恩格列净二甲双胍片项目信息
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101566-202301对照品来源中检院对照品使用方法直接使用
对照品含量(%)100对照品水分(%)0对照品稀释倍数800
标示量(mg)12.5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%
110.102294362312632307902296552306422303570.34
210.172306472312412309440.19
单位质量响应值RSD%判断
22807.6222708.360.31数据可信
供试品溶液-3216399批-恩格列净-pH1.2
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
60min1248352-24835298.21596.562.1398.2296.562.13
2245088-24508896.92496.92
3244578-24457896.72396.72
4233977-23397792.53092.53
5247228-24722897.77197.77
6245711-24571197.17197.17
120min1252074-25207499.68798.402.2599.8598.562.25
2248432-24843298.24798.41
3249313-24931398.59598.76
4238021-23802194.13094.28
5252385-25238599.81099.97
6252755-25275599.956100.12
240min1255588-255588101.077100.252.22101.41100.582.22
2252056-25205699.680100.01
3254137-254137100.503100.83
4243129-24312996.15096.46
5257212-257212101.719102.05
6258874-258874102.376102.70
360min1253886-253886100.40499.752.35100.90100.242.35
2251284-25128499.37599.87
3252832-25283299.987100.48
4241286-24128695.42195.89
5255489-255489101.038101.54
6258556-258556102.250102.75
480min1253935-253935100.42399.381.98101.09100.041.98
2249449-24944998.64999.31
3252147-25214799.716100.38
4242239-24223995.79896.43
5254080-254080100.480101.15
6255966-255966101.226101.90
600min1251182-25118299.33498.782.04100.1799.602.04
2248082-24808298.10898.93
3251246-25124699.360100.19
4240533-24053395.12395.91
5252229-25222999.748100.58
6255345-255345100.981101.82
720min1250380-25038099.01798.081.94100.0299.071.94
2244813-24481396.81697.80
3250915-25091599.229100.22
4239626-23962694.76495.71
5250493-25049399.062100.06
6251813-25181399.584100.59
840min1247014-24701497.68696.992.0798.8598.142.07
2243777-24377796.40697.55
3246886-24688697.63598.79
4235902-23590293.29294.40
5247248-24724897.77998.94
6250678-25067899.135100.31
960min1246400-24640097.44396.382.0998.7797.692.09
2242154-24215495.76497.07
3244930-24493096.86298.18
4234170-23417092.60793.87
5246465-24646597.46998.80
6248081-24808198.10899.45
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
极限1245051-24505196.91096.392.0198.4097.872.01
2240854-24085495.25096.72
3244609-24460996.73598.22
4236004-23600493.33294.75
5245453-24545397.06998.56
6250488-25048899.060100.56
恩格列净二甲双胍片项目信息
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%
110.189518149582419563489501309556189544300.36
210.149572499606769589620.26
单位质量响应值RSD%判断
93755.4094572.190.62数据可信
供试品溶液-3216399批-二甲双胍-pH1.2
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
60min1286980-28698027.43026.892.9527.4326.892.95
2287844-28784427.51227.51
3282400-28240026.99226.99
4282222-28222226.97526.97
5283480-28348027.09527.09
6265149-26514925.34325.34
120min1454626-45462643.45342.672.3743.5042.722.37
2453765-45376543.37143.42
3448082-44808242.82842.87
4447210-44721042.74442.79
5449188-44918842.93342.98
6425781-42578140.69640.74
240min1673576-67357664.38063.452.4164.5063.572.41
2680850-68085065.07665.19
3659966-65996663.08063.20
4660658-66065863.14663.26
5672335-67233564.26264.38
6635725-63572560.76360.87
360min1817997-81799778.18477.121.5578.4177.341.55
2815245-81524577.92178.15
3802468-80246876.70076.92
4808010-80801077.23077.45
5813449-81344977.74977.97
6784190-78419074.95375.16
480min1930320-93032088.92087.561.5989.2887.911.59
2931950-93195089.07689.43
3916139-91613987.56587.91
4909421-90942186.92287.27
5916171-91617187.56887.92
6892447-89244785.30085.64
600min1999325-99932595.51594.161.3896.0294.661.38
2997996-99799695.38895.89
3980974-98097493.76194.26
4982501-98250193.90794.40
5987719-98771994.40694.91
6962450-96245091.99192.47
720min11029395-102939598.39097.400.7199.0598.050.71
21017972-101797297.29897.96
31021216-102121697.60898.26
41013611-101361196.88197.53
51022848-102284897.76498.42
61009068-100906896.44797.08
840min11050808-1050808100.43698.990.92101.2699.800.92
21031910-103191098.63099.46
31042228-104222899.616100.43
41028534-102853498.30799.12
51035008-103500898.92699.75
61025328-102532898.00198.79
960min11058089-1058089101.13299.790.73102.13100.770.73
21043969-104396999.782100.77
31045102-104510299.891100.87
41041671-104167199.563100.54
51037017-103701799.118100.10
61038215-103821599.233100.19
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
极限11052640-1052640100.611100.170.58101.77101.310.57
21038886-103888699.297100.45
31049233-1049233100.286101.43
41054408-1054408100.780101.92
51042744-104274499.665100.82
61050051-1050051100.364101.49
恩格列净二甲双胍片项目信息
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101566-202301对照品来源中检院对照品使用方法直接使用
对照品含量(%)100对照品水分(%)0对照品稀释倍数800
标示量(mg)12.5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%
110.102304782306382319772312142304462309510.29
210.172326842315052320940.36
单位质量响应值RSD%判断
22866.4422821.440.14数据可信
供试品溶液-3216399批-恩格列净-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%
60min1242169-24216995.40993.584.1095.4193.584.10
2248031-24803197.71997.72
3222600-22260087.70087.70
4228814-22881490.14890.15
5243670-24367096.00196.00
6239837-23983794.49194.49
120min1247717-24771797.59596.862.9497.7597.022.94
2256448-256448101.035101.20
3237309-23730993.49593.64
4239193-23919394.23794.39
5250607-25060798.73498.89
6243880-24388096.08396.24
240min1253721-25372199.96099.013.35100.2899.333.35
2262326-262326103.351103.68
3244723-24472396.41596.72
4241314-24131495.07295.38
5259139-259139102.095102.42
6246684-24668497.18897.51
360min1251039-25103998.90498.812.9899.3999.302.98
2262561-262561103.443103.95
3246956-24695697.29597.76
4241232-24123295.04095.51
5255579-255579100.693101.19
6247457-24745797.49397.97
480min1249852-24985298.43698.412.4799.0999.062.47
2258901-258901102.001102.68
3246564-24656497.14197.77
4246407-24640797.07997.70
5254832-254832100.398101.06
6242123-24212395.39196.03
600min1249161-24916198.16497.752.8798.9898.562.87
2257764-257764101.553102.40
3245886-24588696.87497.66
4239678-23967894.42895.21
5254502-254502100.268101.10
6241727-24172795.23596.04
720min1247331-24733197.44396.932.9998.4297.902.98
2256025-256025100.868101.88
3243515-24351595.94096.89
4236978-23697893.36494.31
5252464-25246499.465100.46
6239887-23988794.51095.47
840min1245277-24527796.63496.532.9597.7897.662.94
2254783-254783100.379101.56
3244397-24439796.28797.40
4236376-23637693.12794.23
5251288-25128899.002100.16
6237922-23792293.73694.85
960min1245420-24542096.69095.993.0897.9997.283.08
2252775-25277599.588100.94
3242866-24286695.68496.95
4235190-23519092.66093.91
5250583-25058398.724100.05
6235027-23502792.59593.87
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
极限1243910-24391096.09595.872.6997.5697.322.69
2251350-25135099.026100.54
3240752-24075294.85196.28
4235649-23564992.84194.25
5250532-25053298.704100.20
6237786-23778693.68295.11
恩格列净二甲双胍片项目信息
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%
110.189567609546699565999554299598119566540.21
210.149585399590339587860.04
单位质量响应值RSD%判断
93973.8794554.830.44数据可信
供试品溶液-3216399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%
60min1255757-25575724.41923.486.1724.4223.486.17
2250464-25046423.91423.91
3226361-22636121.61221.61
4231009-23100922.05622.06
5245622-24562223.45123.45
6266597-26659725.45425.45
120min1400735-40073538.26137.673.4438.3037.713.44
2400145-40014538.20538.24
3371914-37191435.50935.55
4387439-38743936.99237.03
5395836-39583637.79337.83
6411486-41148639.28739.33
240min1594721-59472156.78256.063.8156.8956.163.81
2598918-59891857.18357.29
3556843-55684353.16653.26
4562754-56275453.73053.83
5613775-61377558.60158.70
6595717-59571756.87756.99
360min1713217-71321768.09667.462.8468.2967.652.84
2710383-71038367.82568.02
3680372-68037264.96065.14
4685914-68591465.48965.68
5715311-71531168.29668.50
6734076-73407670.08770.29
480min1806253-80625376.97976.492.1077.2976.802.10
2809895-80989577.32677.64
3770010-77001073.51873.81
4797205-79720576.11576.41
5818683-81868378.16578.48
6804886-80488676.84877.17
600min1871703-87170383.22882.351.7383.6782.791.74
2869901-86990183.05683.50
3841330-84133080.32880.74
4850199-85019981.17581.60
5881585-88158584.17184.62
6860544-86054482.16282.61
720min1908970-90897086.78686.321.5287.3786.901.52
2912691-91269187.14187.72
3888797-88879784.86085.41
4889743-88974384.95085.51
5923755-92375588.19788.78
6900761-90076186.00286.59
840min1932743-93274389.05688.621.1289.7889.341.13
2934998-93499889.27190.00
3916863-91686387.53988.23
4917234-91723487.57588.28
5942643-94264390.00190.73
6924820-92482088.29989.03
960min1948610-94861090.57189.641.0991.4490.501.10
2944545-94454590.18291.06
3931621-93162188.94889.78
4927040-92704088.51189.36
5950569-95056990.75891.64
6930708-93070888.86189.74
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
极限1942464-94246489.98489.570.8891.0190.580.88
2937152-93715289.47790.50
3936471-93647189.41290.40
4926481-92648188.45889.45
5951009-95100990.80091.83
6935062-93506289.27790.30
恩格列净二甲双胍片项目信息
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101566-202301对照品来源中检院对照品使用方法直接使用
对照品含量(%)100对照品水分(%)0对照品稀释倍数800
标示量(mg)12.5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%
110.102326452319412327562326562331252326250.19
210.172340662330162335410.32
单位质量响应值RSD%判断
23032.1822963.720.22数据可信
供试品溶液-3216399批-恩格列净-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%
60min1246169-24616996.33695.235.3596.3495.235.35
2239039-23903993.54693.55
3239146-23914693.58793.59
4253601-25360199.24499.24
5259530-259530101.565101.56
6222513-22251387.07887.08
120min1253461-25346199.18997.535.3499.3597.695.34
2243747-24374795.38895.54
3244322-24432295.61395.77
4259542-259542101.569101.73
5265831-265831104.030104.20
6228454-22845489.40389.55
240min1258281-258281101.07699.825.32101.40100.145.32
2246840-24684096.59896.91
3249853-24985397.77898.09
4266336-266336104.228104.56
5273060-273060106.859107.20
6236015-23601592.36292.66
360min1258511-258511101.16699.365.00101.6699.855.01
2245899-24589996.23096.71
3247202-24720296.74097.22
4265450-265450103.881104.39
5269606-269606105.508106.03
6236714-23671492.63693.08
480min1255790-255790100.10198.984.73100.7699.634.74
2244487-24448795.67896.31
3248060-24806097.07697.72
4262050-262050102.551103.23
5269793-269793105.581106.28
6237319-23731992.87293.47
600min1253930-25393099.37398.594.60100.2099.414.60
2243419-24341995.26096.06
3246736-24673696.55897.36
4262120-262120102.578103.43
5267900-267900104.840105.71
6237532-23753292.95693.71
720min1249390-24939097.59697.284.7298.5998.274.72
2236870-23687092.69793.65
3244676-24467695.75296.71
4258884-258884101.312102.34
5265320-265320103.830104.88
6236408-23640892.51693.43
840min1240429-24042994.09094.716.7595.2595.866.71
2219990-21999086.09187.20
3234873-23487391.91593.04
4257115-257115100.619101.81
5264713-264713103.593104.81
6235004-23500491.96693.03
960min1223938-22393887.63692.229.1088.9593.529.03
2206653-20665380.87282.12
3226889-22688988.79190.07
4256876-256876100.526101.89
5263828-263828103.246104.64
6235761-23576192.26393.48
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
极限1217755-21775585.21690.8910.2686.6892.3510.16
2199944-19994478.24679.63
3223295-22329587.38488.81
4256357-256357100.323101.85
5262535-262535102.740104.31
6233627-23362791.42892.80
恩格列净二甲双胍片项目信息
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%
110.189569439570369573649629349576129583780.27
210.149583659567269575460.13
单位质量响应值RSD%判断
94143.2294432.540.22数据可信
供试品溶液-3216399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%
60min1260610-26061024.87625.252.1724.8825.252.16
2273243-27324326.08226.08
3265858-26585825.37725.38
4262631-26263125.06925.07
5267591-26759125.54225.54
6256946-25694624.52624.53
120min1414891-41489139.60240.081.9039.6440.121.90
2428818-42881840.93240.98
3424252-42425240.49640.54
4419370-41937040.03040.07
5424988-42498840.56640.61
6407015-40701538.85138.89
240min1621653-62165359.33859.540.7159.4559.650.71
2626297-62629759.78259.89
3625523-62552359.70859.82
4622038-62203859.37559.48
5629948-62994860.13060.24
6617408-61740858.93359.04
360min1752270-75227071.80672.030.6772.0172.240.67
2750381-75038171.62671.84
3760527-76052772.59472.80
4753780-75378071.95072.16
5761156-76115672.65472.86
6749714-74971471.56271.77
480min1835822-83582279.78181.051.3280.1181.381.31
2836252-83625279.82280.15
3855954-85595481.70382.03
4851483-85148381.27681.60
5863899-86389982.46182.79
6851513-85151381.27981.60
600min1904910-90491086.37687.110.9786.8387.570.97
2902829-90282986.17786.64
3923862-92386288.18588.65
4906882-90688286.56487.03
5919829-91982987.80088.27
6917242-91724287.55388.01
720min1934132-93413289.16590.451.8489.7791.061.83
2918545-91854587.67788.28
3954381-95438191.09891.71
4960534-96053491.68592.29
5960633-96063391.69592.31
6957641-95764191.40992.01
840min1930353-93035388.80590.753.7489.5691.513.71
2891439-89143985.09085.84
3949883-94988390.66991.43
4966563-96656392.26193.02
5983380-98338093.86694.63
6983045-98304593.83494.59
960min1896464-89646485.57090.036.0186.4790.945.96
2856274-85627481.73482.63
3940931-94093189.81490.73
4979174-97917493.46594.38
5994724-99472494.94995.87
6991603-99160394.65195.56
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
极限1882352-88235284.22389.376.8285.2690.436.76
2842029-84202980.37481.41
3925760-92576088.36689.43
4985545-98554594.07395.14
5996130-99613095.08396.17
6985823-98582394.09995.17
点击查看处理图标(人工保存)
 
原始图谱下载图谱(谢鑫慧 于 2026-03-16 13:40:10 完成)
生成报告数据部分(等待生成报告)
Current page cost:1.649 s