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 10.883786483792753792033790863791953790810.07
2 10.823774463775133774800.02
单位质量响应值RSD%判断
34842.0034887.250.10数据可信
加速6月-供试品溶液-2024122121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%
5min1384139-38413998.76696.891.0298.7796.901.02
2376681-37668196.84896.85
3375310-37531096.49696.50
4372811-37281195.85395.85
5376509-37650996.80496.80
6375700-37570096.59696.60
10min1393120-393120101.07599.611.59101.2499.771.59
2386038-38603899.25499.42
3384141-38414198.76698.93
4384711-38471198.91399.07
5380043-38004397.71297.87
6396468-396468101.935102.10
15min1392353-392353100.87799.551.40101.2199.881.40
2385514-38551499.11999.45
3382903-38290398.44898.77
4383040-38304098.48398.81
5383802-38380298.67999.00
6395521-395521101.692102.02
20min1390701-390701100.45399.301.31100.9599.791.31
2384292-38429298.80599.30
3382032-38203298.22498.71
4382937-38293798.45698.95
5383075-38307598.49298.98
6394267-394267101.370101.87
30min1390591-390591100.42499.081.33101.0999.741.33
2383462-38346298.59199.25
3380788-38078897.90498.56
4382519-38251998.34999.00
5381741-38174198.14998.80
6392991-392991101.041101.71
45min1389018-389018100.02098.891.38100.8699.711.38
2382577-38257798.36499.18
3380287-38028797.77598.59
4381390-38139098.05998.88
5381074-38107497.97898.79
6393287-393287101.118101.96
60min1387715-38771599.68598.551.37100.6999.541.37
2381414-38141498.06599.05
3379557-37955797.58798.57
4380219-38021997.75898.74
5379137-37913797.47998.46
6391867-391867100.752101.76
极限1387414-38741499.60898.411.40100.7899.571.40
2380800-38080097.90799.06
3378684-37868497.36398.51
4379821-37982197.65598.80
5378483-37848397.31198.45
6391374-391374100.626101.80
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 10.883788223787443785013782443784253785470.07
2 10.823794273791743793000.05
单位质量响应值RSD%判断
34792.9235055.450.54数据可信
加速6月-供试品溶液-2024122221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%
5min1376849-37684996.72797.331.2496.7397.331.24
2381861-38186198.01498.01
3379407-37940797.38497.38
4379106-37910697.30797.31
5385930-38593099.05899.06
6371979-37197995.47795.48
10min1386098-38609899.10199.611.1299.2699.781.12
2391239-391239100.421100.58
3390365-390365100.196100.36
4387916-38791699.56899.73
5392349-392349100.706100.87
6380621-38062197.69597.85
15min1385428-38542898.92999.461.1699.2699.791.16
2390605-390605100.258100.59
3388461-38846199.708100.04
4386541-38654199.21599.54
5393476-393476100.995101.33
6380533-38053397.67397.99
20min1384924-38492498.80099.251.1299.2999.751.12
2389418-38941899.953100.45
3388554-38855499.732100.23
4384679-38467998.73799.23
5392342-392342100.704101.21
6380183-38018397.58398.07
30min1383097-38309798.33199.061.2398.9999.721.23
2389515-38951599.978100.64
3387581-38758199.482100.14
4385272-38527298.88999.55
5391672-391672100.532101.20
6378540-37854097.16197.81
45min1382051-38205198.06398.871.1298.8899.691.12
2389022-38902299.852100.68
3387628-38762899.494100.32
4384247-38424798.62699.45
5389503-38950399.975100.81
6378684-37868497.19898.01
60min1381434-38143497.90498.661.1498.8999.651.14
2387695-38769599.511100.51
3386700-38670099.256100.25
4384381-38438198.66199.65
5388861-38886199.810100.81
6377297-37729796.84297.81
极限1381290-38129097.86798.421.1299.0199.571.12
2386286-38628699.150100.31
3385101-38510198.845100.00
4382884-38288498.27699.43
5388623-38862399.749100.92
6376478-37647896.63297.76
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 10.883786833782963788253782023787083785430.08
2 10.823805213796293800750.17
单位质量响应值RSD%判断
34792.5635127.080.68数据可信
加速6月-供试品溶液-2024122321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%
5min1374535-37453596.03697.071.1296.0497.071.12
2378379-37837997.02297.02
3381634-38163497.85797.86
4384511-38451198.59498.59
5373238-37323895.70495.70
6379098-37909897.20697.21
10min1378455-37845597.04198.101.0597.2098.261.06
2382186-38218697.99898.16
3384217-38421798.51998.68
4388870-38887099.71299.88
5378097-37809796.95097.11
6383612-38361298.36498.53
15min1377968-37796896.91697.961.0497.2498.281.04
2381576-38157697.84298.17
3384308-38430898.54298.87
4387785-38778599.43499.76
5377384-37738496.76797.09
6383098-38309898.23298.56
20min1377466-37746696.78897.911.0497.2798.401.04
2381726-38172697.88098.37
3383560-38356098.35098.84
4388141-38814199.525100.02
5377868-37786896.89197.37
6382216-38221698.00698.50
30min1376946-37694696.65497.681.1997.3098.331.18
2379287-37928797.25597.91
3384539-38453998.60199.26
4387403-38740399.336100.00
5375725-37572596.34196.99
6381746-38174697.88598.54
45min1375610-37561096.31297.491.1197.1298.311.11
2379868-37986897.40498.22
3383073-38307398.22599.05
4386382-38638299.07499.90
5375638-37563896.31997.12
6380670-38067097.60998.43
60min1374858-37485896.11997.281.2197.0998.261.20
2378516-37851697.05798.03
3383197-38319798.25799.24
4385626-38562698.88099.87
5374031-37403195.90796.87
6380198-38019897.48898.47
极限1379320-37932097.26396.591.0598.3997.741.05
2374988-37498896.15297.29
3378207-37820796.97898.13
4381610-38161097.85099.01
5370345-37034594.96296.09
6375774-37577496.35497.50
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 10.883789833791473792433791353791233791260.03
2 10.823777103782243779670.10
单位质量响应值RSD%判断
34846.1434932.260.18数据可信
加速6月-供试品溶液-3176A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%
5min1343353-34335388.21790.643.2788.2290.643.26
2351534-35153490.31990.32
3336623-33662386.48886.49
4357288-35728891.79791.80
5359562-35956292.38292.38
6368387-36838794.64994.65
10min1375656-37565696.51798.322.4196.6698.472.41
2378094-37809497.14397.29
3380671-38067197.80597.95
4396776-396776101.943102.10
5373723-37372396.02096.17
6391052-391052100.472100.63
15min1378423-37842397.22798.802.6497.5499.122.64
2378413-37841397.22597.54
3385151-38515198.95699.26
4400797-400797102.976103.30
5373203-37320395.88696.20
6391310-391310100.539100.86
20min1377642-37764297.02798.632.6897.5099.112.68
2377560-37756097.00697.48
3384683-38468398.83699.31
4399942-399942102.756103.25
5372227-37222795.63696.11
6391216-391216100.514101.01
30min1376716-37671696.78998.332.6397.4298.972.63
2376365-37636596.69997.33
3383143-38314398.44099.08
4399420-399420102.622103.29
5371998-37199895.57796.21
6388584-38858499.838100.50
45min1376699-37669996.78598.132.7897.5898.942.78
2374127-37412796.12496.92
3382074-38207498.16698.97
4399422-399422102.623103.46
5370753-37075395.25796.05
6388509-38850999.819100.65
60min1375304-37530496.42697.932.6097.3898.902.60
2375831-37583196.56297.52
3380844-38084497.85098.81
4397303-397303102.078103.09
5369989-36998995.06196.01
6387616-38761699.589100.58
极限1371123-37112395.35296.872.8996.4798.002.88
2369819-36981995.01796.14
3378541-37854197.25898.39
4393444-393444101.087102.26
5364110-36411093.55094.66
6385067-38506798.935100.09
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