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%
1111.65173095140485139635186945211865170400.60
2110.15075795124465100120.68
单位质量响应值RSD%判断
4632.974632.260.02数据可信
供试品溶液-2025112021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%
5min1394532-39453276.34179.281.9676.3479.281.96
2410629-41062979.45679.46
3410112-41011279.35679.36
4410549-41054979.44079.44
5415255-41525580.35180.35
6417325-41732580.75180.75
10min1428673-42867382.94785.951.9183.0786.081.92
2448633-44863386.80986.94
3442337-44233785.59185.72
4444054-44405485.92386.06
5448598-44859886.80386.94
6452914-45291487.63887.77
15min1438364-43836484.82287.801.9085.0988.081.90
2455223-45522388.08588.36
3453533-45353387.75788.03
4453499-45349987.75188.03
5457345-45734588.49588.77
6464631-46463189.90590.19
20min1445520-44552086.20788.991.7386.6189.411.74
2462587-46258789.50989.93
3459252-45925288.86489.29
4461013-46101389.20589.63
5461227-46122789.24689.67
6469843-46984390.91391.34
30min1451196-45119687.30590.031.7487.8690.601.74
2465936-46593690.15790.73
3464603-46460389.90090.47
4465739-46573990.11990.69
5467936-46793690.54491.12
6476178-47617892.13992.72
45min1459786-45978688.96790.831.0689.6691.551.07
2471002-47100291.13891.86
3469515-46951590.85091.57
4471422-47142291.21991.94
5470725-47072591.08491.81
6474130-47413091.74392.48
60min1463194-46319489.62790.590.6890.4791.460.69
2471740-47174091.28192.16
3467623-46762390.48491.35
4468059-46805990.56891.44
5466983-46698390.36091.24
6471541-47154191.24292.13
极限1465202-46520290.01590.281.2191.0191.301.20
2471277-47127791.19192.22
3469951-46995190.93491.96
4469622-46962290.87191.89
5455916-45591688.21989.25
6467434-46743490.44791.49
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%
1111.65132525169855208495207035218975187370.70
2110.15127985147515137740.27
单位质量响应值RSD%判断
4648.184666.430.28数据可信
供试品溶液-2025112021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%
5min1402076-40207677.38977.112.1777.3977.112.17
2396497-39649776.31576.31
3410528-41052879.01579.02
4395710-39571076.16376.16
5410280-41028078.96878.97
6388762-38876274.82674.83
10min1431688-43168883.08882.522.2883.2282.652.28
2421568-42156881.14081.27
3439897-43989784.66884.80
4423320-42332081.47781.60
5439382-43938284.56984.70
6416563-41656380.17780.30
15min1437292-43729284.16783.312.3784.4383.582.37
2427536-42753682.28982.55
3447061-44706186.04786.32
4419363-41936380.71680.98
5439686-43968684.62784.90
6426183-42618382.02982.29
20min1437903-43790384.28484.541.9084.6984.941.91
2433643-43364383.46483.86
3450552-45055286.71987.14
4428383-42838382.45282.85
5447347-44734786.10286.52
6437409-43740984.18984.58
30min1441860-44186085.04685.251.8585.5985.801.85
2437762-43776284.25784.80
3455373-45537387.64788.21
4431453-43145383.04383.58
5447339-44733986.10086.66
6443754-44375485.41085.95
45min1443389-44338985.34081.0214.7686.0381.7114.65
2295533-29553356.88257.56
3456636-45663687.89088.60
4430249-43024982.81183.48
5452986-45298687.18787.89
6447015-44701586.03886.72
60min1439885-43988584.66685.871.4585.5086.691.46
2440433-44043384.77185.55
3455578-45557887.68688.54
4441875-44187585.04985.86
5447627-44762786.15687.00
6451426-45142686.88787.71
极限1445955-44595585.83485.891.4086.8186.851.41
2437450-43745084.19785.11
3456131-45613187.79388.79
4443012-44301285.26886.22
5448868-44886886.39587.38
6446020-44602085.84786.81
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