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对照品来源工作对照品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%
19.911718841718381722051718521721921719940.11
210.011730901727911729400.13
单位质量响应值RSD%判断
17355.6017276.720.33数据可信
供试品溶液-24121901批-依折麦布-pH1.2
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min16891-68913.5733.726.223.573.726.27
27962-79624.1284.13
37254-72543.7613.76
46864-68643.5593.56
56759-67593.5043.50
67314-73143.7923.79
10min114095-140957.3087.341.887.337.361.89
214619-146197.5797.60
314207-142077.3667.39
413833-138337.1727.19
514237-142377.3817.40
614007-140077.2627.28
15min115081-150817.8197.851.597.887.911.62
215530-155308.0528.12
315190-151907.8757.94
414780-147807.6637.72
515131-151317.8457.91
615130-151307.8447.91
20min115110-151107.8347.771.197.947.881.17
214997-149977.7757.88
315268-152687.9168.02
414887-148877.7187.82
514759-147597.6527.76
614934-149347.7437.85
30min115512-155128.0427.941.618.198.091.60
215382-153827.9758.13
315522-155228.0478.20
415496-154968.0348.18
515017-150177.7867.93
615005-150057.7797.93
45min115085-150857.8217.571.848.017.761.77
214448-144487.4917.69
314617-146177.5787.77
414679-146797.6107.80
514410-144107.4717.66
614363-143637.4467.64
60min114439-144397.4867.612.467.727.842.41
215376-153767.9728.21
314382-143827.4567.69
414624-146247.5827.81
514566-145667.5527.78
614707-147077.6257.86
极限114832-148327.6907.651.017.977.930.98
214898-148987.7248.01
314597-145977.5687.85
414738-147387.6417.92
514884-148847.7177.99
614550-145507.5437.82
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100590-202005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%
111.031597141601891600931595091597361598480.18
211.051604021607011605520.14
单位质量响应值RSD%判断
14492.1114529.590.19数据可信
供试品溶液-24121901批-阿托伐他汀钙-pH1.2
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min129561-2956116.82716.613.7416.8316.613.74
229675-2967516.89216.89
330721-3072117.48717.49
428049-2804915.96615.97
527809-2780915.83015.83
629245-2924516.64716.65
10min154565-5456531.06030.452.5531.1530.542.54
253244-5324430.30830.40
355290-5529031.47331.57
451539-5153929.33829.43
553819-5381930.63530.72
652535-5253529.90530.00
15min169124-6912439.34738.272.8939.6138.542.88
265661-6566137.37637.64
368727-6872739.12139.39
465296-6529637.16837.42
569148-6914839.36139.62
665479-6547937.27337.53
20min173173-7317341.65240.023.8742.1440.493.85
267014-6701438.14638.62
373420-7342041.79342.28
468979-6897939.26539.72
571265-7126540.56641.04
667955-6795538.68239.15
30min180057-8005745.57143.752.9946.2944.452.97
275717-7571743.10043.78
377214-7721443.95344.67
476258-7625843.40844.08
578468-7846844.66645.37
673450-7345041.81042.49
45min175288-7528842.85641.723.6143.8342.663.57
269087-6908739.32640.25
373882-7388242.05643.02
473932-7393242.08443.00
576262-7626243.41144.36
671354-7135440.61741.53
60min173949-7394942.09443.763.0843.3044.933.01
276951-7695143.80344.94
376523-7652343.55944.76
477974-7797444.38545.54
580750-8075045.96547.16
675110-7511042.75543.89
极限181911-8191146.62647.342.9348.0748.752.88
280127-8012745.61146.99
382749-8274947.10348.54
483255-8325547.39148.79
587468-8746849.78951.24
683444-8344447.49948.87
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对照品来源工作对照品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%
19.911725271724081724451725491722761724410.07
210.011752111750691751400.06
单位质量响应值RSD%判断
17400.7117496.500.39数据可信
供试品溶液-24121901批-依折麦布-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%
5min18846-88464.5514.1914.094.554.1914.08
26968-69683.5853.59
36394-63943.2903.29
48955-89554.6074.61
58700-87004.4764.48
68964-89644.6124.61
10min116150-161508.3098.232.458.338.252.45
216249-162498.3608.38
315221-152217.8317.85
416143-161438.3068.33
516225-162258.3488.37
615966-159668.2158.24
15min116464-164648.4718.412.788.548.482.73
217015-170158.7548.82
315770-157708.1148.18
415944-159448.2038.28
516268-162688.3708.44
616601-166018.5418.61
20min116455-164558.4668.271.628.588.381.62
215825-158258.1428.26
315791-157918.1258.23
416229-162298.3508.47
516164-161648.3178.43
615946-159468.2048.32
30min115109-151097.7747.674.527.947.844.40
215819-158198.1398.30
314964-149647.6997.85
414905-149057.6697.83
513729-137297.0647.23
614966-149667.7007.86
45min115170-151707.8057.832.268.018.042.22
215904-159048.1838.39
314992-149927.7147.91
415010-150107.7237.93
515152-151527.7968.00
615081-150817.7597.97
60min114117-141177.2637.543.127.527.783.03
215230-152307.8368.09
314330-143307.3737.61
414587-145877.5057.75
515171-151717.8068.05
614447-144477.4337.68
极限114904-149047.6687.553.817.967.843.73
215233-152337.8388.13
313627-136277.0117.29
414852-148527.6427.93
514879-148797.6557.95
614542-145427.4827.77
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100590-202005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%
111.031598801598651598301599691598641598820.04
211.051623411619961621680.16
单位质量响应值RSD%判断
14495.1914675.840.88数据可信
供试品溶液-24121901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%
5min166842-6684237.85535.0310.6337.8635.0310.63
267961-6796138.48938.49
353999-5399930.58230.58
463503-6350335.96435.96
565630-6563037.16937.17
653195-5319530.12630.13
10min1113522-11352264.29261.503.3464.5061.693.36
2111961-11196163.40863.62
3103922-10392258.85559.02
4107208-10720860.71660.92
5108798-10879861.61661.82
6106092-10609260.08460.25
15min1132137-13213774.83472.922.8175.4073.452.81
2132410-13241074.98975.55
3126043-12604371.38371.88
4123229-12322969.78970.33
5128374-12837472.70373.25
6130318-13031873.80474.31
20min1142283-14228380.58077.912.2481.5678.852.21
2133595-13359575.66076.64
3139980-13998079.27680.17
4136326-13632677.20678.13
5136744-13674477.44378.40
6136452-13645277.27878.19
30min1147697-14769783.64680.674.1185.0882.044.05
2146042-14604282.70984.11
3148031-14803183.83585.17
4140275-14027579.44380.80
5133229-13322975.45376.84
6139361-13936178.92580.27
45min1157385-15738589.13387.831.9991.0389.651.99
2157434-15743489.16191.02
3158021-15802189.49391.29
4151177-15117785.61787.41
5154937-15493787.74789.55
6151501-15150185.80187.58
60min1155033-15503387.80188.741.0990.1991.051.03
2155226-15522687.91090.27
3158782-15878289.92492.22
4158731-15873189.89592.17
5155690-15569088.17390.46
6156723-15672388.75891.01
极限1166804-16680494.46790.712.9097.3593.522.83
2159711-15971190.45093.30
3152852-15285286.56689.36
4159921-15992190.56993.34
5158817-15881789.94492.72
6162942-16294292.28095.03
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对照品来源工作对照品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%
19.911725381730361730911726631728641728380.14
210.011725821730651728240.20
单位质量响应值RSD%判断
17440.7717265.130.72数据可信
供试品溶液-24121901批-依折麦布-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%
5min15587-55872.8902.828.752.892.828.75
25754-57542.9772.98
35894-58943.0493.05
44540-45402.3492.35
55486-54862.8382.84
65449-54492.8192.82
10min113811-138117.1457.192.527.167.202.52
214008-140087.2477.26
314159-141597.3257.34
413229-132296.8446.86
514002-140027.2447.26
614149-141497.3207.34
15min114700-147007.6057.612.807.667.672.78
215339-153397.9367.99
314527-145277.5167.57
414083-140837.2867.34
514841-148417.6787.73
614799-147997.6567.71
20min114571-145717.5387.362.777.647.462.79
214535-145357.5207.62
313958-139587.2217.32
413594-135947.0337.12
514214-142147.3547.45
614521-145217.5137.61
30min114003-140037.2457.142.867.387.272.84
214354-143547.4267.57
313407-134076.9367.08
413326-133266.8947.02
513977-139777.2317.37
613681-136817.0787.22
45min113248-132486.8546.802.507.036.982.50
212793-127936.6196.80
313113-131136.7846.96
412748-127486.5956.76
513505-135056.9877.17
613483-134836.9767.16
60min113197-131976.8286.792.697.057.002.59
212875-128756.6616.88
313098-130986.7766.99
413296-132966.8797.08
512624-126246.5316.75
613649-136497.0617.28
极限113321-133216.8926.851.517.157.101.45
213460-134606.9647.22
313158-131586.8077.06
413434-134346.9507.19
512931-129316.6906.94
613169-131696.8137.07
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100590-202005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%
111.031601121599661607041601591599111601700.20
211.051600481607631604060.32
单位质量响应值RSD%判断
14521.3114516.380.03数据可信
供试品溶液-24121901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%
5min170167-7016739.91947.3216.5939.9247.3216.59
290175-9017551.30251.30
397140-9714055.26455.26
480512-8051245.80545.80
564460-6446036.67236.67
696638-9663854.97954.98
10min1112145-11214563.80169.175.0664.0269.435.08
2126694-12669472.07872.36
3122441-12244169.65969.97
4117108-11710866.62566.88
5122280-12228069.56769.77
6128809-12880973.28173.59
15min1123174-12317470.07676.945.6570.6577.595.65
2138573-13857378.83679.52
3137040-13704077.96478.66
4128997-12899773.38874.01
5140298-14029879.81880.41
6143404-14340481.58582.30
20min1126991-12699172.24779.886.1273.2180.966.11
2138930-13893079.03980.16
3140243-14024379.78680.91
4137167-13716778.03679.07
5147518-14751883.92584.96
6151604-15160486.25087.42
30min1129333-12933373.58083.567.7874.9585.087.72
2143167-14316781.45083.01
3147777-14777784.07385.64
4142434-14243481.03382.50
5160466-16046691.29292.79
6158059-15805989.92291.57
45min1135658-13565877.17885.167.4578.9587.147.39
2140795-14079580.10182.12
3148969-14896984.75186.79
4147662-14766284.00785.92
5160078-16007891.07193.08
6164927-16492793.83095.97
60min1141801-14180180.67387.307.6682.8889.767.60
2142394-14239481.01083.47
3152029-15202986.49289.00
4151092-15109285.95988.34
5160637-16063791.38993.90
6172766-17276698.289100.96
极限1162744-16274492.58895.362.5895.2498.302.66
2168850-16885096.06198.97
3165833-16583394.34597.33
4163359-16335992.93895.80
5172778-17277898.296101.32
6172121-17212197.922101.13
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