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%
115.239816498125979599812997940980630.11
215.209595795921959390.03
单位质量响应值RSD%判断
6438.806311.781.41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%
5min151267-5126752.13444.9011.3052.1344.9011.30
243031-4303143.75943.76
348685-4868549.50949.51
437905-3790538.54638.55
543384-4338444.11844.12
640632-4063241.31941.32
10min177137-7713778.44272.226.5778.5372.306.58
269309-6930970.48270.55
375665-7566576.94577.03
464585-6458565.67865.74
568714-6871469.87769.95
670725-7072571.92271.99
15min188275-8827589.76983.784.3089.9983.984.31
282564-8256483.96184.15
383822-8382285.24085.45
478157-7815779.47979.65
579581-7958180.92781.12
681925-8192583.31183.50
20min191595-9159593.14587.903.9293.5188.243.93
287026-8702688.49888.83
388810-8881090.31390.67
482793-8279384.19484.50
583347-8334784.75785.08
685072-8507286.51186.84
30min193995-9399595.58589.743.9796.1190.223.98
288888-8888890.39290.87
389771-8977191.29091.79
484160-8416085.58486.03
585455-8545586.90187.37
687228-8722888.70489.18
45min194570-9457096.17090.883.7196.8591.503.72
291208-9120892.75193.38
389257-8925790.76791.42
484810-8481086.24586.83
587568-8756889.05089.66
688772-8877290.27490.89
极限193669-9366995.25491.312.8896.1092.092.88
286456-8645687.91988.70
391419-9141992.96693.77
490479-9047992.01092.74
588418-8841889.91490.67
688317-8831789.81190.58
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%
111.583649813649673645253644873640843646090.11
211.683574063574913574480.02
单位质量响应值RSD%判断
31486.1030603.422.02数据不可信!(响应值差异过大,请重新称样测定!)
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%
5min1212871-21287156.64953.638.1756.6553.638.16
2192665-19266551.27251.27
3216679-21667957.66357.66
4172723-17272345.96545.97
5203647-20364754.19554.19
6210568-21056856.03756.04
10min1286860-28686076.34075.254.3676.4375.344.36
2279789-27978974.45874.54
3290777-29077777.38277.48
4259443-25944369.04369.12
5286391-28639176.21576.31
6293238-29323878.03778.13
15min1317883-31788384.59583.102.7284.8283.322.73
2314003-31400383.56383.77
3317017-31701784.36584.59
4295885-29588578.74178.93
5310975-31097582.75782.97
6317889-31788984.59784.82
20min1328012-32801287.29186.022.3887.6586.372.38
2326712-32671286.94587.29
3328148-32814887.32787.69
4309084-30908482.25482.58
5319575-31957585.04685.40
6327935-32793587.27087.63
30min1332786-33278688.56187.512.2989.0788.002.29
2333384-33338488.72189.21
3331701-33170188.27388.78
4314897-31489783.80184.26
5325615-32561586.65387.15
6334539-33453989.02889.54
45min1334166-33416688.92988.092.1789.5888.732.17
2336427-33642789.53090.17
3332565-33256588.50389.16
4317404-31740484.46885.07
5329275-32927587.62788.27
6336164-33616489.46090.12
极限1334366-33436688.98289.601.6289.7990.391.58
2336490-33649089.54790.34
3333703-33370388.80589.61
4347130-34713092.37993.12
5331700-33170088.27289.06
6336808-33680889.63290.44
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%
115.239551095830957139572795582956720.14
215.209894398968989560.02
单位质量响应值RSD%判断
6281.816510.262.53数据不可信!(响应值差异过大,请重新称样测定!)
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%
5min183909-8390985.07182.244.6185.0782.244.61
276699-7669977.76177.76
377667-7766778.74278.74
484392-8439285.56085.56
585036-8503686.21386.21
679013-7901380.10780.11
10min190292-9029291.54291.561.7791.6891.701.78
289056-8905690.28990.42
389012-8901290.24490.38
491785-9178593.05693.20
592679-9267993.96294.11
689018-8901890.25090.38
15min192540-9254093.82194.471.4894.1294.761.48
292289-9228993.56793.85
392293-9229393.57193.85
494507-9450795.81596.11
595315-9531596.63496.93
692125-9212593.40093.68
20min194048-9404895.35095.701.4295.8096.151.42
293822-9382295.12195.56
393937-9393795.23795.67
495475-9547596.79797.25
596426-9642697.76198.22
692672-9267293.95594.39
30min194764-9476496.07696.891.2096.6997.501.20
295193-9519396.51197.11
395422-9542296.74397.34
495695-9569597.02097.64
597751-9775199.10499.73
694591-9459195.90096.50
45min195130-9513096.44796.981.3097.2297.751.30
294340-9434095.64696.40
396269-9626997.60298.36
496790-9679098.13098.91
597129-9712998.47499.26
694303-9430395.60896.36
极限194818-9481896.13196.801.9397.0697.731.92
295820-9582097.14698.06
396928-9692898.27099.19
496091-9609197.42198.37
597079-9707998.42399.38
692116-9211693.39194.31
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
211.683699113701193700150.04
单位质量响应值RSD%判断
30794.6531679.372.01数据不可信!(响应值差异过大,请重新称样测定!)
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%
5min1161017-16101742.58640.809.4342.5940.809.43
2138128-13812836.53336.53
3145865-14586538.57938.58
4173172-17317245.80145.80
5166363-16636344.00044.00
6140983-14098337.28837.29
10min1248463-24846365.71464.185.3665.7964.255.36
2231237-23123761.15861.22
3233752-23375261.82361.89
4258432-25843268.35168.43
5255301-25530167.52367.60
6228847-22884760.52660.59
15min1295526-29552678.16276.954.1478.3477.124.15
2283952-28395275.10075.26
3282074-28207474.60474.77
4304458-30445880.52480.71
5303774-30377480.34380.53
6275802-27580272.94573.11
20min1324618-32461885.85684.193.5786.1784.493.58
2313427-31342782.89683.18
3309342-30934281.81682.11
4329544-32954487.15987.48
5330000-33000087.27987.60
6302883-30288380.10780.39
30min1348941-34894192.28991.482.4592.7491.922.46
2342023-34202390.45990.89
3337074-33707489.15089.58
4355565-35556594.04194.51
5354840-35484093.84994.31
6336902-33690289.10589.52
45min1362016-36201695.74795.032.0496.3595.622.05
2353295-35329593.44194.02
3352787-35278793.30693.88
4370689-37068998.04198.67
5363481-36348196.13596.76
6353473-35347393.48894.05
极限1364430-36443096.38697.121.1797.1597.871.18
2367953-36795397.31798.05
3367874-36787497.29698.03
4374570-37457099.06799.86
5366406-36640696.90897.69
6361914-36191495.72096.44
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%
115.239776397720978009775697720977520.04
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
6335524-33552487.71988.22
45min1352308-35230892.10787.633.6292.7788.263.62
2319153-31915383.43984.05
3325675-32567585.14485.77
4332775-33277587.00087.60
5344426-34442690.04690.71
6336778-33677888.04788.69
极限1353173-35317392.33387.803.5093.1588.583.49
2321216-32121683.97884.73
3325975-32597585.22385.99
4334238-33423887.38388.13
5344411-34441190.04290.85
6336033-33603387.85288.65
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