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%
115.099479095042948999491095050949380.12
215.169611896246961820.10
单位质量响应值RSD%判断
6291.456344.460.60数据可信
供试品溶液-GF9438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%
5min185782-8578288.01889.741.9888.0289.741.98
287774-8777490.06290.06
390047-9004792.39492.39
487008-8700889.27689.28
588631-8863190.94190.94
685531-8553187.76087.76
10min191634-9163494.02295.321.8894.1795.471.88
293091-9309195.51795.67
395965-9596598.46698.62
492259-9225994.66494.81
593375-9337595.80995.96
691050-9105093.42393.57
15min192317-9231794.72397.221.9695.0397.521.96
295007-9500797.48397.79
397886-97886100.437100.76
494187-9418796.64296.95
595241-9524197.72398.03
693837-9383796.28396.58
20min192846-9284695.26697.571.7195.7398.041.71
295185-9518597.66698.14
397650-97650100.195100.68
494763-9476397.23397.70
595873-9587398.37298.85
694209-9420996.66497.13
30min192655-9265595.07097.421.8995.6998.061.89
295295-9529597.77998.41
397809-97809100.358101.01
494568-9456897.03397.66
595728-9572898.22398.86
693638-9363896.07996.70
45min193070-9307095.49697.321.5296.2798.121.52
295179-9517997.66098.46
397266-9726699.801100.62
494241-9424196.69797.49
595273-9527397.75698.56
694076-9407696.52897.31
极限192873-9287395.29497.301.7396.2398.261.73
295111-9511197.59098.55
397572-97572100.115101.10
494146-9414696.60097.55
595466-9546697.95498.92
693804-9380496.24997.19
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100590-202005 对照品来源中检院对照品使用方法直接使用
对照品含量(%)94.9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%
111.503557773561393560873561483563023560910.06
211.603607153616223611680.18
单位质量响应值RSD%判断
30964.4331135.170.39数据可信
供试品溶液-GF9438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%
5min1167693-16769344.61145.903.4344.6145.903.43
2176528-17652846.96146.96
3174596-17459646.44746.45
4174696-17469646.47446.47
5178600-17860047.51247.51
6163071-16307143.38143.38
10min1264120-26412070.26371.232.4270.3471.312.42
2270407-27040771.93572.01
3273926-27392672.87272.95
4267963-26796371.28571.36
5273306-27330672.70772.79
6256820-25682068.32168.39
15min1309697-30969782.38883.881.8582.5884.081.85
2317664-31766484.50784.71
3322378-32237885.76185.96
4316332-31633284.15384.35
5318814-31881484.81385.01
6307038-30703881.68081.87
20min1333964-33396488.84390.081.6189.1790.421.61
2340187-34018790.49990.84
3344819-34481991.73192.07
4341558-34155890.86391.20
5340999-34099990.71591.06
6330181-33018187.83788.16
30min1348775-34877592.78394.301.8093.2694.791.81
2356615-35661594.86995.36
3361854-36185496.26396.76
4358620-35862095.40295.89
5356137-35613794.74295.23
6344914-34491491.75692.22
45min1355626-35562694.60696.071.6195.2496.721.62
2363913-36391396.81097.46
3367170-36717097.67798.33
4364659-36465997.00997.66
5363183-36318396.61697.27
6352308-35230893.72394.34
极限1361205-36120596.09097.461.3296.8898.261.32
2368461-36846198.02098.83
3373170-37317099.273100.09
4366388-36638897.46998.28
5368351-36835197.99198.80
6360488-36048895.89996.68
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%
115.099525395419954809538395430953930.09
215.169774097987978640.18
单位质量响应值RSD%判断
6321.606455.411.49数据可信
供试品溶液-GF9438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%
5min186714-8671488.00089.100.9588.0089.100.95
288113-8811389.41989.42
387491-8749188.78888.79
487979-8797989.28389.28
587314-8731488.60988.61
689149-8914990.47190.47
10min191741-9174193.10194.411.1893.2594.561.18
293898-9389895.29095.44
393570-9357094.95795.11
492471-9247193.84293.99
592035-9203593.40093.55
694443-9444395.84395.99
15min193525-9352594.91296.091.0995.2196.401.09
295635-9563597.05397.36
394717-9471796.12196.43
494140-9414095.53695.84
593952-9395295.34595.65
696150-9615097.57697.89
20min193911-9391195.30396.300.7695.7696.770.76
295153-9515396.56497.03
394882-9488296.28996.76
494720-9472096.12496.59
594611-9461196.01496.48
696082-9608297.50797.98
30min193709-9370995.09896.311.0995.7296.941.09
295798-9579897.21897.85
394591-9459195.99396.62
494179-9417995.57596.20
594692-9469296.09696.72
696460-9646097.89098.53
45min192910-9291094.28795.851.1695.0696.641.16
295349-9534996.76397.56
393806-9380695.19795.98
494481-9448195.88296.67
594190-9419095.58696.37
695960-9596097.38398.18
极限193414-9341494.79995.911.1495.7396.861.14
295175-9517596.58697.54
394416-9441695.81696.76
493595-9359594.98395.93
594182-9418295.57896.52
696279-9627997.70698.67
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100590-202005 对照品来源中检院对照品使用方法直接使用
对照品含量(%)94.9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%
111.503582443583643584853584213586683584360.05
211.603680303681923681110.04
单位质量响应值RSD%判断
31168.3531733.711.28数据可信
供试品溶液-GF9438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%
5min1169917-16991744.62945.791.9244.6345.791.92
2179363-17936347.11047.11
3176647-17664746.39746.40
4174087-17408745.72445.72
5173925-17392545.68245.68
6172039-17203945.18645.19
10min1257843-25784367.72370.242.5967.8070.322.59
2277256-27725672.82272.90
3273066-27306671.72171.80
4263366-26336669.17469.25
5266684-26668470.04570.12
6266390-26639069.96870.04
15min1305737-30573780.30282.622.1080.4982.822.10
2323422-32342284.94785.15
3320598-32059884.20684.40
4310705-31070581.60781.80
5311557-31155781.83182.02
6315431-31543182.84983.04
20min1329508-32950886.54688.571.6386.8788.901.63
2343793-34379390.29890.64
3342683-34268390.00690.34
4335288-33528888.06488.39
5333686-33368687.64387.97
6338260-33826088.84589.17
30min1345212-34521290.67192.661.6491.1493.141.64
2359866-35986694.51995.01
3357268-35726893.83794.32
4349651-34965191.83692.31
5348573-34857391.55392.03
6356135-35613593.53994.02
45min1349379-34937991.76593.931.5292.3894.561.53
2363110-36311095.37196.02
3360454-36045494.67495.32
4356912-35691293.74494.37
5353374-35337492.81493.44
6362395-36239595.18495.82
极限1356704-35670493.68995.831.3994.4696.621.39
2368333-36833396.74397.55
3368819-36881996.87197.67
4362087-36208795.10395.89
5363512-36351295.47796.26
6369753-36975397.11697.91
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%
115.099599896095961929626996345961800.15
215.169716597133971490.03
单位质量响应值RSD%判断
6373.766408.250.39数据可信
供试品溶液-GF9438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%
5min151978-5197852.72353.255.6852.7253.245.68
255882-5588256.68356.68
354093-5409354.86854.87
448786-4878649.48549.48
549283-4928349.98949.99
654941-5494155.72855.73
10min170636-7063671.64873.514.7171.7473.604.71
278474-7847479.59879.69
372388-7238873.42573.52
472961-7296174.00674.09
568166-6816669.14369.23
672205-7220573.23973.33
15min176506-7650677.60279.515.3777.8179.725.37
285692-8569286.92087.15
377687-7768778.80079.01
479280-7928080.41680.62
572885-7288573.92974.13
678276-7827679.39779.61
20min177318-7731878.42681.375.3578.7681.715.34
287804-8780489.06289.43
379418-7941880.55680.90
482157-8215783.33483.67
575824-7582476.91077.23
678776-7877679.90580.25
30min178707-7870779.83582.465.5680.3082.945.56
289073-8907390.34990.87
378617-7861779.74380.22
484185-8418585.39185.87
577039-7703978.14378.59
680151-8015181.29981.78
45min178972-7897280.10382.834.6280.7083.454.62
288234-8823489.49890.17
380387-8038781.53982.15
483615-8361584.81385.43
577830-7783078.94579.53
680920-8092082.07982.70
极限191947-9194793.26487.727.2394.0088.487.19
288617-8861789.88790.71
380637-8063781.79282.54
488988-8898890.26391.03
576889-7688977.99178.70
691798-9179893.11393.87
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100590-202005 对照品来源中检院对照品使用方法直接使用
对照品含量(%)94.9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%
111.503642383644023646683649073650703646570.10
211.603671423672153671780.02
单位质量响应值RSD%判断
31709.3031653.280.13数据可信
供试品溶液-GF9438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%
5min1199711-19971152.06953.276.2152.0753.276.21
2216402-21640256.42156.42
3213159-21315955.57555.58
4185906-18590648.47048.47
5194917-19491750.81950.82
6215726-21572656.24556.24
10min1264659-26465969.00271.854.7969.0971.944.79
2299031-29903177.96478.06
3276959-27695972.20972.30
4272283-27228370.99071.07
5262160-26216068.35168.44
6278311-27831172.56272.66
15min1284404-28440474.15077.204.8874.3577.404.87
2322722-32272284.14184.36
3293330-29333076.47876.69
4296632-29663277.33877.54
5282451-28245173.64173.84
6296980-29698077.42977.64
20min1292104-29210476.15878.884.8576.4879.224.85
2329765-32976585.97786.34
3297954-29795477.68378.02
4305254-30525479.58679.91
5288491-28849175.21675.54
6301748-30174878.67279.02
30min1294054-29405476.66679.714.8977.1280.184.89
2333375-33337586.91887.43
3300420-30042078.32678.80
4309372-30937280.66081.12
5292662-29266276.30376.75
6304491-30449179.38779.86
45min1293967-29396776.64480.004.8777.2280.604.87
2333562-33356286.96787.62
3301256-30125678.54479.14
4312974-31297481.59982.19
5294030-29403076.66077.23
6305314-30531479.60280.21
极限1357751-35775193.27485.978.1193.9886.708.05
2334267-33426787.15187.95
3302363-30236378.83379.56
4331131-33113186.33387.06
5294830-29483076.86977.57
6358016-35801693.34394.08
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%
115.099590595814958209585695969958730.07
215.169714097257971980.09
单位质量响应值RSD%判断
6353.416411.480.65数据可信
供试品溶液-GF9438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%
5min151201-5120152.00553.675.5452.0053.675.54
256299-5629957.18357.18
351740-5174052.55252.55
454407-5440755.26155.26
555025-5502555.88955.89
648399-4839949.15949.16
10min169481-6948170.57275.464.3670.6675.564.36
277578-7757878.79678.89
375281-7528176.46376.55
476780-7678077.98578.08
575501-7550176.68676.78
671169-7116972.28672.37
15min174578-7457875.74982.465.5475.9582.675.54
283327-8332784.63584.86
386489-8648987.84788.06
483191-8319184.49784.72
582654-8265483.95284.17
676875-7687578.08278.28
20min177149-7714978.36084.245.1178.6984.595.11
284195-8419585.51785.88
388615-8861590.00690.37
484516-8451685.84386.21
584412-8441285.73786.10
678746-7874679.98280.31
30min178315-7831579.54485.514.6280.0186.004.62
285618-8561886.96287.47
388403-8840389.79190.30
486553-8655387.91288.42
585678-8567887.02387.53
680536-8053681.80082.27
45min178964-7896480.20485.994.8280.8086.634.82
285767-8576787.11387.77
390289-9028991.70692.37
486680-8668088.04188.69
585272-8527286.61187.26
681013-8101382.28582.89
极限192023-9202393.46889.853.2894.2090.633.25
285762-8576287.10887.91
390413-9041391.83292.65
490517-9051791.93892.74
584978-8497886.31287.11
687066-8706688.43389.17
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100590-202005 对照品来源中检院对照品使用方法直接使用
对照品含量(%)94.9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%
111.503606053601593603443601873606093603810.07
211.603679883682153681020.05
单位质量响应值RSD%判断
31337.4831732.930.89数据可信
供试品溶液-GF9438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%
5min1201356-20135652.74353.435.3952.7453.435.40
2214507-21450756.18856.19
3197295-19729551.67951.68
4212328-21232855.61755.62
5211980-21198055.52655.53
6186430-18643048.83348.83
10min1267222-26722269.99673.833.4470.0873.923.45
2289935-28993575.94676.04
3286304-28630474.99475.08
4287512-28751275.31175.40
5288291-28829175.51575.61
6271994-27199471.24671.33
15min1285588-28558874.80779.834.6675.0180.044.66
2310261-31026181.27081.49
3321602-32160284.24084.45
4310837-31083781.42181.64
5311342-31134281.55381.77
6289051-28905175.71475.91
20min1290644-29064476.13181.694.7876.4682.044.78
2314849-31484982.47182.83
3330909-33090986.67887.03
4319339-31933983.64884.00
5317760-31776083.23483.59
6297794-29779478.00478.33
30min1294847-29484777.23282.634.8777.6983.124.86
2317907-31790783.27383.77
3336657-33665788.18488.68
4321331-32133184.16984.66
5321559-32155984.22984.72
6300484-30048478.70979.17
45min1295868-29586877.50083.024.7078.0883.644.70
2318421-31842183.40784.04
3338215-33821588.59289.23
4322345-32234584.43585.07
5322311-32231184.42685.06
6304604-30460479.78880.38
极限1358387-35838793.87688.384.7994.5989.144.74
2318788-31878883.50384.27
3337992-33799288.53489.32
4353964-35396492.71793.49
5322598-32259884.50185.28
6332688-33268887.14487.86
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