依折麦布阿托伐他汀钙片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号DSMF-387-240606对照品来源自制对照品使用方法直接使用
对照品含量(%)99.75对照品水分(%)0对照品稀释倍数5000
标示量(mg)10供试品稀释倍数5系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.521818981820721824461826091826291823310.19
210.471816341814101815220.09
单位质量响应值RSD%判断
17331.8417337.340.03数据可信
供试品溶液-2024011221批-依折麦布-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%
5min19220-92204.7754.4910.544.774.4910.48
27078-70783.6663.67
38275-82754.2864.29
49134-91344.7304.73
59655-96555.0005.00
68687-86874.4994.50
10min115443-154437.9987.772.328.027.792.30
215163-151637.8537.87
315186-151867.8657.89
414973-149737.7547.78
514729-147297.6287.66
614480-144807.4997.52
15min116052-160528.3138.032.248.388.092.21
215749-157498.1568.22
315436-154367.9948.06
415126-151267.8347.90
515206-152067.8757.95
615421-154217.9868.05
20min115122-151227.8327.952.117.958.062.03
215825-158258.1968.30
314993-149937.7657.88
415178-151787.8617.97
515358-153587.9548.07
615647-156478.1048.21
30min114910-149107.7227.751.057.887.911.02
215074-150747.8077.96
315143-151437.8428.00
414951-149517.7437.90
514698-146987.6127.77
615026-150267.7827.94
45min115388-153887.9697.862.298.178.062.24
215639-156398.0998.30
315310-153107.9298.13
414706-147067.6167.82
514857-148577.6947.89
615120-151207.8318.03
60min115042-150427.7907.672.498.047.912.42
215112-151127.8268.07
314751-147517.6397.88
415172-151727.8588.10
514324-143247.4187.66
614410-144107.4637.71
极限114443-144437.4807.552.587.777.842.50
215160-151607.8518.14
314814-148147.6727.96
414113-141137.3097.59
514310-143107.4117.70
614620-146207.5727.86
依折麦布阿托伐他汀钙片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)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5000
标示量(mg)10供试品稀释倍数5系数0.9671
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.741485381484901486131485141486981485710.06
210.731477861473951475900.19
单位质量响应值RSD%判断
13833.4313754.890.41数据可信
供试品溶液-2024011221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%
5min117191-1719110.31612.2323.8610.3212.2323.84
216276-162769.7679.77
321605-2160512.96512.96
415745-157459.4489.45
523403-2340314.04314.04
628066-2806616.84216.84
10min162121-6212137.27737.407.0537.3337.477.07
257612-5761234.57134.63
365607-6560739.36939.44
457040-5704034.22834.28
563424-6342438.05938.14
668174-6817440.90941.00
15min190327-9032754.20353.193.5254.4753.463.55
285067-8506751.04651.29
388843-8884353.31253.60
485416-8541651.25651.50
588785-8878553.27753.57
693372-9337256.03056.35
20min199043-9904359.43361.463.0360.0062.043.05
2100497-10049760.30560.84
3101421-10142160.86061.45
4101372-10137260.83061.36
5104785-10478562.87863.46
6107449-10744964.47765.11
30min1108581-10858165.15666.092.3866.0567.002.40
2106029-10602963.62564.49
3112392-11239267.44368.37
4109384-10938465.63866.50
5112756-11275667.66268.60
6111703-11170367.03068.02
45min1119669-11966971.81072.232.3373.0773.512.36
2118272-11827270.97272.19
3123080-12308073.85775.16
4116153-11615369.70070.93
5122628-12262873.58674.90
6122406-12240673.45274.82
60min1122851-12285173.71973.402.1875.3875.082.20
2119214-11921471.53773.15
3125136-12513675.09076.80
4118888-11888871.34172.96
5124583-12458374.75976.48
6123196-12319673.92675.70
极限1127043-12704376.23577.582.4778.3079.672.48
2128111-12811176.87678.89
3133450-13345080.07982.21
4124912-12491274.95676.97
5130291-13029178.18480.32
6131888-13188879.14281.32
依折麦布阿托伐他汀钙片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号DSMF-387-240606对照品来源自制对照品使用方法直接使用
对照品含量(%)99.75对照品水分(%)0对照品稀释倍数5000
标示量(mg)10供试品稀释倍数5系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.521826741825571824611827431829231826720.10
210.471823971823851823910.01
单位质量响应值RSD%判断
17364.2617420.340.23数据可信
供试品溶液-2024011222批-依折麦布-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%
5min110294-102945.3145.469.455.315.469.43
29021-90214.6564.66
311940-119406.1636.16
410849-108495.6005.60
511192-111925.7775.78
610161-101615.2455.24
10min116478-164788.5068.672.298.548.702.25
217117-171178.8358.86
316437-164378.4848.52
417397-173978.9809.01
516666-166668.6038.63
616641-166418.5908.62
15min115695-156958.1018.383.818.188.463.78
216654-166548.5968.67
315233-152337.8637.94
416708-167088.6248.71
516512-165128.5238.60
616603-166038.5708.65
20min115582-155828.0438.353.198.168.473.19
216768-167688.6558.78
315571-155718.0378.16
416639-166398.5898.72
516366-163668.4488.58
616108-161088.3158.44
30min115375-153757.9368.091.578.108.261.59
215483-154837.9928.16
315817-158178.1648.33
416060-160608.2908.47
515634-156348.0708.24
615632-156328.0698.24
45min115408-154087.9538.012.868.168.232.78
216381-163818.4568.67
315268-152687.8818.10
415612-156128.0598.28
515195-151957.8438.06
615297-152977.8968.11
60min114528-145287.4997.673.587.757.943.51
214933-149337.7087.97
314006-140067.2307.49
415363-153637.9308.20
515413-154137.9568.22
614955-149557.7197.98
极限114426-144267.4467.643.517.747.943.41
215046-150467.7668.07
313928-139287.1897.49
414926-149267.7048.02
515107-151077.7988.10
615319-153197.9078.21
依折麦布阿托伐他汀钙片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)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5000
标示量(mg)10供试品稀释倍数5系数0.9671
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.741489071490411490871488751491501490120.08
210.731484671484111484390.03
单位质量响应值RSD%判断
13874.4913834.020.21数据可信
供试品溶液-2024011222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%
5min124812-2481214.82418.1314.7314.8218.1314.74
233162-3316219.81319.81
325664-2566415.33315.33
431179-3117918.62818.63
536547-3654721.83621.84
630734-3073418.36218.36
10min175564-7556445.14744.814.6045.2344.914.61
280587-8058748.14848.26
370307-7030742.00642.09
475539-7553945.13245.24
575313-7531344.99745.12
672648-7264843.40543.51
15min194144-9414456.24856.563.3256.5856.913.34
299065-9906559.18859.57
389389-8938953.40753.73
495238-9523856.90157.26
595812-9581257.24457.62
694365-9436556.38056.72
20min1105370-10537062.95564.062.6163.6064.732.62
2112736-11273667.35668.06
3105435-10543562.99463.61
4107300-10730064.10864.78
5106224-10622463.46564.15
6106293-10629363.50664.16
30min1113409-11340967.75868.301.2068.7569.321.14
2113205-11320567.63668.72
3116860-11686069.82070.78
4114344-11434468.31769.34
5114583-11458368.45969.50
6113492-11349267.80768.82
45min1121234-12123472.43372.662.5773.8074.062.56
2127636-12763676.25877.71
3119107-11910771.16272.52
4119265-11926571.25772.66
5120954-12095472.26673.69
6121502-12150272.59373.98
60min1117630-11763070.28072.003.4472.0573.803.39
2120058-12005871.73073.61
3114504-11450468.41270.16
4121417-12141772.54274.34
5126270-12627075.44277.27
6123182-12318273.59775.39
极限1125600-12560075.04276.293.9677.2178.503.89
2128297-12829776.65378.93
3120801-12080172.17474.30
4124970-12497074.66576.87
5131512-13151278.57480.82
6134999-13499980.65782.86
依折麦布阿托伐他汀钙片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号DSMF-387-240606对照品来源自制对照品使用方法直接使用
对照品含量(%)99.75对照品水分(%)0对照品稀释倍数5000
标示量(mg)10供试品稀释倍数5系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.521815591814741814581818081816771815950.09
210.471815511817081816300.07
单位质量响应值RSD%判断
17261.8817347.660.36数据可信
供试品溶液-2024011223批-依折麦布-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%
5min19701-97015.0335.778.475.035.778.48
210868-108685.6385.64
310600-106005.4995.50
411320-113205.8735.87
512298-122986.3806.38
611932-119326.1906.19
10min116063-160638.3338.152.988.368.182.97
216105-161058.3558.39
315332-153327.9547.98
415353-153537.9658.00
516229-162298.4198.45
615190-151907.8807.91
15min116062-160628.3338.191.308.418.271.31
215902-159028.2508.33
315555-155558.0708.14
415741-157418.1668.24
515927-159278.2638.34
615576-155768.0818.16
20min115198-151987.8857.841.158.017.961.15
215367-153677.9728.10
315081-150817.8247.94
414873-148737.7167.84
515171-151717.8718.00
614985-149857.7747.90
30min114756-147567.6557.732.757.827.902.69
215425-154258.0028.17
314288-142887.4127.58
415195-151957.8838.05
514676-146767.6147.79
615072-150727.8197.99
45min115283-152837.9297.771.808.147.981.74
215224-152247.8988.11
314893-148937.7267.93
414702-147027.6277.84
515074-150747.8208.03
614641-146417.5967.81
60min114633-146337.5917.631.657.847.881.57
214743-147437.6497.90
315085-150857.8268.07
414611-146117.5807.83
514847-148477.7027.96
614368-143687.4547.71
极限115282-152827.9287.582.848.227.882.74
214794-147947.6757.97
314516-145167.5317.82
414224-142247.3797.67
514734-147347.6447.94
614160-141607.3467.64
依折麦布阿托伐他汀钙片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)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5000
标示量(mg)10供试品稀释倍数5系数0.9671
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.741478051479541479121479051478751478900.04
210.731476351475971476160.02
单位质量响应值RSD%判断
13770.0213757.320.07数据可信
供试品溶液-2024011223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%
5min126965-2696516.21721.6617.1216.2221.6617.11
238747-3874723.30223.30
332992-3299219.84119.84
435837-3583721.55221.55
536005-3600521.65321.65
645581-4558127.41227.41
10min169749-6974941.94744.234.3742.0444.354.40
275554-7555445.43845.57
370125-7012542.17342.28
473297-7329744.08144.20
574502-7450244.80544.93
678072-7807246.95247.10
15min188833-8883353.42456.113.3053.7556.473.33
293495-9349556.22756.61
391361-9136154.94455.29
493758-9375856.38656.75
594278-9427856.69857.07
698031-9803158.95559.37
20min199111-9911159.60560.882.4660.2261.562.50
2101244-10124460.88861.58
399300-9930059.71960.37
499962-9996260.11760.79
5102022-10202261.35662.04
6105757-10575763.60264.34
30min1105039-10503963.17064.995.1964.1266.015.17
2109284-10928465.72366.76
398374-9837459.16260.14
4110341-11034166.35967.37
5111216-11121666.88567.91
6114154-11415468.65269.75
45min1114439-11443968.82369.812.2570.1371.182.27
2116472-11647270.04671.44
3114142-11414268.64569.95
4113139-11313968.04169.42
5119131-11913171.64573.04
6119122-11912271.63973.11
60min1110562-11056266.49269.763.0868.1871.533.08
2116195-11619569.87971.67
3116169-11616969.86471.56
4113608-11360868.32370.08
5119974-11997472.15273.95
6119521-11952171.87973.75
极限1118489-11848971.25973.902.7673.3176.062.77
2124738-12473875.01777.19
3122366-12236673.59075.67
4119362-11936271.78473.92
5126297-12629775.95478.15
6126061-12606175.81378.09
依折麦布阿托伐他汀钙片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号DSMF-387-240606对照品来源自制对照品使用方法直接使用
对照品含量(%)99.75对照品水分(%)0对照品稀释倍数5000
标示量(mg)10供试品稀释倍数5系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.521825441826031827701830201829061827690.11
210.471820461820641820550.01
单位质量响应值RSD%判断
17373.4817388.250.07数据可信
供试品溶液-2024011821批-依折麦布-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%
5min19356-93564.8335.206.634.835.206.64
210807-108075.5825.58
310455-104555.4005.40
49294-92944.8014.80
59858-98585.0925.09
610688-106885.5215.52
10min116686-166868.6198.542.218.658.572.20
217114-171148.8408.87
316202-162028.3698.40
416305-163058.4228.45
516200-162008.3688.40
616708-167088.6308.66
15min116535-165358.5418.581.428.628.661.37
216532-165328.5398.62
316360-163608.4508.53
416731-167318.6428.72
517012-170128.7878.86
616451-164518.4978.58
20min115864-158648.1948.220.998.328.350.94
215887-158878.2068.33
315669-156698.0938.22
416125-161258.3298.45
516032-160328.2818.40
615948-159488.2378.36
30min115330-153307.9188.091.358.098.261.31
215672-156728.0958.27
315578-155788.0468.21
415941-159418.2348.40
515813-158138.1688.34
615604-156048.0608.23
45min115445-154457.9788.051.918.198.271.82
215309-153097.9078.13
315263-152637.8848.10
415993-159938.2618.47
515834-158348.1798.39
615708-157088.1138.33
60min115027-150277.7627.801.788.028.061.74
215214-152147.8588.12
314629-146297.5567.81
415276-152767.8908.15
515398-153987.9538.21
615107-151077.8038.06
极限115351-153517.9297.662.718.237.962.59
214695-146957.5907.90
314166-141667.3177.62
415061-150617.7798.08
514950-149507.7228.03
614762-147627.6257.93
依折麦布阿托伐他汀钙片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)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5000
标示量(mg)10供试品稀释倍数5系数0.9671
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.742975752976772980702980782977832978370.08
210.732963272953522958400.24
单位质量响应值RSD%判断
27731.5627571.300.41数据可信
供试品溶液-2024011821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%
5min130951-309519.26511.6437.099.2711.6437.07
247427-4742714.19714.20
329668-296688.8818.88
426923-269238.0598.06
533967-3396710.16810.17
664421-6442119.28419.28
10min1116671-11667134.92637.806.0834.9837.866.12
2135270-13527040.49340.57
3121127-12112736.25936.31
4121579-12157936.39536.44
5128503-12850338.46738.52
6134514-13451440.26740.37
15min1161088-16108848.22251.203.9248.4751.473.91
2171706-17170651.40051.70
3167851-16785150.24650.50
4172406-17240651.61051.86
5181631-18163154.37154.64
6171510-17151051.34251.67
20min1182848-18284854.73656.472.1155.2557.022.13
2187291-18729156.06656.66
3186113-18611355.71356.24
4191323-19132357.27357.81
5193838-19383858.02658.60
6190334-19033456.97757.59
30min1206239-20623961.73861.841.7462.5662.721.69
2203489-20348960.91561.82
3207772-20777262.19763.04
4207999-20799962.26563.12
5212046-21204663.47664.37
6201949-20194960.45461.39
45min1233314-23331469.84366.902.6871.0068.122.59
2214887-21488764.32765.57
3221052-22105266.17267.36
4224125-22412567.09268.29
5224649-22464967.24968.50
6222923-22292366.73268.00
60min1238655-23865571.44267.602.9372.9969.182.85
2222723-22272366.67268.27
3220696-22069666.06667.62
4221902-22190266.42768.00
5224586-22458667.23068.85
6226291-22629167.74069.38
极限1255759-25575976.56272.023.5278.5173.993.43
2235073-23507370.36972.34
3230903-23090369.12171.04
4239637-23963771.73673.68
5241879-24187972.40774.40
6240297-24029771.93373.95
依折麦布阿托伐他汀钙片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号DSMF-387-240606对照品来源自制对照品使用方法直接使用
对照品含量(%)99.75对照品水分(%)0对照品稀释倍数5000
标示量(mg)10供试品稀释倍数5系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.521817561820271818501819981821821819630.10
210.471831601831251831420.02
单位质量响应值RSD%判断
17296.8617492.070.80数据可信
供试品溶液-2024012021批-依折麦布-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%
5min110099-100995.2125.017.335.215.017.32
29982-99825.1525.15
39825-98255.0715.07
49048-90484.6704.67
510600-106005.4715.47
68681-86814.4814.48
10min114999-149997.7418.032.387.778.062.36
215863-158638.1878.22
315765-157658.1378.16
415516-155168.0088.03
515281-152817.8877.92
615949-159498.2328.26
15min115616-156168.0608.110.868.138.180.86
215519-155198.0108.08
315823-158238.1678.24
415791-157918.1508.22
515867-158678.1898.26
615674-156748.0908.16
20min114995-149957.7397.912.257.868.032.19
215699-156998.1038.22
315480-154807.9908.11
415516-155168.0088.12
514819-148197.6497.77
615498-154987.9998.11
30min114862-148627.6717.791.137.837.951.11
215043-150437.7647.93
315064-150647.7757.94
415382-153827.9398.10
515051-150517.7687.93
615142-151427.8157.98
45min114972-149727.7277.662.157.937.862.12
215150-151507.8198.03
314524-145247.4967.70
415012-150127.7487.95
514353-143537.4087.61
615004-150047.7447.95
60min114477-144777.4727.531.397.727.781.34
214738-147387.6077.86
314375-143757.4197.67
414732-147327.6047.85
514411-144117.4387.68
614857-148577.6687.91
极限114883-148837.6827.593.127.977.883.02
215367-153677.9318.22
314441-144417.4537.74
414948-149487.7158.00
514056-140567.2557.54
614533-145337.5017.79
依折麦布阿托伐他汀钙片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)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5000
标示量(mg)10供试品稀释倍数5系数0.9671
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.742951982954092955432957372956072954990.07
210.732979732977622978680.06
单位质量响应值RSD%判断
27513.8727760.300.64数据可信
供试品溶液-2024012021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%
5min135151-3515110.52810.2823.4310.5310.2823.42
236263-3626310.86110.86
332444-324449.7179.72
426575-265757.9597.96
548552-4855214.54214.54
627047-270478.1018.10
10min1119324-11932435.73936.933.1135.8036.993.13
2125535-12553537.59937.66
3123160-12316036.88836.94
4123870-12387037.10037.14
5129051-12905138.65238.73
6118945-11894535.62535.67
15min1167212-16721250.08251.492.0350.3451.752.03
2169405-16940550.73851.01
3171299-17129951.30651.56
4175808-17580852.65652.91
5176006-17600652.71553.01
6171698-17169851.42551.67
20min1183660-18366055.00857.673.2455.5458.223.20
2189823-18982356.85457.40
3194055-19405558.12158.67
4200026-20002659.91060.45
5189039-18903956.61957.21
6198672-19867259.50460.03
30min1205419-20541961.52562.841.8862.3763.711.87
2204740-20474061.32262.19
3211041-21104163.20964.08
4212935-21293563.77664.65
5210310-21031062.99063.89
6214418-21441864.22065.08
45min1225133-22513367.43067.882.4768.6169.102.42
2225875-22587567.65268.86
3223257-22325766.86868.09
4227291-22729168.07669.31
5221036-22103666.20267.46
6237139-23713971.02572.24
60min1223344-22334466.89468.662.9368.4570.262.88
2228297-22829768.37769.96
3226663-22666367.88869.48
4227918-22791868.26469.87
5226832-22683267.93869.56
6242484-24248472.62674.24
极限1246340-24634073.78174.492.0975.7176.462.03
2256261-25626176.75378.72
3248095-24809574.30776.27
4249681-24968174.78276.77
5240690-24069072.08974.09
6251102-25110275.20777.22
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