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%
1121.95821105846245876825799015892045847040.66
2122.56024415978116001260.55
单位质量响应值RSD%判断
4796.594898.991.50数据可信
供试品溶液-2410100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%
5min1308441-30844156.35347.6519.1256.3547.6519.12
2246946-24694645.11745.12
3294723-29472353.84653.85
4306297-30629755.96155.96
5216837-21683739.61639.62
6191462-19146234.98034.98
10min1375631-37563168.62865.985.0468.7266.065.04
2384491-38449170.24770.32
3343376-34337662.73562.83
4349636-34963663.87963.97
5371238-37123867.82667.89
6342443-34244362.56562.62
15min1394188-39418872.01970.424.3072.2370.614.30
2395691-39569172.29372.49
3370002-37000267.60067.79
4372647-37264768.08368.28
5409351-40935174.78974.97
6370714-37071467.73067.89
20min1417953-41795376.36174.353.8276.6974.663.82
2417708-41770876.31676.63
3385442-38544270.42170.73
4400671-40067173.20373.52
5425019-42501977.65277.96
6394992-39499272.16672.44
30min1444607-44460781.23080.611.6481.6981.041.65
2449241-44924182.07782.52
3430093-43009378.57979.00
4441558-44155880.67381.11
5446388-44638881.55681.99
6435420-43542079.55279.95
45min1476692-47669287.09286.611.9587.6887.171.96
2480868-48086887.85588.43
3463806-46380684.73885.29
4473919-47391986.58687.16
5486069-48606988.80689.37
6462959-46295984.58385.11
60min1490335-49033589.58590.011.8790.3290.721.87
2502615-50261591.82992.55
3486355-48635588.85889.55
4491021-49102189.71090.42
5504511-50451192.17592.89
6481085-48108587.89588.56
90min1509515-50951593.08994.341.9293.9795.201.92
2529012-52901296.65197.53
3507554-50755492.73193.58
4517094-51709494.47495.34
5527582-52758296.39097.26
6507486-50748692.71993.53
极限1516115-51611594.29595.712.1295.3496.722.11
2533012-53301297.38298.42
3523071-52307195.56696.57
4516907-51690794.44095.46
5541139-54113998.86799.90
6512776-51277693.68594.66
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%
1121.95903655897455886835841845961485898250.73
2122.55976425969845973130.08
单位质量响应值RSD%判断
4838.604876.020.55数据可信
供试品溶液-2410100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%
5min1297696-29769654.27835.1131.9754.2835.1131.97
2169643-16964330.93030.93
3176577-17657732.19532.19
4196020-19602035.74035.74
5206008-20600837.56137.56
6109411-10941119.94819.95
10min1392812-39281271.62068.103.1171.7168.163.13
2375898-37589868.53668.59
3357794-35779465.23565.29
4376376-37637668.62368.68
5369114-36911467.29967.36
6368969-36896967.27367.31
15min1425887-42588777.65074.702.9377.8674.882.95
2413952-41395275.47475.64
3401740-40174073.24873.41
4411895-41189575.09975.27
5413950-41395075.47475.65
6390940-39094071.27871.42
20min1459134-45913483.71280.952.7684.0581.252.78
2448580-44858081.78882.08
3449094-44909481.88182.17
4444802-44480281.09981.40
5439796-43979680.18680.49
6422661-42266177.06277.33
30min1498252-49825290.84487.242.3891.3287.682.39
2476957-47695786.96287.39
3484679-48467988.36988.79
4471911-47191186.04286.48
5472041-47204186.06586.50
6467165-46716585.17685.57
45min1518611-51861194.55691.941.5895.1992.511.60
2499658-49965891.10191.67
3502206-50220691.56592.13
4499818-49981891.13091.71
5508028-50802892.62793.20
6497080-49708090.63191.17
60min1531035-53103596.82193.372.0297.6194.102.04
2511075-51107593.18293.91
3509746-50974692.94093.66
4503877-50387791.87092.60
5514687-51468793.84194.57
6502358-50235891.59392.28
90min1531475-53147596.90293.382.0497.8594.272.06
2509444-50944492.88593.76
3500801-50080191.30992.18
4508127-50812792.64593.53
5514692-51469293.84294.73
6508553-50855392.72293.56
极限1527783-52778396.22892.961.9197.3494.001.93
2500888-50088891.32592.36
3502165-50216591.55892.59
4510737-51073793.12194.16
5510976-51097693.16494.21
6506647-50664792.37593.37
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