磷酸西格列汀片项目信息
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101546-202302对照品来源中检院对照品使用方法直接使用
对照品含量(%)96.3对照品水分(%)0对照品稀释倍数100
标示量(mg)100供试品稀释倍数1系数0.8061
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
1 12.683625773624023624913627263631873626770.09
2 12.723623803620973622380.06
单位质量响应值RSD%判断
28602.2928477.830.31数据可信
供试品溶液-2025060411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%
5min1400494-40049498.03995.093.6698.0495.103.66
2390648-39064895.62995.63
3390272-39027295.53795.54
4399106-39910697.70097.70
5361268-36126888.43788.44
6388968-38896895.21895.22
10min1408676-408676100.04299.240.94100.2199.400.94
2408608-408608100.026100.19
3398617-39861797.58097.74
4406509-40650999.51299.67
5403727-40372798.83198.98
6406267-40626799.45399.61
15min1409846-409846100.32999.620.92100.6699.940.92
2409659-409659100.283100.61
3399870-39987097.88798.21
4408661-408661100.039100.37
5406772-40677299.57699.89
6406877-40687799.60299.93
20min1410591-410591100.51199.740.85101.01100.230.85
2409582-409582100.264100.76
3400876-40087698.13398.62
4408686-408686100.045100.54
5407357-40735799.720100.20
6407458-40745899.744100.23
30min1410432-410432100.47299.611.23101.14100.271.22
2410456-410456100.478101.14
3399834-39983497.87898.53
4409435-409435100.228100.89
5410137-410137100.400101.04
6401247-40124798.22498.88
45min1412569-412569100.995100.061.05101.83100.881.05
2411107-411107100.637101.47
3400608-40060898.06798.88
4410143-410143100.402101.23
5410294-410294100.438101.25
6407775-40777599.822100.64
极限1415317-415317101.668100.840.90102.67101.830.90
2414684-414684101.513102.51
3405020-40502099.147100.12
4411286-411286100.681101.68
5412539-412539100.988101.97
6412760-412760101.042102.03
磷酸西格列汀片项目信息
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101546-202302对照品来源中检院对照品使用方法直接使用
对照品含量(%)96.3对照品水分(%)0对照品稀释倍数100
标示量(mg)100供试品稀释倍数1系数0.8061
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
1 12.683622473636183630173632723624413629190.16
2 12.723618943621963620450.06
单位质量响应值RSD%判断
28621.3728462.660.40数据可信
供试品溶液-2025060412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%
5min1386441-38644194.59395.040.5194.5995.040.51
2388950-38895095.20795.21
3389974-38997495.45895.46
4385379-38537994.33394.33
5390222-39022295.51995.52
6388551-38855195.11095.11
10min1394564-39456496.58196.940.6596.7497.100.65
2398275-39827597.49097.65
3397153-39715397.21597.37
4391816-39181695.90996.07
5398602-39860297.57097.73
6395828-39582896.89197.05
15min1396321-39632197.01297.320.5997.3397.640.59
2399796-39979697.86298.18
3398812-39881297.62197.94
4394045-39404596.45496.77
5399908-39990897.89098.21
6396532-39653297.06397.38
20min1396920-39692097.15897.340.5397.6497.820.53
2399786-39978697.86098.34
3398782-39878297.61498.10
4394251-39425196.50596.98
5399494-39949497.78898.27
6396743-39674397.11597.60
30min1397746-39774697.36097.560.5998.0098.210.59
2400332-40033297.99398.64
3400036-40003697.92198.57
4395757-39575796.87497.51
5401381-40138198.25098.90
6396218-39621896.98697.63
45min1400361-40036198.00098.100.6098.8098.900.60
2402338-40233898.48499.30
3401681-40168198.32499.13
4397437-39743797.28598.08
5403884-40388498.86399.67
6398828-39882897.62598.43
极限1403326-40332698.72698.750.4499.6999.720.44
2405296-40529699.208100.18
3404116-40411698.92099.89
4400597-40059798.05899.02
5404861-40486199.102100.08
6402322-40232298.48099.45
磷酸西格列汀片项目信息
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101546-202302对照品来源中检院对照品使用方法直接使用
对照品含量(%)96.3对照品水分(%)0对照品稀释倍数100
标示量(mg)100供试品稀释倍数1系数0.8061
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
1 12.683626043628553627023623723626533626370.05
2 12.723620803626643623720.12
单位质量响应值RSD%判断
28599.1328488.360.28数据可信
供试品溶液-2025060511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%
5min1384694-38469494.15993.851.9694.1693.851.96
2384732-38473294.16994.17
3373868-37386891.51091.51
4375414-37541491.88891.89
5393351-39335196.27896.28
6388418-38841895.07195.07
10min1393383-39338396.28697.300.8996.4497.450.89
2399529-39952997.79097.95
3400341-40034197.98998.14
4392685-39268596.11596.27
5400266-40026697.97198.13
6398882-39888297.63297.79
15min1393188-39318896.23897.520.9796.5697.840.97
2399985-39998597.90298.22
3401986-40198698.39298.71
4393974-39397496.43196.74
5400560-40056098.04398.37
6400950-40095098.13898.46
20min1394072-39407296.45597.621.0196.9398.101.01
2400842-40084298.11298.59
3402911-40291198.61899.10
4393525-39352596.32196.79
5400852-40085298.11498.60
6400907-40090798.12898.61
30min1394752-39475296.62197.830.9797.2698.480.97
2401298-40129898.22398.87
3403109-40310998.66799.31
4394781-39478196.62897.26
5401821-40182198.35199.00
6402459-40245998.50899.16
45min1395923-39592396.90897.850.8897.7198.660.88
2401447-40144798.26099.07
3404327-40432798.96599.77
4395425-39542596.78697.58
5401654-40165498.31199.13
6399800-39980097.85798.67
极限1398913-39891397.64098.710.9498.6099.680.94
2405288-40528899.200100.17
3407176-40717699.662100.64
4398195-39819597.46498.42
5405632-40563299.284100.26
6404441-40444198.99399.97
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