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%
1 15.239669296613966169652296366965620.13
2 15.149627896228962530.04
单位质量响应值RSD%判断
6340.256357.530.20数据可信
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%
5min154446-5444655.59252.619.8455.5952.619.84
252764-5276453.87553.87
350803-5080351.87251.87
457527-5752758.73858.74
551137-5113752.21352.21
642483-4248343.37743.38
10min177392-7739279.02177.713.7679.1177.803.77
276799-7679978.41578.51
375106-7510676.68776.77
480617-8061782.31482.41
574456-7445676.02376.11
672270-7227073.79173.86
15min189641-8964191.52889.223.8991.7589.443.90
286178-8617887.99288.21
385399-8539987.19787.41
493278-9327895.24195.48
585126-8512686.91887.13
684671-8467186.45386.65
20min195183-9518397.18694.213.9797.5694.573.97
290067-9006791.96392.33
389223-8922391.10191.46
498348-98348100.418100.81
590705-9070592.61492.97
690074-9007491.97092.31
30min198704-98704100.78297.224.36101.3297.744.36
293172-9317295.13395.65
392048-9204893.98594.50
4101634-101634103.773104.33
590940-9094092.85493.37
694811-9481196.80797.30
45min198876-98876100.95797.953.93101.6698.643.93
293870-9387095.84696.52
392816-9281694.77095.44
4101999-101999104.146104.88
592556-9255694.50495.17
695480-9548097.49098.14
极限198805-98805100.88598.462.94101.7699.312.95
295291-9529197.29798.14
394116-9411696.09796.92
4101034-101034103.161104.07
595118-9511897.12097.95
694214-9421496.19797.01
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 11.431775261773201775571772071773811773980.09
2 11.391778161775231776700.12
单位质量响应值RSD%判断
15520.3815598.770.36数据可信
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%
5min1101755-10175554.13253.947.0154.1353.947.01
2108034-10803457.47257.47
3105134-10513455.93055.93
4107328-10732857.09757.10
596269-9626951.21451.21
689866-8986647.80747.81
10min1144822-14482277.04377.274.0877.1377.364.08
2152912-15291281.34781.44
3148578-14857879.04179.13
4147753-14775378.60278.70
5136193-13619372.45372.54
6141187-14118775.10975.19
15min1164788-16478887.66588.123.0187.8888.343.02
2171522-17152291.24791.48
3167136-16713688.91489.14
4168396-16839689.58489.81
5156767-15676783.39883.60
6165218-16521887.89388.10
20min1175026-17502693.11192.892.7393.4893.252.73
2178195-17819594.79795.18
3174657-17465792.91593.29
4178235-17823594.81895.19
5165397-16539787.98988.33
6176100-17610093.68394.03
30min1179496-17949695.48995.613.0596.0196.143.05
2182627-18262797.15597.70
3179426-17942695.45295.98
4184155-18415597.96898.50
5169324-16932490.07890.57
6183355-18335597.54298.05
45min1181816-18181696.72396.663.1697.4097.343.16
2184620-18462098.21598.92
3181613-18161396.61597.30
4185385-18538598.62299.32
5170620-17062090.76791.41
6186141-18614199.02499.69
极限1181455-18145596.53197.183.1797.3798.023.17
2188944-188944100.515101.38
3182289-18228996.97597.82
4185323-18532398.58999.45
5172221-17222191.61992.41
6185861-18586198.87599.71
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%
1 15.239637696238961359605196165961930.13
2 15.149588095865958720.02
单位质量响应值RSD%判断
6316.026332.360.19数据可信
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%
5min146047-4604747.20047.758.5247.2047.748.53
251057-5105752.33552.34
344053-4405345.15645.16
447563-4756348.75448.75
550286-5028651.54551.54
640470-4047041.48341.48
10min170076-7007671.83072.513.6571.9172.593.65
273566-7356675.40875.49
367560-6756069.25169.33
469675-6967571.41971.50
574164-7416476.02176.11
669388-6938871.12571.19
15min181371-8137183.40883.152.8383.6183.352.83
282545-8254584.61284.82
378023-7802379.97680.17
479671-7967181.66681.87
584601-8460186.71986.93
680487-8048782.50282.69
20min187868-8786890.06888.432.9090.4188.772.90
288394-8839490.60790.96
385186-8518687.31987.64
482322-8232284.38384.72
588736-8873690.95891.31
685139-8513987.27087.60
30min190483-9048392.74891.362.8193.2491.852.81
290688-9068892.95893.46
389483-8948391.72392.19
484503-8450386.61987.10
591330-9133093.61694.13
688308-8830890.51990.99
45min192194-9219494.50293.103.0895.1493.743.07
292651-9265194.97195.63
390904-9090493.18093.80
485928-8592888.07988.70
593698-9369896.04496.71
689605-8960591.84892.47
极限193148-9314895.48093.332.7196.2894.122.71
292397-9239794.71095.53
389787-8978792.03592.81
486936-8693689.11289.88
593377-9337795.71596.54
690630-9063092.89993.67
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 11.431773361774711770621772201772981772770.09
2 11.391768231768761768500.03
单位质量响应值RSD%判断
15509.8015526.780.08数据可信
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%
5min199608-9960853.13153.206.5653.1353.206.56
2104491-10449155.73555.74
392521-9252149.35049.35
4104180-10418055.56955.57
5106498-10649856.80656.81
691171-9117148.63048.63
10min1144541-14454177.09876.233.1577.1976.323.15
2146179-14617977.97178.06
3134765-13476571.88371.97
4143113-14311376.33676.43
5147345-14734578.59378.69
6141567-14156775.51175.59
15min1165800-16580088.43786.942.3688.6587.152.36
2163593-16359387.26087.48
3157391-15739183.95284.15
4160180-16018085.44085.66
5168119-16811989.67489.90
6162846-16284686.86287.07
20min1176957-17695794.38891.912.4394.7592.282.43
2172236-17223691.87092.24
3167673-16767389.43689.78
4167690-16769089.44589.81
5177112-17711294.47194.85
6172248-17224891.87792.23
30min1183549-18354997.90594.862.3698.4395.382.36
2177028-17702894.42694.95
3174671-17467193.16993.66
4172389-17238991.95292.46
5181714-18171496.92697.46
6177699-17769994.78495.29
45min1185397-18539798.89096.302.5599.5896.972.55
2183828-18382898.05398.73
3177020-17702094.42295.07
4173575-17357592.58493.25
5183654-18365497.96198.65
6179753-17975395.88096.54
极限1185237-18523798.80596.002.2799.6596.832.27
2179785-17978595.89796.74
3176822-17682294.31695.12
4174162-17416292.89893.72
5183404-18340497.82798.68
6180406-18040696.22897.05
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%
1 15.239608996214960909603596023960900.08
2 15.149556895567955680.01
单位质量响应值RSD%判断
6309.266312.290.04数据可信
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%
5min149617-4961750.96751.352.3050.9751.352.30
248051-4805149.35949.36
351345-5134552.74252.74
450444-5044451.81751.82
549725-4972551.07851.08
650749-5074952.13052.13
10min171292-7129273.23273.002.0873.3273.082.08
268232-6823270.08970.17
370906-7090672.83672.92
472220-7222074.18574.27
571597-7159773.54573.63
672142-7214274.10574.19
15min182052-8205284.28584.050.8084.4984.250.80
280862-8086283.06383.26
382127-8212784.36284.57
482236-8223684.47484.68
582479-8247984.72484.93
681174-8117483.38383.59
20min188044-8804490.44089.601.0890.7989.941.08
286063-8606388.40588.74
386988-8698889.35589.71
487696-8769690.08390.43
588297-8829790.70091.05
686251-8625188.59888.95
30min191087-9108793.56693.651.0594.0694.151.05
290793-9079393.26493.75
389786-8978692.22992.73
492046-9204694.55195.05
592449-9244994.96595.46
690870-9087093.34393.84
45min191577-9157794.06994.661.6894.7295.321.67
290777-9077793.24793.89
391425-9142593.91394.57
495076-9507697.66398.32
592569-9256995.08895.75
691514-9151494.00494.66
极限191220-9122093.70294.260.8794.5195.060.87
290731-9073193.20094.00
391493-9149393.98394.79
492942-9294295.47196.29
592315-9231594.82795.64
691852-9185294.35295.16
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 11.431771681773931772571772671772791772730.05
2 11.391768381764561766470.16
单位质量响应值RSD%判断
15509.4515508.960.01数据可信
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%
5min1104794-10479455.93057.173.4255.9357.173.42
2102685-10268554.80454.80
3108010-10801057.64657.65
4104908-10490855.99055.99
5109835-10983558.62058.62
6112468-11246860.02560.03
10min1145822-14582277.82778.221.9677.9278.321.96
2143059-14305976.35276.44
3146671-14667178.28078.38
4144158-14415876.93877.03
5149138-14913879.59679.69
6150520-15052080.33480.43
15min1165855-16585588.51889.161.2688.7489.381.27
2165382-16538288.26688.48
3166513-16651388.87089.10
4165196-16519688.16788.39
5170136-17013690.80391.03
6169213-16921390.31190.54
20min1176039-17603993.95494.840.9294.3295.220.93
2176925-17692594.42794.79
3176828-17682894.37594.75
4176925-17692594.42794.80
5179955-17995596.04496.43
6179564-17956495.83596.22
30min1182798-18279897.56198.260.7898.0998.790.78
2183215-18321597.78498.31
3182447-18244797.37497.91
4185457-18545798.98099.51
5185199-18519998.84299.38
6185478-18547898.99199.54
45min1184725-18472598.58999.602.1199.28100.302.10
2183398-18339897.88198.57
3184082-18408298.24698.94
4186167-18616799.359100.05
5187271-18727199.948100.65
6194108-194108103.597104.31
极限1184773-18477398.61598.980.9599.4799.840.95
2183579-18357997.97898.83
3184059-18405998.23499.09
4185529-18552999.01999.88
5188377-188377100.539101.41
6186381-18638199.473100.36
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%
1 15.239578295762957449594095751957960.09
2 15.149554195431954860.09
单位质量响应值RSD%判断
6289.956306.870.19数据可信
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%
5min151371-5137152.87351.305.6052.8751.305.60
248991-4899150.42350.42
353025-5302554.57554.57
451317-5131752.81752.82
549362-4936250.80550.80
645019-4501946.33546.33
10min173519-7351975.66873.792.8575.7673.882.85
269897-6989771.94072.02
372849-7284974.97875.07
472552-7255274.67374.76
572932-7293275.06475.15
668430-6843070.43070.51
15min181967-8196784.36384.952.0484.5885.162.04
280284-8028482.63182.83
383931-8393186.38486.60
484206-8420686.66786.88
583824-8382486.27486.48
681011-8101183.37983.57
20min189350-8935091.96290.301.7092.3290.651.70
285741-8574188.24788.59
386986-8698689.52989.89
489322-8932291.93392.29
588311-8831190.89291.25
686691-8669189.22589.56
30min191505-9150594.18093.701.9194.6994.201.90
287948-8794890.51991.01
390314-9031492.95493.46
492141-9214194.83495.34
592860-9286095.57496.08
691452-9145294.12594.61
45min192675-9267595.38493.941.6096.0594.591.60
289014-8901491.61692.26
390727-9072793.37994.04
491473-9147394.14794.82
592972-9297295.69096.35
690742-9074293.39594.03
极限192844-9284495.55893.761.9396.3894.571.92
288332-8833290.91491.71
390263-9026392.90293.72
493075-9307595.79696.62
591156-9115693.82194.64
690891-9089193.54894.34
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 11.431779651777051779461779171779521778970.07
2 11.391767851765931766890.08
单位质量响应值RSD%判断
15564.0415512.640.24数据可信
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%
5min1108637-10863757.87256.185.0257.8756.185.02
2107921-10792157.49157.49
3111535-11153559.41659.42
4105190-10519056.03656.04
5102961-10296154.84854.85
696490-9649051.40151.40
10min1151200-15120080.54677.942.6880.6478.032.68
2147115-14711578.37078.47
3149058-14905879.40579.50
4146118-14611877.83977.93
5144409-14440976.92877.02
6139943-13994374.54974.63
15min1174011-17401192.69788.832.3892.9389.052.38
2165937-16593788.39688.62
3167020-16702088.97389.20
4166470-16647088.68088.90
5164885-16488587.83688.06
6162156-16215686.38286.59
20min1181100-18110096.47493.531.6796.8693.901.67
2174812-17481293.12493.50
3174328-17432892.86693.25
4175551-17555193.51893.89
5175243-17524393.35493.72
6172404-17240491.84192.20
30min1186229-18622999.20696.581.4399.7597.111.43
2179719-17971995.73896.27
3178969-17896995.33995.87
4181070-18107096.45896.98
5181611-18161196.74697.27
6180192-18019295.99096.50
45min1186675-18667599.44497.131.30100.1597.811.30
2181083-18108396.46597.15
3180001-18000195.88896.58
4182036-18203696.97297.66
5182992-18299297.48298.16
6181173-18117396.51397.18
极限1189034-189034100.70097.301.82101.5898.151.82
2180720-18072096.27197.12
3180085-18008595.93396.79
4182140-18214097.02897.88
5183124-18312497.55298.40
6180750-18075096.28797.12
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