替米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对照品来源中检所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10000
标示量(mg)5供试品稀释倍数5系数0.7210
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
114.722861828459284612856528570285350.25
214.662857728457285170.30
单位质量响应值RSD%判断
1938.521945.230.25数据可信
供试品溶液-24D1516批-氨氯地平-pH6.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min113894-1389446.38248.013.0646.3848.013.06
214895-1489549.72449.72
313860-1386046.26946.27
414660-1466048.93948.94
514282-1428247.67747.68
614706-1470649.09349.09
10min119569-1956965.32769.042.7765.5869.312.77
220876-2087669.69069.97
320598-2059868.76269.02
421115-2111570.48870.76
520979-2097970.03470.30
620952-2095269.94470.22
15min121883-2188373.05275.674.2673.6776.324.24
223087-2308777.07177.73
321084-2108470.38471.02
423357-2335777.97278.64
523082-2308277.05477.71
623506-2350678.47079.13
20min121961-2196173.31278.476.6174.3479.546.56
224560-2456081.98883.08
321141-2114170.57571.60
424685-2468582.40683.50
524080-2408080.38681.47
624615-2461582.17283.27
30min123820-2382079.51882.783.1580.9584.283.11
225959-2595986.65988.21
325267-2526784.34985.77
424558-2455881.98283.54
525016-2501683.51185.04
624158-2415880.64682.20
45min125079-2507983.72185.891.7885.6087.861.80
225975-2597586.71288.74
325382-2538284.73286.62
425946-2594686.61588.63
526350-2635087.96489.96
625636-2563685.58087.58
60min125399-2539984.78987.232.2287.1389.672.24
226843-2684389.61092.12
325549-2554985.29087.65
426271-2627187.70090.19
526063-2606387.00689.49
626654-2665488.97991.46
极限125792-2579286.10188.652.9788.9191.582.96
227574-2757492.05095.06
325472-2547285.03387.87
426754-2675489.31392.29
526696-2669689.11992.08
627048-2704890.29493.27
替米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100629-202204对照品来源中检所对照品使用方法直接使用
对照品含量(%)100对照品水分(%)0对照品稀释倍数625
标示量(mg)80供试品稀释倍数5系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.914249094247284252624258494252614252020.11
210.934257704255704256700.04
单位质量响应值RSD%判断
38973.6038945.110.06数据可信
供试品溶液-24D1516批-替米沙坦-pH6.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1140052-14005232.35334.814.0832.3534.814.08
2158452-15845236.60436.60
3150712-15071234.81634.82
4153289-15328935.41135.41
5148718-14871834.35534.36
6152883-15288335.31835.32
10min1284816-28481665.79571.324.7365.9871.514.73
2329337-32933776.08076.28
3313077-31307772.32472.52
4302659-30265969.91770.11
5311608-31160871.98572.18
6310853-31085371.81072.01
15min1380483-38048387.89592.104.8888.4492.694.88
2433489-433489100.140100.77
3383640-38364088.62589.22
4389136-38913689.89490.48
5402060-40206092.88093.47
6403198-40319893.14393.74
20min1419099-41909996.81699.165.5097.85100.265.48
2472035-472035109.045110.23
3401944-40194492.85393.94
4420890-42089097.23098.31
5426830-42683098.60299.71
6434553-434553100.386101.50
30min1430114-43011499.361100.865.58100.93102.525.54
2480459-480459110.991112.78
3449337-449337103.801105.40
4418745-41874596.73498.36
5419591-41959196.93098.58
6421477-42147797.36599.04
45min1428825-42882599.06398.804.44101.19101.024.43
2463119-463119106.985109.39
3414684-41468495.79697.98
4408725-40872594.42096.58
5426938-42693898.627100.82
6423959-42395997.939100.15
60min1428952-42895299.09298.934.72101.77101.694.70
2464677-464677107.345110.34
3418795-41879596.74699.46
4406214-40621493.84096.53
5417616-41761696.47399.21
6433312-433312100.099102.85
极限1429281-42928199.16899.215.28102.39102.525.25
2472380-472380109.125112.72
3412787-41278795.35898.61
4410438-41043894.81598.02
5420325-42032597.099100.38
6431680-43168099.722103.03
替米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对照品来源中检所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10000
标示量(mg)5供试品稀释倍数5系数0.7210
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
114.722863528594285962868328463285940.29
214.662855128545285480.02
单位质量响应值RSD%判断
1942.531947.340.18数据可信
供试品溶液-24D1516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%
5min126508-2650888.35284.253.8588.3584.253.85
225070-2507083.55983.56
323825-2382579.40979.41
424637-2463782.11682.12
525635-2563585.44285.44
625995-2599586.64286.64
10min127432-2743291.43290.162.3391.9290.622.33
226843-2684389.46989.93
326182-2618287.26587.71
426741-2674189.12989.58
527081-2708190.26290.74
628020-2802093.39193.87
15min128191-2819193.96189.892.9794.9690.862.95
226530-2653088.42589.39
326038-2603886.78587.71
426765-2676589.20990.16
527659-2765992.18893.16
626628-2662888.75289.75
20min127863-2786392.86890.682.2294.3992.142.23
227440-2744091.45892.91
326358-2635887.85289.26
426662-2666288.86590.31
527139-2713990.45591.94
627769-2776992.55594.05
30min127789-2778992.62289.841.8694.6691.811.87
227111-2711190.36292.32
326428-2642888.08589.98
426586-2658688.61290.55
526666-2666688.87990.87
627141-2714190.46292.47
45min126792-2679289.29988.601.4891.8591.081.49
226229-2622987.42289.88
326313-2631387.70290.09
426299-2629987.65590.09
526616-2661688.71291.20
627254-2725490.83893.35
60min127680-2768092.25888.922.3195.3191.892.30
226229-2622987.42290.37
325980-2598086.59289.46
426377-2637787.91590.84
526922-2692289.73292.71
626890-2689089.62592.64
极限127217-2721790.71588.231.8494.2891.681.85
226067-2606786.88290.32
326216-2621687.37990.73
425925-2592586.40989.82
526716-2671689.04592.52
626679-2667988.92292.43
替米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100629-202204对照品来源中检所对照品使用方法直接使用
对照品含量(%)100对照品水分(%)0对照品稀释倍数625
标示量(mg)80供试品稀释倍数5系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.914260464262754263874274654265314265410.13
210.934252594246354249470.11
单位质量响应值RSD%判断
39096.3338878.960.40数据可信
供试品溶液-24D1516批-替米沙坦-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%
5min154234-5423412.52012.1212.8312.5212.1212.81
252035-5203512.01212.01
352427-5242712.10212.10
461705-6170514.24414.24
540794-407949.4179.42
653721-5372112.40112.40
10min1136570-13657031.52629.498.0031.6029.568.01
2126271-12627129.14929.22
3124644-12464428.77328.84
4131900-13190030.44830.53
5109747-10974725.33425.39
6137280-13728031.69031.76
15min1173833-17383340.12837.864.3340.3738.104.33
2162060-16206037.41137.64
3170028-17002839.25039.48
4160150-16015036.97037.22
5154022-15402235.55535.75
6164028-16402837.86538.11
20min1191248-19124844.14842.373.7744.6242.813.76
2186643-18664343.08543.52
3187044-18704443.17843.62
4171501-17150139.59040.04
5180115-18011541.57841.97
6184689-18468942.63443.09
30min1201316-20131646.47344.403.5847.1945.083.55
2192729-19272944.49045.17
3197990-19799045.70546.39
4181824-18182441.97342.65
5191359-19135944.17444.80
6188806-18880643.58544.28
45min1199457-19945746.04344.952.4647.0145.872.44
2191394-19139444.18245.11
3199309-19930946.00946.95
4187143-18714343.20144.11
5196273-19627345.30846.18
6194633-19463344.93045.86
60min1205765-20576547.50045.652.4348.7346.832.42
2194175-19417544.82445.99
3199463-19946346.04547.24
4192082-19208244.34145.49
5198791-19879145.89047.01
6196290-19629045.31246.50
极限1202372-20237246.71645.602.3848.2147.032.35
2192106-19210644.34745.76
3202973-20297346.85548.31
4194734-19473444.95346.35
5199479-19947946.04947.42
6193583-19358344.68846.12
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