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%
1110.05225025218415217645243325231695227220.21
2111.25259995262825261400.04
单位质量响应值RSD%判断
4752.024731.470.31数据可信
供试品溶液-4YG05N批-pH4.0(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%
5min1372791-37279169.62570.471.3869.6370.481.38
2376433-37643370.30570.31
3380866-38086671.13371.13
4370283-37028369.15769.16
5379486-37948670.87670.88
6384164-38416471.74971.75
10min1406639-40663975.94777.021.1376.0677.141.13
2410617-41061776.69076.81
3415711-41571177.64177.76
4408048-40804876.21076.33
5418246-41824678.11578.23
6415192-41519277.54477.66
15min1428294-42829479.99181.261.2180.2381.501.21
2432770-43277080.82781.07
3439325-43932582.05282.30
4430384-43038480.38280.62
5440612-44061282.29282.54
6439055-43905582.00182.25
20min1444500-44450083.01883.940.9783.3984.320.97
2445925-44592583.28483.66
3451556-45155684.33684.72
4446663-44666383.42283.80
5452708-45270884.55184.94
6455245-45524585.02585.41
30min1460440-46044085.99587.291.2186.5187.811.21
2465954-46595487.02587.54
3472862-47286288.31588.84
4461197-46119786.13786.65
5471551-47155188.07088.60
6472225-47222588.19688.72
45min1471574-47157488.07589.921.2988.7390.581.29
2478962-47896289.45590.12
3486110-48611090.79091.46
4478512-47851289.37090.03
5485888-48588890.74891.42
6487667-48766791.08091.75
60min1480742-48074289.78791.361.0790.5992.181.07
2487906-48790691.12591.94
3493146-49314692.10492.93
4486175-48617590.80291.61
5492890-49289092.05692.88
6494076-49407692.27793.10
90min1489412-48941291.40693.071.0692.3694.031.06
2498197-49819793.04794.01
3502739-50273993.89594.87
4495112-49511292.47193.43
5502338-50233893.82094.80
6501986-50198693.75594.73
120min1490200-49020091.55393.781.3292.6694.901.32
2502644-50264493.87895.00
3506379-50637994.57595.71
4499302-49930293.25394.37
5507684-50768494.81995.95
6506449-50644994.58895.72
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
极限1500440-50044093.46695.090.9894.7296.370.98
2509853-50985395.22496.50
3514085-51408596.01497.31
4506603-50660394.61795.89
5512110-51211095.64696.94
6511617-51161795.55396.85
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%
1110.05327115341965328545327795334165331910.12
2111.25278065277465277760.01
单位质量响应值RSD%判断
4847.194746.191.49数据可信
供试品溶液-4YG05N批-pH4.0(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%
5min1368053-36805367.96069.972.2467.9669.972.24
2386814-38681471.42471.42
3378642-37864269.91569.92
4374882-37488269.22169.22
5374485-37448569.14869.15
6390851-39085172.17072.17
10min1405084-40508474.79876.041.8474.9176.161.84
2419361-41936177.43477.55
3404427-40442774.67774.79
4409592-40959275.63075.75
5409699-40969975.65075.77
6422759-42275978.06278.18
15min1427724-42772478.97880.041.4479.2280.281.44
2439667-43966781.18481.43
3427851-42785179.00279.24
4430133-43013379.42379.66
5433135-43313579.97780.22
6442429-44242981.69481.94
20min1443094-44309481.81682.821.5882.1983.201.57
2456548-45654884.30184.68
3440010-44001081.24781.62
4445515-44551582.26382.64
5448999-44899982.90783.28
6457052-45705284.39484.78
30min1459722-45972284.88786.041.5185.3986.561.51
2475554-47555487.81088.33
3459093-45909384.77185.28
4462328-46232885.36885.88
5465793-46579386.00886.52
6473359-47335987.40587.93
45min1473314-47331487.39688.861.6388.0489.521.63
2491106-49110690.68291.35
3473204-47320487.37688.03
4479804-47980488.59589.25
5480081-48008188.64689.30
6490065-49006590.48991.16
60min1484495-48449589.46190.701.7690.2591.501.76
2498817-49881792.10592.93
3483316-48331689.24390.04
4486121-48612189.76190.56
5489916-48991690.46291.27
6504513-50451393.15793.98
90min1498476-49847692.04392.521.3492.9893.481.34
2506826-50682693.58494.56
3495977-49597791.58192.52
4494879-49487991.37892.33
5498514-49851492.05093.00
6511686-51168694.48295.46
120min1502651-50265192.81393.341.2093.9194.451.20
2510504-51050494.26395.39
3502828-50282892.84693.94
4498911-49891192.12393.23
5503016-50301692.88193.99
6515138-51513895.11996.26
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
极限1506729-50672993.56694.321.2794.8295.601.27
2517353-51735395.52896.82
3505363-50536393.31494.57
4506764-50676493.57394.83
5508172-50817293.83395.10
6520625-52062596.13297.43
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