富马酸比索洛尔片项目信息
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100711-202203对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.8对照品水分(%)0对照品稀释倍数2000
标示量(mg)5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%
110.128339783516835508345883607835060.10
210.158375883276835170.41
单位质量响应值RSD%判断
8251.588228.280.20数据可信
供试品溶液-G01T78批-pH4.5
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min163047-6304768.72567.8117.3168.7367.8117.31
267589-6758973.67673.68
341531-4153145.27145.27
472436-7243678.96078.96
562205-6220567.80767.81
666419-6641972.40172.40
10min178112-7811285.14781.2113.4185.2681.3313.42
277148-7714884.09684.22
356175-5617561.23461.31
485857-8585793.58993.72
572226-7222678.73178.84
677505-7750584.48584.61
15min181773-8177389.13785.9711.2689.3986.2211.27
281001-8100188.29688.56
363021-6302168.69768.87
489676-8967697.75298.04
576319-7631983.19283.44
681422-8142288.75589.02
20min183331-8333190.83688.899.4091.2489.289.42
283799-8379991.34691.76
368283-6828374.43374.72
491241-9124199.45899.91
578549-7854985.62386.01
684073-8407391.64592.05
30min184816-8481692.45592.006.7193.0192.546.74
285528-8552893.23193.79
375603-7560382.41282.83
492469-92469100.797101.41
581177-8117788.48889.01
686806-8680694.62495.19
45min185803-8580393.53093.815.0794.2494.505.11
286348-8634894.12594.84
379834-7983487.02487.58
493076-93076101.458102.24
583818-8381891.36792.04
687473-8747395.35196.07
极限189148-8914897.177100.202.9598.04101.052.89
289280-8928097.32198.20
395286-95286103.867104.57
493960-93960102.422103.38
593738-93738102.180103.01
690112-9011298.22899.11
富马酸比索洛尔片项目信息
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100711-202203对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.8对照品水分(%)0对照品稀释倍数2000
标示量(mg)5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%
110.128344683376832338339883353833610.10
210.158354683497835220.05
单位质量响应值RSD%判断
8237.258228.770.08数据可信
供试品溶液-G01T78批-pH4.5
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min159295-5929564.68968.2615.7164.6968.2615.71
269805-6980576.15576.16
346416-4641650.63950.64
458235-5823563.53363.53
572080-7208078.63778.64
669595-6959575.92675.93
10min172549-7254979.14980.639.4779.2680.749.48
279724-7972486.97787.10
362639-6263968.33868.42
469526-6952675.85175.96
579942-7994287.21587.35
679059-7905986.25186.38
15min180002-8000287.28087.096.0187.5287.346.03
283686-8368691.29991.57
371925-7192578.46878.67
476478-7647883.43683.67
583837-8383791.46491.74
683047-8304790.60290.87
20min184053-8405391.70090.864.3892.0891.254.40
286289-8628994.13994.56
377363-7736384.40184.73
480436-8043687.75488.12
586550-8655094.42494.85
685004-8500492.73793.16
30min188257-8825796.28694.563.1996.8295.103.21
288996-8899697.09297.67
382146-8214689.61990.09
484804-8480492.51993.04
589161-8916197.27297.86
686684-8668494.57095.15
45min190438-9043898.66696.772.1799.3697.472.20
290371-9037198.59299.34
385552-8555293.33593.95
487737-8773795.71996.39
589923-8992398.10498.85
688175-8817596.19796.93
极限194083-94083102.642101.631.03103.51102.501.03
292910-92910101.362102.27
392182-92182100.568101.34
494339-94339102.921103.75
593400-93400101.897102.81
692037-92037100.410101.30
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