氢溴酸伏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171336-202301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(%)99.9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%
114.191820871818941819321818371819841819470.06
214.301819131823131821130.16
单位质量响应值RSD%判断
12822.2012735.170.49数据可信
供试品溶液-2816279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%
2min130221-3022116.72817.6626.9316.7317.6626.92
233916-3391618.77318.77
333250-3325018.40518.40
425738-2573814.24714.25
546626-4662625.80925.81
621636-2163611.97611.98
5min1127664-12766470.66567.108.3070.6767.108.31
2113716-11371662.94462.94
3126937-12693770.26370.26
4132721-13272173.46473.46
5120622-12062266.76766.77
6105639-10563958.47458.47
10min1170984-17098494.64489.216.9894.6489.216.97
2151001-15100183.58383.58
3169174-16917493.64293.64
4173409-17340995.98695.99
5154405-15440585.46785.47
6148068-14806881.95981.96
15min1180715-180715100.03095.636.12100.0395.636.12
2163019-16301990.23590.23
3179534-17953499.37699.38
4186289-186289103.115103.12
5163415-16341590.45490.45
6163609-16360990.56190.56
20min1179753-17975399.49796.833.9699.5096.833.96
2168582-16858293.31493.31
3179966-17996699.61599.62
4183586-183586101.619101.62
5167846-16784692.90792.91
6169890-16989094.03894.04
30min1186318-186318103.13198.983.72103.1398.983.72
2173365-17336595.96295.96
3181949-181949100.713100.71
4185338-185338102.589102.59
5170321-17032194.27794.28
6175627-17562797.21497.21
45min1183336-183336101.48199.363.23101.4899.353.23
2175319-17531997.04397.04
3182944-182944101.264101.26
4186713-186713103.350103.35
5171341-17134194.84194.84
6177323-17732398.15298.15
60min1183517-183517101.581100.142.89101.58100.142.89
2176693-17669397.80497.80
3182240-182240100.874100.87
4186623-186623103.300103.30
5172595-17259595.53595.54
6183806-183806101.741101.74
极限1187298-187298103.674103.111.30103.67103.101.29
2183616-183616101.636101.64
3189082-189082104.661104.66
4187995-187995104.060104.06
5183133-183133101.368101.37
6186501-186501103.233103.23
氢溴酸伏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171336-202301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(%)99.9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%
114.191820351820511824251818241821881821050.13
214.301837841830171834000.30
单位质量响应值RSD%判断
12833.3312825.170.05数据可信
供试品溶液-2816279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%
2min133028-3302818.21014.3622.4718.2114.3522.48
225213-2521313.90113.90
328975-2897515.97515.97
430466-3046616.79716.80
520174-2017411.12311.12
618362-1836210.12410.12
5min1140527-14052777.47766.899.2677.4866.899.26
2107476-10747659.25559.26
3126588-12658869.79269.79
4117763-11776364.92764.93
5119320-11932065.78565.79
6116240-11624064.08764.09
10min1176584-17658497.35791.804.5397.3691.804.53
2156605-15660586.34286.34
3167349-16734992.26592.27
4158760-15876087.53087.53
5169463-16946393.43193.43
6170288-17028893.88693.89
15min1182980-182980100.88397.873.05100.8897.863.05
2169991-16999193.72293.72
3177605-17760597.92097.92
4171952-17195294.80394.80
5181613-181613100.130100.13
6180908-18090899.74199.74
20min1184569-184569101.75998.184.13101.7698.184.13
2177248-17724897.72397.72
3182474-182474100.604100.60
4176053-17605397.06497.06
5164811-16481190.86690.87
6183333-183333101.078101.08
30min1185235-185235102.127101.161.41102.13101.161.40
2180709-18070999.63199.63
3183693-183693101.276101.28
4180143-18014399.31999.32
5186664-186664102.914102.91
6184439-184439101.688101.69
45min1185565-185565102.309101.791.14102.31101.801.14
2181535-181535100.087100.09
3183643-183643101.249101.25
4183924-183924101.404101.40
5187702-187702103.487103.49
6185428-185428102.233102.23
60min1185700-185700102.383102.311.21102.38102.311.21
2182536-182536100.639100.64
3184987-184987101.990101.99
4184426-184426101.681101.68
5189222-189222104.325104.32
6186544-186544102.848102.85
极限1186347-186347102.740101.804.61102.74101.804.61
2186299-186299102.713102.71
3187101-187101103.155103.16
4191770-191770105.730105.73
5167793-16779392.51092.51
6188542-188542103.950103.95
氢溴酸伏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171336-202301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(%)99.9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%
114.191841241843071845691834031843221841450.25
214.301832281824941828610.29
单位质量响应值RSD%判断
12977.1012787.481.05数据可信
供试品溶液-2816279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%
2min151014-5101428.01233.0814.7528.0133.0814.75
265724-6572436.08936.09
349929-4992927.41627.42
457262-5726231.44231.44
571828-7182839.44039.44
665692-6569236.07136.07
5min1124887-12488768.57568.907.3668.5768.907.36
2124754-12475468.50268.50
3121395-12139566.65766.66
4131922-13192272.43872.44
5138507-13850776.05476.05
6111422-11142261.18161.18
10min1150870-15087082.84282.854.8982.8482.844.88
2149782-14978282.24582.24
3143523-14352378.80878.81
4160914-16091488.35788.36
5157632-15763286.55586.55
6142535-14253578.26578.27
15min1160517-16051788.13988.414.0888.1488.414.08
2160121-16012187.92287.92
3153069-15306984.04984.05
4172074-17207494.48594.49
5163869-16386989.98089.98
6156434-15643485.89785.90
20min1165064-16506490.63690.933.7790.6490.933.77
2164763-16476390.47190.47
3157953-15795386.73186.73
4176634-17663496.98996.99
5166897-16689791.64291.64
6162243-16224389.08789.09
30min1163605-16360589.83592.323.8489.8392.323.85
2165808-16580891.04491.04
3162179-16217989.05289.05
4179856-17985698.75898.76
5170794-17079493.78293.78
6166576-16657691.46691.47
45min1172922-17292294.95194.823.0094.9594.823.00
2169298-16929892.96192.96
3166728-16672891.55091.55
4181275-18127599.53799.54
5175487-17548796.35996.36
6170414-17041493.57493.57
60min1172504-17250494.72196.443.5594.7296.443.55
2174601-17460195.87395.87
3167893-16789392.18992.19
4186318-186318102.306102.31
5178216-17821697.85897.86
6174305-17430595.71095.71
极限1195344-195344107.262108.710.82107.26108.720.83
2196781-196781108.051108.05
3199306-199306109.438109.44
4198108-198108108.780108.78
5199192-199192109.375109.38
6199195-199195109.377109.38
氢溴酸伏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171336-202301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(%)99.9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%
114.191830681832011831911824401831521830100.18
214.301841291837881839580.14
单位质量响应值RSD%判断
12897.1112864.200.19数据可信
供试品溶液-2816279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%
2min156757-5675731.16727.0913.1331.1727.0913.13
250027-5002727.47227.47
357015-5701531.30931.31
444258-4425824.30424.30
541549-4154922.81622.82
646397-4639725.47825.48
5min1150312-15031282.54269.0012.3182.5469.0012.31
2118683-11868365.17365.17
3137772-13777275.65675.66
4114383-11438362.81262.81
5109549-10954960.15760.16
6123262-12326267.68867.69
10min1175199-17519996.20886.597.5896.2186.597.58
2155001-15500185.11785.12
3168309-16830992.42592.42
4148168-14816881.36481.36
5143876-14387679.00879.01
6155557-15555785.42285.42
15min1177502-17750297.47389.797.1797.4789.797.17
2168983-16898392.79592.79
3174770-17477095.97395.97
4155678-15567885.48885.49
5154486-15448684.83484.83
6149675-14967582.19282.19
20min1183705-183705100.87991.877.74100.8891.877.74
2172967-17296794.98294.98
3179280-17928098.44998.45
4155166-15516685.20785.21
5157743-15774386.62286.62
6154929-15492985.07785.08
30min1167898-16789892.19994.012.6392.2094.012.63
2178168-17816897.83897.84
3170544-17054493.65293.65
4171402-17140294.12394.12
5165375-16537590.81390.81
6173826-17382695.45495.45
45min1187273-187273102.83895.064.48102.8495.064.48
2164466-16446690.31490.31
3174890-17489096.03896.04
4169286-16928692.96192.96
5172122-17212294.51894.52
6170638-17063893.70393.70
60min1190520-190520104.62198.363.84104.6298.363.84
2175734-17573496.50296.50
3184106-184106101.099101.10
4173812-17381295.44695.45
5172824-17282494.90494.90
6177719-17771997.59297.59
极限1193122-193122106.050102.823.92106.05102.823.92
2192084-192084105.480105.48
3188540-188540103.534103.53
4179887-17988798.78298.78
5176418-17641896.87796.88
6193395-193395106.200106.20
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