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%
115.139643896711969519646196565966250.22
215.149698596969969770.02
单位质量响应值RSD%判断
6386.326405.350.22数据可信
供试品溶液-24042501批-氨氯地平-磷酸盐缓冲液(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%
5min136785-3678537.28444.3618.8037.2844.3618.80
252836-5283653.55253.55
341688-4168842.25342.25
10min145396-4539646.01144.523.9946.0744.593.95
241987-4198742.55642.65
344386-4438644.98845.06
15min157008-5700857.78163.8214.1257.9263.9714.10
273181-7318174.17374.33
358716-5871659.51259.66
20min162963-6296363.81662.392.9764.0562.652.91
259497-5949760.30360.59
362222-6222263.06563.31
30min164812-6481265.69071.3912.0866.0371.7512.05
280218-8021881.30581.69
366277-6627767.17567.53
45min169993-6999370.94268.743.3471.3969.223.26
265483-6548366.37166.89
367998-6799868.92069.38
极限167016-6701667.92475.2612.7968.4975.8612.74
285005-8500586.15786.79
370750-7075071.70972.29
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%
111.483634073638353641393628893629163634370.16
211.583664833662703663760.05
单位质量响应值RSD%判断
31658.2831638.690.05数据可信
供试品溶液-24042501批-阿托伐他汀钙-磷酸盐缓冲液(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%
5min1163177-16317742.58850.0018.7842.5950.0018.78
2232022-23202260.55660.56
3179520-17952046.85346.85
10min1205988-20598853.76152.294.3653.8352.384.32
2190306-19030649.66849.77
3204795-20479553.45053.53
15min1227457-22745759.36465.9515.2559.5366.1215.23
2297039-29703977.52577.71
3233598-23359860.96761.13
20min1257222-25722267.13365.634.1467.3965.914.08
2239465-23946562.49862.81
3257670-25767067.25067.52
30min1256339-25633966.90272.9413.3767.2773.3313.33
2322568-32256884.18884.60
3259511-25951167.73068.11
45min1282580-28258073.75171.474.4774.2371.984.38
2259871-25987167.82468.38
3279058-27905872.83273.33
极限1270059-27005970.48377.0513.7971.0977.6813.73
2342180-34218089.30689.98
3273406-27340671.35771.97
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%
115.139641796596966289660196561965610.09
215.149669696727967120.03
单位质量响应值RSD%判断
6382.096387.850.07数据可信
供试品溶液-24042501批-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%
5min145132-4513245.82143.963.9045.8243.963.89
241821-4182142.46042.46
342935-4293543.59143.59
10min149865-4986550.62758.3517.0450.7058.4217.01
268514-6851469.56169.63
354037-5403754.86354.94
15min166211-6621167.22363.515.0767.3863.685.03
260821-6082161.75061.94
360641-6064161.56761.73
20min173142-7314274.25978.847.7874.5379.117.77
284507-8450785.79886.09
375301-7530176.45176.72
30min174350-7435075.48670.026.9875.8870.436.92
265080-6508066.07466.51
367477-6747768.50868.90
45min183146-8314684.41686.894.3984.9487.414.38
289902-8990291.27591.82
383698-8369884.97785.48
极限177929-7792979.12075.374.9679.7876.044.92
274198-7419875.33276.03
370579-7057971.65772.31
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%
111.483621813626533628293628313627723626530.08
211.583654653650043652340.09
单位质量响应值RSD%判断
31589.9831540.070.12数据可信
供试品溶液-24042501批-阿托伐他汀钙
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1198572-19857251.96348.966.8351.9648.966.83
2189377-18937749.55749.56
3173356-17335645.36445.36
10min1201059-20105952.61461.0714.4052.7061.1614.38
2268128-26812870.16470.25
3230966-23096660.44060.52
15min1269508-26950870.52565.237.8770.7065.417.84
2247899-24789964.87165.07
3230392-23039260.28960.47
20min1290924-29092476.13081.376.2976.4281.666.28
2329971-32997186.34886.66
3311948-31194881.63181.91
30min1297448-29744877.83771.797.9778.2672.227.93
2271584-27158471.06971.52
3254002-25400266.46866.88
45min1329370-32937086.19089.353.3186.7489.903.30
2351744-35174492.04592.62
3343238-34323889.81990.34
极限1310996-31099681.38275.747.7382.0776.447.67
2291014-29101476.15376.88
3266349-26634969.69970.37
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%
115.139628496343962789624796378963060.06
215.149683196952968920.09
单位质量响应值RSD%判断
6365.236399.740.39数据可信
供试品溶液-24042501批-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%
5min140485-4048541.12044.7317.6241.1244.7317.63
238693-3869339.30039.30
352938-5293853.76853.77
10min148809-4880949.57448.456.6349.6448.526.59
250160-5016050.94651.01
344141-4414144.83344.92
15min167588-6758868.64868.858.1468.8069.008.13
262373-6237363.35163.50
373394-7339474.54574.71
20min170190-7019071.29171.985.4371.5672.255.39
275007-7500776.18376.44
367401-6740168.45868.75
30min179441-7944180.68779.144.6681.0779.534.65
273775-7377574.93275.31
380539-8053981.80282.20
45min178055-7805579.27981.264.3379.8081.784.28
283999-8399985.31685.82
377955-7795579.17779.72
极限184610-8461085.93783.864.0986.5984.524.06
278678-7867879.91280.56
384420-8442085.74486.41
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%
111.483623303626833621383619823628523623970.11
211.583649153655733652440.13
单位质量响应值RSD%判断
31567.6831540.930.06数据可信
供试品溶液-24042501批-阿托伐他汀钙
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1179257-17925746.92450.4618.7746.9250.4618.77
2165301-16530143.27143.27
3233739-23373961.18661.19
10min1213829-21382955.97454.1510.6356.0554.2310.58
2224516-22451658.77258.84
3182247-18224747.70747.81
15min1280768-28076873.49773.088.7573.6773.258.74
2253982-25398266.48566.66
3302734-30273479.24779.43
20min1292640-29264076.60576.856.2376.9077.156.19
2312321-31232181.75782.04
3275800-27580072.19672.51
30min1321801-32180184.23882.715.8384.6683.145.81
2295352-29535277.31577.73
3330775-33077586.58787.02
45min1322464-32246484.41285.524.9384.9786.084.87
2344451-34445190.16790.71
3313136-31313681.97082.55
极限1339388-33938888.84287.044.5189.5487.744.49
2315298-31529882.53683.23
3342810-34281089.73890.45
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%
115.139698597014968379684697108969580.12
215.149891098902989060.01
单位质量响应值RSD%判断
6408.336532.761.36数据可信
供试品溶液-24042501批-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%
5min143348-4334843.43243.354.5543.4343.354.55
241259-4125941.33941.34
345190-4519045.27845.28
10min147068-4706847.15949.285.4547.2349.365.44
252200-5220052.30152.37
348300-4830048.39448.47
15min159881-5988159.99762.475.0960.1562.635.08
261244-6124461.36361.52
365928-6592866.05666.21
20min166679-6667966.80867.423.0967.0667.683.07
269609-6960969.74470.00
365595-6559565.72265.99
30min166779-6677966.90969.944.9467.2770.314.92
269067-6906769.20169.58
373555-7355573.69874.07
45min172410-7241072.55173.654.0373.0274.144.01
276864-7686477.01377.50
371255-7125571.39371.89
极限178073-7807378.22576.911.6678.8277.521.63
275535-7553575.68276.30
376671-7667176.82077.44
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%
111.483630823633953633283633293639213634110.09
211.583735213731243733220.08
单位质量响应值RSD%判断
31656.0132238.511.29数据可信
供试品溶液-24042501批-阿托伐他汀钙
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1189388-18938848.97152.006.1248.9752.006.12
2199966-19996651.70651.71
3213911-21391155.31255.31
10min1178695-17869546.20649.137.1146.2949.217.10
2186338-18633848.18248.27
3204929-20492952.98953.08
15min1241618-24161862.47667.767.9962.6367.937.99
2261082-26108267.50967.68
3283445-28344573.29173.47
20min1261673-26167367.66170.587.2567.9270.857.25
2261376-26137667.58567.86
3295780-29578076.48176.78
30min1263688-26368868.18273.637.6768.5674.037.66
2283297-28329773.25373.64
3307281-30728179.45479.88
45min1290317-29031775.06878.547.9175.5679.067.90
2289438-28943874.84175.35
3331437-33143785.70186.26
极限1311188-31118880.46581.190.9881.0881.841.03
2313513-31351381.06681.70
3317241-31724182.03082.74
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