瑞舒伐他汀钙片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号101028-202405对照品来源中检所对照品使用方法直接使用
对照品含量(%)98.4对照品水分(%)0对照品稀释倍数5000
标示量(mg)5供试品稀释倍数2.5系数0.9620
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.05253195
253195+0		252312
252312+0		252472
252472+0		252615
252615+0		251914
251914+0		2525020.19
211.15251633
251633+0		251628
251628+0		2516300.01
单位质量响应值RSD%判断
22850.8622567.710.89数据可信
供试品溶液-506264批-pH1.2
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min1180011
166217+13794*1		-18001167.53468.075.2867.5368.075.28
2170767
157671+13096*1		-17076764.06664.07
3169734
156480+13254*1		-16973463.67963.68
4189386
174933+14453*1		-18938671.05271.05
5186512
172229+14283*1		-18651269.97369.97
6192197
177371+14826*1		-19219772.10672.11
10min1239201
218885+20316*1		-23920189.74187.625.9890.4988.385.98
2218596
200625+17971*1		-21859682.01082.72
3213576
195920+17656*1		-21357680.12780.83
4247879
227498+20381*1		-24787992.99693.79
5239829
219960+19869*1		-23982989.97690.75
6242209
221364+20845*1		-24220990.86991.67
15min1248614
226169+22445*1		-24861493.27289.964.6895.0291.694.67
2231637
210354+21283*1		-23163786.90388.53
3226617
205799+20818*1		-22661785.02086.62
4254513
231602+22911*1		-25451395.48597.31
5245435
222515+22920*1		-24543592.07993.86
6231889
210832+21057*1		-23188986.99788.81
20min1245041
220103+24938*1		-24504191.93290.025.5094.7292.765.48
2229566
206959+22607*1		-22956686.12688.71
3221148
199134+22014*1		-22114882.96885.51
4258670
232868+25802*1		-25867097.04599.93
5245539
220949+24590*1		-24553992.11894.92
6239780
215234+24546*1		-23978089.95892.74
30min1246160
219818+26342*1		-24616092.35190.155.3496.1693.885.32
2222856
199165+23691*1		-22285683.60887.15
3226108
201744+24364*1		-22610884.82988.29
4253915
226931+26984*1		-25391595.26199.22
5249782
222618+27164*1		-24978293.71097.53
6242926
216457+26469*1		-24292691.13894.92
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
45min1244912
216481+28431*1		-24491291.88389.834.0496.7194.564.08
2228460
202239+26221*1		-22846085.71190.19
3226335
200812+25523*1		-22633584.91489.32
4249005
220873+28132*1		-24900593.41998.44
5246324
218032+28292*1		-24632492.41397.28
6241636
213475+28161*1		-24163690.65495.44
60min1234885
207855+27030*1		-23488588.12189.485.4093.9795.215.35
2225268
199245+26023*1		-22526884.51389.94
3223849
197276+26573*1		-22384983.98189.33
4256809
226586+30223*1		-25680996.347102.41
5244432
215464+28968*1		-24443291.70397.60
6245828
216632+29196*1		-24582892.22798.02
极限1246391
217155+29236*1		-24639192.43894.343.4399.27101.073.44
2238114
210492+27622*1		-23811489.33395.70
3250159
221145+29014*1		-25015993.852100.14
4259320
228333+30987*1		-25932097.289104.42
5261502
230389+31113*1		-26150298.107105.02
6253355
223386+29969*1		-25335595.051101.87
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