替普瑞酮胶囊项目信息
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%
1121.95601105596165598265606765608105602080.10
2122.55633585639195636380.08
单位质量响应值RSD%判断
4595.644601.130.09数据可信
供试品溶液-25061101批-pH6.8(内含5%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1310317-31031759.76454.7710.8259.7654.7710.82
2246101-24610147.39647.40
3282917-28291754.48754.49
4302682-30268258.29358.29
5248678-24867847.89347.89
6315706-31570660.80260.80
10min1358158-35815868.97869.084.1269.0869.184.12
2330516-33051663.65463.73
3359931-35993169.31969.41
4365984-36598470.48570.58
5364742-36474270.24670.33
6372890-37289071.81571.92
15min1389711-38971175.05474.372.7875.2774.582.80
2367790-36779070.83371.02
3386578-38657874.45174.66
4393481-39348175.78075.99
5381107-38110773.39773.59
6398282-39828276.70576.93
20min1411827-41182779.31478.252.9279.6578.582.92
2389013-38901374.92075.22
3408005-40800578.57878.91
4412309-41230979.40679.75
5395595-39559576.18776.51
6421020-42102081.08481.43
30min1448772-44877286.42984.832.4986.9085.292.50
2425798-42579882.00482.43
3444487-44448785.60486.06
4440475-44047584.83185.30
5429546-42954682.72683.17
6453843-45384387.40587.89
45min1481029-48102992.64190.991.8593.2691.591.86
2461449-46144988.87089.43
3471222-47122290.75291.36
4471803-47180390.86491.48
5465324-46532489.61790.20
6483877-48387793.19093.82
60min1498577-49857796.02194.411.6596.7995.171.66
2482440-48244092.91393.63
3489823-48982394.33595.09
4488938-48893894.16494.93
5480955-48095592.62793.36
6500633-50063396.41797.20
90min1515948-51594899.36697.701.55100.3098.621.56
2500822-50082296.45397.32
3501825-50182596.64697.56
4503365-50336596.94397.87
5503220-50322096.91597.80
6518707-51870799.898100.84
极限1521586-521586100.45298.901.62101.5599.981.62
2505800-50580097.41298.44
3504573-50457397.17698.25
4510759-51075998.36799.45
5513577-51357798.91099.96
6524902-524902101.091102.20
替普瑞酮胶囊项目信息
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%
1121.95682195666325685065652045652145667550.28
2122.55652635640415646520.16
单位质量响应值RSD%判断
4649.344609.400.62数据可信
供试品溶液-25061101批-pH4.0(内含5%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1294584-29458456.35551.7310.4756.3651.7310.47
2247418-24741847.33247.33
3233166-23316644.60644.61
4256088-25608848.99148.99
5291774-29177455.81755.82
6299450-29945057.28657.29
10min1329448-32944863.02560.485.1263.1260.575.12
2321193-32119361.44561.52
3303800-30380058.11858.19
4293703-29370356.18656.27
5311896-31189659.66759.76
6336922-33692264.45464.55
15min1360241-36024168.91565.264.5269.1165.444.52
2336997-33699764.46964.65
3333057-33305763.71563.89
4327136-32713662.58262.76
5328598-32859862.86263.05
6360714-36071469.00669.21
20min1366962-36696270.20167.593.3270.5267.893.32
2352865-35286567.50467.79
3348078-34807866.58966.87
4346117-34611766.21366.49
5338475-33847564.75265.05
6367402-36740270.28570.60
30min1404468-40446877.37673.333.4277.8173.743.43
2377212-37721272.16272.56
3377377-37737772.19472.58
4375586-37558671.85172.24
5370829-37082970.94171.35
6394396-39439675.44975.88
45min1425399-42539981.38079.212.6181.9479.742.62
2411670-41167078.75479.28
3406940-40694077.84978.36
4412866-41286678.98379.49
5399612-39961276.44776.97
6427763-42776381.83382.39
60min1445541-44554185.23483.772.1185.9384.432.12
2434866-43486683.19183.84
3434000-43400083.02683.66
4439477-43947784.07484.71
5423701-42370181.05681.71
6449701-44970186.02986.73
90min1472690-47269090.42789.741.9591.2690.541.96
2467195-46719589.37690.17
3464911-46491188.93989.72
4469622-46962289.84090.62
5456245-45624587.28188.07
6483873-48387392.56793.41
极限1501172-50117295.87693.352.2596.8694.302.26
2485142-48514292.80993.75
3483480-48348092.49293.42
4486205-48620593.01393.94
5471969-47196990.28991.22
6499817-49981795.61796.61
替普瑞酮胶囊项目信息
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%
1121.95656955638985642795651295643635646730.13
2122.55689825681655685740.11
单位质量响应值RSD%判断
4632.264641.420.14数据可信
供试品溶液-25061101批-pH1.2(内含5%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1273722-27372252.27947.6515.0252.2847.6515.02
2193540-19354036.96536.96
3287745-28774554.95754.96
4272915-27291552.12552.12
5254907-25490748.68548.69
6214036-21403640.87940.88
10min1356315-35631568.05367.824.4468.1467.904.45
2338255-33825564.60464.67
3375010-37501071.62471.72
4372471-37247171.13971.23
5347140-34714066.30166.38
6341248-34124865.17665.24
15min1398484-39848476.10775.462.7776.3175.652.78
2382317-38231773.02073.19
3408708-40870878.06078.27
4399030-39903076.21276.42
5400707-40070776.53276.72
6381319-38131972.82973.01
20min1423554-42355480.89681.041.8881.2281.361.89
2421039-42103980.41580.71
3434562-43456282.99883.34
4424092-42409280.99881.33
5430898-43089882.29882.62
6411741-41174178.63978.94
30min1454001-45400186.71186.812.4287.1787.262.43
2446502-44650285.27885.70
3471760-47176090.10290.58
4445843-44584385.15385.62
5463720-46372088.56789.02
6445421-44542185.07285.50
45min1475009-47500990.72391.352.4091.3391.952.40
2473434-47343490.42290.99
3494416-49441694.43095.06
4463153-46315388.45989.07
5489190-48919093.43194.04
6474591-47459190.64391.21
60min1481432-48143291.95093.082.4792.7193.832.46
2483672-48367292.37893.10
3502235-50223595.92396.71
4470841-47084189.92790.68
5500556-50055695.60296.36
6485226-48522692.67493.40
90min1481304-48130491.92593.132.5792.8494.042.56
2482629-48262992.17893.05
3501994-50199495.87796.82
4469354-46935489.64390.55
5500859-50085995.66096.58
6489562-48956293.50394.38
极限1478808-47880891.44992.702.5792.5193.762.56
2479126-47912691.50992.53
3498452-49845295.20096.31
4467262-46726289.24390.30
5498393-49839395.18996.27
6490023-49002393.59194.62
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