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%
1113.08807188032880598794987922880070.08
2113.08493985032849860.08
单位质量响应值RSD%判断
778.82752.092.47数据不可信!(响应值差异过大,请重新称样测定!)
供试品溶液-25051301批-pH6.8(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%
5min138917-3891745.03942.9915.2745.0442.9915.27
233477-3347738.74338.74
331376-3137636.31236.31
437386-3738643.26743.27
547312-4731254.75554.75
634418-3441839.83239.83
10min151451-5145159.54559.685.1359.6259.765.14
250435-5043558.36958.43
347356-4735654.80654.87
454345-5434562.89462.97
554423-5442362.98463.08
651407-5140759.49459.56
15min158904-5890468.17068.474.5668.3468.644.58
258850-5885068.10868.27
354748-5474863.36063.51
459987-5998769.42469.60
563166-6316673.10373.30
659316-5931668.64768.81
20min162799-6279972.67873.403.8272.9773.693.83
262490-6249072.32072.60
360154-6015469.61769.87
464318-6431874.43674.73
567486-6748678.10278.42
663298-6329873.25573.54
30min169555-6955580.49781.423.6480.9181.833.65
269649-6964980.60681.00
366517-6651776.98177.35
472285-7228583.65684.07
573969-7396985.60586.05
670145-7014581.18081.58
45min176131-7613188.10789.233.0088.6589.773.01
276515-7651588.55289.08
373649-7364985.23585.74
479075-7907591.51492.07
580197-8019792.81393.40
677044-7704489.16489.70
60min179873-7987392.43893.962.9893.1394.653.00
280581-8058193.25793.94
377692-7769289.91490.56
483631-8363196.78797.50
584180-8418097.42298.17
681170-8117093.93994.62
90min183609-8360996.76298.482.6097.6199.332.61
284287-8428797.54698.38
382509-8250995.48996.28
487811-87811101.625102.49
587768-87768101.575102.48
684597-8459797.90598.75
极限184785-8478598.12399.892.6999.13100.902.69
285996-8599699.524100.52
383344-8334496.45597.41
489177-89177103.205104.24
588935-88935102.925104.00
685644-8564499.117100.12
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%
1113.08475284616845778452784452845850.14
2113.08373783745837410.01
单位质量响应值RSD%判断
748.54741.070.71数据可信
供试品溶液-25051302批-pH6.8(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%
5min117194-1719420.44540.4025.6620.4440.4025.67
235357-3535742.04242.04
342769-4276950.85550.86
434657-3465741.20941.21
537635-3763544.75044.75
636269-3626943.12643.13
10min146715-4671555.54758.967.2455.5859.037.24
255078-5507865.49165.56
352917-5291762.92263.01
446272-4627255.02055.09
548678-4867857.88157.96
647865-4786556.91556.99
15min155150-5515065.57766.475.6465.7066.645.64
261288-6128872.87573.05
357495-5749568.36568.55
452182-5218262.04862.21
554094-5409464.32164.49
655206-5520665.64465.81
20min158226-5822669.23570.734.1969.4771.014.20
263584-6358475.60675.91
360990-6099072.52172.82
456433-5643367.10367.37
559170-5917070.35770.64
658515-5851569.57869.85
30min166264-6626478.79279.072.3979.1479.462.40
269153-6915382.22782.65
367542-6754280.31280.74
465135-6513577.45077.83
565049-6504977.34877.74
665836-6583678.28378.68
45min172177-7217785.82386.541.8786.3187.061.89
274487-7448788.57089.13
374443-7444388.51889.08
471739-7173985.30285.81
571390-7139084.88785.41
672420-7242086.11286.63
60min175654-7565489.95890.901.4290.5891.571.44
277367-7736791.99492.71
378008-7800892.75793.46
476014-7601490.38691.03
575129-7512989.33390.00
676508-7650890.97391.64
90min180020-8002095.14996.611.6795.9297.431.68
282383-8238397.95998.82
382967-8296798.65399.51
481524-8152496.93797.73
579441-7944194.46195.28
681163-8116396.50897.33
极限182314-8231497.87798.921.6098.8199.901.62
285116-85116101.208102.24
383867-8386799.723100.75
483633-8363399.445100.40
581282-8128296.65097.62
682914-8291498.59099.57
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