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 14.879434894239943479429394058942570.13
2 14.899426594308942860.04
单位质量响应值RSD%判断
6338.746332.170.08数据可信
供试品溶液-24102201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%
5min160187-6018761.58456.437.5261.5856.437.52
256148-5614857.45157.45
356727-5672758.04458.04
449194-4919450.33650.34
557517-5751758.85258.85
651142-5114252.32952.33
10min178781-7878180.61078.224.1180.7178.314.11
275999-7599977.76377.86
377881-7788179.68979.79
471440-7144073.09873.18
580021-8002181.87881.98
674537-7453776.26776.35
15min186663-8666388.67585.863.2488.9186.083.24
284116-8411686.06986.29
385422-8542287.40587.63
479152-7915280.98981.20
585505-8550587.49087.72
682618-8261884.53684.75
20min189002-8900291.06888.942.4691.4589.312.47
287371-8737189.39989.77
387816-8781689.85490.23
483327-8332785.26185.60
588513-8851390.56890.95
685501-8550187.48687.84
30min190371-9037192.46990.562.2193.0191.082.21
288567-8856790.62391.14
390245-9024592.34092.86
487967-8796790.00990.49
588876-8887690.93991.47
685022-8502286.99687.50
45min189649-8964991.73091.200.8492.4291.870.84
289135-8913591.20491.87
388474-8847490.52891.21
489269-8926991.34191.97
590146-9014692.23892.92
688119-8811990.16490.81
极限193575-9357595.74794.601.7696.5995.421.74
291439-9143993.56294.38
392499-9249994.64695.48
492619-9261994.76995.55
589977-8997792.06692.90
694635-9463596.83297.63
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%
111.553654093647573646553649983640423647720.14
211.493663523657183660350.13
单位质量响应值RSD%判断
31581.9931856.830.62数据可信
供试品溶液-24102201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%
5min1275663-27566371.78666.647.5571.7966.647.56
2260267-26026767.77767.78
3260985-26098567.96467.96
4227117-22711759.14459.14
5272971-27297171.08571.09
6238328-23832862.06462.06
10min1331274-33127486.26882.964.7686.3983.074.76
2320858-32085883.55683.67
3321278-32127883.66583.78
4294194-29419476.61276.71
5335258-33525887.30687.42
6308623-30862380.37080.47
15min1349498-34949891.01488.203.7991.2888.453.80
2339032-33903288.28888.54
3341929-34192989.04389.30
4317470-31747082.67382.90
5352637-35263791.83192.10
6331528-33152886.33486.57
20min1354797-35479792.39490.282.8492.8190.672.85
2346389-34638990.20490.60
3348291-34829190.70091.10
4332137-33213786.49386.86
5358901-35890193.46393.88
6339464-33946488.40188.78
30min1357863-35786393.19291.691.8393.7692.241.84
2350020-35002091.15091.70
3353149-35314991.96592.52
4347179-34717990.41090.92
5360703-36070393.93294.50
6343733-34373389.51390.04
45min1357987-35798793.22592.041.5693.9592.741.57
2352219-35221991.72392.42
3353311-35331192.00792.71
4349969-34996991.13791.80
5361170-36117094.05394.78
6345890-34589090.07490.75
极限1371896-37189696.84795.751.4797.7396.601.45
2360843-36084393.96894.82
3368206-36820695.88696.74
4373196-37319697.18598.00
5361248-36124894.07494.96
6370666-37066696.52697.35
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 14.879476894570946019458294285945610.19
2 14.899409494166941300.06
单位质量响应值RSD%判断
6359.186321.690.42数据可信
供试品溶液-24102201批-氨氯地平-pH2.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min170745-7074572.33172.033.2572.3372.023.25
273019-7301974.65674.66
372998-7299874.63474.63
470014-7001471.58371.58
567587-6758769.10269.10
668321-6832169.85369.85
10min187273-8727389.22987.042.2389.3587.162.23
286569-8656988.51088.63
384768-8476886.66886.79
486303-8630388.23888.36
582834-8283484.69184.81
683021-8302184.88285.00
15min191939-9193994.00092.242.2294.2792.512.22
291281-9128193.32793.60
389716-8971691.72792.00
492508-9250894.58294.85
587885-8788589.85590.11
688002-8800289.97590.23
20min193380-9338095.47393.612.0695.9094.032.06
292909-9290994.99295.42
390877-9087792.91493.34
493312-9331295.40495.83
589403-8940391.40791.81
689484-8948491.49091.90
30min193276-9327695.36793.532.1095.9594.112.10
292715-9271594.79395.38
390876-9087692.91393.49
493331-9333195.42396.01
589940-8994091.95692.51
688764-8876490.75491.31
45min193716-9371695.81793.852.4296.5694.582.42
293335-9333595.42796.17
391834-9183493.89394.62
493598-9359895.69696.44
589826-8982691.84092.55
688422-8842290.40491.12
极限193290-9329095.38193.811.9596.2894.691.95
292750-9275094.82995.73
391212-9121293.25794.14
493779-9377995.88196.78
589838-8983891.85292.72
689635-8963591.64492.51
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%
111.553678113678173671043674263665063673330.15
211.493674653677663676160.06
单位质量响应值RSD%判断
31803.7231994.430.43数据可信
供试品溶液-24102201批-阿托伐他汀钙-pH2.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min167686-6768617.52718.676.7017.5318.676.69
274303-7430319.24019.24
378980-7898020.45120.45
466706-6670617.27317.27
569695-6969518.04718.05
675234-7523419.48119.48
10min1112882-11288229.23030.366.6029.2630.406.59
2115482-11548229.90329.94
3132449-13244934.29734.33
4113067-11306729.27829.31
5111982-11198228.99729.03
6117659-11765930.46730.50
15min1137450-13745035.59236.652.7535.6736.732.75
2140449-14044936.36836.45
3145479-14547937.67137.76
4145813-14581337.75737.83
5136904-13690435.45035.53
6143042-14304237.04037.12
20min1153186-15318639.66740.703.7239.8040.853.71
2155286-15528640.21040.35
3161786-16178641.89442.05
4165446-16544642.84142.98
5149416-14941638.69038.83
6158029-15802940.92141.07
30min1169085-16908543.78445.614.9943.9945.824.97
2169866-16986643.98644.20
3182046-18204647.14047.36
4191130-19113049.49249.70
5170400-17040044.12444.33
6174221-17422145.11345.33
45min1184696-18469647.82649.485.1948.1049.765.18
2185765-18576548.10348.39
3202230-20223052.36652.67
4205326-20532653.16853.46
5183473-18347347.50947.78
6185003-18500347.90548.19
极限1207883-20788353.83055.173.2154.1955.543.21
2207397-20739753.70454.07
3218779-21877956.65257.04
4224185-22418558.05158.43
5210161-21016154.42054.77
6209948-20994854.36554.73
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 14.879418394151942889396093815940790.21
2 14.899538495117952500.20
单位质量响应值RSD%判断
6326.776396.910.78数据可信
供试品溶液-24102201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%
5min183627-8362785.21683.632.1885.2283.632.18
278610-7861080.10480.10
383011-8301184.58884.59
482856-8285684.43084.43
582296-8229683.86083.86
682042-8204283.60183.60
10min192472-9247294.22992.242.5794.3792.382.57
286069-8606987.70487.84
391414-9141493.15193.29
492008-9200893.75693.90
590954-9095492.68292.82
690220-9022091.93492.07
15min194744-9474496.54494.882.3896.8495.172.38
288793-8879390.48090.76
394296-9429696.08896.38
494331-9433196.12396.42
593568-9356895.34695.64
692915-9291594.68094.97
20min195769-9576997.58995.912.6098.0596.362.60
289361-8936191.05991.49
395405-9540597.21897.67
495704-9570497.52297.98
594569-9456996.36696.82
693945-9394595.73096.18
30min195916-9591697.73896.172.3698.3696.782.36
290375-9037592.09292.67
396292-9629298.12198.74
495811-9581197.63198.25
594280-9428096.07196.69
693613-9361395.39296.00
45min195718-9571897.53796.792.4498.3297.562.44
290383-9038392.10092.84
396346-9634698.17798.96
496420-9642098.25299.03
596033-9603397.85898.63
695011-9501196.81697.59
极限196350-9635098.18196.162.8099.1397.092.80
289452-8945291.15292.04
396331-9633198.16199.11
495924-9592497.74698.69
593725-9372595.50696.44
694401-9440196.19597.12
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%
111.553675083669373675603670573650533668230.28
211.493710913714893712900.08
单位质量响应值RSD%判断
31759.5732314.191.23数据可信
供试品溶液-24102201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%
5min1178230-17823045.95646.330.7345.9646.330.73
2179796-17979646.36046.36
3177910-17791045.87445.87
4180889-18088946.64246.64
5180637-18063746.57746.58
6180544-18054446.55346.55
10min1263181-26318167.86068.160.9467.9468.240.94
2262924-26292467.79467.87
3263039-26303967.82467.90
4269317-26931769.44369.52
5263999-26399968.07168.15
6263691-26369167.99268.07
15min1305080-30508078.66479.390.9378.8579.580.93
2305944-30594478.88779.08
3306983-30698379.15579.34
4313190-31319080.75580.95
5308198-30819879.46879.66
6307971-30797179.40979.60
20min1328864-32886484.79785.631.0985.1285.951.09
2327294-32729484.39284.71
3331139-33113985.38385.70
4336539-33653986.77687.10
5333922-33392286.10186.42
6334818-33481886.33286.66
30min1346319-34631989.29790.701.0789.7691.171.07
2348608-34860889.88890.35
3354648-35464891.44591.91
4353343-35334391.10991.58
5356197-35619791.84492.31
6351500-35150090.63391.10
45min1355615-35561591.69494.071.6792.3194.691.66
2359752-35975292.76193.37
3368515-36851595.02195.64
4366853-36685394.59295.22
5372238-37223895.98196.60
6366082-36608294.39395.01
极限1364598-36459894.01194.940.9594.7795.720.95
2364668-36466894.02994.80
3372618-37261896.07996.85
4370905-37090595.63796.42
5366167-36616794.41595.20
6370339-37033995.49196.27
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 14.879398593623936639386693905938080.17
2 14.899417294116941440.05
单位质量响应值RSD%判断
6308.546322.630.16数据可信
供试品溶液-24102201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%
5min148342-4834249.62047.175.3049.6247.165.30
244557-4455745.73545.73
347002-4700248.24448.24
443104-4310444.24344.24
548841-4884150.13250.13
643859-4385945.01845.02
10min165708-6570867.44566.106.1667.5366.186.16
260753-6075362.35962.44
370921-7092172.79672.88
461754-6175463.38663.46
566171-6617167.92068.00
661102-6110262.71762.79
15min169666-6966671.50771.747.4271.7071.937.41
265154-6515466.87667.06
379356-7935681.45481.66
468629-6862970.44370.62
571033-7103372.91173.11
665510-6551067.24267.42
20min172338-7233874.25073.826.6174.5674.136.60
267246-6724669.02369.32
380178-8017882.29782.63
470639-7063972.50672.80
573490-7349075.43275.75
667631-6763169.41969.71
30min174390-7439076.35675.527.2576.7975.957.24
268295-6829570.10070.51
383379-8337985.58386.06
471694-7169473.58974.01
573837-7383775.78976.23
669845-6984571.69172.10
45min174350-7435076.31575.517.3976.8876.077.38
269028-6902870.85371.38
383116-8311685.31385.93
472904-7290474.83175.37
574262-7426276.22576.80
667723-6772369.51370.04
极限175207-7520777.19577.646.6977.8978.326.67
269059-6905970.88471.53
383752-8375285.96686.73
473572-7357275.51776.18
573491-7349175.43476.13
678737-7873780.81881.46
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%
111.553685543677673671553686733677223679740.18
211.493684503684763684630.01
单位质量响应值RSD%判断
31859.2232068.150.47数据可信
供试品溶液-24102201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%
5min1227703-22770358.84357.654.0858.8457.654.07
2222782-22278257.57257.57
3226695-22669558.58358.58
4210896-21089654.50054.50
5235714-23571460.91360.91
6214725-21472555.48955.49
10min1274699-27469970.98871.824.8871.0971.924.88
2272405-27240570.39570.49
3300515-30051577.65977.76
4268575-26857569.40569.50
5287313-28731374.24874.35
6264112-26411268.25268.34
15min1287571-28757174.31475.445.6174.5375.665.61
2284165-28416573.43473.65
3321259-32125983.02083.25
4283754-28375473.32873.53
5299495-29949577.39677.62
6275329-27532971.15171.36
20min1294365-29436576.07077.055.2876.4177.395.27
2288761-28876174.62274.96
3327003-32700384.50484.87
4291949-29194975.44675.77
5303838-30383878.51878.87
6283000-28300073.13373.46
30min1297223-29722376.80977.745.2777.2878.215.26
2291083-29108375.22275.68
3330497-33049785.40785.91
4293971-29397175.96876.42
5305394-30539478.92079.41
6286786-28678674.11274.56
45min1298044-29804477.02178.005.2077.6278.605.20
2291359-29135975.29375.88
3331351-33135185.62886.28
4295089-29508976.25776.84
5306345-30634579.16679.78
6288811-28881174.63575.21
极限1298500-29850077.13979.084.7177.8679.804.70
2291580-29158075.35076.06
3330029-33002985.28686.08
4295432-29543276.34677.05
5305299-30529978.89679.64
6315154-31515481.44282.14
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