坎地沙坦酯氨氯地平片项目信息
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%
115.187132771184713987132071455713370.15
215.207166771643716550.03
单位质量响应值RSD%判断
4699.414714.140.23数据可信
中间条件24月-供试品溶液-2023022521批-shui(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%
5min14923-49235.8726.249.495.876.249.47
24381-43815.2255.23
35524-55246.5886.59
45451-54516.5016.50
55356-53566.3886.39
65743-57436.8506.85
10min112738-1273815.19317.388.9815.2017.408.98
213095-1309515.61815.63
315272-1527218.21518.23
415073-1507317.97817.99
515629-1562918.64118.65
615648-1564818.66318.67
15min119412-1941223.15326.558.2323.1926.598.23
220609-2060924.58024.62
323199-2319927.66927.71
422713-2271327.09027.13
523920-2392028.52928.57
623705-2370528.27328.32
20min124814-2481429.59633.506.9729.6733.586.97
226623-2662331.75331.83
329115-2911534.72534.81
428688-2868834.21634.30
529633-2963335.34335.43
629657-2965735.37235.46
30min133566-3356640.03444.125.3640.1644.265.36
235664-3566442.53642.67
338275-3827545.65145.80
437613-3761344.86145.00
538411-3841145.81345.96
638438-3843845.84545.99
45min142735-4273550.97054.853.9651.1655.063.97
244981-4498153.64953.85
347309-4730956.42556.65
446730-4673055.73555.95
546702-4670255.70155.93
647449-4744956.59256.82
60min149127-4912758.59462.013.0558.8762.313.06
251273-5127361.15361.44
353055-5305563.27963.59
452652-5265262.79863.11
552388-5238862.48362.80
653443-5344363.74164.06
极限152403-5240362.50166.122.9062.8766.522.91
255002-5500265.60165.99
356459-5645967.33967.76
456020-5602066.81567.23
555950-5595066.73167.15
656778-5677867.71968.14
坎地沙坦酯氨氯地平片项目信息
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%
115.187114171358714447134671294713170.16
215.207178371603716930.18
单位质量响应值RSD%判断
4698.094716.640.28数据可信
中间条件24月-供试品溶液-2023022721批-shui(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%
5min16777-67778.0825.7222.618.085.7122.60
24010-40104.7824.78
35025-50255.9935.99
43696-36964.4084.41
54596-45965.4815.48
64649-46495.5445.54
10min115819-1581918.86515.3112.3018.8815.3212.32
212157-1215714.49814.51
312488-1248814.89314.90
411125-1112513.26713.27
512847-1284715.32115.33
612598-1259815.02415.03
15min123475-2347527.99524.188.1328.0424.228.14
219845-1984523.66623.70
319975-1997523.82123.86
418626-1862622.21222.24
519974-1997423.82023.85
619771-1977123.57823.61
20min129159-2915934.77431.196.2734.8731.266.29
226063-2606331.08131.15
325966-2596630.96631.04
424143-2414328.79228.86
525920-2592030.91130.99
625652-2565230.59130.66
30min137937-3793745.24241.624.6845.3941.754.70
234777-3477741.47341.60
334777-3477741.47341.60
432999-3299939.35339.47
534676-3467641.35341.48
634252-3425240.84740.97
45min146528-4652855.48752.303.3455.7152.493.35
243813-4381352.24952.44
344045-4404552.52652.72
442319-4231950.46850.65
543582-4358251.97452.17
642823-4282351.06951.26
60min152235-5223562.29359.592.7262.6159.872.74
250103-5010359.75060.03
349816-4981659.40859.69
448451-4845157.78058.04
550456-5045660.17160.45
648744-4874458.13058.41
极限155575-5557566.27663.632.4366.7064.012.44
253373-5337363.65064.03
353253-5325363.50763.89
452251-5225162.31262.67
553749-5374964.09864.48
651931-5193161.93062.30
坎地沙坦酯氨氯地平片项目信息
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%
115.187166971615716937154371610716260.09
215.207148071717715980.24
单位质量响应值RSD%判断
4718.454710.390.13数据可信
中间条件24月-供试品溶液-2023022821批-shui(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%
5min16967-69678.2967.6714.138.307.6714.15
25514-55146.5666.57
37496-74968.9268.93
45183-51836.1726.17
56489-64897.7277.73
66994-69948.3288.33
10min115354-1535418.28317.5011.8418.3017.5111.84
213535-1353516.11716.13
317021-1702120.26820.28
412053-1205314.35214.36
514531-1453117.30317.32
615660-1566018.64718.66
15min122982-2298227.36626.537.3027.4126.577.32
221376-2137625.45425.49
324437-2443729.09929.15
419825-1982523.60723.64
521784-2178425.94025.98
623271-2327127.71027.76
20min128790-2879034.28233.416.3334.3733.506.34
227448-2744832.68432.76
330302-3030236.08236.18
425311-2531130.13930.21
527212-2721232.40332.49
629307-2930734.89834.99
30min138181-3818145.46444.284.8445.6144.424.85
237052-3705244.12044.25
339414-3941446.93347.09
434346-3434640.89841.02
536047-3604742.92343.06
638095-3809545.36245.51
45min146928-4692855.88054.803.3056.1055.013.30
246396-4639655.24755.45
347481-4748156.53956.77
443441-4344151.72851.92
545010-4501053.59653.81
646850-4685055.78756.01
60min153629-5362963.85962.412.9864.1862.722.98
253648-5364863.88264.18
353334-5333463.50863.84
449834-4983459.34059.62
551207-5120760.97561.28
652825-5282562.90263.22
极限156365-5636567.11766.262.3067.5466.672.31
256646-5664667.45267.86
356845-5684567.68968.12
453552-5355263.76864.14
554742-5474265.18565.59
655735-5573566.36766.79
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