替普瑞酮胶囊项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号3A5724009091对照品来源原料药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2000
标示量(mg)50供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
1111.6214553
85817+128736*1		213669
85306+128363*1		213820
85484+128336*1		213858
85371+128487*1		213896
85440+128456*1		2139590.17
2112.1214031
85369+128662*1		213856
85401+128455*1		2139440.06
单位质量响应值RSD%判断
1917.201908.510.33数据可信
供试品溶液-2410100批-pH6.8(内含5%SDS)
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min113027
5624+7403*1		-130276.03123.2852.266.0323.2852.26
277612
31375+46237*1		-7761235.93235.93
346794
18987+27807*1		-4679421.66421.66
438190
19150+19040*1		-3819017.68117.68
583444
33577+49867*1		-8344438.63338.63
642632
17306+25326*1		-4263219.73819.74
10min146770
19078+27692*1		-4677021.65348.0827.6421.6648.1127.66
2120045
47990+72055*1		-12004555.57855.64
3115872
46261+69611*1		-11587253.64653.68
4104525
42502+62023*1		-10452548.39348.42
5123239
49117+74122*1		-12323957.05757.12
6112601
45120+67481*1		-11260152.13252.16
15min1104014
41667+62347*1		-10401448.15660.1110.6248.2060.2310.67
2136957
54535+82422*1		-13695763.40863.56
3137478
54674+82804*1		-13747863.64963.77
4128653
51366+77287*1		-12865359.56359.67
5142940
56912+86028*1		-14294066.17866.34
6128997
51369+77628*1		-12899759.72259.84
20min1117586
46792+70794*1		-11758654.43967.1210.1154.5767.3410.15
2152988
60848+92140*1		-15298870.83071.09
3154580
61442+93138*1		-15458071.56771.80
4146278
58261+88017*1		-14627867.72367.93
5157256
62612+94644*1		-15725672.80673.08
6141228
56205+85023*1		-14122865.38565.60
30min1139459
55383+84076*1		-13945964.56677.639.0364.7877.969.07
2176862
70386+106476*1		-17686281.88382.26
3179702
71533+108169*1		-17970283.19883.55
4170038
67671+102367*1		-17003878.72379.05
5177191
70657+106534*1		-17719182.03582.43
6162757
64873+97884*1		-16275775.35375.68
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
45min1163481
64953+98528*1		-16348175.68886.536.6076.0186.996.64
2195929
78259+117670*1		-19592990.71091.22
3197007
78749+118258*1		-19700791.20991.70
4188084
75259+112825*1		-18808487.07887.53
5191669
76698+114971*1		-19166988.73889.27
6185246
73861+111385*1		-18524685.76486.22
60min1178351
70896+107455*1		-17835182.57291.175.0483.0291.775.09
2205119
82043+123076*1		-20511994.96595.63
3204929
81943+122986*1		-20492994.87795.52
4197183
78879+118304*1		-19718391.29191.89
5200445
80187+120258*1		-20044592.80193.48
6195447
78195+117252*1		-19544790.48791.08
90min1194205
77457+116748*1		-19420589.91296.093.5390.5096.853.59
2215162
86110+129052*1		-21516299.615100.44
3212869
85420+127449*1		-21286998.55399.35
4207105
83104+124001*1		-20710595.88596.64
5209272
83676+125596*1		-20927296.88897.72
6206741
82742+123999*1		-20674195.71696.46
120min1201664
80675+120989*1		-20166493.36698.242.8094.1099.152.86
2218638
87935+130703*1		-218638101.224102.21
3216917
87042+129875*1		-216917100.427101.39
4211818
84982+126836*1		-21181898.06798.98
5212593
85196+127397*1		-21259398.42599.42
6211481
84823+126658*1		-21148197.91198.82
极限1204726
81899+122827*1		-20472694.78399.002.3495.68100.082.40
2218924
88002+130922*1		-218924101.357102.51
3217447
87683+129764*1		-217447100.673101.80
4214056
86159+127897*1		-21405699.103100.18
5214987
86709+128278*1		-21498799.534100.69
6212843
85458+127385*1		-21284398.54199.61
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
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