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%
19.851624531625191625801626541626451625700.06
29.911620191628001624100.35
单位质量响应值RSD%判断
16504.5716388.500.50数据可信
供试品溶液-2022092001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%
5min16245-62453.4063.789.403.413.789.43
26811-68113.7153.71
38097-80974.4164.42
46421-64213.5023.50
56967-69673.8003.80
67058-70583.8503.85
10min115468-154688.4378.492.368.468.512.37
215832-158328.6358.66
315911-159118.6788.70
414887-148878.1208.14
515621-156218.5208.54
615676-156768.5508.57
15min116501-165019.0009.091.109.079.161.09
216902-169029.2199.29
316537-165379.0209.09
416630-166309.0709.14
516541-165419.0229.09
616889-168899.2129.28
20min116481-164818.9899.021.899.119.141.84
216799-167999.1639.28
316406-164068.9489.07
416796-167969.1619.28
516742-167429.1329.25
616003-160038.7288.85
30min115042-150428.2048.743.658.378.913.59
216374-163748.9319.10
315816-158168.6278.80
416701-167019.1099.28
515903-159038.6748.84
616343-163438.9149.08
45min115242-152428.3138.722.708.528.942.66
216225-162258.8509.07
315842-158428.6418.86
416171-161718.8209.04
516495-164958.9979.21
616001-160018.7278.95
60min115650-156508.5368.833.508.799.103.43
217215-172159.3909.66
315891-158918.6678.94
416254-162548.8659.13
516334-163348.9099.18
615807-158078.6228.89
极限115630-156308.5258.631.978.838.941.92
216047-160478.7529.07
315393-153938.3968.71
415723-157238.5768.89
516272-162728.8759.19
615831-158318.6358.95
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%
111.003076033077473077263078573079503077770.05
211.053070573082823076700.29
单位质量响应值RSD%判断
27979.7327843.440.35数据可信
供试品溶液-2022092001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%
5min153352-5335215.78914.2031.6115.7914.2031.60
246019-4601913.61913.62
360425-6042517.88217.88
427843-278438.2408.24
566712-6671219.74319.74
633615-336159.9489.95
10min1164596-16459648.71045.0517.4848.8045.1317.50
2164540-16454048.69348.77
3163349-16334948.34148.44
4112682-11268233.34733.39
5181836-18183653.81253.92
6126362-12636237.39537.45
15min1205050-20505060.68258.848.6661.0459.178.72
2208147-20814761.59861.94
3200123-20012359.22459.59
4169592-16959250.18850.42
5219558-21955864.97565.38
6190495-19049556.37456.64
20min1221882-22188265.66365.026.4366.3665.676.50
2225548-22554866.74867.44
3214944-21494463.61064.31
4199079-19907958.91559.42
5241786-24178671.55372.32
6214966-21496663.61664.19
30min1230124-23012468.10269.774.7869.1670.794.83
2238212-23821270.49671.55
3231885-23188568.62369.67
4219775-21977565.03965.88
5252759-25275974.80175.97
6241840-24184071.56972.50
45min1245687-24568772.70874.805.3474.1576.215.38
2246833-24683373.04774.50
3263395-26339577.94879.38
4233814-23381469.19470.39
5271363-27136380.30681.89
6255466-25546675.60276.93
60min1268605-26860579.49081.566.8081.3383.386.75
2280877-28087783.12284.98
3292796-29279686.64988.51
4242385-24238571.73173.31
5276785-27678581.91183.94
6292159-29215986.46088.21
极限1294079-29407987.02987.392.6789.3189.662.69
2287820-28782085.17687.49
3298338-29833888.28990.64
4285727-28572784.55786.54
5298661-29866188.38590.87
6307152-30715290.89793.13
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%
19.851626891634671639681643641647911638560.50
29.911657641665831661740.35
单位质量响应值RSD%判断
16635.1316768.310.57数据可信
供试品溶液-2022092001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%
5min18681-86814.6633.7319.994.663.7320.03
28427-84274.5264.53
36092-60923.2723.27
47271-72713.9053.91
55419-54192.9112.91
65817-58173.1243.12
10min115587-155878.3728.243.048.408.263.09
216016-160168.6028.63
315345-153458.2428.26
415449-154498.2988.32
514717-147177.9047.92
614934-149348.0218.04
15min116572-165728.9018.971.098.979.031.10
216802-168029.0249.10
316472-164728.8478.91
416650-166508.9439.01
516990-169909.1259.19
616687-166878.9639.02
20min116823-168239.0369.071.799.169.181.71
216675-166758.9569.08
317033-170339.1489.26
416533-165338.8809.00
517396-173969.3439.45
616854-168549.0529.16
30min116710-167108.9758.961.629.159.121.57
216349-163498.7818.95
316407-164078.8128.98
416840-168409.0459.21
517070-170709.1689.33
616705-167058.9729.13
45min117145-171459.2098.763.059.438.983.00
215985-159858.5858.81
316122-161228.6598.87
415799-157998.4868.70
516655-166558.9459.16
616180-161808.6908.90
60min115787-157878.4798.611.268.758.881.21
215855-158558.5168.78
316038-160388.6148.87
416108-161088.6528.92
516359-163598.7869.05
616047-160478.6198.88
极限116007-160078.5978.600.508.928.910.45
215870-158708.5248.84
316023-160238.6068.91
416108-161088.6528.96
516025-160258.6078.92
616050-160508.6208.93
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%
111.003083443096623104123112503118683103070.45
211.053138203147023142610.20
单位质量响应值RSD%判断
28209.7328439.910.58数据可信
供试品溶液-2022092001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%
5min183247-8324724.27718.4028.3124.2818.4028.31
286437-8643725.20725.21
360183-6018317.55117.55
442540-4254012.40612.41
550485-5048514.72314.72
655728-5572816.25216.25
10min1176058-17605851.34248.929.2751.4849.029.30
2186995-18699554.53254.67
3178922-17892252.17852.28
4146848-14684842.82442.89
5154000-15400044.91044.99
6163652-16365247.72547.81
15min1210122-21012261.27662.083.9261.7062.463.97
2225922-22592265.88466.33
3220411-22041164.27764.66
4204679-20467959.68960.00
5207558-20755860.52860.86
6208641-20864160.84461.20
20min1230191-23019167.12967.883.1067.8968.603.13
2241016-24101670.28671.09
3241555-24155570.44371.19
4224202-22420265.38266.02
5232701-23270167.86168.53
6226960-22696066.18766.88
30min1256557-25655774.81873.152.1875.9574.252.23
2257663-25766375.14076.34
3249490-24949072.75773.89
4244774-24477471.38172.38
5251356-25135673.30174.35
6245246-24524671.51972.58
45min1274092-27409279.93177.162.1481.4878.662.18
2265194-26519477.33678.95
3267384-26738477.97579.52
4258845-25884575.48576.88
5259928-25992875.80177.25
6261993-26199376.40377.86
60min1268877-26887778.41079.192.2880.4081.122.26
2273132-27313279.65181.70
3281692-28169282.14884.12
4272034-27203479.33181.15
5262752-26275276.62478.50
6270799-27079978.97180.85
极限1294472-29447285.87487.221.0088.3089.600.95
2297810-29781086.84889.34
3302434-30243488.19690.63
4297718-29771886.82189.08
5301404-30140487.89690.19
6300773-30077387.71290.03
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%
19.851637091636141633681633391632451634550.13
29.911654321661211657760.30
单位质量响应值RSD%判断
16594.4216728.150.57数据可信
供试品溶液-2022092201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%
5min111971-119716.4456.195.976.456.196.00
211188-111886.0246.02
312534-125346.7486.75
411401-114016.1386.14
511358-113586.1156.12
610531-105315.6705.67
10min117098-170989.2069.291.569.249.321.55
217696-176969.5289.56
317229-172299.2769.31
417215-172159.2699.30
516894-168949.0969.13
617352-173529.3429.37
15min117416-174169.3779.351.619.469.441.59
217757-177579.5609.65
317133-171339.2249.31
417000-170009.1539.24
517570-175709.4609.54
617331-173319.3319.41
20min117143-171439.2309.332.349.379.462.30
218045-180459.7159.85
316942-169429.1229.26
417463-174639.4029.54
517001-170019.1539.29
617351-173519.3429.48
30min116251-162518.7509.022.378.949.212.33
217064-170649.1879.38
316419-164198.8409.03
417159-171599.2389.43
517072-170729.1929.38
616513-165138.8919.08
45min116137-161378.6888.802.138.939.042.07
216765-167659.0269.27
315804-158048.5098.75
416304-163048.7789.02
516532-165328.9019.14
616579-165798.9269.16
60min115971-159718.5998.691.088.898.981.08
216368-163688.8139.11
316203-162038.7249.01
416076-160768.6558.94
516278-162788.7649.05
615931-159318.5778.86
极限115674-156748.4398.572.008.778.911.97
216381-163818.8209.16
315653-156538.4288.76
415941-159418.5838.92
516226-162268.7369.07
615659-156598.4318.76
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%
111.003090723089383084573082413080973085610.14
211.053123153131933127540.20
单位质量响应值RSD%判断
28051.0028303.530.64数据可信
供试品溶液-2022092201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%
5min181680-8168023.94429.4115.3423.9429.4115.34
299319-9931929.11529.12
3101381-10138129.72029.72
4118437-11843734.72034.72
5116466-11646634.14234.14
684679-8467924.82424.82
10min1196234-19623457.52660.713.8757.6660.873.90
2205082-20508260.12060.28
3208927-20892761.24761.41
4213937-21393762.71662.91
5217535-21753563.77063.96
6200800-20080058.86559.00
15min1240203-24020370.41671.802.8470.8772.302.86
2241163-24116370.69771.19
3247804-24780472.64473.15
4244766-24476671.75372.29
5257302-25730275.42875.97
6238373-23837369.87970.34
20min1257839-25783975.58677.531.9276.4378.431.95
2263823-26382377.34078.23
3268763-26876378.78879.70
4265271-26527177.76478.70
5271144-27114479.48680.45
6259958-25995876.20777.06
30min1265560-26556077.84980.713.2579.1182.043.25
2271284-27128479.52780.85
3281162-28116282.42383.77
4273312-27331280.12181.49
5290272-29027285.09386.50
6270270-27027079.23080.51
45min1282475-28247582.80885.953.9384.5087.733.87
2305766-30576689.63591.40
3285122-28512283.58485.39
4281173-28117382.42684.24
5304944-30494489.39491.27
6299725-29972587.86489.58
60min1289980-28998085.00888.543.5887.1690.793.54
2309149-30914990.62792.89
3303157-30315788.87091.14
4288095-28809584.45586.73
5315077-31507792.36594.74
6306617-30661789.88592.09
极限1304199-30419989.17692.002.4091.8094.752.40
2322258-32225894.47097.23
3312454-31245491.59694.36
4307393-30739390.11292.86
5322505-32250594.54297.43
6314267-31426792.12794.83
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%
19.851662691660341659871658281659461660130.10
29.911631431644461637940.57
单位质量响应值RSD%判断
16854.1116528.151.39数据可信
供试品溶液-2022092201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%
5min112220-122206.5686.666.976.576.666.97
212020-120206.4616.46
313171-131717.0797.08
411377-113776.1156.11
511853-118536.3716.37
613665-136657.3457.34
10min117021-170219.1489.321.649.189.361.67
217473-174739.3919.43
317274-172749.2849.32
417063-170639.1719.20
517775-177759.5549.59
617456-174569.3829.42
15min117304-173049.3019.430.969.399.520.93
217487-174879.3999.49
317541-175419.4289.52
417702-177029.5149.60
517774-177749.5539.64
617501-175019.4069.50
20min117231-172319.2619.350.979.409.490.95
217356-173569.3299.47
317599-175999.4599.60
417479-174799.3959.53
517511-175119.4129.55
617169-171699.2289.37
30min116492-164928.8649.011.219.059.201.21
216926-169269.0979.29
317048-170489.1639.36
416757-167579.0079.20
516683-166838.9679.16
616631-166318.9399.14
45min115653-156538.4138.772.208.659.012.18
216753-167539.0049.25
316383-163838.8069.05
416338-163388.7819.02
516367-163678.7979.04
616382-163828.8059.05
60min115705-157058.4418.652.318.738.942.23
216356-163568.7919.08
316369-163698.7989.09
416286-162868.7539.04
516294-162948.7589.05
615531-155318.3488.64
极限115606-156068.3888.562.428.728.902.35
216429-164298.8309.17
315921-159218.5578.90
415902-159028.5478.88
516293-162938.7579.10
615428-154288.2928.63
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%
111.003139333133853132883128963130013133010.13
211.053083223109013096120.59
单位质量响应值RSD%判断
28481.9128019.191.16数据可信
供试品溶液-2022092201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%
5min1128530-12853037.58333.5622.3237.5833.5622.32
2110086-11008632.19032.19
3128631-12863137.61237.61
465395-6539519.12219.12
5121389-12138935.49535.49
6134686-13468639.38339.38
10min1218775-21877563.97161.227.6764.1861.407.72
2202674-20267459.26359.44
3215258-21525862.94263.15
4179494-17949452.48552.59
5221235-22123564.69064.89
6218716-21871663.95364.17
15min1255866-25586674.81672.404.7675.3872.924.81
2239135-23913569.92470.43
3251176-25117673.44574.00
4228202-22820266.72767.12
5259813-25981375.97076.53
6251434-25143473.52074.09
20min1274511-27451180.26877.274.2281.2578.204.27
2254552-25455274.43275.33
3267890-26789078.33279.30
4247247-24724772.29673.06
5274923-27492380.38881.37
6266439-26643977.90878.89
30min1283625-28362582.93380.234.0284.3681.594.08
2267039-26703978.08379.39
3277083-27708381.02082.42
4256300-25630074.94376.11
5285739-28573983.55184.98
6276491-27649180.84782.26
45min1311333-31133391.03584.605.4292.9286.405.43
2277484-27748481.13782.88
3288380-28838084.32386.18
4266676-26667677.97779.56
5296073-29607386.57388.46
6296001-29600186.55288.42
60min1316321-31632192.49386.664.6094.8988.934.63
2291575-29157585.25887.45
3294329-29432986.06388.38
4275281-27528180.49382.51
5303825-30382588.83991.21
6296869-29686986.80589.15
极限1322835-32283594.39891.212.5597.3093.962.62
2307366-30736689.87592.54
3314137-31413791.85594.65
4302310-30231088.39690.86
5318714-31871493.19396.06
6306275-30627589.55692.38
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