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%
114.181824271824621823591821781821281823110.09
214.231818771820571819670.07
单位质量响应值RSD%判断
12856.9112787.560.39数据可信
供试品溶液-2025102321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%
2min1133200-13320073.47967.398.5773.4867.398.57
2127577-12757770.37770.38
3116444-11644464.23564.24
4124252-12425268.54268.54
5103975-10397557.35757.36
6127503-12750370.33670.34
5min1171019-17101994.34193.141.3594.3493.141.35
2169570-16957093.54293.54
3165294-16529491.18391.18
4168358-16835892.87392.87
5167559-16755992.43292.43
6171298-17129894.49594.50
10min1174574-17457496.30295.861.2996.3095.861.28
2172767-17276795.30595.31
3170001-17000193.78093.78
4176368-17636897.29297.29
5175235-17523596.66796.67
6173731-17373195.83795.84
15min1174376-17437696.19396.170.9896.1996.170.98
2175052-17505296.56696.57
3171273-17127394.48194.48
4174027-17402796.00096.00
5176378-17637897.29797.30
6174916-17491696.49196.49
20min1175572-17557296.85396.311.5996.8596.321.59
2169863-16986393.70393.70
3172751-17275195.29795.30
4177220-17722097.76297.76
5175963-17596397.06897.07
6176213-17621397.20697.21
30min1176560-17656097.39896.861.2997.4096.861.29
2176107-17610797.14897.15
3171033-17103394.34994.35
4177012-17701297.64797.65
5176700-17670097.47597.47
6176121-17612197.15697.16
45min1177229-17722997.76797.321.2197.7797.321.21
2175091-17509196.58796.59
3172857-17285795.35595.36
4177262-17726297.78597.78
5178929-17892998.70598.70
6177165-17716597.73197.73
60min1177936-17793698.15797.731.1698.1697.741.16
2176912-17691297.59297.59
3173892-17389295.92695.93
4178854-17885498.66398.66
5179446-17944698.99098.99
6175985-17598597.08197.08
极限1173877-17387795.91897.161.3295.9297.161.32
2174109-17410996.04696.05
3174623-17462396.32996.33
4176742-17674297.49897.50
5179616-17961699.08499.08
6177823-17782398.09498.09
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%
114.181817721818831817421818861818091818180.04
214.231830151829151829650.04
单位质量响应值RSD%判断
12822.1412857.700.20数据可信
供试品溶液-2025102321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%
2min1130476-13047671.87668.7610.0371.8868.7610.03
2118770-11877065.42865.43
3105917-10591758.34758.35
4142634-14263478.57478.57
5121176-12117666.75366.75
6129913-12991371.56671.57
5min1172134-17213494.82594.401.8194.8294.401.81
2172347-17234794.94294.94
3165153-16515390.97990.98
4172152-17215294.83594.83
5173720-17372095.69995.70
6172654-17265495.11195.11
10min1177929-17792998.01798.000.4598.0298.000.45
2178715-17871598.45098.45
3178681-17868198.43198.43
4177116-17711697.56997.57
5178139-17813998.13398.13
6176812-17681297.40297.40
15min1179514-17951498.89098.420.7098.8998.420.70
2179973-17997399.14399.14
3179207-17920798.72198.72
4177495-17749597.77897.78
5179040-17904098.62998.63
6176781-17678197.38597.38
20min1179419-17941998.83898.271.5198.8498.271.51
2179963-17996399.13899.14
3181263-18126399.85499.85
4175596-17559696.73296.73
5179577-17957798.92598.93
6174539-17453996.15096.15
30min1171641-17164194.55398.171.8994.5598.171.89
2179580-17958098.92798.93
3180585-18058599.48099.48
4179020-17902098.61898.62
5180411-18041199.38599.38
6177973-17797398.04198.04
45min1179771-17977199.03299.381.0299.0399.381.02
2182296-182296100.423100.42
3182146-182146100.340100.34
4177801-17780197.94797.95
5181411-18141199.93599.94
6179002-17900298.60898.61
60min1182206-182206100.37399.910.89100.3799.910.89
2182980-182980100.800100.80
3182819-182819100.711100.71
4180149-18014999.24099.24
5181158-18115899.79699.80
6178906-17890698.55598.56
极限1182332-182332100.44399.530.71100.4499.530.71
2181949-181949100.232100.23
3180777-18077799.58699.59
4179569-17956998.92198.92
5179143-17914398.68698.69
6180244-18024499.29399.29
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%
114.181826881823141826601823721823251824720.11
214.231840161836871838520.13
单位质量响应值RSD%判断
12868.2712920.030.29数据可信
供试品溶液-2025102421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%
2min1126827-12682769.57371.202.7569.5771.202.75
2128708-12870870.60470.60
3130127-13012771.38371.38
4135145-13514574.13674.14
5125559-12555968.87768.88
6132421-13242172.64172.64
5min1169821-16982193.15793.000.7993.1693.000.79
2169061-16906192.74192.74
3171586-17158694.12694.13
4170038-17003893.27793.28
5169117-16911792.77192.77
6167547-16754791.91091.91
10min1171461-17146194.05795.400.8594.0695.400.85
2175404-17540496.22096.22
3174996-17499695.99696.00
4174708-17470895.83895.84
5173919-17391995.40595.41
6172990-17299094.89694.90
15min1173804-17380495.34295.560.7795.3495.550.78
2171820-17182094.25494.25
3175301-17530196.16496.16
4175425-17542596.23296.23
5173970-17397095.43395.43
6174834-17483495.90795.91
20min1174720-17472095.84596.280.8995.8496.280.89
2173411-17341195.12795.13
3176822-17682296.99897.00
4177059-17705997.12897.13
5176746-17674696.95696.96
6174368-17436895.65295.65
30min1174378-17437895.65796.661.0595.6696.671.05
2174303-17430395.61695.62
3177572-17757297.40997.41
4176868-17686897.02397.02
5178825-17882598.09798.10
6175342-17534296.18696.19
45min1175565-17556596.30896.690.7396.3196.690.73
2174917-17491795.95395.95
3178044-17804497.66897.67
4177531-17753197.38797.39
5175239-17523996.13096.13
6176247-17624796.68396.68
60min1177085-17708597.14296.880.9997.1496.880.99
2177788-17778897.52897.53
3175163-17516396.08896.09
4177944-17794497.61397.61
5177887-17788797.58297.58
6173756-17375695.31695.32
极限1176580-17658096.86597.460.5396.8797.460.53
2177377-17737797.30297.30
3179125-17912598.26198.26
4178221-17822197.76597.77
5177838-17783897.55597.56
6176845-17684597.01197.01
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%
114.181822871826111826331825661825201825230.08
214.231843671849271846470.22
单位质量响应值RSD%判断
12871.8612975.900.57数据可信
供试品溶液-2025102421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%
2min1140733-14073377.02470.008.8977.0270.008.89
2135779-13577974.31374.31
3137380-13738075.18975.19
4118018-11801864.59264.59
5114139-11413962.46962.47
6121397-12139766.44166.44
5min1177013-17701396.88193.393.8196.8893.393.81
2172282-17228294.29194.29
3174154-17415495.31695.32
4168722-16872292.34392.34
5158568-15856886.78586.79
6173057-17305794.71594.72
10min1179516-17951698.25097.390.9998.2597.390.99
2177552-17755297.17697.18
3179697-17969798.34998.35
4175989-17598996.32096.32
5179074-17907498.00998.01
6175827-17582796.23196.23
15min1176803-17680396.76697.251.0196.7797.251.01
2175671-17567196.14696.15
3177968-17796897.40397.40
4176129-17612996.39796.40
5179522-17952298.25498.25
6179987-17998798.50898.51
20min1180266-18026698.66198.410.8798.6698.410.88
2178952-17895297.94297.94
3179674-17967498.33798.34
4177989-17798997.41597.41
5179395-17939598.18498.18
6182597-18259799.93799.94
30min1178128-17812897.49198.011.1697.4998.011.16
2177338-17733897.05897.06
3180766-18076698.93598.93
4176580-17658096.64496.64
5181855-18185599.53199.53
6179793-17979398.40298.40
45min1176982-17698296.86497.891.5796.8697.901.57
2176751-17675196.73796.74
3180306-18030698.68398.68
4175599-17559996.10796.11
5182644-18264499.96299.96
6180915-18091599.01699.02
60min1179780-17978098.39598.260.8398.3998.260.83
2178462-17846297.67497.67
3180401-18040198.73598.73
4177091-17709196.92396.92
5180540-18054098.81198.81
6180943-18094399.03199.03
极限1177847-17784797.33797.961.2297.3497.961.22
2177971-17797197.40597.40
3179696-17969698.34998.35
4175807-17580796.22096.22
5181005-18100599.06599.07
6181574-18157499.37799.38
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