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%
19.771683511684851680851683591679241682410.14
29.811683571698741691160.64
单位质量响应值RSD%判断
17220.1617239.140.08数据可信
供试品溶液-SC24092711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%
5min19649-96495.0285.106.805.035.106.78
210431-104315.4355.44
310225-102255.3285.33
49345-93454.8694.87
58724-87244.5464.55
610296-102965.3655.36
10min115175-151757.9078.122.617.938.152.62
215616-156168.1378.17
316339-163398.5138.54
415378-153788.0138.04
515385-153858.0168.04
615654-156548.1578.19
15min115442-154428.0468.171.348.128.241.33
215580-155808.1188.19
316039-160398.3578.43
415775-157758.2208.29
515567-155678.1118.18
615714-157148.1888.26
20min115058-150587.8468.102.297.968.222.29
215646-156468.1528.27
316113-161138.3968.52
415415-154158.0328.15
515655-156558.1578.27
615372-153728.0108.13
30min114667-146677.6427.882.937.808.052.89
215471-154718.0618.23
315112-151127.8748.04
415828-158288.2478.41
514810-148107.7177.88
614890-148907.7587.92
45min115057-150577.8457.961.798.058.171.80
215348-153487.9978.21
315256-152567.9498.16
415733-157338.1988.41
514949-149497.7897.99
615332-153327.9898.20
60min114613-146137.6147.761.677.868.011.62
214888-148887.7578.01
314727-147277.6737.93
415330-153307.9888.24
514952-149527.7918.04
614821-148217.7227.98
极限114545-145457.5797.802.067.878.102.03
215388-153888.0188.32
314762-147627.6927.99
415238-152387.9408.24
514904-149047.7668.06
615006-150067.8198.11
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对照品来源工作对照品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%
110.991593001591831589571591231588621590850.12
210.981593401604681599040.50
单位质量响应值RSD%判断
14475.4314563.210.43数据可信
供试品溶液-SC24092711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%
5min137015-3701521.10222.414.8721.1022.414.87
237203-3720321.20921.21
340934-4093423.33723.34
438751-3875122.09222.09
541242-4124223.51223.51
640678-4067823.19123.19
10min163867-6386736.41137.665.0936.5337.785.09
260550-6055034.52034.64
368923-6892339.29339.42
466118-6611837.69437.82
569375-6937539.55139.68
667513-6751338.48938.62
15min176231-7623143.45945.015.1143.7845.355.11
272057-7205741.08041.39
381055-8105546.21046.56
480206-8020645.72646.06
582661-8266147.12547.48
681500-8150046.46346.81
20min181296-8129646.34747.824.8346.9148.414.83
277053-7705343.92844.47
386491-8649149.30949.91
484306-8430648.06348.65
587856-8785650.08750.70
686320-8632049.21149.81
30min178922-7892244.99446.605.0145.8147.455.00
274698-7469842.58543.37
383106-8310647.37948.26
484597-8459748.22949.08
584894-8489448.39849.29
684223-8422348.01648.89
45min181499-8149946.46347.824.1247.5348.934.13
277999-7799944.46745.49
384716-8471648.29749.44
485978-8597849.01650.14
586812-8681249.49250.65
686271-8627149.18350.32
60min177047-7704743.92546.225.1945.2547.595.17
274671-7467142.57043.84
382177-8217746.84948.26
483421-8342147.55848.95
585031-8503148.47649.91
684055-8405547.92049.33
极限186742-8674249.45250.902.9651.0252.532.99
285915-8591548.98050.48
388317-8831750.35052.02
491610-9161052.22753.88
591686-9168652.27053.97
691468-9146852.14653.83
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%
19.771698911698051693991696521690701695630.20
29.811686041677801681920.35
单位质量响应值RSD%判断
17355.4817144.950.87数据可信
供试品溶液-SC24092711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%
5min111288-112885.8755.649.505.875.649.46
212434-124346.4716.47
310025-100255.2175.22
49622-96225.0085.01
510371-103715.3985.40
611269-112695.8655.86
10min115767-157678.2068.162.858.248.202.83
215683-156838.1628.20
316180-161808.4218.45
416136-161368.3988.43
515197-151977.9097.94
615134-151347.8767.91
15min115878-158788.2648.142.298.348.222.27
215557-155578.0978.18
316036-160368.3468.42
415679-156798.1608.23
515715-157158.1798.25
614997-149977.8057.88
20min115549-155498.0927.962.048.228.082.02
215565-155658.1018.23
315464-154648.0488.17
415290-152907.9588.08
515153-151537.8868.01
614750-147507.6777.80
30min114909-149097.7597.771.727.937.941.67
215108-151087.8638.03
315076-150767.8468.01
415233-152337.9288.09
514765-147657.6847.85
614536-145367.5657.73
45min114448-144487.5197.620.887.737.830.81
214549-145497.5727.79
314634-146347.6167.83
414693-146937.6477.86
514784-147847.6947.90
614755-147557.6797.88
60min114653-146537.6267.581.547.887.831.52
214467-144677.5297.79
314748-147487.6767.93
414777-147777.6917.94
514535-145357.5657.81
614172-141727.3767.62
极限114001-140017.2877.683.517.587.973.39
214751-147517.6777.98
315384-153848.0078.30
414666-146667.6337.93
515275-152757.9508.24
614443-144437.5177.80
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对照品来源工作对照品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%
110.991602121603241594681599841590441598060.34
210.981593241585641589440.34
单位质量响应值RSD%判断
14541.0414475.770.32数据可信
供试品溶液-SC24092711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%
5min189462-8946251.04145.1717.2051.0445.1717.20
294057-9405753.66253.66
390240-9024051.48451.48
469586-6958639.70139.70
561944-6194435.34135.34
669763-6976339.80239.80
10min1127595-12759572.79772.573.9573.0872.823.98
2129729-12972974.01474.31
3134601-13460176.79477.08
4125814-12581471.78072.00
5126101-12610171.94472.14
6119365-11936568.10168.32
15min1142742-14274281.43879.642.7082.1380.302.71
2140381-14038180.09180.80
3141575-14157580.77281.49
4137059-13705978.19678.82
5142608-14260881.36281.96
6133208-13320875.99976.60
20min1145701-14570183.12681.532.7184.2782.632.73
2145247-14524782.86784.02
3144666-14466682.53683.70
4139271-13927179.45880.51
5145731-14573183.14484.19
6136821-13682178.06079.08
30min1147947-14794784.40883.452.1386.0185.002.13
2147715-14771584.27685.89
3145723-14572383.13984.76
4146154-14615483.38584.88
5149498-14949885.29386.80
6140573-14057380.20181.66
45min1150912-15091286.10084.911.8588.1786.921.80
2148536-14853684.74486.83
3146202-14620283.41285.49
4145044-14504482.75284.71
5151933-15193386.68288.67
6150343-15034385.77587.68
60min1153363-15336387.49885.262.3390.0587.742.31
2147719-14771984.27886.83
3150310-15031085.75688.30
4146286-14628683.46085.88
5153424-15342487.53390.00
6145534-14553483.03185.41
极限1152575-15257587.04888.531.7790.0891.491.70
2155192-15519288.54191.56
3153457-15345787.55290.57
4154427-15442788.10590.99
5160408-16040891.51794.47
6155002-15500288.43391.27
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%
19.771690021694891690041692911694691692510.15
29.811693301702861698080.40
单位质量响应值RSD%判断
17323.5417309.680.06数据可信
供试品溶液-SC24092711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%
5min19553-95534.9535.2811.024.955.2811.02
29720-97205.0395.04
310804-108045.6015.60
412192-121926.3216.32
59450-94504.8994.90
69338-93384.8414.84
10min114438-144387.4857.411.677.517.441.58
214156-141567.3397.37
314129-141297.3257.36
413965-139657.2407.28
514497-144977.5167.54
614552-145527.5447.57
15min114936-149367.7437.503.217.817.573.16
214304-143047.4167.48
314284-142847.4057.48
413897-138977.2057.28
514257-142577.3917.46
615120-151207.8397.91
20min114111-141117.3167.282.397.437.392.34
214605-146057.5727.68
313930-139307.2227.33
413577-135777.0397.15
514074-140747.2967.41
613955-139557.2357.35
30min113517-135177.0086.941.047.167.091.05
213509-135097.0047.16
313488-134886.9937.15
413293-132936.8927.05
513202-132026.8446.99
613289-132896.8897.04
45min113835-138357.1736.932.677.367.122.59
213598-135987.0507.24
313372-133726.9327.12
412977-129776.7286.92
513503-135037.0007.19
612928-129286.7026.89
60min113404-134046.9496.793.227.187.023.12
213244-132446.8667.10
312697-126976.5836.81
412553-125536.5086.74
513655-136557.0797.31
613044-130446.7626.99
极限113549-135497.0246.802.147.297.062.04
213100-131006.7917.06
313088-130886.7857.05
412828-128286.6506.92
513277-132776.8837.15
612810-128106.6416.91
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对照品来源工作对照品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%
110.991611301613791615241614921612951613640.10
210.981597011609851603430.57
单位质量响应值RSD%判断
14682.8014603.190.39数据可信
供试品溶液-SC24092711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%
5min1115127-11512765.08067.755.9565.0867.755.95
2119735-11973567.68467.68
3126898-12689871.73471.73
4123661-12366169.90469.90
5108209-10820961.16961.17
6125485-12548570.93570.93
10min1131800-13180074.50576.324.3474.8776.704.34
2137610-13761077.78978.16
3139361-13936178.77979.18
4129961-12996173.46573.85
5128297-12829772.52472.86
6143030-14303080.85381.25
15min1135156-13515676.40277.964.4277.1878.764.42
2139839-13983979.04979.86
3141603-14160380.04680.88
4134029-13402975.76576.56
5129892-12989273.42674.17
6146913-14691383.04883.89
20min1131636-13163674.41276.683.8075.6177.913.80
2140626-14062679.49480.74
3137365-13736577.65078.93
4131510-13151074.34175.56
5130434-13043473.73274.88
6142289-14228980.43481.74
30min1136775-13677577.31778.124.4978.9379.784.47
2140089-14008979.19080.88
3145356-14535682.16883.88
4140985-14098579.69781.33
5126926-12692671.74973.31
6139047-13904778.60180.35
45min1139328-13932878.76082.545.4780.8084.645.41
2154913-15491387.57089.70
3151627-15162785.71387.88
4151031-15103185.37687.45
5134334-13433475.93777.90
6144861-14486181.88884.08
60min1139792-13979279.02282.685.0481.5085.234.98
2155353-15535387.81990.43
3150822-15082285.25787.90
4151292-15129285.52388.07
5136583-13658377.20879.59
6143743-14374381.25683.90
极限1161924-16192491.53392.380.9294.4595.390.95
2163513-16351392.43195.53
3166008-16600893.84296.96
4161950-16195091.54894.57
5163805-16380592.59795.41
6163369-16336992.35095.44
点击查看处理图标(人工保存)
 
原始图谱下载图谱(谢鑫慧 于 2024-11-26 16:20:44 完成)
生成报告数据部分(等待生成报告)
Current page cost:70 ms