厄贝沙坦左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100546-202105对照品来源中检院对照品使用方法左氨氯地平需分装,厄贝沙坦105℃烘干2小时
对照品含量(%)97.3对照品水分(%)0对照品稀释倍数8000
标示量(mg)2.5供试品稀释倍数2系数0.7210
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
114.053304432904329603288632848329280.24
214.153269932754327260.12
单位质量响应值RSD%判断
2343.632312.790.94数据可信
供试品溶液-2024042411批-左氨氯地平-水
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min113673-1367337.08132.9710.6437.0832.9710.64
210123-1012327.45327.45
312350-1235033.49333.49
411243-1124330.49130.49
513150-1315035.66335.66
612406-1240633.64533.64
10min124186-2418665.59264.443.4065.8064.633.41
222228-2222860.28260.43
323752-2375264.41564.60
424550-2455066.57966.75
523797-2379764.53764.74
624065-2406565.26465.45
15min126335-2633571.42070.212.7571.9970.742.74
225222-2522268.40268.89
326434-2643471.68972.23
426399-2639971.59472.13
526161-2616170.94871.50
624773-2477367.18467.73
20min127932-2793275.75175.451.4476.7276.381.45
227096-2709673.48474.35
328086-2808676.16977.11
428061-2806176.10177.04
527622-2762274.91075.86
628123-2812376.26977.19
30min130531-3053182.80083.411.1684.1984.761.17
230217-3021781.94883.22
330730-3073083.33984.70
431228-3122884.69086.05
530987-3098784.03685.40
630850-3085083.66585.01
45min132946-3294689.34988.741.6091.2090.561.61
231891-3189186.48888.22
332403-3240387.87689.70
433370-3337090.49992.33
533036-3303689.59391.43
632684-3268488.63990.45
60min132982-3298289.44789.271.2591.7991.581.27
232138-3213887.15889.37
332994-3299489.47991.80
433331-3333190.39392.73
533135-3313589.86292.19
632920-3292089.27991.58
极限133219-3321990.08989.281.3092.9392.081.29
232640-3264088.51991.21
333170-3317089.95792.77
433472-3347290.77693.61
532368-3236887.78290.61
632656-3265688.56391.36
厄贝沙坦左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100607-201804对照品来源中检院对照品使用方法105℃烘干2小时
对照品含量(%)100.0对照品水分(%)0对照品稀释倍数200
标示量(mg)150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%
115.222100337209911520991582099883209943320995850.03
215.252093229209437820938040.04
单位质量响应值RSD%判断
137949.08137298.620.34数据可信
供试品溶液-2024042411批-厄贝沙坦-水
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min184554-845543.6863.1112.123.693.1112.18
264795-647952.8252.82
371472-714723.1163.12
460776-607762.6502.65
577479-774793.3783.38
668733-687332.9973.00
10min1148447-1484476.4726.232.816.496.242.81
2142016-1420166.1926.21
3139112-1391126.0656.08
4137656-1376566.0016.02
5144598-1445986.3046.32
6144936-1449366.3196.34
15min1181265-1812657.9037.652.387.967.712.38
2177002-1770027.7177.77
3171005-1710057.4557.51
4170454-1704547.4317.48
5177780-1777807.7517.80
6175863-1758637.6677.72
20min1200877-2008778.7588.512.258.868.602.29
2196304-1963048.5588.65
3190429-1904298.3028.39
4189492-1894928.2618.35
5196783-1967838.5798.68
6197343-1973438.6048.70
30min1224834-2248349.8029.622.189.959.762.20
2223878-2238789.7609.90
3215016-2150169.3749.51
4214181-2141819.3389.47
5224062-2240629.7699.91
6222155-2221559.6859.83
45min1243601-24360110.62010.482.3410.8210.682.33
2243670-24367010.62310.82
3232569-23256910.13910.33
4233921-23392110.19810.39
5245421-24542110.70010.90
6243168-24316810.60110.80
60min1251743-25174310.97510.832.7611.2411.082.73
2253887-25388711.06911.32
3241048-24104810.50910.76
4239312-23931210.43310.68
5255877-25587711.15611.41
6248154-24815410.81911.07
极限1257285-25728511.21711.053.2511.5411.363.23
2260016-26001611.33611.65
3244069-24406910.64110.95
4244563-24456310.66210.96
5263686-26368611.49611.82
6250589-25058910.92511.24
厄贝沙坦左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100546-202105对照品来源中检院对照品使用方法左氨氯地平需分装,厄贝沙坦105℃烘干2小时
对照品含量(%)97.3对照品水分(%)0对照品稀释倍数8000
标示量(mg)2.5供试品稀释倍数2系数0.7210
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
114.053296232908329133289632869329100.11
214.153288932882328860.02
单位质量响应值RSD%判断
2342.352324.100.56数据可信
供试品溶液-2024042411批-左氨氯地平-pH2.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min124548-2454866.42971.487.2266.4371.487.22
224813-2481367.14667.15
326924-2692472.85972.86
429132-2913278.83478.83
525050-2505067.78767.79
628030-2803075.85175.85
10min137557-37557101.63298.502.21102.0098.902.20
235080-3508094.92995.30
336541-3654198.88399.29
436618-3661899.09199.53
536450-3645098.63799.01
636148-3614897.81998.24
15min136847-3684799.71198.441.79100.6499.381.79
235341-3534195.63696.54
336552-3655298.91399.87
437166-37166100.574101.56
536356-3635698.38299.31
635991-3599197.39598.36
20min136660-3666099.20597.951.40100.6999.441.41
235576-3557696.27297.70
336454-3645498.647100.15
436795-3679599.570101.12
535856-3585697.02998.50
635829-3582996.95698.46
30min136345-3634598.35397.271.36100.3999.301.37
235286-3528695.48797.45
336034-3603497.51199.56
436609-3660999.067101.17
535785-3578596.83798.85
635612-3561296.36998.41
45min136237-3623798.06096.701.32100.6599.281.32
235204-3520495.26597.76
335995-3599597.405100.00
436200-3620097.960100.61
535517-3551796.11298.66
635252-3525295.39597.97
60min136197-3619797.95296.281.29101.0899.401.29
235063-3506394.88397.91
335765-3576596.78399.92
435907-3590797.167100.36
535462-3546295.96399.05
635083-3508394.93798.05
极限135670-3567096.52695.781.16100.2099.421.17
234912-3491294.47598.03
335642-3564296.450100.12
435866-3586697.056100.79
535362-3536295.69299.31
634906-3490694.45898.10
厄贝沙坦左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100607-201804对照品来源中检院对照品使用方法105℃烘干2小时
对照品含量(%)100.0对照品水分(%)0对照品稀释倍数200
标示量(mg)150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%
115.222096696209593820948922094634209418320952690.05
215.252092290209284420925670.02
单位质量响应值RSD%判断
137665.51137217.510.24数据可信
供试品溶液-2024042411批-厄贝沙坦-pH2.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1178989-1789897.8148.8211.967.818.8211.99
2171884-1718847.5047.50
3224017-2240179.7799.78
4228832-2288329.9909.99
5192580-1925808.4078.41
6215759-2157599.4199.42
10min1519662-51966222.68622.912.7022.7322.962.71
2500959-50095921.86921.91
3538300-53830023.50023.55
4538969-53896923.52923.58
5522189-52218922.79622.84
6528659-52865923.07923.13
15min1724751-72475131.63931.632.0731.8131.812.08
2698346-69834630.48630.65
3737178-73717832.18232.37
4740047-74004732.30732.49
5727489-72748931.75931.93
6719584-71958431.41331.59
20min1871837-87183738.06037.571.5238.4137.921.53
2838815-83881536.61936.95
3872004-87200438.06738.43
4868452-86845237.91238.28
5858777-85877737.49037.84
6853417-85341737.25637.61
30min11067802-106780246.61545.701.6847.1746.261.68
21018370-101837044.45744.99
31055553-105555346.08046.66
41052591-105259145.95146.53
51052262-105226245.93746.49
61034761-103476145.17345.73
45min11269514-126951455.42153.661.8956.2454.481.88
21202319-120231952.48753.27
31233508-123350853.84954.68
41219740-121974053.24854.08
51235248-123524853.92554.74
61215231-121523153.05153.86
60min11401041-140104161.16358.842.1962.2959.962.17
21320922-132092257.66558.74
31346707-134670758.79159.92
41328925-132892558.01459.14
51359155-135915559.33460.45
61330817-133081758.09759.20
极限11486825-148682564.90762.662.0466.3764.102.02
21405594-140559461.36162.76
31433847-143384762.59564.05
41417292-141729261.87263.32
51448192-144819263.22164.66
61419710-141971061.97863.41
厄贝沙坦左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100546-202105对照品来源中检院对照品使用方法左氨氯地平需分装,厄贝沙坦105℃烘干2小时
对照品含量(%)97.3对照品水分(%)0对照品稀释倍数8000
标示量(mg)2.5供试品稀释倍数2系数0.7210
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
114.053304933044330023298533048330260.10
214.153296632984329750.04
单位质量响应值RSD%判断
2350.602330.390.62数据可信
供试品溶液-2024042411批-左氨氯地平-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%
5min127325-2732573.71475.498.5573.7175.498.55
231272-3127284.36284.36
325822-2582269.66069.66
425177-2517767.92067.92
528148-2814875.93475.93
630165-3016581.37681.38
10min133991-3399191.69794.492.4292.1194.912.42
236042-3604297.23097.70
335688-3568896.27596.66
434795-3479593.86694.24
534152-3415292.13192.55
635492-3549295.74696.20
15min135008-3500894.44094.590.7395.3695.540.72
235080-3508094.63595.64
335515-3551595.80896.73
435094-3509494.67295.57
534738-3473893.71294.65
634953-3495394.29295.28
20min135237-3523795.05895.331.3196.5096.801.32
235369-3536995.41496.95
335502-3550295.77397.23
434972-3497294.34395.77
534824-3482493.94495.40
636132-3613297.47398.98
30min134161-3416192.15595.532.7094.1397.532.66
235503-3550395.77697.84
335579-3557995.98197.97
436182-3618297.60899.56
534443-3444392.91694.89
636602-3660298.741100.79
45min135457-3545795.65295.690.9598.1498.220.95
235205-3520594.97297.57
335433-3543395.58798.11
435655-3565596.18698.68
535059-3505994.57897.07
636009-3600997.14199.74
60min135146-3514694.81395.431.9397.8398.491.87
234879-3487994.09297.22
336595-3659598.722101.77
435044-3504494.53897.56
534846-3484694.00397.02
635738-3573896.41099.55
极限134851-3485194.01794.111.1197.5697.701.10
234505-3450593.08396.73
335270-3527095.14798.75
434830-3483093.96097.51
534463-3446392.97096.51
635401-3540195.50199.17
厄贝沙坦左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100607-201804对照品来源中检院对照品使用方法105℃烘干2小时
对照品含量(%)100.0对照品水分(%)0对照品稀释倍数200
标示量(mg)150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%
115.222101431210289221009912101487210274721019100.05
215.252103219210268021029500.02
单位质量响应值RSD%判断
138101.84137898.360.11数据可信
供试品溶液-2024042411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%
5min123875-238751.0381.068.691.041.068.58
227114-271141.1791.18
322334-223340.9710.97
422723-227230.9880.99
523367-233671.0161.02
626978-269781.1731.17
10min157159-571592.4852.573.192.492.583.17
262216-622162.7052.71
360012-600122.6092.61
457685-576852.5082.51
558220-582202.5312.54
659955-599552.6072.61
15min178577-785773.4163.470.923.443.500.92
280440-804403.4973.52
379649-796493.4633.48
479789-797893.4693.49
580485-804853.4993.52
680396-803963.4953.52
20min194718-947184.1184.161.354.164.201.30
295968-959684.1734.21
396219-962194.1834.22
494342-943424.1024.14
594921-949214.1274.17
697826-978264.2534.29
30min1108327-1083274.7104.902.354.774.962.32
2113386-1133864.9304.99
3113802-1138024.9485.01
4114270-1142704.9685.03
5111016-1110164.8274.89
6115683-1156835.0305.09
45min1128263-1282635.5775.620.995.665.711.00
2128197-1281975.5745.67
3129263-1292635.6205.71
4129742-1297425.6415.73
5128351-1283515.5805.67
6131463-1314635.7165.81
60min1136716-1367165.9446.021.786.066.141.77
2136221-1362215.9236.05
3142239-1422396.1846.31
4137463-1374635.9776.10
5137111-1371115.9616.08
6140722-1407226.1186.24
极限1141326-1413266.1456.201.346.306.351.31
2140564-1405646.1116.27
3144123-1441236.2666.42
4142482-1424826.1956.35
5141255-1412556.1426.29
6145474-1454746.3256.48
厄贝沙坦左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100546-202105对照品来源中检院对照品使用方法左氨氯地平需分装,厄贝沙坦105℃烘干2小时
对照品含量(%)97.3对照品水分(%)0对照品稀释倍数8000
标示量(mg)2.5供试品稀释倍数2系数0.7210
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
114.053296132935329593294232972329540.05
214.153291932954329360.08
单位质量响应值RSD%判断
2345.482327.630.55数据可信
供试品溶液-2024042411批-左氨氯地平-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%
5min127426-2742674.11178.197.5774.1178.197.57
232185-3218586.97186.97
326720-2672072.20372.20
427112-2711273.26373.26
529757-2975780.41080.41
630420-3042082.20282.20
10min135232-3523295.20595.344.1295.6295.774.12
236412-3641298.39398.88
332582-3258288.04488.44
436393-3639398.34298.75
534986-3498694.54094.99
636083-3608397.50497.96
15min135746-3574696.59495.213.7897.5396.173.78
235802-3580296.74597.77
332622-3262288.15289.04
435435-3543595.75396.71
535384-3538495.61596.59
636407-3640798.38099.38
20min136103-3610397.55895.283.9699.0496.773.96
236638-3663899.004100.57
332895-3289588.89090.27
435363-3536395.55997.04
534414-3441492.99494.50
636148-3614897.68099.22
30min135735-3573596.56495.033.3598.5897.053.36
235908-3590897.03199.15
332811-3281188.66390.54
435514-3551495.96797.98
535266-3526695.29697.32
635760-3576096.63198.72
45min135231-3523195.20294.673.4497.7697.223.45
235784-3578496.69699.35
332687-3268788.32790.69
435342-3534295.50298.05
535133-3513394.93797.49
636039-3603997.385100.01
60min135279-3527995.33294.303.4198.4297.383.42
235625-3562596.26799.46
332557-3255787.97690.83
434879-3487994.25197.33
535268-3526895.30298.38
635777-3577796.67799.84
极限135124-3512494.91394.374.4998.5397.964.46
235618-3561896.24899.98
332269-3226987.19890.54
434568-3456893.41097.01
534885-3488594.26797.87
637066-37066100.160103.86
厄贝沙坦左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100607-201804对照品来源中检院对照品使用方法105℃烘干2小时
对照品含量(%)100.0对照品水分(%)0对照品稀释倍数200
标示量(mg)150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%
115.222100428209970820999022099347209967220998110.02
215.252099079209860720988430.02
单位质量响应值RSD%判断
137963.93137629.050.18数据可信
供试品溶液-2024042411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%
5min122389-223890.9751.085.970.971.086.06
226023-260231.1331.13
323903-239031.0411.04
426216-262161.1421.14
525040-250401.0901.09
625756-257561.1211.12
10min156971-569712.4812.613.752.492.623.73
260664-606642.6412.65
358576-585762.5512.56
463662-636622.7722.78
559530-595302.5922.60
660310-603102.6262.63
15min178664-786643.4253.522.483.443.542.47
280234-802343.4943.51
379120-791203.4453.47
484099-840993.6623.68
580499-804993.5053.53
681886-818863.5663.59
20min193631-936314.0774.122.304.124.162.32
295328-953284.1514.19
393533-935334.0734.11
498473-984734.2884.33
592159-921594.0134.05
695003-950034.1374.18
30min1111319-1113194.8474.912.144.914.982.15
2111345-1113454.8484.91
3111976-1119764.8764.94
4117661-1176615.1235.19
5112587-1125874.9024.96
6112152-1121524.8834.95
45min1125899-1258995.4825.581.955.575.671.96
2126409-1264095.5045.59
3127438-1274385.5495.64
4132867-1328675.7855.88
5127822-1278225.5665.66
6128255-1282555.5855.68
60min1135438-1354385.8975.971.536.026.091.54
2135159-1351595.8856.01
3136605-1366055.9486.07
4140769-1407696.1296.26
5138164-1381646.0166.14
6136431-1364315.9416.06
极限1141548-1415486.1636.261.536.316.411.56
2141905-1419056.1796.33
3142806-1428066.2186.37
4146064-1460646.3606.52
5143339-1433396.2416.40
6146819-1468196.3936.55
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