苯磺酸美洛加巴林片项目信息
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D405-1-240701对照品来源原料对照品使用方法直接使用
对照品含量(%)99.66对照品水分(%)0.03对照品稀释倍数2000
标示量(mg)5供试品稀释倍数1系数0.5695
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
119.582006242004022006012003862002772004580.08
219.632001232000752000990.02
单位质量响应值RSD%判断
10237.9010193.530.31数据可信
供试品溶液-YBA2319批-pH1.2
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1152001-15200175.98166.8113.5475.9866.8113.53
2120642-12064260.30660.31
3108088-10808854.03054.03
4141903-14190370.93470.93
5126712-12671263.34063.34
6152625-15262576.29376.29
10min1208854-208854104.401103.280.87104.53103.390.88
2206566-206566103.257103.36
3203578-203578101.763101.85
4206137-206137103.042103.16
5206690-206690103.319103.42
6207834-207834103.891104.02
15min1209509-209509104.728104.221.14105.03104.511.15
2208999-208999104.473104.75
3205481-205481102.715102.97
4206311-206311103.129103.42
5208602-208602104.275104.55
6212095-212095106.021106.32
20min1209276-209276104.612103.940.79105.09104.390.80
2208764-208764104.356104.80
3205105-205105102.527102.96
4206826-206826103.387103.85
5208429-208429104.188104.64
6209146-209146104.547105.02
30min1208032-208032103.990103.700.85104.64104.330.86
2207982-207982103.965104.59
3204902-204902102.425103.03
4205822-205822102.885103.52
5209709-209709104.828105.45
6208233-208233104.090104.74
45min1207567-207567103.757103.360.65104.58104.160.66
2207782-207782103.865104.66
3204402-204402102.175102.95
4206103-206103103.025103.83
5206961-206961103.454104.25
6207797-207797103.872104.70
60min1207299-207299103.623103.140.73104.62104.120.73
2207569-207569103.758104.73
3204326-204326102.137103.08
4204647-204647102.298103.27
5206532-206532103.240104.21
6207629-207629103.788104.79
极限1207140-207140103.544102.960.74104.71104.100.75
2207291-207291103.619104.76
3203843-203843101.896103.01
4204269-204269102.109103.26
5206382-206382103.165104.31
6206880-206880103.414104.58
苯磺酸美洛加巴林片项目信息
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D405-1-240701对照品来源原料对照品使用方法直接使用
对照品含量(%)99.66对照品水分(%)0.03对照品稀释倍数2000
标示量(mg)5供试品稀释倍数1系数0.5695
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
119.581998142002032001542001602000402000740.08
219.631998281997401997840.04
单位质量响应值RSD%判断
10218.2810177.480.29数据可信
供试品溶液-YBA2319批-pH1.2
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min184394-8439442.26065.3118.2542.2665.3118.25
2150432-15043275.32875.33
3132619-13261966.40966.41
4143945-14394572.08072.08
5129585-12958564.88964.89
6141534-14153470.87370.87
10min1199758-199758100.028102.401.26100.10102.511.27
2204826-204826102.566102.69
3205440-205440102.873102.98
4206622-206622103.465103.59
5203754-203754102.029102.14
6206571-206571103.440103.56
15min1204070-204070102.187103.230.62102.42103.520.64
2205669-205669102.988103.28
3206058-206058103.183103.47
4207678-207678103.994104.29
5206287-206287103.298103.58
6207206-207206103.758104.05
20min1204587-204587102.446103.240.56102.85103.690.57
2204994-204994102.650103.12
3207368-207368103.839104.29
4207086-207086103.698104.16
5206227-206227103.268103.72
6206753-206753103.531103.99
30min1203778-203778102.041102.930.53102.62103.550.55
2206230-206230103.269103.91
3205166-205166102.736103.36
4206919-206919103.614104.25
5205316-205316102.811103.43
6205863-205863103.085103.72
45min1203399-203399101.851102.710.64102.60103.510.65
2204163-204163102.234103.05
3204844-204844102.575103.37
4206366-206366103.337104.15
5205047-205047102.677103.47
6206868-206868103.589104.40
60min1202676-202676101.489102.350.58102.41103.320.60
2203720-203720102.012102.99
3204045-204045102.175103.14
4205980-205980103.144104.13
5204667-204667102.486103.45
6205338-205338102.822103.80
极限1202806-202806101.555102.140.42102.64103.280.44
2203250-203250101.777102.93
3203688-203688101.996103.14
4204899-204899102.603103.76
5204457-204457102.381103.52
6204732-204732102.519103.67
苯磺酸美洛加巴林片项目信息
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D405-1-240701对照品来源原料对照品使用方法直接使用
对照品含量(%)99.66对照品水分(%)0.03对照品稀释倍数2000
标示量(mg)5供试品稀释倍数1系数0.5695
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
119.581997571996871997231995161996351996640.05
219.632000222002202001210.07
单位质量响应值RSD%判断
10197.3410194.650.02数据可信
供试品溶液-YBA2319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%
5min1118923-11892359.56160.9314.2059.5660.9214.20
2125359-12535962.78562.78
392355-9235546.25546.25
4123521-12352161.86461.86
5146243-14624373.24473.24
6123488-12348861.84761.85
10min1208152-208152104.250103.421.09104.35103.521.10
2204994-204994102.669102.77
3204413-204413102.378102.45
4206578-206578103.462103.57
5210047-210047105.199105.32
6204771-204771102.557102.66
15min1209517-209517104.934104.260.78105.21104.530.79
2206773-206773103.560103.84
3206407-206407103.376103.62
4208262-208262104.305104.58
5210535-210535105.444105.74
6207529-207529103.938104.21
20min1208834-208834104.592104.020.77105.04104.470.78
2206176-206176103.261103.71
3206383-206383103.364103.78
4206720-206720103.533103.98
5210230-210230105.291105.76
6207812-207812104.080104.53
30min1208936-208936104.643104.000.82105.27104.620.83
2206006-206006103.176103.80
3205865-205865103.105103.70
4207218-207218103.783104.40
5210217-210217105.285105.93
6207669-207669104.008104.63
45min1205951-205951103.148103.600.66103.94104.390.67
2206460-206460103.403104.20
3205930-205930103.138103.90
4206099-206099103.222104.02
5209427-209427104.889105.71
6207192-207192103.770104.56
60min1208569-208569104.459103.800.85105.43104.770.86
2205725-205725103.035104.00
3205338-205338102.841103.78
4206533-206533103.440104.41
5209894-209894105.123106.12
6207481-207481103.914104.88
极限1207891-207891104.120103.470.69105.26104.610.70
2205554-205554102.949104.09
3205072-205072102.708103.82
4205653-205653102.999104.14
5208604-208604104.477105.65
6206791-206791103.569104.71
苯磺酸美洛加巴林片项目信息
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D405-1-240701对照品来源原料对照品使用方法直接使用
对照品含量(%)99.66对照品水分(%)0.03对照品稀释倍数2000
标示量(mg)5供试品稀释倍数1系数0.5695
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
119.582001622001442004112002162000642001990.07
219.632009362006332007840.11
单位质量响应值RSD%判断
10224.6710228.430.03数据可信
供试品溶液-YBA2319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%
5min1125739-12573962.78760.8021.2062.7960.8021.20
2145031-14503172.42072.42
3111856-11185655.85455.85
489392-8939244.63744.64
5101749-10174950.80850.81
6156765-15676578.27978.28
10min1205982-205982102.855102.160.72102.96102.260.73
2204578-204578102.154102.28
3206322-206322103.025103.12
4202539-202539101.136101.21
5203371-203371101.552101.64
6204768-204768102.249102.38
15min1207607-207607103.667103.330.54103.94103.600.53
2205525-205525102.627102.92
3208481-208481104.103104.37
4207533-207533103.630103.87
5206383-206383103.056103.31
6206088-206088102.908103.21
20min1208020-208020103.873103.450.68104.32103.890.66
2205639-205639102.684103.15
3209064-209064104.394104.83
4207523-207523103.625104.04
5207299-207299103.513103.94
6205476-205476102.603103.08
30min1208246-208246103.986103.320.70104.61103.940.69
2205917-205917102.823103.46
3208892-208892104.308104.92
4207193-207193103.460104.05
5205847-205847102.788103.39
6205369-205369102.549103.19
45min1207706-207706103.716103.070.75104.51103.860.73
2205329-205329102.529103.33
3208429-208429104.077104.86
4207030-207030103.379104.14
5205451-205451102.590103.36
6204546-204546102.138102.95
60min1207450-207450103.588102.890.75104.56103.850.74
2205069-205069102.399103.37
3208279-208279104.002104.96
4206062-206062102.895103.83
5205126-205126102.428103.37
6204330-204330102.030103.02
极限1206125-206125102.927102.600.50104.07103.730.49
2204034-204034101.883103.03
3206989-206989103.358104.49
4205607-205607102.668103.77
5205107-205107102.418103.53
6204943-204943102.337103.49
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