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%
1110.55326275321985311655309275310445315920.15
2112.85369075372515370790.05
单位质量响应值RSD%判断
4810.794761.340.74数据可信
供试品溶液-4YG05N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%
5min1393898-39389873.77774.981.4973.7874.981.49
2405050-40505075.86575.87
3396587-39658774.28074.28
4394429-39442973.87673.88
5405272-40527275.90775.91
6406580-40658076.15276.15
10min1432944-43294481.09082.441.2381.2182.561.23
2442152-44215282.81582.94
3439111-43911182.24582.37
4435208-43520881.51481.64
5444544-44454483.26383.39
6446890-44689083.70283.83
15min1457924-45792485.76986.761.0986.0387.021.09
2463763-46376386.86287.13
3461292-46129286.39986.66
4459086-45908685.98686.25
5465281-46528187.14787.41
6471810-47181088.36988.64
20min1470557-47055788.13589.121.0288.5489.521.02
2477992-47799289.52789.94
3474280-47428088.83289.24
4470513-47051388.12788.53
5479021-47902189.72090.13
6482390-48239090.35190.76
30min1484923-48492390.82691.691.1291.3792.251.12
2491626-49162692.08192.64
3486629-48662991.14591.70
4483440-48344090.54891.10
5493167-49316792.37092.93
6497580-49758093.19693.76
45min1492876-49287692.31593.150.9793.0193.860.97
2500081-50008193.66594.38
3495693-49569392.84393.55
4491458-49145892.05092.75
5500241-50024193.69594.41
6503752-50375294.35295.07
60min1495982-49598292.89793.690.9293.7594.550.92
2503302-50330294.26895.14
3498960-49896093.45594.31
4494395-49439592.60093.45
5502169-50216994.05694.93
6506399-50639994.84895.72
极限1498285-49828593.32894.101.1394.3495.121.13
2506372-50637294.84395.87
3501178-50117893.87094.89
4494366-49436692.59493.60
5504453-50445394.48395.51
6509923-50992395.50896.54
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%
1110.55442195439885443995439145440025441040.04
2112.85666485674365670420.10
单位质量响应值RSD%判断
4924.025026.971.47数据可信
供试品溶液-4YG05N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%
5min1397190-39719071.56773.611.5971.5773.611.59
2414148-41414874.62274.62
3410096-41009673.89273.89
4408315-40831573.57173.57
5406354-40635473.21873.22
6415110-41511074.79574.80
10min1442665-44266579.76081.461.0679.8881.581.06
2455896-45589682.14482.27
3453875-45387581.78081.90
4452538-45253881.53981.66
5452686-45268681.56681.69
6454836-45483681.95382.08
15min1464895-46489583.76685.661.1584.0285.921.15
2477171-47717185.97886.24
3480134-48013486.51286.77
4476463-47646385.85086.11
5475073-47507385.60085.86
6478652-47865286.24586.51
20min1478539-47853986.22487.991.0486.6288.391.03
2490249-49024988.33488.74
3492542-49254288.74789.15
4489265-48926588.15788.56
5488181-48818187.96288.36
6491279-49127988.52088.92
30min1490051-49005188.29990.171.1188.8390.721.11
2501337-50133790.33290.88
3504935-50493590.98091.53
4501387-50138790.34190.89
5499726-49972690.04290.59
6505232-50523291.03491.59
45min1496523-49652389.46591.551.2190.1592.241.21
2513522-51352292.52893.23
3512361-51236192.31893.02
4507895-50789591.51492.21
5507825-50782591.50192.20
6510345-51034591.95592.66
60min1498735-49873589.86391.911.1990.7092.761.18
2510457-51045791.97592.83
3515481-51548192.88193.74
4511110-51111092.09392.94
5509797-50979791.85692.71
6514830-51483092.76393.62
极限1502588-50258890.55792.381.0991.5493.391.09
2513531-51353192.52993.54
3518845-51884593.48794.50
4512928-51292892.42193.43
5512014-51201492.25693.26
6516449-51644993.05594.07
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