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%
113.711768841768091768261767911773161769250.13
213.761788341786841787590.06
单位质量响应值RSD%判断
12904.8112991.210.48数据可信
供试品溶液-2024051221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%
2min145957-4595725.08828.699.0925.0928.709.09
257126-5712631.18531.19
353882-5388229.41429.41
453080-5308028.97628.98
547784-4778426.08526.09
657539-5753931.41131.41
5min1115451-11545163.02562.852.2963.0262.852.29
2111602-11160260.92460.92
3117403-11740364.09164.09
4115240-11524062.91062.91
5112686-11268661.51561.52
6118410-11841064.64064.64
10min1137830-13783075.24274.411.7475.2474.401.74
2133427-13342772.83872.84
3134222-13422273.27273.27
4139529-13952976.16976.17
5137534-13753475.08075.08
6135248-13524873.83273.83
15min1145993-14599379.69878.822.0779.7078.822.08
2143907-14390778.55978.56
3138967-13896775.86275.86
4147686-14768680.62280.62
5144177-14417778.70678.71
6145625-14562579.49779.50
20min1147741-14774180.65280.831.1780.6580.831.18
2147943-14794380.76280.76
3146395-14639579.91779.92
4149982-14998281.87581.88
5150227-15022782.00982.01
6146133-14613379.77479.77
30min1146076-14607679.74380.972.2879.7480.972.28
2146036-14603679.72179.72
3149466-14946681.59481.59
4153730-15373083.92183.92
5144677-14467778.97978.98
6149934-14993481.84981.85
45min1153871-15387183.99882.911.4484.0082.911.44
2151545-15154582.72982.73
3147885-14788580.73180.73
4151662-15166282.79382.79
5153597-15359783.84983.85
6152696-15269683.35783.36
60min1150171-15017181.97983.521.2181.9883.521.22
2152335-15233583.16083.16
3152189-15218983.08083.08
4155463-15546384.86884.87
5154315-15431584.24184.24
6153481-15348183.78683.79
90min1154437-15443784.30782.812.3884.3182.822.39
2149898-14989881.83081.83
3146261-14626179.84479.84
4154821-15482184.51784.52
5155044-15504484.63984.64
6149748-14974881.74881.75
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
120min1145588-14558879.47783.022.2379.4883.022.23
2153795-15379583.95783.96
3152267-15226783.12383.12
4154735-15473584.47084.47
5154349-15434984.25984.26
6151790-15179082.86282.86
极限1154781-15478184.49583.281.7984.5083.281.79
2151782-15178282.85882.86
3147724-14772480.64380.64
4154688-15468884.44484.44
5154338-15433884.25384.25
6151982-15198282.96782.97
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%
113.711766441765651770951767561769021767920.12
213.761767361765531766440.08
单位质量响应值RSD%判断
12895.1112837.500.32数据可信
供试品溶液-2024051221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%
2min165020-6502035.72034.544.1035.7234.544.09
260123-6012333.02933.03
360936-6093633.47633.48
466586-6658636.58036.58
563434-6343434.84834.85
661125-6112533.58033.58
5min1121995-12199567.02066.181.0567.0266.181.04
2119304-11930465.54165.54
3121593-12159366.79966.80
4118991-11899165.36965.37
5121068-12106866.51166.51
6119876-11987665.85665.86
10min1138719-13871976.20775.642.6476.2175.642.64
2136106-13610674.77274.77
3131268-13126872.11472.11
4139709-13970976.75176.75
5141701-14170177.84677.85
6138616-13861676.15176.15
15min1144471-14447179.36779.991.3779.3779.991.37
2145140-14514079.73579.73
3142694-14269478.39178.39
4147656-14765681.11781.12
5147973-14797381.29181.29
6145658-14565880.01980.02
20min1148221-14822181.42781.112.4781.4381.122.47
2146487-14648780.47580.47
3141402-14140277.68177.68
4147380-14738080.96580.97
5151021-15102182.96682.97
6151394-15139483.17183.17
30min1150807-15080782.84883.161.6782.8583.161.67
2149646-14964682.21082.21
3147645-14764581.11181.11
4154616-15461684.94184.94
5152373-15237383.70883.71
6153167-15316784.14584.14
45min1143303-14330378.72682.923.2478.7382.923.23
2150446-15044682.65082.65
3147532-14753281.04981.05
4153279-15327984.20684.21
5156316-15631685.87585.87
6154724-15472485.00085.00
60min1152390-15239083.71883.232.6283.7283.232.62
2152506-15250683.78183.78
3145426-14542679.89279.89
4155587-15558785.47485.47
5154923-15492385.10985.11
6148169-14816981.39981.40
90min1153493-15349384.32484.440.7884.3284.440.78
2153711-15371184.44384.44
3154809-15480985.04785.05
4154994-15499485.14885.15
5151659-15165983.31683.32
6153514-15351484.33584.34
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
120min1143713-14371378.95182.334.7478.9582.334.74
2147415-14741580.98580.98
3140132-14013276.98476.98
4155074-15507485.19285.19
5156631-15663186.04886.05
6156223-15622385.82385.82
极限1151904-15190483.45182.542.5783.4582.542.57
2149953-14995382.37982.38
3150275-15027582.55682.56
4154176-15417684.69984.70
5143021-14302178.57178.57
6152186-15218683.60683.61
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%
113.711765901766901765781763461763801765170.09
213.761775111775401775260.02
单位质量响应值RSD%判断
12875.0512901.600.15数据可信
供试品溶液-2763566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%
2min119796-1979610.85710.5317.6110.8610.5317.61
218678-1867810.24310.24
320119-2011911.03411.03
424765-2476513.58213.58
514641-146418.0298.03
617220-172209.4449.44
5min158306-5830631.97634.487.2031.9834.487.20
263684-6368434.92634.93
368458-6845837.54437.54
465975-6597536.18236.18
556671-5667131.08031.08
664166-6416635.19035.19
10min178340-7834042.96449.058.4042.9649.058.41
294371-9437151.75551.76
395398-9539852.31952.32
493820-9382051.45351.45
581384-8138444.63344.63
693320-9332051.17951.18
15min190223-9022349.48056.878.5749.4856.878.57
2106306-10630658.30158.30
3112858-11285861.89461.89
4108021-10802159.24159.24
595335-9533552.28452.28
6109474-10947460.03860.04
20min1100707-10070755.23061.698.3355.2361.688.34
2119855-11985565.73165.73
3123151-12315167.53967.54
4108424-10842459.46259.46
5103848-10384856.95356.95
6118885-11888565.19965.20
30min1115765-11576563.48869.616.4863.4969.616.48
2132114-13211472.45572.45
3137556-13755675.43975.44
4126730-12673069.50269.50
5119052-11905265.29165.29
6130345-13034571.48471.48
45min1129367-12936770.94875.744.2470.9575.744.24
2140441-14044177.02177.02
3146120-14612080.13680.14
4140576-14057677.09577.10
5133766-13376673.36173.36
6138310-13831075.85375.85
60min1137138-13713875.21078.313.7175.2178.313.71
2145825-14582579.97479.97
3148430-14843081.40381.40
4147767-14776781.03981.04
5141049-14104977.35577.35
6136551-13655174.88874.89
90min1145625-14562579.86481.662.2179.8681.662.21
2148766-14876681.58781.59
3154734-15473484.86084.86
4148605-14860581.49981.50
5149657-14965782.07682.08
6146001-14600180.07080.07
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
120min1149465-14946581.97083.201.0181.9783.201.01
2153057-15305783.94083.94
3152522-15252283.64783.65
4152849-15284983.82683.83
5152232-15223283.48883.49
6150098-15009882.31782.32
极限1157382-15738286.31286.462.0686.3186.462.06
2160712-16071288.13888.14
3160561-16056188.05688.06
4154482-15448284.72284.72
5153132-15313283.98183.98
6159633-15963387.54787.55
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%
113.711765411766011763751761001762701763770.12
213.761778981779031779000.01
单位质量响应值RSD%判断
12864.8412928.780.36数据可信
供试品溶液-2763566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%
2min122301-2230112.2229.2923.8912.229.3023.91
218402-1840210.08610.09
319040-1904010.43510.44
417734-177349.7199.72
512050-120506.6046.60
612229-122296.7026.70
5min158305-5830531.95530.8412.9231.9630.8412.92
268035-6803537.28837.29
353782-5378229.47629.48
457811-5781131.68431.68
545935-4593525.17525.18
653793-5379329.48229.48
10min192491-9249150.69147.4510.5150.6947.4510.51
2102453-10245356.15156.15
381305-8130544.56144.56
481924-8192444.90044.90
578763-7876343.16743.17
682533-8253345.23445.23
15min1110263-11026360.43156.779.5260.4356.789.52
2120725-12072566.16566.17
396388-9638852.82752.83
497301-9730153.32753.33
597267-9726753.30953.31
699583-9958354.57854.58
20min1116169-11616963.66862.378.8263.6762.378.82
2132924-13292472.85172.85
3105133-10513357.62057.62
4110426-11042660.52160.52
5108264-10826459.33659.34
6109903-10990360.23460.23
30min1136083-13608374.58269.836.6274.5869.836.62
2138830-13883076.08876.09
3118461-11846164.92464.92
4126470-12647069.31469.31
5119428-11942865.45465.45
6125245-12524568.64368.64
45min1148648-14864881.46977.216.5181.4777.216.51
2153371-15337184.05784.06
3128650-12865070.50970.51
4142272-14227277.97477.97
5138109-13810975.69375.69
6134193-13419373.54773.55
60min1154052-15405284.43180.935.3184.4380.935.32
2156815-15681585.94585.95
3136725-13672574.93474.93
4149629-14962982.00782.01
5148738-14873881.51881.52
6140056-14005676.76076.76
90min1159140-15914087.21983.794.1887.2283.794.18
2158598-15859886.92286.92
3143710-14371078.76378.76
4154506-15450684.68084.68
5154842-15484284.86484.86
6146477-14647780.27980.28
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
120min1157490-15749086.31584.933.4786.3184.933.47
2158605-15860586.92686.93
3149476-14947681.92381.92
4160119-16011987.75687.76
5157041-15704186.06986.07
6147020-14702080.57780.58
极限1154781-15478184.83086.801.4784.8386.801.48
2161398-16139888.45788.46
3159662-15966287.50587.51
4157254-15725486.18686.19
5159599-15959987.47187.47
6157598-15759886.37486.37
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