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%
19.844567064500594558904567214564644551680.64
29.894544314544104544200.01
单位质量响应值RSD%判断
46256.9145947.420.48数据可信
供试品溶液-3215076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%
5min1-0.0000.00-0.000.00-
2-0.0000.00
3-0.0000.00
4-0.0000.00
5-0.0000.00
6-0.0000.00
10min1-0.00020.9855.320.0020.9855.32
2170914-17091433.36633.37
3145213-14521328.34928.35
493488-9348818.25118.25
5106040-10604020.70120.70
6129133-12913325.20925.21
15min1234700-23470045.81853.9110.3345.8253.9510.35
2315023-31502361.49961.55
3288541-28854156.32956.38
4253402-25340249.46949.50
5288970-28897056.41356.45
6276358-27635853.95153.99
20min1346310-34631067.60772.084.6167.6872.204.63
2398836-39883677.86178.02
3364042-36404271.06971.21
4367644-36764471.77271.88
5371633-37163372.55072.68
6366735-36673571.59471.73
30min1444753-44475386.82588.033.5587.0188.273.55
2462923-46292390.37290.66
3430754-43075484.09284.35
4463540-46354090.49390.73
5467967-46796791.35791.61
6435524-43552485.02385.27
45min1479068-47906893.52493.893.6093.8694.283.58
2486051-48605194.88795.33
3461385-46138590.07290.47
4498547-49854797.32797.71
5499925-49992597.59698.00
6460731-46073189.94490.34
60min1480934-48093493.88894.063.7394.3894.613.72
2485679-48567994.81595.41
3459796-45979689.76290.31
4500083-50008397.62798.17
5502012-50201298.00398.57
6462513-46251390.29290.84
120min1480391-48039193.78294.303.4994.4395.013.48
2490302-49030295.71796.47
3463404-46340490.46691.17
4499249-49924997.46498.17
5501357-50135797.87598.60
6463630-46363090.51091.20
240min1476266-47626692.97793.993.2993.7894.853.29
2489419-48941995.54596.46
3463476-46347690.48091.33
4497036-49703697.03297.90
5498535-49853597.32498.22
6463973-46397390.57791.42
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
360min1475724-47572492.87193.883.1593.8394.903.15
2490408-49040895.73896.81
3464528-46452890.68691.69
4496167-49616796.86297.89
5495490-49549096.73097.78
6463130-46313090.41391.41
480min1471749-47174992.09593.392.9393.2194.572.93
2488100-48810095.28796.52
3463531-46353190.49191.64
4492242-49224296.09697.29
5491952-49195296.03997.25
6462776-46277690.34391.49
600min1484403-48440394.56695.882.8795.8397.212.88
2503608-50360898.31599.71
3476563-47656393.03594.34
4504908-50490898.56999.92
5502332-50233298.06699.44
6474929-47492992.71694.01
720min1481478-48147893.99595.342.8195.4296.832.81
2499526-49952697.51899.07
3474363-47436392.60694.06
4500840-50084097.77499.29
5501348-50134897.87499.41
6472695-47269592.28093.73
840min1478525-47852593.41894.832.8095.0096.482.80
2497262-49726297.07698.79
3471084-47108491.96593.58
4499337-49933797.48199.16
5497093-49709397.04398.74
6471266-47126692.00193.61
960min1470950-47095091.93993.792.6393.6795.592.64
2493408-49340896.32498.20
3468452-46845291.45293.22
4495439-49543996.72098.56
5485715-48571594.82296.68
6468510-46851091.46393.22
极限1469670-46967091.68993.512.6393.5895.482.64
2492779-49277996.20198.24
3466738-46673891.11793.04
4494317-49431796.50198.51
5482500-48250094.19496.21
6468094-46809491.38293.29
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%
19.918932088959568996308954158958668960150.26
29.968925608925928925760.01
单位质量响应值RSD%判断
90415.2489616.060.63数据可信
供试品溶液-3215076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%
5min1-0.0000.00-0.000.00-
2-0.0000.00
3-0.0000.00
4-0.0000.00
5-0.0000.00
6-0.0000.00
10min1-0.0000.35147.090.000.35147.73
22381-23810.2380.24
314001-140011.4001.40
41747-17470.1750.17
51487-14870.1490.15
61547-15470.1550.15
15min113300-133001.3302.3843.061.332.3842.97
222788-227882.2782.28
322927-229272.2922.29
419763-197631.9761.98
543539-435394.3534.35
620759-207592.0762.08
20min142783-427834.2785.319.764.285.319.78
256434-564345.6435.65
354947-549475.4945.50
453247-532475.3245.33
556371-563715.6365.64
654696-546965.4695.47
30min1110529-11052911.05111.934.0111.0611.944.02
2118344-11834411.83311.85
3120913-12091312.08912.10
4122107-12210712.20912.22
5124353-12435312.43312.45
6119790-11979011.97711.99
45min1190416-19041619.03919.964.4919.0719.994.49
2198302-19830219.82719.86
3215534-21553421.55021.59
4201371-20137120.13420.17
5199922-19992219.98920.03
6192062-19206219.20319.24
60min1242415-24241524.23824.632.1524.3024.692.15
2239963-23996323.99324.06
3245917-24591724.58824.66
4250772-25077225.07325.14
5254160-25416025.41225.48
6244583-24458324.45524.52
120min1383252-38325238.31938.761.6238.4238.871.63
2379143-37914337.90838.01
3389445-38944538.93839.05
4392092-39209239.20339.31
5396423-39642339.63639.75
6385570-38557038.55138.66
240min1559330-55933055.92456.521.2356.0956.701.24
2555140-55514055.50555.67
3570639-57063957.05557.23
4570657-57065757.05757.23
5571948-57194857.18657.37
6564194-56419456.41156.58
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
360min1689299-68929968.91969.490.8069.1869.760.80
2689620-68962068.95169.21
3701472-70147270.13670.41
4699663-69966369.95670.22
5698664-69866469.85670.13
6691360-69136069.12569.39
480min1769426-76942676.93177.750.9077.3078.130.91
2769450-76945076.93377.31
3786570-78657078.64579.03
4780100-78010077.99878.38
5782467-78246778.23578.63
6777495-77749577.73878.12
600min1853539-85353985.34186.170.7185.8486.680.71
2857839-85783985.77186.28
3871261-87126187.11387.63
4864026-86402686.38986.90
5864061-86406186.39386.91
6860395-86039586.02686.53
720min1892056-89205689.19290.060.8889.8390.720.88
2892409-89240989.22789.88
3910418-91041891.02891.69
4902279-90227990.21490.87
5908794-90879490.86591.53
6898771-89877189.86390.52
840min1912544-91254491.24092.240.8692.0393.040.86
2912841-91284191.27092.07
3930773-93077393.06393.88
4926800-92680092.66693.48
5927389-92738992.72593.54
6924775-92477592.46393.26
960min1914677-91467791.45492.821.1292.4093.781.12
2920970-92097092.08393.03
3941275-94127594.11395.09
4936234-93623493.60994.57
5922701-92270192.25693.23
6934309-93430993.41694.37
极限1914648-91464891.45192.801.1092.5593.911.09
2922042-92204292.19093.29
3940416-94041694.02795.16
4935248-93524893.51094.63
5921384-92138492.12493.25
6934923-93492393.47894.59
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%
19.844553544560674557184556604555674556730.06
29.894632824636174634500.06
单位质量响应值RSD%判断
46308.2346860.470.84数据可信
供试品溶液-3215076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%
5min1-0.0000.18244.950.000.18244.95
2-0.0000.00
3-0.0000.00
4-0.0000.00
5-0.0000.00
65515-55151.0661.07
10min1123670-12367023.89417.8759.3323.8917.8759.33
283070-8307016.05016.05
3-0.0000.00
480780-8078015.60715.61
5164536-16453631.78931.79
6102761-10276119.85419.86
15min1278921-27892153.88949.9116.2853.9349.9416.29
2225737-22573743.61343.64
3242873-24287346.92446.92
4211277-21127740.82040.85
5328156-32815663.40163.45
6262927-26292750.79950.83
20min1372988-37298872.06369.138.8572.1969.248.88
2332197-33219764.18264.28
3343117-34311766.29266.37
4328748-32874863.51663.61
5413149-41314979.82279.98
6356665-35666568.90969.03
30min1441352-44135285.27186.072.7385.5286.302.75
2445395-44539586.05286.26
3448858-44885886.72186.91
4434166-43416683.88384.08
5467426-46742690.30990.60
6435626-43562684.16584.40
45min1463264-46326489.50591.662.5389.9092.032.52
2483139-48313993.34593.69
3489148-48914894.50694.84
4461940-46194089.24989.59
5482977-48297793.31393.76
6466061-46606190.04590.42
60min1466537-46653790.13792.112.5990.6892.642.58
2485224-48522493.74894.25
3493506-49350695.34895.84
4463886-46388689.62590.11
5484020-48402093.51594.11
6467430-46743090.31090.83
120min1468311-46831190.48092.102.7391.1792.782.72
2491818-49181895.02295.68
3490155-49015594.70095.35
4461864-46186489.23489.87
5482128-48212893.14993.90
6465911-46591190.01690.69
240min1463870-46387089.62291.312.7190.4692.142.69
2485335-48533593.76994.59
3487702-48770294.22695.03
4458201-45820188.52789.31
5478424-47842492.43493.34
6462163-46216389.29290.12
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
360min1460781-46078189.02591.062.7490.0292.042.72
2484950-48495093.69594.67
3485932-48593293.88494.85
4458195-45819588.52589.46
5477133-47713392.18493.25
6460766-46076689.02290.00
480min1459117-45911788.70490.622.6889.8491.752.67
2482437-48243793.20994.34
3482358-48235893.19494.31
4454853-45485387.88088.96
5475756-47575691.91893.13
6459730-45973088.82289.94
600min1470864-47086490.97392.213.0092.2693.502.94
2494718-49471895.58296.87
3494963-49496395.62996.91
4468751-46875190.56591.79
5460706-46070689.01190.38
6473629-47362991.50792.78
720min1468322-46832290.48290.345.9691.9291.785.83
2491742-49174295.00796.45
3491889-49188995.03596.47
4463013-46301389.45690.84
5416303-41630380.43281.95
6474352-47435291.64793.07
840min1465637-46563789.96389.397.2791.5590.987.11
2489927-48992794.65696.26
3489742-48974294.62096.21
4460775-46077589.02490.55
5398771-39877177.04478.70
6471139-47113991.02692.60
960min1462771-46277189.41088.278.3691.1590.018.18
2484646-48464693.63695.40
3484304-48430493.57095.32
4457288-45728888.35090.03
5382384-38238473.87875.66
6469953-46995390.79792.52
极限1461381-46138189.14187.519.0491.0389.398.85
2479821-47982192.70494.62
3481462-48146293.02194.93
4454866-45486687.88289.71
5372073-37207371.88673.79
6467915-46791590.40392.28
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%
19.918937088953118946018945258944588945210.07
29.969093109097639095360.04
单位质量响应值RSD%判断
90264.4891318.880.83数据可信
供试品溶液-3215076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%
5min1-0.0000.02244.950.000.02244.95
2-0.0000.00
3-0.0000.00
4-0.0000.00
5-0.0000.00
61103-11030.1090.11
10min12708-27080.2680.2161.920.270.2161.96
21492-14920.1480.15
3-0.0000.00
43909-39090.3880.39
52769-27690.2740.27
62030-20300.2010.20
15min123751-237512.3542.1817.142.352.1817.08
219775-197751.9601.96
315699-156991.5561.56
425697-256972.5472.55
525124-251242.4912.49
622059-220592.1872.19
20min162357-623576.1825.6212.256.195.6312.28
253887-538875.3425.35
344276-442764.3894.39
460374-603745.9855.99
562455-624556.1916.20
656805-568055.6315.64
30min1127414-12741412.63112.296.4112.6512.306.43
2120109-12010911.90711.92
3111061-11106111.01011.02
4128822-12882212.77012.79
5133771-13377113.26113.28
6122438-12243812.13712.15
45min1201044-20104419.93019.871.7919.9719.901.80
2196141-19614119.44419.48
3195923-19592319.42219.45
4201769-20176920.00220.04
5203159-20315920.13920.18
6204419-20441920.26420.30
60min1255171-25517125.29525.001.5825.3625.071.59
2246944-24694424.48024.54
3247897-24789724.57424.63
4254023-25402325.18225.25
5256669-25666925.44425.51
6252690-25269025.05025.12
120min1407082-40708240.35539.091.9340.4739.201.93
2391244-39124438.78538.89
3390262-39026238.68738.79
4392882-39288238.94739.06
5398859-39885939.53939.65
6385626-38562638.22838.34
240min1572371-57237156.74056.551.0356.9256.721.03
2567454-56745456.25256.42
3572558-57255856.75856.92
4569280-56928056.43456.61
5579249-57924957.42257.60
6561847-56184755.69755.87
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
360min1702293-70229369.61969.110.9669.8969.370.96
2696524-69652469.04769.31
3698706-69870669.26469.52
4695435-69543568.93969.21
5704301-70430169.81870.09
6685443-68544367.94968.21
480min1786568-78656877.97477.490.7278.3677.870.72
2778791-77879177.20377.58
3782244-78224477.54577.92
4780744-78074477.39677.78
5788610-78861078.17678.57
6773001-77300176.62977.01
600min1872314-87231486.47485.032.5486.9985.542.52
2862893-86289385.54086.05
3868229-86822986.06986.57
4868116-86811686.05886.57
5814155-81415580.70881.23
6860827-86082785.33585.84
720min1909838-90983890.19387.426.2190.8688.086.16
2900899-90089989.30789.96
3906477-90647789.86090.51
4902779-90277989.49490.15
5770388-77038876.37077.03
6901074-90107489.32589.97
840min1931545-93154592.34589.227.1693.1690.027.10
2923935-92393591.59192.39
3928615-92861592.05592.85
4926228-92622891.81892.63
5768808-76880876.21377.00
6920815-92081591.28292.08
960min1940875-94087593.27089.857.9694.2490.807.90
2928454-92845492.03992.99
3934296-93429692.61893.57
4937283-93728392.91493.87
5759380-75938075.27876.19
6937759-93775992.96193.91
极限1938424-93842493.02789.378.2494.1590.468.17
2922400-92240091.43992.54
3931678-93167892.35993.46
4934428-93442892.63193.75
5750360-75036074.38475.42
6931788-93178892.36993.47
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