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%
1 15.042963229689295742957929641296230.17
2 14.972952729623295750.23
单位质量响应值RSD%判断
1969.611975.620.22数据可信
供试品溶液-24A2941批-氨氯地平-pH7.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min116161-1616153.10954.261.9253.1154.261.92
216082-1608252.85052.85
316544-1654454.36854.37
416707-1670754.90454.90
516841-1684155.34455.34
616727-1672754.96954.97
10min120567-2056767.58865.995.4467.8866.295.41
220161-2016166.25466.55
320865-2086568.56868.87
421171-2117169.57369.88
518179-1817959.74160.05
619542-1954264.22064.53
15min122745-2274574.74674.821.2275.4275.491.23
222466-2246673.82974.49
322695-2269574.58275.26
423232-2323276.34677.04
522554-2255474.11874.76
622921-2292175.32475.99
20min123440-2344077.03077.201.1978.1278.291.18
223284-2328476.51777.59
323111-2311175.94977.05
423866-2386678.43079.55
523526-2352677.31378.36
623732-2373277.98979.07
30min124226-2422679.61380.902.2581.1382.422.22
224233-2423379.63681.13
323966-2396678.75880.28
425305-2530583.15984.71
524817-2481781.55583.04
625160-2516082.68284.20
45min125092-2509282.45982.941.7384.4184.901.71
225284-2528483.09085.03
325549-2554983.96185.92
425804-2580484.79986.81
524534-2453480.62582.56
625158-2515882.67684.65
60min125554-2555483.97786.315.3086.3988.735.18
227247-2724789.54191.94
323973-2397378.78181.20
427640-2764090.83293.32
525930-2593085.21387.59
627244-2724489.53191.96
极限125409-2540983.50183.961.7686.3886.861.68
225501-2550183.80386.70
325527-2552783.88886.75
424824-2482481.57884.57
525904-2590485.12787.98
626129-2612985.86788.80
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%
111.158707678694798711508705608702328704380.08
211.098701478689028695240.11
单位质量响应值RSD%判断
78066.1978406.130.31数据可信
供试品溶液-24A2941批-替米沙坦-pH7.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1294287-29428733.85434.027.2833.8534.027.28
2287448-28744833.06733.07
3304685-30468535.05035.05
4263499-26349930.31230.31
5329235-32923537.87437.87
6295119-29511933.95033.95
10min1604182-60418269.50364.369.7869.6964.559.74
2586661-58666167.48867.67
3621585-62158571.50571.70
4548474-54847463.09563.26
5479404-47940455.14955.36
6516762-51676259.44759.64
15min1794660-79466091.41588.665.0891.9989.215.07
2789821-78982190.85991.42
3798989-79898991.91392.51
4703426-70342680.92081.44
5794939-79493991.44791.96
6742589-74258985.42585.94
20min1843732-84373297.06094.743.4898.1495.773.48
2856582-85658298.53999.60
3826062-82606295.02896.13
4775760-77576089.24190.21
5830943-83094395.58996.61
6808030-80803092.95393.95
30min1865691-86569199.58698.211.86101.2199.781.87
2879703-879703101.198102.81
3847007-84700797.43799.07
4838352-83835296.44197.91
5842291-84229196.89598.45
6849425-84942597.71599.23
45min1864908-86490899.49698.093.59101.67100.203.57
2907112-907112104.351106.52
3852053-85205398.018100.19
4837720-83772096.36998.37
5822384-82238494.60496.70
6831944-83194495.70497.76
60min1849297-84929797.70097.623.19100.43100.283.11
2888762-888762102.240104.99
3807818-80781892.92995.65
4856354-85635498.512101.05
5832971-83297195.82298.44
6856594-85659498.540101.12
极限1855392-85539298.40296.402.96101.6799.602.94
2873526-873526100.488103.81
3834620-83462096.01299.24
4800739-80073992.11595.20
5829163-82916395.38498.54
6834402-83440295.98799.12
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%
1 15.042959029678295732959629727296330.23
2 14.972934929458294040.27
单位质量响应值RSD%判断
1970.281964.200.22数据可信
供试品溶液-24D1516批-氨氯地平-pH7.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min113492-1349244.45942.457.0344.4642.457.02
212529-1252941.28641.29
312085-1208539.82339.82
412038-1203839.66839.67
512769-1276942.07742.08
614376-1437647.37247.37
10min120330-2033066.99264.204.9367.2464.444.92
219132-1913263.04563.27
317873-1787358.89659.12
419300-1930063.59863.82
520510-2051067.58567.82
619758-1975865.10765.37
15min122360-2236073.68272.481.7274.3073.071.73
222056-2205672.68073.26
321909-2190972.19672.74
421289-2128970.15270.73
522210-2221073.18773.80
622147-2214772.98073.60
20min124271-2427179.97979.402.9081.0180.402.87
223889-2388978.72079.70
325030-2503082.48083.43
422923-2292375.53776.50
524421-2442180.47381.49
624040-2404079.21880.25
30min124850-2485081.88781.760.9283.3683.190.91
224468-2446880.62882.05
325029-2502982.47783.88
424760-2476081.59082.97
524684-2468481.34082.80
625075-2507582.62884.10
45min125191-2519183.01086.321.9784.9488.221.91
226420-2642087.06088.93
326134-2613486.11887.98
426400-2640086.99488.83
526590-2659087.62189.54
626445-2644587.14389.07
60min126244-2624486.48087.882.9788.8790.252.90
227291-2729189.93192.28
325304-2530483.38385.73
427029-2702989.06791.39
526722-2672288.05690.46
627419-2741990.35292.77
极限126237-2623786.45788.483.1589.3391.343.05
227840-2784091.74094.59
326031-2603185.77888.59
427214-2721489.67792.49
527730-2773091.37794.27
626051-2605185.84488.76
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%
111.154338584341804341644332274341814339220.10
211.094339204337864338530.03
单位质量响应值RSD%判断
38916.7739121.100.38数据可信
供试品溶液-24D1516批-替米沙坦-pH7.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1137159-13715931.63731.867.9531.6431.867.95
2129582-12958229.88929.89
3130774-13077430.16430.16
4135517-13551731.25831.26
5136176-13617631.41031.41
6159678-15967836.83136.83
10min1292528-29252867.47466.893.4967.6567.073.50
2284118-28411865.53465.70
3274907-27490763.41063.58
4301171-30117169.46869.64
5286856-28685666.16666.34
6300418-30041869.29469.50
15min1397709-39770991.73589.711.2992.2990.261.27
2389855-38985589.92390.45
3389365-38936589.81090.33
4386251-38625189.09289.65
5387825-38782589.45590.00
6382689-38268988.27188.86
20min1458726-458726105.809101.013.07106.87102.063.04
2443215-443215102.231103.26
3443504-443504102.298103.32
4422784-42278497.51998.57
5425055-42505598.04399.08
6434283-434283100.171101.25
30min1444238-444238102.46798.393.99104.12100.003.94
2448494-448494103.449105.05
3415436-41543695.82497.41
4420586-42058697.01298.61
5404403-40440393.27994.86
6426185-42618598.30399.94
45min1442215-442215102.00199.483.43104.22101.643.39
2453784-453784104.669106.84
3415151-41515195.75897.88
4430767-43076799.360101.50
5417269-41726996.24798.35
6428551-42855198.849101.03
60min1440764-440764101.66698.864.78104.45101.564.70
2455697-455697105.111107.86
3397743-39774391.74394.39
4427677-42767798.647101.33
5414025-41402595.49998.14
6435585-435585100.472103.20
极限1450910-450910104.00698.705.59107.36101.965.46
2460563-460563106.233109.57
3402799-40279992.90996.07
4427457-42745798.597101.83
5422137-42213797.370100.54
6403565-40356593.08696.38
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