氨氯地平阿托伐他汀钙片项目信息
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2000
标示量(mg)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%
115.229077090777906659077790957907890.12
215.149148991185913370.24
单位质量响应值RSD%判断
5965.116032.830.80数据可信
供试品溶液-24070201批-氨氯地平-pH2.0盐酸溶液
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min145261-4526148.91142.6217.4148.9142.6217.42
228043-2804330.30430.30
340806-4080644.09744.10
444460-4446048.04548.05
543751-4375147.27947.28
634314-3431437.08137.08
10min169463-6946375.06464.5612.4075.1564.6412.39
266837-6683772.22772.28
355238-5523859.69259.77
459248-5924864.02664.11
558290-5829062.99063.07
649400-4940053.38453.45
15min174525-7452580.53573.1310.3380.7473.3110.32
277207-7720783.43383.60
362140-6214067.15167.32
466777-6677772.16272.35
566287-6628771.63271.82
659123-5912363.89164.04
20min181899-8189988.50379.2113.0288.8479.5112.98
288387-8838795.51495.82
366022-6602271.34671.63
470480-7048076.16376.47
566269-6626971.61371.92
666755-6675572.13872.40
30min184076-8407690.85686.289.5791.3486.729.55
292902-92902100.393100.86
372403-7240378.24178.65
474314-7431480.30780.74
575660-7566081.76182.18
679716-7971686.14486.52
45min186031-8603192.96891.827.2893.6192.407.27
293662-93662101.215101.85
378623-7862384.96385.50
477396-7739683.63784.20
589066-8906696.24896.81
685047-8504791.90592.43
极限190800-9080098.12299.252.2598.9299.982.25
294350-94350101.958102.76
390425-9042597.71798.39
489380-8938096.58797.29
591839-9183999.24599.96
694267-94267101.869102.54
氨氯地平阿托伐他汀钙片项目信息
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2000
标示量(mg)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%
115.229184091676916089158591372916160.19
215.149210991920920140.15
单位质量响应值RSD%判断
6019.456077.540.68数据可信
供试品溶液-24070201批-氨氯地平
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min185866-8586692.03070.6316.3492.0370.6316.34
269505-6950574.49474.49
360952-6095265.32765.33
458288-5828862.47262.47
563886-6388668.47268.47
656883-5688360.96660.97
10min191233-9123397.78284.6210.1597.9484.7410.16
284714-8471490.79590.92
370658-7065875.73075.84
471420-7142076.54776.65
575722-7572281.15781.27
679965-7996585.70585.81
15min192577-9257799.22291.476.0799.5491.736.08
290016-9001696.47796.75
378843-7884384.50284.74
483061-8306189.02389.25
581862-8186287.73887.99
685704-8570491.85692.10
20min193116-9311699.80093.474.88100.2893.884.90
290957-9095797.48697.92
381667-8166787.52987.91
485804-8580491.96392.34
584253-8425390.30190.70
687440-8744093.71794.11
30min193094-9309499.77694.554.61100.4295.114.62
292933-9293399.604100.20
383116-8311689.08289.60
486758-8675892.98693.52
585353-8535391.48092.03
688041-8804194.36194.91
45min193599-93599100.31894.814.90101.1395.534.92
293572-93572100.289101.05
383361-8336189.34590.01
486688-8668892.91193.60
584983-8498391.08391.78
688535-8853594.89095.60
极限193556-93556100.27294.604.74101.2595.484.76
292783-9278399.443100.37
382899-8289988.85089.67
486682-8668292.90493.75
585478-8547891.61492.46
688193-8819394.52495.39
氨氯地平阿托伐他汀钙片项目信息
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2000
标示量(mg)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%
115.229196091948919469185791642918710.15
215.149227092337923040.06
单位质量响应值RSD%判断
6036.206096.700.71数据可信
供试品溶液-24070201批-氨氯地平
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min123125-2312524.71224.4136.7324.7124.4136.73
216921-1692118.08218.08
336407-3640738.90538.90
415201-1520116.24416.24
516610-1661017.75017.75
628814-2881430.79130.79
10min134041-3404136.37736.6630.0936.4236.7130.10
227699-2769929.59929.63
351675-5167555.22055.29
425163-2516326.88926.92
526467-2646728.28328.31
640819-4081943.62043.67
15min138988-3898841.66342.9926.0441.7643.0926.06
234455-3445536.81936.90
358379-5837962.38462.54
430760-3076032.87032.94
532568-3256834.80334.88
646212-4621249.38349.51
20min141963-4196344.84247.2521.3245.0147.4221.35
240032-4003242.77942.92
361011-6101165.19765.46
436657-3665739.17239.30
536558-3655839.06639.20
649080-4908052.44752.65
30min145439-4543948.55751.7917.8548.8052.0417.89
245941-4594149.09349.31
364315-6431568.72869.10
442010-4201044.89245.08
541144-4114443.96744.17
651924-5192455.48755.78
45min148426-4842651.74956.0713.5052.0856.4113.56
251625-5162555.16755.46
365680-6568070.18670.67
446851-4685150.06550.33
547656-4765650.92651.20
654572-5457258.31658.70
极限186330-8633092.25396.043.4492.6796.473.46
294442-94442100.922101.31
391878-9187898.18298.78
488876-8887694.97495.32
586978-8697892.94693.30
690736-9073696.96197.44
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