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%
1 16.133938139142391893929239275392560.24
2 16.103996239837399000.23
单位质量响应值RSD%判断
2433.732478.261.29数据可信
供试品溶液-2025030421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%
5min14286-42869.7978.1117.519.808.1117.52
24239-42399.6909.69
33247-32477.4227.42
42690-26906.1496.15
53265-32657.4647.46
63563-35638.1458.14
10min16737-673715.40013.1116.0715.4213.1316.06
25643-564312.89912.92
35203-520311.89411.91
44633-463310.59110.60
55247-524711.99412.01
66959-695915.90815.92
15min111293-1129325.81522.2014.7525.8622.2414.75
29764-976422.32022.36
38836-883620.19820.23
48107-810718.53218.56
58712-871219.91519.95
611556-1155626.41626.46
20min115127-1512734.57930.8611.3934.6630.9311.40
213624-1362431.14331.22
312976-1297629.66229.73
411316-1131625.86825.93
512619-1261928.84628.91
615326-1532635.03435.12
30min121241-2124148.55545.317.0048.7045.437.03
220162-2016246.08946.22
319610-1961044.82744.94
417665-1766540.38140.48
518979-1897943.38543.50
621267-2126748.61548.76
45min127616-2761663.12860.674.7763.3560.874.79
227190-2719062.15462.36
326475-2647560.52060.71
424384-2438455.74055.91
525882-2588259.16459.35
627698-2769863.31563.54
60min131846-3184672.79770.923.4473.1371.223.46
231991-3199173.12973.44
331139-3113971.18171.47
429201-2920166.75167.01
530374-3037469.43369.72
631589-3158972.21072.54
极限133878-3387877.44276.593.3177.8977.013.32
234766-3476679.47279.90
334078-3407877.90078.31
431641-3164172.32972.70
532815-3281575.01375.41
633853-3385377.38577.83
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%
1 16.133952239515392663946139393394310.27
2 16.103937539372393740.01
单位质量响应值RSD%判断
2444.582445.590.03数据可信
供试品溶液-2025030421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%
5min14904-490411.2598.2223.6111.268.2223.60
23795-37958.7138.71
32728-27286.2636.26
44104-41049.4239.42
52869-28696.5876.59
63069-30697.0467.05
10min15897-589713.53912.3412.6113.5612.3512.62
26105-610514.01714.03
34719-471910.83510.84
45399-539912.39612.41
55722-572213.13713.15
64406-440610.11610.13
15min110556-1055624.23622.3812.3024.2822.4112.30
210983-1098325.21625.25
38256-825618.95518.98
410326-1032623.70823.74
510133-1013323.26523.30
68234-823418.90518.93
20min114588-1458833.49331.489.3733.5731.559.38
215205-1520534.91034.99
312063-1206327.69627.76
414304-1430432.84132.92
513862-1386231.82631.90
612242-1224228.10728.17
30min120679-2067947.47846.665.4247.6246.785.44
221705-2170549.83349.97
318735-1873543.01443.12
420850-2085047.87048.00
520691-2069147.50547.63
619278-1927844.26144.37
45min127397-2739762.90262.374.1563.1262.574.16
228860-2886066.26166.48
325779-2577959.18759.36
427545-2754563.24263.45
527384-2738462.87263.08
626027-2602759.75659.94
60min131752-3175272.90173.132.9573.2273.442.96
233042-3304275.86276.19
330292-3029269.54869.83
432339-3233974.24874.56
532232-3223274.00374.31
631463-3146372.23772.52
极限133859-3385977.73878.022.7178.1878.452.72
235256-3525680.94581.40
332684-3268475.04075.43
434241-3424178.61579.05
534570-3457079.37079.80
633291-3329176.43476.83
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%
1 16.133959739342393463951539104393810.49
2 16.103937339388393800.03
单位质量响应值RSD%判断
2441.482445.960.13数据可信
供试品溶液-KC031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%
5min12847-28476.5402.94110.276.542.94110.27
22463-24635.6585.66
32364-23645.4315.43
4-0.0000.00
5-0.0000.00
6-0.0000.00
10min13816-38168.7668.036.708.788.046.74
23573-35738.2088.22
33473-34737.9787.99
43468-34687.9677.97
53548-35488.1518.15
63094-30947.1087.11
15min17388-738816.97215.486.3617.0015.506.39
27086-708616.27816.30
36529-652914.99915.02
46620-662015.20815.22
56636-663615.24415.26
66185-618514.20814.22
20min111901-1190127.33924.177.8927.3924.227.89
210897-1089725.03325.08
39829-982922.57922.63
410430-1043023.96024.00
510512-1051224.14824.19
69567-956721.97722.01
30min119228-1922844.17140.066.1244.2740.146.13
217959-1795941.25641.35
316492-1649237.88637.97
417127-1712739.34439.42
517493-1749340.18540.26
616338-1633837.53237.60
45min126495-2649560.86558.132.7061.0458.282.71
225589-2558958.78458.94
324607-2460756.52856.68
425010-2501057.45357.60
525327-2532758.18258.33
624803-2480356.97857.11
60min131491-3149172.34269.662.1272.6269.912.13
230442-3044269.93270.19
329595-2959567.98668.23
430201-3020169.37869.62
530221-3022169.42469.67
629987-2998768.88769.12
极限133543-3354377.05674.881.6877.4575.241.69
232542-3254274.75675.13
331838-3183873.13973.49
432495-3249574.64875.00
532626-3262674.94975.31
632535-3253574.74075.08
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%
1 16.133994239388397583977439626396980.52
2 16.103958340021398020.78
单位质量响应值RSD%判断
2461.132472.170.32数据可信
供试品溶液-KC031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%
5min12566-25665.8403.4978.535.843.4978.53
22467-24675.6155.61
3-0.0000.00
4-0.0000.00
52045-20454.6544.65
62123-21234.8324.83
10min13741-37418.5148.575.988.528.586.00
24161-41619.4709.48
33778-37788.5988.60
43719-37198.4648.46
53737-37378.5058.51
63460-34607.8757.88
15min16749-674915.36016.816.9715.3816.836.97
28188-818818.63518.66
37652-765217.41517.43
47544-754417.16917.18
57039-703916.02016.04
67144-714416.25916.28
20min110388-1038823.64226.006.8723.6926.056.85
212104-1210427.54727.60
312240-1224027.85727.90
411968-1196827.23827.28
510723-1072324.40424.45
611131-1113125.33325.38
30min117324-1732439.42742.124.5039.5242.224.50
219108-1910843.48743.59
319053-1905343.36243.45
419247-1924743.80443.89
517604-1760440.06440.15
618718-1871842.60042.69
45min125119-2511957.16859.062.5457.3259.222.55
226715-2671560.80060.97
326228-2622859.69259.85
426467-2646760.23560.40
525209-2520957.37257.53
625971-2597159.10759.27
60min130148-3014868.61370.221.4168.8670.481.41
231259-3125971.14171.42
330798-3079870.09270.35
431358-3135871.36771.63
530813-3081370.12670.38
630739-3073969.95870.22
极限132224-3222473.33874.831.5773.7075.201.58
233551-3355176.35876.75
332755-3275574.54674.92
433162-3316275.47275.85
532381-3238173.69574.06
633193-3319375.54375.92
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