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%
112.511573371580951579071575711581821578180.23
212.571597251594171595710.14
单位质量响应值RSD%判断
12615.3512694.590.45数据可信
供试品溶液-TL3539批-达格列净-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%
5min1110584-11058456.20648.9917.7056.2148.9917.71
2110552-11055256.19056.19
372390-7239036.79336.79
4106090-10609053.92253.92
5101314-10131451.49451.49
677443-7744339.36139.36
10min1185366-18536694.21581.8513.7094.3081.9213.71
2184112-18411293.57793.66
3137120-13712069.69369.75
4163014-16301482.85482.94
5162570-16257082.62882.71
6134005-13400568.11068.17
15min1201278-201278102.30289.4311.63102.5389.6211.64
2193780-19378098.49198.72
3152058-15205877.28677.45
4178803-17880390.87991.08
5177298-17729890.11490.32
6152439-15243977.47977.64
20min1202046-202046102.69392.029.78103.0792.369.79
2196350-19635099.798100.17
3157567-15756780.08680.36
4183107-18310793.06793.41
5184239-18423993.64293.98
6163027-16302782.86183.14
30min1200714-200714102.01694.397.04102.5594.867.07
2197983-197983100.628101.15
3166667-16666784.71185.11
4187218-18721895.15695.64
5186543-18654394.81395.29
6175097-17509788.99589.40
45min1203545-203545103.45595.985.87104.1496.595.90
2197815-197815100.542101.22
3172346-17234687.59788.12
4189111-18911196.11896.74
5187948-18794895.52796.15
6182210-18221092.61193.15
60min1203488-203488103.42696.914.93104.2797.664.97
2197520-197520100.392101.22
3175783-17578389.34490.00
4189772-18977296.45497.22
5189035-18903596.08096.84
6188379-18837995.74696.42
120min1203422-203422103.39298.514.22104.3999.414.25
2199870-199870101.587102.56
3179565-17956591.26692.05
4193061-19306198.12699.04
5192920-19292098.05498.96
6194088-19408898.64899.47
180min1203691-203691103.52999.003.05104.68100.053.09
2199398-199398101.347102.47
3186989-18698995.04095.96
4193141-19314198.16799.23
5191421-19142197.29298.35
6194058-19405898.63399.60
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
240min1201541-201541102.43698.363.60103.7499.553.63
2197871-197871100.571101.85
3181028-18102892.01093.08
4193158-19315898.17599.38
5192706-19270697.94599.14
6194776-19477698.998100.11
360min1203289-203289103.32499.223.37104.78100.563.40
2197710-197710100.489101.92
3183847-18384793.44394.65
4192996-19299698.09399.45
5195020-19502099.122100.47
6198377-198377100.828102.09
480min1208720-208720106.085101.973.64107.70103.463.66
2204576-204576103.979105.56
3188097-18809795.60396.95
4198427-198427100.853102.35
5198823-198823101.055102.55
6205109-205109104.249105.66
600min1208113-208113105.776101.863.57107.55103.503.59
2203651-203651103.508105.24
3188075-18807595.59297.08
4202044-202044102.692104.34
5196364-19636499.805101.45
6204159-204159103.767105.34
720min1204975-204975104.181100.703.12106.11102.493.15
2201179-201179102.252104.14
3187797-18779795.45097.08
4196936-196936100.095101.90
5195376-19537699.303101.10
6202453-202453102.900104.62
960min1203420-203420103.39199.553.40105.48101.503.43
2199511-199511101.404103.45
3184182-18418293.61395.39
4194375-19437598.794100.75
5194609-19460998.913100.86
6199101-199101101.196103.08
1440min1201926-201926102.63298.363.86104.88100.453.86
2195612-19561299.423101.62
3181838-18183892.42294.34
4191274-19127497.21899.32
5189921-18992196.53098.62
6200498-200498101.906103.94
极限1200714-200714102.01698.053.70104.41100.293.72
2198252-198252100.764103.11
3180973-18097391.98294.04
4190975-19097597.06699.32
5190292-19029296.71998.96
6196222-19622299.733101.92
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%
110.069225829276529311379206819231339250370.47
210.049262169344889303520.63
单位质量响应值RSD%判断
91951.9992664.540.55数据可信
供试品溶液-TL3539批-二甲双胍-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%
5min127385-273852.9672.924.242.972.924.25
226096-260962.8272.83
326711-267112.8942.89
425772-257722.7922.79
526855-268552.9092.91
628986-289863.1403.14
10min166258-662587.1787.126.257.187.126.25
268526-685267.4247.43
360437-604376.5476.55
464632-646327.0027.01
571770-717707.7757.78
662516-625166.7736.78
15min1102962-10296211.15410.675.7211.1710.685.71
2104949-10494911.37011.38
390538-905389.8089.82
498859-9885910.71010.72
5100473-10047310.88510.90
693102-9310210.08610.10
20min1135045-13504514.63013.856.0614.6613.886.05
2135562-13556214.68614.72
3116831-11683112.65712.69
4127489-12748913.81113.84
5131432-13143214.23914.27
6120480-12048013.05213.08
30min1183437-18343719.87319.124.8019.9319.174.81
2185422-18542220.08820.14
3165642-16564217.94517.99
4176870-17687019.16119.21
5180864-18086419.59419.65
6166820-16682018.07218.12
45min1246402-24640226.69425.503.9726.7825.583.98
2243880-24388026.42126.51
3223911-22391124.25724.33
4233604-23360425.30725.39
5238836-23883625.87425.96
6225672-22567224.44824.52
60min1293465-29346531.79230.763.1431.9230.883.15
2293366-29336631.78231.91
3272674-27267429.54029.65
4282554-28255430.61030.73
5286512-28651231.03931.16
6274983-27498329.79029.90
120min1439577-43957747.62146.722.3147.7946.882.31
2444513-44451348.15648.33
3419379-41937945.43345.59
4427761-42776146.34146.51
5434169-43416947.03547.20
6421913-42191345.70845.87
180min1549199-54919959.49758.391.6659.7458.621.66
2549146-54914659.49159.74
3537167-53716758.19458.42
4533994-53399457.85058.08
5537812-53781258.26358.50
6526399-52639957.02757.25
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
240min1626161-62616167.83567.331.3368.1767.661.34
2628807-62880768.12168.45
3614531-61453166.57566.89
4620022-62002267.17067.49
5630076-63007668.25968.59
6609639-60963966.04566.36
360min1750288-75028881.28280.920.9881.7281.340.99
2754354-75435481.72282.16
3744361-74436180.64081.05
4738551-73855180.01080.43
5754864-75486481.77882.21
6739156-73915680.07680.49
480min1841848-84184891.20191.310.7291.7691.860.73
2853005-85300592.41092.97
3842337-84233791.25491.79
4834497-83449790.40590.95
5844954-84495491.53792.09
6840579-84057991.06491.59
600min1892889-89288996.73096.480.7197.4297.160.71
2893031-89303196.74697.44
3894272-89427296.88097.55
4897713-89771397.25397.93
5881983-88198395.54996.24
6883606-88360695.72596.39
720min1908493-90849398.42198.270.6399.2699.100.63
2910290-91029098.61699.46
3916435-91643599.281100.10
4901912-90191297.70898.53
5902824-90282497.80798.64
6902850-90285097.81098.62
960min1923880-923880100.08899.780.22101.07100.760.22
2920670-92067099.740100.73
3920794-92079499.754100.72
4919190-91919099.580100.55
5922855-92285599.977100.96
6918950-91895099.554100.51
1440min1923098-923098100.003100.010.69101.14101.140.68
2919167-91916799.577100.72
3928170-928170100.553101.67
4914732-91473299.097100.22
5921528-92152899.833100.96
6932495-932495101.021102.13
极限1920850-92085099.76099.620.18101.05100.890.20
2921203-92120399.798101.09
3918151-91815199.467100.73
4920661-92066199.739101.01
5919179-91917999.579100.86
6917118-91711899.355100.61
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%
112.511605961599301613181607961602981605880.33
212.571601161609051605100.35
单位质量响应值RSD%判断
12836.7712769.290.38数据可信
供试品溶液-TL3539批-达格列净-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%
5min1100250-10025050.36445.9117.0350.3645.9217.03
294464-9446447.45747.46
395251-9525147.85347.85
4107403-10740353.95853.96
588654-8865444.53844.54
662335-6233531.31631.32
10min1176155-17615588.49883.2712.7188.5783.3412.71
2174167-17416787.49987.57
3178737-17873789.79589.87
4162039-16203981.40681.49
5178703-17870389.77889.84
6124647-12464762.62162.67
15min1184354-18435492.61790.9310.2092.8291.1210.20
2187234-18723494.06394.27
3193326-19332697.12497.33
4176933-17693388.88889.09
5197761-19776199.35299.55
6146319-14631973.50873.65
20min1187264-18726494.07992.917.9794.4393.247.99
2189237-18923795.07095.41
3195903-19590398.41998.77
4181044-18104490.95491.29
5198516-19851699.731100.08
6157687-15768779.22079.47
30min1187582-18758294.23894.797.2394.7395.267.25
2198019-19801999.48299.97
3196441-19644198.68999.19
4187580-18758094.23794.71
5199553-199553100.252100.75
6162950-16295081.86482.23
45min1190648-19064895.77995.735.4096.4196.345.42
2193974-19397497.45098.08
3197609-19760999.27699.92
4187974-18797494.43595.05
5201155-201155101.057101.71
6171905-17190586.36286.86
60min1188680-18868094.79095.754.5995.5696.514.61
2191545-19154596.22997.01
3197156-19715699.04899.84
4188864-18886494.88295.64
5201374-201374101.167101.97
6175957-17595788.39889.02
120min1189485-18948595.19496.753.6896.1197.653.71
2193303-19330397.11298.04
3199027-19902799.988100.93
4190342-19034295.62596.52
5201455-201455101.208102.16
6181879-18187991.37392.13
180min1190959-19095995.93597.313.2896.9998.353.32
2193463-19346397.19398.26
3198267-19826799.606100.70
4191272-19127296.09297.13
5203238-203238102.104103.21
6184983-18498392.93393.82
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
240min1189786-18978695.34697.432.6996.5598.622.72
2192995-19299596.95898.18
3198197-19819799.571100.82
4191113-19111396.01297.20
5202280-202280101.622102.88
6189280-18928095.09196.12
360min1191205-19120596.05897.682.8097.4099.012.84
2193966-19396697.44698.81
3199262-199262100.106101.50
4192205-19220596.56197.89
5202327-202327101.646103.06
6187592-18759294.24395.42
480min1194956-19495697.943100.752.5799.43102.232.59
2200177-200177100.566102.07
3204844-204844102.910104.45
4199446-199446100.199101.67
5208127-208127104.560106.12
6195707-19570798.32099.64
600min1194593-19459397.761100.292.5899.40101.922.60
2198819-19881999.884101.54
3204318-204318102.646104.34
4198156-19815699.551101.18
5207167-207167104.077105.80
6194660-19466097.79499.26
720min1194382-19438297.65599.872.6599.44101.662.67
2197200-19720099.070100.88
3204645-204645102.810104.66
4195679-19567998.306100.08
5206220-206220103.602105.48
6194671-19467197.80099.41
960min1196910-19691098.92599.392.57100.85101.332.59
2195806-19580698.370100.33
3201693-201693101.327103.33
4192991-19299196.95698.88
5206054-206054103.518105.55
6193618-19361897.27199.03
1440min1191497-19149796.20596.981.8198.2899.061.86
2192591-19259196.75598.86
3196112-19611298.524100.68
4190863-19086395.88797.95
5198250-19825099.598101.79
6188932-18893294.91796.82
极限1190008-19000895.45796.632.3697.6898.862.40
2191371-19137196.14298.39
3195037-19503797.984100.29
4190314-19031495.61197.82
5200056-200056100.505102.84
6187287-18728794.09096.13
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%
110.069332089403179384239378249353279370200.30
210.049267449297569282500.23
单位质量响应值RSD%判断
93143.1492455.180.53数据可信
供试品溶液-TL3539批-二甲双胍-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%
5min124579-245792.6493.4948.612.653.4948.62
226204-262042.8242.82
326094-260942.8122.81
427979-279793.0153.02
524999-249992.6942.69
664407-644076.9416.94
10min165655-656557.0756.894.867.086.894.81
265690-656907.0797.08
362964-629646.7856.79
467360-673607.2597.26
563218-632186.8126.82
658558-585586.3106.32
15min1112644-11264412.13911.399.7312.1511.419.70
2113820-11382012.26512.28
3100423-10042310.82210.84
4102991-10299111.09811.11
5115580-11558012.45512.47
688922-889229.5829.60
20min1133528-13352814.38913.914.9714.4213.954.94
2130912-13091214.10714.14
3131866-13186614.21014.24
4130661-13066114.08014.11
5131598-13159814.18114.21
6116193-11619312.52112.56
30min1183464-18346419.77019.255.5219.8219.305.51
2184003-18400319.82819.88
3180912-18091219.49519.55
4183045-18304519.72519.78
5181776-18177619.58819.64
6158644-15864417.09617.15
45min1243827-24382726.27525.554.5326.3625.644.53
2239529-23952925.81225.90
3243100-24310026.19726.28
4238284-23828425.67825.76
5242421-24242126.12426.21
6215668-21566823.24123.32
60min1293015-29301531.57630.754.2031.7030.874.19
2287583-28758330.99031.11
3291725-29172531.43731.56
4285434-28543430.75930.88
5292633-29263331.53431.66
6261708-26170828.20228.32
120min1444445-44444547.89446.713.4048.0646.883.40
2437577-43757747.15447.32
3441302-44130247.55547.72
4429866-42986646.32346.49
5442477-44247747.68247.85
6405314-40531443.67743.83
180min1554082-55408259.70858.602.6559.9558.842.65
2547445-54744558.99359.23
3549913-54991359.25959.50
4539397-53939758.12658.36
5555295-55529559.83960.08
6516884-51688455.70055.92
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
240min1636811-63681168.62367.832.1968.9668.152.19
2631786-63178668.08268.41
3636917-63691768.63568.96
4622713-62271367.10467.43
5643296-64329669.32269.65
6605093-60509365.20565.51
360min1764249-76424982.35681.172.2082.7981.602.20
2761820-76182082.09582.53
3762296-76229682.14682.58
4742057-74205779.96580.39
5764655-76465582.40082.84
6724351-72435178.05778.46
480min1855479-85547992.18792.041.1792.7592.591.18
2864841-86484193.19693.75
3860175-86017592.69393.25
4851208-85120891.72792.27
5857005-85700592.35292.91
6836080-83608090.09790.62
600min1897998-89799896.76996.491.2397.4797.181.24
2908067-90806797.85498.55
3902866-90286697.29497.99
4889342-88934295.83696.52
5897489-89748996.71497.41
6876895-87689594.49595.15
720min1931537-931537100.38399.041.26101.2399.871.26
2929358-929358100.149100.99
3924342-92434299.608100.45
4906621-90662197.69898.52
5918177-91817798.94499.79
6904381-90438197.45798.25
960min1956979-956979103.125100.661.50104.12101.641.50
2937183-937183100.992101.98
3937966-937966101.076102.06
4918476-91847698.97699.95
5933111-933111100.553101.54
6920791-92079199.225100.17
1440min1941022-941022101.40699.971.40102.55101.101.40
2944858-944858101.819102.96
3925257-92525799.707100.85
4918558-91855898.985100.11
5925129-92512999.693100.83
6911465-91146598.22099.31
极限1930322-930322100.25399.641.24101.55100.911.25
2936672-936672100.937102.23
3925497-92549799.733101.02
4912332-91233298.31499.58
5933662-933662100.612101.90
6909064-90906497.96299.20
点击查看处理图标(自动生成)
 
原始图谱下载图谱(谢鑫慧 于 2025-01-03 15:47:22 完成)
生成报告数据部分(等待生成报告)
Current page cost:1.508 s