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%
115.187064570094702587022770555703560.34
215.207049370453704730.05
单位质量响应值RSD%判断
4634.784636.380.03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%
5min13989-39894.8315.4622.544.835.4622.52
23403-34034.1214.12
33457-34574.1864.19
45577-55776.7546.75
55563-55636.7376.74
65063-50636.1316.13
10min113743-1374316.64318.179.9716.6518.189.98
213584-1358416.45016.46
313904-1390416.83816.84
416225-1622519.64919.66
515413-1541318.66518.68
617172-1717220.79620.81
15min122539-2253927.29529.268.7827.3329.308.78
222803-2280327.61527.65
322714-2271427.50727.54
425163-2516330.47330.52
523736-2373628.74528.79
627997-2799733.90533.95
20min129007-2900735.12837.287.6335.2137.367.63
229796-2979636.08336.16
329303-2930335.48635.57
431477-3147738.11938.21
529869-2986936.17236.26
635243-3524342.68042.78
30min138651-3865146.80748.696.1046.9548.846.10
239467-3946747.79547.94
338702-3870246.86947.01
440362-4036248.87949.04
539006-3900647.23747.39
645038-4503854.54254.71
45min147901-4790158.00959.675.2458.2359.905.25
248586-4858658.83859.06
347668-4766857.72757.94
449243-4924359.63459.87
547839-4783957.93458.16
654402-5440265.88266.14
60min154172-5417265.60366.914.7565.9267.244.76
255041-5504166.65566.97
353511-5351164.80365.12
454776-5477666.33466.67
553556-5355664.85765.18
660449-6044973.20573.58
极限158043-5804370.29171.024.1670.7171.464.17
258584-5858470.94671.38
357100-5710069.14969.57
457900-5790070.11870.57
556783-5678368.76569.20
663435-6343576.82177.32
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%
115.187014370396702647015070359702620.17
215.207087871027709520.15
单位质量响应值RSD%判断
4628.594667.890.60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%
5min14725-47255.7075.7215.105.715.7215.10
25459-54596.5936.59
34951-49515.9805.98
43639-36394.3954.39
54205-42055.0795.08
65444-54446.5756.57
10min112910-1291015.59215.165.9015.6015.175.89
212551-1255115.15815.17
312976-1297615.67215.68
411168-1116813.48813.50
512447-1244715.03315.04
613262-1326216.01716.03
15min120138-2013824.32123.762.9324.3623.792.93
219177-1917723.16123.20
319923-1992324.06224.10
418747-1874722.64122.67
519914-1991424.05124.08
620132-2013224.31424.35
20min126108-2610831.53230.812.5931.6130.892.59
224628-2462829.74429.82
325808-2580831.16931.25
424719-2471929.85429.92
525847-2584731.21631.29
625963-2596331.35631.43
30min134783-3478342.00941.261.9342.1441.391.93
233133-3313340.01640.14
334787-3478742.01442.14
433652-3365240.64340.76
534252-3425241.36741.49
634392-3439241.53641.67
45min142921-4292151.83751.791.7552.0451.991.74
242083-4208350.82551.02
344213-4421353.39853.60
443056-4305652.00052.19
542326-4232651.11951.31
642700-4270051.57051.77
60min148563-4856358.65159.031.8358.9459.321.82
247875-4787557.82058.10
350470-5047060.95461.24
449248-4924859.47959.75
548515-4851558.59358.87
648610-4861058.70858.99
极限151888-5188862.66763.062.1163.0563.442.11
251307-5130761.96562.34
354143-5414365.39065.78
452529-5252963.44163.81
551073-5107361.68362.06
652341-5234163.21463.60
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%
115.187027270686702537036770434704020.25
215.207034769833700900.52
单位质量响应值RSD%判断
4637.814611.180.41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%
5min18877-887710.7767.5122.8010.787.5122.83
26155-61557.4727.47
36147-61477.4627.46
45795-57957.0357.03
55201-52016.3146.31
64931-49315.9865.99
10min121633-2163326.26118.5921.2626.2818.6021.27
214351-1435117.42117.43
314052-1405217.05817.07
414894-1489418.08018.09
514818-1481817.98818.00
612135-1213514.73114.74
15min131301-3130137.99729.0916.9938.0629.1417.00
222030-2203026.74326.78
322008-2200826.71626.76
424774-2477430.07430.12
524257-2425729.44629.49
619410-1941023.56223.60
20min137755-3775545.83237.0813.6745.9637.1713.68
228513-2851334.61334.70
327832-2783233.78633.87
432408-3240839.34139.43
530697-3069737.26437.35
626063-2606331.63931.71
30min147708-4770857.91448.4512.2358.1248.6112.25
237689-3768945.75245.90
336178-3617843.91744.06
442552-4255251.65551.81
541028-4102849.80549.96
634325-3432541.66841.79
45min156319-5631968.36759.829.7668.6760.069.78
247391-4739157.52957.75
344638-4463854.18754.40
452747-5274764.03164.27
550537-5053761.34861.58
644055-4405553.47953.68
60min162803-6280376.23867.559.0276.6567.889.04
253845-5384565.36465.68
350634-5063461.46661.77
459433-5943372.14772.50
556998-5699869.19169.53
650163-5016360.89461.18
极限166563-6656380.80371.838.5981.3472.288.61
257386-5738669.66270.09
353889-5388965.41765.82
462911-6291176.36976.84
560385-6038573.30373.76
653903-5390365.43465.82
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