叶酸片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号100074-202217对照品来源中检院对照品使用方法直接使用
对照品含量(%)91.2对照品水分(%)0对照品稀释倍数2000
标示量(mg)5供试品稀释倍数2系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.391304735130527213050211304804130506513049790.02
210.381299108129997212995400.05
单位质量响应值RSD%判断
125599.52125196.530.23数据可信
供试品溶液-24081901批-pH4.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1121912-12191215.96016.172.4215.9616.172.42
2126958-12695816.62016.62
3119875-11987515.69315.69
4121002-12100215.84115.84
5126532-12653216.56416.56
6124737-12473716.33016.33
10min1198550-19855025.99226.623.0026.1726.803.00
2210134-21013427.50927.69
3194430-19443025.45325.63
4203508-20350826.64226.82
5209398-20939827.41327.60
6204228-20422826.73626.92
15min1259762-25976234.00634.563.5334.4735.043.52
2271380-27138035.52736.02
3247687-24768732.42532.88
4267663-26766335.04035.51
5273000-27300035.73936.23
6264476-26447634.62335.10
20min1303448-30344839.72540.734.4840.5741.594.44
2314841-31484141.21642.10
3289842-28984237.94438.76
4317101-31710141.51242.37
5331286-33128643.36944.25
6310409-31040940.63641.50
30min1381974-38197450.00550.374.2751.2951.684.24
2380316-38031649.78851.13
3360716-36071647.22248.46
4395922-39592251.83153.15
5409193-40919353.56854.94
6380340-38034049.79151.11
45min1462245-46224560.51360.954.8262.3562.824.78
2465284-46528460.91162.81
3424035-42403555.51157.27
4475744-47574462.28064.18
5488623-48862363.96665.93
6477497-47749762.51064.38
60min1519275-51927567.97967.713.0170.4970.263.04
2522755-52275568.43571.01
3487286-48728663.79166.17
4517513-51751367.74870.34
5532640-53264069.72972.40
6523679-52367968.55671.12
90min1571530-57153074.82075.161.8578.0978.471.91
2585719-58571976.67780.01
3557731-55773173.01376.10
4568140-56814074.37677.72
5584418-58441876.50779.96
6577419-57741975.59178.92
极限1596499-59649978.08978.741.1382.1982.881.18
2612024-61202480.12184.31
3595924-59592478.01381.91
4596467-59646778.08482.25
5607436-60743679.52083.82
6600512-60051278.61482.78
叶酸片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号100074-202217对照品来源中检院对照品使用方法直接使用
对照品含量(%)91.2对照品水分(%)0对照品稀释倍数2000
标示量(mg)5供试品稀释倍数2系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.391304648130433113049271305124130612213050300.06
210.381300066130081713004420.05
单位质量响应值RSD%判断
125604.43125283.430.19数据可信
供试品溶液-24081902批-pH4.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1103412-10341213.53313.333.3113.5313.333.31
295596-9559612.51012.51
3100557-10055713.15913.16
4104578-10457813.68513.69
5103942-10394213.60213.60
6103095-10309513.49113.49
10min1174846-17484622.88122.073.3623.0322.223.36
2159959-15995920.93321.07
3164215-16421521.49021.64
4171900-17190022.49522.65
5172705-17270522.60122.75
6168441-16844122.04322.19
15min1236229-23622930.91428.744.4131.3229.134.39
2208142-20814227.23827.61
3212450-21245027.80228.19
4222351-22235129.09829.50
5220092-22009228.80229.20
6218398-21839828.58028.98
20min1279034-27903436.51534.143.8537.2634.853.84
2252546-25254633.04933.72
3253015-25301533.11033.80
4264036-26403634.55335.28
5261351-26135134.20134.92
6255167-25516733.39234.10
30min1334485-33448543.77241.842.7844.9342.942.80
2312775-31277540.93141.97
3313757-31375741.05942.12
4325408-32540842.58443.69
5320157-32015741.89743.00
6311942-31194240.82241.91
45min1391738-39173851.26450.433.3552.9051.993.29
2378830-37883049.57551.07
3396990-39699051.95153.47
4399214-39921452.24353.82
5380012-38001249.73051.30
6365526-36552647.83449.37
60min1439365-43936557.49756.843.2559.7158.963.18
2426350-42635055.79457.84
3450457-45045758.94861.04
4449451-44945158.81760.98
5422973-42297355.35257.47
6417448-41744854.62956.70
90min1490221-49022164.15265.202.4267.0067.952.36
2494631-49463164.72967.40
3515934-51593467.51770.27
4510615-51061566.82169.64
5491283-49128364.29167.03
6486773-48677363.70166.38
极限1554258-55425872.53272.291.1176.0975.761.12
2551997-55199772.23675.62
3559268-55926873.18876.69
4557139-55713972.90976.47
5542088-54208870.94074.39
6549500-54950071.90975.29
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