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%
1112.95571275496835553515563395542375545470.53
2119.25983095961095972090.27
单位质量响应值RSD%判断
4911.845010.141.41数据可信
供试品溶液-25102201批-pH4.0(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%
5min1383408-38340868.45071.563.8468.4571.563.84
2396702-39670270.82370.82
3406673-40667372.60372.60
4401425-40142571.66671.67
5427191-42719176.26676.27
6389442-38944269.52769.53
10min1411026-41102673.38176.292.8173.4976.412.81
2423762-42376275.65475.77
3433600-43360077.41177.53
4426616-42661676.16476.28
5446665-44666579.74379.87
6422397-42239775.41175.53
15min1425711-42571176.00278.462.5576.2478.712.55
2436517-43651777.93178.18
3434722-43472277.61177.86
4446834-44683479.77380.02
5457733-45773381.71981.98
6435518-43551877.75377.99
20min1439490-43949078.46279.451.8378.8379.821.83
2437098-43709878.03578.41
3440801-44080178.69679.08
4449362-44936280.22580.60
5459165-45916581.97582.37
6444114-44411479.28879.66
30min1444407-44440779.34080.302.5579.8380.812.55
2443433-44343379.16679.67
3438858-43885878.34978.86
4461562-46156282.40382.92
5466808-46680883.33983.87
6443590-44359079.19479.70
45min1455745-45574581.36482.762.2281.9983.402.22
2461860-46186082.45683.09
3451973-45197380.69181.33
4467479-46747983.45984.11
5481291-48129185.92586.60
6463036-46303682.66683.30
60min1467210-46721083.41184.851.4484.1785.631.45
2476992-47699285.15785.93
3472423-47242384.34285.12
4484212-48421286.44687.24
5481535-48153585.96986.78
6469118-46911883.75284.52
90min1480173-48017385.72587.291.3986.6388.211.39
2488078-48807887.13788.05
3489808-48980887.44688.36
4498749-49874989.04289.98
5493564-49356488.11689.07
6483205-48320586.26787.18
120min1493992-49399288.19288.181.0589.2489.251.05
2491478-49147887.74488.80
3493199-49319988.05189.11
4502452-50245289.70390.78
5495707-49570788.49989.60
6486833-48683386.91487.97
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
极限1490987-49098787.65689.001.3188.8590.221.31
2492210-49221087.87489.08
3497382-49738288.79890.01
4504335-50433590.03991.27
5507444-50744490.59491.85
6498672-49867289.02890.23
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%
1112.95550925578025590725560055541355564210.37
2119.25989995984465987220.07
单位质量响应值RSD%判断
4928.445022.841.35数据可信
供试品溶液-25102301批-pH4.0(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%
5min1399548-39954871.12170.111.9871.1270.111.98
2406632-40663272.38272.38
3389987-38998769.41969.42
4385492-38549268.61968.62
5389375-38937569.31069.31
6392314-39231469.83369.83
10min1425879-42587975.80875.481.5775.9375.601.57
2435132-43513277.45577.58
3421599-42159975.04675.16
4416585-41658574.15374.27
5418807-41880774.54974.66
6426364-42636475.89476.01
15min1439244-43924478.18778.131.8478.4378.371.84
2449165-44916579.95380.20
3434993-43499377.43077.67
4434889-43488977.41277.65
5428041-42804176.19376.43
6447240-44724079.61079.85
20min1445583-44558379.31579.321.7379.6979.701.73
2458838-45883881.67582.06
3442615-44261578.78779.16
4436554-43655477.70878.07
5441238-44123878.54278.91
6448879-44887979.90280.28
30min1450192-45019280.13680.431.2780.6480.931.27
2459206-45920681.74082.26
3445209-44520979.24979.75
4451507-45150780.37080.87
5446911-44691179.55280.05
6457974-45797481.52182.03
45min1466856-46685683.10283.071.8283.7483.711.82
2477539-47753985.00385.66
3463993-46399382.59283.23
4455855-45585581.14481.77
5460405-46040581.95482.58
6475475-47547584.63685.28
60min1474930-47493084.53985.070.9985.3285.850.99
2483828-48382886.12386.92
3474704-47470484.49985.27
4472492-47249284.10584.87
5478520-47852085.17885.94
6483034-48303485.98286.77
90min1487976-48797686.86187.151.4587.7888.071.44
2496522-49652288.38389.32
3477409-47740984.98085.89
4491321-49132187.45788.36
5488161-48816186.89487.80
6496297-49629788.34289.27
120min1500595-50059589.10888.890.6290.1789.960.62
2503711-50371189.66290.75
3495430-49543088.18889.24
4501329-50132989.23890.29
5498195-49819588.68089.73
6497009-49700988.46989.55
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
极限1499756-49975688.95888.831.4290.1790.041.42
2508926-50892690.59091.83
3491248-49124887.44488.64
4497836-49783688.61689.82
5491498-49149887.48888.69
6504807-50480789.85791.08
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