坎地沙坦酯片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号100685-201903对照品来源中检所对照品使用方法直接使用
对照品含量(%)99.8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%
116.137822078953786887803278830785450.51
216.107843279460789460.93
单位质量响应值RSD%判断
4869.504903.480.50数据可信
供试品溶液-2025030221批-pH4.5(内含1%Tween80)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min12563-25632.9443.3720.432.943.3720.44
22939-29393.3763.38
32518-25182.8932.89
43702-37024.2534.25
53619-36194.1584.16
62279-22792.6182.62
10min15937-59376.8217.6220.476.837.6320.47
26681-66817.6757.68
35313-53136.1046.11
46958-69587.9948.00
59123-912310.48110.49
65803-58036.6676.67
15min112023-1202313.81314.6115.5613.8314.6315.55
212757-1275714.65614.67
310872-1087212.49012.51
412461-1246114.31614.34
516528-1652818.98819.01
611669-1166913.40613.42
20min119187-1918722.04322.2611.2622.0822.3111.27
219630-1963022.55222.59
317099-1709919.64419.68
418362-1836221.09521.14
523469-2346926.96227.02
618530-1853021.28821.33
30min131745-3174536.47035.825.8036.5535.905.82
231120-3112035.75235.83
329399-2939933.77533.84
429674-2967434.09134.17
534395-3439539.51539.62
630732-3073235.30635.38
45min144329-4432950.92750.652.1251.0650.792.13
243767-4376750.28250.42
342992-4299249.39149.52
443564-4356450.04850.18
545730-4573052.53752.70
644146-4414650.71750.85
60min153734-5373461.73261.361.0661.9561.581.07
252959-5295960.84261.07
352529-5252960.34860.55
453397-5339761.34561.56
553841-5384161.85562.11
653980-5398062.01562.23
极限158959-5895967.73567.300.8968.0667.630.89
258085-5808566.73167.06
358007-5800766.64166.95
458417-5841767.11267.43
558666-5866667.39867.76
659355-5935568.19068.51
坎地沙坦酯片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号100685-201903对照品来源中检所对照品使用方法直接使用
对照品含量(%)99.8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%
116.137898179323792957886778824790580.30
216.107903979557792980.47
单位质量响应值RSD%判断
4901.304925.340.35数据可信
供试品溶液-2025030221批-pH4.5(内含1%Tween80)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min12914-29143.3293.2910.793.333.2910.81
23223-32233.6823.68
32612-26122.9842.98
43280-32803.7483.75
52689-26893.0723.07
62571-25712.9382.94
10min16173-61737.0537.466.287.067.466.27
26218-62187.1047.11
36686-66867.6397.64
47257-72578.2928.30
56288-62887.1847.19
66529-65297.4607.46
15min112224-1222413.96714.347.6413.9814.357.65
211636-1163613.29513.31
312011-1201113.72313.74
414175-1417516.19616.22
512025-1202513.73913.76
613210-1321015.09315.11
20min118904-1890421.59922.046.1921.6422.086.19
218398-1839821.02121.06
318885-1888521.57721.62
421289-2128924.32424.37
518143-1814320.73020.77
620130-2013023.00023.04
30min130969-3096935.38435.724.2335.4635.804.24
231036-3103635.46135.54
330747-3074735.13035.21
433513-3351338.29138.38
529535-2953533.74633.82
631784-3178436.31536.40
45min144191-4419150.49150.452.1950.6350.592.20
244416-4441650.74850.88
343714-4371449.94650.08
445733-4573352.25352.40
542774-4277448.87249.00
644107-4410750.39550.54
60min153697-5369761.35261.021.7661.5761.241.76
254274-5427462.01262.23
352885-5288560.42460.64
454377-5437762.12962.37
551885-5188559.28259.49
653302-5330260.90161.13
极限159259-5925967.70767.311.4668.0367.631.46
259987-5998768.53968.86
358499-5849966.83967.16
459681-5968168.18968.53
557976-5797666.24166.55
658051-5805166.32766.65
坎地沙坦酯片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号100685-201903对照品来源中检所对照品使用方法直接使用
对照品含量(%)99.8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%
116.138000879666787737967279427795090.58
216.107934980140797440.71
单位质量响应值RSD%判断
4929.264953.040.35数据可信
供试品溶液-12412515批-pH4.5(内含1%Tween80)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min12539-25392.8853.3227.892.883.3227.93
22788-27883.1683.17
32405-24052.7322.73
42193-21932.4922.49
53185-31853.6193.62
64436-44365.0405.04
10min16246-62467.0967.7115.577.107.7115.57
26427-64277.3027.31
36059-60596.8846.89
46130-61306.9646.97
57013-70137.9687.97
68821-882110.02210.03
15min113321-1332115.13415.209.5015.1515.229.51
212652-1265214.37414.39
312644-1264414.36514.38
412115-1211513.76413.78
513891-1389115.78215.80
615645-1564517.77517.80
20min120729-2072923.55123.889.2023.5923.939.21
219454-1945422.10222.14
320558-2055823.35723.40
419118-1911821.72021.76
521846-2184624.82024.87
624431-2443127.75727.81
30min135148-3514839.93339.725.6540.0139.805.66
233136-3313637.64737.72
334247-3424738.90938.99
432847-3284737.31837.39
536439-3643941.39941.49
637947-3794743.11343.21
45min149743-4974356.51456.482.9456.6656.632.95
248812-4881255.45755.60
349392-4939256.11656.26
447748-4774854.24854.38
550624-5062457.51557.67
651955-5195559.02859.20
60min159309-5930967.38367.411.9067.6267.661.92
258881-5888166.89667.13
359269-5926967.33767.57
457616-5761665.45965.69
559935-5993568.09468.35
661011-6101169.31669.59
极限163959-6395972.66672.661.1873.0273.021.19
263684-6368472.35372.70
363845-6384572.53672.89
462978-6297871.55171.89
563976-6397672.68573.05
665284-6528474.17174.56
坎地沙坦酯片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号100685-201903对照品来源中检所对照品使用方法直接使用
对照品含量(%)99.8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%
116.137893179342787807924279163790920.30
216.107988279661797720.20
单位质量响应值RSD%判断
4903.414954.780.74数据可信
供试品溶液-12412515批-pH4.5(内含1%Tween80)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min12707-27073.0833.208.613.083.208.64
22790-27903.1783.18
32633-26332.9993.00
43291-32913.7483.75
52716-27163.0933.09
62710-27103.0873.09
10min16272-62727.1437.4112.337.157.4212.30
27812-78128.8978.90
35739-57396.5366.54
47152-71528.1468.15
56068-60686.9116.92
66000-60006.8346.84
15min113291-1329115.13814.989.7115.1515.009.72
215348-1534817.48017.50
311930-1193013.58713.60
413735-1373515.64315.66
512121-1212113.80513.82
612508-1250814.24614.26
20min121658-2165824.66723.8410.3224.7123.8810.32
224531-2453127.93927.99
318500-1850021.07021.11
421550-2155024.54424.59
519226-1922621.89721.94
620136-2013622.93422.97
30min135358-3535840.27039.635.5440.3539.725.55
238010-3801043.29143.39
332356-3235636.85136.92
435303-3530340.20840.29
533768-3376838.45938.54
633998-3399838.72138.80
45min149998-4999856.94456.443.0557.0956.593.06
251979-5197959.20159.37
347370-4737053.95154.09
449732-4973256.64156.80
549405-4940556.26956.41
648859-4885955.64755.79
60min159053-5905367.25767.372.0667.5067.612.07
261070-6107069.55569.82
357521-5752165.51265.74
459228-5922867.45767.70
559701-5970167.99568.23
658315-5831566.41766.65
极限163903-6390372.78172.441.8973.1472.801.89
264940-6494073.96274.34
362256-6225670.90571.24
463397-6339772.20572.57
564888-6488873.90374.25
662259-6225970.90971.26
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