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%
115.129428994448947269478494739945970.23
215.099516194932950460.18
单位质量响应值RSD%判断
6256.426298.610.48数据可信
加速6月-供试品溶液-LC1771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%
5min146718-4671848.24454.637.6048.2454.627.61
253580-5358055.33055.33
357878-5787859.76959.77
455638-5563857.45657.46
553694-5369455.44855.45
649875-4987551.50451.50
10min191124-9112494.10196.181.6594.1896.281.65
294535-9453597.62397.72
394735-9473597.83097.93
491744-9174494.74194.84
594102-9410297.17697.27
692613-9261395.63895.72
15min197128-97128100.30199.641.89100.5499.891.89
297095-97095100.267100.52
399401-99401102.648102.91
495999-9599999.13599.39
595089-9508998.19598.45
694215-9421597.29397.54
20min198029-98029101.23199.572.02101.6499.992.01
297845-97845101.041101.46
397681-97681100.872101.31
492990-9299096.02896.45
595444-9544498.56298.98
696548-9654899.702100.11
30min196432-9643299.58299.320.99100.1699.900.98
297737-97737100.930101.52
395493-9549398.61399.21
496459-9645999.610100.19
595890-9589099.02399.60
695028-9502898.13298.71
45min196536-9653699.69097.725.42100.4398.475.38
298849-98849102.078102.84
396211-9621199.354100.12
496063-9606399.20199.95
584418-8441887.17687.92
695688-9568898.81499.55
极限196668-9666899.82697.903.77100.7398.813.74
296961-96961100.129101.06
396847-96847100.011100.94
496448-9644899.599100.51
594034-9403497.10698.00
687872-8787290.74391.64
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 11.541787051787271790201784441784691786730.14
2 11.521776201768111772160.33
单位质量响应值RSD%判断
15482.9315383.330.46数据可信
加速6月-供试品溶液-LC1771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%
5min1100883-10088354.10860.285.3254.1160.285.31
2111889-11188960.01160.01
3116549-11654962.51162.51
4114823-11482361.58561.58
5117049-11704962.77962.78
6113136-11313660.68060.68
10min1157519-15751984.48587.281.8984.5787.381.90
2164045-16404587.98588.08
3164158-16415888.04588.15
4166036-16603689.05389.16
5163860-16386087.88687.99
6160735-16073586.21086.31
15min1177766-17776695.34495.751.0795.5896.001.07
2179348-17934896.19396.44
3178430-17843095.70095.95
4181487-18148797.34097.59
5178437-17843795.70495.96
6175667-17566794.21894.46
20min1183221-18322198.27098.050.6198.6698.450.61
2183308-18330898.31698.72
3182336-18233697.79598.21
4184342-18434298.87199.28
5182561-18256197.91698.33
6181045-18104597.10397.50
30min1186334-18633499.93998.930.81100.4999.500.81
2184550-18455098.98399.55
3183564-18356498.45499.03
4185946-18594699.731100.31
5183919-18391998.64499.22
6182386-18238697.82298.39
45min1186356-18635699.95199.110.88100.6799.850.88
2185816-18581699.662100.40
3184162-18416298.77599.51
4186396-18639699.973100.72
5183391-18339198.36199.10
6182633-18263397.95498.68
极限1186039-18603999.78199.100.87100.67100.000.86
2186124-18612499.827100.73
3183424-18342498.37999.28
4186461-186461100.008100.92
5183442-18344298.38899.29
6183106-18310698.20899.10
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%
115.129512294822947359499894770948890.18
215.099451495144948290.47
单位质量响应值RSD%判断
6275.736284.230.10数据可信
加速6月-供试品溶液-LA6362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%
5min170173-7017372.43669.764.8872.4469.764.88
269409-6940971.64871.65
370711-7071172.99272.99
466638-6663868.78768.79
566679-6667968.82968.83
661862-6186263.85763.86
10min188377-8837791.22790.811.6091.3590.931.60
289056-8905691.92892.05
389693-8969392.58692.71
487357-8735790.17490.29
587610-8761090.43690.55
685737-8573788.50288.61
15min191989-9198994.95694.581.2295.2394.851.22
291299-9129994.24394.52
393145-9314596.14996.42
490532-9053293.45293.72
592473-9247395.45595.72
690306-9030693.21893.47
20min191818-9181894.77994.751.4695.2195.171.46
292376-9237695.35595.78
393415-9341596.42896.86
489610-8961092.50092.92
592510-9251095.49495.92
690982-9098293.91694.33
30min192346-9234695.32495.231.8195.9195.811.80
290220-9022093.13093.72
394411-9441197.45698.05
492562-9256295.54796.12
593546-9354696.56397.15
690444-9044493.36193.93
45min193074-9307496.07696.061.1596.8296.801.15
293633-9363396.65397.40
394733-9473397.78898.55
491696-9169694.65395.39
592962-9296295.96096.70
692234-9223495.20995.93
极限192866-9286695.86195.340.9096.7796.250.90
293223-9322396.23097.13
393054-9305496.05596.98
492098-9209895.06895.96
591084-9108494.02294.93
691867-9186794.83095.71
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 11.543568113566483564023578553568013569030.16
2 11.523554773580513567640.52
单位质量响应值RSD%判断
30927.4730969.100.10数据可信
加速6月-供试品溶液-LA6362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%
5min1248316-24831666.41464.984.2066.4164.984.21
2244925-24492565.50865.51
3255236-25523668.26568.27
4245371-24537165.62765.63
5238513-23851363.79363.79
6225320-22532060.26460.26
10min1327012-32701287.46286.912.2787.5787.022.27
2319771-31977185.52685.63
3336273-33627389.93990.05
4327923-32792387.70687.82
5323788-32378886.60086.71
6314854-31485484.21184.31
15min1343427-34342791.85391.812.6692.1192.062.66
2333062-33306289.08189.33
3355890-35589095.18695.45
4349269-34926993.41593.67
5345244-34524492.33992.59
6332641-33264188.96889.21
20min1347712-34771292.99993.082.7193.4193.492.71
2338153-33815390.44290.84
3361213-36121396.61097.03
4354114-35411494.71195.12
5350312-35031293.69494.10
6336672-33667290.04690.44
30min1348166-34816693.12093.572.4593.6894.132.45
2340852-34085291.16491.72
3361119-36111996.58597.17
4356352-35635295.31095.88
5352887-35288794.38394.94
6339695-33969590.85591.39
45min1349600-34960093.50493.812.2194.2294.532.21
2343371-34337191.83892.54
3361835-36183596.77697.52
4356491-35649195.34796.07
5351816-35181694.09794.81
6341462-34146291.32792.02
极限1349338-34933893.43493.912.0094.3194.782.00
2344510-34451092.14293.00
3361195-36119596.60597.51
4357127-35712795.51796.40
5351276-35127693.95294.83
6343284-34328491.81592.66
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%
115.129531094668950559466795254949910.33
215.099432294474943980.12
单位质量响应值RSD%判断
6282.476255.670.31数据可信
长期6月-供试品溶液-LA6362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%
5min157410-5741059.36557.124.8659.3657.124.86
252522-5252254.31054.31
356932-5693258.87158.87
453146-5314654.95654.96
558567-5856760.56160.56
652883-5288354.68454.68
10min181703-8170384.48586.002.1284.5886.092.12
280573-8057383.31783.41
385404-8540488.31288.41
483628-8362886.47686.57
584327-8432787.19887.30
683353-8335386.19186.28
15min186615-8661589.56493.172.8389.8093.402.83
287177-8717790.14690.37
391811-9181194.93795.18
491948-9194895.07995.31
592327-9232795.47195.72
690715-9071593.80494.04
20min188867-8886791.89394.842.7692.2895.232.76
288307-8830791.31491.69
393956-9395697.15597.56
493659-9365996.84897.24
593525-9352596.71097.12
691970-9197095.10295.49
30min189464-8946492.51094.953.0593.0595.503.04
288442-8844291.45491.99
394319-9431997.53198.10
494133-9413397.33897.89
594515-9451597.73398.30
690045-9004593.11193.66
45min189272-8927292.31294.652.2093.0195.362.20
289506-8950692.55493.24
393143-9314396.31597.04
491243-9124394.35095.07
594407-9440797.62298.35
691616-9161694.73695.44
极限188791-8879191.81494.882.2292.6695.752.21
289933-8993392.99593.83
391549-9154994.66695.55
493558-9355896.74497.62
593350-9335096.52997.42
693380-9338096.56097.42
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 11.543622883603993622403608963626523616950.28
2 11.523589403593823591610.09
单位质量响应值RSD%判断
31342.7231177.170.38数据可信
长期6月-供试品溶液-LA6362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%
5min1201470-20147053.34853.234.4553.3553.234.45
2190143-19014350.34950.35
3203977-20397754.01254.01
4196665-19666552.07652.08
5216500-21650057.32857.33
6197374-19737452.26452.26
10min1296028-29602878.38782.013.6278.4882.103.62
2295583-29558378.26978.35
3315622-31562283.57583.67
4319192-31919284.52084.61
5320314-32031484.81784.91
6311516-31151682.48882.57
15min1317375-31737584.03989.784.5984.2690.014.59
2321747-32174785.19785.41
3346313-34631391.70291.93
4353979-35397993.73293.96
5350850-35085092.90393.14
6344119-34411991.12191.35
20min1322720-32272085.45591.664.7385.8192.044.72
2328354-32835486.94687.30
3353793-35379393.68394.06
4360899-36089995.56495.95
5358374-35837494.89695.29
6352802-35280293.42093.80
30min1324438-32443885.90992.444.7986.4192.974.79
2332395-33239588.01688.52
3356921-35692194.51195.05
4366365-36636597.01197.55
5360201-36020195.37995.93
6354395-35439593.84294.37
45min1324699-32469985.97992.414.6786.6293.094.66
2332741-33274188.10888.76
3356645-35664594.43895.13
4364963-36496396.64097.35
5360015-36001595.33096.04
6354792-35479293.94794.64
极限1323868-32386885.75992.094.5686.5592.924.55
2332489-33248988.04188.84
3353281-35328193.54794.40
4364079-36407996.40697.27
5357586-35758694.68795.55
6355272-35527294.07494.92
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