依折麦布瑞舒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%
110.251743731750961741591738771736521742310.32
210.281761931768751765340.28
单位质量响应值RSD%判断
16998.1517172.570.73数据可信
供试品溶液-2023121221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%
5min19344-93444.9064.9512.604.914.9512.64
29566-95665.0235.02
39812-98125.1525.15
47169-71693.7643.76
510189-101895.3505.35
610523-105235.5255.53
10min114721-147217.7298.069.427.768.089.40
216782-167828.8118.84
316620-166208.7268.75
412852-128526.7486.77
515364-153648.0678.10
615721-157218.2548.28
15min116506-165068.6668.914.598.748.984.59
217625-176259.2549.33
317933-179339.4169.49
415784-157848.2878.35
517111-171118.9849.06
616828-168288.8358.91
20min117761-177619.3259.202.449.449.322.44
218046-180469.4759.60
317710-177109.2989.43
417061-170618.9589.06
517563-175639.2219.35
616950-169508.8999.03
30min117641-176419.2629.092.309.439.262.20
217230-172309.0469.23
317019-170198.9369.12
417574-175749.2279.38
517688-176889.2879.46
616694-166948.7658.94
45min117635-176359.2599.101.399.489.321.38
217275-172759.0709.30
317625-176259.2549.48
417168-171689.0149.22
517237-172379.0509.28
617065-170658.9609.18
60min117135-171358.9978.851.789.279.121.71
216378-163788.5998.88
317160-171609.0109.29
416946-169468.8979.15
516812-168128.8279.10
616661-166618.7489.02
极限117559-175599.2198.912.599.549.232.46
216863-168638.8549.18
317075-170758.9659.30
417236-172369.0509.35
516759-167598.7999.13
616280-162808.5488.87
依折麦布瑞舒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%
110.523091613091213093773090783088503091170.07
210.523129703131853130780.05
单位质量响应值RSD%判断
29383.7529760.270.91数据可信
供试品溶液-2023121221批-瑞舒伐他汀钙-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%
5min145222-4522212.63215.5740.1612.6315.5740.16
260500-6050016.89916.90
398527-9852727.52227.52
436982-3698210.33010.33
549762-4976213.90013.90
643390-4339012.12012.12
10min1130809-13080936.53941.0611.2336.6141.1511.29
2152667-15266742.64442.74
3176618-17661849.33549.49
4133947-13394737.41537.47
5143365-14336540.04640.12
6144626-14462640.39840.47
15min1180658-18065850.46355.286.0550.7455.606.08
2193074-19307453.93154.26
3213091-21309159.52359.95
4193930-19393054.17054.44
5196678-19667854.93855.24
6210017-21001758.66458.96
20min1218297-21829760.97764.373.9961.5364.994.02
2223896-22389662.54163.17
3238386-23838666.58867.35
4226896-22689663.37963.94
5232357-23235764.90465.51
6242771-24277167.81368.43
30min1247150-24715069.03670.363.3469.9371.343.29
2242345-24234567.69468.67
3247011-24701168.99770.13
4250686-25068670.02470.94
5260149-26014972.66773.63
6263958-26395873.73174.73
45min1279926-27992678.19277.912.9079.4779.282.86
2269266-26926675.21476.57
3275485-27548576.95178.46
4273415-27341576.37377.68
5283446-28344679.17580.54
6291883-29188381.53282.94
60min1279710-27971078.13177.833.5779.8479.643.53
2261390-26139073.01474.79
3279744-27974478.14180.08
4276302-27630277.17978.91
5282955-28295579.03880.85
6291698-29169881.48083.34
极限1295026-29502682.40981.411.4084.5583.641.37
2286666-28666680.07482.25
3290994-29099481.28383.66
4293264-29326481.91784.08
5286648-28664880.06982.32
6295992-29599282.67984.99
依折麦布瑞舒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%
110.251770561767911781791780561773011774770.35
210.281800641807211803920.26
单位质量响应值RSD%判断
17314.8317547.860.95数据可信
供试品溶液-2023121421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%
5min18774-87744.5155.8814.024.525.8814.00
211949-119496.1496.15
313272-132726.8306.83
412688-126886.5306.53
510825-108255.5715.57
611044-110445.6845.68
10min115147-151477.7958.565.027.828.595.04
216959-169598.7288.76
317676-176769.0979.13
416593-165938.5398.58
516518-165188.5018.53
616885-168858.6908.72
15min117452-174528.9819.382.369.059.462.38
218063-180639.2969.38
318277-182779.4069.49
418394-183949.4669.55
518625-186259.5859.66
618549-185499.5469.63
20min118631-186319.5889.612.739.719.752.70
219336-193369.95110.09
317898-178989.2119.35
419105-191059.8329.97
518418-184189.4789.61
618710-187109.6299.76
30min118417-184179.4789.431.509.659.621.45
218280-182809.4079.60
317851-178519.1879.38
418688-186889.6179.81
518412-184129.4759.66
618344-183449.4409.63
45min118381-183819.4599.362.379.689.602.31
218511-185119.5269.77
317725-177259.1229.36
418713-187139.6309.87
517642-176429.0799.32
618188-181889.3609.60
60min118025-180259.2769.143.109.559.433.01
217473-174738.9929.29
317326-173268.9169.21
418514-185149.5289.83
517077-170778.7889.08
618127-181279.3299.62
极限118239-182399.3869.153.289.719.493.17
218154-181549.3439.69
317459-174598.9859.33
418034-180349.2819.63
516741-167418.6158.95
618086-180869.3089.65
依折麦布瑞舒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%
110.523139323153443157103157073146173150620.25
210.523203023200933201980.05
单位质量响应值RSD%判断
29948.8630437.071.15数据可信
供试品溶液-2023121421批-瑞舒伐他汀钙-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%
5min146411-4641112.69816.6442.1912.7016.6442.17
259575-5957516.29916.30
321841-218415.9765.98
459883-5988316.38316.38
591685-9168525.08425.08
685486-8548623.38823.39
10min1146663-14666340.12638.9718.2440.2039.0618.28
2128451-12845135.14335.23
396981-9698126.53326.57
4156149-15614942.72142.81
5167919-16791945.94146.08
6158366-15836643.32843.46
15min1192965-19296552.79452.2310.0553.0952.5410.13
2173736-17373647.53347.82
3162221-16222144.38244.56
4204601-20460155.97756.31
5212196-21219658.05558.45
6199691-19969154.63455.00
20min1231790-23179063.41661.445.9664.0062.046.05
2216580-21658059.25459.80
3201483-20148355.12455.55
4237139-23713964.87965.52
5233695-23369563.93764.65
6226819-22681962.05662.73
30min1253050-25305069.23268.493.3870.1769.433.48
2238552-23855265.26666.14
3241240-24124066.00166.73
4257404-25740470.42471.42
5258673-25867370.77171.84
6253144-25314469.25870.28
45min1278584-27858476.21875.601.6077.5476.921.66
2270014-27001473.87475.12
3274250-27425075.03276.13
4283188-28318877.47878.87
5276419-27641975.62677.09
6275533-27553375.38476.79
60min1272423-27242374.53376.182.3276.2877.922.30
2270832-27083274.09775.75
3281519-28151977.02178.54
4288065-28806578.81280.63
5276610-27661075.67877.56
6281173-28117376.92778.75
极限1291674-29167479.80079.721.6081.9681.891.51
2295463-29546380.83682.90
3290997-29099779.61481.56
4296154-29615481.02583.28
5283150-28315077.46779.77
6290943-29094379.60081.85
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