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%
114.939491194426946249452494486945940.21
214.979546795397954320.06
单位质量响应值RSD%判断
6335.836374.880.44数据可信
供试品溶液-24090901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%
5min157540-5754058.69253.0116.0358.6953.0116.03
248814-4881449.79149.79
364281-6428165.56865.57
452676-5267653.73053.73
548441-4844149.41149.41
640087-4008740.88940.89
10min180761-8076182.37875.2811.1382.4875.3711.14
271784-7178473.22173.30
381072-8107282.69582.80
479034-7903480.61680.71
570219-7021971.62571.71
659964-5996461.16461.23
15min188331-8833190.09983.329.7690.3383.549.76
281175-8117582.80083.00
387709-8770989.46589.71
486530-8653088.26288.49
579043-7904380.62580.83
667330-6733068.67868.85
20min190556-9055692.36986.659.3792.7587.009.37
284556-8455686.24986.59
388637-8863790.41190.81
492950-9295094.81195.18
582175-8217583.82084.16
670832-7083272.25072.53
30min191345-9134593.17388.188.4793.7188.688.48
282215-8221583.86184.35
390864-9086492.68393.23
494217-9421796.10396.63
585692-8569287.40787.88
674385-7438575.87476.28
45min192197-9219794.04290.316.8394.7490.956.85
288455-8845590.22690.85
391652-9165293.48794.19
494646-9464696.54197.23
586599-8659988.33288.95
677653-7765379.20779.74
极限192532-9253294.38494.381.3095.2495.171.33
292395-9239594.24495.02
391436-9143693.26694.12
494560-9456096.45397.30
592983-9298394.84495.61
691247-9124793.07393.74
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100590-202005 对照品来源中检院对照品使用方法直接使用
对照品含量(%)94.9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%
111.623646203660753657123662453654243656150.18
211.683703143701213702180.04
单位质量响应值RSD%判断
31464.2931696.750.53数据可信
供试品溶液-24090901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%
5min1268795-26879570.30562.3413.9470.3162.3413.94
2226951-22695159.36159.36
3283825-28382574.23674.24
4233266-23326661.01261.01
5225769-22576959.05259.05
6191386-19138650.05850.06
10min1327570-32757085.67878.8610.6185.8078.9710.61
2300020-30002078.47278.57
3329164-32916486.09586.22
4317789-31778983.12083.22
5290208-29020875.90676.00
6244330-24433063.90663.99
15min1346682-34668290.67784.619.6190.9484.849.62
2326244-32624485.33185.56
3343613-34361389.87490.14
4344134-34413490.01190.25
5314760-31476082.32882.55
6265382-26538269.41369.60
20min1352476-35247692.19386.878.8492.6087.258.85
2336579-33657988.03588.41
3348676-34867691.19991.62
4353450-35345092.44792.84
5325185-32518585.05485.42
6276488-27648872.31772.62
30min1354874-35487492.82088.277.6993.3888.797.71
2343229-34322989.77490.29
3350247-35024791.61092.18
4356946-35694693.36293.91
5331742-33174286.77087.27
6287909-28790975.30575.73
45min1355276-35527692.92589.046.3493.6489.716.36
2344867-34486790.20290.87
3350621-35062191.70792.43
4357472-35747293.49994.20
5334539-33453987.50188.15
6299755-29975578.40378.95
极限1354882-35488292.82294.052.1593.7094.872.08
2359913-35991394.13894.96
3350024-35002491.55192.43
4356312-35631293.19694.05
5371756-37175697.23598.03
6364563-36456395.35496.04
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%
114.939492394875948889473794815948480.08
214.979513695200951680.05
单位质量响应值RSD%判断
6352.856357.250.05数据可信
供试品溶液-24090902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%
5min154198-5419855.28552.1216.2055.2952.1216.20
255985-5598557.10857.11
354461-5446155.55355.55
455332-5533256.44256.44
552160-5216053.20653.21
634410-3441035.10035.10
10min177865-7786579.42778.096.3379.5278.186.34
279173-7917380.76180.86
379953-7995381.55781.65
477615-7761579.17279.27
577845-7784579.40679.50
666851-6685168.19268.25
15min180914-8091482.53787.164.6282.7687.384.63
288146-8814689.91490.14
389290-8929091.08191.31
487118-8711888.86589.09
587192-8719288.94189.16
680020-8002081.62581.80
20min190432-9043292.24692.612.8792.6192.972.88
293178-9317895.04795.43
391835-9183593.67794.06
490089-9008991.89692.27
593016-9301694.88295.25
686169-8616987.89788.21
30min191278-9127893.10996.502.9593.6297.022.96
297445-9744599.39999.94
397305-9730599.25799.79
494564-9456496.46196.99
595763-9576397.68498.21
691289-9128993.12093.57
45min192832-9283294.69497.482.2495.3698.162.25
296587-9658798.52499.23
398523-98523100.499101.20
496995-9699598.94099.63
594200-9420096.08996.78
694259-9425996.15096.76
极限192863-9286394.72697.742.3395.5598.582.33
295369-9536997.28298.15
399099-99099101.087101.96
497641-9764199.599100.45
595367-9536797.28098.13
694552-9455296.44897.22
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100590-202005 对照品来源中检院对照品使用方法直接使用
对照品含量(%)94.9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%
111.621829151830031827381818481822741825560.27
211.681843041841451842240.07
单位质量响应值RSD%判断
15710.5015772.600.28数据可信
供试品溶液-24090902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%
5min1115547-11554760.63153.9317.5760.6353.9317.57
2112393-11239358.97658.98
3104899-10489955.04355.04
4107798-10779856.56556.56
5109355-10935557.38257.38
666701-6670135.00035.00
10min1154697-15469781.17476.446.5181.2776.536.52
2151537-15153779.51679.61
3143666-14366675.38675.48
4144626-14462675.88975.98
5151167-15116779.32279.42
6128406-12840667.37867.44
15min1171056-17105689.75886.253.6489.9986.473.65
2168618-16861888.47988.71
3160639-16063984.29284.51
4161856-16185684.93085.15
5168552-16855288.44488.67
6155549-15554981.62181.79
20min1179634-17963494.25991.302.6494.6491.672.65
2176966-17696692.85993.24
3169321-16932188.84789.21
4171381-17138189.92890.29
5177525-17752593.15293.53
6169202-16920288.78589.09
30min1184331-18433196.72495.151.8197.2795.671.82
2183389-18338996.22996.76
3176322-17632292.52193.03
4178513-17851393.67194.18
5184053-18405396.57897.11
6181430-18143095.20195.66
45min1185946-18594697.57196.451.8498.2897.121.83
2184916-18491697.03197.72
3178201-17820193.50794.17
4181207-18120795.08495.75
5186017-18601797.60898.30
6186585-18658597.90698.52
极限1185463-18546397.31896.551.7698.1897.381.75
2184679-18467996.90697.76
3178639-17863993.73794.55
4181844-18184495.41996.25
5185802-18580297.49698.35
6187606-18760698.44299.22
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%
114.939398394079940319408794053940470.05
214.979475394737947450.02
单位质量响应值RSD%判断
6299.206328.990.34数据可信
供试品溶液-24090901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%
5min142711-4271143.85045.577.6543.8545.577.65
244462-4446245.64845.65
347505-4750548.77248.77
438959-3895939.99840.00
544327-4432745.51045.51
648338-4833849.62849.63
10min163648-6364865.34668.348.5965.4268.428.59
264905-6490566.63766.71
369394-6939471.24571.33
458176-5817659.72859.79
574953-7495376.95377.03
668338-6833870.16170.24
15min176328-7632878.36478.918.9278.5579.108.92
273567-7356775.53075.72
378263-7826380.35180.55
466221-6622167.98868.15
586799-8679989.11589.32
679967-7996782.10082.30
20min183672-8367285.90482.248.1486.2282.568.13
276359-7635978.39678.71
381068-8106883.23183.56
469042-6904270.88471.16
587388-8738889.71990.07
683114-8311485.33185.67
30min189755-8975592.15086.118.7092.6186.568.69
279315-7931581.43181.87
382623-8262384.82785.30
472668-7266874.60775.00
592722-9272295.19695.70
686135-8613588.43388.91
45min189913-8991392.31287.297.9992.9287.897.98
280147-8014782.28582.86
382480-8248084.68085.29
475140-7514077.14577.67
592174-9217494.63395.29
690272-9027292.68093.31
极限192454-9245494.92196.031.3995.6896.771.37
292784-9278495.25995.98
393813-9381396.31697.07
494088-9408896.59897.25
592314-9231494.77795.60
695730-9573098.28499.06
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100590-202005 对照品来源中检院对照品使用方法直接使用
对照品含量(%)94.9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%
111.623670123671443669433669863670693670310.03
211.683726743726123726430.02
单位质量响应值RSD%判断
31586.1431904.370.71数据可信
供试品溶液-24090901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%
5min1206871-20687153.82853.056.5453.8353.056.54
2207439-20743953.97653.98
3212099-21209955.18955.19
4179864-17986446.80146.80
5199082-19908251.80251.80
6217994-21799456.72356.72
10min1270577-27057770.40571.048.3670.4971.138.35
2266496-26649669.34369.43
3275010-27501071.55871.65
4236514-23651461.54261.62
5306393-30639379.72479.81
6283158-28315873.67973.77
15min1313596-31359681.59978.298.9481.8178.508.93
2289232-28923275.25975.46
3298101-29810177.56777.78
4257185-25718566.92067.10
5337159-33715987.73087.95
6310008-31000880.66580.88
20min1341158-34115888.77081.699.4989.1182.029.48
2298118-29811877.57177.90
3307213-30721379.93880.28
4267565-26756569.62169.91
5348515-34851590.68591.05
6321045-32104583.53783.89
30min1356416-35641692.74083.979.3693.2384.449.34
2305450-30545079.47979.94
3311860-31186081.14781.62
4277991-27799172.33472.74
5353139-35313991.88892.40
6331455-33145586.24686.74
45min1359284-35928493.48785.558.8394.1386.178.82
2310106-31010680.69081.28
3315092-31509281.98882.60
4286878-28687874.64675.18
5354319-35431992.19592.86
6347090-34709090.31490.95
极限1368748-36874895.94995.212.1396.7595.962.07
2368352-36835295.84696.57
3359251-35925193.47894.22
4374714-37471497.50298.15
5353850-35385092.07392.90
6370478-37047896.39997.18
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%
114.939404594289943899432494280942650.14
214.979316492950930570.17
单位质量响应值RSD%判断
6313.806216.231.11数据可信
供试品溶液-24090902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%
5min135028-3502836.24648.3919.5436.2548.4019.54
249710-4971051.43951.44
353253-5325355.10555.11
435285-3528536.51236.51
552714-5271454.54754.55
654610-5461056.50956.51
10min158128-5812860.15072.939.5560.2173.019.56
274475-7447577.06577.15
375043-7504377.65377.74
467191-6719169.52869.59
573263-7326375.81175.90
674784-7478477.38577.48
15min169817-6981772.24585.127.6972.4185.327.70
286242-8624289.24189.46
386046-8604689.03989.26
481597-8159784.43584.61
584780-8478087.72987.95
685070-8507088.02988.25
20min176276-7627678.92989.515.9679.2189.855.98
290481-9048193.62893.99
387952-8795291.01191.38
486939-8693989.96390.28
589218-8921892.32192.68
688143-8814391.20891.58
30min182158-8215885.01594.595.3485.4395.085.35
295129-9512998.43798.96
395398-9539898.71699.24
493015-9301596.25096.72
590727-9072793.88294.40
692021-9202195.22195.74
45min184639-8463987.58395.314.6588.1495.964.65
295391-9539198.70999.39
395333-9533398.64999.33
495507-9550798.82999.46
590944-9094494.10794.78
690844-9084494.00394.68
极限191268-9126894.44296.603.7295.1497.413.70
296308-9630899.657100.50
396114-9611499.457100.31
495301-9530198.61599.41
593724-9372496.98497.81
687407-8740790.44791.28
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100590-202005 对照品来源中检院对照品使用方法直接使用
对照品含量(%)94.9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%
111.621819681822401821901818261819011820250.10
211.681801561796991799280.18
单位质量响应值RSD%判断
15664.8015404.791.19数据可信
供试品溶液-24090902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%
5min172318-7231838.45551.1719.9338.4551.1719.94
2100628-10062853.50953.51
3104764-10476455.70855.71
472447-7244738.52338.52
5112022-11202259.56759.57
6115180-11518061.24761.25
10min1124236-12423666.06275.748.3666.1375.828.37
2147156-14715678.25078.34
3145133-14513377.17477.27
4131837-13183770.10470.17
5151206-15120680.40380.50
6155020-15502082.43182.53
15min1143584-14358476.35086.206.3876.5286.416.40
2167171-16717188.89389.11
3164510-16451087.47887.70
4156964-15696483.46583.65
5169017-16901789.87490.11
6171382-17138291.13291.37
20min1156926-15692683.44591.634.7683.7591.984.77
2176873-17687394.05294.42
3173733-17373392.38292.75
4170023-17002390.40990.73
5177175-17717594.21294.60
6179168-17916895.27295.66
30min1167428-16742889.02996.153.7289.4796.663.74
2185259-18525998.51199.04
3181693-18169396.61597.14
4182019-18201996.78897.26
5183771-18377197.72098.26
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2187486-18748699.695100.38
3184139-18413997.91598.60
4186661-18666199.25699.89
5184837-18483798.28698.99
6185794-18579498.79599.51
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2187811-18781199.868100.72
3183840-18384097.75698.60
4187255-18725599.572100.37
5184838-18483898.28799.15
6184871-18487198.30599.18
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