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%
1 112.45530165566795539295519905479345527100.58
2 114.15652355631085641720.27
单位质量响应值RSD%判断
4917.354944.540.39数据可信
供试品溶液-js2M批-pH6.8(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%
5min1371803-37180366.77767.321.2266.7867.321.22
2373544-37354467.08967.09
3383280-38328068.83868.84
4376533-37653367.62667.63
5370915-37091566.61766.62
6372809-37280966.95766.96
10min1435697-43569778.25278.691.3078.3678.811.30
2435314-43531478.18378.30
3448091-44809180.47880.59
4441886-44188679.36479.48
5434388-43438878.01778.13
6433585-43358577.87377.98
15min1462732-46273283.10883.781.0183.3584.031.01
2465760-46576083.65183.89
3475098-47509885.32885.58
4468026-46802684.05884.30
5464918-46491883.50083.74
6462480-46248083.06283.30
20min1477065-47706585.68286.641.1686.0687.021.16
2481788-48178886.53086.91
3491257-49125788.23188.62
4486931-48693187.45487.84
5478756-47875685.98586.37
6478509-47850985.94186.32
30min1491109-49110988.20489.121.0988.7389.641.09
2493246-49324688.58889.11
3505655-50565590.81791.35
4499406-49940689.69490.23
5494122-49412288.74589.27
6493589-49358988.64989.17
45min1500163-50016389.83090.570.9790.5091.240.98
2502342-50234290.22290.89
3512946-51294692.12692.82
4507107-50710791.07791.76
5501457-50145790.06390.73
6501599-50159990.08890.76
60min1504587-50458790.62591.221.0191.4492.051.01
2505151-50515190.72691.55
3517143-51714392.88093.72
4510655-51065591.71592.55
5505365-50536590.76491.59
6504491-50449190.60891.43
极限1505645-50564590.81591.511.0091.7992.491.00
2506271-50627190.92791.90
3518174-51817493.06594.06
4513375-51337592.20393.19
5506651-50665190.99591.97
6507115-50711591.07992.05
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%
1 112.45535055572065569185534915576975557630.38
2 114.15628595669135648860.51
单位质量响应值RSD%判断
4944.514950.800.09数据可信
供试品溶液-js2M批-pH6.8(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%
5min1357279-35727963.95165.552.0263.9565.552.03
2373632-37363266.87866.88
3357357-35735763.96563.96
4372177-37217766.61766.62
5365667-36566765.45265.45
6371156-37115666.43566.43
10min1426709-42670976.37877.451.5476.4877.561.54
2440611-44061178.86778.98
3424995-42499576.07276.18
4439069-43906978.59178.70
5429191-42919176.82376.93
6435654-43565477.97978.09
15min1455676-45567681.56382.771.6081.8083.011.60
2470326-47032684.18684.43
3453795-45379581.22781.46
4469737-46973784.08084.32
5458114-45811482.00082.24
6466793-46679383.55383.79
20min1470697-47069784.25285.781.6484.6286.161.64
2484719-48471986.76287.15
3471617-47161784.41784.79
4488480-48848087.43587.82
5474494-47449484.93285.31
6485373-48537386.87987.26
30min1487401-48740187.24288.381.6687.7588.901.66
2499936-49993689.48690.01
3484046-48404686.64187.15
4504272-50427290.26290.79
5488461-48846187.43287.95
6498429-49842989.21689.74
45min1498810-49881089.28490.041.5889.9490.711.58
2510315-51031591.34392.02
3492895-49289588.22588.88
4512298-51229891.69892.38
5496972-49697288.95589.62
6507071-50707190.76391.44
60min1502488-50248889.94290.771.5890.7591.591.58
2515682-51568292.30493.13
3498024-49802489.14389.94
4515743-51574392.31593.15
5499885-49988589.47690.29
6510968-51096891.46092.28
极限1504512-50451290.30591.111.4591.2692.081.46
2516476-51647692.44693.43
3500209-50020989.53490.48
4517191-51719192.57493.56
5502922-50292290.02090.98
6512838-51283891.79592.77
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