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%
110.972850742853442851982848342848002850500.09
211.002846182849192847680.08
单位质量响应值RSD%判断
25984.5025888.000.27数据可信
供试品溶液-2023102221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%
5min125789-257898.9227.2773.308.927.2773.30
222106-221067.6487.65
33994-39941.3821.38
428341-283419.8059.80
52804-28040.9700.97
643108-4310814.91414.91
10min19728-97283.3663.2413.593.423.2813.69
28329-83292.8822.92
37441-74412.5742.58
49651-96513.3393.39
511013-110133.8103.82
69972-99723.4503.53
15min116137-161375.5835.276.025.655.336.15
214354-143544.9665.02
313951-139514.8274.85
415376-153765.3205.39
516186-161865.6005.63
615451-154515.3465.45
20min119865-198656.8736.603.786.976.683.85
218633-186336.4466.53
318006-180066.2296.28
419055-190556.5926.69
519867-198676.8736.93
619019-190196.5806.71
30min125249-252498.7358.412.758.878.532.72
223472-234728.1208.24
323946-239468.2848.37
424504-245048.4788.62
524821-248218.5878.68
623849-238498.2518.42
45min129997-2999710.37810.012.5410.5610.182.43
227968-279689.6769.84
329091-2909110.06410.19
428935-2893510.01010.20
529383-2938310.16510.31
628304-283049.79210.01
60min132528-3252811.25411.061.6411.5011.301.51
231288-3128810.82511.05
332351-3235111.19211.38
432039-3203911.08411.33
532301-3230111.17511.38
631391-3139110.86011.13
极限134770-3477012.02911.751.6912.3412.041.58
233418-3341811.56111.84
334387-3438711.89712.14
433884-3388411.72312.03
534013-3401311.76712.03
633260-3326011.50711.84
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%
115.037185471970720017211571807719490.18
214.957200172079720400.08
单位质量响应值RSD%判断
4787.034818.730.47数据可信
供试品溶液-2023102221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%
5min1-0.00010.17244.950.0010.17244.95
2-0.0000.00
3-0.0000.00
4-0.0000.00
545187-4518760.99961.00
6-0.0000.00
10min162456-6245684.31091.494.8084.3191.544.79
269500-6950093.81993.82
366014-6601489.11389.11
469409-6940993.69693.70
567525-6752591.15391.49
671730-7173096.82996.83
15min168778-6877892.84595.913.0993.3196.483.01
273350-7335099.01699.54
370681-7068195.41395.91
472176-7217697.43297.95
568220-6822092.09192.94
673105-7310598.68699.22
20min168864-6886492.96195.873.3693.9496.963.27
274477-74477100.538101.61
370183-7018394.74195.77
471443-7144396.44297.50
568287-6828792.18293.54
672855-7285598.34899.43
30min168753-6875392.81195.442.8794.3197.072.79
273157-7315798.756100.39
370293-7029394.89096.44
470895-7089595.70297.30
568271-6827192.16094.03
672826-7282698.30999.94
45min167612-6761291.27194.092.9693.2996.252.86
271829-7182996.96399.14
369813-6981394.24296.32
470303-7030394.90397.03
566920-6692090.33692.72
671738-7173896.84099.02
60min166788-6678890.15893.633.2192.6896.323.13
272203-7220397.468100.19
369012-6901293.16095.76
469899-6989994.35897.01
566955-6695590.38493.27
671307-7130796.25898.98
极限166369-6636989.59392.843.0592.6296.052.96
271392-7139296.37399.63
369051-6905193.21396.33
469526-6952693.85497.03
566179-6617989.33692.72
670153-7015394.70197.95
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%
110.972842762848052846362838142831822841430.24
211.002844412844712844560.01
单位质量响应值RSD%判断
25901.8225859.640.12数据可信
供试品溶液-2023102221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%
5min14495-44951.55810.0656.761.5610.0656.75
248121-4812116.68416.68
342634-4263414.78114.78
418847-188476.5346.53
522979-229797.9677.97
637055-3705512.84712.85
10min111957-119574.1463.4114.044.153.4613.16
210249-102493.5533.65
38065-80652.7962.88
410549-105493.6573.69
59283-92833.2183.26
68888-88883.0823.15
15min116709-167095.7935.415.265.825.484.90
216039-160395.5615.67
315041-150415.2155.31
416173-161735.6075.66
515008-150085.2035.27
614627-146275.0715.16
20min120057-200576.9546.763.447.026.863.33
219804-198046.8667.01
319642-196426.8106.94
420083-200836.9637.05
519002-190026.5886.68
618391-183916.3766.49
30min124573-245738.5208.503.648.628.643.65
224917-249178.6398.82
325528-255288.8519.02
425112-251128.7068.83
523893-238938.2848.41
623088-230888.0058.16
45min128841-288419.99910.123.9710.1510.314.00
229775-2977510.32310.55
330520-3052010.58110.80
430035-3003510.41310.59
528517-285179.88710.06
627375-273759.4919.69
60min131389-3138910.88311.153.1011.0911.403.17
232901-3290111.40711.69
333185-3318511.50511.78
432944-3294411.42211.65
531798-3179811.02511.25
630737-3073710.65710.91
极限133469-3346911.60411.873.4811.8712.173.59
235414-3541412.27812.63
335658-3565812.36312.70
434558-3455811.98112.28
533608-3360811.65211.94
632629-3262911.31311.62
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%
115.037172571750720927151371535717230.33
214.957184071862718510.03
单位质量响应值RSD%判断
4771.994806.090.51数据可信
供试品溶液-2023102221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%
5min153715-5371572.72012.12244.9572.7212.12244.95
2-0.0000.00
3-0.0000.00
4-0.0000.00
5-0.0000.00
6-0.0000.00
10min170188-7018895.02296.982.8995.4397.042.84
272221-7222197.77497.77
373148-7314899.02999.03
470428-7042895.34795.35
569154-6915493.62293.62
674649-74649101.061101.06
15min171791-7179197.19299.882.2598.12100.492.16
273635-7363599.688100.23
375101-75101101.673102.22
473608-7360899.652100.18
572327-7232797.91898.44
676210-76210103.175103.74
20min171656-7165697.00999.592.3898.48100.752.30
272700-7270098.42399.52
375043-75043101.595102.71
473130-7313099.005100.09
572542-7254298.20999.27
676297-76297103.292104.43
30min171231-7123196.43498.762.1598.44100.472.07
272695-7269598.416100.06
374448-74448100.789102.47
472468-7246898.10999.74
571652-7165297.00498.61
675202-75202101.810103.52
45min170602-7060295.58297.951.9398.13100.221.83
271817-7181797.22799.42
373081-7308198.938101.18
473187-7318799.082101.26
571156-7115696.33298.48
674268-74268100.545102.82
60min169544-6954494.15097.172.4297.2399.982.30
271418-7141896.68799.42
371742-7174297.12699.91
472131-7213197.652100.38
571015-7101596.14198.83
674801-74801101.267104.10
极限169738-6973894.41396.992.2198.01100.332.11
272613-7261398.305101.57
372461-7246198.099101.43
471174-7117496.35799.63
570079-7007994.87498.09
673775-7377599.878103.27
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%
110.972888962888282890842889712886742888910.06
211.002865352866572865960.04
单位质量响应值RSD%判断
26334.6426054.180.76数据可信
供试品溶液-2024010621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%
5min13747-37471.2842.84132.011.282.84132.04
23784-37841.2961.30
330580-3058010.47610.48
42262-22620.7750.77
54919-49191.6851.69
64495-44951.5401.54
10min112632-126324.3274.248.664.334.268.33
212773-127734.3764.38
310973-109733.7593.82
411166-111663.8253.83
513606-136064.6614.67
613127-131274.4974.51
15min117762-177626.0856.014.906.126.054.69
218025-180256.1756.21
316349-163495.6015.68
416595-165955.6855.71
518388-183886.2996.33
618153-181536.2196.25
20min121960-219607.5237.293.657.597.363.53
221472-214727.3567.42
320378-203786.9817.09
420256-202566.9397.00
522028-220287.5467.62
621575-215757.3917.46
30min127105-271059.2859.012.749.399.122.63
226428-264289.0539.16
325354-253548.6858.83
425465-254658.7238.82
526611-266119.1169.23
626772-267729.1719.28
45min131467-3146710.77910.511.6410.9410.681.55
230848-3084810.56710.72
330065-3006510.29910.50
430225-3022510.35410.50
530830-3083010.56110.72
630697-3069710.51610.68
60min134609-3460911.85611.521.7312.0711.741.64
233237-3323711.38611.60
333019-3301911.31111.57
433394-3339411.44011.64
533972-3397211.63811.86
633505-3350511.47811.70
极限136384-3638412.46412.091.7412.7512.381.69
235525-3552512.17012.45
334744-3474411.90212.22
434795-3479511.92012.18
535316-3531612.09812.38
635009-3500911.99312.28
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%
115.037309172783731037295372823729510.21
214.957231072366723380.06
单位质量响应值RSD%判断
4853.694838.660.22数据可信
供试品溶液-2024010621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%
5min163467-6346784.90965.8551.9484.9165.8551.94
262926-6292684.18584.19
3-0.0000.00
442649-4264957.05857.06
559727-5972779.90579.91
666547-6654789.02989.03
10min176083-76083101.78796.963.33102.2697.323.41
273920-7392098.89399.36
371363-7136395.47395.47
468936-6893692.22692.54
572478-7247896.96497.41
672067-7206796.41496.91
15min176216-76216101.96598.112.17103.0099.022.19
273303-7330398.06899.09
373631-7363198.50799.04
471561-7156195.73796.57
572917-7291797.55298.53
672395-7239596.85397.88
20min176318-76318102.10298.152.38103.7199.602.35
272638-7263897.17898.74
374507-7450799.679100.76
471693-7169395.91497.28
573002-7300297.66599.19
672045-7204596.38597.95
30min175793-75793101.39998.021.85103.57100.011.86
272611-7261197.14299.24
373658-7365898.543100.17
472294-7229496.71898.61
573065-7306597.75099.82
672164-7216496.54498.65
45min174778-74778100.04196.911.95102.7899.451.92
272591-7259197.11599.76
373166-7316697.885100.06
471751-7175195.99298.42
571543-7154395.71398.32
670809-7080994.73197.37
60min174737-7473799.98696.631.91103.2899.711.89
271641-7164195.84499.03
372874-7287497.494100.22
471655-7165595.86398.83
571447-7144795.58598.73
670998-7099894.98498.15
极限174248-7424899.33295.342.28103.1898.962.29
271382-7138295.49899.21
371414-7141495.54198.81
470227-7022793.95397.45
570755-7075594.65998.33
669557-6955793.05696.75
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%
110.972846782849022846512844682847462846890.06
211.002854132852222853180.05
单位质量响应值RSD%判断
25951.6025938.000.04数据可信
供试品溶液-2024010621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%
5min13462-34621.1973.54154.861.203.54154.90
242617-4261714.73914.74
34247-42471.4691.47
42876-28760.9950.99
53911-39111.3531.35
64366-43661.5101.51
10min111894-118944.1144.256.304.124.275.90
211283-112833.9023.98
313035-130354.5084.52
411751-117514.0644.07
512525-125254.3324.34
613248-132484.5824.59
15min117398-173986.0176.153.326.056.193.00
216991-169915.8765.98
318170-181706.2846.32
417378-173786.0106.04
518366-183666.3526.38
618333-183336.3406.37
20min121088-210887.2937.441.967.367.522.07
221615-216157.4767.61
321739-217397.5187.59
420941-209417.2427.30
521739-217397.5187.59
622025-220257.6177.69
30min126002-260028.9939.081.659.109.201.46
225726-257268.8979.08
326712-267129.2389.35
425917-259178.9639.07
526626-266269.2099.32
626611-266119.2039.31
45min131079-3107910.74910.650.8910.9010.820.75
230416-3041610.51910.75
331017-3101710.72710.89
430507-3050710.55110.70
530931-3093110.69710.86
630795-3079510.65010.81
60min133338-3333811.53011.621.4311.7411.841.28
232978-3297811.40511.69
333836-3383611.70211.92
433237-3323711.49511.71
534248-3424811.84512.06
633877-3387711.71611.94
极限135502-3550212.27812.401.2512.5612.691.10
235314-3531412.21312.56
335965-3596512.43812.72
436501-3650112.62412.90
535612-3561212.31612.60
636157-3615712.50512.79
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%
115.037169071841716827174271712717330.09
214.957191172053719820.14
单位质量响应值RSD%判断
4772.654814.850.63数据可信
供试品溶液-2024010621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%
5min146441-4644162.81163.5950.9462.8163.5950.94
2-0.0000.00
356444-5644476.34076.34
461166-6116682.72782.73
552765-5276571.36571.36
665300-6530088.31888.32
10min172628-7262898.22999.172.1998.5899.522.21
273408-7340899.28499.28
373127-7312798.90499.33
476199-76199103.059103.52
571324-7132496.46696.86
673243-7324399.06199.55
15min174130-74130100.261101.101.64101.16102.001.56
275823-75823102.550103.10
374293-74293100.481101.45
476317-76317103.219104.25
574994-74994101.429102.36
672956-7295698.67399.71
20min173753-7375399.751101.012.53101.20102.472.40
277564-77564104.905106.03
373086-7308698.849100.38
476544-76544103.526105.13
573845-7384599.875101.37
673292-7329299.127100.72
30min173284-7328499.11699.911.70101.12101.941.60
275477-75477102.082103.79
373193-7319398.993101.07
475372-75372101.940104.12
573458-7345899.352101.40
672455-7245597.995100.14
45min173648-7364899.60998.922.31102.17101.512.18
275176-75176101.675103.95
372003-7200397.384100.01
474790-74790101.153103.90
572372-7237297.883100.49
670863-7086395.84298.53
60min171750-7175097.04298.191.72100.15101.321.63
273991-73991100.073102.91
371979-7197997.351100.52
474121-74121100.248103.56
572712-7271298.343101.49
671056-7105696.10399.32
极限172197-7219797.64698.352.27101.30102.032.22
273432-7343299.317102.71
371270-7127096.392100.11
475721-75721102.412106.28
571621-7162196.867100.56
672048-7204897.445101.20
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