奥美沙坦酯左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100546-202105对照品来源中检院对照品使用方法直接使用
对照品含量(%)97.3对照品水分(%)0对照品稀释倍数4000
标示量(mg)2.5供试品稀释倍数1系数0.7210
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.221779817762176241777817778177480.40
211.241827917848180641.69
单位质量响应值RSD%判断
1581.821607.121.13数据可信
供试品溶液-SA017YA批-左氨氯地平-pH4.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min111267-1126744.61847.119.3244.6247.119.31
211229-1122944.46844.47
312158-1215848.14648.15
412187-1218748.26148.26
510707-1070742.40042.40
613826-1382654.75254.75
10min119503-1950377.23378.733.3477.3178.803.35
219385-1938576.76676.84
319975-1997579.10279.18
420124-2012479.69279.77
519250-1925076.23176.30
621042-2104283.32883.42
15min124603-2460397.42996.992.0697.6397.192.07
224136-2413695.58095.78
324646-2464697.60097.81
424635-2463597.55697.77
523726-2372693.95694.15
625199-2519999.790100.02
20min127436-27436108.648108.941.96109.01109.321.96
226862-26862106.375106.74
327331-27331108.233108.61
428173-28173111.567111.94
527120-27120107.397107.75
628143-28143111.448111.84
30min131353-31353124.160123.981.66124.71124.531.67
230745-30745121.752122.29
331546-31546124.924125.48
431940-31940126.484127.05
530624-30624121.273121.81
631634-31634125.273125.85
45min134595-34595136.998137.570.99137.75138.330.99
234425-34425136.325137.07
334597-34597137.006137.77
435369-35369140.064140.84
534574-34574136.915137.65
634872-34872138.095138.89
60min137034-37034146.657146.241.22147.64147.231.22
236530-36530144.661145.63
336659-36659145.172146.16
437572-37572148.788149.79
536473-36473144.435145.40
637308-37308147.742148.76
极限138326-38326151.773152.100.93153.00153.330.93
238274-38274151.567152.78
337879-37879150.003151.24
438897-38897154.035155.29
538373-38373151.960153.16
638701-38701153.258154.53
奥美沙坦酯左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100864-202205对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.8对照品水分(%)0对照品稀释倍数500
标示量(mg)20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%
111.222303272310192301892311242310262307370.20
211.222338642346022342330.23
单位质量响应值RSD%判断
20564.8020876.381.07数据可信
供试品溶液-SA017YA批-奥美沙坦酯-pH4.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1-0.0000.00-0.000.00-
2-0.0000.00
3-0.0000.00
4-0.0000.00
5-0.0000.00
6-0.0000.00
10min1-0.0000.00-0.000.00-
2-0.0000.00
3-0.0000.00
4-0.0000.00
5-0.0000.00
6-0.0000.00
15min1-0.0000.00-0.000.00-
2-0.0000.00
3-0.0000.00
4-0.0000.00
5-0.0000.00
6-0.0000.00
20min1-0.0000.00-0.000.00-
2-0.0000.00
3-0.0000.00
4-0.0000.00
5-0.0000.00
6-0.0000.00
30min1-0.0000.00-0.000.00-
2-0.0000.00
3-0.0000.00
4-0.0000.00
5-0.0000.00
6-0.0000.00
45min1-0.0000.00-0.000.00-
2-0.0000.00
3-0.0000.00
4-0.0000.00
5-0.0000.00
6-0.0000.00
60min1-0.0000.00-0.000.00-
2-0.0000.00
3-0.0000.00
4-0.0000.00
5-0.0000.00
6-0.0000.00
极限1-0.0000.00-0.000.00-
2-0.0000.00
3-0.0000.00
4-0.0000.00
5-0.0000.00
6-0.0000.00
奥美沙坦酯左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100546-202105对照品来源中检院对照品使用方法直接使用
对照品含量(%)97.3对照品水分(%)0对照品稀释倍数4000
标示量(mg)2.5供试品稀释倍数1系数0.7210
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.221831717850180291788217905179971.07
211.241802517896179600.51
单位质量响应值RSD%判断
1604.011597.860.28数据可信
供试品溶液-SA017YA批-左氨氯地平-pH4.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min112377-1237748.81349.565.8648.8149.565.86
211972-1197247.21547.22
312355-1235548.72648.73
411793-1179346.51046.51
513215-1321552.11852.12
613687-1368753.97953.98
10min120072-2007279.16079.993.0479.2480.073.04
219564-1956477.15777.24
320273-2027379.95380.03
419763-1976377.94278.02
521042-2104282.98683.07
620978-2097882.73482.82
15min124207-2420795.46896.382.6695.6896.602.66
223809-2380993.89994.11
324347-2434796.02096.23
423830-2383093.98194.19
525388-25388100.126100.35
625052-2505298.80199.03
20min126721-26721105.383108.112.60105.76108.492.60
226874-26874105.986106.35
327296-27296107.651108.03
426994-26994106.460106.82
528242-28242111.382111.77
628352-28352111.815112.21
30min130650-30650120.878122.191.52121.43122.751.52
230678-30678120.989121.53
330776-30776121.375121.93
430633-30633120.811121.35
531511-31511124.274124.85
631652-31652124.830125.41
45min134502-34502136.070135.761.20136.82136.521.21
234002-34002134.098134.84
334125-34125134.583135.34
434147-34147134.670135.41
535078-35078138.342139.13
634681-34681136.776137.56
60min136557-36557144.174144.771.44145.15145.761.45
236349-36349143.354144.32
336200-36200142.767143.75
436462-36462143.800144.77
537590-37590148.248149.26
637092-37092146.284147.30
极限137610-37610148.327149.420.80149.54150.650.81
237549-37549148.087149.29
338100-38100150.260151.48
437814-37814149.132150.34
537896-37896149.455150.72
638353-38353151.258152.52
奥美沙坦酯左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100864-202205对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.8对照品水分(%)0对照品稀释倍数500
标示量(mg)20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%
111.222369942336292337782344022341202345850.59
211.222341162341152341160.01
单位质量响应值RSD%判断
20907.7520865.950.15数据可信
供试品溶液-SA017YA批-奥美沙坦酯-pH4.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1-0.0000.00-0.000.00-
2-0.0000.00
3-0.0000.00
4-0.0000.00
5-0.0000.00
6-0.0000.00
10min1-0.0000.00-0.000.00-
2-0.0000.00
3-0.0000.00
4-0.0000.00
5-0.0000.00
6-0.0000.00
15min1-0.0000.00-0.000.00-
2-0.0000.00
3-0.0000.00
4-0.0000.00
5-0.0000.00
6-0.0000.00
20min1-0.0000.00-0.000.00-
2-0.0000.00
3-0.0000.00
4-0.0000.00
5-0.0000.00
6-0.0000.00
30min1-0.0000.00-0.000.00-
2-0.0000.00
3-0.0000.00
4-0.0000.00
5-0.0000.00
6-0.0000.00
45min1-0.0000.00-0.000.00-
2-0.0000.00
3-0.0000.00
4-0.0000.00
5-0.0000.00
6-0.0000.00
60min1-0.0000.00-0.000.00-
2-0.0000.00
3-0.0000.00
4-0.0000.00
5-0.0000.00
6-0.0000.00
极限1-0.0000.00-0.000.00-
2-0.0000.00
3-0.0000.00
4-0.0000.00
5-0.0000.00
6-0.0000.00
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