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)1.5补液体积(ml)0
对照品批号382/2305001对照品来源工作对照品能对照品使用方法直接使用
对照品含量(%)100.4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%
114.221790391789011784611791001778721786750.29
214.201789261781731785500.30
单位质量响应值RSD%判断
12565.0512573.940.06数据可信
供试品溶液-2批-pH6.8
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min184905-8490548.01851.134.6048.0251.134.60
290767-9076751.33351.33
392897-9289752.53752.54
488064-8806449.80449.80
596878-9687854.78954.79
688938-8893850.29850.30
10min1113239-11323964.04267.423.1764.1267.503.17
2118144-11814466.81666.90
3119298-11929867.46867.56
4120385-12038568.08368.17
5124958-12495870.66970.76
6119237-11923767.43467.52
15min1121225-12122568.55872.603.7768.7572.803.76
2127896-12789672.33172.53
3130247-13024773.66173.86
4127577-12757772.15172.35
5136102-13610276.97277.18
6127193-12719371.93372.13
20min1130709-13070973.92276.262.8474.2276.582.84
2133654-13365475.58775.90
3134918-13491876.30276.63
4134006-13400675.78676.10
5142081-14208180.35380.69
6133693-13369375.60975.93
30min1136723-13672377.32379.802.9377.7580.242.93
2139608-13960878.95579.40
3142435-14243580.55381.00
4139983-13998379.16779.61
5148653-14865384.07084.54
6139166-13916678.70579.15
45min1141293-14129379.90882.663.1980.4683.243.19
2145890-14589082.50783.08
3149365-14936584.47385.06
4142902-14290280.81881.39
5153766-15376686.96287.57
6143767-14376781.30781.88
60min1145436-14543682.25185.003.4082.9485.723.39
2150132-15013284.90685.62
3151494-15149485.67786.40
4149987-14998784.82485.53
5159319-15931990.10290.86
6145453-14545382.26082.97
极限1151417-15141785.63387.762.4386.4688.622.43
2154946-15494687.62988.48
3157748-15774889.21490.08
4153175-15317586.62787.48
5161374-16137491.26492.17
6152453-15245386.21987.07
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)1.5补液体积(ml)0
对照品批号382/2305001对照品来源工作对照品能对照品使用方法直接使用
对照品含量(%)100.4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%
114.221783851798331801911795341794601794810.38
214.201781601774871778240.27
单位质量响应值RSD%判断
12621.7312522.820.56数据可信
供试品溶液-24022601批-pH6.8
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min180423-8042345.47447.974.1445.4747.974.15
281667-8166746.17746.18
387538-8753849.49749.50
483413-8341347.16447.16
589205-8920550.43950.44
686771-8677149.06349.06
10min1119811-11981167.74568.862.0867.8268.942.09
2120086-12008667.90067.98
3124615-12461570.46170.54
4120661-12066168.22568.30
5125429-12542970.92171.01
6120131-12013167.92668.01
15min1132545-13254574.94575.881.6675.1376.081.66
2132090-13209074.68874.88
3135851-13585176.81477.01
4133329-13332975.38875.58
5137872-13787277.95778.16
6133513-13351375.49275.69
20min1139173-13917378.69279.691.8679.0180.001.86
2139257-13925778.74079.05
3143479-14347981.12781.46
4140171-14017179.25779.57
5144900-14490081.93182.26
6138592-13859278.36478.68
30min1145286-14528682.14983.821.8382.5984.271.83
2145481-14548182.25982.71
3151109-15110985.44185.90
4148098-14809883.73984.19
5151679-15167985.76486.23
6147750-14775083.54283.99
45min1153161-15316186.60287.101.7487.1887.691.74
2151563-15156385.69886.28
3157959-15795989.31589.92
4153109-15310986.57287.16
5156736-15673688.62389.23
6151741-15174185.79986.39
60min1156965-15696588.75389.411.7789.4890.151.77
2154628-15462887.43188.16
3161338-16133891.22591.98
4156800-15680088.65989.39
5161705-16170591.43392.19
6157340-15734088.96589.70
极限1155860-15586088.12889.582.4489.0090.472.44
2154243-15424387.21488.08
3163440-16344092.41493.32
4156936-15693688.73689.62
5163049-16304992.19393.10
6157081-15708188.81889.70
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)1.5补液体积(ml)0
对照品批号382/2305001对照品来源工作对照品能对照品使用方法直接使用
对照品含量(%)100.4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%
114.221793421805391795021797721790111796330.33
214.201798131793941796040.17
单位质量响应值RSD%判断
12632.4212648.170.09数据可信
供试品溶液-24021602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%
5min1168684-16868494.86495.461.4294.8695.461.42
2169703-16970395.43795.44
3173110-17311097.35397.35
4172053-17205396.75996.76
5168040-16804094.50294.50
6166869-16686993.84393.84
10min1178576-178576100.427101.381.58100.59101.541.58
2180597-180597101.564101.72
3184561-184561103.793103.96
4180379-180379101.441101.60
5181472-181472102.056102.21
6176069-17606999.01799.17
15min1176064-17606499.015100.981.8699.34101.311.86
2181739-181739102.206102.53
3184544-184544103.783104.12
4180007-180007101.232101.56
5179060-179060100.699101.03
6175938-17593898.94499.27
20min1176304-17630499.150101.322.2799.64101.812.26
2181623-181623102.141102.64
3186429-186429104.844105.35
4179745-179745101.085101.58
5181636-181636102.148102.64
6175206-17520698.53299.02
30min1176779-17677999.417101.821.92100.07102.491.92
2183116-183116102.980103.65
3185377-185377104.252104.93
4180724-180724101.635102.30
5183136-183136102.992103.66
6177220-17722099.665100.32
45min1177044-17704499.566102.122.37100.39102.962.36
2185095-185095104.093104.93
3186883-186883105.099105.96
4178575-178575100.427101.26
5184203-184203103.592104.43
6177707-17770799.939100.76
60min1178993-178993100.662102.501.88101.65103.511.87
2185326-185326104.223105.24
3186372-186372104.812105.84
4180912-180912101.741102.75
5183860-183860103.399104.41
6178158-178158100.192101.18
极限1178134-178134100.179102.312.08101.33103.482.07
2184492-184492103.754104.94
3186954-186954105.139106.35
4179783-179783101.106102.28
5184149-184149103.561104.74
6178022-178022100.116101.27
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