氢溴酸氟硫西汀口崩片项目信息
介质体积(ml)900取样体积(ml)0补液体积(ml)0
对照品批号D382/2305001对照品来源工作对照品对照品使用方法直接使用
对照品含量(%)99.83对照品水分(%)0对照品稀释倍数1000
标示量(mg)10供试品稀释倍数1系数0.7867
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
113.211691711692171689271688001684941689220.18
213.271688951689661689300.03
单位质量响应值RSD%判断
12787.4312730.220.32数据可信
影响因素30天-供试品溶液-2024051221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%
2min1111214-11121461.61259.753.8461.6159.753.84
2106921-10692159.23359.23
3112554-11255462.35462.35
4101263-10126356.09956.10
5105598-10559858.50158.50
6109570-10957060.70160.70
5min1171220-17122094.85592.841.5694.8592.841.55
2169243-16924393.75993.76
3165610-16561091.74791.75
4168979-16897993.61393.61
5165802-16580291.85391.85
6164619-16461991.19891.20
10min1179991-17999199.71498.941.6699.7198.941.65
2181648-181648100.632100.63
3173479-17347996.10696.11
4180779-180779100.150100.15
5177584-17758498.38098.38
6178094-17809498.66398.66
15min1181024-181024100.28699.041.98100.2999.041.98
2182389-182389101.042101.04
3173915-17391596.34896.35
4181916-181916100.780100.78
5177697-17769798.44398.44
6175726-17572697.35197.35
20min1180502-18050299.99799.061.96100.0099.061.96
2183000-183000101.381101.38
3174562-17456296.70696.71
4181790-181790100.710100.71
5177659-17765998.42298.42
6175316-17531697.12497.12
30min1185790-185790102.92699.712.48102.9399.712.49
2183741-183741101.791101.79
3174909-17490996.89896.90
4181700-181700100.661100.66
5178325-17832598.79198.79
6175475-17547597.21297.21
45min1182243-182243100.96199.502.09100.9699.502.09
2184093-184093101.986101.99
3174972-17497296.93396.93
4182172-182172100.922100.92
5178047-17804798.63798.64
6176078-17607897.54697.55
60min1182111-182111100.88899.182.23100.8999.182.23
2183716-183716101.777101.78
3174379-17437996.60596.60
4181728-181728100.676100.68
5177083-17708398.10398.10
6175136-17513697.02497.02
极限1181545-181545100.57599.442.03100.5799.442.03
2183988-183988101.928101.93
3174765-17476596.81996.82
4181973-181973100.812100.81
5178816-17881699.06399.06
6175933-17593397.46697.47
氢溴酸氟硫西汀口崩片项目信息
介质体积(ml)900取样体积(ml)0补液体积(ml)0
对照品批号D382/2305001对照品来源工作对照品对照品使用方法直接使用
对照品含量(%)99.83对照品水分(%)0对照品稀释倍数1000
标示量(mg)10供试品稀释倍数1系数0.7867
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
113.211690651691001690791692771689401690920.08
213.271689621690431690020.04
单位质量响应值RSD%判断
12800.3012735.640.36数据可信
影响因素30天-供试品溶液-2024051221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%
2min1123162-12316268.18265.102.8568.1865.102.85
2113420-11342062.78962.79
3117728-11772865.17465.17
4118929-11892965.83965.84
5117114-11711464.83464.83
6115209-11520963.77963.78
5min1171270-17127094.81594.170.9594.8194.170.95
2167598-16759892.78292.78
3171732-17173295.07095.07
4169312-16931293.73193.73
5169403-16940393.78193.78
6171341-17134194.85494.85
10min1177624-17762498.33297.570.4698.3397.570.46
2176217-17621797.55397.55
3175851-17585197.35197.35
4175460-17546097.13497.13
5175672-17567297.25197.25
6176685-17668597.81297.81
15min1178147-17814798.62297.400.9298.6297.400.92
2173566-17356696.08696.09
3175674-17567497.25397.25
4175243-17524397.01497.01
5175726-17572697.28197.28
6177316-17731698.16298.16
20min1180580-18058099.96997.721.3099.9797.721.30
2173772-17377296.20096.20
3176250-17625097.57197.57
4175574-17557497.19797.20
5175699-17569997.26697.27
6177213-17721398.10598.10
30min1178229-17822998.66797.520.8898.6797.520.88
2173833-17383396.23396.23
3175833-17583397.34197.34
4175464-17546497.13697.14
5176207-17620797.54897.55
6177428-17742898.22498.22
45min1178483-17848398.80897.450.9898.8197.450.98
2173227-17322795.89895.90
3176101-17610197.48997.49
4175949-17594997.40597.40
5175653-17565397.24197.24
6176808-17680897.88097.88
60min1178555-17855598.84797.901.0098.8597.901.00
2174508-17450896.60796.61
3175747-17574797.29397.29
4179164-17916499.18599.18
5176098-17609897.48797.49
6176969-17696997.96997.97
极限1177906-17790698.48897.431.0998.4997.431.09
2173705-17370596.16396.16
3177604-17760498.32198.32
4174607-17460796.66296.66
5174554-17455496.63396.63
6177613-17761398.32698.33
氢溴酸氟硫西汀口崩片项目信息
介质体积(ml)900取样体积(ml)0补液体积(ml)0
对照品批号D382/2305001对照品来源工作对照品对照品使用方法直接使用
对照品含量(%)99.83对照品水分(%)0对照品稀释倍数1000
标示量(mg)10供试品稀释倍数1系数0.7867
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
113.211688131687451686561687681687841687530.04
213.271689071691481690280.11
单位质量响应值RSD%判断
12774.6412737.600.21数据可信
影响因素30天-供试品溶液-2024051221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%
2min1124682-12468269.08763.6510.1069.0963.6410.10
2121967-12196767.58367.58
3108751-10875160.26060.26
4121489-12148967.31867.32
594069-9406952.12452.12
6118213-11821365.50365.50
5min1172076-17207695.34995.270.8695.3595.270.86
2173160-17316095.94995.95
3171354-17135494.94994.95
4171493-17149395.02695.03
5173844-17384496.32896.33
6169702-16970294.03394.03
10min1178451-17845198.88199.081.5298.8899.081.52
2180696-180696100.125100.13
3177358-17735898.27698.28
4177545-17754598.37998.38
5183202-183202101.514101.51
6175627-17562797.31697.32
15min1180106-18010699.79899.251.8599.8099.251.85
2180817-180817100.192100.19
3175634-17563497.32097.32
4178237-17823798.76398.76
5184219-184219102.077102.08
6175721-17572197.36997.37
20min1179045-17904599.21099.331.5599.2199.331.55
2180798-180798100.182100.18
3177778-17777898.50898.51
4178070-17807098.67098.67
5183910-183910101.906101.91
6175981-17598197.51397.51
30min1179116-17911699.25099.561.7099.2599.561.70
2181325-181325100.474100.47
3178200-17820098.74298.74
4178422-17842298.86598.87
5184848-184848102.426102.43
6176124-17612497.59297.59
45min1176731-17673197.92899.561.7597.9399.561.75
2181808-181808100.741100.74
3178401-17840198.85498.85
4178786-17878699.06799.07
5184953-184953102.484102.48
6177331-17733198.26198.26
60min1179019-17901999.19699.611.5599.2099.611.55
2181632-181632100.644100.64
3178555-17855598.93998.94
4178878-17887899.11899.12
5184240-184240102.089102.09
6176270-17627097.67397.67
极限1178839-17883999.09699.431.7099.1099.431.70
2181428-181428100.531100.53
3177826-17782698.53598.53
4178606-17860698.96798.97
5184333-184333102.141102.14
6175590-17559097.29697.30
氢溴酸氟硫西汀口崩片项目信息
介质体积(ml)900取样体积(ml)0补液体积(ml)0
对照品批号D382/2305001对照品来源工作对照品对照品使用方法直接使用
对照品含量(%)99.83对照品水分(%)0对照品稀释倍数1000
标示量(mg)10供试品稀释倍数1系数0.7867
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
113.211686881689501688041689081689931688690.08
213.271691551695441693500.17
单位质量响应值RSD%判断
12783.4212761.870.12数据可信
影响因素30天-供试品溶液-2763566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%
2min130914-3091417.10816.4017.6817.1116.4017.66
221224-2122411.74511.75
328581-2858115.81615.82
427885-2788515.43115.43
532210-3221017.82517.82
636975-3697520.46220.46
5min1110950-11095061.39963.7610.5761.4063.7610.57
292285-9228551.07051.07
3123056-12305668.09868.10
4124372-12437268.82668.83
5120314-12031466.58166.58
6120332-12033266.59166.59
10min1148527-14852782.19484.686.9282.1984.686.92
2133554-13355473.90873.91
3162348-16234889.84289.84
4158930-15893087.95087.95
5157237-15723787.01487.01
6157548-15754887.18687.19
15min1158882-15888287.92491.004.8487.9291.004.84
2151788-15178883.99884.00
3174619-17461996.63396.63
4167417-16741792.64792.65
5166863-16686392.34192.34
6167126-16712692.48692.49
20min1166141-16614191.94193.943.7291.9493.943.72
2160856-16085689.01689.02
3179975-17997599.59799.60
4171025-17102594.64494.64
5169956-16995694.05294.05
6170537-17053794.37494.37
30min1170005-17000594.07995.522.4394.0895.522.43
2167248-16724892.55492.55
3179713-17971399.45299.45
4172568-17256895.49895.50
5172286-17228695.34295.34
6173776-17377696.16696.17
45min1171808-17180895.07796.071.9995.0896.071.99
2170668-17066894.44694.45
3180086-18008699.65899.66
4174674-17467496.66396.66
5172652-17265295.54495.54
6171718-17171895.02795.03
60min1172763-17276395.60697.021.7095.6197.021.70
2172732-17273295.58895.59
3180751-180751100.026100.03
4174975-17497596.83096.83
5174525-17452596.58196.58
6176127-17612797.46797.47
极限1176763-17676397.81998.611.4797.8298.611.47
2177760-17776098.37198.37
3183371-183371101.476101.48
4176474-17647497.65997.66
5176811-17681197.84697.85
6177945-17794598.47398.47
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