培哚普利氨氯地平片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号DJ468-220103对照品来源中检院对照品使用方法直接使用
对照品含量(%)94.8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1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
1102036420116201842017220198202070.47
29.972013720145201410.03
单位质量响应值RSD%判断
2020.702020.160.02数据可信
供试品溶液-2025110421批-培哚普利-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%
5min115992-1599267.53258.9726.6867.5358.9726.69
212194-1219451.49451.49
319025-1902580.34080.34
414385-1438560.74660.75
514247-1424760.16360.16
67941-794133.53433.53
10min122055-2205593.13591.634.7193.8992.284.82
220290-2029085.68286.25
322490-2249094.97295.86
422862-2286296.54397.22
521839-2183992.22392.89
620649-2064987.19887.57
15min122807-2280796.31196.632.0198.1098.302.09
222022-2202292.99694.52
323239-2323998.135100.08
423236-2323698.12299.87
523106-2310697.57399.27
622881-2288196.62397.96
20min122793-2279396.25296.562.0099.1199.302.02
222065-2206593.17795.73
322887-2288796.64999.69
423446-2344699.009101.85
522891-2289196.66699.44
623111-2311197.595100.01
30min122242-2224293.92597.152.5697.85100.972.52
222339-2233994.33597.93
323391-2339198.777102.89
423651-2365199.875103.81
523037-2303797.282101.13
623372-2337298.697102.20
45min122492-2249294.98196.531.6199.95101.421.41
222784-2278496.214100.85
322459-2245994.841100.05
423141-2314197.721102.77
522872-2287296.585101.52
623399-2339998.811103.41
极限121833-2183392.19896.422.8398.22102.402.65
222384-2238494.525100.23
322743-2274396.041102.30
423249-2324998.177104.31
523233-2323398.110104.12
623562-2356299.499105.19
培哚普利氨氯地平片项目信息
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0.721
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
113.698116981140813908123381376812620.15
213.747967480489800820.72
单位质量响应值RSD%判断
5935.875828.381.30数据可信
供试品溶液-2025110421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%
5min146907-4690751.69943.5629.4251.7043.5629.42
235557-3555739.19039.19
354602-5460260.18060.18
440642-4064244.79444.79
539294-3929443.30843.31
620114-2011422.16922.17
10min179180-7918087.26985.294.9787.8485.785.07
273246-7324680.72981.16
379858-7985888.01688.69
481597-8159789.93390.43
578401-7840186.41186.89
672045-7204579.40579.65
15min182707-8270791.15691.062.0092.7092.492.02
280171-8017188.36189.69
381777-8177790.13191.78
484910-8491093.58595.08
583837-8383792.40293.84
682315-8231590.72491.85
20min182939-8293991.41291.832.2493.9794.282.15
281064-8106489.34691.66
381286-8128689.59092.24
485478-8547894.21196.75
584224-8422492.82895.30
684918-8491893.59395.73
30min181589-8158989.92492.021.8893.5095.481.84
281721-8172190.07093.38
383491-8349192.02195.66
485564-8556494.30597.89
584342-8434292.95996.46
684209-8420992.81295.99
45min182783-8278391.24092.271.3395.8196.761.25
283719-8371992.27296.58
382263-8226390.66795.33
485417-8541794.14398.77
584104-8410492.69697.23
684018-8401892.60196.81
极限180961-8096189.23292.902.6394.8298.412.45
283320-8332091.83297.17
383155-8315591.65097.32
486581-8658195.426101.10
585114-8511493.80999.37
686591-8659195.437100.67
培哚普利氨氯地平片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号DJ468-220103对照品来源中检院对照品使用方法直接使用
对照品含量(%)94.8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1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
1102002219832199552008120170200120.64
29.972014019927200340.76
单位质量响应值RSD%判断
2001.202009.430.30数据可信
供试品溶液-2025110521批-培哚普利-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%
5min113847-1384758.91557.3936.0158.9257.4036.01
212233-1223352.04852.05
318328-1832877.98077.98
46783-678328.86028.86
510179-1017943.30943.31
619566-1956683.24883.25
10min121540-2154091.64788.0810.9592.3088.7211.12
221215-2121590.26490.84
321919-2191993.25994.13
416986-1698672.27172.59
519184-1918481.62282.10
623368-2336899.424100.35
15min122448-2244895.51094.854.2997.1896.474.50
223326-2332699.245100.83
322675-2267596.47698.38
421046-2104689.54590.67
521204-2120490.21791.61
623062-2306298.122100.15
20min122549-2254995.94095.961.7798.6798.631.97
223175-2317598.603101.29
322564-2256496.00398.98
422196-2219694.43896.56
522072-2207293.91096.30
622768-2276896.87199.99
30min122607-2260796.18696.381.5699.99100.111.51
223039-2303998.024101.80
322676-2267696.480100.52
422998-2299897.850101.02
522082-2208293.95397.39
622507-2250795.76199.96
45min122644-2264496.34496.681.53101.21101.491.31
222870-2287097.305102.17
322577-2257796.059101.17
423344-2334499.322103.58
522350-2235095.09399.57
622556-2255695.969101.23
极限122688-2268896.53197.262.06102.47103.141.63
222628-2262896.276102.23
322550-2255095.944102.12
423747-23747101.037106.40
523021-2302197.948103.48
622526-2252695.842102.17
培哚普利氨氯地平片项目信息
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0.721
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
113.698109780906814778117781338811990.28
213.748099381621813070.55
单位质量响应值RSD%判断
5931.265917.540.17数据可信
供试品溶液-2025110521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%
5min141556-4155645.47143.5641.8045.4743.5641.80
235363-3536338.69438.69
355465-5546560.69060.69
416019-1601917.52817.53
529558-2955832.34332.34
660922-6092266.66166.66
10min176222-7622283.40381.1411.9583.9181.6212.12
275622-7562282.74683.18
379448-7944886.93387.61
459458-5945865.05965.25
569195-6919575.71476.07
684971-8497192.97693.72
15min180197-8019787.75288.695.2389.1890.075.36
286885-8688595.07096.42
380793-8079388.40490.04
477395-7739584.68685.60
575989-7598983.14884.35
685044-8504493.05694.83
20min182343-8234390.10089.682.6492.5192.052.80
284271-8427192.21094.62
381243-8124388.89791.52
481184-8118488.83290.69
578527-7852785.92588.05
684175-8417592.10594.91
30min182665-8266590.45389.851.9993.8693.222.12
283448-8344891.30994.74
381124-8112488.76692.38
482298-8229890.05192.90
579390-7939086.86989.95
683783-8378391.67695.51
45min183224-8322491.06490.902.2095.4895.262.12
284609-8460992.58097.02
380989-8098988.61993.22
484878-8487892.87496.72
580696-8069688.29892.34
684044-8404491.96296.81
极限184158-8415892.08692.772.1897.5198.151.87
283039-8303990.86296.34
384201-8420192.13397.71
488361-8836196.685101.56
584158-8415892.08697.11
684791-8479192.77998.65
培哚普利氨氯地平片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号DJ468-220103对照品来源中检院对照品使用方法直接使用
对照品含量(%)94.8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1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
1102017020239202242009520031201520.44
29.972028420054201690.81
单位质量响应值RSD%判断
2015.202022.970.28数据可信
供试品溶液-2025110621批-培哚普利-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%
5min113456-1345656.86150.3835.1956.8650.3835.19
210327-1032743.63943.64
314823-1482362.63762.64
49232-923239.01239.01
56043-604325.53625.54
617657-1765774.61374.61
10min121032-2103288.87589.197.3289.5189.747.43
221594-2159491.25091.73
323064-2306497.46198.16
421177-2117789.48889.92
518326-1832677.44077.72
621441-2144190.60391.43
15min122381-2238194.57596.503.6196.1998.053.62
222984-2298497.12398.62
324411-24411103.153104.93
422498-2249895.07096.50
522634-2263495.64496.79
622106-2210693.41395.25
20min122494-2249495.05396.812.2197.7299.432.14
222777-2277796.24998.83
323712-23712100.200103.12
422879-2287996.68099.16
523249-2324998.243100.45
622342-2234294.41097.28
30min122675-2267595.81896.941.8899.54100.641.81
222724-2272496.02599.67
323572-2357299.608103.65
422858-2285896.591100.15
523352-2335298.678101.98
622460-2246094.90998.83
45min122594-2259495.47596.092.10100.27100.861.99
222357-2235794.47499.19
323352-2335298.678103.82
422678-2267895.830100.46
523269-2326998.328102.72
622181-2218193.73098.71
极限122272-2227294.11595.161.4699.97101.011.41
222606-2260695.526101.29
322962-2296297.030103.27
422417-2241794.727100.42
522783-2278396.274101.76
622082-2208293.31299.33
培哚普利氨氯地平片项目信息
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0.721
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
113.698108281218810598144480995811600.23
213.748096980795808820.16
单位质量响应值RSD%判断
5928.415886.610.51数据可信
供试品溶液-2025110621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%
5min149153-4915353.93847.4531.3753.9447.4531.37
238697-3869742.46442.46
352889-5288958.03858.04
435447-3544738.89838.90
522852-2285225.07725.08
660397-6039766.27666.28
10min174786-7478682.06683.058.2482.6783.588.33
278207-7820785.82086.29
382859-8285990.92591.57
476799-7679984.27584.71
564201-6420170.45170.73
677248-7724884.76885.50
15min179999-7999987.78790.842.9389.3092.292.90
283792-8379291.94993.37
386769-8676995.21696.87
482638-8263890.68392.05
582849-8284990.91491.98
680634-8063488.48490.16
20min181840-8184089.80791.612.4592.2994.072.33
283585-8358591.72294.17
385958-8595894.32697.04
483921-8392192.09094.47
585133-8513393.42095.49
680465-8046588.29890.96
30min182415-8241590.43892.202.4293.9295.682.26
284100-8410092.28795.75
386078-8607894.45798.22
483704-8370491.85295.25
586528-8652894.95198.06
681315-8131589.23192.87
45min183021-8302191.10392.092.0395.5996.591.88
283292-8329291.40095.89
385445-8544593.76398.57
484673-8467392.91697.34
585787-8578794.13898.30
681310-8131089.22593.86
极限183629-8362991.77092.551.0497.2798.081.06
284599-8459992.83498.34
385702-8570294.04599.90
484047-8404792.22997.68
584775-8477593.02898.24
683298-8329891.40797.03
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