达格列净二甲双胍缓释片项目信息
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1250
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%
112.447918979217790797930878997791580.16
212.257934279460794010.11
单位质量响应值RSD%判断
6363.186481.711.31数据可信
供试品溶液-WL0116批-达格列净-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%
5min190695-9069590.83890.453.6490.8490.453.64
287884-8788488.02288.02
393299-9329993.44693.45
492285-9228592.43092.43
592765-9276592.91192.91
684933-8493385.06785.07
10min199990-99990100.14798.871.39100.2899.001.39
299573-9957399.73099.86
396952-9695297.10497.24
499928-99928100.085100.22
598672-9867298.82798.97
697165-9716597.31897.45
15min1100944-100944101.10399.591.40101.3999.881.39
2100283-100283100.441100.72
397366-9736697.51997.80
4100536-100536100.694100.98
599007-9900799.16399.45
698492-9849298.64798.92
20min1101002-101002101.16199.691.18101.60100.121.18
2100388-100388100.546100.98
397682-9768297.83698.27
499827-9982799.984100.42
599455-9945599.611100.05
698842-9884298.99799.42
30min1101377-101377101.536101.052.18102.13101.642.16
2105126-105126105.291105.87
399805-9980599.962100.54
4100070-100070100.227100.82
599710-9971099.867100.45
699283-9928399.439100.01
45min1101632-101632101.792100.261.28102.53100.991.28
2101273-101273101.432102.17
398070-9807098.22498.95
4100130-100130100.287101.03
599903-99903100.060100.80
699596-9959699.753100.47
60min1102238-102238102.399100.251.62103.29101.141.61
2101135-101135101.294102.19
397406-9740697.55998.44
4100160-100160100.317101.21
599770-9977099.927100.81
699849-99849100.006100.87
120min1101672-101672101.832100.972.21102.88102.002.19
2101346-101346101.505102.55
397701-9770197.85598.88
4104303-104303104.467105.51
5100160-100160100.317101.35
699664-9966499.821100.84
180min1101326-101326101.485100.251.30102.69101.441.30
2101239-101239101.398102.60
397730-9773097.88499.05
4100108-100108100.265101.46
599943-99943100.100101.29
6100215-100215100.373101.54
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
240min1101900-101900102.060101.692.12103.41103.022.10
2101991-101991102.151103.50
397892-9789298.04699.36
4103180-103180103.342104.69
5100348-100348100.506101.84
6103851-103851104.014105.33
360min1100954-100954101.113100.081.28102.62101.581.28
2101308-101308101.467102.97
397662-9766297.81699.28
499968-99968100.125101.63
599903-99903100.060101.55
699772-9977299.929101.40
480min1104684-104684104.849103.812.07106.51105.442.05
2104710-104710104.875106.53
3100540-100540100.698102.31
4102775-102775102.937104.59
5102495-102495102.656104.29
6106650-106650106.818108.44
600min1103623-103623103.786102.491.35105.60104.281.35
2103878-103878104.041105.85
3100038-100038100.195101.96
4102041-102041102.201104.01
5101984-101984102.144103.94
6102401-102401102.562104.35
720min1103103-103103103.265101.821.53105.24103.781.53
2103268-103268103.430105.40
398967-9896799.123101.03
4101596-101596101.756103.72
5101322-101322101.481103.43
6101733-101733101.893103.83
960min1102298-102298102.459100.681.39104.58102.781.38
2101549-101549101.709103.83
398201-9820198.355100.42
4100413-100413100.571102.68
5100266-100266100.424102.52
6100427-100427100.585102.68
达格列净二甲双胍缓释片项目信息
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100664-202106对照品来源中检院对照品使用方法直接使用
对照品含量(%)100.0对照品水分(%)0对照品稀释倍数10
标示量(mg)1000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%
110.205490775487465492675494855489365491020.06
210.145460805473035466920.16
单位质量响应值RSD%判断
53833.5353914.400.11数据可信
供试品溶液-WL0116批-二甲双胍-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%
5min120860-208603.8723.7714.303.873.7714.37
214950-149502.7752.77
323682-236824.3964.40
420317-203173.7713.77
521603-216034.0104.01
620346-203463.7773.78
10min148680-486809.0368.854.439.048.854.42
245274-452748.4048.41
350668-506689.4059.41
448742-487429.0479.05
547248-472488.7708.78
645400-454008.4278.43
15min169239-6923912.85212.473.5612.8712.493.55
263827-6382711.84711.86
370273-7027313.04413.06
466744-6674412.38912.41
567684-6768412.56312.58
665446-6544612.14812.17
20min185391-8539115.85015.543.0915.8915.583.10
280243-8024314.89514.93
387577-8757716.25616.30
483983-8398315.58915.63
583410-8341015.48215.52
681836-8183615.19015.23
30min1112359-11235920.85621.025.9520.9221.095.94
2109259-10925920.28020.34
3126788-12678823.53423.60
4111242-11124220.64920.71
5110740-11074020.55520.62
6109222-10922220.27420.33
45min1145082-14508226.93026.651.7827.0226.741.79
2139929-13992925.97326.06
3147185-14718527.32027.42
4144477-14447726.81826.91
5142526-14252626.45526.55
6142193-14219326.39426.48
60min1172503-17250332.02031.801.4632.1531.931.47
2167559-16755931.10231.23
3174844-17484432.45432.60
4172254-17225431.97432.11
5170099-17009931.57431.71
6170502-17050231.64831.78
120min1252667-25266746.90046.811.3047.0846.991.31
2249417-24941746.29646.47
3255388-25538847.40547.59
4256750-25675047.65847.84
5249657-24965746.34146.52
6249315-24931546.27746.45
180min1309164-30916457.38757.620.8557.6457.870.86
2308180-30818057.20457.45
3314564-31456458.38958.65
4312736-31273658.05058.30
5309772-30977257.49957.75
6308204-30820457.20857.45
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
240min1356281-35628166.13266.861.0566.4767.201.05
2357369-35736966.33466.66
3361575-36157567.11567.46
4360392-36039266.89567.23
5358785-35878566.59766.93
6366803-36680368.08568.42
360min1416996-41699677.40278.470.8877.8478.910.88
2423118-42311878.53978.97
3425809-42580979.03879.49
4424509-42450978.79779.24
5426378-42637879.14479.58
6419680-41968077.90078.33
480min1478485-47848588.81690.471.3989.3791.031.38
2484017-48401789.84390.39
3486713-48671390.34390.91
4486107-48610790.23090.79
5490670-49067091.07791.63
6498546-49854692.53993.09
600min1508839-50883994.45095.670.9995.1496.360.99
2515693-51569395.72296.40
3516402-51640295.85496.56
4517231-51723196.00896.70
5523263-52326397.12797.82
6510960-51096094.84495.53
720min1530711-53071198.51099.660.9499.34100.490.94
2535558-53555899.409100.23
3536944-53694499.667100.51
4538327-53832799.923100.76
5545667-545667101.286102.12
6534204-53420499.15899.99
960min1551554-551554102.379103.121.03103.36104.111.02
2553139-553139102.673103.65
3553380-553380102.718103.71
4557056-557056103.400104.39
5566443-566443105.142106.13
6551765-551765102.418103.40
达格列净二甲双胍缓释片项目信息
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1250
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%
112.447990780154800978035380268801560.22
212.257979480005799000.19
单位质量响应值RSD%判断
6443.416522.450.87数据可信
供试品溶液-WL0116批-达格列净-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%
5min189273-8927388.57586.594.5888.5786.584.57
291500-9150090.78590.78
388134-8813487.44587.44
490067-9006789.36389.36
582543-8254381.89881.90
682099-8209981.45781.46
10min196176-9617695.42496.331.5995.5696.461.59
2100016-10001699.23499.37
396202-9620295.45095.58
497616-9761696.85396.99
596453-9645395.69995.82
696099-9609995.34895.47
15min197071-9707196.31297.941.7096.5998.221.69
2101859-101859101.063101.35
397696-9769696.93297.21
498916-9891698.14398.42
598425-9842597.65597.92
698309-9830997.54097.81
20min197579-9757996.81698.351.6297.2498.771.62
2102080-102080101.282101.72
398132-9813297.36597.78
499632-9963298.85399.28
598785-9878598.01398.43
698527-9852797.75798.17
30min198402-9840297.63399.031.4598.2099.601.45
2102377-102377101.577102.17
398702-9870297.93098.50
4100337-10033799.552100.13
599295-9929598.51999.08
699770-9977098.99099.55
45min198158-9815897.39199.141.7298.1099.861.72
2102992-102992102.187102.93
398930-9893098.15698.87
4100687-10068799.900100.62
599442-9944298.66499.37
699311-9931198.53499.24
60min198563-9856397.79299.121.4698.6599.991.46
2102470-102470101.669102.56
399237-9923798.46199.32
4100681-10068199.894100.77
598903-9890398.13098.99
699565-9956598.78799.64
120min198105-9810597.33899.101.6098.34100.111.60
2102350-102350101.550102.60
398861-9886198.08899.10
4101214-101214100.423101.45
599211-9921198.43599.44
699523-9952398.74599.75
180min198083-9808397.31699.621.6198.47100.791.61
2102106-102106101.308102.51
399025-9902598.25199.41
4102081-102081101.283102.46
5100572-10057299.786100.94
6100588-10058899.802100.95
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
240min198775-9877598.003100.182.6399.30101.492.61
2106075-106075105.246106.60
399505-9950598.727100.03
4101192-101192100.401101.73
599617-9961798.838100.14
6100648-10064899.861101.16
360min198131-9813197.36499.241.5798.81100.701.57
2102348-102348101.548103.06
399446-9944698.668100.12
4101066-101066100.276101.75
598718-9871897.94699.39
6100401-10040199.616101.07
480min1100810-100810100.022102.191.55101.61103.801.55
2105273-105273104.450106.11
3102295-102295101.495103.09
4104170-104170103.356104.98
5102115-102115101.317102.91
6103325-103325102.517104.12
600min1100751-10075199.963101.741.46101.70103.501.46
2104749-104749103.930105.75
3101867-101867101.071102.82
4103597-103597102.787104.57
5101380-101380100.587102.33
6102895-102895102.090103.84
720min1100295-10029599.511101.081.68101.40103.001.68
2104295-104295103.480105.45
3100325-10032599.541101.44
4103098-103098102.292104.23
5100577-10057799.791101.69
6102653-102653101.850103.76
960min198955-9895598.181100.141.69100.22102.211.69
2103196-103196102.389104.52
399676-9967698.897100.95
4102280-102280101.480103.57
599748-9974898.968101.02
6101727-101727100.932102.99
达格列净二甲双胍缓释片项目信息
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100664-202106对照品来源中检院对照品使用方法直接使用
对照品含量(%)100.0对照品水分(%)0对照品稀释倍数10
标示量(mg)1000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%
110.205509545508425517345509255515035511920.08
210.145476435482985479700.09
单位质量响应值RSD%判断
54038.4354040.430.01数据可信
供试品溶液-WL0116批-二甲双胍-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%
5min122759-227594.2123.6317.134.213.6317.19
216070-160702.9742.97
322040-220404.0794.08
414829-148292.7442.74
521813-218134.0364.04
620096-200963.7193.72
10min149543-495439.1688.644.909.178.654.90
247571-475718.8038.81
346292-462928.5668.57
443964-439648.1368.14
548577-485778.9899.00
644222-442228.1838.19
15min169343-6934312.83212.354.3412.8512.374.34
269354-6935412.83412.85
366805-6680512.36212.38
462698-6269811.60211.62
568541-6854112.68412.70
663802-6380211.80711.82
20min185578-8557815.83615.193.2215.8815.223.24
283364-8336415.42715.46
382592-8259215.28415.32
478416-7841614.51114.54
582939-8293915.34815.39
679522-7952214.71614.75
30min1112075-11207520.73920.142.0420.8020.202.04
2109434-10943420.25120.31
3109737-10973720.30720.37
4105624-10562419.54619.60
5108881-10888120.14820.21
6107265-10726519.84919.91
45min1143605-14360526.57425.882.0326.6725.982.04
2140821-14082126.05926.15
3142533-14253326.37626.47
4136906-13690625.33425.42
5137454-13745425.43625.53
6137954-13795425.52825.62
60min1171035-17103531.65030.831.9331.7830.961.92
2167110-16711030.92431.05
3169576-16957631.38031.51
4163521-16352130.26030.38
5163446-16344630.24630.38
6164849-16484930.50530.63
120min1249656-24965646.19945.351.5846.3845.531.58
2247330-24733045.76845.94
3247834-24783445.86246.04
4243093-24309344.98445.15
5239193-23919344.26344.44
6243412-24341245.04345.21
180min1309155-30915557.20956.490.9057.4656.730.90
2305340-30534056.50356.75
3305981-30598156.62256.87
4305884-30588456.60456.84
5300703-30070355.64555.89
6304511-30451156.35056.59
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
240min1356642-35664265.99765.301.9466.3365.631.93
2364002-36400267.35967.69
3352137-35213765.16365.49
4349498-34949864.67565.00
5344007-34400763.65963.98
6350955-35095564.94465.27
360min1420584-42058477.82977.061.0278.2677.481.02
2418882-41888277.51477.94
3416367-41636777.04977.48
4416003-41600376.98177.40
5408458-40845875.58576.01
6418204-41820477.38977.81
480min1480239-48023988.86888.580.6089.4289.120.60
2479617-47961788.75389.30
3478369-47836988.52289.07
4478698-47869888.58389.12
5473389-47338987.60188.13
6481693-48169389.13789.67
600min1513195-51319594.96794.650.4395.6595.320.43
2511170-51117094.59295.27
3509509-50950994.28594.96
4512176-51217694.77895.44
5508494-50849494.09794.76
6514247-51424795.16195.83
720min1534602-53460298.92898.720.5799.7699.540.56
2533452-53345298.71599.54
3529454-52945497.97598.79
4534068-53406898.82999.64
5531141-53114198.28899.09
6538118-53811899.579100.39
960min1553651-553651102.453102.520.57103.43103.480.56
2552923-552923102.318103.29
3549606-549606101.705102.67
4556099-556099102.906103.86
5552979-552979102.329103.28
6558776-558776103.402104.36
点击查看处理图标(自动生成)
 
原始图谱下载图谱(谢鑫慧 于 2025-03-12 16:23:02 完成)
生成报告数据部分(等待生成报告)
Current page cost:86 ms