达格列净片项目信息
介质体积(ml)1000取样体积(ml)1.5补液体积(ml)1.5
对照品批号101568-202301对照品来源中检院对照品使用方法直接使用
对照品含量(%)80.4对照品水分(%)0对照品稀释倍数1000
标示量(mg)10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 12.312004181997001995891998402006412000380.24
2 12.271989691989951989820.01
单位质量响应值RSD%判断
16250.0416216.950.15数据可信
供试品溶液-WA3063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%
5min1173945-17394586.15084.032.7086.1584.032.70
2168578-16857883.49283.49
3165204-16520481.82181.82
4176504-17650487.41887.42
5165598-16559882.01682.02
6168198-16819883.30483.30
10min1197472-19747297.80398.051.4997.9398.181.48
2201068-20106899.58499.71
3195914-19591497.03197.15
4193488-19348895.82995.96
5200659-20065999.38199.50
6199276-19927698.69698.82
15min1196723-19672397.43298.561.4997.7198.831.49
2201501-20150199.798100.07
3197249-19724997.69297.96
4195522-19552296.83797.11
5203031-203031100.556100.83
6199929-19992999.01999.29
20min1196436-19643697.28998.801.5697.7199.221.55
2202538-202538100.312100.74
3199980-19998099.04599.46
4195875-19587597.01297.43
5203388-203388100.733101.16
6198664-19866498.39398.81
30min1196391-19639197.26798.511.5997.8499.081.58
2201227-20122799.662100.24
3198028-19802898.07898.64
4195005-19500596.58197.15
5203591-203591100.833101.41
6199190-19919098.65399.22
45min1196460-19646097.30198.451.3898.0299.171.37
2200299-20029999.20399.93
3198636-19863698.37999.09
4195659-19565996.90597.62
5203209-203209100.644101.37
6198398-19839898.26198.98
60min1197242-19724297.68998.381.2298.5599.251.22
2200987-20098799.543100.42
3198779-19877998.45099.31
4195041-19504196.59897.45
5201593-20159399.844100.72
6198241-19824198.18399.05
极限1197130-19713097.63398.771.2998.6499.781.28
2200393-20039399.249100.27
3200291-20029199.199100.20
4196424-19642497.28398.28
5203477-203477100.777101.80
6198882-19888298.50199.51
达格列净片项目信息
介质体积(ml)1000取样体积(ml)1.5补液体积(ml)1.5
对照品批号101568-202301对照品来源中检院对照品使用方法直接使用
对照品含量(%)80.4对照品水分(%)0对照品稀释倍数1000
标示量(mg)10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 12.312001651994751997721999501986511996030.30
2 12.271994221996311995260.08
单位质量响应值RSD%判断
16214.7016261.290.21数据可信
供试品溶液-WA3063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%
5min1172189-17218985.25781.9812.3185.2681.9812.31
2183450-18345090.83390.83
3177794-17779488.03288.03
4155893-15589377.18877.19
5128565-12856563.65763.66
6175507-17550786.90086.90
10min1194969-19496996.53697.290.7096.6697.410.70
2196000-19600097.04797.18
3198947-19894798.50698.64
4196372-19637297.23197.35
5196848-19684897.46797.56
6195789-19578996.94297.07
15min1196044-19604497.06898.390.9297.3498.660.91
2196829-19682997.45797.74
3200083-20008399.06899.35
4200132-20013299.09399.35
5200131-20013199.09299.33
6199070-19907098.56798.84
20min1195822-19582296.95998.541.2297.3898.961.21
2196333-19633397.21297.64
3199192-19919298.62799.06
4201760-20176099.899100.31
5200659-20065999.35399.74
6200340-20034099.19699.62
30min1195535-19553596.81698.951.6797.3899.511.65
2196596-19659697.34297.92
3200631-20063199.34099.92
4200167-20016799.11099.67
5201508-20150899.774100.31
6204589-204589101.299101.87
45min1195609-19560996.85398.381.0297.5699.091.01
2196972-19697297.52898.25
3198814-19881498.44099.17
4199885-19988598.97099.68
5200775-20077599.411100.10
6200097-20009799.07599.80
60min1195350-19535096.72598.141.0097.5899.000.98
2196961-19696197.52298.39
3198182-19818298.12799.00
4199589-19958998.82499.68
5200974-20097499.509100.35
6198192-19819298.13299.00
极限1194955-19495596.52998.191.0997.5399.201.07
2196803-19680397.44498.46
3198320-19832098.19599.22
4199308-19930898.68599.69
5200982-20098299.513100.50
6199503-19950398.78199.80
达格列净片项目信息
介质体积(ml)1000取样体积(ml)1.5补液体积(ml)1.5
对照品批号101568-202301对照品来源中检院对照品使用方法直接使用
对照品含量(%)80.4对照品水分(%)0对照品稀释倍数1000
标示量(mg)10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 12.312004052001252006162006281999222003390.16
2 12.271997372004472000920.26
单位质量响应值RSD%判断
16274.4916307.420.15数据可信
供试品溶液-WC2484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%
5min1115150-11515056.83058.148.4156.8358.148.41
2104029-10402951.34151.34
3122289-12228960.35360.35
4134039-13403966.15266.15
5115244-11524456.87656.88
6116083-11608357.29057.29
10min1196928-19692897.18998.432.4097.2798.512.40
2200193-20019398.80098.88
3208771-208771103.034103.12
4196862-19686297.15697.26
5196275-19627596.86796.95
6197580-19758097.51197.60
15min1199384-19938498.40199.091.6298.6399.321.62
2202656-202656100.016100.24
3206570-206570101.948102.19
4198856-19885698.14198.39
5198230-19823097.83298.06
6198987-19898798.20598.44
20min1199462-19946298.44099.161.5498.8299.541.54
2202759-202759100.067100.44
3206389-206389101.858102.26
4199220-19922098.32098.71
5198200-19820097.81798.19
6199481-19948198.44998.83
30min1199199-19919998.31098.991.6598.8499.531.65
2202523-20252399.950100.48
3206484-206484101.905102.46
4198290-19829097.86198.40
5198375-19837597.90398.43
6198614-19861498.02198.55
45min1198806-19880698.11698.911.7998.7999.591.79
2203644-203644100.504101.18
3206132-206132101.731102.44
4197574-19757497.50898.19
5197986-19798697.71198.38
6198384-19838497.90898.58
60min1198893-19889398.15998.951.6298.9899.781.61
2202633-202633100.005100.83
3206151-206151101.741102.60
4198599-19859998.01498.85
5198165-19816597.80098.62
6198499-19849997.96498.79
极限1198498-19849897.96498.791.6898.9399.771.67
2202509-20250999.943100.92
3205992-205992101.662102.67
4197939-19793997.68898.67
5197886-19788697.66298.63
6198254-19825497.84398.81
达格列净片项目信息
介质体积(ml)1000取样体积(ml)1.5补液体积(ml)1.5
对照品批号101568-202301对照品来源中检院对照品使用方法直接使用
对照品含量(%)80.4对照品水分(%)0对照品稀释倍数1000
标示量(mg)10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 12.312010802009182002852011292007312008290.18
2 12.272008842012722010780.14
单位质量响应值RSD%判断
16314.3016387.780.32数据可信
供试品溶液-WC2484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%
5min1102356-10235650.33056.4215.5450.3356.4215.54
2149134-14913473.33173.33
3114033-11403356.07256.07
4102973-10297350.63350.63
5104149-10414951.21251.21
6115781-11578156.93156.93
10min1191282-19128294.05696.461.7294.1396.541.71
2193771-19377195.28095.39
3198461-19846197.58697.67
4197542-19754297.13497.21
5200526-20052698.60298.68
6195425-19542596.09396.18
15min1196890-19689096.81498.651.5897.0398.881.57
2198117-19811797.41797.67
3201321-20132198.99299.22
4200931-20093198.80199.02
5205997-205997101.292101.52
6200477-20047798.57798.81
20min1197502-19750297.11598.501.7797.4898.881.76
2196108-19610896.42996.83
3201304-20130498.98499.36
4200986-20098698.82899.20
5206265-206265101.423101.80
6199724-19972498.20798.58
30min1196669-19666996.70598.441.8097.2198.961.79
2196075-19607596.41396.96
3201549-20154999.10599.63
4200761-20076198.71799.24
5205916-205916101.252101.78
6200177-20017798.43098.95
45min1197134-19713496.93498.331.6597.5999.001.64
2196611-19661196.67697.36
3201147-20114798.90799.58
4199760-19976098.22598.89
5205704-205704101.148101.83
6199500-19950098.09798.77
60min1196986-19698696.86198.522.0897.6699.342.07
2196076-19607696.41397.25
3201335-20133598.99999.82
4200330-20033098.50599.32
5207813-207813102.185103.02
6199649-19964998.17098.99
极限1196355-19635596.55198.191.8497.4999.161.83
2196025-19602596.38897.37
3200469-20046998.57499.55
4199783-19978398.23699.20
5206174-206174101.379102.36
6199289-19928997.99398.96
点击查看处理图标(人工保存)
 
原始图谱下载图谱(姜进硙 于 2024-12-26 14:04:58 完成)
生成报告数据部分(等待生成报告)
Current page cost:63 ms