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%
115.179652696490966109703296890967100.25
215.169745297085972680.27
单位质量响应值RSD%判断
6375.086416.090.46数据可信
加速6月-供试品溶液-2025021021批-氨氯地平-pH6.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min143497-4349744.08944.9118.2444.0944.9118.25
250311-5031150.99551.00
351514-5151452.21552.21
435105-3510535.58235.58
551306-5130652.00452.00
634101-3410134.56534.56
10min165055-6505565.94070.188.6866.0170.258.69
272325-7232573.30973.39
375276-7527676.30076.39
466106-6610667.00567.06
575573-7557376.60176.69
661066-6106661.89761.95
15min173258-7325874.25481.297.4674.4481.497.47
281375-8137582.48282.69
386379-8637987.55487.77
480650-8065081.74781.92
586506-8650687.68387.90
673043-7304374.03674.20
20min179074-7907480.15086.266.7780.4686.586.77
285918-8591887.08787.43
391661-9166192.90893.27
486998-8699888.18188.49
589663-8966390.88391.24
677281-7728178.33278.62
30min182489-8248983.61188.345.7784.0588.815.78
286042-8604287.21287.70
393205-9320594.47394.99
489045-8904590.25690.71
591586-9158692.83293.34
680575-8057581.67182.09
45min182893-8289384.02089.055.5584.6089.675.56
287183-8718388.36989.00
393065-9306594.33195.00
490198-9019891.42592.03
592343-9234393.59994.27
681475-8147582.58383.13
极限183202-8320284.33490.777.0685.0591.547.05
292686-9268693.94794.73
393560-9356094.83395.66
494165-9416595.44696.20
593817-9381795.09395.92
679874-7987480.96081.65
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100590-202406对照品来源中检院对照品使用方法直接使用
对照品含量(%)95.1对照品水分(%)0对照品稀释倍数500
标示量(mg)20供试品稀释倍数1系数0.9671
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
1 11.503614923611103604743597173607513607090.19
2 11.513628883629643629260.02
单位质量响应值RSD%判断
31366.0031531.360.38数据可信
加速6月-供试品溶液-2025021021批-阿托伐他汀钙-pH6.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1209737-20973755.20454.3217.2955.2054.3217.29
2223664-22366458.87058.87
3245169-24516964.53064.53
4162576-16257642.79142.79
5233971-23397161.58261.58
6163153-16315342.94342.94
10min1272581-27258171.74574.598.1671.8474.688.17
2284501-28450174.88274.98
3315393-31539383.01383.12
4269792-26979271.01171.08
5304595-30459580.17180.27
6253534-25353466.73266.80
15min1300007-30000778.96383.236.6879.1883.456.68
2308275-30827581.14081.36
3346750-34675091.26791.51
4315972-31597283.16683.36
5335004-33500488.17588.41
6291386-29138676.69476.88
20min1310577-31057781.74686.756.4782.0987.116.47
2320305-32030584.30684.66
3359394-35939494.59494.99
4334219-33421987.96888.30
5347693-34769391.51591.90
6305434-30543480.39280.70
30min1317518-31751883.57288.306.4384.0588.806.44
2324299-32429985.35785.86
3366334-36633496.42196.98
4341127-34112789.78790.26
5352646-35264692.81893.35
6311031-31103181.86582.31
45min1319493-31949384.09288.776.4484.7189.416.45
2324270-32427085.35085.99
3368073-36807396.87997.60
4344057-34405790.55891.18
5354429-35442993.28893.98
6313158-31315882.42583.01
极限1320366-32036684.32290.266.4185.0891.056.40
2342061-34206190.03290.82
3368048-36804896.87297.75
4359394-35939494.59495.37
5354165-35416593.21894.06
6313424-31342482.49583.21
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%
115.179751597906981359811997664978680.29
215.169658496304964440.21
单位质量响应值RSD%判断
6451.426361.740.99数据可信
加速6月-供试品溶液-2025021121批-氨氯地平-pH6.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min149595-4959550.18545.198.6650.1945.208.66
246266-4626646.81746.82
343657-4365744.17744.18
444789-4478945.32245.32
537911-3791138.36238.36
645756-4575646.30146.30
10min171667-7166772.52065.917.3272.6065.987.32
266159-6615966.94667.02
358684-5868459.38259.46
468020-6802068.83068.91
560703-6070361.42561.49
665577-6557766.35766.43
15min179442-7944280.38774.665.9880.5974.855.98
274872-7487275.76375.95
366783-6678367.57867.75
476669-7666977.58177.77
571182-7118272.02972.20
673756-7375674.63474.82
20min183509-8350984.50379.556.0784.8479.866.07
278525-7852579.46079.78
370977-7097771.82272.11
483858-8385884.85685.18
576709-7670977.62277.91
678092-7809279.02179.33
30min184897-8489785.90781.966.8186.3982.406.80
280690-8069081.65082.10
371446-7144672.29672.70
487691-8769188.73589.20
580998-8099881.96282.38
680239-8023981.19481.64
45min186472-8647287.50183.277.1788.1283.857.15
281747-8174782.72083.30
372309-7230973.17073.70
489551-8955190.61791.23
583114-8311484.10384.66
680569-8056981.52882.11
极限189906-8990690.97685.836.8991.7486.546.89
283289-8328984.28085.00
374776-7477675.66676.31
491232-9123292.31893.08
584353-8435385.35786.05
685359-8535986.37587.09
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100590-202406对照品来源中检院对照品使用方法直接使用
对照品含量(%)95.1对照品水分(%)0对照品稀释倍数500
标示量(mg)20供试品稀释倍数1系数0.9671
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
1 11.503650303659693667833666073672183663210.24
2 11.513643003634053638520.18
单位质量响应值RSD%判断
31854.0031611.820.54数据可信
加速6月-供试品溶液-2025021121批-阿托伐他汀钙-pH6.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1233115-23311560.80854.089.2760.8154.089.26
2219876-21987657.35557.35
3205158-20515853.51553.52
4200561-20056152.31652.32
5176217-17621745.96645.97
6208934-20893454.50054.50
10min1298512-29851277.86770.046.8277.9770.136.82
2275592-27559271.88871.98
3259535-25953567.70067.79
4266013-26601369.38969.48
5243265-24326563.45663.53
6268174-26817469.95370.04
15min1321954-32195483.98276.645.5084.2176.845.50
2298500-29850077.86478.08
3280601-28060173.19573.40
4293700-29370076.61276.81
5276180-27618072.04272.22
6291841-29184176.12776.33
20min1329076-32907685.83979.564.6486.2179.894.64
2307581-30758180.23380.58
3291469-29146976.03076.35
4310035-31003580.87381.20
5291598-29159876.06376.37
6300224-30022478.31378.65
30min1334594-33459487.27981.234.5287.7981.704.52
2311805-31180581.33481.81
3294210-29421076.74577.20
4318943-31894383.19683.66
5304706-30470679.48379.91
6304241-30424179.36179.83
45min1336103-33610387.67282.054.1488.3382.654.15
2313738-31373881.83982.45
3298439-29843977.84878.43
4321583-32158383.88584.49
5310362-31036280.95881.52
6307084-30708480.10380.70
极限1356638-35663893.02984.595.7393.8385.335.72
2320375-32037583.57084.32
3300040-30004078.26578.97
4327274-32727485.36986.11
5316385-31638582.52983.23
6325015-32501584.78085.51
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%
115.179667196386967369646596619965750.16
215.169644596970967080.39
单位质量响应值RSD%判断
6366.186379.160.15数据可信
加速6月-供试品溶液-2025021221批-氨氯地平-pH6.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min152730-5273053.63948.829.2053.6448.829.20
246785-4678547.59147.59
351802-5180252.69552.69
448621-4862149.45949.46
547704-4770448.52648.53
640345-4034541.04041.04
10min173388-7338874.65372.354.8574.7472.444.86
269594-6959470.79470.87
375667-7566776.97177.06
471531-7153172.76472.85
571041-7104172.26672.35
665542-6554266.67266.74
15min181488-8148882.89381.404.2183.1181.604.22
279924-7992481.30281.50
383713-8371385.15685.37
480774-8077482.16682.37
580513-8051381.90182.10
673695-7369574.96575.14
20min186492-8649287.98385.605.0188.3385.945.01
283765-8376585.20985.54
389494-8949491.03791.39
484509-8450985.96686.31
583847-8384785.29285.63
676781-7678178.10578.41
30min187642-8764289.15387.684.4389.6588.164.43
285038-8503886.50486.98
390557-9055792.11892.63
486676-8667688.17088.65
587911-8791189.42689.91
679333-7933380.70081.14
45min188969-8896990.50388.324.7391.1588.944.73
285218-8521886.68787.31
392041-9204193.62894.29
487213-8721388.71689.35
587634-8763489.14589.77
679836-7983681.21281.78
极限189855-8985591.40490.184.7692.2090.954.76
290935-9093592.50293.27
392310-9231093.90194.72
489218-8921890.75691.53
589169-8916990.70691.48
680400-8040081.78682.49
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100590-202406对照品来源中检院对照品使用方法直接使用
对照品含量(%)95.1对照品水分(%)0对照品稀释倍数500
标示量(mg)20供试品稀释倍数1系数0.9671
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
1 11.503631493626373630803630283626773629140.07
2 11.513637463648953643200.23
单位质量响应值RSD%判断
31557.7431652.480.22数据可信
加速6月-供试品溶液-2025021221批-阿托伐他汀钙-pH6.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1242961-24296163.63257.978.3963.6357.978.39
2221198-22119857.93257.93
3229368-22936860.07260.07
4222122-22212258.17458.17
5225313-22531359.01059.01
6187092-18709249.00049.00
10min1307907-30790780.64176.285.2180.7576.385.21
2292622-29262276.63876.73
3296725-29672577.71377.81
4290432-29043276.06576.16
5297022-29702277.79177.89
6262883-26288368.84968.93
15min1333521-33352187.35083.205.0587.5983.425.05
2320609-32060983.96884.19
3324484-32448484.98385.21
4314575-31457582.38882.61
5325316-32531685.20185.43
6287540-28754075.30775.50
20min1343854-34385490.05685.794.9890.4486.154.98
2330207-33020786.48286.85
3335273-33527387.80988.18
4323424-32342484.70585.07
5335309-33530987.81888.19
6297254-29725477.85178.17
30min1348984-34898491.39987.004.9991.9487.515.00
2333626-33362687.37787.89
3340302-34030289.12689.64
4327814-32781485.85586.36
5340777-34077789.25089.77
6301727-30172779.02379.47
45min1350289-35028991.74187.135.3592.4387.785.35
2334472-33447287.59988.25
3341432-34143289.42290.09
4328629-32862986.06886.71
5341696-34169689.49190.16
6299609-29960978.46879.05
极限1351447-35144792.04589.105.7992.8989.895.78
2355576-35557693.12693.93
3343186-34318689.88190.70
4337970-33797088.51589.30
5350814-35081491.87992.69
6302173-30217379.14079.85
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