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(%)99.60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%
1110.15609665572535612525564295576715587140.40
2111.65793215769715781460.29
单位质量响应值RSD%判断
5074.605180.521.47数据可信
供试品溶液-4YG05N批-pH1.2(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%
5min1395015-39501569.06468.851.4269.0668.851.42
2394966-39496669.05569.06
3401206-40120670.14670.15
4387122-38712267.68467.68
5397100-39710069.42869.43
6387315-38731567.71867.72
10min1435352-43535276.11675.741.2676.2375.851.26
2434909-43490976.03976.15
3437472-43747276.48776.60
4429776-42977675.14175.25
5437874-43787476.55776.67
6423809-42380974.09874.21
15min1449790-44979078.64178.441.2678.8878.681.26
2450672-45067278.79579.04
3453902-45390279.36079.60
4443348-44334877.51477.75
5453856-45385679.35279.59
6440315-44031576.98477.22
20min1459923-45992380.41279.731.1380.7980.111.13
2456112-45611279.74680.12
3463172-46317280.98081.36
4450639-45063978.78979.16
5456432-45643279.80280.18
6450007-45000778.67979.04
30min1461593-46159380.70480.071.0181.2180.571.01
2460685-46068580.54681.05
3462291-46229180.82681.34
4453589-45358979.30579.80
5458379-45837980.14280.65
6451138-45113878.87679.37
45min1459033-45903380.25779.940.9180.9080.580.92
2460050-46005080.43481.07
3461465-46146580.68281.33
4454843-45484379.52480.15
5457955-45795580.06880.71
6450077-45007778.69179.32
60min1455014-45501479.55479.241.0280.3380.011.02
2455019-45501979.55580.33
3458029-45802980.08180.86
4451660-45166078.96879.73
5454788-45478879.51480.29
6444833-44483377.77478.53
极限1452596-45259679.13178.011.4080.0478.911.39
2449987-44998778.67579.58
3448490-44849078.41379.33
4437556-43755676.50277.40
5449191-44919178.53679.44
6439184-43918476.78677.67
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(%)99.60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%
1110.15715445706925762725694695710145717980.46
2111.65667725680235673980.16
单位质量响应值RSD%判断
5193.445084.211.51数据可信
供试品溶液-4YG05N批-pH1.2(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%
5min1386567-38656767.43966.091.4567.4466.081.45
2373272-37327265.12065.12
3380991-38099166.46666.47
4373620-37362065.18065.18
5382854-38285466.79166.79
6375537-37553765.51565.51
10min1429954-42995475.00873.001.4475.1273.111.44
2413952-41395272.21772.33
3419735-41973573.22573.34
4414716-41471672.35072.46
5417201-41720172.78372.89
6415007-41500772.40172.51
15min1444778-44477877.59475.661.5677.8375.891.56
2428779-42877974.80375.03
3438592-43859276.51576.75
4429291-42929174.89375.12
5432870-43287075.51775.75
6427749-42774974.62474.85
20min1452390-45239078.92276.901.6779.2977.261.67
2434009-43400975.71676.07
3444831-44483177.60477.96
4436614-43661476.17076.52
5443141-44314177.30977.67
6433739-43373975.66976.02
30min1453972-45397279.19877.531.3279.7078.011.32
2438039-43803976.41976.90
3447578-44757878.08378.57
4441174-44117476.96677.45
5445337-44533777.69278.18
6440241-44024176.80377.28
45min1454984-45498479.37577.581.4080.0178.191.40
2440340-44034076.82077.43
3448606-44860678.26278.88
4439394-43939476.65577.26
5444825-44482577.60378.22
6439901-43990176.74477.35
60min1447577-44757778.08376.771.2478.8577.511.24
2436058-43605876.07376.81
3444288-44428877.50978.26
4433051-43305175.54976.29
5441458-44145877.01577.76
6437771-43777176.37277.11
极限1443391-44339177.35275.971.2478.2576.851.24
2432348-43234875.42676.29
3440972-44097276.93077.81
4430611-43061175.12375.99
5434276-43427675.76276.64
6431347-43134775.25176.11
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