盐酸氟西汀胶囊项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号100513-202203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1000
标示量(mg)20供试品稀释倍数2系数0.8946
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.725177695185625177305176845177435178980.08
211.725187655179775183710.11
单位质量响应值RSD%判断
44189.2544229.610.07数据可信
供试品溶液-2022042701批-pH1.0
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min1353771-35377164.30062.2314.4364.3062.2314.43
2414656-41465675.36675.37
3334957-33495760.88060.88
4300553-30055354.62754.63
5278035-27803550.53450.53
6372222-37222267.65367.65
10min1511999-51199993.05996.212.0493.7796.902.06
2545620-54562099.169100.01
3527729-52772995.91896.59
4530672-53067296.45297.06
5532107-53210796.71397.27
6527941-52794195.95696.71
15min1513743-51374393.37696.273.2795.1298.043.24
2548904-54890499.766101.71
3524292-52429295.29397.04
4510734-51073492.82994.51
5551638-551638100.263101.90
6528807-52880796.11397.93
20min1513244-51324493.28596.553.7296.0799.383.68
2557091-557091101.254104.30
3531408-53140896.58699.39
4510457-51045792.77895.49
5552409-552409100.403103.15
6522738-52273895.01097.90
30min1506107-50610791.98895.613.7495.8199.513.70
2551284-551284100.199104.37
3528672-52867296.08999.96
4507543-50754392.24995.99
5546948-54694899.411103.28
6515533-51553393.70197.64
盐酸氟西汀胶囊项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号100513-202203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1000
标示量(mg)20供试品稀释倍数2系数0.8946
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.725181395177255178795176165177515178220.04
211.725168845173445171140.07
单位质量响应值RSD%判断
44182.7644122.350.10数据可信
供试品溶液-2022042801批-pH1.0
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min1376288-37628868.48073.216.0768.4873.216.07
2406062-40606273.89973.90
3447879-44787981.50981.51
4398641-39864172.54872.55
5392866-39286671.49771.50
6391957-39195771.33271.33
10min1494895-49489590.06695.776.0390.8396.586.02
2542741-54274198.77399.59
3560391-560391101.985102.89
4555831-555831101.155101.96
5485458-48545888.34889.14
6518076-51807694.28495.08
15min1484072-48407288.09695.636.4689.8697.516.43
2540696-54069698.401100.32
3550928-550928100.263102.30
4564517-564517102.736104.67
5485184-48518488.29890.07
6527569-52756996.01297.85
20min1503456-50345691.62495.605.5794.3698.545.57
2546208-54620899.404102.42
3562369-562369102.345105.50
4534242-53424297.226100.30
5481677-48167787.66090.42
6523828-52382895.33198.24
30min1512702-51270293.30697.195.1197.06101.195.11
2546956-54695699.540103.66
3554976-554976101.000105.29
4567469-567469103.273107.43
5495634-49563490.20093.93
6526497-52649795.81799.78
盐酸氟西汀胶囊项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号100513-202203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1000
标示量(mg)20供试品稀释倍数2系数0.8946
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.725148455151845149675145785147965148740.05
211.725184255182745183500.03
单位质量响应值RSD%判断
43931.2344227.820.48数据可信
供试品溶液-2022050701批-pH1.0
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min1298197-29819754.35961.587.1054.3661.577.10
2333814-33381460.85260.85
3363112-36311266.19366.19
4332238-33223860.56560.56
5362613-36261366.10266.10
6336714-33671461.38161.38
10min1498014-49801490.78490.773.6091.3991.463.59
2468361-46836185.37986.06
3490204-49020489.36190.10
4505630-50563092.17392.85
5522059-52205995.16895.90
6503386-50338691.76492.45
15min1506592-50659292.34891.482.1893.9693.172.18
2480385-48038587.57189.20
3500941-50094191.31893.05
4505087-50508792.07493.77
5509417-50941792.86394.66
6508495-50849592.69594.40
20min1517314-51731494.30392.301.5296.9495.011.49
2500535-50053591.24493.84
3497394-49739490.67193.41
4504712-50471292.00594.73
5513752-51375293.65396.48
6504380-50438091.94594.68
30min1502081-50208191.52692.001.5495.2195.731.54
2497889-49788990.76294.37
3496496-49649690.50894.26
4503759-50375991.83295.57
5511505-51150593.24497.11
6516283-51628394.11597.87
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