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%
115.239476594884948069484094568947730.13
215.149338093492934360.09
单位质量响应值RSD%判断
6222.786171.470.59数据可信
供试品溶液-2025021021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%
5min171513-7151374.80881.184.9674.8181.184.96
280866-8086684.59184.59
380464-8046484.17184.17
480159-8015983.85283.85
578343-7834381.95281.95
674283-7428377.70577.71
10min186438-8643890.42093.582.8590.5493.712.86
291004-9100495.19695.34
389364-8936493.48193.62
492717-9271796.98897.13
590720-9072094.89995.04
686500-8650090.48590.61
15min191728-9172895.95497.881.9996.2398.182.00
293811-9381198.13398.43
393417-9341797.72198.02
496531-96531100.978101.28
594450-9445098.80199.10
691498-9149895.71395.99
20min193556-9355697.86699.621.8298.30100.071.82
296469-96469100.913101.38
394928-9492899.30199.76
497667-97667102.166102.64
595619-95619100.024100.48
693142-9314297.43397.87
30min195392-9539299.787100.621.62100.39101.251.62
296672-96672101.126101.76
395081-9508199.461100.09
498808-98808103.360104.00
596699-96699101.154101.78
694505-9450598.85999.46
45min196514-96514100.960101.451.59101.73102.231.59
297655-97655102.154102.95
397062-97062101.534102.32
499211-99211103.782104.59
596933-96933101.399102.19
694496-9449698.84999.62
极限196398-96398100.839101.631.71101.77102.581.71
297291-97291101.773102.74
397044-97044101.515102.47
4100152-100152104.766105.75
596891-96891101.355102.32
695136-9513699.519100.45
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%
111.433572843572573570703579363577343574560.11
211.393585153586073585610.02
单位质量响应值RSD%判断
31273.4931480.330.47数据可信
供试品溶液-2025021021批-阿托伐他汀钙-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%
5min1134446-13444635.46839.017.0635.4739.007.06
2154595-15459540.78340.78
3162882-16288242.97042.97
4151551-15155139.98039.98
5143618-14361837.88837.89
6140043-14004336.94536.94
10min1226456-22645659.74162.583.4959.8062.653.49
2242970-24297064.09864.17
3245236-24523664.69564.77
4240403-24040363.42063.49
5241159-24115963.62063.68
6227110-22711059.91459.98
15min1275262-27526272.61674.812.3672.7874.982.36
2286035-28603575.45875.63
3291591-29159176.92477.10
4284732-28473275.11575.29
5288081-28808175.99876.17
6275761-27576172.74872.91
20min1304271-30427180.26982.092.2780.5582.392.27
2314590-31459082.99283.29
3319622-31962284.31984.63
4308170-30817081.29881.60
5317500-31750083.75984.06
6302896-30289679.90780.19
30min1334691-33469188.29488.991.9188.7189.421.91
2335964-33596488.63089.07
3343872-34387290.71691.16
4333105-33310587.87688.31
5346363-34636391.37491.81
6329917-32991787.03587.45
45min1358236-35823694.50694.341.9495.0794.921.94
2356839-35683994.13794.72
3362902-36290295.73796.34
4350561-35056192.48193.06
5367529-36752996.95797.55
6349647-34964792.24092.80
极限1373551-37355198.54698.511.2299.2699.251.22
2371199-37119997.92598.67
3376303-37630399.272100.03
4371961-37196198.12798.86
5380353-380353100.340101.09
6367147-36714796.85797.57
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%
115.239407393925944199424494051941420.21
215.149345893222933400.18
单位质量响应值RSD%判断
6181.356165.130.19数据可信
供试品溶液-2025021021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%
5min178302-7830282.22582.472.3982.2282.472.39
281155-8115585.22185.22
375651-7565179.44179.44
477606-7760681.49481.49
578824-7882482.77382.77
679690-7969083.68383.68
10min188500-8850092.93493.111.5393.0793.251.53
289585-8958594.07394.22
386245-8624590.56690.70
490219-9021994.73994.87
588854-8885493.30693.44
688624-8862493.06493.20
15min190882-9088295.43597.451.4495.7397.741.44
293677-9367798.37098.67
391354-9135495.93196.21
494085-9408598.79999.09
593379-9337998.05798.35
693407-9340798.08798.38
20min192825-9282597.47698.791.9597.9399.241.95
294768-9476899.51699.98
390936-9093695.49295.94
495720-95720100.516100.97
594912-9491299.667100.12
695274-95274100.047100.51
30min193463-9346398.14699.892.2198.76100.512.20
296365-96365101.193101.82
391653-9165396.24596.85
497016-97016101.877102.50
595903-95903100.708101.33
696332-96332101.158101.78
45min194357-9435799.084100.391.8199.86101.181.81
296473-96473101.306102.10
392632-9263297.27398.04
496987-96987101.846102.64
596463-96463101.296102.09
696687-96687101.531102.32
极限194989-9498999.748101.071.21100.69102.031.21
296099-96099100.914101.88
394876-9487699.629100.55
497754-97754102.652103.62
596653-96653101.495102.46
697127-97127101.993102.96
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%
111.433584333578373593083581343587273584880.16
211.393604163598473601320.12
单位质量响应值RSD%判断
31363.7831618.260.58数据可信
供试品溶液-2025021021批-阿托伐他汀钙-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%
5min1154672-15467240.65640.157.0040.6640.157.00
2162792-16279242.79142.79
3133660-13366035.13335.13
4148036-14803638.91238.91
5160790-16079042.26442.26
6156579-15657941.15741.16
10min1242562-24256263.75862.284.8163.8362.344.82
2242957-24295763.86263.93
3214511-21451156.38556.44
4240586-24058663.23963.30
5244942-24494264.38464.45
6236064-23606462.05062.12
15min1284197-28419774.70274.733.8474.8874.903.84
2288739-28873975.89676.07
3263352-26335269.22369.38
4285981-28598175.17175.34
5295012-29501277.54577.72
6288587-28858775.85676.03
20min1312376-31237682.10982.014.4982.4182.314.49
2314917-31491782.77783.08
3284941-28494174.89875.17
4316796-31679683.27183.57
5325617-32561785.59085.90
6317362-31736283.42083.72
30min1335717-33571788.24588.944.5288.6889.374.52
2340082-34008289.39289.83
3309942-30994281.47081.86
4344357-34435790.51690.95
5354432-35443293.16493.61
6345657-34565790.85791.29
45min1350808-35080892.21193.474.1692.7994.054.16
2355937-35593793.56094.15
3329341-32934186.56987.10
4360100-36010094.65495.24
5371405-37140597.62598.23
6365933-36593396.18796.78
极限1366531-36653196.34497.342.9497.0898.072.95
2366260-36626096.27397.02
3352135-35213592.56093.23
4378598-37859899.516100.26
5380467-380467100.007100.77
6377892-37789299.330100.08
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%
115.239390493735937879370693894938050.10
215.149355993863937110.23
单位质量响应值RSD%判断
6159.236189.630.35数据可信
供试品溶液-2025021121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%
5min178179-7817982.08081.891.7282.0881.891.72
278490-7849082.40782.41
377135-7713580.98480.98
476129-7612979.92879.93
577943-7794381.83381.83
680110-8011084.10884.11
10min189103-8910393.55093.680.8193.6993.820.81
289272-8927293.72793.86
388899-8889993.33593.47
490395-9039594.90695.04
589487-8948793.95394.09
688222-8822292.62592.76
15min192716-9271697.34397.720.9697.6498.020.96
292547-9254797.16597.46
392663-9266397.28797.58
494834-9483499.56799.86
592528-9252897.14597.44
693189-9318997.83998.13
20min194162-9416298.86199.171.1099.3299.631.10
294360-9436099.06999.52
393948-9394898.63699.09
496333-96333101.140101.60
593262-9326297.91698.37
694700-9470099.42699.88
30min194456-9445699.170100.091.0099.79100.710.99
295359-95359100.118100.74
394893-9489399.628100.25
496853-96853101.686102.31
594449-9444999.16299.78
695976-95976100.765101.39
45min195479-95479100.244100.580.89101.03101.360.89
295622-95622100.394101.18
395194-9519499.944100.73
497105-97105101.951102.75
594853-9485399.586100.37
696526-96526101.343102.13
极限195392-95392100.152100.701.28101.10101.661.28
296251-96251101.054102.01
395037-9503799.780100.73
498097-98097102.992103.96
594666-9466699.390100.34
696066-96066100.860101.82
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%
111.433563653555203553163548123554313554890.16
211.393591613599433595520.16
单位质量响应值RSD%判断
31101.4031567.341.06数据可信
供试品溶液-2025021121批-阿托伐他汀钙-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%
5min1167261-16726144.18743.533.3744.1943.533.37
2162958-16295843.05043.05
3161823-16182342.75042.75
4157603-15760341.63541.64
5165013-16501343.59343.59
6173953-17395345.95545.95
10min1255092-25509267.39067.641.1467.4667.711.14
2256838-25683867.85167.92
3255884-25588467.59967.67
4253641-25364167.00667.08
5261362-26136269.04669.12
6253446-25344666.95567.03
15min1298939-29893978.97380.291.0579.1680.481.05
2302743-30274379.97880.16
3304201-30420180.36380.55
4303632-30363280.21380.39
5308604-30860481.52781.71
6305483-30548380.70280.89
20min1322962-32296285.32086.931.2685.6487.261.26
2328188-32818886.70087.02
3327366-32736686.48386.80
4328795-32879586.86187.18
5334932-33493288.48288.81
6332185-33218587.75688.08
30min1343440-34344090.72992.871.7191.1993.331.70
2351984-35198492.98793.45
3347684-34768491.85192.31
4349566-34956692.34892.81
5359651-35965195.01295.48
6356937-35693794.29594.76
45min1357694-35769494.49596.461.7095.1197.081.69
2365584-36558496.57997.20
3363127-36312795.93096.55
4359839-35983995.06295.68
5372702-37270298.46099.09
6371906-37190698.25098.88
极限1367223-36722397.01299.041.2397.7899.821.23
2377313-37731399.678100.46
3371191-37119198.06198.84
4377251-37725199.662100.43
5378252-37825299.926100.72
6378091-37809199.884100.67
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%
115.239681196528967579660796779966960.13
215.149464994466945580.14
单位质量响应值RSD%判断
6349.056245.571.17数据可信
供试品溶液-2025021121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%
5min177862-7786280.15781.422.2080.1681.422.20
280277-8027782.64382.64
378645-7864580.96380.96
481939-8193984.35484.35
577185-7718579.46079.46
678644-7864480.96280.96
10min192358-9235895.08192.832.3995.2192.962.38
290903-9090393.58393.72
387103-8710389.67189.81
492536-9253695.26495.40
588693-8869391.30891.44
689411-8941192.04792.18
15min195317-9531798.12796.452.4098.4296.742.40
294864-9486497.66097.95
389502-8950292.14092.42
495497-9549798.31298.61
593131-9313195.87696.16
693834-9383496.60096.89
20min196563-9656399.41097.662.9699.8798.122.96
295927-9592798.75599.21
389507-8950792.14692.58
497224-97224100.090100.55
594294-9429497.07497.52
695690-9569098.51198.96
30min197588-97588100.46598.842.44101.0999.452.44
296619-9661999.467100.09
391615-9161594.31694.91
498074-98074100.965101.60
595417-9541798.23098.84
696724-9672499.575100.19
45min197270-97270100.13798.383.08100.9399.163.07
296946-9694699.804100.59
390213-9021392.87293.62
498505-98505101.409102.21
594612-9461297.40198.17
695853-9585398.67999.46
极限198018-98018100.90798.653.48101.8699.593.47
297081-9708199.943100.90
389223-8922391.85392.76
497879-97879100.764101.73
595760-9576098.58399.52
696983-9698399.842100.79
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%
111.433577403571113577403572023576573574900.09
211.393558653553283555960.11
单位质量响应值RSD%判断
31276.4731220.020.13数据可信
供试品溶液-2025021121批-阿托伐他汀钙-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%
5min1153352-15335240.62242.904.4040.6242.904.41
2170550-17055045.17745.18
3158283-15828341.92841.93
4170735-17073545.22645.23
5160403-16040342.49042.49
6158355-15835541.94741.95
10min1252073-25207366.77266.153.6166.8466.223.61
2258203-25820368.39668.47
3234669-23466962.16262.23
4258870-25887068.57368.65
5248788-24878865.90265.97
6245707-24570765.08665.16
15min1300115-30011579.49878.863.2379.6879.043.23
2305378-30537880.89281.08
3278972-27897273.89874.07
4303555-30355580.40980.60
5300965-30096579.72379.90
6297185-29718578.72278.90
20min1324802-32480286.03885.134.1686.3585.444.15
2326424-32642486.46786.79
3294242-29424277.94278.24
4327329-32732986.70787.03
5328285-32828586.96087.27
6327219-32721986.67886.99
30min1348751-34875192.38191.593.4892.8492.043.47
2347441-34744192.03492.50
3321838-32183885.25285.68
4349433-34943392.56293.03
5354484-35448493.90094.36
6352633-35263393.41093.86
45min1360240-36024095.42594.374.3596.0394.974.35
2362731-36273196.08596.71
3324755-32475586.02586.59
4361786-36178695.83496.46
5363661-36366196.33196.95
6364274-36427496.49397.10
极限1371989-37198998.53797.164.6399.3097.934.62
2373939-37393999.05499.84
3332344-33234488.03588.75
4371788-37178898.48499.27
5375126-37512699.368100.14
6375609-37560999.496100.27
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