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%
115.239622395941957569609396097960220.19
215.209626696233962500.03
单位质量响应值RSD%判断
6304.796332.240.31数据可信
供试品溶液-24082801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%
5min180243-8024382.32682.585.0482.3382.585.04
282442-8244284.58284.58
373186-7318675.08675.09
479491-7949181.55581.55
584784-8478486.98586.98
682824-8282484.97484.97
10min189967-8996792.30392.223.4792.4492.353.47
288740-8874091.04491.18
385173-8517387.38487.51
489021-8902191.33291.47
594251-9425196.69896.84
692140-9214094.53294.67
15min193963-9396396.40295.642.5996.6995.932.59
292077-9207794.46794.76
389418-8941891.73992.01
492489-9248994.89095.18
595651-9565198.13498.44
695717-9571798.20298.50
20min194959-9495997.42497.003.2097.8897.453.21
292805-9280595.21495.66
390088-9008892.42792.85
493781-9378196.21696.66
598342-98342100.895101.36
697317-9731799.843100.31
30min196257-9625798.75698.632.5099.3799.242.50
294575-9457597.03097.64
392633-9263395.03895.62
495811-9581198.29898.90
599031-99031101.602102.24
698486-98486101.043101.67
45min196732-9673299.24399.072.30100.0299.852.31
294480-9448096.93397.70
393819-9381996.25596.99
496383-9638398.88599.66
599669-99669102.256103.06
698318-98318100.870101.67
极限196951-9695199.46899.162.55100.41100.102.56
294143-9414396.58797.52
394197-9419796.64297.54
495661-9566198.14499.08
5100199-100199102.800103.78
698746-98746101.309102.28
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%
111.583571733563853558473562663567643564870.15
211.683595743597033596380.03
单位质量响应值RSD%判断
30784.7230790.920.02数据可信
供试品溶液-24082801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%
5min1151465-15146540.63640.698.2240.6440.698.23
2160616-16061643.09143.09
3130728-13072835.07335.07
4150209-15020940.29940.30
5167534-16753444.94744.95
6149480-14948040.10440.10
10min1232501-23250162.37763.544.6262.4463.614.62
2244993-24499365.72965.80
3223074-22307459.84859.91
4233622-23362262.67862.75
5254042-25404268.15668.23
6232846-23284662.47062.54
15min1281447-28144775.50976.173.5475.6876.343.54
2291448-29144878.19278.37
3272539-27253973.11973.28
4282480-28248075.78675.96
5299575-29957580.37280.56
6275936-27593674.03074.20
20min1308187-30818782.68383.463.6882.9883.763.68
2319820-31982085.80486.12
3297511-29751179.81980.10
4311069-31106983.45683.75
5328244-32824488.06488.39
6301625-30162580.92281.22
30min1336164-33616490.18990.802.9190.6291.242.92
2345557-34555792.70993.16
3323908-32390886.90187.31
4340210-34021091.27491.71
5351934-35193494.42094.89
6332808-33280889.28889.72
45min1350473-35047394.02895.011.8994.6195.601.90
2356558-35655895.66096.27
3346487-34648792.95893.52
4354430-35443095.08995.68
5365778-36577898.13498.76
6351000-35100094.16994.75
极限1360324-36032496.67197.381.5397.4198.121.54
2360076-36007696.60497.37
3361100-36110096.87997.59
4359779-35977996.52497.27
5374130-374130100.375101.16
6362350-36235097.21497.95
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%
115.239432795011941149415294896945000.45
215.209595795921959390.03
单位质量响应值RSD%判断
6204.866311.781.21数据可信
供试品溶液-24082801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%
5min151267-5126753.10745.7411.3053.1145.7411.30
243031-4303144.57644.58
348685-4868550.43350.43
437905-3790539.26639.27
543384-4338444.94144.94
640632-4063242.09142.09
10min177137-7713779.90673.576.5779.9973.656.57
269309-6930971.79771.87
375665-7566578.38178.47
464585-6458566.90466.97
568714-6871471.18171.26
670725-7072573.26473.33
15min188275-8827591.44485.344.3091.6785.544.31
282564-8256485.52885.72
383822-8382286.83187.05
478157-7815780.96381.14
579581-7958182.43882.63
681925-8192584.86685.06
20min191595-9159594.88389.543.9295.2689.893.93
287026-8702690.15090.49
388810-8881091.99892.36
482793-8279385.76586.08
583347-8334786.33986.67
685072-8507288.12688.46
30min193995-9399597.36991.423.9797.9091.913.98
288888-8888892.07992.57
389771-8977192.99493.51
484160-8416087.18187.64
585455-8545588.52389.00
687228-8722890.35990.84
45min194570-9457097.96592.573.7198.6693.213.72
291208-9120894.48295.12
389257-8925792.46193.13
484810-8481087.85588.45
587568-8756890.71291.33
688772-8877291.95992.59
极限193669-9366997.03293.022.8897.8993.812.88
286456-8645689.56090.36
391419-9141994.70195.52
490479-9047993.72794.47
588418-8841891.59292.37
688317-8831791.48792.27
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%
111.583623543622923618003618483610093618610.15
211.683574063574913574480.02
单位质量响应值RSD%判断
31248.7930603.421.48数据可信
供试品溶液-24082801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%
5min1212871-21287156.86253.838.1756.8653.838.17
2192665-19266551.46451.46
3216679-21667957.87957.88
4172723-17272346.13746.14
5203647-20364754.39854.40
6210568-21056856.24656.25
10min1286860-28686076.62575.534.3676.7275.624.36
2279789-27978974.73774.82
3290777-29077777.67277.77
4259443-25944369.30269.38
5286391-28639176.50076.59
6293238-29323878.32978.42
15min1317883-31788384.91283.412.7285.1383.632.72
2314003-31400383.87684.09
3317017-31701784.68184.91
4295885-29588579.03679.23
5310975-31097583.06783.28
6317889-31788984.91485.14
20min1328012-32801287.61886.342.3887.9886.702.39
2326712-32671287.27087.62
3328148-32814887.65488.02
4309084-30908482.56282.89
5319575-31957585.36485.72
6327935-32793587.59787.96
30min1332786-33278688.89387.832.2989.4088.332.29
2333384-33338489.05389.55
3331701-33170188.60389.12
4314897-31489784.11484.58
5325615-32561586.97787.48
6334539-33453989.36189.87
45min1334166-33416689.26288.422.1789.9289.062.17
2336427-33642789.86590.51
3332565-33256588.83489.49
4317404-31740484.78485.39
5329275-32927587.95588.60
6336164-33616489.79590.46
极限1334366-33436689.31589.941.6290.1290.731.59
2336490-33649089.88290.68
3333703-33370389.13889.95
4347130-34713092.72493.47
5331700-33170088.60389.39
6336808-33680889.96790.78
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%
115.239551095830957139572795582956720.14
215.209534995450954000.08
单位质量响应值RSD%判断
6281.816276.320.07数据可信
供试品溶液-24082802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%
5min183909-8390986.62883.754.6186.6383.754.61
276699-7669979.18479.18
377667-7766780.18380.18
484392-8439287.12687.13
585036-8503687.79187.79
679013-7901381.57381.57
10min190292-9029293.21893.231.7793.3693.371.77
289056-8905691.94292.07
389012-8901291.89692.03
491785-9178594.75994.90
592679-9267995.68295.83
689018-8901891.90292.04
15min192540-9254095.53896.201.4895.8496.491.48
292289-9228995.27995.56
392293-9229395.28395.57
494507-9450797.56997.87
595315-9531598.40398.71
692125-9212595.11095.40
20min194048-9404897.09597.461.4297.5597.911.42
293822-9382296.86297.31
393937-9393796.98197.43
495475-9547598.56899.03
596426-9642699.550100.02
692672-9267295.67596.12
30min194764-9476497.83498.671.2098.4699.281.20
295193-9519398.27798.88
395422-9542298.51499.12
495695-9569598.79699.43
597751-97751100.918101.55
694591-9459197.65698.26
45min195130-9513098.21298.761.3099.0099.541.30
294340-9434097.39798.17
396269-9626999.388100.16
496790-9679099.926100.72
597129-97129100.276101.08
694303-9430397.35998.13
极限194818-9481897.89098.571.9398.8499.521.92
295820-9582098.92599.86
396928-96928100.069101.01
496091-9609199.204100.17
597079-97079100.224101.20
692116-9211695.10196.03
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%
111.583559973573923566593567263562343566020.15
211.683665333668213666770.06
单位质量响应值RSD%判断
30794.6531393.581.37数据可信
供试品溶液-24082802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%
5min1161017-16101742.77740.989.4342.7840.989.43
2138128-13812836.69636.70
3145865-14586538.75238.75
4173172-17317246.00746.01
5166363-16636344.19844.20
6140983-14098337.45537.45
10min1248463-24846366.00964.475.3666.0864.545.36
2231237-23123761.43361.49
3233752-23375262.10162.17
4258432-25843268.65868.73
5255301-25530167.82667.90
6228847-22884760.79860.86
15min1295526-29552678.51277.294.1478.6977.474.15
2283952-28395275.43775.60
3282074-28207474.93975.11
4304458-30445880.88581.08
5303774-30377480.70480.89
6275802-27580273.27273.44
20min1324618-32461886.24184.563.5786.5584.873.58
2313427-31342783.26883.56
3309342-30934282.18382.48
4329544-32954487.55087.88
5330000-33000087.67187.99
6302883-30288380.46780.75
30min1348941-34894192.70391.892.4593.1692.342.46
2342023-34202390.86591.29
3337074-33707489.55089.98
4355565-35556594.46394.93
5354840-35484094.27094.74
6336902-33690289.50589.92
45min1362016-36201696.17795.452.0496.7996.052.05
2353295-35329593.86094.44
3352787-35278793.72594.30
4370689-37068998.48199.11
5363481-36348196.56697.19
6353473-35347393.90794.48
极限1364430-36443096.81897.551.1797.5998.311.18
2367953-36795397.75498.49
3367874-36787497.73398.47
4374570-37457099.512100.31
5366406-36640697.34398.13
6361914-36191496.15096.88
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%
115.239776397720978009775697720977520.04
215.209761097803977060.14
单位质量响应值RSD%判断
6418.386428.030.11数据可信
供试品溶液-24082802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%
5min142639-4263943.03346.0710.1443.0346.0710.14
247309-4730947.74647.75
347630-4763048.07048.07
437654-3765438.00238.00
548848-4884849.29949.30
649790-4979050.25050.25
10min171406-7140672.06572.192.1272.1472.272.12
269690-6969070.33370.41
372429-7242973.09873.18
469863-6986370.50870.57
573480-7348074.15874.24
672327-7232772.99573.08
15min180488-8048881.23183.472.6481.4283.672.64
280635-8063581.38081.58
381053-8105381.80182.00
484547-8454785.32885.51
584877-8487785.66185.87
684636-8463685.41785.62
20min189167-8916789.99088.322.5490.3288.652.53
284121-8412184.89885.23
385275-8527586.06286.40
489195-8919590.01990.34
588531-8853189.34889.70
688765-8876589.58589.93
30min191095-9109591.93690.482.4792.4190.962.46
286742-8674287.54388.02
386960-8696087.76388.24
491797-9179792.64593.12
590808-9080891.64692.14
690500-9050091.33691.83
45min191574-9157492.42091.131.8993.0591.771.88
288004-8800488.81789.44
388398-8839889.21489.84
492107-9210792.95793.58
590980-9098091.82092.47
690740-9074091.57892.23
极限192260-9226093.11291.392.3793.9092.182.36
287753-8775388.56389.33
387926-8792688.73889.51
492358-9235893.21193.99
591753-9175392.60093.40
691286-9128692.12992.93
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%
111.583669483667093674243667263666863668990.09
211.683676623683043679830.13
单位质量响应值RSD%判断
31683.8531505.390.40数据可信
供试品溶液-24082802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%
5min1199692-19969252.20752.4411.3552.2152.4411.36
2206043-20604353.86853.87
3207254-20725454.18454.18
4156299-15629940.86340.86
5218992-21899257.25357.25
6215292-21529256.28656.29
10min1294707-29470777.04873.854.0977.1373.944.09
2273079-27307971.39471.48
3281250-28125073.53073.62
4265305-26530569.36169.43
5292512-29251276.47476.57
6287964-28796475.28575.38
15min1331891-33189186.76982.523.7586.9882.733.75
2299610-29961078.33078.54
3309960-30996081.03681.25
4308671-30867180.69980.88
5324946-32494684.95485.18
6318762-31876283.33783.56
20min1344921-34492190.17685.503.8790.5485.843.87
2309692-30969280.96681.30
3318636-31863683.30483.65
4323197-32319784.49684.81
5336371-33637187.94188.30
6329387-32938786.11586.47
30min1350314-35031491.58687.073.7792.1087.563.76
2315801-31580182.56383.04
3323309-32330984.52685.01
4330960-33096086.52686.98
5342225-34222589.47189.98
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3325675-32567585.14485.77
4332775-33277587.00087.60
5344426-34442690.04690.71
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2321216-32121683.97884.73
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