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DJ333-221017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(%)99.67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%
19.851636171635201635551636171635611635740.03
29.911633631636201634920.12
单位质量响应值RSD%判断
16606.5016497.680.47数据可信
供试品溶液-2022091403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%
5min110948-109485.9336.208.925.936.208.96
210573-105735.7305.73
312004-120046.5066.51
410323-103235.5955.59
511726-117266.3556.35
613040-130407.0677.07
10min116609-166099.0018.991.019.039.021.02
216688-166889.0449.08
316470-164708.9268.96
416360-163608.8668.90
516547-165478.9689.00
616835-168359.1249.16
15min116767-167679.0879.091.349.179.171.28
216825-168259.1189.20
316786-167869.0979.18
417150-171509.2949.37
516500-165008.9429.03
616595-165958.9949.08
20min116433-164338.9068.990.989.049.130.96
216822-168229.1179.25
316435-164358.9079.04
416574-165748.9829.11
516754-167549.0809.21
616549-165498.9699.11
30min116087-160878.7188.720.738.908.910.72
216226-162268.7948.98
316202-162028.7818.97
415982-159828.6618.84
516130-161308.7428.93
615935-159358.6368.83
45min115829-158298.5798.562.308.818.802.22
216169-161698.7639.00
315113-151138.1908.43
415995-159958.6688.90
515904-159048.6198.85
615784-157848.5548.79
60min115583-155838.4458.461.078.728.741.02
215703-157038.5108.79
315632-156328.4728.75
415700-157008.5098.79
515286-152868.2848.57
615731-157318.5258.81
极限115501-155018.4018.392.118.738.722.03
216075-160758.7129.04
315132-151328.2018.53
415322-153228.3048.63
515332-153328.3098.64
615566-155668.4368.77
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%
111.001543471533481533761542011540141538570.31
211.051529911542201536060.57
单位质量响应值RSD%判断
13987.0013901.000.44数据可信
供试品溶液-2022091403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%
5min172314-7231442.83735.4213.0342.8435.4213.03
260941-6094136.10036.10
354292-5429232.16132.16
450353-5035329.82829.83
556877-5687733.69333.69
663938-6393837.87537.88
10min1102219-10221960.55260.232.7260.7960.432.74
2105165-10516562.29762.50
3100308-10030859.42059.60
497076-9707657.50557.67
5102019-10201960.43460.62
6103286-10328661.18461.39
15min1129052-12905276.44771.823.3877.0272.353.39
2118462-11846270.17470.72
3121878-12187872.19872.71
4117805-11780569.78570.27
5120606-12060671.44471.97
6119641-11964170.87271.42
20min1138967-13896782.32176.944.1383.3277.874.13
2128372-12837276.04476.98
3128624-12862476.19477.10
4122991-12299172.85773.73
5132324-13232478.38579.31
6128033-12803375.84476.79
30min1144304-14430485.48280.514.6186.9481.864.59
2130905-13090577.54578.90
3136931-13693181.11582.45
4128363-12836376.03977.32
5141818-14181884.00985.36
6133107-13310778.84980.21
45min1150646-15064689.23986.345.1991.1788.145.14
2149892-14989288.79290.58
3141125-14112583.59985.38
4137216-13721681.28382.98
5156225-15622592.54494.37
6139368-13936882.55884.36
60min1157612-15761293.36591.445.2595.7993.725.19
2158186-15818693.70595.99
3159062-15906294.22496.47
4142358-14235884.32986.48
5162722-16272296.39298.73
6146184-14618486.59688.86
极限1162271-16227196.12594.493.0499.0797.283.05
2163405-16340596.79799.60
3158464-15846493.87096.64
4152780-15278090.50393.12
5164935-16493597.703100.58
6155179-15517991.92494.67
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DJ333-221017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(%)99.67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%
19.851657511659421658551659041656531658210.08
29.911655661663571659620.34
单位质量响应值RSD%判断
16834.6216746.920.37数据可信
供试品溶液-2022091403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%
5min112224-122246.5316.238.186.536.238.19
212815-128156.8466.85
312383-123836.6166.62
411058-110585.9085.91
510327-103275.5175.52
611178-111785.9725.97
10min116783-167838.9669.090.869.009.130.87
217089-170899.1309.17
317063-170639.1169.15
417189-171899.1839.22
516919-169199.0399.07
617090-170909.1309.16
15min116810-168108.9819.020.899.079.100.84
216720-167208.9339.02
316749-167498.9489.04
416984-169849.0749.16
517106-171069.1399.22
616915-169159.0379.12
20min116595-165958.8668.911.029.009.050.98
216546-165468.8408.98
316583-165838.8599.00
416549-165498.8418.98
516912-169129.0359.17
616878-168789.0179.15
30min116614-166148.8768.662.039.068.841.96
216022-160228.5608.75
315880-158808.4848.67
415948-159488.5208.70
516604-166048.8719.05
616141-161418.6238.81
45min115957-159578.5258.531.308.768.761.28
216074-160748.5878.82
315647-156478.3598.59
415910-159108.5008.73
516276-162768.6958.93
615922-159228.5068.74
60min115632-156328.3518.391.708.638.671.64
215289-152898.1688.45
315653-156538.3638.64
416044-160448.5718.85
515948-159488.5208.80
615688-156888.3818.66
极限115614-156148.3428.261.628.678.591.55
215030-150308.0308.36
315399-153998.2278.55
415692-156928.3838.71
515658-156588.3658.69
615368-153688.2108.54
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%
111.001564601562901562871562881560291562710.10
211.051550421569061559740.85
单位质量响应值RSD%判断
14206.4514115.290.46数据可信
供试品溶液-2022091403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%
5min178384-7838445.72240.8815.3845.7240.8815.37
276539-7653944.64544.65
377018-7701844.92544.92
449767-4976729.02929.03
567418-6741839.32539.33
671352-7135241.62041.62
10min1115117-11511767.14864.655.1867.4064.875.21
2116705-11670568.07468.32
3113368-11336866.12866.38
4100756-10075658.77158.93
5109353-10935363.78664.00
6109681-10968163.97764.21
15min1134330-13433078.35575.023.9878.9875.604.02
2133008-13300877.58478.21
3129605-12960575.59976.22
4120154-12015470.08670.57
5128463-12846374.93375.51
6126092-12609273.55074.14
20min1142532-14253283.13980.443.9584.2081.443.98
2143739-14373983.84384.90
3137604-13760480.26581.30
4128354-12835474.86975.75
5138438-13843880.75181.74
6136783-13678379.78680.78
30min1148499-14849986.62083.953.7688.1485.403.78
2150722-15072287.91789.44
3142584-14258483.17084.65
4135376-13537678.96580.26
5144348-14434884.19985.64
6142035-14203582.85084.29
45min1155300-15530090.58787.683.7992.5989.603.82
2158279-15827992.32594.34
3147451-14745186.00987.95
4142393-14239383.05884.79
5148673-14867386.72188.63
6149800-14980087.37989.28
60min1158576-15857692.49889.492.7295.0191.892.77
2157854-15785492.07794.60
3152660-15266089.04791.47
4147738-14773886.17688.37
5150732-15073287.92290.31
6152956-15295689.22091.60
极限1164737-16473796.09293.201.7499.1196.101.79
2160975-16097593.89796.93
3159379-15937992.96695.88
4157126-15712691.65294.32
5157867-15786792.08494.96
6158581-15858192.50195.38
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