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(%)0.00对照品稀释倍数2000
标示量(mg)2.5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%
119.239478194805950629512995223950000.21
219.229503095179951040.12
单位质量响应值RSD%判断
4940.204948.180.12数据可信
供试品溶液-YAB2147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%
5min179234-79234163.721163.653.81163.72163.643.81
276997-76997159.099159.10
377763-77763160.681160.68
475635-75635156.284156.28
582463-82463170.393170.39
683092-83092171.693171.69
10min197110-97110200.658203.981.03200.93204.251.03
298932-98932204.423204.69
399120-99120204.811205.08
4100149-100149206.937207.20
598164-98164202.836203.12
698826-98826204.204204.49
15min197268-97268200.984204.201.20201.59204.821.20
299579-99579205.760206.37
399960-99960206.547207.16
4100049-100049206.731207.34
597922-97922202.336202.96
698178-98178202.865203.49
20min196513-96513199.424203.321.45200.37204.271.44
298536-98536203.604204.55
398816-98816204.183205.14
4100790-100790208.262209.21
597726-97726201.931202.89
697999-97999202.495203.46
30min196438-96438199.269202.631.08200.54203.921.08
298290-98290203.096204.38
398520-98520203.571204.87
499636-99636205.877207.17
597665-97665201.805203.10
697830-97830202.146203.45
45min196325-96325199.036202.681.14200.64204.311.13
298726-98726203.997205.62
398438-98438203.402205.03
499584-99584205.770207.41
597654-97654201.782203.41
697804-97804202.092203.73
极限196069-96069198.507202.161.06200.45204.131.05
298377-98377203.276205.24
398121-98121202.747204.72
499150-99150204.873206.86
597710-97710201.898203.87
697592-97592201.654203.63
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(%)0.00对照品稀释倍数2000
标示量(mg)2.5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%
119.239524495234956549510095273953010.22
219.229483395007949200.13
单位质量响应值RSD%判断
4955.854938.610.25数据可信
供试品溶液-YAB2147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%
5min180083-80083165.374156.675.42165.37156.675.42
269682-69682143.895143.90
375036-75036154.952154.95
480851-80851166.960166.96
574254-74254153.337153.34
675296-75296155.489155.49
10min1100321-100321207.166202.761.64207.44203.021.64
299779-99779206.047206.29
397188-97188200.696200.95
496430-96430199.131199.41
598501-98501203.408203.66
696913-96913200.128200.39
15min1100322-100322207.168202.631.81207.79203.221.81
2100056-100056206.619207.20
396804-96804199.903200.50
496421-96421199.112199.72
598541-98541203.490204.08
696589-96589199.459200.05
20min1100771-100771208.095202.861.98209.06203.801.98
2100269-100269207.059207.99
397258-97258200.841201.77
496044-96044198.334199.28
598421-98421203.242204.18
696644-96644199.573200.50
30min1100780-100780208.114202.831.82209.43204.111.81
299809-99809206.109207.38
396966-96966200.238201.50
496518-96518199.313200.59
598523-98523203.453204.73
696737-96737199.765201.02
45min1100543-100543207.624202.221.88209.28203.841.87
299657-99657205.795207.41
396805-96805199.905201.50
496217-96217198.691200.30
598079-98079202.536204.15
696265-96265198.790200.38
极限1100236-100236206.990201.941.85209.00203.891.85
299441-99441205.349207.31
396433-96433199.137201.06
496051-96051198.348200.28
598358-98358203.112205.06
696228-96228198.714200.64
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(%)0.00对照品稀释倍数2000
标示量(mg)2.5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%
119.231896491896371900611894891897081897090.12
219.221885811885431885620.02
单位质量响应值RSD%判断
9865.269810.720.40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%
5min166839-6683969.40949.5022.2569.4149.5022.26
237308-3730838.74238.74
347872-4787249.71349.71
450588-5058852.53352.53
543723-4372345.40445.40
639699-3969941.22541.23
10min1189386-189386196.667196.901.35196.78196.991.35
2192558-192558199.961200.03
3187809-187809195.030195.11
4192482-192482199.882199.97
5186129-186129193.285193.36
6189320-189320196.599196.67
15min1194057-194057201.518203.100.52201.96203.510.51
2195515-195515203.032203.43
3195762-195762203.288203.70
4196976-196976204.549204.97
5196182-196182203.724204.12
6194964-194964202.460202.86
20min1193852-193852201.305202.770.47202.08203.520.47
2194879-194879202.371203.11
3195821-195821203.350204.10
4196430-196430203.982204.74
5195728-195728203.253203.99
6194893-194893202.386203.12
30min1193619-193619201.063202.120.51202.18203.200.51
2194285-194285201.755202.83
3195207-195207202.712203.80
4196063-196063203.601204.70
5195074-195074202.574203.65
6193560-193560201.002202.07
45min1192996-192996200.416201.660.51201.87203.090.50
2193913-193913201.368202.78
3194602-194602202.084203.51
4195588-195588203.108204.55
5194769-194769202.257203.67
6193306-193306200.738202.14
极限1192364-192364199.760200.880.48201.54202.640.47
2193449-193449200.886202.63
3194213-194213201.680203.44
4194314-194314201.785203.56
5194014-194014201.473203.22
6192293-192293199.686201.43
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(%)0.00对照品稀释倍数2000
标示量(mg)2.5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%
119.231887651889561887401888731888661888400.05
219.221872591873321872960.03
单位质量响应值RSD%判断
9820.079744.850.55数据可信
供试品溶液-YBA2319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%
5min126177-2617727.33844.9044.9127.3444.9044.91
229668-2966830.98430.98
352038-5203854.34654.35
469976-6997673.07973.08
557033-5703359.56259.56
623085-2308524.10924.11
10min1193937-193937202.538198.842.46202.58198.922.46
2192552-192552201.091201.14
3183814-183814191.966192.06
4190406-190406198.850198.97
5195749-195749204.430204.53
6185945-185945194.191194.23
15min1197122-197122205.864204.080.89206.25204.480.89
2195206-195206203.863204.25
3196240-196240204.943205.35
4192274-192274200.801201.25
5196599-196599205.318205.76
6195014-195014203.663204.03
20min1196869-196869205.600203.870.89206.33204.620.88
2195206-195206203.863204.59
3196205-196205204.906205.66
4192023-192023200.539201.33
5196102-196102204.799205.58
6194884-194884203.527204.23
30min1196112-196112204.809203.330.85205.88204.410.84
2194671-194671203.304204.37
3196026-196026204.719205.81
4191695-191695200.196201.32
5195412-195412204.078205.20
6194243-194243202.857203.90
45min1195657-195657204.334202.680.89205.74204.100.88
2194047-194047202.653204.06
3195357-195357204.021205.46
4191007-191007199.478200.93
5194891-194891203.534205.00
6193476-193476202.056203.44
极限1195025-195025203.674202.221.00205.42203.990.99
2194174-194174202.785204.53
3194700-194700203.335205.11
4189774-189774198.190199.98
5194210-194210202.823204.63
6193933-193933202.534204.25
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