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%
1111.3214231
85956+128275*1		214035
85508+128527*1		214156
85388+128768*1		214019
85666+128353*1		215079
86072+129007*1		2143040.21
2110.7213075
85293+127782*1		212582
84904+127678*1		2128280.17
单位质量响应值RSD%判断
1925.461922.570.11数据可信
供试品溶液-25031801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%
5min156399
22077+34322*1		-5639925.96023.0538.6725.9623.0538.67
281471
32031+49440*1		-8147137.50037.50
343996
17185+26811*1		-4399620.25120.25
455230
21522+33708*1		-5523025.42225.42
524329
9395+14934*1		-2432911.19811.20
639018
15231+23787*1		-3901817.96017.96
10min1113185
44111+69074*1		-11318552.09850.608.4052.1450.648.42
2124772
48776+75996*1		-12477257.43157.49
3108552
42234+66318*1		-10855249.96550.00
4110731
43283+67448*1		-11073150.96851.01
596773
37612+59161*1		-9677344.54344.56
6105536
41171+64365*1		-10553648.57748.61
15min1132570
51715+80855*1		-13257061.02060.676.9361.1560.796.95
2145825
56889+88936*1		-14582567.12167.28
3131995
51586+80409*1		-13199560.75660.87
4135300
52950+82350*1		-13530062.27762.40
5118323
46223+72100*1		-11832354.46354.56
6126816
49589+77227*1		-12681658.37258.48
20min1149565
58426+91139*1		-14956568.84367.046.6169.0767.266.63
2159609
62375+97234*1		-15960973.46673.74
3144894
56576+88318*1		-14489466.69366.91
4148989
58238+90751*1		-14898968.57868.81
5131539
51268+80271*1		-13153960.54660.73
6139229
54431+84798*1		-13922964.08564.29
30min1169284
66069+103215*1		-16928477.91974.816.3978.2775.146.41
2176732
69114+107618*1		-17673281.34881.74
3161383
62945+98438*1		-16138374.28374.61
4165355
64478+100877*1		-16535576.11176.46
5147666
57408+90258*1		-14766667.96968.25
6154719
60459+94260*1		-15471971.21571.53
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
45min1186626
73079+113547*1		-18662685.90282.315.4786.3882.775.49
2190029
74738+115291*1		-19002987.46888.00
3178136
69999+108137*1		-17813681.99482.45
4180387
70814+109573*1		-18038783.03083.50
5162174
63478+98696*1		-16217474.64775.04
6175525
68999+106526*1		-17552580.79281.23
60min1196902
77519+119383*1		-19690290.63287.964.7091.2588.564.72
2199237
78695+120542*1		-19923791.70692.38
3190090
74896+115194*1		-19009087.49688.09
4192035
75697+116338*1		-19203588.39189.00
5174043
68191+105852*1		-17404380.11080.63
6194300
76452+117848*1		-19430089.43490.00
90min1220068
87565+132503*1		-220068101.29597.613.49102.0798.363.51
2214739
85219+129520*1		-21473998.84299.67
3208835
82717+126118*1		-20883596.12496.86
4212612
84357+128255*1		-21261297.86398.62
5199139
78774+120365*1		-19913991.66192.32
6217019
86487+130532*1		-21701999.891100.61
120min1224831
89861+134970*1		-224831103.487102.241.57104.43103.151.61
2223875
89416+134459*1		-223875103.047104.04
3222390
88879+133511*1		-222390102.363103.26
4225731
90316+135415*1		-225731103.901104.82
5216898
86549+130349*1		-21689899.836100.64
6219028
87231+131797*1		-219028100.816101.70
极限1225372
90001+135371*1		-225372103.736102.731.37104.85103.811.40
2225047
89971+135076*1		-225047103.586104.75
3224758
90070+134688*1		-224758103.453104.52
4225297
89729+135568*1		-225297103.701104.80
5219950
87697+132253*1		-219950101.240102.22
6218654
87374+131280*1		-218654100.644101.70
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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