西格列汀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DSTP-202308101B对照品来源中检院对照品使用方法直接使用
对照品含量(%)96.28对照品水分(%)0对照品稀释倍数200
标示量(mg)50供试品稀释倍数1系数0.8061
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
114.13 8263582627825828267582774826590.09
214.14 8293082993829620.06
单位质量响应值RSD%判断
5849.895867.190.21数据可信
供试品溶液-2024050621批-西格列汀-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%
5min113162-1316215.69315.2114.1715.6915.2114.17
211547-1154713.76713.77
313886-1388616.55616.56
411263-1126313.42913.43
515632-1563218.63818.64
611047-1104713.17113.17
10min138040-3804045.35444.0813.7245.3844.1013.72
234301-3430140.89640.92
341557-4155749.54849.58
432355-3235538.57638.60
543975-4397552.43152.46
631597-3159737.67337.69
15min159543-5954370.99268.039.0171.0968.139.02
254149-5414964.56164.65
362357-6235774.34774.46
452821-5282162.97863.06
562715-6271574.77474.89
650791-5079160.55760.64
20min172722-7272286.70584.116.1486.9384.326.15
267539-6753980.52680.72
374874-7487489.27189.51
467864-6786480.91381.10
575318-7531889.80090.04
664959-6495977.44977.64
30min183134-8313499.11996.452.1899.4896.802.20
279617-7961794.92695.26
382833-8283398.76099.14
479864-7986495.22095.55
581032-8103296.61397.01
678888-7888894.05794.37
45min183964-83964100.10998.131.61100.6498.641.62
280880-8088096.43296.92
383968-83968100.114100.66
481711-8171197.42397.91
581576-8157697.26297.82
681734-8173497.45097.92
60min183817-8381799.93498.121.53100.6398.791.54
280886-8088696.43997.09
383895-83895100.027100.74
481604-8160497.29597.94
581679-8167997.38498.10
681872-8187297.61598.25
极限184411-84411100.64298.651.57101.5099.501.58
281409-8140997.06397.88
384338-84338100.555101.44
482185-8218597.98898.80
581940-8194097.69698.57
682180-8218097.98298.78
西格列汀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DA-1142209074对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.9对照品水分(%)0对照品稀释倍数20
标示量(mg)850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%
119.973988619399130740033673992905399513539942670.15
219.943962712397221639674640.17
单位质量响应值RSD%判断
200013.37198970.110.37数据可信
供试品溶液-2024050621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%
5min1836788-83678822.18521.5911.1522.1821.5911.14
2762510-76251020.21520.22
3886069-88606923.49123.49
4730073-73007319.35519.36
5946763-94676325.10025.10
6723676-72367619.18619.19
10min11993264-199326452.84551.6610.4352.8851.6910.43
21850796-185079649.06849.10
32141990-214199056.78856.83
41761455-176145546.69946.73
52217765-221776558.79758.84
61725471-172547145.74545.78
15min12828547-282854774.99072.736.6175.1172.856.61
22652438-265243870.32170.44
32933503-293350377.77277.91
42589806-258980668.66068.77
52937909-293790977.88978.03
62517911-251791166.75466.86
20min13293319-329331987.31185.384.2087.5685.624.21
23137417-313741783.17883.41
33349477-334947788.80089.06
43137591-313759183.18383.41
53368172-336817289.29689.57
63037138-303713880.52080.74
30min13628860-362886096.20794.521.2396.6094.911.25
23534189-353418993.69794.07
33607439-360743995.63996.05
43542188-354218893.90994.27
53561575-356157594.42394.84
63518119-351811993.27193.62
45min13654737-365473796.89395.750.8997.4596.290.90
23580554-358055494.92695.45
33644870-364487096.63297.20
43606947-360694795.62696.15
53577900-357790094.85695.43
63604378-360437895.55896.07
60min13651322-365132296.80395.770.8497.5296.470.84
23582789-358278994.98695.67
33645091-364509196.63797.37
43604388-360438895.55896.24
53581163-358116394.94395.68
63609315-360931595.68996.36
极限13656359-365635996.93695.880.8797.8196.740.87
23589628-358962895.16796.01
33651895-365189596.81897.71
43612880-361288095.78396.62
53581511-358151194.95295.84
63606627-360662795.61896.45
西格列汀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DSTP-202308101B对照品来源中检院对照品使用方法直接使用
对照品含量(%)96.28对照品水分(%)0对照品稀释倍数200
标示量(mg)50供试品稀释倍数1系数0.8061
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
114.13 8261982671826488251682594826100.08
214.14 8295783004829800.05
单位质量响应值RSD%判断
5846.435868.460.27数据可信
供试品溶液-2024050721批-西格列汀-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%
5min110762-1076212.83415.5818.6012.8315.5818.61
215267-1526718.20618.21
315772-1577218.80818.81
49896-989611.80111.80
512394-1239414.78014.78
614309-1430917.06417.06
10min134576-3457641.23244.3210.7941.2544.3510.79
240915-4091548.79148.82
343109-4310951.40851.44
432776-3277639.08639.11
535015-3501541.75641.78
636612-3661243.66043.69
15min154668-5466865.19268.698.2765.2868.798.27
261663-6166373.53473.65
365199-6519977.75077.87
453077-5307763.29563.38
554770-5477065.31465.41
656226-5622667.05067.15
20min168660-6866081.87885.565.5982.0885.785.60
273928-7392888.16088.39
378752-7875293.91294.16
467976-6797681.06281.25
570504-7050484.07784.28
670676-7067684.28284.49
30min180679-8067996.21097.090.8396.5597.450.84
281013-8101396.60996.99
382464-8246498.33998.74
481179-8117996.80797.13
581987-8198797.77098.11
681193-8119396.82397.18
45min182514-8251498.39997.630.6998.8998.150.68
281450-8145097.13097.67
382233-8223398.06398.63
481476-8147697.16197.65
582352-8235298.20598.71
681206-8120696.83997.35
60min182460-8246098.33497.500.7698.9998.180.76
281272-8127296.91797.62
382119-8211997.92898.66
481252-8125296.89497.54
582376-8237698.23498.90
681100-8110096.71297.39
极限182526-8252698.41397.480.7299.2498.330.71
281314-8131496.96897.83
381962-8196297.74098.63
481627-8162797.34198.15
582132-8213297.94398.78
680912-8091296.48897.33
西格列汀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DA-1142209074对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.9对照品水分(%)0对照品稀释倍数20
标示量(mg)850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%
119.973973282397579239872323978358397555839780440.14
219.943959292397037539648340.20
单位质量响应值RSD%判断
199201.00198838.210.13数据可信
供试品溶液-2024050721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%
5min1693611-69361118.43221.8115.8018.4321.8215.80
2942120-94212025.03625.04
3956017-95601725.40625.41
4655819-65581917.42817.43
5779693-77969320.72020.72
6897717-89771723.85623.86
10min11849399-184939949.14752.008.4649.1852.048.47
22104556-210455655.92755.97
32199659-219965958.45558.50
41767877-176787746.98047.01
51862345-186234549.49149.53
61957717-195771752.02552.06
15min12644810-264481070.28473.406.2670.4073.526.26
22902180-290218077.12477.26
33040668-304066880.80480.94
42601689-260168969.13869.25
52657081-265708170.61070.73
62726214-272621472.44872.57
20min13152205-315220583.76886.924.1884.0087.164.19
23337482-333748288.69288.96
33509941-350994193.27593.55
43147563-314756383.64583.87
53224858-322485885.69985.93
63252108-325210886.42386.67
30min13566198-356619894.77095.550.7095.1495.940.71
23573400-357340094.96195.37
33631679-363167996.51096.94
43585057-358505795.27195.63
53613866-361386696.03696.41
63602527-360252795.73596.13
45min13625469-362546996.34595.960.5396.8796.510.52
23580769-358076995.15795.73
33624881-362488196.32996.92
43602142-360214295.72596.25
53629762-362976296.45997.00
63602942-360294295.74696.30
60min13623186-362318696.28495.850.5696.9796.560.56
23580124-358012495.14095.87
33621308-362130896.23496.99
43589788-358978895.39696.08
53628146-362814696.41697.11
63598421-359842195.62696.34
极限13619474-361947496.18595.690.4997.0396.560.48
23576730-357673095.04995.94
33613684-361368496.03296.94
43591964-359196495.45496.29
53614817-361481796.06296.92
63588957-358895795.37496.24
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