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%
113.843174931747316833170731714317200.09
213.953145431474314640.05
单位质量响应值RSD%判断
2291.912255.481.14数据可信
供试品溶液-24032501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%
5min117102-1710247.49345.979.4147.4945.979.42
216285-1628545.22545.22
313796-1379638.31238.31
417908-1790849.73249.73
518036-1803650.08750.09
616204-1620445.00045.00
10min123692-2369265.79468.923.1766.0669.183.16
225415-2541570.57970.83
324745-2474568.71868.93
425638-2563871.19871.47
525325-2532570.32970.61
624094-2409466.91167.16
15min124895-2489569.13572.713.4369.7673.343.41
227103-2710375.26775.91
327044-2704475.10375.70
426516-2651673.63774.31
526164-2616472.65973.33
625366-2536670.44371.06
20min127224-2722475.60378.684.2876.6279.724.24
229677-2967782.41583.48
329690-2969082.45183.46
428619-2861979.47780.56
527933-2793377.57278.64
626844-2684474.54875.56
30min129329-2932981.44987.824.3482.8889.304.32
232620-3262090.58892.11
332147-3214789.27490.74
432799-3279991.08592.61
532266-3226689.60591.11
630579-3057984.92086.35
45min130921-3092185.87092.683.9587.7694.653.91
233278-3327892.41594.44
334201-3420194.97896.94
434580-3458096.03198.06
534060-3406094.58796.59
633197-3319792.19094.09
60min131165-3116586.54793.594.0788.9196.084.04
234278-3427895.19297.73
333853-3385394.01296.51
435069-3506997.38999.95
534476-3447695.74298.27
633372-3337292.67695.09
极限131240-3124086.75693.713.7289.6096.713.69
233984-3398494.37697.44
334207-3420794.99598.01
434446-3444695.65998.76
534624-3462496.15399.21
633954-3395494.29297.22
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100607-202305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%
114.982027165202713720271512026847202663820269880.02
215.102002673200226620024700.02
单位质量响应值RSD%判断
135312.95132613.911.43数据可信
供试品溶液-24032501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%
5min1142817-1428176.3976.1812.426.406.1812.43
2134578-1345786.0286.03
3106536-1065364.7724.77
4154926-1549266.9406.94
5150531-1505316.7436.74
6138915-1389156.2226.22
10min1159255-1592557.1337.4012.527.177.4412.49
2144757-1447576.4846.52
3138836-1388366.2196.25
4187903-1879038.4178.46
5182472-1824728.1738.21
6178588-1785887.9998.03
15min1176005-1760057.8848.3412.537.968.4212.54
2162182-1621827.2657.33
3158697-1586977.1087.17
4209447-2094479.3829.47
5206796-2067969.2639.35
6204049-2040499.1409.22
20min1196170-1961708.7879.1511.078.919.2711.08
2180425-1804258.0828.19
3176944-1769447.9268.03
4224583-22458310.06010.20
5225802-22580210.11410.25
6221481-2214819.92110.05
30min1217083-2170839.72410.2811.699.8910.4511.68
2202725-2027259.0819.24
3197578-1975788.8508.99
4254474-25447411.39911.59
5256581-25658111.49311.68
6248182-24818211.11711.30
45min1231659-23165910.37710.9610.8410.6011.1910.86
2214060-2140609.5889.79
3217601-2176019.7479.94
4269464-26946412.07012.33
5268410-26841012.02312.28
6266951-26695111.95812.20
60min1241229-24122910.80511.3610.3211.0811.6610.37
2226960-22696010.16610.42
3223280-22328010.00110.25
4278720-27872012.48512.81
5277222-27722212.41812.74
6274898-27489812.31312.63
极限1241698-24169810.82611.4210.3711.1711.7810.40
2226570-22657010.14910.46
3226420-22642010.14210.45
4275476-27547612.33912.73
5284307-28430712.73513.13
6275361-27536112.33412.72
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%
113.843195031947319193188731940319290.09
213.953198631929319580.13
单位质量响应值RSD%判断
2307.012290.900.50数据可信
供试品溶液-24032501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%
5min118609-1860951.10847.667.2251.1147.667.22
215726-1572643.19043.19
318453-1845350.68050.68
418228-1822850.06250.06
516126-1612644.28944.29
616977-1697746.62646.63
10min123774-2377465.29367.483.4665.5867.743.46
223578-2357864.75564.99
325630-2563070.39170.67
425060-2506068.82569.10
524143-2414366.30766.55
625239-2523969.31769.58
15min122696-2269662.33370.886.4562.9871.526.39
225898-2589871.12771.73
327398-2739875.24675.92
425738-2573870.68771.35
527051-2705174.29374.91
626068-2606871.59472.24
20min128188-2818877.41677.241.6978.4178.271.68
227411-2741175.28276.28
328223-2822377.51278.60
428410-2841078.02679.08
528745-2874578.94679.97
627768-2776876.26277.30
30min130502-3050283.77186.051.7785.1987.511.77
231335-3133586.05987.47
331745-3174587.18588.71
431254-3125485.83687.32
532099-3209988.15789.62
631056-3105685.29386.76
45min133160-3316091.07192.501.6692.9694.441.65
233449-3344991.86593.76
334008-3400893.40095.41
433275-3327591.38793.35
534648-3464895.15897.11
633544-3354492.12694.07
60min134006-3400693.39593.530.7195.7995.980.67
234279-3427994.14496.55
333847-3384792.95895.48
433738-3373892.65995.13
534350-3435094.33996.82
634106-3410693.66996.12
极限134000-3400093.37894.921.5296.2997.901.51
234122-3412293.71396.64
334418-3441894.52697.57
434643-3464395.14498.13
535460-3546097.388100.40
634726-3472695.37298.34
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100607-202305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%
114.982039283203886520385662037953203962220388580.04
215.102036007203474020353740.05
单位质量响应值RSD%判断
136105.34134792.980.69数据可信
供试品溶液-24032501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%
5min1143998-1439986.3796.3712.396.386.3712.40
2119820-1198205.3085.31
3140092-1400926.2066.21
4173950-1739507.7067.71
5135928-1359286.0216.02
6148811-1488116.5926.59
10min1176572-1765727.8228.058.917.868.088.91
2165708-1657087.3417.37
3175577-1755777.7787.81
4212207-2122079.4009.44
5174938-1749387.7497.78
6185500-1855008.2178.25
15min1203824-2038249.0299.156.859.119.236.88
2195248-1952488.6498.72
3201743-2017438.9379.01
4234428-23442810.38510.48
5198649-1986498.8008.88
6205227-2052279.0919.17
20min1224664-2246649.95210.048.1010.0810.178.12
2211802-2118029.3829.50
3214158-2141589.4879.61
4260814-26081411.55411.71
5216292-2162929.5819.71
6231628-23162810.26110.39
30min1244841-24484110.84611.209.5911.0311.389.60
2238020-23802010.54410.71
3239603-23960310.61410.79
4301586-30158613.36013.58
5243176-24317610.77210.95
6249761-24976111.06411.25
45min1268797-26879711.90712.017.5912.1512.267.61
2255604-25560411.32311.55
3259401-25940111.49111.73
4311590-31159013.80314.09
5261408-26140811.58011.82
6269939-26993911.95812.21
60min1281417-28141712.46612.458.9312.7812.778.92
2267485-26748511.84912.14
3263581-26358111.67611.98
4330429-33042914.63715.01
5266887-26688711.82312.13
6276923-27692312.26712.58
极限1283650-28365012.56512.9715.0312.9513.3514.83
2268648-26864811.90112.26
3266290-26629011.79612.16
4381410-38141016.89617.34
5274192-27419212.14612.51
6282528-28252812.51512.90
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%
113.843194631960319533199431976319660.07
213.953219832218322080.05
单位质量响应值RSD%判断
2309.682308.820.03数据可信
供试品溶液-24032502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%
5min118968-1896851.86148.609.8751.8648.609.88
215358-1535841.99141.99
318014-1801449.25349.25
415977-1597743.68343.68
519856-1985654.28954.29
618482-1848250.53250.53
10min126004-2600471.09867.973.8271.3968.243.84
223834-2383465.16565.40
325351-2535169.31369.59
424178-2417866.10666.35
525746-2574670.39370.69
624052-2405265.76166.04
15min129157-2915779.71974.384.3380.4075.034.33
226250-2625071.77172.37
327794-2779475.99376.65
426502-2650272.46073.07
527465-2746575.09375.79
626066-2606671.26871.91
20min131419-3141985.90480.694.6987.0381.754.69
227817-2781776.05577.05
330411-3041183.14884.23
429041-2904179.40280.41
530152-3015282.44083.55
628240-2824077.21278.25
30min132941-3294190.06586.324.3691.6787.834.36
229066-2906679.47080.89
332314-3231488.35189.89
431286-3128685.54086.99
532382-3238288.53790.10
631447-3144785.98087.45
45min133983-3398392.91487.735.9695.0289.725.92
229458-2945880.54282.40
332898-3289889.94891.98
432616-3261689.17791.11
533601-3360191.87093.93
629963-2996381.92383.87
60min134263-3426393.68089.775.1796.3092.255.15
229530-2953080.73983.04
333388-3338891.28793.82
432820-3282089.73492.16
533853-3385392.55995.13
633145-3314590.62393.03
极限134389-3438994.02492.696.3597.1695.666.24
229965-2996581.92884.68
334099-3409993.23196.27
436524-3652499.861102.78
534587-3458794.56597.65
633847-3384792.54295.45
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100607-202305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%
114.982018043201896320182462018515201902420185580.03
215.102038805203448820366460.15
单位质量响应值RSD%判断
134750.20134877.220.07数据可信
供试品溶液-24032502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%
5min1132379-1323795.8925.119.635.895.119.61
2115001-1150015.1185.12
3112689-1126895.0155.02
4101860-1018604.5334.53
5121393-1213935.4035.40
6105562-1055624.6984.70
10min1207974-2079749.2568.209.739.298.239.71
2203839-2038399.0729.10
3179432-1794327.9868.01
4173299-1732997.7137.74
5179447-1794477.9868.02
6162049-1620497.2127.24
15min1241018-24101810.7279.579.8210.819.649.80
2240121-24012110.68710.77
3209115-2091159.3079.38
4204938-2049389.1219.19
5205593-2055939.1509.22
6188723-1887238.3998.47
20min1260354-26035411.58710.379.9111.7310.509.89
2262385-26238511.67811.82
3225407-22540710.03210.16
4221043-2210439.8389.96
5223399-2233999.94310.07
6205461-2054619.1449.26
30min1277999-27799912.37311.318.7012.5811.498.70
2284630-28463012.66812.87
3249092-24909211.08611.27
4240158-24015810.68810.86
5242405-24240510.78810.97
6230028-23002810.23810.40
45min1301173-30117313.40412.039.6113.6812.289.59
2304922-30492213.57113.84
3258764-25876411.51711.76
4253029-25302911.26111.49
5259011-25901111.52811.77
6244676-24467610.89011.11
60min1310013-31001313.79712.469.1214.1512.779.13
2314322-31432213.98914.34
3268210-26821011.93712.24
4264977-26497711.79312.09
5266906-26690611.87912.18
6254697-25469711.33611.62
极限1316545-31654514.08813.018.6414.5213.398.63
2325142-32514214.47114.90
3276104-27610412.28812.66
4298305-29830513.27613.64
5276175-27617512.29112.66
6261355-26135511.63211.98
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%
113.843168731621316443168531699316670.11
213.953166331743317030.18
单位质量响应值RSD%判断
2288.082272.620.48数据可信
供试品溶液-24032502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%
5min120466-2046656.66752.997.0256.6752.997.02
220414-2041456.52356.52
317244-1724447.74647.75
417923-1792349.62649.63
518928-1892852.40852.41
619857-1985754.98054.98
10min126957-2695774.63970.564.4774.9570.854.47
226643-2664373.77074.08
325250-2525069.91370.18
424414-2441467.59867.87
524154-2415466.87867.17
625476-2547670.53870.84
15min130255-3025583.77176.816.0384.5077.496.01
228790-2879079.71480.44
325426-2542670.40071.05
427369-2736975.78076.43
526736-2673674.02774.69
627865-2786577.15377.85
20min131693-3169387.75282.874.1088.9583.994.11
230979-3097985.77586.94
328962-2896280.19181.24
429823-2982382.57483.65
528404-2840478.64679.72
629720-2972082.28983.42
30min133511-3351192.78689.742.6494.4791.322.65
232098-3209888.87490.52
331576-3157687.42888.92
433159-3315991.81193.34
531412-3141286.97488.49
632720-3272090.59692.18
45min134331-3433195.05692.352.1797.2594.422.19
232859-3285990.98193.12
332620-3262090.31992.29
433557-3355792.91394.95
532733-3273390.63292.63
634026-3402694.21296.30
60min133702-3370293.31593.742.1596.0496.332.11
233633-3363393.12495.77
333326-3332692.27494.75
435202-3520297.468100.03
533203-3320391.93394.43
634068-3406894.32896.94
极限133888-3388893.83094.482.6197.0797.592.53
233274-3327492.13095.29
333944-3394493.98596.98
435614-3561498.609101.71
533343-3334392.32195.33
634678-3467896.01799.15
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100607-202305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%
114.982020643202056820230422027180202434420231550.14
215.102031145203443020327880.12
单位质量响应值RSD%判断
135057.08134621.720.23数据可信
供试品溶液-24032502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%
5min1144579-1445796.4335.8210.046.435.8210.03
2148634-1486346.6146.61
3115835-1158355.1545.15
4124126-1241265.5235.52
5121749-1217495.4185.42
6129413-1294135.7595.76
10min1211562-2115629.4148.2111.139.458.2411.13
2209910-2099109.3409.38
3173593-1735937.7247.75
4170268-1702687.5767.61
5167189-1671897.4397.47
6174170-1741707.7507.78
15min1243267-24326710.8259.4510.1910.919.5310.19
2236727-23672710.53410.62
3197615-1976158.7938.86
4198697-1986978.8428.91
5194528-1945288.6568.73
6203928-2039289.0749.15
20min1255540-25554011.37110.198.7711.5210.328.80
2252902-25290211.25411.40
3217401-2174019.6749.79
4217756-2177569.6909.81
5208526-2085269.2799.40
6221337-2213379.8499.97
30min1277012-27701212.32611.147.7812.5411.337.80
2273347-27334712.16312.37
3239265-23926510.64710.82
4237976-23797610.58910.77
5233187-23318710.37610.55
6241253-24125310.73510.92
45min1300918-30091813.39011.908.6013.6712.148.64
2291902-29190212.98913.27
3254167-25416711.31011.54
4248319-24831911.05011.28
5249996-24999611.12411.35
6258632-25863211.50811.75
60min1297392-29739213.23312.217.0413.5912.537.10
2300707-30070713.38113.73
3262350-26235011.67411.97
4264061-26406111.75012.05
5256598-25659811.41811.71
6265622-26562211.82012.12
极限1303489-30348913.50512.416.7113.9312.796.78
2300828-30082813.38613.81
3267043-26704311.88312.24
4267759-26775911.91512.28
5259579-25957911.55111.90
6274032-27403212.19412.56
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