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%
112.331603361593601595811591741597501596400.28
212.361609651606581608120.14
单位质量响应值RSD%判断
12947.2813010.680.35数据可信
供试品溶液-24120501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%
5min1106703-10670352.87951.946.4452.8851.946.43
2113313-11331356.15556.15
3103629-10362951.35651.36
4101986-10198650.54250.54
593807-9380746.48846.49
6109373-10937354.20254.20
10min1178355-17835588.38887.932.8688.4788.002.86
2181180-18118089.78889.87
3179783-17978389.09689.17
4177599-17759988.01388.09
5167442-16744282.98083.05
6180197-18019789.30189.38
15min1186011-18601192.18292.081.8592.3992.291.85
2188655-18865593.49293.71
3188637-18863793.48393.69
4185381-18538191.87092.08
5179375-17937588.89389.09
6186751-18675192.54992.76
20min1188492-18849293.41293.441.5093.7693.791.50
2191151-19115194.72995.09
3190890-19089094.60094.95
4188353-18835393.34393.69
5183341-18334190.85991.19
6189102-18910293.71494.07
30min1191581-19158194.94294.731.0695.4395.221.07
2193248-19324895.76996.27
3192037-19203795.16895.66
4191505-19150594.90595.39
5187305-18730592.82393.29
6191249-19124994.77895.27
45min1193018-19301895.65595.770.8896.2996.400.89
2195387-19538796.82997.47
3193431-19343195.85996.49
4194516-19451696.39797.02
5190425-19042594.37094.97
6192782-19278295.53896.17
60min1193992-19399296.13796.080.6296.9196.860.62
2195175-19517596.72497.51
3194113-19411396.19796.98
4195006-19500696.64097.41
5192170-19217095.23495.98
6192847-19284795.57096.35
120min1196423-19642397.34297.370.6598.2698.290.65
2197607-19760797.92998.86
3196040-19604097.15298.08
4198319-19831998.28299.20
5195074-19507496.67397.56
6195440-19544096.85597.78
180min1196153-19615397.20897.080.7398.2798.140.73
2197318-19731897.78698.87
3194444-19444496.36197.43
4197700-19770097.97599.04
5195364-19536496.81797.85
6194361-19436196.32097.39
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
240min1195470-19547096.87096.910.6898.0898.120.67
2196848-19684897.55398.78
3194842-19484296.55997.77
4197310-19731097.78298.99
5194976-19497696.62597.80
6193825-19382596.05597.27
360min1195006-19500696.64097.270.7398.0098.630.73
2197232-19723297.74399.12
3196053-19605397.15998.52
4198634-19863498.43899.80
5195807-19580797.03798.36
6194951-19495196.61397.97
480min1195407-19540796.83996.840.7398.3498.340.72
2196415-19641597.33898.86
3194459-19445996.36997.87
4197661-19766197.95699.46
5194701-19470196.48997.96
6193831-19383196.05797.56
600min1199243-19924398.74098.740.77100.39100.380.76
2199988-19998899.109100.78
3197785-19778598.01799.67
4201876-201876100.044101.70
5198441-19844198.34299.96
6198076-19807698.16199.81
720min1198728-19872898.48498.260.86100.28100.050.85
2199214-19921498.725100.54
3197298-19729897.77699.57
4200948-20094899.584101.39
5197161-19716197.70899.47
6196298-19629897.28099.07
960min1196578-19657897.41997.530.7899.3699.470.77
2197723-19772397.98699.95
3195861-19586197.06499.01
4199349-19934998.792100.74
5196128-19612897.19699.10
6195127-19512796.70098.64
1200min1195084-19508496.67896.760.9498.7798.840.93
2196316-19631697.28999.40
3193738-19373896.01198.10
4198355-19835598.299100.40
5194481-19448196.38098.43
6193493-19349395.89097.97
极限1194724-19472496.50096.580.9798.7398.820.96
2196211-19621197.23799.49
3193026-19302695.65997.89
4197691-19769197.970100.22
5194954-19495496.61498.81
6192743-19274395.51897.75
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%
1 9.881077303107592310764751073505107228710750990.20
2 9.921075995107557010757820.03
单位质量响应值RSD%判断
108815.69108445.770.25数据可信
供试品溶液-24120501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%
5min139529-395293.6394.2312.383.644.2412.39
244667-446674.1124.11
345109-451094.1534.15
446461-464614.2774.28
556579-565795.2085.21
643656-436564.0194.02
10min199585-995859.1679.402.669.179.412.65
2101855-1018559.3769.38
3106313-1063139.7879.79
4103730-1037309.5499.56
598946-989469.1089.12
6102272-1022729.4159.42
15min1149359-14935913.74914.052.3013.7714.082.31
2152104-15210414.00214.02
3159094-15909414.64514.67
4153928-15392814.17014.19
5150892-15089213.89013.91
6150661-15066113.86913.89
20min1188359-18835917.33917.752.2217.3817.792.22
2192841-19284117.75217.79
3200306-20030618.43918.48
4194497-19449717.90417.95
5190530-19053017.53917.58
6190126-19012617.50217.54
30min1255735-25573523.54223.641.7223.6123.711.71
2255634-25563423.53223.60
3265051-26505124.39924.47
4257632-25763223.71623.79
5254102-25410223.39123.46
6252568-25256823.25023.32
45min1329358-32935830.31930.611.7230.4230.721.72
2330728-33072830.44530.55
3343481-34348131.61931.73
4332548-33254830.61330.72
5331783-33178330.54230.65
6327138-32713830.11530.22
60min1391424-39142436.03336.311.9136.1836.461.91
2390623-39062335.95936.11
3408717-40871737.62537.78
4394106-39410636.28036.43
5394958-39495836.35836.51
6387036-38703635.62935.78
120min1573939-57393952.83453.181.4653.0353.381.46
2576051-57605153.02953.23
3591415-59141554.44354.65
4577250-57725053.13953.34
5581601-58160153.53953.74
6566165-56616552.11852.32
180min1702311-70231164.65164.821.3264.9365.101.33
2703965-70396564.80465.09
3717710-71771066.06966.36
4702469-70246964.66664.95
5709103-70910365.27765.56
6689422-68942263.46563.74
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
240min1797330-79733073.39873.491.2073.7873.871.20
2798603-79860373.51673.90
3811267-81126774.68175.07
4796437-79643773.31673.70
5803849-80384973.99974.38
6782409-78240972.02572.40
360min1931981-93198185.79485.941.1086.2886.431.10
2934481-93448186.02486.51
3945689-94568987.05687.56
4934991-93499186.07186.56
5939323-93932386.47086.96
6915156-91515684.24584.73
480min11008988-100898892.88392.940.9593.5093.560.95
21011106-101110693.07893.70
31017032-101703293.62394.26
41013818-101381893.32793.95
51015474-101547493.48094.10
6991066-99106691.23391.84
600min11070442-107044298.54098.810.8699.2999.580.86
21074788-107478898.94099.70
31079596-107959699.382100.16
41081358-108135899.545100.31
51077921-107792199.22899.99
61056428-105642897.25098.00
720min11092028-1092028100.527100.510.76101.43101.420.76
21090826-1090826100.416101.32
31096646-1096646100.952101.88
41098841-1098841101.154102.06
51096403-1096403100.930101.84
61076226-107622699.07299.96
960min11098234-1098234101.098101.440.91102.15102.500.91
21103253-1103253101.560102.62
31107990-1107990101.996103.07
41110163-1110163102.196103.26
51108574-1108574102.050103.11
61083723-108372399.762100.80
1200min11097459-1097459101.027101.260.96102.23102.470.96
21100812-1100812101.336102.55
31103268-1103268101.562102.79
41110317-1110317102.211103.43
51107556-1107556101.956103.17
61080713-108071399.485100.67
极限11094533-1094533100.758101.101.03102.11102.461.03
21100395-1100395101.297102.66
31101181-1101181101.369102.75
41107664-1107664101.966103.33
51107878-1107878101.986103.36
61077653-107765399.204100.54
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%
112.331606461602271605101606571599451603970.20
212.361610251609991610120.02
单位质量响应值RSD%判断
13008.6813026.860.10数据可信
供试品溶液-24112601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%
5min166149-6614932.68433.8310.1032.6833.8310.10
271397-7139735.27735.28
360941-6094130.11130.11
479461-7946139.26139.26
570835-7083534.99935.00
662018-6201830.64330.64
10min1183603-18360390.71788.625.2390.7788.675.23
2184950-18495091.38391.44
3174737-17473786.33786.38
4186470-18647092.13492.19
5184219-18421991.02291.07
6162213-16221380.14880.19
15min1198776-19877698.21496.501.5498.4096.691.55
2194629-19462996.16596.36
3194268-19426895.98796.16
4198755-19875598.20498.40
5194495-19449596.09996.29
6190938-19093894.34194.51
20min1201199-20119999.41197.791.6199.7498.121.62
2195832-19583296.75997.09
3197753-19775397.70998.03
4202308-20230899.959100.30
5196104-19610496.89497.23
6194317-19431796.01196.32
30min1202540-202540100.07498.631.48100.5699.101.48
2197407-19740797.53898.02
3199134-19913498.39198.86
4203771-203771100.682101.18
5198509-19850998.08298.56
6196310-19631096.99697.45
45min1203367-203367100.48299.041.38101.1199.661.39
2198877-19887798.26498.89
3199586-19958698.61499.23
4204422-204422101.004101.65
5198745-19874598.19998.82
6197652-19765297.65998.26
60min1203216-203216100.40898.671.35101.1999.441.36
2197722-19772297.69398.47
3199212-19921298.42999.19
4202838-202838100.221101.02
5198284-19828497.97198.74
6196896-19689697.28598.03
120min1206324-206324101.94399.771.35102.88100.691.35
2199532-19953298.58899.51
3201443-20144399.532100.44
4204073-204073100.831101.78
5200049-20004998.84399.76
6200094-20009498.86599.75
180min1204136-204136100.86299.301.12101.95100.371.13
2199494-19949498.56999.64
3200072-20007298.85499.91
4203488-203488100.542101.64
5198824-19882498.23899.31
6199849-19984998.74499.78
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
240min1203654-203654100.62498.881.27101.86100.101.27
2198430-19843098.04399.26
3199876-19987698.75899.96
4202726-202726100.166101.41
5198750-19875098.20199.42
6197304-19730497.48798.67
360min1209401-209401103.464101.701.20104.85103.061.21
2204314-204314100.950102.31
3206468-206468102.015103.37
4207690-207690102.618104.02
5204249-204249100.918102.28
6202831-202831100.218101.55
480min1208654-208654103.095101.361.16104.64102.881.17
2203419-203419100.508102.02
3205003-205003101.291102.80
4207258-207258102.405103.96
5203969-203969100.780102.29
6202503-202503100.056101.54
600min1207231-207231102.392100.571.38104.09102.241.39
2201168-20116899.396101.06
3203745-203745100.669102.33
4206556-206556102.058103.77
5201976-20197699.795101.46
6200621-20062199.126100.76
720min1206040-206040101.803100.001.22103.65101.821.23
2200724-20072499.177100.99
3202424-202424100.017101.83
4204475-204475101.030102.89
5201273-20127399.448101.26
6199451-19945198.548100.33
960min1204185-204185100.88798.901.49102.89100.881.48
2196226-19622696.95498.92
3200631-20063199.131101.09
4202664-202664100.135102.15
5199480-19948098.562100.53
6197848-19784897.75699.68
1200min1201760-20176099.68898.131.17101.84100.251.17
2195470-19547096.58198.69
3198848-19884898.250100.36
4200677-20067799.153101.32
5197437-19743797.55299.66
6197461-19746197.56499.64
极限1201896-20189699.75698.001.16102.06100.271.17
2196891-19689197.28399.54
3198148-19814897.904100.16
4200345-20034598.989101.30
5196612-19661297.14599.40
6196199-19619996.94199.16
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%
1 9.881074521107407310736381074428107384810741020.04
2 9.921074322107521510747680.06
单位质量响应值RSD%判断
108714.78108343.550.25数据可信
供试品溶液-24112601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%
5min148268-482684.4474.186.024.454.186.06
244285-442854.0804.08
340942-409423.7723.77
446115-461154.2494.25
544809-448094.1294.13
648070-480704.4294.43
10min194455-944558.7039.053.798.719.063.79
2101766-1017669.3779.38
392751-927518.5468.55
4101185-1011859.3239.33
599291-992919.1499.16
699736-997369.1909.20
15min1148628-14862813.69513.972.4013.7113.982.40
2155398-15539814.31914.34
3146092-14609213.46113.48
4154630-15463014.24814.27
5151409-15140913.95113.97
6153277-15327714.12314.14
20min1191613-19161317.65518.003.5017.7018.043.50
2196231-19623118.08118.12
3187994-18799417.32217.36
4207901-20790119.15619.20
5192730-19273017.75817.80
6195465-19546518.01018.05
30min1256231-25623123.60923.991.4323.6824.061.42
2262056-26205624.14624.21
3256071-25607123.59523.66
4265156-26515624.43224.50
5259623-25962323.92223.99
6262912-26291224.22524.29
45min1334124-33412430.78731.181.6030.8931.291.60
2339541-33954131.28631.39
3333221-33322130.70330.80
4346826-34682631.95732.06
5334657-33465730.83630.94
6342195-34219531.53031.64
60min1396693-39669336.55236.760.7436.7036.910.74
2400196-40019636.87537.03
3395487-39548736.44136.59
4401442-40144236.98937.14
5396896-39689636.57136.72
6402764-40276437.11137.26
120min1582642-58264253.68553.570.7353.8953.780.73
2580227-58022753.46353.67
3578464-57846453.30053.50
4580394-58039453.47853.69
5577458-57745853.20853.41
6589208-58920854.29054.50
180min1700712-70071264.56564.931.1164.8565.221.11
2705700-70570065.02465.31
3698162-69816264.33064.61
4704488-70448864.91365.20
5699688-69968864.47064.75
6719504-71950466.29666.59
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
240min1792655-79265573.03673.210.3173.4273.600.31
2796533-79653373.39473.78
3791981-79198172.97473.35
4795724-79572473.31973.71
5792744-79274473.04573.43
6797675-79767573.49973.89
360min1943314-94331486.91887.260.3887.4187.760.38
2952597-95259787.77488.27
3944352-94435287.01487.50
4949280-94928087.46887.97
5944969-94496987.07187.56
6947802-94780287.33287.83
480min11020245-102024594.00794.470.3994.6395.090.40
21029716-102971694.87995.51
31021674-102167494.13894.76
41029086-102908694.82195.45
51023569-102356994.31394.93
61027186-102718694.64695.28
600min11060089-106008997.67898.180.4198.4498.950.41
21067343-106734398.34699.12
31061808-106180897.83698.59
41072323-107232398.80599.58
51066125-106612598.23499.00
61065557-106555798.18298.95
720min11079610-107961099.477100.160.52100.38101.080.52
21091948-1091948100.614101.53
31081917-108191799.689100.59
41092036-1092036100.622101.54
51091565-1091565100.578101.49
61085388-1085388100.009100.93
960min11088591-1088591100.304100.890.53101.36101.950.53
21090163-1090163100.449101.52
31092435-1092435100.658101.71
41104348-1104348101.756102.83
51096355-1096355101.020102.08
61097613-1097613101.136102.20
1200min11085898-1085898100.056100.890.64101.26102.100.64
21089510-1089510100.389101.61
31094451-1094451100.844102.05
41104020-1104020101.726102.95
51093812-1093812100.785102.00
61101805-1101805101.522102.74
极限11083293-108329399.816100.660.63101.17102.020.63
21098314-1098314101.200102.57
31089712-1089712100.408101.76
41101791-1101791101.521102.90
51088117-1088117100.261101.62
61093153-1093153100.725102.10
点击查看处理图标(人工保存)
 
原始图谱下载图谱(姜进硙 于 2024-12-16 16:57:46 完成)
生成报告数据部分(等待生成报告)
Current page cost:94 ms