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%
114.501864451865121865521864381866941865280.06
214.521869761867621868690.09
单位质量响应值RSD%判断
12864.0012869.770.04数据可信
供试品溶液-24050602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%
2min156105-5610530.82129.087.4830.8229.087.48
252119-5211928.63128.63
349652-4965227.27627.28
458613-5861332.19832.20
553131-5313129.18729.19
647991-4799126.36326.36
5min1108435-10843559.56757.582.4059.5757.582.40
2102754-10275456.44756.45
3104544-10454457.43057.43
4102992-10299256.57756.58
5107396-10739658.99759.00
6102795-10279556.46956.47
10min1129327-12932771.04468.851.7871.0468.851.78
2125209-12520968.78268.78
3123197-12319767.67767.68
4124882-12488268.60268.60
5125972-12597269.20169.20
6123435-12343567.80767.81
15min1137976-13797675.79573.991.9175.8073.991.91
2132982-13298273.05273.05
3133992-13399273.60773.61
4134603-13460373.94373.94
5137335-13733575.44375.44
6131265-13126572.10972.11
20min1144001-14400179.10576.742.6179.1176.742.61
2138418-13841876.03876.04
3134561-13456173.91973.92
4139312-13931276.52976.53
5143836-14383679.01579.01
6138076-13807675.85075.85
30min1149155-14915581.93680.081.8981.9480.081.89
2143787-14378778.98878.99
3144008-14400879.10979.11
4145010-14501079.65979.66
5149327-14932782.03182.03
6143312-14331278.72778.73
45min1150850-15085082.86881.303.0482.8781.303.04
2139853-13985376.82776.83
3149057-14905781.88381.88
4149146-14914681.93281.93
5152659-15265983.86183.86
6146453-14645380.45280.45
60min1153665-15366584.41482.751.6484.4182.751.64
2147125-14712580.82180.82
3151324-15132483.12883.13
4150753-15075382.81482.81
5152528-15252883.78983.79
6148447-14844781.54881.55
90min1158619-15861987.13584.332.4887.1484.342.48
2150376-15037682.60782.61
3152737-15273783.90483.90
4153228-15322884.17484.17
5157267-15726786.39386.39
6148900-14890081.79681.80
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
120min1158832-15883287.25284.232.0887.2584.232.08
2150525-15052582.68982.69
3153669-15366984.41684.42
4152753-15275383.91383.91
5154220-15422084.71984.72
6150005-15000582.40382.40
极限1154135-15413584.67284.751.3184.6784.751.31
2152408-15240883.72383.72
3153963-15396384.57884.58
4154665-15466584.96384.96
5157958-15795886.77286.77
6152582-15258283.81983.82
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%
114.501866681868871865991866311861391865850.15
214.521873101868101870600.19
单位质量响应值RSD%判断
12867.9312882.920.09数据可信
供试品溶液-24050602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%
2min157627-5762731.63630.534.5331.6430.534.53
254054-5405429.67429.67
359161-5916132.47832.48
453850-5385029.56229.56
552620-5262028.88728.89
656322-5632230.91930.92
5min1104087-10408757.14157.172.2957.1457.172.29
2103034-10303456.56356.56
3105052-10505257.67157.67
4104666-10466657.45957.46
5100385-10038555.10955.11
6107590-10759059.06459.06
10min1123863-12386367.99768.852.6868.0068.852.68
2126456-12645669.42169.42
3127661-12766170.08270.08
4123983-12398368.06368.06
5120481-12048166.14166.14
6130042-13004271.39071.39
15min1131057-13105771.94774.192.0671.9574.182.05
2135377-13537774.31874.32
3137411-13741175.43575.43
4134708-13470873.95173.95
5133441-13344173.25673.26
6138811-13881176.20476.20
20min1136836-13683675.11975.295.5875.1275.295.58
2141579-14157977.72377.72
3143622-14362278.84578.84
4125493-12549368.89268.89
5130810-13081071.81171.81
6144564-14456479.36279.36
30min1141105-14110577.46380.012.5377.4680.012.53
2147741-14774181.10681.11
3148223-14822381.37081.37
4143973-14397379.03779.04
5142733-14273378.35778.36
6150653-15065382.70482.70
45min1145897-14589780.09482.122.9180.0982.132.91
2151958-15195883.42183.42
3152676-15267683.81583.82
4148633-14863381.59681.60
5143532-14353278.79578.80
6154884-15488485.02785.03
60min1149589-14958982.12082.623.2582.1282.623.25
2153287-15328784.15084.15
3154566-15456684.85384.85
4151027-15102782.91082.91
5141217-14121777.52477.52
6153312-15331284.16484.16
90min1149704-14970482.18482.961.3882.1882.961.38
2152523-15252383.73183.73
3151220-15122083.01683.02
4150260-15026082.48982.49
5148651-14865181.60581.61
6154392-15439284.75784.76
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
120min1150239-15023982.47783.843.2582.4883.843.25
2154471-15447184.80084.80
3156567-15656785.95185.95
4152125-15212583.51383.51
5144574-14457479.36779.37
6158373-15837386.94386.94
极限1150193-15019382.45283.502.7782.4583.502.77
2148447-14844781.49381.49
3154947-15494785.06285.06
4153506-15350684.27184.27
5147254-14725480.83980.84
6158243-15824386.87186.87
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%
114.501866471868711870191866891869231868300.09
214.521863571862091862830.06
单位质量响应值RSD%判断
12884.8312829.410.31数据可信
供试品溶液-24050603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%
2min152776-5277629.01427.789.2529.0127.789.26
248460-4846026.64126.64
355405-5540530.45930.46
454681-5468130.06130.06
548833-4883326.84626.85
643044-4304423.66423.66
5min195539-9553952.52351.464.0052.5251.464.00
296727-9672753.17653.18
397041-9704153.34953.35
491502-9150250.30450.30
593548-9354851.42951.43
687269-8726947.97747.98
10min1119286-11928665.57864.352.3865.5864.362.38
2118681-11868165.24665.25
3118929-11892965.38265.38
4118035-11803564.89164.89
5115162-11516263.31163.31
6112261-11226161.71661.72
15min1127325-12732569.99870.591.0570.0070.591.05
2129645-12964571.27371.27
3130129-13012971.53971.54
4128610-12861070.70470.70
5128128-12812870.43970.44
6126616-12661669.60869.61
20min1134754-13475474.08274.282.0174.0874.282.01
2139100-13910076.47176.47
3132246-13224672.70372.70
4137551-13755175.62075.62
5132653-13265372.92772.93
6134326-13432673.84773.85
30min1145873-14587380.19579.381.7880.1979.381.78
2140720-14072077.36277.36
3145378-14537879.92379.92
4147968-14796881.34781.35
5142734-14273478.46978.47
6143637-14363778.96678.97
45min1148943-14894381.88383.041.5681.8883.041.55
2152036-15203683.58383.58
3150781-15078182.89382.89
4152864-15286484.03884.04
5147768-14776881.23781.24
6153855-15385584.58384.58
60min1155327-15532785.39283.971.3185.3983.971.31
2152995-15299584.11084.11
3153218-15321884.23384.23
4153855-15385584.58384.58
5149583-14958382.23482.23
6151503-15150383.29083.29
90min1158772-15877287.28686.462.1087.2986.462.10
2158312-15831287.03387.03
3160494-16049488.23388.23
4159772-15977287.83687.84
5153497-15349784.38684.39
6152787-15278783.99684.00
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
120min1158946-15894687.38287.201.2987.3887.201.29
2160480-16048088.22588.23
3157736-15773686.71786.72
4159484-15948487.67887.68
5154950-15495085.18585.18
6160054-16005487.99187.99
极限1152157-15215783.64986.652.5383.6586.652.53
2158688-15868887.24087.24
3161003-16100388.51388.51
4162096-16209689.11389.11
5153574-15357484.42884.43
6158219-15821986.98286.98
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%
114.501857381858991860521860291860791859590.08
214.521877731874971876350.11
单位质量响应值RSD%判断
12824.7612922.520.54数据可信
供试品溶液-24050603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%
2min152859-5285929.02330.474.9329.0230.474.94
254334-5433429.83229.83
358443-5844332.08932.09
455578-5557830.51630.52
552731-5273128.95228.95
659066-5906632.43132.43
5min191701-9170150.34953.385.7850.3553.385.78
296686-9668653.08653.09
3103115-10311556.61656.62
4100740-10074055.31255.31
589479-8947949.12949.13
6101643-10164355.80855.81
10min1118965-11896565.31965.533.5065.3265.533.51
2117829-11782964.69564.69
3123968-12396868.06668.07
4120408-12040866.11166.11
5112217-11221761.61461.61
6122726-12272667.38467.38
15min1129790-12979071.26271.423.0671.2671.423.06
2128261-12826170.42370.42
3135377-13537774.33074.33
4130727-13072771.77771.78
5123709-12370967.92367.92
6132593-13259372.80172.80
20min1136439-13643974.91375.212.8874.9175.212.89
2133398-13339873.24373.24
3141952-14195277.94077.94
4138741-13874176.17776.18
5131594-13159472.25372.25
6139767-13976776.74076.74
30min1141602-14160277.74879.372.7877.7579.372.78
2141136-14113677.49277.49
3151516-15151683.19183.19
4146129-14612980.23380.23
5141632-14163277.76477.76
6145376-14537679.82079.82
45min1152035-15203583.47680.854.9583.4880.864.95
2142364-14236478.16678.17
3157376-15737686.40886.41
4141244-14124477.55177.55
5139271-13927176.46876.47
6151274-15127483.05883.06
60min1147928-14792881.22184.582.8981.2284.582.89
2152815-15281583.90483.90
3160180-16018087.94887.95
4156525-15652585.94185.94
5150664-15066482.72382.72
6156116-15611685.71785.72
90min1158417-15841786.98085.103.3486.9885.103.34
2156703-15670386.03986.04
3161077-16107788.44088.44
4153953-15395384.52984.53
5146108-14610880.22280.22
6153742-15374284.41384.41
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
120min1156099-15609985.70786.502.8485.7186.502.84
2158067-15806786.78886.79
3163196-16319689.60489.60
4152536-15253683.75183.75
5153206-15320684.11984.12
6162205-16220589.06089.06
极限1158981-15898187.29087.021.0587.2987.021.05
2157412-15741286.42886.43
3159476-15947687.56187.56
4157999-15799986.75086.75
5156167-15616785.74585.74
6160866-16086688.32588.32
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