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对照品来源工作对照品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%
110.181684101683721688491689021689401686950.17
210.201683451685021684240.07
单位质量响应值RSD%判断
16571.2216512.160.26数据可信
供试品溶液-U039846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%
5min17316-73163.9713.488.553.973.488.56
26111-61113.3173.32
36761-67613.6693.67
46483-64833.5183.52
55882-58823.1923.19
65976-59763.2433.24
10min114885-148858.0788.103.328.108.123.33
215714-157148.5288.55
315203-152038.2518.27
414935-149358.1068.13
514381-143817.8057.82
614447-144477.8417.86
15min116504-165048.9578.943.699.029.003.68
217028-170289.2419.31
317286-172869.3819.45
416315-163158.8558.92
515745-157458.5458.61
615908-159088.6348.70
20min116622-166229.0218.923.989.149.043.98
216871-168719.1569.27
317317-173179.3989.52
416478-164788.9439.06
515794-157948.5728.68
615583-155838.4578.57
30min116229-162298.8088.901.028.979.061.05
216393-163938.8979.06
316595-165959.0069.18
416558-165588.9869.15
516406-164068.9049.06
616186-161868.7848.94
45min116303-163038.8488.771.839.068.981.83
216427-164278.9159.13
316288-162888.8409.06
416352-163528.8759.09
515912-159128.6368.84
615683-156838.5128.72
60min115916-159168.6388.652.008.908.922.03
216154-161548.7679.03
316450-164508.9289.20
415912-159128.6368.90
515602-156028.4688.72
615645-156458.4918.74
极限115974-159748.6698.701.408.989.011.43
216064-160648.7189.03
316434-164348.9199.24
415987-159878.6768.99
515760-157608.5538.85
615954-159548.6598.96
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%
111.513127803123973129453125403146263130580.29
211.533133893124013128950.23
单位质量响应值RSD%判断
27198.7827137.470.16数据可信
供试品溶液-U039846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%
5min142691-4269112.9798.1532.7912.988.1432.81
225517-255177.7587.76
327195-271958.2688.27
426540-265408.0698.07
522706-227066.9036.90
616096-160964.8944.89
10min1103509-10350931.47025.7615.4131.5425.8015.44
285444-8544425.97826.02
387037-8703726.46226.51
490996-9099627.66627.71
576109-7610923.14023.18
665242-6524219.83619.86
15min1171525-17152552.14949.245.4352.4049.435.47
2167132-16713250.81451.00
3168074-16807451.10051.29
4159537-15953748.50548.70
5158021-15802148.04448.21
6147519-14751944.85144.99
20min1200379-20037960.92259.193.5561.4659.653.59
2194846-19484659.24059.71
3200205-20020560.86961.35
4191331-19133158.17158.64
5198748-19874860.42660.86
6182519-18251955.49255.88
30min1220392-22039267.00665.712.7267.8866.502.73
2213209-21320964.82365.62
3217077-21707765.99966.81
4212622-21262264.64465.44
5224814-22481468.35169.12
6208606-20860663.42364.12
45min1241831-24183173.52572.092.0974.7773.242.11
2236854-23685472.01173.17
3232508-23250870.69071.87
4236164-23616471.80272.95
5243834-24383474.13475.28
6231407-23140770.35571.40
60min1245234-24523474.55973.572.0276.2275.132.02
2237809-23780972.30273.86
3243339-24333973.98375.56
4236349-23634971.85873.41
5249304-24930475.79777.36
6239935-23993572.94874.39
极限1261144-26114479.39679.381.3981.4781.341.37
2255543-25554377.69479.65
3262788-26278879.89681.88
4259245-25924578.81980.77
5266414-26641480.99982.98
6261333-26133379.45481.30
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对照品来源工作对照品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%
110.181688341695431691391692531684891690520.24
210.201695261689671692460.24
单位质量响应值RSD%判断
16606.2916592.750.06数据可信
供试品溶液-U039846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%
5min18003-80034.3284.758.984.334.759.01
28561-85614.6304.63
38358-83584.5204.52
48376-83764.5304.53
59169-91694.9594.96
610179-101795.5055.51
10min114855-148558.0348.565.448.068.595.43
216574-165748.9648.99
315412-154128.3358.36
415206-152068.2248.25
515839-158398.5668.59
617107-171079.2529.28
15min116874-168749.1269.191.559.199.271.57
217061-170619.2279.30
317167-171679.2849.36
416594-165948.9759.05
516921-169219.1519.23
617355-173559.3869.47
20min116529-165298.9399.041.669.069.171.67
217200-172009.3029.43
316527-165278.9389.06
416559-165598.9569.08
516593-165938.9749.10
616909-169099.1459.28
30min116189-161898.7558.931.758.929.101.74
216619-166198.9889.17
316983-169839.1859.36
416329-163298.8319.00
516584-165848.9699.14
616324-163248.8289.01
45min116390-163908.8648.851.469.089.071.44
216621-166218.9899.22
315934-159348.6188.84
416479-164798.9129.13
516461-164618.9039.13
616265-162658.7979.03
60min115620-156208.4488.651.868.718.931.87
216305-163058.8189.10
316040-160408.6758.95
415817-158178.5548.82
516384-163848.8619.14
615852-158528.5738.86
极限115916-159168.6088.752.128.929.082.10
216675-166759.0189.35
316265-162658.7979.12
415920-159208.6108.93
516484-164848.9159.24
615854-158548.5748.90
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%
111.513143903144593141103122673121313134710.38
211.533137283140193138740.07
单位质量响应值RSD%判断
27234.6727222.380.04数据可信
供试品溶液-U039846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%
5min117089-170895.1847.6229.755.187.6229.77
219604-196045.9475.95
332134-321349.7489.75
423289-232897.0657.06
522346-223466.7796.78
636257-3625710.99911.00
10min168288-6828820.71626.2425.9620.7426.2825.96
277969-7796923.65323.69
3106736-10673632.37932.43
466153-6615320.06820.11
578311-7831123.75623.79
6121499-12149936.85836.92
15min1154619-15461946.90548.786.7247.0548.976.79
2156740-15674047.54847.71
3170649-17064951.76852.00
4144529-14452943.84443.99
5165526-16552650.21450.38
6172829-17282952.42952.70
20min1192908-19290858.52057.843.0058.9258.302.98
2193349-19334958.65459.08
3187196-18719656.78757.31
4181641-18164155.10255.50
5198266-19826660.14660.59
6190616-19061657.82558.38
30min1212752-21275264.54063.973.2465.2764.763.18
2218402-21840266.25467.01
3207134-20713462.83663.67
4203760-20376061.81262.51
5218958-21895866.42367.21
6204317-20431761.98162.86
45min1235438-23543871.42270.964.4272.5172.104.32
2244603-24460374.20275.32
3221192-22119267.10068.29
4228790-22879069.40570.45
5247076-24707674.95376.10
6226475-22647568.70369.93
60min1238198-23819872.25974.445.4773.7475.975.40
2254594-25459477.23378.77
3227384-22738468.97970.54
4235420-23542071.41772.85
5259868-25986878.83380.40
6256783-25678377.89779.50
极限1257036-25703677.97478.953.5079.8680.893.45
2271175-27117582.26384.23
3251183-25118376.19878.14
4255071-25507177.37879.20
5272257-27225782.59184.60
6254722-25472277.27279.31
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