二甲双胍恩格列净片项目信息
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DC033-12306002对照品来源中检院对照品使用方法直接使用
对照品含量(%)98.99对照品水分(%)0对照品稀释倍数2000
标示量(mg)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%
110.239441494634942349459794420944600.18
210.219389794319941080.32
单位质量响应值RSD%判断
9233.639217.240.13数据可信
供试品溶液-24090901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%
5min137402-3740236.12034.2613.4436.1234.2613.44
227997-2799727.03727.04
336907-3690735.64235.64
437492-3749236.20636.21
531754-3175430.66530.67
641311-4131139.89539.89
10min172415-7241569.93269.099.0869.9969.159.09
262715-6271560.56560.61
370121-7012167.71767.78
473413-7341370.89670.96
568285-6828565.94465.99
682319-8231979.49679.56
15min190181-9018187.08988.444.1887.2788.614.19
286350-8635083.38983.54
389814-8981486.73486.91
492849-9284989.66589.84
592492-9249289.32189.48
697764-9776494.41294.61
20min196753-9675393.43593.891.3293.7694.211.32
297620-9762094.27394.56
394904-9490491.65091.97
497558-9755894.21394.54
597991-9799194.63194.94
698510-9851095.13295.49
30min198377-9837795.00494.881.8295.4895.361.80
2100468-10046897.02397.47
395123-9512391.86192.33
497734-9773494.38394.87
598768-9876895.38195.85
699005-9900595.61096.13
45min198366-9836694.99395.061.7995.6395.691.78
2100858-10085897.40098.00
395462-9546292.18992.81
498283-9828394.91395.56
598358-9835894.98595.61
699254-9925495.85196.52
60min197941-9794194.58394.641.6695.3895.441.65
2100409-10040996.96697.73
395313-9531392.04592.82
497997-9799794.63795.44
597980-9798094.62095.41
698382-9838295.00995.84
极限199215-9921595.81395.631.7996.7796.581.77
2101681-10168198.19599.12
396394-9639493.08994.02
497921-9792194.56395.52
599476-9947696.06597.01
699445-9944596.03597.03
二甲双胍恩格列净片项目信息
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对照品来源中检所对照品对照品使用方法105℃烘干2小时
对照品含量(%)100对照品水分(%)0对照品稀释倍数20
标示量(mg)500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%
110.178518258559698558668558548564928552010.23
210.208508948537868523400.24
单位质量响应值RSD%判断
84090.5683562.750.45数据可信
供试品溶液-24090901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%
5min1444306-44430647.70345.7811.1847.7045.7811.18
2352175-35217537.81137.81
3441111-44111147.36047.36
4447850-44785048.08448.08
5388181-38818141.67741.68
6484543-48454352.02352.02
10min1762408-76240881.85681.077.2381.9481.157.24
2677866-67786672.77972.84
3746862-74686280.18780.27
4773949-77394983.09583.18
5726817-72681778.03578.10
6842534-84253490.45990.55
15min1905776-90577697.24998.212.6797.4798.422.68
2876762-87676294.13494.32
3909292-90929297.62797.84
4918855-91885598.65398.87
5927798-92779899.61399.81
6949812-949812101.977102.21
20min1952048-952048102.217102.130.99102.60102.510.98
2962618-962618103.352103.69
3935223-935223100.411100.79
4946768-946768101.650102.03
5955397-955397102.577102.94
6955516-955516102.589103.00
30min1953882-953882102.414102.621.25102.96103.161.23
2977086-977086104.905105.42
3941801-941801101.117101.66
4949396-949396101.932102.48
5958653-958653102.926103.46
6953801-953801102.405102.98
45min1957053-957053102.754102.281.40103.47103.001.38
2977003-977003104.896105.58
3939928-939928100.916101.63
4943593-943593101.309102.03
5950617-950617102.063102.77
6947762-947762101.757102.51
60min1951070-951070102.112101.981.33103.00102.861.31
2972358-972358104.398105.26
3934163-934163100.297101.18
4946806-946806101.654102.55
5949801-949801101.976102.85
6944655-944655101.423102.34
极限1953539-953539102.377102.011.48103.44103.071.46
2974484-974484104.626105.66
3933413-933413100.216101.26
4942486-942486101.190102.25
5952444-952444102.260103.31
6944568-944568101.414102.50
二甲双胍恩格列净片项目信息
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DC033-12306002对照品来源中检院对照品使用方法直接使用
对照品含量(%)98.99对照品水分(%)0对照品稀释倍数2000
标示量(mg)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%
110.239534694730945899478794913948730.31
210.219396594248941060.22
单位质量响应值RSD%判断
9274.009217.040.44数据可信
供试品溶液-24091002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%
5min142884-4288441.32439.549.3341.3239.549.33
244308-4430842.69642.70
345657-4565743.99644.00
439361-3936137.92937.93
536004-3600434.69434.69
637952-3795236.57136.57
10min180258-8025877.33875.386.5277.4175.456.52
280598-8059877.66677.74
386106-8610682.97483.05
472492-7249269.85569.92
576319-7631973.54373.60
673604-7360470.92670.99
15min194713-9471391.26892.453.0391.4792.643.03
298013-9801394.44794.65
3100839-10083997.17197.38
493163-9316389.77489.95
594289-9428990.85991.04
694620-9462091.17891.36
20min196135-9613592.63897.102.5692.9997.452.56
2100712-10071297.04897.41
3104090-104090100.303100.68
4101376-10137697.68898.02
5101052-10105297.37697.71
6101235-10123597.55297.88
30min196034-9603492.54097.232.5393.0497.732.53
2100792-10079297.12597.65
3103234-10323499.479100.02
4102070-10207098.35798.85
5102320-10232098.59899.09
6100926-10092697.25497.75
45min196307-9630792.80497.032.1893.4697.702.17
2101308-10130897.62398.30
3101566-10156697.87198.58
4101965-10196598.25698.91
5102091-10209198.37799.04
6100890-10089097.22097.88
60min195882-9588292.39497.092.4793.2197.922.46
2101147-10114797.46798.31
3102662-10266298.92799.80
4101568-10156897.87398.69
5102342-10234298.61999.44
6100925-10092597.25498.07
极限196368-9636892.86297.202.4193.8398.192.40
2100997-10099797.32398.33
3102549-10254998.81899.85
4102375-10237598.65199.63
5102738-10273899.00199.99
6100166-10016696.52297.50
二甲双胍恩格列净片项目信息
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对照品来源中检所对照品对照品使用方法105℃烘干2小时
对照品含量(%)100对照品水分(%)0对照品稀释倍数20
标示量(mg)500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%
110.178581418566468544838563188546578560490.18
210.208534998512718523850.19
单位质量响应值RSD%判断
84173.9483567.160.52数据可信
供试品溶液-24091002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%
5min1463508-46350849.73946.888.3049.7446.888.30
2458582-45858249.21049.21
3482301-48230151.75651.76
4416355-41635544.67944.68
5389815-38981541.83141.83
6410751-41075144.07844.08
10min1794982-79498285.30981.466.1085.3981.536.10
2772163-77216382.86182.94
3824415-82441588.46888.55
4704765-70476575.62875.70
5739330-73933079.33779.41
6718805-71880577.13577.21
15min1918257-91825798.53897.032.6298.7697.242.63
2908035-90803597.44197.66
3941624-941624101.045101.28
4875605-87560593.96194.16
5888836-88883695.38195.58
6892805-89280595.80796.01
20min1923208-92320899.069100.641.2499.46101.021.24
2933638-933638100.188100.57
3958576-958576102.864103.27
4936072-936072100.450100.81
5938571-938571100.718101.08
6936987-936987100.548100.91
30min1927892-92789299.572101.151.26100.13101.701.27
2938185-938185100.676101.23
3962094-962094103.242103.82
4936874-936874100.536101.06
5949877-949877101.931102.46
6940869-940869100.964101.49
45min1924548-92454899.213100.590.9099.93101.300.89
2932845-932845100.103100.82
3943929-943929101.293102.04
4935632-935632100.402101.09
5948096-948096101.740102.44
6939293-939293100.795101.49
60min1920084-92008498.734100.541.2699.62101.421.26
2932035-932035100.016100.90
3953606-953606102.331103.25
4932686-932686100.086100.95
5946135-946135101.529102.40
6937173-937173100.568101.43
极限1921878-92187898.926100.401.1799.98101.441.17
2928587-92858799.646100.70
3951780-951780102.135103.22
4934877-934877100.321101.35
5944633-944633101.368102.41
6931693-93169399.980101.01
二甲双胍恩格列净片项目信息
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DC033-12306002对照品来源中检院对照品使用方法直接使用
对照品含量(%)98.99对照品水分(%)0对照品稀释倍数2000
标示量(mg)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%
110.239298493322935739358093319933560.27
210.219302793227931270.16
单位质量响应值RSD%判断
9125.719121.160.04数据可信
供试品溶液-24090902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%
5min153591-5359152.33237.9325.9052.3337.9325.89
230759-3075930.03630.04
348084-4808446.95446.95
432689-3268931.92131.92
539050-3905038.13338.13
628867-2886728.18928.19
10min193751-9375191.54973.5317.0091.6473.6017.00
265628-6562864.08664.14
386291-8629184.26484.34
466977-6697765.40465.46
577609-7760975.78675.85
661550-6155060.10460.15
15min197529-9752995.23889.826.0295.4890.016.04
288696-8869686.61286.77
396288-9628894.02694.24
489166-8916687.07187.23
596342-9634294.07994.27
683869-8386981.89982.05
20min198124-9812495.81994.181.3296.2294.511.35
295878-9587893.62693.93
396664-9666494.39394.77
496012-9601293.75694.06
597432-9743295.14395.49
694537-9453792.31692.60
30min197614-9761495.32195.070.5195.8895.560.53
297738-9773895.44295.90
397281-9728194.99695.53
497247-9724794.96295.43
597781-9778195.48495.99
696473-9647394.20794.64
45min197980-9798095.67895.240.7496.4095.890.75
298195-9819595.88896.50
397245-9724594.96095.65
497961-9796195.66096.28
597524-9752495.23395.90
696255-9625593.99494.59
60min197723-9772395.42795.180.4096.3095.990.40
297831-9783195.53396.31
396991-9699194.71295.56
497686-9768695.39196.17
597633-9763395.33996.16
696984-9698494.70695.46
极限199527-9952797.18997.420.5898.2298.390.53
2100045-10004597.69598.63
398799-9879996.47897.49
499977-9997797.62898.57
599734-9973497.39198.37
6100488-10048898.12799.04
二甲双胍恩格列净片项目信息
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对照品来源中检所对照品对照品使用方法105℃烘干2小时
对照品含量(%)100对照品水分(%)0对照品稀释倍数20
标示量(mg)500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%
110.174636964639534660434638964632974641770.24
210.204633374625124629240.13
单位质量响应值RSD%判断
45641.7945384.710.40数据可信
供试品溶液-24090902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%
5min1319873-31987363.25447.9721.8363.2547.9621.83
2199381-19938139.42739.43
3292527-29252757.84657.85
4210438-21043841.61341.61
5241938-24193847.84247.84
6191217-19121737.81237.81
10min1499792-49979298.83282.6513.7098.9482.7313.71
2373382-37338273.83573.90
3469170-46917092.77792.87
4381300-38130075.40175.47
5426740-42674084.38684.47
6357484-35748470.69170.75
15min1507301-507301100.31796.894.21100.5997.114.23
2475875-47587594.10294.29
3507375-507375100.331100.58
4480949-48094995.10695.30
5508391-508391100.532100.75
6459998-45999890.96391.14
20min1506573-506573100.17399.980.44100.61100.360.47
2503519-50351999.56999.91
3506913-506913100.240100.66
4506461-506461100.151100.50
5507875-507875100.430100.82
6502266-50226699.32199.65
30min1505146-50514699.891100.360.36100.49100.900.34
2506256-506256100.110100.62
3506677-506677100.193100.78
4509827-509827100.816101.34
5509205-509205100.693101.25
6508003-508003100.456100.95
45min1504472-50447299.757100.611.19100.53101.321.17
2506301-506301100.119100.80
3506970-506970100.251101.00
4520927-520927103.011103.70
5506311-506311100.121100.84
6507701-507701100.396101.06
60min1502676-50267699.40299.760.39100.34100.640.35
2505375-50537599.936100.78
3502935-50293599.453100.37
4504171-50417199.698100.56
5503912-50391299.647100.54
6507952-507952100.446101.28
极限1502407-50240799.34999.730.57100.45100.780.53
2503628-50362899.591100.60
3501919-50191999.253100.34
4503768-50376899.618100.64
5504478-50447899.759100.81
6509786-509786100.808101.81
二甲双胍恩格列净片项目信息
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DC033-12306002对照品来源中检院对照品使用方法直接使用
对照品含量(%)98.99对照品水分(%)0对照品稀释倍数2000
标示量(mg)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%
110.239333493442937039305593145933360.28
210.219391894428941730.39
单位质量响应值RSD%判断
9123.759223.600.77数据可信
供试品溶液-24091001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%
5min131953-3195331.03238.0418.2831.0338.0418.27
248304-4830446.91246.91
347778-4777846.40146.40
435519-3551934.49634.50
533552-3355232.58532.59
637897-3789736.80536.81
10min167969-6796966.01173.2113.3566.0673.2813.36
287860-8786085.32985.41
388694-8869486.13986.22
470105-7010568.08568.14
567302-6730265.36365.42
670387-7038768.35968.42
15min191229-9122988.60091.355.5288.7691.545.54
299399-9939996.53596.76
3101630-10163098.70298.92
489828-8982887.24087.41
589410-8941086.83487.00
692868-9286890.19290.37
20min198814-9881495.96796.701.4696.2897.041.48
299607-9960796.73797.12
3102031-10203199.09199.48
497660-9766094.84695.16
599321-9932196.45996.77
699981-9998197.10097.43
30min199793-9979396.91897.211.1897.3997.711.19
299561-9956196.69297.23
3101670-10167098.74199.29
498357-9835795.52396.00
5100080-10008097.19697.67
6101112-10111298.19998.69
45min199991-9999197.11097.131.1597.7497.791.16
299467-9946796.60197.30
3101284-10128498.36699.08
498056-9805695.23195.86
5100483-10048397.58898.22
6100814-10081497.90998.56
60min1100156-10015697.27096.781.5098.0697.601.50
299262-9926296.40297.27
3101334-10133498.41499.29
497066-9706694.26995.06
599396-9939696.53297.33
6100670-10067097.76998.58
极限1100615-10061597.71696.821.2898.6797.801.29
299253-9925396.39397.42
3101096-10109698.18399.23
497489-9748994.68095.63
599535-9953596.66797.62
6100150-10015097.26498.24
二甲双胍恩格列净片项目信息
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对照品来源中检所对照品对照品使用方法105℃烘干2小时
对照品含量(%)100对照品水分(%)0对照品稀释倍数20
标示量(mg)500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%
110.174631034632514648374629704626874633700.19
210.204682084660414671240.33
单位质量响应值RSD%判断
45562.4445796.470.37数据可信
供试品溶液-24091001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%
5min1190038-19003837.44344.7315.2437.4444.7315.25
2270652-27065253.32653.33
3268731-26873152.94752.95
4211781-21178141.72641.73
5200698-20069839.54339.54
6220228-22022843.39143.39
10min1367224-36722472.35378.9711.0372.4279.0511.03
2455600-45560089.76589.85
3459475-45947590.52990.62
4378366-37836674.54874.62
5367662-36766272.43972.51
6376550-37655074.19074.26
15min1472999-47299993.19395.354.2893.3895.564.29
2504648-50464899.42999.67
3515181-515181101.504101.74
4469445-46944592.49392.69
5465706-46570691.75691.94
6475669-47566993.71993.92
20min1504858-50485899.470100.100.7499.81100.470.76
2506206-50620699.736100.14
3515102-515102101.489101.90
4505540-50554099.60599.95
5508329-508329100.154100.49
6508434-508434100.175100.53
30min1509546-509546100.394100.290.99100.90100.830.99
2504123-50412399.32699.90
3513836-513836101.239101.82
4501662-50166298.84199.35
5512791-512791101.033101.54
6512263-512263100.929101.45
45min1511555-511555100.790100.351.07101.46101.051.07
2505484-50548499.594100.33
3514263-514263101.323102.07
4500244-50024498.56199.24
5513661-513661101.205101.88
6510872-510872100.655101.34
60min1511722-511722100.82399.921.04101.66100.781.04
2502314-50231498.96999.87
3512414-512414100.959101.87
4499556-49955698.42699.27
5506664-50666499.826100.67
6510154-510154100.514101.37
极限1508012-508012100.09299.580.82101.10100.610.82
2501666-50166698.84199.91
3509956-509956100.475101.56
4499168-49916898.34999.36
5506100-50610099.715100.72
6507598-507598100.010101.03
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