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%
115.239825298138980309784797845980220.19
215.149769097735977120.04
单位质量响应值RSD%判断
6436.116453.900.20数据可信
供试品溶液-2025021321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%
5min182904-8290483.38782.961.3983.3982.961.40
283224-8322483.70883.71
381590-8159082.06582.06
483837-8383784.32584.33
582650-8265083.13183.13
680701-8070181.17181.17
10min193091-9309193.63392.602.0993.7792.742.09
292661-9266193.20093.34
391127-9112791.65791.79
493268-9326893.81193.95
593682-9368294.22794.37
688583-8858389.09989.23
15min195386-9538695.94196.111.8996.2496.401.90
296920-9692097.48497.78
394610-9461095.16195.45
497463-9746398.03098.33
596402-9640296.96397.26
692528-9252893.06793.35
20min196884-9688497.44897.511.9597.9097.961.95
298451-9845199.02499.48
395871-9587196.42996.88
498465-9846599.03899.50
598246-9824698.81899.28
693729-9372994.27594.71
30min197891-9789198.46198.071.8199.0898.691.81
298824-9882499.399100.02
395859-9585996.41797.03
499255-9925599.833100.46
598361-9836198.93499.56
694829-9482995.38195.98
45min197008-9700897.57398.571.7698.3599.341.76
299424-99424100.003100.79
397278-9727897.84498.61
499577-99577100.157100.95
599344-9934499.922100.71
695349-9534995.90496.66
极限197056-9705697.62198.511.8998.5799.461.89
299693-99693100.273101.23
396953-9695397.51798.45
499862-99862100.443101.40
598906-9890699.482100.44
695180-9518095.73496.65
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 11.431790601790901792361791001793071791590.06
2 11.391777991775611776800.10
单位质量响应值RSD%判断
15674.4515599.650.34数据可信
供试品溶液-2025021321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%
5min170162-7016237.14037.012.7537.1437.012.74
267792-6779235.88635.89
370347-7034737.23837.24
470076-7007637.09537.09
568038-6803836.01636.02
673088-7308838.68938.69
10min1124327-12432765.81263.242.4465.8763.302.44
2116491-11649161.66461.72
3118402-11840262.67662.74
4118930-11893062.95563.02
5121411-12141164.26964.33
6117291-11729162.08862.15
15min1149550-14955079.16477.042.1079.3477.212.10
2142747-14274775.56375.73
3143435-14343575.92776.09
4146209-14620977.39677.56
5148616-14861678.67078.84
6142644-14264475.50875.68
20min1165639-16563987.68185.632.1187.9885.922.11
2158827-15882784.07584.36
3158630-15863083.97184.26
4161991-16199185.75086.05
5166089-16608987.91988.22
6159367-15936784.36184.65
30min1180763-18076395.68793.622.2596.1494.062.25
2173038-17303891.59792.03
3171617-17161790.84591.28
4178322-17832294.39594.83
5181217-18121795.92796.37
6176182-17618293.26293.70
45min1186640-18664098.79898.571.4399.4199.161.43
2183573-18357397.17497.76
3183607-18360797.19297.78
4187129-18712999.05799.65
5190678-190678100.935101.54
6185612-18561298.25498.84
极限1188764-18876499.922100.571.32100.70101.331.32
2188465-18846599.764100.51
3189375-189375100.245100.99
4190992-190992101.101101.86
5194596-194596103.009103.78
6187770-18777099.396100.15
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%
115.239721497221971589726697413972540.10
215.149701396996970040.02
单位质量响应值RSD%判断
6385.696407.130.24数据可信
供试品溶液-2025021321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%
5min182465-8246583.57582.101.4983.5882.101.49
281559-8155982.65782.66
380176-8017681.25581.26
479314-7931480.38280.38
582009-8200983.11383.11
680521-8052181.60581.61
10min191884-9188493.12191.941.2193.2692.071.21
291934-9193493.17293.31
390744-9074491.96692.10
489377-8937790.58090.71
590789-9078992.01192.15
689571-8957190.77790.91
15min194476-9447695.74894.851.2596.0495.141.24
294486-9448695.75896.05
394607-9460795.88196.17
491727-9172792.96293.25
593422-9342294.68094.97
692798-9279894.04794.33
20min195269-9526996.55295.990.9697.0196.440.96
295659-9565996.94797.40
395481-9548196.76797.22
493448-9344894.70695.15
594575-9457595.84896.30
693869-9386995.13395.58
30min195076-9507696.35696.830.8496.9797.440.84
296232-9623297.52898.14
396696-9669697.99898.61
494518-9451895.79196.39
595543-9554396.82997.44
695210-9521096.49297.09
45min195597-9559796.88497.221.0397.6697.991.03
296616-9661697.91798.69
397142-9714298.45099.22
494266-9426695.53596.29
595887-9588797.17897.95
696057-9605797.35098.11
极限196725-9672598.02797.071.1498.9698.001.14
296587-9658797.88798.83
396473-9647397.77298.71
494045-9404595.31196.23
594856-9485696.13397.07
695996-9599697.28898.21
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 11.431792101793171792741792521792741792650.03
2 11.391803471801821802640.07
单位质量响应值RSD%判断
15683.7315826.510.65数据可信
供试品溶液-2025021321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%
5min174764-7476439.28036.575.1839.2836.575.18
271740-7174037.69137.69
365472-6547234.39834.40
465717-6571734.52734.53
570794-7079437.19437.19
669166-6916636.33936.34
10min1127435-12743566.95362.674.3567.0262.734.35
2122397-12239764.30664.37
3117790-11779061.88661.94
4115793-11579360.83660.89
5119583-11958362.82862.89
6112673-11267359.19759.26
15min1151042-15104279.35675.903.4379.5376.073.43
2146671-14667177.05977.23
3144841-14484176.09876.26
4140206-14020673.66373.82
5146734-14673477.09377.26
6137331-13733172.15272.31
20min1165716-16571687.06584.312.6887.3784.602.68
2162503-16250385.37785.68
3160934-16093484.55384.84
4158283-15828383.16083.44
5162198-16219885.21785.51
6153219-15321980.50080.78
30min1178570-17857093.81992.281.5494.2792.721.55
2176058-17605892.49992.94
3177365-17736593.18693.61
4173644-17364491.23191.65
5176971-17697192.97993.42
6171286-17128689.99290.41
45min1186955-18695598.22497.051.1998.8497.641.19
2184764-18476497.07397.67
3186731-18673198.10798.69
4181769-18176995.50096.07
5185677-18567797.55398.14
6182448-18244895.85696.42
极限1191379-191379100.54999.021.24101.3299.771.25
2188322-18832298.94299.70
3190645-190645100.163100.91
4185694-18569497.56298.29
5188832-18883299.21099.97
6185995-18599597.72098.44
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%
115.239724797445973689723197373973330.10
215.149671696736967260.02
单位质量响应值RSD%判断
6390.876388.770.03数据可信
供试品溶液-2025021421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%
5min179506-7950680.65982.803.2880.6682.803.28
278308-7830879.44479.44
380541-8054181.70981.71
485322-8532286.56086.56
583892-8389285.10985.11
682147-8214783.33983.34
10min189707-8970791.00892.352.6691.1492.492.66
287534-8753488.80488.94
391234-9123492.55792.69
494625-9462595.99896.14
592507-9250793.84993.99
690596-9059691.91092.05
15min192049-9204993.38495.712.5793.6796.002.57
291140-9114092.46292.74
394862-9486296.23896.53
497704-9770499.12199.43
595798-9579897.18897.49
694495-9449595.86696.16
20min193247-9324794.60097.022.7595.0497.472.75
291907-9190793.24093.67
395771-9577197.16097.61
498871-98871100.305100.77
597615-9761599.03199.49
696377-9637797.77598.23
30min194329-9432995.69797.702.6496.3098.312.64
292265-9226593.60394.19
396635-9663598.03798.65
499050-99050100.487101.12
598006-9800699.428100.05
697542-9754298.95799.57
45min194529-9452995.90098.312.9796.6699.082.97
292783-9278394.12994.87
396424-9642497.82398.60
4100337-100337101.792102.60
599177-99177100.616101.41
698149-9814999.573100.35
极限194742-9474296.11698.062.4897.0499.002.48
293366-9336694.72095.62
396109-9610997.50398.44
499561-99561101.005101.98
598873-98873100.307101.27
697298-9729898.70999.66
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 11.431785961787151786131787331785791786470.04
2 11.391776451776521776480.01
单位质量响应值RSD%判断
15629.6615596.840.15数据可信
供试品溶液-2025021421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%
5min179150-7915041.96242.092.3241.9642.092.32
279223-7922342.00042.00
375976-7597640.27940.28
481130-8113043.01143.01
580435-8043542.64342.64
680428-8042842.63942.64
10min1125139-12513966.34365.862.2166.4165.942.20
2124099-12409965.79265.86
3124494-12449466.00166.07
4128640-12864068.19968.27
5122637-12263765.01665.09
6120410-12041063.83663.91
15min1150131-15013179.59279.782.2379.7779.962.23
2150113-15011379.58379.76
3152500-15250080.84881.03
4155906-15590682.65482.84
5147270-14727078.07678.26
6147012-14701277.93978.12
20min1164657-16465787.29387.711.6987.6188.021.69
2164226-16422687.06587.38
3166459-16645988.24988.56
4170503-17050390.39390.72
5162520-16252086.16186.47
6164275-16427587.09187.40
30min1177809-17780994.26694.701.3694.7295.161.36
2176076-17607693.34793.80
3179424-17942495.12295.58
4182477-18247796.74197.21
5176279-17627993.45593.91
6179697-17969795.26795.72
45min1184593-18459397.86398.631.2198.4899.251.21
2183476-18347697.27097.88
3185604-18560498.39999.02
4189493-189493100.460101.10
5185188-18518898.17898.79
6187896-18789699.614100.23
极限1187371-18737199.335100.240.99100.11101.020.99
2187280-18728099.287100.06
3189523-189523100.476101.26
4192220-192220101.906102.71
5188281-18828199.818100.59
6189765-189765100.605101.38
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%
115.239752097422974289747397514974710.05
215.149703397098970660.05
单位质量响应值RSD%判断
6399.936411.230.13数据可信
供试品溶液-2025021421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%
5min181641-8164182.62281.502.9982.6281.502.99
278279-7827979.21979.22
377531-7753178.46278.46
479705-7970580.66280.66
582539-8253983.53083.53
683495-8349584.49884.50
10min190894-9089491.98690.921.9992.1291.051.99
287736-8773688.79088.92
387588-8758888.64088.77
490044-9004491.12591.26
591859-9185992.96293.10
690906-9090691.99892.14
15min193906-9390695.03494.141.7595.3294.431.75
291166-9116692.26192.54
391185-9118592.28092.56
492593-9259393.70593.99
594602-9460295.73896.03
694702-9470295.83996.13
20min195012-9501296.15395.331.6496.6095.781.64
292391-9239193.50193.93
392326-9232693.43593.87
494111-9411195.24195.68
595765-9576596.91597.37
695595-9559596.74397.20
30min195429-9542996.57596.031.3997.1896.631.40
293364-9336494.48595.07
393646-9364694.77195.36
494971-9497196.11296.71
594908-9490896.04896.66
697011-9701198.17698.79
45min195559-9555996.70796.831.6297.4897.601.62
293999-9399995.12895.88
394105-9410595.23595.98
495466-9546696.61397.37
597351-9735198.52099.30
697612-9761298.78499.56
极限193320-9332094.44196.241.8295.3797.161.81
293518-9351894.64195.55
394367-9436795.50096.41
495008-9500896.14997.07
597227-9722798.39599.33
697129-9712998.29699.24
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 11.431784931785321781461785351784841784380.10
2 11.391780971779151780060.08
单位质量响应值RSD%判断
15611.3715628.270.08数据可信
供试品溶液-2025021421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%
5min183681-8368144.34542.644.9144.3542.644.91
280368-8036842.58942.59
374019-7401939.22539.22
478289-7828941.48841.49
581479-8147943.17843.18
684948-8494845.01645.02
10min1130073-13007368.93065.923.5469.0065.993.54
2123955-12395565.68765.76
3116952-11695261.97662.04
4123803-12380365.60765.68
5127303-12730367.46267.53
6124241-12424165.83965.91
15min1155739-15573982.53179.313.0982.7279.483.10
2148726-14872678.81478.99
3141910-14191075.20275.37
4148473-14847378.68078.86
5152039-15203980.57080.75
6151029-15102980.03580.22
20min1169201-16920189.66586.812.5889.9987.122.59
2162370-16237086.04586.36
3156694-15669483.03783.33
4163294-16329486.53486.84
5166061-16606188.00188.32
6165232-16523287.56187.88
30min1181072-18107295.95593.871.7796.4394.331.77
2176000-17600093.26893.72
3173124-17312491.74492.18
4176411-17641193.48593.94
5175477-17547792.99193.46
6180707-18070795.76296.23
45min1187663-18766399.44898.321.44100.0898.941.44
2184188-18418897.60798.22
3181770-18177096.32596.91
4183781-18378197.39198.00
5187545-18754599.386100.01
6188309-18830999.791100.41
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2186337-18633798.74699.52
3186911-18691199.05099.80
4185891-18589198.50999.28
5189611-189611100.481101.27
6189657-189657100.505101.29
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