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%
110.03 1668991668051667501666681667191667680.06
210.091673771673811673790.01
单位质量响应值RSD%判断
16626.9216588.600.17数据可信
供试品溶液-2023121221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%
5min18075-80754.3625.259.424.365.259.43
29878-98785.3355.34
310664-106645.7605.76
410282-102825.5545.55
510087-100875.4485.45
69372-93725.0625.06
10min117463-174639.4329.752.419.469.782.41
218538-1853810.01310.04
317884-178849.6609.69
418580-1858010.03610.07
517958-179589.7009.73
617857-178579.6459.67
15min118021-180219.7349.941.609.8110.021.62
218730-1873010.11710.20
318541-1854110.01510.10
418662-1866210.08010.17
518300-183009.8849.97
618123-181239.7899.87
20min117544-175449.4769.651.939.619.791.92
218236-182369.8509.99
318302-183029.88510.03
417576-175769.4939.64
517595-175959.5049.64
617947-179479.6949.83
30min116663-166639.0009.503.079.189.693.08
217941-179419.6909.89
318166-181669.81210.01
417782-177829.6059.80
517283-172839.3359.53
617683-176839.5519.74
45min116960-169609.1619.442.579.399.692.57
217393-173939.3949.64
317993-179939.7199.97
417958-179589.7009.95
517011-170119.1889.43
617596-175969.5049.75
60min116002-160028.6439.032.758.939.322.71
216573-165738.9529.25
316977-169779.1709.47
417382-173829.3889.69
516620-166208.9779.27
616745-167459.0449.34
极限116186-161868.7439.062.639.079.402.62
216766-167669.0569.41
317227-172279.3059.66
417197-171979.2899.64
516304-163048.8069.15
616910-169109.1349.48
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%
110.732936732934972934452933732933702934720.05
210.782943682940842942260.07
单位质量响应值RSD%判断
27350.6127293.690.15数据可信
供试品溶液-2023121221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%
5min186437-8643726.13228.4819.3026.1328.4819.30
2107622-10762232.53632.54
3104946-10494631.72731.73
4112629-11262934.05034.05
563584-6358419.22319.22
689946-8994627.19227.19
10min1224730-22473067.94066.204.4368.0966.364.45
2231669-23166970.03870.22
3217275-21727565.68665.86
4224090-22409067.74767.94
5206348-20634862.38362.49
6209708-20970863.39963.55
15min1267571-26757180.89278.252.8181.4178.782.82
2265988-26598880.41380.98
3259099-25909978.33178.87
4258693-25869378.20878.77
5252802-25280276.42776.88
6248869-24886975.23875.74
20min1282271-28227185.33682.302.8186.3183.262.80
2280132-28013284.68985.71
3273116-27311682.56883.54
4263984-26398479.80780.81
5265877-26587780.38081.26
6267953-26795381.00781.93
30min1286903-28690386.73686.081.2288.1887.501.26
2289407-28940787.49388.98
3286831-28683186.71588.15
4282651-28265185.45186.89
5282088-28208885.28186.61
6280511-28051184.80486.18
45min1303635-30363591.79588.811.9393.7290.711.93
2296507-29650789.64091.61
3292029-29202988.28690.20
4292632-29263288.46890.39
5290261-29026187.75189.55
6287590-28759086.94488.79
60min1295869-29586989.44787.281.4491.8889.661.44
2289785-28978587.60890.08
3285649-28564986.35788.76
4289012-28901287.37489.78
5287904-28790487.03989.32
6283889-28388985.82588.15
极限1315404-31540495.35393.631.9298.2996.501.94
2317087-31708795.86198.82
3310138-31013893.76196.65
4309495-30949593.56696.46
5303338-30333891.70594.47
6302800-30280091.54294.34
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%
110.03 1670331671121671231671951674411671810.10
210.091674221677431675820.14
单位质量响应值RSD%判断
16668.1016608.720.26数据可信
供试品溶液-2023121421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%
5min111253-112536.0676.162.836.076.162.80
211361-113616.1256.13
311604-116046.2566.26
411990-119906.4646.46
511317-113176.1016.10
611069-110695.9685.97
10min117976-179769.6919.921.609.739.961.58
218331-183319.8839.92
318494-184949.97110.01
418318-183189.8769.91
518876-1887610.17710.21
618442-184429.9439.98
15min117682-176829.5339.812.289.629.902.24
217954-179549.6809.77
318450-184509.94710.04
417873-178739.6369.73
518649-1864910.05410.14
618595-1859510.02510.11
20min118060-180609.7379.731.689.889.881.65
217803-178039.5989.74
318557-1855710.00510.15
417745-177459.5679.71
517916-179169.6599.81
618210-182109.8189.96
30min117553-175539.4639.602.729.669.802.68
217273-172739.3129.51
318584-1858410.01910.22
417446-174469.4069.60
517887-178879.6439.84
618080-180809.7489.95
45min117138-171389.2409.422.579.499.672.52
217182-171829.2639.51
318005-180059.7079.96
416947-169479.1379.39
517949-179499.6779.93
617632-176329.5069.76
60min116100-161008.6809.203.928.989.513.84
216583-165838.9409.24
317801-178019.5979.91
416841-168419.0809.38
517538-175389.4559.76
617569-175699.4729.78
极限116732-167329.0219.213.729.379.563.63
216149-161498.7069.06
317740-177409.5649.93
416731-167319.0209.37
517518-175189.4459.80
617598-175989.4889.85
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%
110.732929272930452930012930482933982930840.07
210.782936112938172937140.05
单位质量响应值RSD%判断
27314.4527246.200.18数据可信
供试品溶液-2023121421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%
5min193696-9369628.37029.8113.6628.3729.8113.66
2114012-11401234.52134.52
397708-9770829.58429.58
4111805-11180533.85333.85
596461-9646129.20729.21
677095-7709523.34323.34
10min1217978-21797866.00067.983.9366.1668.143.95
2233062-23306270.56770.76
3220547-22054766.77866.94
4230764-23076469.87170.06
5232577-23257770.42070.58
6212144-21214464.23464.36
15min1255799-25579977.45279.792.9077.9880.332.91
2270253-27025381.82882.41
3255625-25562577.39977.93
4264568-26456880.10780.68
5274226-27422683.03183.58
6260631-26063178.91579.40
20min1277781-27778184.10785.002.0285.0685.992.04
2288984-28898487.49988.54
3274333-27433383.06384.03
4279373-27937384.58985.61
5286328-28632886.69587.71
6277682-27768284.07785.00
30min1287866-28786687.16189.341.9888.5890.801.99
2300013-30001390.83992.36
3290532-29053287.96889.39
4293038-29303888.72790.22
5303379-30337991.85893.35
6295624-29562489.51090.90
45min1294717-29471789.23591.113.2091.1493.063.18
2310435-31043593.99496.02
3292061-29206188.43190.35
4295511-29551189.47691.46
5315489-31548995.52597.53
6297158-29715889.97491.86
60min1285795-28579586.53490.692.8188.9493.152.79
2305098-30509892.37894.93
3295114-29511489.35591.76
4300278-30027890.91993.40
5310096-31009693.89296.43
6300793-30079391.07593.46
极限1310752-31075294.09095.771.9696.9798.741.94
2313309-31330994.86597.93
3312810-31281094.71497.62
4313613-31361394.95797.94
5327061-32706199.028102.09
6320307-32030796.98399.88
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%
110.03 1667801666991666081665521666131666500.06
210.091680421679261679840.05
单位质量响应值RSD%判断
16615.1516648.560.15数据可信
供试品溶液-2023121621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%
5min113165-131657.1006.825.757.106.825.77
212737-127376.8706.87
313122-131227.0777.08
413255-132557.1497.15
511408-114086.1536.15
612161-121616.5596.56
10min118368-183689.9079.990.999.9510.020.99
218677-1867710.07310.11
318503-185039.97910.02
418631-1863110.04910.09
518688-1868810.07910.11
618238-182389.8379.87
15min118719-1871910.0969.970.9810.1910.060.98
218583-1858310.02310.12
318362-183629.90310.00
418529-185299.99410.09
518203-182039.8189.91
618521-185219.98910.08
20min118198-181989.8159.972.159.9710.122.10
218573-1857310.01710.17
318344-183449.89410.04
418224-182249.8299.98
518338-183389.89110.04
619252-1925210.38310.53
30min117658-176589.5249.521.369.739.721.33
217645-176459.5179.72
317731-177319.5639.77
417895-178959.6529.86
517759-177599.5789.78
617194-171949.2739.48
45min117570-175709.4769.391.469.739.651.42
217540-175409.4609.72
317172-171729.2629.52
417746-177469.5719.83
517395-173959.3829.63
617078-170789.2119.47
60min117042-170429.1929.261.429.509.571.37
217201-172019.2779.59
317122-171229.2359.54
417311-173119.3379.65
517535-175359.4579.76
616816-168169.0709.38
极限117080-170809.2129.263.239.579.623.13
217747-177479.5729.93
316874-168749.1019.46
417492-174929.4349.80
517559-175599.4709.83
616247-162478.7639.12
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%
110.732916592916342915222912682914342915030.06
210.782938092934942936520.08
单位质量响应值RSD%判断
27167.1027240.450.20数据可信
供试品溶液-2023121621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%
5min1123887-12388737.61631.2427.4037.6231.2427.41
2126117-12611738.29438.29
3115683-11568335.12535.13
4110590-11059033.57933.58
552215-5221515.85415.85
688770-8877026.95426.95
10min1223497-22349767.86165.834.4168.0766.004.47
2225571-22557168.49168.70
3222018-22201867.41267.61
4214968-21496865.27265.46
5199420-19942060.55160.64
6215287-21528765.36965.52
15min1262904-26290479.82777.164.0780.4177.704.10
2261961-26196179.54180.13
3253971-25397177.11477.68
4247188-24718875.05575.60
5237072-23707271.98372.41
6261622-26162279.43879.95
20min1272835-27283582.84281.662.8883.8782.632.92
2275095-27509583.52884.56
3271693-27169382.49583.49
4260299-26029979.03680.00
5258061-25806178.35679.18
6275736-27573683.72384.68
30min1281421-28142185.44984.583.2986.9486.003.32
2285439-28543986.66988.17
3279161-27916184.76386.22
4270680-27068082.18883.59
5265114-26511480.49881.76
6289564-28956487.92289.34
45min1290655-29065588.25386.734.0890.2288.624.07
2293964-29396489.25891.24
3282891-28289185.89687.82
4273532-27353283.05484.92
5271776-27177682.52184.23
6300989-30098991.39193.30
60min1287175-28717587.19687.283.5589.6589.653.54
2294642-29464289.46491.94
3287519-28751987.30189.71
4274865-27486583.45985.78
5278135-27813584.45286.62
6302347-30234791.80394.22
极限1307984-30798493.51593.791.5696.4596.641.56
2318092-31809296.58499.56
3304636-30463692.49895.39
4305645-30564592.80595.59
5309063-30906393.84296.48
6307862-30786293.47896.40
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