富马酸比索洛尔片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号100711-202203对照品来源中检所对照品使用方法直接使用
对照品含量(%)99.8对照品水分(%)0对照品稀释倍数2000
标示量(mg)5供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.101661721673391668091675131670231669710.32
210.051670891670851670870.01
单位质量响应值RSD%判断
16531.7816625.570.41数据可信
供试品溶液-2025120221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%
5min1182727-18272798.999100.842.0499.00100.842.03
2182223-18222398.72698.73
3186120-186120100.837100.84
4186828-186828101.221101.22
5186098-186098100.825100.83
6192779-192779104.445104.44
10min1184458-18445899.937101.881.92100.10102.041.92
2184797-184797100.120100.28
3188046-188046101.880102.05
4188921-188921102.354102.52
5187596-187596101.637101.80
6194418-194418105.333105.51
15min1184191-18419199.792101.801.96100.12102.141.96
2184535-18453599.978100.31
3187865-187865101.782102.12
4188378-188378102.060102.40
5188085-188085101.902102.24
6194371-194371105.307105.66
20min1183467-18346799.400101.561.9599.90102.071.95
2184583-184583100.004100.50
3187745-187745101.717102.22
4188259-188259101.996102.51
5186819-186819101.216101.72
6193890-193890105.047105.57
30min1183445-18344599.388101.561.89100.05102.241.89
2184419-18441999.915100.58
3187733-187733101.711102.39
4188340-188340102.040102.72
5187301-187301101.477102.15
6193493-193493104.832105.53
45min1183123-18312399.213101.372.09100.04102.212.09
2183861-18386199.613100.44
3186924-186924101.273102.12
4187351-187351101.504102.35
5187180-187180101.411102.26
6194135-194135105.179106.05
极限1182939-18293999.114101.331.86100.11102.351.86
2184487-18448799.952100.95
3187179-187179101.411102.43
4187720-187720101.704102.72
5186794-186794101.202102.22
6193075-193075104.605105.66
富马酸比索洛尔片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号100711-202203对照品来源中检所对照品使用方法直接使用
对照品含量(%)99.8对照品水分(%)0对照品稀释倍数2000
标示量(mg)5供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.101658501661571655231657991659531658560.14
210.051659421660431659920.05
单位质量响应值RSD%判断
16421.3916516.620.41数据可信
供试品溶液-2025120321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%
5min1187406-187406102.210102.251.29102.21102.241.29
2189571-189571103.391103.39
3188679-188679102.904102.90
4183463-183463100.059100.06
5189702-189702103.462103.46
6186015-186015101.451101.45
10min1188886-188886103.017102.731.09103.19102.901.09
2190247-190247103.759103.93
3189996-189996103.622103.79
4184746-184746100.759100.93
5188963-188963103.059103.23
6187350-187350102.179102.35
15min1187967-187967102.516102.691.17102.86103.041.17
2190346-190346103.813104.16
3189486-189486103.344103.69
4184590-184590100.674101.01
5190155-190155103.709104.05
6187198-187198102.096102.44
20min1189125-189125103.147103.061.25103.66103.571.25
2190777-190777104.048104.57
3190215-190215103.742104.26
4184919-184919100.853101.36
5191136-191136104.244104.76
6187574-187574102.302102.81
30min1188598-188598102.860102.921.16103.54103.601.16
2190304-190304103.790104.48
3189941-189941103.592104.28
4184982-184982100.888101.56
5190835-190835104.080104.77
6187546-187546102.286102.97
45min1188289-188289102.691102.681.27103.55103.541.28
2190606-190606103.955104.82
3189800-189800103.516104.38
4184277-184277100.503101.34
5189889-189889103.564104.43
6186789-186789101.873102.72
极限1187956-187956102.510102.351.22103.54103.381.22
2189916-189916103.579104.62
3188442-188442102.775103.81
4183836-183836100.263101.27
5189551-189551103.380104.42
6186275-186275101.593102.61
富马酸比索洛尔片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号100711-202203对照品来源中检所对照品使用方法直接使用
对照品含量(%)99.8对照品水分(%)0对照品稀释倍数2000
标示量(mg)5供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.101675381674211671371671061666791671760.20
210.051656571655501656040.05
单位质量响应值RSD%判断
16552.0816478.010.32数据可信
供试品溶液-2025120421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%
5min1183547-18354799.826101.791.9799.83101.781.97
2188803-188803102.684102.68
3186408-186408101.382101.38
4191954-191954104.398104.40
5189720-189720103.183103.18
6182478-18247899.24499.24
10min1186042-186042101.183102.911.83101.35103.081.83
2190074-190074103.376103.55
3188414-188414102.473102.64
4194015-194015105.519105.69
5191805-191805104.317104.49
6184926-184926100.576100.74
15min1185543-185543100.911102.791.93101.25103.131.93
2188999-188999102.791103.13
3188523-188523102.532102.87
4194337-194337105.694106.04
5191794-191794104.311104.66
6184764-184764100.488100.82
20min1185090-185090100.665102.651.99101.17103.171.99
2189779-189779103.215103.73
3187858-187858102.170102.68
4193851-193851105.430105.96
5191647-191647104.231104.75
6184251-184251100.209100.71
30min1184766-184766100.489102.452.02101.16103.132.02
2189286-189286102.947103.63
3187568-187568102.013102.69
4194008-194008105.515106.22
5190721-190721103.728104.42
6183844-18384499.987100.65
45min1183734-18373499.927102.482.05100.77103.342.05
2189590-189590103.112103.97
3190028-190028103.351104.20
4192726-192726104.818105.70
5190969-190969103.862104.73
6183570-18357099.838100.67
极限1183122-18312299.595101.762.13100.60102.782.13
2188418-188418102.475103.51
3186814-186814101.603102.63
4191962-191962104.402105.45
5190391-190391103.548104.59
6181907-18190798.93499.93
富马酸比索洛尔片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号100711-202203对照品来源中检所对照品使用方法直接使用
对照品含量(%)99.8对照品水分(%)0对照品稀释倍数2000
标示量(mg)5供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.101667411664941670501667261664991667020.14
210.051660481658351659420.10
单位质量响应值RSD%判断
16505.1516511.640.03数据可信
供试品溶液-G01T79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%
5min1133517-13351772.64568.607.3772.6468.607.38
2127343-12734369.28669.29
3112597-11259761.26361.26
4116546-11654663.41163.41
5133378-13337872.56972.57
6133061-13306172.39772.40
10min1165831-16583190.22686.824.8990.3586.934.89
2160779-16077987.47887.59
3155087-15508784.38184.48
4145955-14595579.41279.52
5163973-16397389.21689.34
6165763-16576390.18990.31
15min1177069-17706996.34194.483.4496.6194.743.44
2175901-17590195.70595.97
3172323-17232393.75994.00
4162234-16223488.26988.51
5175753-17575395.62595.89
6178636-17863697.19397.46
20min1180627-18062798.27797.681.9998.7198.102.00
2182427-18242799.25699.68
3180693-18069398.31398.71
4172569-17256993.89394.28
5179295-17929597.55297.98
6181622-18162298.81899.25
30min1182493-18249399.29299.510.6899.89100.090.67
2184894-184894100.598101.18
3183900-183900100.058100.62
4182082-18208299.06899.61
5181795-18179598.91299.50
6182181-18218199.12299.72
45min1182299-18229999.18699.600.5699.95100.340.54
2184451-184451100.357101.11
3183755-18375599.979100.71
4183527-18352799.855100.56
5181795-18179598.91299.67
6182502-18250299.297100.06
极限1181121-18112198.54699.330.6799.47100.240.65
2183595-18359599.892100.81
3183376-18337699.772100.67
4183884-183884100.049100.92
5181255-18125598.61899.54
6182103-18210399.080100.01
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