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%
115.069397894075943129400593749940240.22
215.019460194356944780.19
单位质量响应值RSD%判断
6243.296294.340.58数据可信
加速6月-供试品溶液-2025021321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%
5min145428-4542846.97748.825.9546.9848.825.95
247459-4745949.07849.08
349789-4978951.48751.49
446349-4634947.93047.93
543321-4332144.79844.80
650903-5090352.63952.64
10min176796-7679679.41580.202.8279.4980.282.82
275031-7503177.59077.67
379752-7975282.47282.56
475136-7513677.69977.78
579149-7914981.84881.92
679472-7947282.18282.27
15min185033-8503387.93389.801.4588.1490.011.46
286053-8605388.98889.20
387836-8783690.83291.05
488266-8826691.27691.49
586204-8620489.14489.36
687621-8762190.60990.83
20min188611-8861191.63394.061.4491.9994.421.44
291084-9108494.19094.55
391224-9122494.33594.71
492259-9225995.40695.77
590571-9057193.66094.02
692000-9200095.13895.51
30min192622-9262295.78196.311.5296.2996.831.51
293472-9347296.66097.18
394519-9451997.74398.27
493928-9392897.13197.65
590552-9055293.64094.16
693694-9369496.89097.42
45min191271-9127194.38496.441.6795.0597.121.66
294381-9438197.60098.28
394842-9484298.07798.77
491990-9199095.12795.81
592411-9241195.56396.23
694653-9465397.88198.58
极限192413-9241395.56596.431.3796.3997.281.37
293553-9355396.74497.58
394343-9434397.56198.42
492121-9212195.26396.10
592015-9201595.15395.98
695080-9508098.32399.18
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 11.641814441821091817881814371814261816410.17
2 11.571831561835241833400.15
单位质量响应值RSD%判断
15604.9015846.151.09数据可信
加速6月-供试品溶液-2025021321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%
5min1107676-10767656.68156.645.6556.6856.645.66
2106420-10642056.01956.02
3112862-11286259.41059.41
498981-9898152.10352.10
5103865-10386554.67454.67
6115802-11580260.95860.96
10min1150388-15038879.16479.732.3079.2679.822.30
2149876-14987678.89578.99
3155268-15526881.73381.83
4149611-14961178.75578.84
5147412-14741277.59777.69
6156180-15618082.21382.31
15min1170175-17017589.58089.851.5089.8190.071.50
2170126-17012689.55489.78
3172586-17258690.84991.08
4171782-17178290.42690.64
5166148-16614887.46087.68
6173267-17326791.20891.45
20min1179125-17912594.29194.521.5294.6794.901.52
2180242-18024294.87995.25
3181018-18101895.28895.67
4180633-18063395.08595.45
5174356-17435691.78192.15
6182008-18200895.80996.20
30min1185502-18550297.64897.561.4598.1898.091.45
2186381-18638198.11198.64
3186022-18602297.92298.47
4187162-18716298.52299.05
5180020-18002094.76295.28
6186901-18690198.38498.93
45min1187090-18709098.48498.101.4199.1898.801.41
2187703-18770398.80799.50
3186513-18651398.18098.89
4187995-18799598.96099.65
5181143-18114395.35396.03
6187749-18774998.83199.55
极限1187026-18702698.45098.331.4499.3199.201.44
2187476-18747698.68799.55
3188096-18809699.01399.89
4188133-18813399.03399.89
5181439-18143995.50996.35
6188647-18864799.304100.18
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%
115.069350493554939079370193205935740.28
215.019408194041940610.04
单位质量响应值RSD%判断
6213.416266.560.61数据可信
加速6月-供试品溶液-2025021421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%
5min155954-5595458.13058.064.2658.1358.064.26
253965-5396556.06356.06
357907-5790760.15960.16
456238-5623858.42558.42
552451-5245154.49154.49
658802-5880261.08961.09
10min176121-7612179.08180.502.1479.1880.602.14
276712-7671279.69579.79
378670-7867081.72981.83
478348-7834881.39581.49
575405-7540578.33778.43
679650-7965082.74782.85
15min184601-8460187.89189.021.7388.1289.251.74
284309-8430987.58787.81
387241-8724190.63390.87
484956-8495688.26088.49
585157-8515788.46888.69
687843-8784391.25991.50
20min190221-9022193.72993.170.7294.1093.550.71
289573-8957393.05693.43
389181-8918192.64993.04
488930-8893092.38892.77
589573-8957393.05693.42
690638-9063894.16294.55
30min193056-9305696.67595.581.5897.2196.121.56
291501-9150195.05995.59
389427-8942792.90493.45
493279-9327996.90697.44
592915-9291596.52897.05
691862-9186295.43495.98
45min193050-9305096.66896.340.6597.3697.030.65
292362-9236295.95496.64
392838-9283896.44897.14
493161-9316196.78497.48
591701-9170195.26795.95
693265-9326596.89297.60
极限193169-9316996.79296.280.5797.6597.140.57
292583-9258396.18397.03
392117-9211795.69996.56
492873-9287396.48497.34
593294-9329496.92297.77
692036-9203695.61596.48
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 11.641810831809081811331815031810661811390.13
2 11.571825021827091826060.09
单位质量响应值RSD%判断
15561.7715782.711.00数据可信
加速6月-供试品溶液-2025021421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%
5min1109120-10912057.63559.165.7857.6459.165.78
2102852-10285254.32554.32
3120150-12015063.46163.46
4113265-11326559.82559.82
5108573-10857357.34657.35
6118106-11810662.38262.38
10min1148018-14801878.18180.373.3778.2880.463.38
2144918-14491876.54376.63
3158582-15858283.76083.87
4152391-15239180.49080.59
5152329-15232980.45880.55
6156689-15668982.76182.86
15min1165704-16570487.52289.682.7387.7589.912.73
2163162-16316286.17986.40
3175787-17578792.84893.09
4169914-16991489.74689.98
5171671-17167190.67490.90
6172456-17245691.08891.33
20min1174145-17414591.98194.082.1492.3594.462.14
2173677-17367791.73392.10
3183188-18318896.75797.16
4177606-17760693.80994.19
5181330-18133095.77696.16
6178801-17880194.44094.83
30min1179514-17951494.81697.232.7995.3497.762.79
2179118-17911894.60795.12
3187123-18712398.83599.40
4183208-18320896.76797.31
5192698-192698101.780102.32
6182801-18280196.55297.10
45min1180998-18099895.60097.301.8596.2898.001.86
2180225-18022595.19295.86
3187435-18743599.00099.73
4184228-18422897.30698.01
5188763-18876399.702100.41
6183596-18359696.97297.68
极限1180547-18054795.36297.201.9196.2098.061.91
2180367-18036795.26796.10
3187091-18709198.81899.71
4183219-18321996.77397.64
5189092-18909299.875100.75
6183860-18386097.11297.99
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%
115.069397793916941049432093902940440.19
215.019181891816918170.01
单位质量响应值RSD%判断
6244.626117.061.46数据可信
加速6月-供试品溶液-2025021521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%
5min154626-5462657.29857.006.1857.3057.006.17
257120-5712059.91459.91
350229-5022952.68652.69
459226-5922662.12362.12
552899-5289955.48755.49
651970-5197054.51254.51
10min176195-7619579.92279.932.0580.0280.032.05
275422-7542279.11279.21
376819-7681980.57780.66
478892-7889282.75182.85
574305-7430577.94078.03
675600-7560079.29879.39
15min185374-8537489.55090.231.6289.7890.461.62
288615-8861592.95093.18
384728-8472888.87389.09
486292-8629290.51390.75
586020-8602090.22890.45
685127-8512789.29189.51
20min186302-8630290.52494.912.8290.9095.292.81
292829-9282997.37097.76
389324-8932493.69494.06
493289-9328997.85398.24
590888-9088895.33495.71
690280-9028094.69695.07
30min192453-9245396.97698.311.6497.5098.851.64
296143-96143100.846101.40
392618-9261897.14997.68
495072-9507299.723100.28
593345-9334597.91198.44
692711-9271197.24697.78
45min193137-9313797.69398.771.9798.3899.471.97
296140-96140100.843101.56
392134-9213496.64197.33
496693-96693101.423102.14
593964-9396498.56199.26
692902-9290297.44798.14
极限192991-9299197.54098.841.9498.3999.711.94
297521-97521102.292103.18
393069-9306997.62298.47
495085-9508599.737100.63
593916-9391698.51099.37
692806-9280697.34698.20
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 11.641825391828981831601834341829211829900.19
2 11.571791101787121789110.16
单位质量响应值RSD%判断
15720.7915463.351.17数据可信
加速6月-供试品溶液-2025021521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%
5min1107950-10795057.31257.443.1257.3157.443.12
2106314-10631456.44356.44
3104851-10485155.66655.67
4113597-11359760.31060.31
5110765-11076558.80658.81
6105725-10572556.13056.13
10min1146610-14661077.83778.612.1577.9378.702.16
2147047-14704778.06978.16
3145827-14582777.42177.51
4151877-15187780.63380.73
5152211-15221180.81080.91
6144784-14478476.86776.96
15min1164794-16479487.49188.132.1987.7288.362.19
2165152-16515287.68187.90
3163289-16328986.69286.91
4168836-16883689.63789.87
5171778-17177891.19991.43
6162166-16216686.09586.32
20min1173853-17385392.30092.582.1892.6792.962.18
2173661-17366192.19892.57
3171414-17141491.00591.37
4176771-17677193.84994.23
5180558-18055895.86096.24
6170050-17005090.28190.65
30min1176825-17682593.87894.932.2694.4095.462.26
2178606-17860694.82495.35
3175801-17580193.33493.85
4181846-18184696.54497.08
5185204-18520498.32698.87
6174560-17456092.67593.19
45min1178209-17820994.61395.662.3995.2996.352.39
2180397-18039795.77496.46
3177288-17728894.12494.80
4182573-18257396.93097.63
5187316-18731699.448100.16
6175360-17536093.10093.77
极限1177985-17798594.49495.982.5295.3396.822.52
2180293-18029395.71996.56
3178533-17853394.78595.62
4182796-18279697.04897.91
5188855-188855100.265101.14
6176211-17621193.55294.38
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