坎地沙坦酯氢氯噻嗪片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)0
对照品批号100309-202205对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.7对照品水分(%)0对照品稀释倍数2000
标示量(mg)6.25供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111004100623697623704723695814259890.65
212363222369492366360.19
单位质量响应值RSD%判断
142598.00236636.0035.07数据不可信!(响应值差异过大,请重新称样测定!)
中间条件36月-供试品溶液-2023021221批-氢氯噻嗪-pH6.8(内含0.1%Tween)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min188009-880093.5504.3117.593.554.3117.64
292577-925773.7343.73
389310-893103.6033.60
4120025-1200254.8424.84
5121743-1217434.9114.91
6129296-1292965.2155.22
10min1230850-2308509.3129.656.059.329.666.05
2222566-2225668.9788.98
3225993-2259939.1169.12
4251276-25127610.13610.14
5248124-24812410.00910.02
6256452-25645210.34510.35
15min1266558-26655810.75210.860.6610.7710.880.68
2268149-26814910.81710.84
3270646-27064610.91710.94
4269246-26924610.86110.89
5269144-26914410.85710.88
6271487-27148710.95110.98
20min1267665-26766510.79710.900.6010.8410.940.59
2270316-27031610.90410.94
3271870-27187010.96711.01
4269689-26968910.87910.92
5269565-26956510.87410.92
6271882-27188210.96711.01
30min1266872-26687210.76510.890.6410.8210.940.65
2269763-26976310.88210.94
3271540-27154010.95311.01
4270156-27015610.89710.96
5269363-26936310.86510.93
6271477-27147710.95111.01
45min1266721-26672110.75910.880.6110.8310.950.62
2269681-26968110.87810.95
3271097-27109710.93511.01
4270284-27028410.90310.98
5268900-26890010.84710.93
6270951-27095110.93011.01
60min1266238-26623810.73910.860.6210.8310.950.62
2269186-26918610.85810.95
3270626-27062610.91611.01
4269908-26990810.88710.98
5268643-26864310.83610.93
6270554-27055410.91411.01
极限1265926-26592610.72710.840.6210.8410.960.63
2269025-26902510.85210.96
3270559-27055910.91411.03
4269115-26911510.85510.97
5267893-26789310.80610.92
6269919-26991910.88811.01
坎地沙坦酯氢氯噻嗪片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)0
对照品批号100685-201903对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.8对照品水分(%)0对照品稀释倍数2000
标示量(mg)8供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
1123681623685576857769887681214086662.20
217690376833768680.07
单位质量响应值RSD%判断
140866.0076868.0041.57数据不可信!(响应值差异过大,请重新称样测定!)
中间条件36月-供试品溶液-2023021221批-坎地沙坦酯-pH6.8(内含0.1%Tween)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min111929-119290.6730.8318.900.670.8318.86
212970-129700.7320.73
311796-117960.6660.67
416836-168360.9500.95
516784-167840.9470.95
617961-179611.0141.01
10min141505-415052.3432.477.952.342.477.98
240748-407482.3002.30
339803-398032.2472.25
446560-465602.6282.63
546116-461162.6032.60
647933-479332.7052.71
15min160228-602283.3993.492.813.403.502.88
260387-603873.4083.41
360475-604753.4133.42
463108-631083.5623.57
562661-626613.5373.54
664312-643123.6303.64
20min168738-687383.8803.951.503.893.961.52
269344-693443.9143.92
369635-696353.9303.94
471192-711924.0184.03
570057-700573.9543.97
671401-714014.0304.04
30min175360-753604.2534.351.324.274.371.34
277155-771554.3554.37
377642-776424.3824.40
477781-777814.3904.41
576570-765704.3224.34
678111-781114.4094.43
45min178680-786804.4414.561.684.474.591.69
280855-808554.5644.59
382227-822274.6414.67
481573-815734.6044.63
579657-796574.4964.52
681685-816854.6104.64
60min179335-793354.4784.591.434.514.621.42
281656-816564.6094.64
382139-821394.6364.67
482206-822064.6404.67
580596-805964.5494.58
682163-821634.6374.67
极限179753-797534.5014.591.294.544.631.28
281521-815214.6014.64
382718-827184.6694.71
481635-816354.6084.65
580596-805964.5494.59
681895-818954.6224.66
坎地沙坦酯氢氯噻嗪片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)0
对照品批号100309-202205对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.7对照品水分(%)0对照品稀释倍数2000
标示量(mg)6.25供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
112375852372792370142370702371472372190.10
212376522377892377200.05
单位质量响应值RSD%判断
237219.00237720.000.15数据可信
中间条件36月-供试品溶液-2023021321批-氢氯噻嗪-pH6.8(内含0.1%Tween)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1107977-1079773.2643.317.693.263.307.69
297615-976152.9512.95
3119649-1196493.6173.62
4112907-1129073.4133.41
5115807-1158073.5013.50
6102096-1020963.0863.09
10min1241326-2413267.2957.267.167.307.267.14
2241446-2414467.2997.30
3259876-2598767.8567.86
4257535-2575357.7857.79
5218656-2186566.6106.62
6222206-2222066.7176.72
15min1269636-2696368.1518.241.068.178.261.08
2277532-2775328.3898.41
3273814-2738148.2778.30
4272694-2726948.2438.26
5270141-2701418.1668.18
6271665-2716658.2128.23
20min1270386-2703868.1738.271.018.208.301.01
2278212-2782128.4108.44
3274076-2740768.2858.32
4273288-2732888.2618.29
5271174-2711748.1978.23
6273983-2739838.2828.31
30min1270896-2708968.1898.271.048.238.311.05
2278361-2783618.4158.46
3274070-2740708.2858.33
4273526-2735268.2688.31
5270422-2704228.1758.22
6273333-2733338.2638.31
45min1270247-2702478.1698.271.118.238.331.10
2278584-2785848.4218.48
3274866-2748668.3098.37
4272700-2727008.2438.30
5271077-2710778.1948.25
6274398-2743988.2958.35
60min1269743-2697438.1548.251.098.238.331.05
2277899-2778998.4018.47
3274886-2748868.3098.38
4272426-2724268.2358.31
5270726-2707268.1848.26
6272677-2726778.2438.31
极限1270100-2701008.1658.241.008.258.330.97
2277146-2771468.3788.46
3274060-2740608.2848.37
4271526-2715268.2088.30
5269975-2699758.1618.25
6272653-2726538.2428.33
坎地沙坦酯氢氯噻嗪片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)0
对照品批号100685-201903对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.8对照品水分(%)0对照品稀释倍数2000
标示量(mg)8供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
117712977101768997679376785769410.22
217733977194772660.14
单位质量响应值RSD%判断
76941.0077266.000.30数据可信
中间条件36月-供试品溶液-2023021321批-坎地沙坦酯-pH6.8(内含0.1%Tween)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min113752-137521.0011.059.831.001.049.85
212782-127820.9310.93
316099-160991.1721.17
415015-150151.0931.09
515699-156991.1431.14
612979-129790.9450.94
10min143042-430423.1343.186.863.143.186.84
242502-425023.0943.10
347925-479253.4893.49
446635-466353.3953.40
541810-418103.0443.05
640112-401122.9202.92
15min161392-613924.4704.542.754.484.552.72
263142-631424.5974.60
364869-648694.7234.73
463377-633774.6144.62
560932-609324.4364.44
660414-604144.3994.41
20min169708-697085.0755.151.625.095.171.63
271810-718105.2285.24
372450-724505.2755.29
470811-708115.1565.17
569633-696335.0705.08
670279-702795.1175.13
30min177141-771415.6175.681.185.645.701.19
279323-793235.7755.80
378826-788265.7395.76
477724-777245.6595.68
577053-770535.6105.63
677746-777465.6615.68
45min180194-801945.8395.931.385.875.971.38
283325-833256.0676.10
382060-820605.9756.01
480807-808075.8835.92
580830-808305.8855.92
681632-816325.9435.98
60min180882-808825.8895.981.185.936.021.17
283652-836526.0916.13
382381-823815.9986.04
481437-814375.9295.97
581870-818705.9616.00
682481-824816.0056.05
极限181804-818045.9566.011.316.016.061.32
284433-844336.1476.20
382577-825776.0126.07
481709-817095.9496.00
581608-816085.9425.99
682912-829126.0376.09
坎地沙坦酯氢氯噻嗪片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)0
对照品批号100309-202205对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.7对照品水分(%)0对照品稀释倍数2000
标示量(mg)6.25供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
112373402373412370102373272370252372090.08
212412922413412413160.02
单位质量响应值RSD%判断
237209.00241316.001.22数据可信
中间条件36月-供试品溶液-2023021321批-氢氯噻嗪-pH6.8(内含0.1%Tween)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1101791-1017913.0543.5411.553.053.5411.55
2116187-1161873.4863.49
3142753-1427534.2834.28
4111013-1110133.3313.33
5118779-1187793.5643.56
6117702-1177023.5323.53
10min1221418-2214186.6447.355.636.657.365.63
2261389-2613897.8437.85
3255700-2557007.6727.68
4242715-2427157.2837.29
5246148-2461487.3867.39
6242977-2429777.2907.30
15min1265973-2659737.9808.171.268.008.191.25
2272762-2727628.1848.20
3273766-2737668.2148.23
4272637-2726378.1808.20
5272797-2727978.1858.20
6276296-2762968.2908.31
20min1269002-2690028.0718.180.668.108.210.69
2272770-2727708.1848.22
3274058-2740588.2238.26
4273301-2733018.2008.23
5272856-2728568.1878.22
6273280-2732808.2008.23
30min1268533-2685338.0578.170.738.108.220.74
2273075-2730758.1938.24
3274150-2741508.2268.27
4273049-2730498.1938.24
5272956-2729568.1908.24
6272936-2729368.1898.23
45min1269112-2691128.0758.180.708.138.240.72
2272967-2729678.1908.25
3274920-2749208.2498.31
4272999-2729998.1918.25
5272855-2728558.1878.25
6273137-2731378.1958.25
60min1268669-2686698.0618.170.698.138.240.70
2272749-2727498.1848.26
3274151-2741518.2268.30
4272415-2724158.1748.25
5272070-2720708.1638.24
6272817-2728178.1868.26
极限1268548-2685488.0588.150.698.148.240.70
2271997-2719978.1618.25
3273585-2735858.2098.30
4270614-2706148.1208.21
5272478-2724788.1768.26
6273056-2730568.1938.28
坎地沙坦酯氢氯噻嗪片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)0
对照品批号100685-201903对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.8对照品水分(%)0对照品稀释倍数2000
标示量(mg)8供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
117726376859770067707576827770060.23
217935979377793680.02
单位质量响应值RSD%判断
77006.0079368.002.14数据不可信!(响应值差异过大,请重新称样测定!)
中间条件36月-供试品溶液-2023021321批-坎地沙坦酯-pH6.8(内含0.1%Tween)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min114174-141741.0181.1611.231.021.1611.21
215535-155351.1161.12
319319-193191.3871.39
414838-148381.0661.07
516183-161831.1621.16
616788-167881.2061.21
10min141850-418503.0053.275.623.013.285.60
248127-481273.4563.46
348646-486463.4943.50
443923-439233.1543.16
545678-456783.2803.28
645310-453103.2543.26
15min160349-603494.3344.532.384.344.542.42
264463-644634.6294.64
364288-642884.6174.63
462526-625264.4904.50
563352-633524.5504.56
663137-631374.5344.54
20min169272-692724.9755.101.544.995.121.51
271506-715065.1355.15
372533-725335.2095.22
470506-705065.0635.08
571299-712995.1205.14
670962-709625.0965.11
30min175637-756375.4325.571.395.455.601.41
278187-781875.6155.64
378650-786505.6485.67
477434-774345.5615.58
578267-782675.6215.64
677458-774585.5635.59
45min178959-789595.6705.821.405.705.861.43
281369-813695.8445.88
382220-822205.9055.94
480905-809055.8105.84
581403-814035.8465.88
681652-816525.8645.90
60min180281-802815.7655.870.995.815.920.98
281766-817665.8725.92
382612-826125.9335.98
481518-815185.8545.90
582059-820595.8935.94
682161-821615.9005.94
极限180149-801495.7565.871.195.815.921.19
282287-822875.9095.96
382626-826265.9345.99
480924-809245.8125.86
582234-822345.9065.96
682116-821165.8975.95
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