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%
1110.15539655518225541365509935521175526070.26
2111.65594835546845570840.61
单位质量响应值RSD%判断
5019.144991.790.39数据可信
供试品溶液-2025112021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%
5min1429895-42989576.98877.921.2176.9977.921.21
2435111-43511177.92277.92
3430851-43085177.15977.16
4432536-43253677.46177.46
5438573-43857378.54278.54
6443681-44368179.45779.46
10min1466276-46627683.50383.811.0083.6383.941.00
2472989-47298984.70684.84
3462952-46295282.90883.04
4464405-46440583.16883.30
5466847-46684783.60683.74
6474442-47444284.96685.10
15min1472828-47282884.67784.790.6684.9485.060.66
2477521-47752185.51785.79
3472555-47255584.62884.89
4468258-46825883.85884.13
5475100-47510085.08485.35
6474514-47451484.97985.25
20min1472844-47284484.68085.000.9385.0985.400.93
2476084-47608485.26085.67
3471130-47113084.37384.78
4468867-46886783.96784.37
5479950-47995085.95286.36
6478794-47879485.74586.16
30min1474648-47464885.00384.740.6485.5585.290.64
2475075-47507585.07985.63
3469697-46969784.11684.66
4471087-47108784.36584.91
5471217-47121784.38884.94
6477464-47746485.50786.07
45min1470351-47035184.23384.070.5884.9284.760.58
2469409-46940984.06484.76
3465912-46591283.43884.13
4466771-46677183.59284.28
5470966-47096684.34385.04
6473123-47312384.73085.43
60min1466556-46655683.55383.150.7684.3983.990.76
2466101-46610183.47284.31
3460684-46068482.50283.33
4459108-45910882.22083.05
5465870-46587083.43184.27
6467538-46753883.72984.57
极限1460782-46078282.51982.790.6583.4983.760.65
2463770-46377083.05584.03
3459510-45951082.29283.26
4458795-45879582.16483.13
5464995-46499583.27484.25
6465936-46593683.44284.42
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%
1110.15558765566615571005564155572655566630.10
2111.65635055615745625400.25
单位质量响应值RSD%判断
5055.985040.680.22数据可信
供试品溶液-2025112021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%
5min1426318-42631875.69975.081.3075.7075.081.30
2429586-42958676.27976.28
3419545-41954574.49674.50
4414024-41402473.51673.52
5422878-42287875.08875.09
6424707-42470775.41375.41
10min1460086-46008681.69580.921.3781.8281.041.37
2464145-46414582.41582.54
3451759-45175980.21680.34
4446343-44634379.25579.38
5455699-45569980.91681.04
6456209-45620981.00681.13
15min1468690-46869083.22382.511.4783.4882.761.47
2473692-47369284.11184.38
3457687-45768781.26981.53
4455631-45563180.90481.16
5466721-46672182.87383.13
6465469-46546982.65182.91
20min1470083-47008383.47082.820.9383.8783.220.93
2471340-47134083.69384.10
3463570-46357082.31382.71
4459631-45963181.61482.00
5467698-46769883.04683.44
6466259-46625982.79183.19
30min1467341-46734182.98382.451.1483.5282.981.14
2470317-47031783.51184.06
3458141-45814181.34981.88
4457529-45752981.24181.77
5467186-46718682.95583.49
6465362-46536282.63283.17
45min1465510-46551082.65881.841.1983.3482.521.19
2467918-46791883.08583.77
3456732-45673281.09981.77
4453121-45312180.45881.12
5461963-46196382.02882.70
6460311-46031181.73582.41
60min1462790-46279082.17581.320.9982.9982.131.00
2463129-46312982.23583.06
3454129-45412980.63781.44
4452049-45204980.26881.06
5459191-45919181.53682.35
6456697-45669781.09381.90
极限1461059-46105981.86880.811.3482.8281.751.34
2461087-46108781.87382.83
3450351-45035179.96680.90
4445904-44590479.17780.11
5457490-45749081.23482.18
6454561-45456180.71481.66
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