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%
110.972853312880452881082884642875932875080.44
211.002858742875882867310.43
单位质量响应值RSD%判断
26208.5726066.450.39数据可信
供试品溶液-2024010921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%
5min16264-62642.1501.8417.632.151.8417.71
25196-51961.7841.78
35715-57151.9621.96
43799-37991.3041.30
56303-63032.1642.16
64935-49351.6941.69
10min115276-152765.2444.966.145.264.976.18
214610-146105.0165.03
314725-147255.0555.07
412964-129644.4514.46
515214-152145.2235.24
613856-138564.7574.77
15min120389-203897.0006.813.447.046.853.49
219953-199536.8506.89
320266-202666.9577.00
418970-189706.5126.54
520445-204457.0197.06
619007-190076.5256.56
20min124049-240498.2568.052.898.348.122.94
223725-237258.1458.22
323689-236898.1328.21
422730-227307.8037.87
524014-240148.2448.32
622466-224667.7137.78
30min128250-282509.6989.782.219.829.902.22
228681-286819.8469.97
328935-289359.93310.06
428222-282229.6899.80
529322-2932210.06610.19
627534-275349.4529.57
45min133261-3326111.41911.271.7111.6011.451.73
232350-3235011.10611.28
333524-3352411.50911.69
432648-3264811.20811.37
533134-3313411.37511.56
632097-3209711.01911.19
60min135849-3584912.30712.251.6612.5512.491.66
235839-3583912.30412.54
335826-3582612.29912.54
435654-3565412.24012.47
536342-3634212.47612.72
634568-3456811.86712.10
极限137955-3795513.03012.881.7413.3413.181.74
237369-3736912.82913.13
337702-3770212.94313.25
437771-3777112.96713.26
538040-3804013.05913.37
636275-3627512.45312.75
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%
115.037227172948729037330872926728710.52
214.957224172609724250.36
单位质量响应值RSD%判断
4848.374844.480.06数据可信
供试品溶液-2024010921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%
5min161932-6193282.85176.218.8982.8576.218.89
258078-5807877.69577.70
352426-5242670.13470.13
456814-5681476.00476.00
562628-6262883.78283.78
649926-4992666.79066.79
10min172386-7238696.83694.692.9997.3095.122.99
271300-7130095.38395.81
371641-7164195.83996.23
472128-7212896.49196.91
570562-7056294.39694.86
666682-6668289.20589.58
15min172421-7242196.88395.142.7997.8896.092.80
270979-7097994.95495.92
372957-7295797.60098.52
472339-7233996.77397.73
570477-7047794.28295.27
667558-6755890.37791.24
20min172813-7281397.40794.522.7298.9496.002.72
270338-7033894.09695.59
372155-7215596.52797.99
471166-7116695.20496.70
570105-7010593.78495.30
667363-6736390.11691.49
30min170758-7075894.65894.452.5396.7496.462.52
270922-7092294.87796.89
372692-7269297.24599.25
472033-7203396.36498.39
569451-6945192.91094.94
667773-6777390.66592.53
45min171171-7117195.21193.342.4597.8195.862.45
269014-6901492.32594.86
371518-7151895.67598.22
470709-7070994.59297.15
569214-6921492.59395.14
666993-6699389.62191.99
60min170568-7056894.40493.102.1197.5496.152.13
269915-6991593.53096.58
370742-7074294.63797.71
470399-7039994.17897.26
569077-6907792.40995.47
666863-6686389.44792.32
极限170200-7020093.91292.222.6897.5795.782.68
269310-6931092.72196.29
369975-6997593.61197.21
470187-7018793.89497.50
568530-6853091.67795.26
665412-6541287.50690.87
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%
110.972860422866912868942848252864162861740.29
211.002888792879392884090.24
单位质量响应值RSD%判断
26086.9626219.000.36数据可信
供试品溶液-2024010921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%
5min15702-57021.9561.6116.031.961.6116.12
25234-52341.7961.80
34844-48441.6621.66
44601-46011.5791.58
53634-36341.2471.25
64095-40951.4051.40
10min114445-144454.9564.793.784.974.803.81
214545-145454.9905.00
313678-136784.6934.70
414196-141964.8714.88
513151-131514.5124.52
613796-137964.7334.74
15min120237-202376.9436.712.326.986.752.31
219996-199966.8616.90
319092-190926.5506.59
419419-194196.6636.70
519195-191956.5866.62
619483-194836.6856.72
20min123732-237328.1427.971.688.228.041.71
223577-235778.0898.17
322863-228637.8447.92
423143-231437.9408.01
522744-227447.8037.87
623305-233057.9968.07
30min128605-286059.8149.641.529.949.761.51
228427-284279.7539.87
327455-274559.4209.54
428322-283229.7179.83
527854-278549.5579.67
627951-279519.5909.71
45min132227-3222711.05711.131.1511.2311.301.13
232794-3279411.25211.43
331820-3182010.91711.09
432502-3250211.15111.32
532803-3280311.25511.42
632469-3246911.14011.31
60min134510-3451011.84012.041.4912.0812.271.48
235763-3576312.27012.51
334425-3442511.81112.04
435315-3531512.11712.35
535089-3508912.03912.27
635371-3537112.13612.37
极限137440-3744012.84612.761.3913.1513.061.38
237467-3746712.85513.16
336297-3629712.45312.75
437771-3777112.95913.26
536959-3695912.68112.98
637141-3714112.74313.04
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%
115.037212972520725197244472835724890.35
214.957331572727730210.57
单位质量响应值RSD%判断
4822.954884.350.90数据可信
供试品溶液-2024010921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%
5min157222-5722276.43973.079.8876.4473.079.88
259701-5970179.75179.75
356918-5691876.03376.03
455584-5558474.25174.25
544265-4426559.13159.13
654497-5449772.79972.80
10min170713-7071394.46194.261.8194.8994.671.79
269420-6942092.73493.18
369521-6952192.86893.29
469730-6973093.14893.56
571316-7131695.26695.59
672680-7268097.08897.49
15min171933-7193396.09195.172.2097.0496.102.16
270277-7027793.87894.84
369909-6990993.38794.33
469444-6944492.76693.70
572904-7290497.38898.25
672993-7299397.50698.45
20min171669-7166995.73894.712.0097.2296.171.96
269032-6903292.21593.70
370183-7018393.75395.21
469835-6983593.28894.73
572161-7216196.39597.79
672539-7253996.90098.39
30min170870-7087094.67193.671.7896.6995.661.75
269404-6940492.71294.70
368669-6866991.73093.71
469007-6900792.18294.15
571211-7121195.12697.06
671582-7158295.62297.65
45min169571-6957192.93592.602.0195.4895.101.96
268240-6824091.15793.66
368445-6844591.43193.92
467790-6779090.55693.03
571169-7116995.07097.53
670683-7068394.42196.98
60min168702-6870291.77491.561.7394.8394.581.70
268285-6828591.21794.23
367313-6731389.91992.91
467237-6723789.81792.80
569554-6955492.91395.90
670167-7016793.73196.81
极限169680-6968093.08191.831.3996.6595.361.37
268153-6815391.04194.56
367476-6747690.13793.63
468106-6810690.97894.46
569361-6936192.65596.16
669686-6968693.08996.69
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