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
2110.15070405147515108961.07
单位质量响应值RSD%判断
4648.184640.290.13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%
5min1402076-40207677.60677.332.1777.6177.332.17
2396497-39649776.52976.53
3410528-41052879.23779.24
4395710-39571076.37776.38
5410280-41028079.19079.19
6388762-38876275.03675.04
10min1431688-43168883.32282.752.2883.4582.882.28
2421568-42156881.36881.50
3439897-43989784.90685.04
4423320-42332081.70781.83
5439382-43938284.80784.94
6416563-41656380.40280.53
15min1437292-43729284.40383.552.3784.6783.812.36
2427536-42753682.52082.78
3447061-44706186.28986.56
4419363-41936380.94381.21
5439686-43968684.86585.14
6426183-42618382.25982.52
20min1437903-43790384.52184.771.9084.9385.181.91
2433643-43364383.69984.10
3450552-45055286.96387.38
4428383-42838382.68483.08
5447347-44734786.34486.76
6437409-43740984.42684.82
30min1441860-44186085.28585.491.8585.8386.041.85
2437762-43776284.49485.03
3455373-45537387.89388.46
4431453-43145383.27683.81
5447339-44733986.34386.90
6443754-44375485.65186.19
45min1443389-44338985.58081.2514.7686.2781.9414.65
2295533-29553357.04257.72
3456636-45663688.13788.85
4430249-43024983.04483.72
5452986-45298687.43288.14
6447015-44701586.28086.96
60min1439885-43988584.90486.111.4585.7486.941.46
2440433-44043385.01085.79
3455578-45557887.93388.79
4441875-44187585.28886.10
5447627-44762786.39887.25
6451426-45142687.13187.95
极限1445955-44595586.07586.131.4087.0587.101.41
2437450-43745084.43485.35
3456131-45613188.03989.04
4443012-44301285.50786.46
5448868-44886886.63887.63
6446020-44602086.08887.06
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