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%
110.221689611688001689951688591687991688830.06
210.161697481695961696720.07
单位质量响应值RSD%判断
16524.7616700.000.75数据可信
供试品溶液-X013993批-依折麦布-水
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min114673-146737.9237.7017.047.927.7017.06
214984-149848.0918.09
315732-157328.4958.50
410228-102285.5235.52
512798-127986.9116.91
617132-171329.2519.25
10min122259-2225912.02011.955.1312.0611.995.18
222447-2244712.12112.17
322948-2294812.39212.44
420431-2043111.03311.06
521191-2119111.44311.48
623502-2350212.69112.74
15min125847-2584713.95714.013.0214.0714.123.07
226403-2640314.25714.37
326706-2670614.42114.54
424919-2491913.45613.55
525146-2514613.57913.68
626699-2669914.41714.54
20min124278-2427813.11013.243.6813.3013.423.72
224720-2472013.34913.54
324992-2499213.49513.69
424045-2404512.98413.15
523190-2319012.52212.70
625842-2584213.95414.16
30min114712-147127.9447.991.678.218.251.80
214960-149608.0788.34
314781-147817.9828.25
414452-144527.8048.04
514730-147307.9548.20
615182-151828.1988.48
45min117235-172359.3079.452.919.619.762.95
217298-172989.3419.65
317984-179849.71110.03
417480-174809.4399.72
516818-168189.0829.37
618195-181959.82510.15
60min121236-2123611.46711.622.2411.8211.982.28
221798-2179811.77112.13
321611-2161111.67012.04
421344-2134411.52611.86
520886-2088611.27811.62
622266-2226612.02312.40
极限117426-174269.4109.352.359.839.782.42
217607-176079.5089.94
317474-174749.4369.87
416778-167789.0609.46
516854-168549.1019.51
617765-177659.59310.04
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2500
标示量(mg)20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%
111.143124283122433120863124863122603123010.06
211.073137343133123135230.10
单位质量响应值RSD%判断
28034.2028321.860.73数据可信
供试品溶液-X013993批-阿托伐他汀钙-水
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min193492-9349227.40728.0715.1827.4128.0715.17
298967-9896729.01229.01
397762-9776228.65828.66
469744-6974420.44520.45
5100361-10036129.42029.42
6114157-11415733.46433.46
10min1248794-24879472.93275.9414.1573.0876.1014.15
2268635-26863578.74978.91
3281189-28118982.42982.59
4202280-20228059.29759.41
5243776-24377671.46171.62
6309723-30972390.79390.98
15min1319883-31988393.77295.222.4194.3395.792.46
2319887-31988793.77394.37
3335166-33516698.25298.87
4319541-31954193.67194.11
5319750-31975093.73394.29
6334639-33463998.09798.79
20min1321140-32114094.14097.572.1495.2298.682.15
2329447-32944796.57597.69
3339371-33937199.485100.65
4337186-33718698.84499.81
5330817-33081796.97798.06
6339128-33912899.413100.65
30min1325278-32527895.35397.681.5196.9599.331.51
2330047-33004796.75198.41
3332343-33234397.42499.14
4336234-33623498.565100.08
5336760-33676098.719100.34
6338647-33864799.272101.06
45min1325730-32573095.48697.301.9397.6299.491.90
2322524-32252494.54696.74
3338298-33829899.170101.43
4337416-33741698.911100.97
5334047-33404797.924100.09
6333408-33340897.737100.08
60min1330197-33019796.79597.621.3299.46100.361.25
2328094-32809496.17998.90
3331076-33107697.05399.86
4338628-33862899.267101.88
5338240-33824099.153101.87
6331917-33191797.299100.18
极限1333752-33375297.83797.691.12101.04100.961.10
2331055-33105597.047100.30
3339418-33941899.498102.85
4330599-33059996.913100.07
5335205-33520598.263101.53
6329421-32942196.56899.99
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%
110.221712651709791709281704931708391709010.17
210.161706161722291714220.67
单位质量响应值RSD%判断
16722.2116872.240.64数据可信
供试品溶液-X013993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%
5min18923-89234.7656.0213.104.776.0213.09
212840-128406.8576.86
312520-125206.6866.69
411394-113946.0856.08
510222-102225.4595.46
611772-117726.2876.29
10min115946-159468.5168.892.658.548.932.69
217169-171699.1699.21
316331-163318.7218.76
416783-167838.9639.00
516760-167608.9518.98
616914-169149.0339.07
15min116624-166248.8788.911.778.959.001.78
217153-171539.1609.25
316403-164038.7608.85
416952-169529.0539.14
516529-165298.8278.91
616494-164948.8098.89
20min116718-167188.9288.792.599.058.922.54
216857-168579.0029.14
316333-163338.7238.86
416221-162218.6638.80
516813-168138.9799.11
615766-157668.4208.55
30min116387-163878.7518.682.548.928.862.49
216529-165298.8279.02
315854-158548.4678.65
416215-162158.6608.84
516802-168028.9739.15
615714-157148.3928.57
45min116196-161968.6498.432.498.878.662.39
215798-157988.4378.68
315215-152158.1258.36
415933-159338.5098.74
516125-161258.6118.84
615415-154158.2328.46
60min115610-156108.3368.372.718.618.642.66
216062-160628.5788.86
315514-155148.2858.56
415590-155908.3268.60
516196-161968.6498.93
615014-150148.0188.29
极限115360-153608.2038.092.498.528.412.45
215545-155458.3028.64
314717-147177.8608.18
415447-154478.2498.57
515159-151598.0968.42
614665-146657.8328.15
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2500
标示量(mg)20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%
111.143156973152883150643149283150993152150.10
211.073160993180823170900.45
单位质量响应值RSD%判断
28295.7828644.080.87数据可信
供试品溶液-X013993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%
5min165646-6564619.04735.2545.6619.0535.2545.65
2224955-22495565.26965.27
3125083-12508336.29236.29
486272-8627225.03125.03
5122961-12296135.67635.68
6104081-10408130.19830.20
10min1241085-24108569.94975.3210.5970.0575.5210.65
2302211-30221187.68488.05
3271856-27185678.87779.08
4252760-25276073.33673.48
5222696-22269664.61364.81
6266974-26697477.46077.63
15min1295726-29572685.80288.303.8986.3088.923.98
2320194-32019492.90293.75
3309097-30909789.68290.32
4303958-30395888.19188.74
5286631-28663183.16483.72
6310501-31050190.08990.69
20min1314296-31429691.19091.351.4792.1692.451.58
2321478-32147893.27494.64
3319014-31901492.55993.70
4312622-31262290.70591.74
5308985-30898589.64990.67
6312627-31262790.70691.80
30min1320507-32050792.99293.220.5394.4794.830.64
2324166-32416694.05495.94
3319736-31973692.76994.42
4319892-31989292.81494.35
5321300-32130093.22294.74
6322194-32219493.48295.08
45min1322886-32288693.68391.551.8995.6893.681.70
2305116-30511688.52790.93
3314191-31419191.16093.33
4316165-31616591.73393.79
5315830-31583091.63593.67
6318963-31896392.54494.67
60min1316041-31604191.69793.151.3994.2195.791.42
2325863-32586394.54697.44
3320287-32028792.92995.60
4321316-32131693.22795.79
5326336-32633694.68497.23
6316429-31642991.80994.45
极限1316685-31668591.88390.531.3594.9193.691.32
2314911-31491191.36994.79
3309266-30926689.73192.92
4315759-31575991.61594.70
5308308-30830889.45392.52
6307257-30725789.14892.29
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%
110.221710881712641713581710951712771712160.07
210.161718111731881725000.57
单位质量响应值RSD%判断
16753.0316978.350.95数据可信
供试品溶液-X013993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%
5min111668-116686.2066.085.856.216.085.87
211782-117826.2676.27
310214-102145.4335.43
412087-120876.4296.43
511164-111645.9385.94
611703-117036.2256.22
10min115753-157538.3798.531.938.418.561.95
216287-162878.6638.70
315574-155748.2848.31
416041-160418.5328.57
516247-162478.6428.67
616314-163148.6778.71
15min116123-161238.5768.801.408.668.881.36
216736-167368.9028.98
316615-166158.8378.91
416488-164888.7708.85
516529-165298.7928.87
616754-167548.9118.99
20min116508-165088.7808.661.908.918.791.85
215957-159578.4878.62
316527-165278.7918.92
415958-159588.4888.62
516637-166378.8498.98
616119-161198.5748.71
30min116273-162738.6558.501.788.838.671.74
216101-161018.5648.74
315981-159818.5008.67
415482-154828.2358.41
515842-158428.4268.61
616164-161648.5978.78
45min116410-164108.7288.552.438.958.772.38
216501-165018.7779.00
316018-160188.5208.74
415397-153978.1908.41
516010-160108.5168.74
616055-160558.5408.77
60min115930-159308.4738.491.548.758.761.49
216327-163278.6848.96
316149-161498.5898.86
415738-157388.3718.64
515896-158968.4558.73
615685-156858.3438.62
极限116184-161848.6088.564.058.938.883.88
216319-163198.6809.00
316177-161778.6048.92
415188-151888.0788.40
515577-155778.2858.61
617074-170749.0819.40
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2500
标示量(mg)20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%
111.143141323148543150333147963143513146330.12
211.073168983192843180910.54
单位质量响应值RSD%判断
28243.5428734.511.22数据可信
供试品溶液-X013993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%
5min133530-335309.72211.3026.709.7211.3026.71
238489-3848911.16011.16
324879-248797.2147.21
442066-4206612.19712.20
556380-5638016.34816.35
638542-3854211.17611.18
10min1128456-12845637.24736.7121.2137.3036.7721.21
2139281-13928140.38640.45
372709-7270921.08321.12
4143047-14304741.47841.55
5139001-13900140.30440.40
6137090-13709039.75039.81
15min1191480-19148055.52155.889.0155.7856.149.06
2199386-19938657.81458.10
3159005-15900546.10546.26
4208209-20820960.37260.67
5197967-19796757.40257.72
6200162-20016258.03958.32
20min1229029-22902966.40966.023.8466.9866.603.92
2225101-22510165.27065.88
3212142-21214261.51261.93
4237491-23749168.86269.50
5233496-23349667.70468.34
6228960-22896066.38966.99
30min1255688-25568874.13974.461.9175.0875.402.00
2257991-25799174.80775.78
3248014-24801471.91472.67
4260945-26094575.66376.68
5256612-25661274.40775.42
6261502-26150275.82576.80
45min1274854-27485479.69679.301.4481.0580.661.46
2279965-27996581.17882.56
3269259-26925978.07479.23
4271807-27180778.81380.25
5270272-27027278.36779.79
6274771-27477179.67281.07
60min1271655-27165578.76880.362.0480.5682.161.98
2284378-28437882.45884.29
3279832-27983281.13982.73
4281113-28111381.51183.39
5269879-26987978.25480.11
6276040-27604080.04081.88
极限1280127-28012781.22580.982.2483.4683.232.17
2287160-28716083.26485.56
3280772-28077281.41283.45
4276222-27622280.09382.42
5268810-26881077.94480.24
6282680-28268081.96584.25
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%
110.221705501714101721461727301731511719970.61
210.161737201751051744120.57
单位质量响应值RSD%判断
16829.4517166.541.41数据可信
供试品溶液-X013993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%
5min19106-91064.8064.3012.694.814.3012.70
29266-92664.8904.89
38745-87454.6154.62
47797-77974.1154.12
56893-68933.6383.64
67090-70903.7423.74
10min113914-139147.3447.053.747.377.073.76
213682-136827.2217.25
313695-136957.2287.25
413176-131766.9546.98
513028-130286.8766.90
612601-126016.6516.67
15min114144-141447.4657.441.447.537.501.46
213950-139507.3637.43
314445-144457.6247.69
414087-140877.4357.50
513852-138527.3117.37
614063-140637.4227.48
20min114663-146637.7397.481.847.857.581.87
214076-140767.4297.54
314250-142507.5217.63
413982-139827.3797.48
513971-139717.3747.47
614107-141077.4457.54
30min114479-144797.6427.372.397.797.522.36
213630-136307.1947.34
313879-138797.3257.47
413704-137047.2337.38
513836-138367.3027.44
614259-142597.5267.67
45min114086-140867.4347.371.027.637.561.02
213753-137537.2597.45
314080-140807.4317.62
413880-138807.3267.51
514090-140907.4367.62
613891-138917.3317.51
60min114142-141427.4647.312.437.707.532.39
213266-132667.0027.23
313964-139647.3707.60
413775-137757.2707.49
513729-137297.2467.47
614177-141777.4827.71
极限113740-137407.2527.322.627.537.582.49
213356-133567.0497.32
314086-140867.4347.71
414131-141317.4587.72
514283-142837.5387.80
613569-135697.1617.43
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2500
标示量(mg)20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%
111.143148483166733179763188203195553175740.59
211.073203583223993213780.45
单位质量响应值RSD%判断
28507.5429031.441.29数据可信
供试品溶液-X013993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%
5min1173881-17388149.92744.8522.8849.9344.8622.88
292397-9239726.53026.53
3163412-16341246.92146.92
4146170-14617041.97041.97
5162696-16269646.71546.72
6198707-19870757.05557.06
10min1323315-32331592.83585.408.3293.1185.658.33
2283751-28375181.47481.62
3288471-28847182.83083.09
4258775-25877574.30374.54
5316175-31617590.78491.04
6314036-31403690.17090.49
15min1330189-33018994.80892.013.3695.6092.733.41
2315384-31538490.55791.16
3315380-31538090.55691.28
4303729-30372987.21187.86
5330986-33098695.03795.80
6326961-32696193.88194.70
20min1338737-33873797.26393.793.1898.5895.033.22
2324644-32464493.21694.32
3323251-32325192.81694.04
4309159-30915988.77089.90
5334362-33436296.00797.30
6329796-32979694.69696.03
30min1336335-33633596.57393.583.1198.4395.343.16
2319303-31930391.68393.30
3323042-32304292.75694.50
4310418-31041889.13190.76
5334886-33488696.15797.98
6331467-33146795.17597.04
45min1331357-33135795.14494.412.2797.5496.692.32
2326433-32643393.73095.86
3332606-33260695.50297.76
4315071-31507190.46792.59
5336332-33633296.57298.93
6331112-33111295.07397.47
60min1328805-32880594.41193.462.3797.3496.262.43
2314630-31463090.34192.99
3331500-33150095.18597.97
4316704-31670490.93693.56
5330247-33024794.82597.72
6331097-33109795.06997.99
极限1326351-32635193.70693.761.9997.1697.082.00
2320024-32002491.89095.04
3328913-32891394.44297.76
4323240-32324092.81395.94
5338125-33812597.087100.51
6322526-32252692.60896.06
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