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%
114.722879028910287642883828754288110.23
214.662904828693288700.87
单位质量响应值RSD%判断
1957.271969.300.44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%
5min115965-1596552.71551.597.2252.7151.597.22
216792-1679255.44555.45
314856-1485649.05349.05
413845-1384545.71545.71
516678-1667855.06955.07
615610-1561051.54351.54
10min121566-2156671.20971.782.5071.5072.062.52
222482-2248274.23374.54
321715-2171571.70171.97
420947-2094769.16569.42
522201-2220173.30573.61
621516-2151671.04471.33
15min123475-2347577.51277.772.6478.2078.462.65
224125-2412579.65880.38
323695-2369578.23878.91
422374-2237473.87774.51
523949-2394979.07779.79
623709-2370978.28578.97
20min124083-2408379.52080.663.2280.6481.773.22
225475-2547584.11685.28
324528-2452880.98982.09
423188-2318876.56477.61
524308-2430880.26381.42
624980-2498082.48183.60
30min125288-2528883.49884.415.2685.0685.985.22
226730-2673088.26089.89
326011-2601185.88687.44
422997-2299775.93477.41
526082-2608286.12087.72
626284-2628486.78788.36
45min124841-2484182.02283.984.2284.0586.024.20
226673-2667388.07290.19
326099-2609986.17688.21
423670-2367078.15680.05
525344-2534483.68385.76
625976-2597685.77087.83
60min126337-2633786.96288.173.2989.4490.673.30
227943-2794392.26594.87
326935-2693588.93791.45
425268-2526883.43285.76
526960-2696089.01991.56
626770-2677088.39290.92
极限126008-2600885.87688.802.6388.8491.802.65
227738-2773891.58894.71
327259-2725990.00693.01
426078-2607886.10788.90
526948-2694888.98092.02
627338-2733890.26793.29
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%
110.914300344300114305374304414306734303390.07
210.934295734297924296820.04
单位质量响应值RSD%判断
39444.4539312.170.24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%
5min1169650-16965038.77437.166.2638.7737.166.26
2156385-15638535.74235.74
3164233-16423337.53637.54
4146146-14614633.40233.40
5174962-17496239.98839.99
6164150-16415037.51737.52
10min1328667-32866775.11873.393.0875.3373.603.07
2327363-32736374.82075.02
3329064-32906475.20975.42
4318511-31851172.79772.98
5303213-30321369.30069.52
6319917-31991773.11873.33
15min1409138-40913893.51091.904.2994.1492.514.27
2405333-40533392.64093.25
3425297-42529797.20397.83
4395101-39510190.30190.89
5373236-37323685.30485.91
6404361-40436192.41893.03
20min1414184-41418494.66398.223.8895.8299.343.85
2436664-43666499.801100.93
3456801-456801104.403105.57
4423936-42393696.89297.98
5412287-41228794.22995.31
6434513-43451399.309100.44
30min1415331-41533194.92599.094.4396.60100.754.39
2446748-446748102.106103.79
3462249-462249105.648107.39
4412093-41209394.18595.81
5427535-42753597.71499.32
6437241-43724199.933101.61
45min1396415-39641590.60295.754.5092.8197.974.46
2430693-43069398.436100.69
3447409-447409102.257104.59
4406051-40605192.80494.96
5408143-40814393.28295.43
6424927-42492797.11899.35
60min1414728-41472894.78798.573.6597.50101.323.63
2443499-443499101.363104.16
3455649-455649104.140107.04
4417535-41753595.42998.10
5426375-42637597.449100.11
6429777-42977798.227101.00
极限1404668-40466892.48898.233.9095.72101.533.87
2437585-437585100.011103.37
3452858-452858103.502106.98
4424944-42494497.122100.32
5420570-42057096.12299.33
6438121-438121100.134103.45
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%
114.722881028904289512896328915289090.21
214.662872428801287620.19
单位质量响应值RSD%判断
1963.931961.940.08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%
5min112455-1245541.13238.678.0341.1338.678.02
210728-1072835.42935.43
310525-1052534.75834.76
411908-1190839.32639.33
512913-1291342.64542.64
611733-1173338.74838.75
10min119354-1935463.91663.322.4664.1463.532.48
218791-1879162.05762.25
318464-1846460.97761.17
419636-1963664.84765.07
519637-1963764.85065.09
619155-1915563.25963.47
15min121808-2180872.02071.513.1072.6072.083.11
221178-2117869.94070.48
320625-2062568.11368.65
422307-2230773.66874.25
522369-2236973.87374.47
621629-2162971.42972.00
20min123401-2340177.28175.642.2978.2676.602.30
222683-2268374.91075.84
322315-2231573.69474.60
423451-2345177.44678.43
523230-2323076.71677.72
622341-2234173.78074.74
30min124935-2493582.34781.041.7183.7682.421.71
223779-2377978.52979.88
324390-2439080.54781.87
424835-2483582.01783.43
524690-2469081.53882.97
624599-2459981.23782.61
45min125730-2573084.97284.731.3186.8486.561.31
225511-2551184.24986.03
325159-2515983.08784.85
425802-2580285.21087.08
525578-2557884.47086.36
626164-2616486.40688.23
60min126680-2668088.11087.540.5090.4589.840.49
226392-2639287.15989.41
326581-2658187.78390.01
426603-2660387.85590.20
526365-2636587.06989.43
626420-2642087.25189.56
极限127195-2719589.81187.831.3692.6490.621.32
226523-2652387.59190.33
326443-2644387.32790.04
426241-2624186.66089.50
526326-2632686.94189.78
626845-2684588.65591.44
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%
110.914310184312654316134314684312284313180.06
210.934289714288904289300.02
单位质量响应值RSD%判断
39534.1939243.370.53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%
5min1140562-14056232.11831.445.4732.1231.445.47
2128438-12843829.34729.35
3140020-14002031.99431.99
4129098-12909829.49829.50
5147996-14799633.81633.82
6139421-13942131.85731.86
10min1293346-29334667.02868.693.7267.2168.863.72
2296939-29693967.84968.01
3312616-31261671.43171.61
4284365-28436564.97665.14
5312362-31236271.37371.56
6303981-30398169.45869.63
15min1381933-38193387.27088.912.4887.8289.472.48
2385995-38599588.19888.74
3403389-40338992.17292.75
4376554-37655486.04186.57
5394468-39446890.13490.72
6392367-39236789.65490.22
20min1420752-42075296.14095.982.1297.1897.032.10
2427257-42725797.62698.66
3432582-43258298.84399.93
4413953-41395394.58695.59
5408149-40814993.26094.34
6417564-41756495.41196.47
30min1416325-41632595.12895.872.2596.7097.452.24
2416385-41638595.14296.71
3436673-43667399.777101.41
4418158-41815895.54797.08
5408324-40832493.30094.90
6421443-42144396.29797.89
45min1412462-41246294.24596.871.9596.3498.981.95
2428057-42805797.80999.91
3434303-43430399.236101.43
4417056-41705695.29597.35
5421939-42193996.41198.53
6429770-42977098.200100.33
60min1420977-42097796.19197.072.4498.8199.722.41
2430203-43020398.299100.94
3442732-442732101.162103.90
4418003-41800395.51198.10
5413885-41388594.57097.23
6423052-42305296.66599.34
极限1420672-42067296.12196.083.1299.2899.273.07
2425125-42512597.139100.33
3439347-439347100.388103.69
4409688-40968893.61196.73
5402234-40223491.90895.09
6425871-42587197.309100.52
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%
114.722924629317292502915129279292490.22
214.662890528636287700.67
单位质量响应值RSD%判断
1987.021962.480.88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%
5min125694-2569484.34984.101.3384.3584.101.33
225935-2593585.14085.14
325817-2581784.75384.75
425833-2583384.80584.81
525043-2504382.21282.21
625396-2539683.37183.37
10min128564-2856493.77091.921.9894.2492.391.97
228606-2860693.90894.38
327393-2739389.92690.40
427723-2772391.01091.48
527434-2743490.06190.52
628286-2828692.85893.32
15min128973-2897395.11391.992.3196.1092.962.30
228420-2842093.29894.29
327539-2753990.40691.38
428097-2809792.23793.21
527138-2713889.08990.05
627955-2795591.77192.75
20min128810-2881094.57891.002.9296.1092.492.90
228477-2847793.48595.00
326915-2691588.35789.83
427292-2729289.59591.08
526925-2692588.39089.84
627906-2790691.61093.10
30min129256-2925696.04292.673.2498.0994.673.21
229260-2926096.05598.09
327056-2705688.82090.78
427785-2778591.21393.20
527571-2757190.51192.45
628451-2845193.40095.40
45min129159-2915995.72492.652.5198.3095.162.49
228918-2891894.93397.50
328143-2814392.38894.85
427810-2781091.29593.79
527263-2726389.50091.95
628042-2804292.05794.57
60min128200-2820092.57692.001.1495.6895.021.16
228517-2851793.61696.71
327604-2760490.61993.59
428037-2803792.04095.04
527795-2779591.24694.19
627986-2798691.87394.90
极限128874-2887494.78892.302.2598.4195.842.24
228792-2879294.51998.13
327706-2770690.95494.43
428277-2827792.82896.34
527332-2733289.72693.18
627717-2771790.99094.53
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%
110.914299924305124300084305744293004300770.12
210.934279484277004278240.05
单位质量响应值RSD%判断
39420.4439142.180.51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%
5min161194-6119414.02114.297.5314.0214.297.53
256286-5628612.89612.90
360766-6076613.92313.92
463471-6347114.54214.54
570598-7059816.17516.18
661884-6188414.17914.18
10min1130781-13078129.96430.656.3830.0430.736.38
2128305-12830529.39729.47
3123469-12346928.28928.37
4135472-13547231.03931.12
5148244-14824433.96634.06
6136313-13631331.23231.31
15min1170382-17038239.03839.024.4539.2839.274.46
2170023-17002338.95639.19
3157359-15735936.05436.29
4171340-17134039.25739.51
5181082-18108241.48941.77
6171671-17167139.33339.59
20min1188899-18889943.28042.685.1843.7443.155.17
2190402-19040243.62544.08
3168234-16823438.54638.98
4184727-18472742.32542.80
5196549-19654945.03345.54
6188851-18885143.26943.74
30min1204563-20456346.86945.964.8647.5746.664.85
2205572-20557247.10147.79
3181849-18184941.66542.31
4198108-19810845.39046.10
5206911-20691147.40748.17
6206584-20658447.33248.04
45min1210345-21034548.19447.121.5249.1648.081.54
2205990-20599047.19648.15
3202039-20203946.29147.17
4202372-20237246.36747.33
5205879-20587947.17148.19
6207338-20733847.50548.48
60min1200621-20062145.96646.031.5647.2047.251.62
2198732-19873245.53346.75
3196760-19676045.08246.22
4200994-20099446.05247.27
5205923-20592347.18148.47
6202254-20225446.34047.58
极限1201607-20160746.19246.271.1847.6847.751.23
2202554-20255446.40947.88
3197482-19748245.24746.64
4203620-20362046.65348.13
5202289-20228946.34847.90
6204195-20419546.78548.28
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