替普瑞酮颗粒项目信息
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%
1111.95726265720115734965738955753375734730.23
2112.95766385767585766980.02
单位质量响应值RSD%判断
5124.875108.040.24数据可信
供试品溶液-250701701-1批-pH6.8(内含2%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1498764-49876486.33186.641.0286.3386.641.02
2494650-49465085.61885.62
3498305-49830586.25186.25
4508534-50853488.02288.02
5504839-50483987.38287.38
6498384-49838486.26586.26
10min1512265-51226588.66788.821.2188.8188.971.21
2505803-50580387.54987.69
3508896-50889688.08488.23
4523438-52343890.60190.75
5516630-51663089.42389.57
6511987-51198788.61988.76
15min1513775-51377588.92989.041.1989.2289.331.19
2506678-50667887.70087.99
3510830-51083088.41988.71
4524652-52465290.81191.11
5517078-51707889.50189.80
6513492-51349288.88089.17
20min1514104-51410488.98689.031.2089.4389.471.21
2506767-50676787.71688.15
3510642-51064288.38788.82
4524927-52492790.85991.31
5516675-51667589.43189.87
6513011-51301188.79789.24
30min1513420-51342088.86788.991.2689.4689.581.26
2506291-50629187.63388.21
3510176-51017688.30688.89
4525074-52507490.88591.49
5517028-51702889.49290.08
6512833-51283388.76689.35
45min1513708-51370888.91788.871.2189.6589.611.21
2505582-50558287.51188.24
3509626-50962688.21188.94
4523810-52381090.66691.42
5515862-51586289.29090.03
6512179-51217988.65389.39
60min1511737-51173788.57688.691.2389.4689.571.23
2504226-50422687.27688.15
3509147-50914788.12889.01
4522836-52283690.49791.40
5515237-51523789.18290.07
6511097-51109788.46589.35
极限1509659-50965988.21688.491.1989.2589.521.19
2503860-50386087.21388.23
3507376-50737687.82188.85
4521540-52154090.27391.33
5513801-51380188.93389.97
6511211-51121188.48589.52
替普瑞酮颗粒项目信息
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%
1111.95748675738435738695738735734615739830.10
2112.95813405794665804030.23
单位质量响应值RSD%判断
5129.435140.860.16数据可信
供试品溶液-250701701-2批-pH6.8(内含2%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1494499-49449985.28186.280.7185.2886.280.71
2500152-50015286.25686.26
3502865-50286586.72486.72
4502248-50224886.61786.62
5503842-50384286.89286.89
6498071-49807185.89785.90
10min1506792-50679287.40188.570.7387.5488.710.73
2512543-51254388.39388.54
3516624-51662489.09689.24
4516051-51605188.99889.14
5516049-51604988.99789.14
6513257-51325788.51688.66
15min1507624-50762487.54488.660.7087.8388.950.70
2512494-51249488.38488.68
3516731-51673189.11589.41
4516677-51667789.10689.40
5516528-51652889.08089.37
6514512-51451288.73289.02
20min1504895-50489587.07488.570.9087.5189.000.90
2512275-51227588.34688.78
3516833-51683389.13289.57
4516048-51604888.99789.44
5516956-51695689.15489.60
6514292-51429288.69489.13
30min1505590-50559087.19388.470.8187.7789.060.81
2511136-51113688.15088.74
3516803-51680389.12789.72
4515348-51534888.87689.47
5515296-51529688.86789.46
6513942-51394288.63489.22
45min1505617-50561787.19888.360.7887.9289.090.78
2509672-50967287.89788.63
3515556-51555688.91289.65
4514635-51463588.75389.49
5515511-51551188.90489.64
6512997-51299788.47189.21
60min1504037-50403786.92688.250.8587.8089.140.84
2509621-50962187.88988.77
3515169-51516988.84589.73
4514400-51440088.71389.60
5514811-51481188.78489.67
6512425-51242588.37289.25
极限1504176-50417686.95088.210.7887.9689.240.78
2509917-50991787.94088.97
3514118-51411888.66489.70
4514377-51437788.70989.74
5514013-51401388.64689.68
6512163-51216388.32789.36
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