549.21
4149201-1492018.9309.41
5148934-1489348.9149.42
6151347-1513479.0589.56
氨氯地平厄贝沙坦片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
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%
112.566572665374656646536865470655200.26
212.556498164296646380.75
单位质量响应值RSD%判断
5216.565150.440.91数据可信
供试品溶液-2025020311批-氨氯地平-pH4.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min127680-2768034.62350.8324.2834.6250.8324.28
239509-3950949.41949.42
333616-3361642.04842.05
450364-5036462.99763.00
538952-3895248.72248.72
653695-5369567.16367.16
10min167873-6787384.89890.114.3185.2890.674.43
272945-7294591.24291.79
368902-6890286.18586.65
475897-7589794.93495.63
572284-7228490.41590.96
674319-7431992.96093.71
15min173212-7321291.57693.682.4092.9095.242.47
274279-7427992.91094.47
373085-7308591.41792.84
476374-7637495.53197.29
577618-7761897.08798.63
674784-7478493.54295.32
20min172486-7248690.66891.921.7893.0194.531.90
273970-7397092.52495.12
371696-7169689.67992.12
475470-7547094.40097.22
573876-7387692.40695.03
673421-7342191.83794.66
30min171844-7184489.86592.602.1193.2296.232.20
274380-7438093.03796.66
372573-7257390.77694.21
474557-7455793.25897.12
576140-7614095.23898.89
674687-7468793.42197.26
45min173108-7310891.44692.731.6695.8097.381.75
275423-7542394.34199.00
372361-7236190.51194.96
475272-7527294.15299.05
574725-7472593.46898.18
673898-7389892.43497.31
60min175072-7507293.90293.692.5099.2799.382.45
276906-7690696.196101.90
372204-7220490.31595.77
476816-7681696.084102.03
575065-7506593.89499.64
673356-7335691.75697.66
极限173536-7353691.98191.691.6298.3998.421.70
272915-7291591.20497.98
371132-7113288.97495.43
474515-7451593.206100.22
573696-7369692.18198.97
674014-7401492.57999.50
氨氯地平厄贝沙坦片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号100607-202305对照品来源中检所对照品使用方法105℃烘干2小时
对照品含量(%)100对照品水分(%)0对照品稀释倍数200
标示量(mg)100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%
19.011360931135567413603901358081135901213588180.16
29.051347412134129413443530.33
单位质量响应值RSD%判断
150812.21148547.291.07数据可信
供试品溶液-2025020311批-厄贝沙坦-pH4.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min117979-179791.0811.6327.181.081.6227.32
227019-270191.6251.62
320371-203711.2251.22
433566-335662.0182.02
526265-262651.5791.58
637059-370592.2282.23
10min161599-615993.7044.3311.183.724.3511.21
272660-726604.3694.39
365297-652973.9263.94
478944-789444.7474.77
570567-705674.2434.26
682958-829584.9885.01
15min191767-917675.5185.834.855.575.904.95
295790-957905.7605.83
391764-917645.5185.58
4100638-1006386.0526.13
598879-988795.9466.01
6103124-1031246.2016.28
20min1104589-1045896.2896.523.446.406.653.60
2108897-1088976.5486.68
3103814-1038146.2436.36
4112072-1120726.7396.88
5108026-1080266.4966.63
6112858-1128586.7866.94
30min1119994-1199947.2157.472.747.407.682.82
2124353-1243537.4787.68
3120877-1208777.2697.46
4124556-1245567.4907.71
5127421-1274217.6627.86
6128505-1285057.7277.95
45min1134419-1344198.0838.221.708.358.511.83
2137649-1376498.2778.56
3133316-1333168.0178.29
4138657-1386578.3388.64
5137323-1373238.2578.55
6138945-1389458.3558.67
60min1145925-1459258.7758.761.959.139.141.94
2147778-1477788.8869.26
3141175-1411758.4898.85
4149255-1492558.9759.37
5145883-1458838.7729.15
6144087-1440878.6649.07
极限1148377-1483778.9228.921.469.379.391.55
2146614-1466148.8169.29
3145121-1451218.7269.18
4150063-1500639.0249.52
5148874-1488748.9529.43
6150883-1508839.0739.57
氨氯地平厄贝沙坦片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
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%
112.566531764995649516496465156650770.25
212.556515764972650640.21
单位质量响应值RSD%判断
5181.295184.380.05数据可信
供试品溶液-2025020411批-氨氯地平-pH4.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min151224-5122464.07855.949.2464.0855.949.24
244569-4456955.75355.75
343991-4399155.03055.03
447381-4738159.27159.27
541283-4128351.64351.64
639875-3987549.88149.88
10min175451-7545194.38593.234.6095.1093.854.59
269458-6945886.88887.51
377071-7707196.41197.02
478388-7838898.05998.72
575419-7541994.34594.92
671383-7138389.29689.85
15min175852-7585294.88695.354.9096.6597.014.86
269828-6982887.35188.94
380182-80182100.303101.99
479032-7903298.864100.61
577790-7779097.31198.93
674650-7465093.38394.93
20min176120-7612095.22194.755.7798.0497.475.72
268528-6852885.72488.28
380320-80320100.475103.27
479106-7910698.957101.80
577465-7746596.90499.61
672917-7291791.21593.80
30min173628-7362892.10494.334.9595.9898.104.91
269431-6943186.85490.36
379745-7974599.756103.67
478622-7862298.351102.30
576389-7638995.55899.34
674639-7463993.36996.97
45min178124-7812497.72893.755.90102.6298.575.83
267786-6778684.79689.27
378700-7870098.449103.47
477195-7719596.566101.61
576679-7667995.921100.76
671189-7118989.05393.69
60min173484-7348491.92491.915.5397.9197.775.47
265984-6598482.54287.96
377132-7713296.487102.60
476931-7693196.236102.35
574340-7434092.99598.90
672961-7296191.27096.89
极限173209-7320991.58090.634.5798.5897.514.59
266648-6664883.37389.70
375525-7552594.477101.67
474766-7476693.528100.71
573935-7393592.48899.43
670624-7062488.34694.98
氨氯地平厄贝沙坦片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号100607-202305对照品来源中检所对照品使用方法105℃烘干2小时
对照品含量(%)100对照品水分(%)0对照品稀释倍数200
标示量(mg)100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%
19.011353145134701513507461350402134928813501190.17
29.051350552135180313511780.07
单位质量响应值RSD%判断
149846.73149301.440.26数据可信
供试品溶液-2025020411批-厄贝沙坦-pH4.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min136684-366842.2071.9412.302.211.9412.43
235828-358282.1562.16
330160-301601.8151.81
434417-344172.0712.07
526999-269991.6251.62
629190-291901.7561.76
10min181992-819924.9344.458.114.964.478.10
280102-801024.8204.84
370983-709834.2714.29
473625-736254.4304.45
569625-696254.1894.21
666964-669644.0294.05
15min1103089-1030896.2035.893.946.285.963.95
2102136-1021366.1466.22
396142-961425.7855.85
496735-967355.8215.89
595757-957575.7625.83
693424-934245.6215.69
20min1116241-1162416.9946.673.027.146.813.09
2112203-1122036.7516.90
3110605-1106056.6556.79
4110308-1103086.6376.77
5109944-1099446.6156.74
6105965-1059656.3766.50
30min1126204-1262047.5947.621.237.827.831.30
2129722-1297227.8068.03
3126522-1265227.6137.82
4126157-1261577.5917.80
5125481-1254817.5507.75
6125774-1257747.5687.77
45min1138399-1383998.3288.291.758.648.591.75
2139605-1396058.4008.71
3138659-1386598.3438.63
4136813-1368138.2328.53
5139828-1398288.4148.70
6133379-1333798.0268.31
60min1144850-1448508.7168.670.619.129.060.56
2142989-1429898.6049.00
3143687-1436878.6469.03
4143658-1436588.6449.03
5144270-1442708.6819.06
6145351-1453518.7469.12
极限1149997-1499979.0258.931.399.539.411.41
2150071-1500719.0309.53
3147977-1479778.9049.38
4145076-1450768.7299.21
5150080-1500809.0309.51
6147123-1471238.8539.32
氨氯地平厄贝沙坦片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
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%
112.566464564587645516454364514645680.08
212.556543565052652440.42
单位质量响应值RSD%判断
5140.765198.730.80数据可信
供试品溶液-2025020411批-氨氯地平-pH4.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min144144-4414455.36356.978.7055.3656.978.70
252580-5258065.94365.94
343780-4378054.90754.91
446472-4647258.28358.28
540854-4085451.23751.24
644728-4472856.09556.10
10min171511-7151189.68593.503.5790.3094.143.58
276792-7679296.30897.04
373931-7393192.72093.33
477165-7716596.77697.42
571410-7141089.55990.13
676525-7652595.97496.60
15min174902-7490293.93896.572.6695.5598.242.65
276259-7625995.64097.44
375681-7568194.91596.56
479624-7962499.860101.58
576021-7602195.34196.91
679511-7951199.718101.41
20min174231-7423193.09796.353.6295.7599.093.59
275990-7599095.30398.17
374007-7400792.81695.51
480613-80613101.100103.93
576322-7632295.71998.34
679775-79775100.049102.85
30min174609-7460993.57196.263.7297.26100.083.66
276522-7652295.97099.89
372761-7276191.25394.98
479096-7909699.198103.15
576982-7698296.547100.23
680560-80560101.034104.94
45min174151-7415192.99695.383.7997.73100.273.75
276329-7632995.728100.72
372968-7296891.51396.25
479641-7964199.881104.94
573912-7391292.69697.46
679319-7931999.478104.51
60min170836-7083688.83993.974.0994.6099.914.02
276386-7638695.799101.85
371853-7185390.11495.87
478847-7884798.886105.05
574952-7495294.00199.79
676676-7667696.163102.30
极限173477-7347792.15193.502.1298.90100.492.16
274917-7491793.957101.08
373368-7336892.01498.77
477546-7754697.254104.52
573732-7373292.47199.31
674275-7427593.152100.36
氨氯地平厄贝沙坦片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号100607-202305对照品来源中检所对照品使用方法105℃烘干2小时
对照品含量(%)100对照品水分(%)0对照品稀释倍数200
标示量(mg)100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%
19.011347223134316913449731339246134191813433060.23
29.051358657135118913549230.39
单位质量响应值RSD%判断
149090.57149715.250.30数据可信
供试品溶液-2025020411批-厄贝沙坦-pH4.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min132929-329291.9841.998.141.981.998.10
237716-377162.2722.27
332596-325961.9641.96
433223-332232.0012.00
529367-293671.7691.77
632345-323451.9481.95
10min172701-727014.3804.437.564.404.457.61
283351-833515.0215.05
375765-757654.5644.59
471578-715784.3124.33
567110-671104.0434.06
670838-708384.2674.29
15min197636-976365.8825.923.055.955.993.10
2103090-1030906.2106.29
3100207-1002076.0366.11
496345-963455.8045.87
594642-946425.7015.77
697486-974865.8735.94
20min1110602-1106026.6636.781.746.806.911.77
2115768-1157686.9747.12
3113461-1134616.8356.97
4112346-1123466.7686.90
5110533-1105336.6596.79
6112255-1122556.7626.90
30min1127352-1273527.6727.761.537.887.971.53
2131087-1310877.8978.12
3127616-1276167.6887.90
4126331-1263317.6107.82
5129587-1295877.8068.01
6130763-1307637.8778.09
45min1139871-1398718.4268.511.258.728.811.27
2143384-1433848.6378.95
3141120-1411208.5018.80
4141423-1414238.5198.81
5138953-1389538.3718.66
6143193-1431938.6268.92
60min1141931-1419318.5508.862.168.949.262.12
2151250-1512509.1119.52
3147590-1475908.8919.29
4147772-1477728.9029.29
5148872-1488728.9689.35
6145428-1454288.7619.15
极限1153764-1537649.2639.221.789.759.721.73
2154103-1541039.2839.80
3156721-1567219.4419.94
4151409-1514099.1219.61
5153710-1537109.2599.74
6148703-1487038.9589.45
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