比拉斯汀片项目信息
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D1BSF0200923对照品来源自制对照品使用方法直接使用
对照品含量(%)99.6对照品水分(%)0对照品稀释倍数500
标示量(mg)20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%
1 11.053793613806733802693803553806553802630.15
2 11.053809123806833807980.05
单位质量响应值RSD%判断
34412.9434461.360.10数据可信
供试品溶液-3001A批-pH1.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1370844-37084496.53197.291.4196.5397.281.41
2370502-37050296.44296.44
3381389-38138999.27699.28
4377572-37757298.28298.28
5374995-37499597.61197.61
6367152-36715295.57095.57
10min1382072-38207299.454101.002.0799.61101.162.07
2397248-397248103.404103.56
3387923-387923100.977101.14
4389148-389148101.295101.46
5395528-395528102.956103.12
6376047-37604797.88598.04
15min1383200-38320099.747100.391.33100.07100.721.33
2390353-390353101.609101.94
3389220-389220101.314101.65
4388733-388733101.187101.52
5385769-385769100.416100.75
6376655-37665598.04398.37
20min1382638-38263899.601100.421.45100.09100.911.44
2390709-390709101.702102.20
3388924-388924101.237101.74
4390255-390255101.584102.08
5385814-385814100.428100.93
6376277-37627797.94598.43
30min1384971-384971100.208100.531.30100.87101.201.30
2390810-390810101.728102.40
3388735-388735101.188101.86
4389817-389817101.470102.14
5385846-385846100.436101.10
6377114-37711498.16398.81
极限1383298-38329899.773100.321.49100.60101.161.48
2391326-391326101.862102.70
3388017-388017101.001101.84
4389329-389329101.343102.18
5385196-385196100.267101.10
6375349-37534997.70498.52
比拉斯汀片项目信息
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D1BSF0200923对照品来源自制对照品使用方法直接使用
对照品含量(%)99.6对照品水分(%)0对照品稀释倍数500
标示量(mg)20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%
1 11.053808243804363810273806963800023805970.11
2 11.053813393807813810600.11
单位质量响应值RSD%判断
34443.1734485.070.09数据可信
供试品溶液-3001A批-pH1.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1378795-37879598.52396.933.3198.5296.933.31
2366676-36667695.37195.37
3369966-36996696.22796.23
4364728-36472894.86594.86
5361218-36121893.95293.95
6394671-394671102.653102.65
10min1385200-385200100.18999.942.44100.35100.102.44
2378207-37820798.37098.53
3376926-37692698.03798.20
4377600-37760098.21398.37
5385923-385923100.377100.53
6401594-401594104.453104.62
15min1386915-386915100.635100.863.08100.97101.183.08
2381320-38132099.18099.50
3378631-37863198.48198.80
4380437-38043798.95099.27
5388481-388481101.043101.37
6410786-410786106.844107.19
20min1386719-386719100.584100.842.53101.08101.332.53
2380076-38007698.85799.34
3379072-37907298.59599.08
4381111-38111199.12699.61
5396305-396305103.078103.57
6402839-402839104.777105.30
30min1392548-392548102.100100.612.47102.77101.282.47
2378880-37888098.54599.20
3378197-37819798.36899.02
4380455-38045598.95599.61
5388473-388473101.041101.70
6402401-402401104.663105.36
极限1388480-388480101.042100.392.40101.88101.222.41
2378806-37880698.52699.34
3376848-37684898.01798.83
4381629-38162999.260100.08
5387720-387720100.845101.68
6402265-402265104.628105.50
比拉斯汀片项目信息
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D1BSF0200923对照品来源自制对照品使用方法直接使用
对照品含量(%)99.6对照品水分(%)0对照品稀释倍数500
标示量(mg)20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%
1 11.053802803812823810223809893818033810750.15
2 11.053821613819103820360.05
单位质量响应值RSD%判断
34486.4334573.390.18数据可信
供试品溶液-2927A批-pH1.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1380356-38035698.74197.781.0298.7497.781.01
2379362-37936298.48398.48
3374628-37462897.25497.25
4380410-38041098.75598.75
5372764-37276496.77096.77
6372398-37239896.67596.68
10min1384835-38483599.90499.011.07100.0799.181.07
2386113-386113100.235100.40
3379311-37931198.47098.63
4383978-38397899.68199.85
5377487-37748797.99698.16
6376694-37669497.79097.95
15min1390312-390312101.32699.611.28101.6699.941.28
2387550-387550100.609100.94
3379222-37922298.44798.77
4385195-38519599.997100.33
5382250-38225099.23399.56
6377631-37763198.03498.36
20min1385359-385359100.04099.001.18100.5499.501.18
2386102-386102100.233100.73
3379123-37912398.42198.91
4384483-38448399.812100.31
5377454-37745497.98898.48
6375678-37567897.52798.01
30min1384575-38457599.83698.761.19100.5099.421.19
2386001-386001100.206100.87
3378439-37843998.24398.90
4382218-38221899.22499.89
5375771-37577197.55198.20
6375540-37554097.49198.14
极限1382533-38253399.30698.831.34100.1499.661.34
2389023-389023100.991101.82
3379969-37996998.64099.46
4381765-38176599.10799.94
5375943-37594397.59598.41
6375041-37504197.36198.17
比拉斯汀片项目信息
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D1BSF0200923对照品来源自制对照品使用方法直接使用
对照品含量(%)99.6对照品水分(%)0对照品稀释倍数500
标示量(mg)20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%
1 11.053806033799463812463804323815133807480.17
2 11.053844713838093841400.13
单位质量响应值RSD%判断
34456.8334763.800.63数据可信
供试品溶液-2927A批-pH1.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1371134-37113496.12596.840.9596.1296.840.95
2378912-37891298.13998.14
3375889-37588997.35697.36
4369017-36901795.57795.58
5373319-37331996.69196.69
6375150-37515097.16597.16
10min1377390-37739097.74598.111.0797.9198.271.07
2385942-38594299.960100.12
3376009-37600997.38797.55
4374646-37464697.03497.19
5378193-37819397.95398.11
6380694-38069498.60198.76
15min1378216-37821697.95998.310.8098.2898.640.80
2384048-38404899.47099.80
3376741-37674197.57797.90
4376244-37624497.44897.77
5380870-38087098.64698.97
6381369-38136998.77699.10
20min1377633-37763397.80898.190.9398.2998.670.93
2382708-38270899.12399.62
3375638-37563897.29197.78
4375171-37517197.17097.65
5380150-38015098.46098.95
6383248-38324899.26299.75
30min1376255-37625597.45197.900.8998.1098.560.89
2382761-38276199.13699.80
3374886-37488697.09797.75
4374821-37482197.08097.73
5377976-37797697.89798.55
6381236-38123698.74199.40
极限1375543-37554397.26797.670.7898.0898.480.78
2380998-38099898.68099.51
3374410-37441096.97397.78
4373763-37376396.80697.61
5378683-37868398.08098.90
6379194-37919498.21299.03
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