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DJ301-191212对照品来源自制对照品使用方法直接使用
对照品含量(%)99.75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%
111.022863592864372864242867392857602863440.13
210.982858832853332856080.14
单位质量响应值RSD%判断
25984.0326011.660.08数据可信
供试品溶液-2024010921均一性1批-阿齐沙坦-醋酸盐缓冲液(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%
5min17137-71372.4652.5913.722.462.5913.70
29163-91633.1643.16
38381-83812.8942.89
46665-66652.3022.30
56897-68972.3822.38
66751-67512.3312.33
10min118128-181286.2606.324.556.276.334.53
219506-195066.7366.75
318784-187846.4866.50
417125-171255.9145.93
518493-184936.3866.40
617736-177366.1256.14
15min124653-246538.5138.492.888.568.542.91
225250-252508.7198.77
325070-250708.6578.71
423337-233378.0598.10
524977-249778.6258.67
624245-242458.3728.42
20min128262-282629.7599.841.639.869.941.67
228912-289129.98410.09
328560-285609.8629.96
427805-278059.6029.69
529078-2907810.04110.14
628320-283209.7799.87
30min132537-3253711.23611.521.7911.3911.671.77
233366-3336611.52211.68
333955-3395511.72511.88
432965-3296511.38311.53
534116-3411611.78111.93
633217-3321711.47011.62
45min136910-3691012.74612.821.4012.9613.041.38
237037-3703712.79013.01
336474-3647412.59512.82
437021-3702112.78412.99
538019-3801913.12913.35
637371-3737112.90513.12
60min139608-3960813.67713.601.3513.9613.891.32
239017-3901713.47313.77
339028-3902813.47713.77
438834-3883413.41013.69
540249-4024913.89914.19
639560-3956013.66113.94
极限141005-4100514.16014.241.2214.5214.601.19
240634-4063414.03214.40
340941-4094114.13814.50
441277-4127714.25414.61
542046-4204614.51914.89
641533-4153314.34214.70
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(%)99.90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%
115.007198971702720857202371920719440.21
215.037202471925719740.10
单位质量响应值RSD%判断
4796.274788.690.12数据可信
供试品溶液-2024010921均一性1批-苯磺酸氨氯地平-醋酸盐缓冲液(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%
5min172408-7240897.95696.362.7897.9696.362.78
267430-6743091.22191.22
371347-7134796.52096.52
472818-7281898.51098.51
571095-7109596.18096.18
672276-7227697.77797.78
10min174488-74488100.77097.493.52101.3198.033.52
267350-6735091.11391.62
371369-7136996.55097.09
473616-7361699.590100.14
572604-7260498.22198.76
672976-7297698.72499.27
15min174598-74598100.91997.423.32102.0298.503.32
267581-6758191.42692.44
371508-7150896.73897.81
472951-7295198.69099.79
572592-7259298.20599.28
672858-7285898.56599.66
20min173427-7342799.33496.003.56101.0097.623.56
266512-6651289.98091.50
369569-6956994.11595.73
472400-7240097.94599.59
572183-7218397.65199.28
671690-7169096.98498.62
30min171300-7130096.45795.632.7598.6797.782.76
266810-6681090.38392.40
370818-7081895.80597.94
472009-7200997.41699.61
571545-7154596.78898.96
671632-7163296.90699.08
45min172320-7232097.83793.755.32100.5996.445.26
262939-6293985.14687.67
366757-6675790.31192.98
471654-7165496.93699.67
571239-7123996.37499.08
670903-7090395.92098.64
60min172739-7273998.40494.283.54101.7097.493.53
265536-6553688.65991.66
368371-6837192.49495.66
470434-7043495.28598.56
570585-7058595.49098.73
670487-7048795.35798.61
极限172040-7204097.45894.443.03101.3098.163.04
266001-6600189.28892.78
369047-6904793.40997.09
471052-7105296.12199.92
570476-7047695.34299.11
670234-7023495.01598.79
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DJ301-191212对照品来源自制对照品使用方法直接使用
对照品含量(%)99.75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%
111.022867402866402864572864262863572865240.06
210.982861612858742860180.08
单位质量响应值RSD%判断
26000.3626049.000.14数据可信
供试品溶液-2024010921均一性2批-阿齐沙坦
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min17820-78202.6982.2717.502.702.2717.62
24910-49101.6941.69
36576-65762.2682.27
47707-77072.6592.66
55606-56061.9341.93
66857-68572.3652.37
10min118683-186836.4456.073.926.466.083.96
216649-166495.7435.75
317610-176106.0756.09
417858-178586.1606.18
517123-171235.9075.92
617606-176066.0736.09
15min124498-244988.4518.281.608.508.321.60
223473-234738.0978.14
324341-243418.3978.44
423886-238868.2408.29
524019-240198.2868.33
623731-237318.1868.23
20min128339-283399.7769.650.929.879.740.97
227593-275939.5199.60
328126-281269.7029.80
428017-280179.6659.76
527811-278119.5949.68
627992-279929.6569.75
30min133559-3355911.57711.500.6011.7311.640.60
233188-3318811.44911.59
333237-3323711.46511.61
433042-3304211.39811.55
533440-3344011.53611.68
633469-3346911.54611.69
45min137399-3739912.90112.871.0313.1213.071.01
237919-3791913.08113.28
337057-3705712.78312.99
437244-3724412.84813.06
536778-3677812.68712.89
637378-3737812.89413.10
60min139250-3925013.54013.661.1513.8313.941.11
240473-4047313.96214.24
339415-3941513.59713.88
439380-3938013.58513.87
539347-3934713.57313.85
639668-3966813.68413.97
极限141423-4142314.28914.180.7914.6514.540.78
240888-4088814.10514.46
341198-4119814.21214.57
441075-4107514.16914.53
540620-4062014.01214.37
641462-4146214.30314.66
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(%)99.90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%
115.007206271989721087211672100720750.08
215.037181971819718190.00
单位质量响应值RSD%判断
4805.004778.380.40数据可信
供试品溶液-2024010921均一性2批-苯磺酸氨氯地平
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min172322-7232297.85694.594.0297.8694.594.02
271087-7108796.18596.19
372525-7252598.13198.13
465701-6570188.89888.90
570573-7057395.49095.49
667231-6723190.96890.97
10min175093-75093101.606100.571.83102.15101.101.83
275702-75702102.430102.96
375204-75204101.756102.30
474166-74166100.351100.85
571925-7192597.31997.85
673882-7388299.967100.47
15min174657-74657101.016100.011.73102.12101.101.73
275419-75419102.047103.15
374744-74744101.133102.24
473863-7386399.941100.99
572176-7217697.65998.73
672635-7263598.28099.34
20min173781-7378199.83099.241.29101.50100.881.29
273922-73922100.021101.69
374018-74018100.151101.82
473921-73921100.020101.63
571696-7169697.00998.62
672708-7270898.37999.99
30min174110-74110100.27699.191.06102.50101.381.08
274078-74078100.232102.46
373757-7375799.798102.03
472776-7277698.471100.63
572275-7227597.79399.95
672835-7283598.550100.70
45min173477-7347799.41998.482.14102.20101.222.11
274789-74789101.194103.98
372966-7296698.728101.51
472944-7294498.698101.41
570075-7007594.81697.51
672431-7243198.004100.70
60min172593-7259398.22398.042.02101.56101.332.00
274707-74707101.083104.43
373114-7311498.928102.26
472283-7228397.804101.06
570331-7033195.16298.39
671711-7171197.030100.27
极限172964-7296498.72597.151.62102.60100.981.61
272202-7220297.694101.60
372522-7252298.127102.01
471705-7170597.021100.82
569630-6963094.21497.97
671770-7177097.109100.89
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DJ301-191212对照品来源自制对照品使用方法直接使用
对照品含量(%)99.75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%
111.022875992877662877062875922872162875760.08
210.982866532865322865920.03
单位质量响应值RSD%判断
26095.8326101.280.02数据可信
供试品溶液-2023101221均一性1批-阿齐沙坦
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min17860-78602.7042.873.622.702.873.64
28761-87613.0143.01
38491-84912.9212.92
48424-84242.8982.90
58320-83202.8622.86
68208-82082.8232.82
10min118080-180806.2196.391.626.236.401.66
218900-189006.5016.52
318484-184846.3586.37
418480-184806.3576.37
518655-186556.4176.43
618846-188466.4836.50
15min123980-239808.2498.441.198.308.491.19
224776-247768.5238.58
324502-245028.4288.48
424523-245238.4368.49
524657-246578.4828.53
624742-247428.5118.56
20min127638-276389.5079.711.309.609.811.32
228435-284359.7819.88
327897-278979.5969.69
428462-284629.7909.89
528493-284939.8019.90
628425-284259.7789.88
30min132896-3289611.31611.381.0311.4611.531.03
232768-3276811.27211.43
332800-3280011.28311.43
433104-3310411.38711.54
533678-3367811.58511.74
633163-3316311.40811.56
45min136782-3678212.65212.740.6412.8612.950.63
237101-3710112.76212.98
336690-3669012.62112.84
437192-3719212.79313.01
537284-3728412.82513.04
637085-3708512.75712.97
60min139280-3928013.51213.510.9713.7913.800.95
238728-3872813.32213.61
338967-3896713.40413.69
439360-3936013.53913.83
539652-3965213.64013.93
639688-3968813.65213.94
极限140692-4069213.99714.081.1014.3514.441.10
240639-4063913.97914.34
340501-4050113.93214.29
441148-4114814.15414.52
541723-4172314.35214.72
640960-4096014.09014.45
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(%)99.90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%
115.007214572177722777204172175721630.12
215.037208671991720380.10
单位质量响应值RSD%判断
4810.874792.950.27数据可信
供试品溶液-2023101221均一性1批-苯磺酸氨氯地平
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min167461-6746191.08495.684.6991.0895.674.69
267785-6778591.52291.52
368504-6850492.49392.49
473075-7307598.66498.66
575086-75086101.380101.38
673258-7325898.91198.91
10min172338-7233897.66998.132.5998.1898.662.59
270107-7010794.65795.17
371262-7126296.21696.73
472897-7289798.42498.97
575146-75146101.461102.02
674324-74324100.351100.90
15min172318-7231897.64298.192.0898.6999.272.09
270582-7058295.29896.33
371818-7181896.96798.02
472939-7293998.48199.58
574808-74808101.004102.13
673899-7389999.777100.88
20min171789-7178996.92897.411.9598.5299.031.96
270398-7039895.05096.61
370946-7094695.79097.38
472371-7237197.71499.36
574134-74134100.094101.78
673233-7323398.878100.54
30min172097-7209797.34497.212.3299.4799.382.32
269754-6975494.18096.27
370521-7052195.21697.34
472242-7224297.54099.72
574343-74343100.376102.62
673041-7304198.618100.83
45min172009-7200997.22596.961.5399.9099.661.55
270303-7030394.92297.54
370736-7073695.50698.15
472117-7211797.371100.10
573202-7320298.836101.64
672500-7250097.888100.65
60min171272-7127296.23096.072.0599.4499.312.06
268968-6896893.11996.26
370029-7002994.55297.73
471382-7138296.37899.65
572860-7286098.374101.72
672422-7242297.783101.08
极限171081-7108195.97295.982.0699.7299.752.06
269685-6968594.08797.75
369510-6951093.85197.56
471347-7134796.331100.13
573550-7355099.306103.20
671335-7133596.315100.16
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DJ301-191212对照品来源自制对照品使用方法直接使用
对照品含量(%)99.75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%
111.022875602877472874502877562876652876360.05
210.982864302866312865300.05
单位质量响应值RSD%判断
26101.2726095.630.02数据可信
供试品溶液-2023101221均一性2批-阿齐沙坦
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min16505-65052.2381.9517.952.241.9517.95
26137-61372.1112.11
33945-39451.3571.36
45129-51291.7641.76
56651-66512.2882.29
65591-55911.9231.92
10min116597-165975.7095.317.285.725.327.27
215882-158825.4635.47
314674-146745.0485.06
413903-139034.7824.79
516678-166785.7375.75
614897-148975.1245.14
15min123297-232978.0147.468.018.067.518.02
222875-228757.8697.91
318791-187916.4646.50
420772-207727.1457.18
523030-230307.9227.97
621444-214447.3767.42
20min127561-275619.4819.055.539.579.135.54
226756-267569.2049.29
323766-237668.1758.25
425647-256478.8228.90
527681-276819.5229.61
626363-263639.0699.15
30min133138-3313811.39911.123.3111.5411.263.34
232878-3287811.31011.45
330473-3047310.48210.60
431778-3177810.93111.06
533319-3331911.46111.60
632411-3241111.14911.28
45min137670-3767012.95812.721.9213.1612.921.97
237115-3711512.76712.97
335739-3573912.29412.47
436782-3678212.65212.84
537638-3763812.94713.15
636977-3697712.72012.91
60min140093-4009313.79113.521.7514.0713.791.80
239414-3941413.55813.83
338263-3826313.16213.41
438815-3881513.35213.61
539922-3992213.73314.01
639371-3937113.54313.81
极限141522-4152214.28314.200.6114.6414.540.68
241074-4107414.12914.47
340996-4099614.10214.42
441235-4123514.18414.51
541631-4163114.32014.67
641231-4123114.18314.52
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(%)99.90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%
115.007225772209722537207372259722100.11
215.037210172010720560.09
单位质量响应值RSD%判断
4814.004794.150.30数据可信
供试品溶液-2023101221均一性2批-苯磺酸氨氯地平
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min172847-7284798.31284.5015.7798.3184.5015.76
261492-6149282.98882.99
349295-4929566.52766.53
455483-5548374.87874.88
574936-74936101.131101.13
661638-6163883.18583.18
10min175063-75063101.30396.973.95101.8597.443.99
268976-6897693.08893.55
369452-6945293.73094.10
469988-6998894.45494.87
575321-75321101.651102.21
672336-7233697.62398.08
15min175542-75542101.94998.922.35103.0699.932.40
271409-7140996.37297.35
373366-7336699.01399.90
471788-7178896.88397.82
575132-75132101.396102.52
672542-7254297.90198.91
20min174562-74562100.62799.272.31102.30100.822.31
270813-7081395.56797.08
375289-75289101.608103.05
472782-7278298.22499.70
574924-74924101.115102.81
672958-7295898.462100.01
30min174312-74312100.28999.191.73102.52101.301.75
271835-7183596.94698.99
374850-74850101.015103.02
472212-7221297.45599.48
574533-74533100.588102.84
673250-7325098.856100.95
45min174492-74492100.53299.461.40103.32102.121.40
271997-7199797.16599.75
374924-74924101.115103.68
473252-7325298.859101.42
573893-7389399.724102.53
673649-7364999.395102.04
60min173878-7387899.70498.521.70103.05101.741.72
271024-7102495.85298.97
374108-74108100.014103.14
472019-7201997.195100.31
573877-7387799.702103.07
673118-7311898.678101.87
极限173130-7313098.69499.050.54102.60102.820.46
273142-7314298.710102.37
373933-7393399.778103.46
473865-7386599.686103.34
573177-7317798.758102.68
673130-7313098.694102.44
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原始图谱下载图谱(姜进硙 于 2024-01-26 15:43:32 完成)
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