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%
115.042956929481295592941829452294960.23
2 14.972938429356293700.07
单位质量响应值RSD%判断
1961.171961.920.03数据可信
供试品溶液-24D1516批-氨氯地平-pH1.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min122249-2224973.52859.8922.8973.5359.8922.90
214547-1454748.07548.07
322498-2249874.35174.35
415711-1571151.92251.92
513117-1311743.34943.35
620612-2061268.11868.12
10min127394-2739490.53287.534.7690.9487.864.82
226701-2670188.24188.51
327406-2740690.57190.98
424890-2489082.25682.54
524921-2492182.35982.60
627594-2759491.19391.57
15min126990-2699089.19690.282.1390.1191.102.16
227938-2793892.32993.09
327767-2776791.76492.68
427104-2710489.57390.32
526421-2642187.31688.01
627693-2769391.52092.40
20min127496-2749690.86990.821.3692.2892.141.41
227684-2768491.49092.76
327866-2786692.09193.52
426808-2680888.59589.84
527365-2736590.43691.62
627672-2767291.45092.84
30min127458-2745890.74390.052.1292.6591.872.13
226195-2619586.56988.35
327943-2794392.34694.28
427391-2739190.52292.26
527206-2720689.91091.60
627294-2729490.20192.10
45min126471-2647187.48189.582.9089.9091.912.88
226228-2622886.67888.94
327973-2797392.44594.90
427562-2756291.08793.32
526526-2652687.66389.85
627882-2788292.14494.55
60min127235-2723590.00690.981.6592.9193.801.63
226902-2690288.90691.65
327477-2747790.80693.77
427577-2757791.13693.88
527761-2776191.74494.42
628228-2822893.28896.20
极限126880-2688088.83389.560.8892.2392.890.90
227084-2708489.50792.74
327161-2716189.76293.23
427315-2731590.27093.52
526781-2678188.50691.69
627384-2738490.49993.93
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%
111.154484354485264483034472274481004481180.12
2 11.094463364457264460310.10
单位质量响应值RSD%判断
40189.9640219.210.06数据可信
供试品溶液-24D1516批-替米沙坦-pH1.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min136374-363748.1436.5812.788.146.5812.75
229606-296066.6276.63
326523-265235.9375.94
429213-292136.5396.54
525768-257685.7685.77
628913-289136.4726.47
10min185661-8566119.17613.8020.8319.2213.8320.81
261680-6168013.80713.84
356470-5647012.64112.67
463415-6341514.19614.23
552385-5238511.72711.76
650186-5018611.23411.27
15min1131199-13119929.37022.1219.8729.5222.2319.85
298205-9820521.98422.10
399969-9996922.37922.48
4105968-10596823.72123.84
581812-8181218.31418.41
675662-7566216.93717.04
20min1177536-17753639.74229.1323.8840.0629.3723.83
2130221-13022129.15129.39
3137946-13794630.88031.11
4141340-14134031.64031.89
5106361-10636123.80924.01
687392-8739219.56319.76
30min1249889-24988955.93939.4328.8156.4739.8328.70
2160071-16007135.83336.23
3212091-21209147.47847.88
4183104-18310440.98941.41
5145481-14548132.56732.90
6106204-10620423.77424.08
45min1287293-28729364.31246.4427.7865.1647.0527.70
2183028-18302840.97241.57
3259858-25985858.17158.83
4210322-21032247.08247.73
5171219-17121938.32838.84
6132894-13289429.74930.18
60min1354209-35420979.29153.5030.6080.5054.3830.49
2201493-20149345.10545.93
3294116-29411665.83966.83
4233200-23320052.20353.12
5196922-19692244.08244.81
6154089-15408934.49435.09
极限1399701-39970189.47560.0330.6791.1261.2030.58
2251339-25133956.26457.34
3316742-31674270.90472.26
4265001-26500159.32260.52
5210811-21081147.19148.16
6165331-16533137.01037.80
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%
115.042938429341293812931029205293240.25
2 14.972943829406294220.08
单位质量响应值RSD%判断
1949.731965.400.57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%
5min122969-2296976.06378.925.7276.0678.925.71
225526-2552684.53184.53
323608-2360878.18078.18
424384-2438480.74980.75
521732-2173271.96771.97
624772-2477282.03482.03
10min127451-2745190.90690.032.4591.3390.472.47
228058-2805892.91693.39
326590-2659088.05588.49
427215-2721590.12490.57
526244-2624486.90987.31
627563-2756391.27791.73
15min128347-2834793.87390.253.1694.8091.203.13
227730-2773091.83092.82
326991-2699189.38390.31
425860-2586085.63786.59
526941-2694189.21790.10
627656-2765691.58592.55
20min127710-2771091.76490.542.0593.2191.982.06
228141-2814193.19194.69
326929-2692989.17790.60
427267-2726790.29791.72
526567-2656787.97889.36
627433-2743390.84692.32
30min127847-2784792.21790.842.3594.1892.782.35
228206-2820693.40695.42
326841-2684188.88690.80
427604-2760491.41393.34
526486-2648687.71089.58
627601-2760191.40393.38
45min127599-2759991.39689.822.2793.8792.262.27
227948-2794892.55295.08
326569-2656987.98590.39
426932-2693289.18791.62
526355-2635587.27689.63
627329-2732990.50292.99
60min127581-2758191.33689.832.1494.3292.782.14
227437-2743790.86093.91
327005-2700589.42992.33
426935-2693589.19792.13
526115-2611586.48289.32
627678-2767891.65894.64
极限128143-2814393.19789.992.8196.6893.442.77
227593-2759391.37694.93
327219-2721990.13893.53
426316-2631687.14790.57
526227-2622786.85390.17
627556-2755691.25494.75
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%
111.154468464451814461604454394448084456870.19
2 11.094466324460754463540.09
单位质量响应值RSD%判断
39971.9340248.330.49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%
5min162498-6249814.02410.9025.4414.0210.9025.44
250458-5045811.32211.32
342270-422709.4859.48
448326-4832610.84410.84
528399-283996.3726.37
659467-5946713.34313.34
10min175934-7593417.03817.2014.5517.1217.2614.58
282924-8292418.60718.67
370493-7049315.81815.87
482945-8294518.61218.67
558223-5822313.06413.10
689501-8950120.08320.16
15min1103554-10355423.23623.6314.1423.4123.7914.14
2115940-11594026.01526.18
392231-9223120.69520.84
4112062-11206225.14525.31
584396-8439618.93719.05
6123683-12368327.75327.94
20min1120305-12030526.99528.6116.3127.3028.9016.29
2145947-14594732.74833.06
3107902-10790224.21224.47
4144190-14419032.35432.66
5100154-10015422.47322.69
6146461-14646132.86433.20
30min1143189-14318932.12934.4617.7032.5834.9017.65
2176793-17679339.67040.16
3121089-12108927.17127.56
4177412-17741239.80940.29
5124863-12486328.01728.36
6177974-17797439.93540.46
45min1163606-16360636.71139.2511.7837.3439.8911.81
2193027-19302743.31244.03
3144474-14447432.41832.96
4190012-19001242.63643.34
5163861-16386136.76837.26
6194589-19458943.66344.41
60min1169753-16975338.09041.937.9738.9242.788.04
2196363-19636344.06145.01
3169526-16952638.03938.76
4196763-19676344.15145.09
5184100-18410041.30942.01
6204710-20471045.93446.92
极限1201641-20164145.24545.411.5646.2946.501.75
2204516-20451645.89047.09
3201217-20121745.15046.08
4200089-20008944.89746.08
5199150-19915044.68645.61
6207624-20762446.58847.83
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%
115.042931429313292652927329354293040.13
2 14.972923429151291920.21
单位质量响应值RSD%判断
1948.401950.030.06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%
5min113515-1351544.94747.475.3344.9547.475.33
214228-1422847.31847.32
314043-1404346.70346.70
414764-1476449.10149.10
515515-1551551.59851.60
613583-1358345.17345.17
10min119347-1934764.34264.963.9464.5965.233.94
218383-1838361.13661.40
319691-1969165.48665.75
420003-2000366.52466.80
520628-2062868.60268.89
619151-1915163.69063.94
15min123074-2307476.73773.992.5677.3474.612.51
222543-2254374.97175.57
322581-2258175.09875.72
421879-2187972.76373.41
521694-2169472.14872.82
621709-2170972.19872.80
20min123657-2365778.67677.402.3079.7178.442.26
223728-2372878.91279.93
323718-2371878.87979.92
422384-2238474.44275.49
523126-2312676.91077.98
623032-2303276.59777.60
30min124913-2491382.85382.541.1484.3284.011.12
225042-2504283.28284.74
325121-2512183.54585.02
424337-2433780.93782.40
524702-2470282.15183.65
624802-2480282.48483.92
45min126802-2680289.13587.711.9891.0789.641.95
226844-2684489.27591.20
326087-2608786.75788.70
425496-2549684.79286.70
526687-2668788.75390.71
626328-2632887.55989.45
60min127237-2723790.58288.651.5993.0191.061.57
227040-2704089.92792.34
326338-2633887.59290.02
426142-2614286.94089.32
526732-2673288.90391.35
626452-2645287.97190.35
极限127094-2709490.10689.381.3993.0492.281.37
227235-2723590.57593.49
327228-2722890.55293.46
426528-2652888.22491.09
526807-2680789.15292.09
626360-2636087.66590.53
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%
111.154450014446814437664448074453174447140.14
2 11.094434594414414424500.33
单位质量响应值RSD%判断
39884.6639896.300.03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%
5min1101358-10135822.86823.877.3022.8723.867.30
297930-9793022.09522.09
3109391-10939124.68124.68
4119010-11901026.85126.85
5100489-10048922.67222.67
6106485-10648524.02524.02
10min1202358-20235845.65648.8010.8945.7848.9410.88
2182047-18204741.07341.20
3217961-21796149.17649.31
4252009-25200956.85857.01
5215973-21597348.72748.85
6227542-22754251.33851.47
15min1278558-27855862.84866.088.7763.2366.498.77
2270762-27076261.08961.44
3294883-29488366.53166.94
4335483-33548375.69176.16
5269520-26952060.80861.21
6308205-30820569.53769.96
20min1308023-30802369.49576.047.3870.2376.817.39
2312878-31287870.59171.28
3344610-34461077.75078.53
4372563-37256384.05784.94
5329824-32982474.41475.15
6354151-35415179.90380.71
30min1363572-36357282.02888.816.4483.1490.006.46
2366989-36698982.79983.88
3413945-41394593.39394.61
4419929-41992994.74396.10
5383816-38381686.59687.74
6413419-41341993.27594.52
45min1422037-42203795.21997.213.7496.7998.903.77
2403377-40337791.00992.55
3448789-448789101.255102.99
4438856-43885699.014100.89
5432900-43290097.67099.30
6439246-43924699.102100.87
60min1423953-42395395.65197.482.4597.7599.712.52
2417907-41790794.28796.34
3446737-446737100.792103.09
4440369-44036999.355101.78
5429606-42960696.92799.10
6433731-43373197.857100.18
极限1422212-42221295.25996.963.2997.8999.733.33
2412062-41206292.96895.54
3451272-451272101.815104.67
4440982-44098299.493102.47
5423735-42373595.60298.31
6428308-42830896.63499.50
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