氢溴酸替格列汀片项目信息
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DMAD-P/23001对照品来源自制对照品使用方法直接使用
对照品含量(%)95.04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0.6784
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
114.683372383369023372303371543373443371740.05
214.573356503366373361440.21
单位质量响应值RSD%判断
22968.2623070.970.32数据可信
供试品溶液-2025011321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%
5min1170283-17028342.92543.003.2842.9243.003.28
2170811-17081143.05843.06
3177684-17768444.79144.79
4160962-16096240.57540.58
5174064-17406443.87843.88
6169759-16975942.79342.79
10min1335908-33590884.67683.432.9884.7583.502.98
2323041-32304181.43281.50
3332345-33234583.77883.85
4318883-31888380.38480.45
5346673-34667387.38987.46
6328939-32893982.91982.99
15min1398511-398511100.45797.642.60100.6797.852.60
2380367-38036795.88396.09
3380674-38067495.96096.17
4383013-38301396.55096.75
5401808-401808101.288101.51
6379668-37966895.70795.92
20min1399266-399266100.64798.262.21101.0398.632.21
2385920-38592097.28397.65
3381109-38110996.07096.44
4387269-38726997.62397.99
5401688-401688101.258101.65
6383488-38348896.67097.04
30min1398560-398560100.46997.832.48101.0298.362.48
2385578-38557897.19797.73
3381194-38119496.09296.63
4382694-38269496.47096.99
5401577-401577101.230101.79
6378858-37885895.50396.03
45min1397327-397327100.15897.702.40100.8798.402.40
2386883-38688397.52698.22
3380043-38004395.80196.50
4382032-38203296.30396.99
5400508-400508100.960101.69
6378546-37854695.42496.11
极限1395710-39571099.75197.702.97100.6398.572.96
2384308-38430896.87697.73
3378540-37854095.42296.28
4380642-38064295.95296.80
5407158-407158102.637103.53
6379206-37920695.59096.44
氢溴酸替格列汀片项目信息
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DMAD-P/23001对照品来源自制对照品使用方法直接使用
对照品含量(%)95.04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0.6784
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
114.683363903362563363753362113361943362850.03
214.573350003360313355160.22
单位质量响应值RSD%判断
22907.7023027.870.37数据可信
供试品溶液-2025011321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%
5min1172097-17209743.48042.314.8643.4842.314.86
2153867-15386738.87438.87
3164095-16409541.45941.46
4165330-16533041.77141.77
5175819-17581944.42144.42
6173618-17361843.86543.86
10min1322994-32299481.60483.634.5181.6883.704.51
2311158-31115878.61478.68
3323711-32371181.78581.85
4332931-33293184.11584.18
5352362-35236289.02489.10
6342911-34291186.63686.71
15min1375526-37552694.87798.832.8195.0899.042.81
2390148-39014898.57198.77
3387248-38724897.83898.04
4403040-403040101.828102.04
5404586-404586102.219102.44
6386554-38655497.66397.88
20min1375489-37548994.86799.833.1295.23100.213.11
2404053-404053102.084102.44
3393346-39334699.37999.75
4406235-406235102.635103.01
5404894-404894102.296102.69
6386869-38686997.74298.12
30min1381835-38183596.47099.842.4597.00100.392.45
2400266-400266101.127101.66
3393393-39339399.39199.92
4405611-405611102.477103.03
5403711-403711101.997102.56
6386318-38631897.60398.15
45min1374629-37462994.65099.232.8595.3499.942.84
2398577-398577100.700101.40
3392901-39290199.26699.97
4404102-404102102.096102.82
5401349-401349101.401102.13
6384992-38499297.26897.97
极限1372966-37296694.23099.073.0595.0799.943.04
2398199-398199100.605101.47
3391475-39147598.90699.77
4403459-403459101.934102.83
5402736-402736101.751102.65
6383877-38387796.98697.85
氢溴酸替格列汀片项目信息
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DMAD-P/23001对照品来源自制对照品使用方法直接使用
对照品含量(%)95.04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0.6784
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
114.686720966751316739666735996727626735110.18
214.576712236734186723200.24
单位质量响应值RSD%判断
45879.5046144.130.41数据可信
供试品溶液-2025011221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%
5min1263776-26377633.26632.962.7633.2732.962.76
2267607-26760733.74933.75
3263313-26331333.20833.21
4252258-25225831.81431.81
5252690-25269031.86831.87
6268597-26859733.87433.87
10min1562967-56296770.99970.451.8471.0570.501.84
2568511-56851171.69871.75
3557878-55787870.35770.41
4548283-54828369.14769.20
5544825-54482568.71168.76
6569249-56924971.79171.85
15min1745339-74533993.99993.961.6594.1794.141.65
2766369-76636996.65196.83
3747658-74765894.29194.46
4742483-74248393.63993.81
5729105-72910591.95292.12
6739361-73936193.24593.42
20min1790916-79091699.747101.262.78100.08101.592.77
2838404-838404105.736106.07
3808971-808971102.024102.35
4815325-815325102.825103.15
5781691-78169198.58398.90
6782190-78219098.64698.98
30min1789076-78907699.515101.073.12100.01101.573.11
2845834-845834106.673107.19
3807943-807943101.894102.39
4805936-805936101.641102.14
5780660-78066098.45398.94
6779182-77918298.26798.76
45min1787493-78749399.315100.662.8199.98101.332.80
2836170-836170105.454106.14
3806581-806581101.722102.39
4803500-803500101.334102.00
5776110-77611097.88098.53
6779306-77930698.28398.94
极限1785832-78583299.106100.522.7799.93101.362.77
2834438-834438105.236106.10
3804089-804089101.408102.25
4804034-804034101.401102.24
5776282-77628297.90198.71
6777639-77763998.07298.90
氢溴酸替格列汀片项目信息
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DMAD-P/23001对照品来源自制对照品使用方法直接使用
对照品含量(%)95.04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0.6784
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
114.686729556728806727286743996731826732290.11
214.576700586695706698140.06
单位质量响应值RSD%判断
45860.2945972.130.18数据可信
供试品溶液-2025011221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%
5min1266897-26689733.73033.098.3933.7333.098.39
2268108-26810833.88333.88
3270634-27063434.20234.20
4220063-22006327.81127.81
5284742-28474235.98535.98
6260760-26076032.95432.95
10min1563161-56316171.17171.504.1671.2371.564.17
2576730-57673072.88672.94
3572499-57249972.35172.41
4519998-51999865.71665.76
5584642-58464273.88673.95
6577716-57771673.01073.07
15min1746755-74675594.37394.412.3394.5594.582.33
2760375-76037596.09496.27
3743512-74351293.96394.14
4715845-71584590.46790.62
5765143-76514396.69796.88
6750491-75049194.84595.02
20min1795053-795053100.477100.931.03100.81101.261.04
2803535-803535101.549101.89
3801343-801343101.272101.61
4785935-78593599.32499.63
5809773-809773102.337102.68
6796230-796230100.625100.96
30min1794313-794313100.383100.981.25100.88101.481.26
2804108-804108101.621102.13
3809398-809398102.290102.79
4785005-78500599.20799.68
5809043-809043102.245102.76
6792547-792547100.160100.66
45min1793626-793626100.296100.520.97100.96101.190.97
2797821-797821100.827101.50
3800419-800419101.155101.83
4783701-78370199.04299.68
5805556-805556101.804102.49
6791207-79120799.991100.66
极限1794453-794453100.401100.321.05101.23101.161.06
2796756-796756100.692101.54
3796935-796935100.715101.56
4781536-78153698.76899.57
5805602-805602101.810102.66
6787644-78764499.540100.38
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