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%
1110.59351392986928329316193162931310.28
2112.19177491899918360.10
单位质量响应值RSD%判断
842.81819.232.01数据不可信!(响应值差异过大,请重新称样测定!)
供试品溶液-1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%
5min136242-3624238.63030.7925.8138.6330.8025.81
240007-4000742.64342.64
322647-2264724.13924.14
427270-2727029.06729.07
524730-2473026.35926.36
622452-2245223.93123.93
10min155288-5528858.93154.587.0759.0054.637.09
254788-5478858.39858.47
347386-4738650.50850.55
451413-5141354.80154.85
551723-5172355.13155.17
646614-4661449.68549.73
15min164834-6483469.10663.325.3569.2763.465.37
261114-6111465.14165.31
356628-5662860.35960.48
458435-5843562.28562.42
559053-5905362.94463.08
656367-5636760.08160.20
20min167853-6785372.32468.863.5672.6069.113.58
265850-6585070.18970.47
363004-6300467.15567.38
464193-6419368.42368.67
565436-6543669.74769.99
661307-6130765.34665.57
30min176713-7671381.76777.023.8582.1777.383.87
273008-7300877.81878.21
370184-7018474.80875.15
472751-7275177.54477.90
572341-7234177.10777.46
668564-6856473.08273.41
45min184548-8454890.11984.863.2790.6585.363.27
278426-7842683.59384.12
377736-7773682.85883.32
480193-8019385.47785.96
579156-7915684.37184.86
677647-7764782.76383.22
60min189494-8949495.39189.933.2996.0890.563.30
282519-8251987.95688.62
382323-8232387.74788.35
485388-8538891.01491.64
583953-8395389.48590.11
682553-8255387.99288.58
90min195216-95216101.49095.493.48102.3396.273.48
286686-8668692.39893.21
387849-8784993.63794.38
491024-9102497.02197.80
588811-8881194.66395.44
687915-8791593.70894.45
120min196137-96137102.47198.542.45103.4899.482.45
290296-9029696.24597.21
390915-9091596.90597.81
494249-94249100.459101.40
591446-9144697.47198.40
691658-9165897.69798.59
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195668-95668101.97199.551.89103.16100.661.89
291613-9161397.64998.77
392364-9236498.45099.51
495286-95286101.564102.67
591828-9182897.87898.97
693624-9362499.793100.85
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%
1110.59271792493923889226691919923570.32
2112.19258892502925450.07
单位质量响应值RSD%判断
835.81825.560.88数据可信
供试品溶液-2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%
5min134424-3442436.70144.649.7936.7044.649.79
241233-4123343.96143.96
346563-4656349.64349.64
442741-4274145.56845.57
544178-4417847.10047.10
642088-4208844.87244.87
10min155754-5575459.44263.244.3559.5063.324.36
257966-5796661.80061.87
360429-6042964.42664.51
461529-6152965.59965.68
562487-6248766.62166.70
657739-5773961.55861.63
15min162398-6239866.52671.064.0066.6971.244.00
265923-6592370.28470.46
369189-6918973.76673.96
467520-6752071.98672.17
569478-6947874.07474.26
665397-6539769.72369.90
20min166919-6691971.34676.563.9171.6276.863.91
270432-7043275.09175.38
374117-7411779.02079.33
472929-7292977.75378.06
574413-7441379.33579.65
672056-7205676.82377.12
30min174910-7491079.86584.223.0980.2684.643.10
278103-7810383.27083.69
381730-8173087.13687.58
478483-7848383.67584.11
581007-8100786.36686.81
679707-7970784.98085.40
45min181438-8143886.82591.143.3987.3591.703.39
284062-8406289.62390.18
388406-8840694.25494.84
483676-8367689.21189.79
586611-8661192.34092.93
688704-8870494.57295.14
60min184864-8486490.47894.983.4291.1595.703.41
288063-8806393.88894.60
392016-9201698.10398.85
486768-8676892.50893.23
590230-9023096.19996.94
692553-9255398.67599.40
90min189858-8985895.80299.103.1296.6299.973.11
292018-9201898.10598.97
395974-95974102.323103.23
490247-9024796.21797.09
592775-9277598.91299.82
696817-96817103.221104.11
120min193379-9337999.556100.862.44100.53101.902.43
292972-9297299.122100.15
397168-97168103.596104.68
492880-9288099.024100.06
593281-9328199.452100.52
697917-97917104.394105.45
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195223-95223101.522101.252.09102.67102.452.08
292907-9290799.053100.24
396738-96738103.137104.39
494154-94154100.382101.58
593017-9301799.170100.40
697744-97744104.210105.44
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