阿齐沙坦氨氯地平片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号68522100802对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.70对照品水分(%)0对照品稀释倍数1000
标示量(mg)20供试品稀释倍数2系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.972891682884972886382889762876432885840.21
211.002876352880002878180.09
单位质量响应值RSD%判断
26306.6526165.270.39数据可信
供试品溶液-2024010721批-阿齐沙坦-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%
5min13537-35371.2101.4620.001.211.4620.06
24374-43741.4961.50
33400-34001.1631.16
45404-54041.8481.85
55149-51491.7611.76
63739-37391.2791.28
10min112227-122274.1824.356.004.194.366.00
212666-126664.3324.34
312157-121574.1584.16
413664-136644.6734.68
513668-136684.6754.68
611969-119694.0944.10
15min117452-174525.9696.093.116.006.123.17
217931-179316.1336.17
317626-176266.0286.06
418458-184586.3136.35
518333-183336.2706.31
616999-169995.8145.84
20min121131-211317.2277.261.667.297.321.70
221444-214447.3347.40
320950-209507.1657.23
421524-215247.3627.43
521577-215777.3807.45
620703-207037.0817.14
30min126070-260708.9168.902.069.029.002.07
225990-259908.8899.00
326259-262598.9819.08
426175-261758.9529.06
526579-265799.0909.20
625006-250068.5528.65
45min130070-3007010.28410.381.8710.4410.531.88
230842-3084210.54810.70
330709-3070910.50310.66
430410-3041010.40110.56
530684-3068410.49410.66
629329-2932910.03110.18
60min133300-3330011.38911.351.8611.6011.561.85
233193-3319311.35211.57
333635-3363511.50411.71
433440-3344011.43711.66
533527-3352711.46711.69
631967-3196710.93311.14
极限134601-3460111.83411.991.4512.1112.271.45
235516-3551612.14712.43
335661-3566112.19712.47
434682-3468211.86212.14
535366-3536612.09612.38
634536-3453611.81212.08
阿齐沙坦氨氯地平片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号100374-202106对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.9对照品水分(%)0对照品稀释倍数4000
标示量(mg)5供试品稀释倍数2系数0.7211
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
115.037282572585725897265672819726950.17
214.957278272663727220.12
单位质量响应值RSD%判断
4836.664864.350.41数据可信
供试品溶液-2024010721批-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%
5min121582-2158228.84856.5929.8428.8556.5929.85
241243-4124355.12855.13
341291-4129155.19255.19
449482-4948266.14066.14
559953-5995380.13780.14
640461-4046154.08354.08
10min160997-6099781.53294.386.9381.6994.707.00
270636-7063694.41694.72
371681-7168195.81396.12
474453-7445399.51899.89
573399-7339998.10998.55
672506-7250696.91697.22
15min168425-6842591.46197.303.0092.0798.143.08
273390-7339098.09798.93
373916-7391698.80099.64
474268-7426899.271100.19
573092-7309297.69998.69
673657-7365798.45499.29
20min169731-6973193.20697.322.3194.3398.702.38
273838-7383898.696100.07
372912-7291297.45898.85
473813-7381398.663100.13
572262-7226296.59098.12
674307-7430799.323100.71
30min170676-7067694.47097.181.3796.1199.101.49
273125-7312597.74399.67
373028-7302897.61399.54
473105-7310597.71699.74
573223-7322397.87499.94
673056-7305697.65199.59
45min169658-6965893.10996.302.0595.2798.762.10
273716-7371698.533101.00
372049-7204996.30598.78
473154-7315497.782100.34
571141-7114195.09197.70
672566-7256696.99699.48
60min170946-7094694.83195.751.5197.5198.741.52
272580-7258097.015100.03
370559-7055994.31397.32
473179-7317997.815100.92
570716-7071694.52397.66
671824-7182496.00499.02
极限169135-6913592.41094.801.5395.6298.321.59
271906-7190696.11499.67
371126-7112695.07198.60
471411-7141195.45299.10
570143-7014393.75797.42
671811-7181195.98799.54
阿齐沙坦氨氯地平片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号68522100802对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.70对照品水分(%)0对照品稀释倍数1000
标示量(mg)20供试品稀释倍数2系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.972879702872422873302868042877182874130.16
211.002881612865692873650.40
单位质量响应值RSD%判断
26199.9126124.090.21数据可信
供试品溶液-2024010721批-阿齐沙坦-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%
5min15411-54111.8561.5016.661.861.5016.73
24052-40521.3901.39
34484-44841.5381.54
43321-33211.1391.14
54846-48461.6621.66
64037-40371.3851.38
10min113390-133904.5924.424.164.604.434.20
212753-127534.3744.38
313264-132644.5494.56
412090-120904.1474.15
513377-133774.5884.60
612501-125014.2884.30
15min118287-182876.2726.111.716.316.141.73
217544-175446.0176.05
317980-179806.1676.20
417717-177176.0776.11
517847-178476.1216.16
617459-174595.9886.02
20min121810-218107.4807.341.947.557.401.99
220757-207577.1197.18
321861-218617.4987.57
421314-213147.3107.37
521432-214327.3517.42
621158-211587.2577.32
30min126559-265599.1098.921.999.229.031.99
225561-255618.7678.87
326189-261898.9829.09
426281-262819.0149.12
526267-262679.0099.12
625200-252008.6438.75
45min130608-3060810.49810.432.0910.6610.592.09
230042-3004210.30410.46
331188-3118810.69710.86
430651-3065110.51310.67
530611-3061110.49910.66
629350-2935010.06610.22
60min133412-3341211.46011.392.3011.6811.602.27
233167-3316711.37611.59
334291-3429111.76111.98
433293-3329311.41911.63
533106-3310611.35511.57
631921-3192110.94811.16
极限135499-3549912.17512.071.3012.4612.351.31
234826-3482611.94512.22
335460-3546012.16212.45
435641-3564112.22412.50
535286-3528612.10212.38
634467-3446711.82112.09
阿齐沙坦氨氯地平片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号100374-202106对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.9对照品水分(%)0对照品稀释倍数4000
标示量(mg)5供试品稀释倍数2系数0.7211
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
115.037260872507724257286772977726770.33
214.957228472432723580.15
单位质量响应值RSD%判断
4835.464840.000.07数据可信
供试品溶液-2024010721批-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%
5min166219-6621988.74574.6318.3388.7574.6418.33
243022-4302257.65757.66
359591-5959179.86279.86
460116-6011680.56680.57
542706-4270657.23457.23
662484-6248483.74083.74
10min171613-7161395.97498.023.6696.4798.443.67
269357-6935792.95193.27
372380-7238097.00297.45
474250-7425099.50899.96
574038-7403899.22499.54
677195-77195103.455103.92
15min172095-7209596.62097.913.1697.6598.873.19
269549-6954993.20894.04
371992-7199296.48297.46
474795-74795100.238101.24
573942-7394299.09599.96
675969-75969101.812102.85
20min172383-7238397.00697.943.7498.5799.443.76
268817-6881792.22793.58
371696-7169696.08597.60
474726-74726100.146101.70
574196-7419699.436100.86
676659-76659102.737104.34
30min171409-7140995.70197.453.9997.8099.493.98
268545-6854591.86293.73
370707-7070794.76096.81
475080-75080100.620102.73
574948-74948100.444102.42
675578-75578101.288103.46
45min170598-7059894.61496.313.8097.2598.903.79
267641-6764190.65193.03
370647-7064794.67997.26
473195-7319598.094100.77
574658-74658100.055102.59
674437-7443799.759102.50
60min170256-7025694.15595.773.3197.3198.903.33
267937-6793791.04893.93
370467-7046794.43897.54
472568-7256897.254100.47
573057-7305797.909101.00
674499-7449999.842103.14
极限170040-7004093.86695.283.1997.5598.943.21
267579-6757990.56893.95
370086-7008693.92897.56
472237-7223796.810100.57
573201-7320198.102101.73
673423-7342398.400102.25
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