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%
113.98245382705819938213582331823230.34
213.898214782778824620.55
单位质量响应值RSD%判断
5922.525936.790.18数据可信
影响因素30天-供试品溶液-X022139批-西格列汀-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%
5min131529-3152937.14128.0126.9637.1428.0126.96
231156-3115636.70136.70
322534-2253426.54526.54
418083-1808321.30121.30
516265-1626519.16019.16
623118-2311827.23327.23
10min157397-5739767.61358.9615.3667.6759.0015.37
260002-6000270.68170.74
351570-5157060.74960.79
444201-4420152.06852.10
540260-4026047.42647.46
646878-4687855.22155.27
15min170103-7010382.58077.507.5582.7577.657.56
271332-7133284.02884.21
368876-6887681.13581.28
462308-6230873.39873.52
559131-5913169.65569.77
663007-6300774.22174.36
20min173959-7395987.12285.964.1087.4386.244.12
277706-7770691.53691.86
374440-7444087.68987.97
471615-7161584.36184.61
569780-6978082.20082.43
670329-7032982.84683.11
30min175437-7543788.86389.162.7289.3289.572.74
279453-7945393.59494.07
375750-7575089.23289.66
475671-7567189.13989.52
574388-7438887.62887.99
673411-7341186.47786.88
45min177014-7701490.72190.492.5591.3391.062.57
280455-8045594.77595.40
376225-7622589.79290.37
476840-7684090.51691.05
575486-7548688.92189.43
674906-7490688.23888.78
60min176860-7686090.54090.992.1391.3091.712.15
280272-8027294.55995.34
376618-7661890.25590.98
477634-7763491.45192.14
576648-7664890.29090.95
675426-7542688.85189.54
极限180024-8002494.26793.971.1795.1794.841.17
280659-8065995.01595.96
378490-7849092.46093.34
480565-8056594.90495.74
580146-8014694.41195.22
678741-7874192.75693.59
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%
119.533979108396013439557273958979396591739639730.24
219.553956802396157939591900.09
单位质量响应值RSD%判断
202968.41202516.110.16数据可信
影响因素30天-供试品溶液-X022139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%
5min11795581-179558146.84037.1022.5446.8437.1022.54
21804050-180405047.06147.06
31353875-135387535.31835.32
41146901-114690129.91929.92
51038249-103824927.08427.08
61395592-139559236.40636.41
10min12957354-295735477.14769.7811.8177.2269.8411.82
23093082-309308280.68880.77
32747621-274762171.67671.73
42457282-245728264.10264.15
52260577-226057758.97059.02
62533883-253388366.10066.16
15min13471519-347151990.56086.965.4490.7787.145.46
23544492-354449292.46392.68
33451327-345132790.03390.21
43239266-323926684.50184.66
53082447-308244780.41080.55
63212248-321224883.79683.97
20min13644367-364436795.06994.672.9695.4394.992.98
23801232-380123299.16199.53
33683460-368346096.08896.42
43605183-360518394.04794.34
53529439-352943992.07192.35
63510100-351010091.56691.88
30min13711981-371198196.83297.492.0297.3597.972.03
23865036-3865036100.825101.36
33727285-372728597.23297.72
43775196-377519698.48298.94
53695877-369587796.41296.84
63647244-364724495.14495.61
45min13735920-373592097.45798.631.8098.1399.271.81
23885627-3885627101.362102.06
33755109-375510997.95898.61
43843915-3843915100.274100.89
53751285-375128597.85898.45
63713455-371345596.87197.49
60min13756325-375632597.98999.171.7298.8399.981.72
23882588-3882588101.283102.15
33764148-376414898.19399.01
43881905-3881905101.265102.05
53792652-379265298.93799.69
63732601-373260197.37098.15
极限13839774-3839774100.166100.611.16101.17101.581.15
23886964-3886964101.397102.44
33803172-380317299.211100.19
43913366-3913366102.086103.04
53883799-3883799101.315102.23
63813156-381315699.472100.42
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%
113.98164481369814248155281386814750.15
213.898246182562825120.09
单位质量响应值RSD%判断
5861.515940.390.95数据可信
影响因素30天-供试品溶液-X022139批-西格列汀-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%
5min121416-2141625.35119.6815.0125.3519.6815.01
215174-1517417.96217.96
317171-1717120.32620.33
416010-1601018.95218.95
514984-1498417.73817.74
614990-1499017.74517.74
10min145982-4598254.43248.3815.4154.4748.4215.40
237525-3752544.42144.45
340672-4067248.14648.18
450675-5067559.98760.02
534955-3495541.37841.41
635419-3541941.92841.96
15min161641-6164172.96868.118.0873.1068.238.08
255022-5502265.13365.24
358719-5871969.50969.62
463956-6395675.70975.84
552950-5295062.68062.78
652950-5295062.68062.78
20min171046-7104684.10280.735.0484.3680.965.06
267017-6701779.33279.54
369799-6979982.62682.86
472463-7246385.77986.04
564060-6406075.83276.03
664791-6479176.69776.90
30min177968-7796892.29690.392.8992.6990.762.90
277938-7793892.26092.60
377529-7752991.77692.14
477647-7764791.91692.32
573145-7314586.58686.92
673938-7393887.52587.86
45min178713-7871393.17892.801.1993.7393.311.21
279655-7965594.29394.79
377992-7799292.32492.84
478966-7896693.47794.03
576957-7695791.09991.57
678075-7807592.42292.90
60min179314-7931493.88993.480.9294.5994.140.93
279910-7991094.59595.25
378842-7884293.33094.00
478958-7895893.46894.18
577714-7771491.99592.62
679059-7905993.58794.22
极限179454-7945494.05595.491.2194.9296.311.17
281412-8141296.37397.19
379569-7956994.19195.02
480547-8054795.34996.21
581732-8173296.75197.53
681265-8126596.19996.99
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%
119.533934651393253339321043938128393329739341430.07
219.553973506397968839765970.11
单位质量响应值RSD%判断
201441.01203406.500.69数据可信
影响因素30天-供试品溶液-X022139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%
5min11373805-137380535.89528.8912.4635.8928.8912.45
21020310-102031026.65926.66
31123997-112399729.36829.37
41073393-107339328.04628.05
51024539-102453926.76926.77
61018323-101832326.60726.61
10min12576328-257632867.31560.9512.2467.3761.0012.24
22161354-216135456.47256.52
32313540-231354060.44860.50
42775238-277523872.51272.56
52071785-207178554.13254.18
62098924-209892454.84154.89
15min13238171-323817184.60779.566.4784.7879.706.48
22950625-295062577.09477.23
33089470-308947080.72280.87
43300226-330022686.22986.40
52825102-282510273.81573.95
62865465-286546574.86975.00
20min13580623-358062393.55590.163.7993.8790.443.80
23406231-340623188.99889.27
33493602-349360291.28191.57
43605428-360542894.20394.51
53291418-329141885.99886.26
63327120-332712086.93187.19
30min13790675-379067599.04397.691.8499.5198.121.86
23791231-379123199.05899.47
33762362-376236298.30398.74
43782811-378281198.83899.31
53632963-363296394.92295.32
63672240-367224095.94996.35
45min13804441-380444199.40399.440.89100.04100.040.90
23821765-382176599.855100.44
33771927-377192798.55399.15
43841671-3841671100.376101.01
53759751-375975198.23598.79
63835673-3835673100.219100.78
60min13804200-380420099.39799.440.85100.20100.210.86
23833791-3833791100.170100.92
33768654-376865498.46899.23
43826175-382617599.971100.77
53765657-376565798.38999.11
63837761-3837761100.273101.01
极限13800419-380041999.298100.031.17100.26100.961.14
23843175-3843175100.415101.33
33766889-376688998.42299.35
43811577-381157799.589100.56
53892419-3892419101.702102.59
63855861-3855861100.746101.65
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%
113.98242583193824558247082738826560.40
213.898239782229823130.15
单位质量响应值RSD%判断
5946.475926.060.25数据可信
影响因素30天-供试品溶液-X022139批-西格列汀-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%
5min115080-1508017.74417.3515.9517.7417.3515.95
213312-1331215.66415.66
318855-1885522.18622.19
413258-1325815.60015.60
515597-1559718.35318.35
612372-1237214.55814.56
10min136828-3682843.33443.3711.2543.3643.4011.25
234206-3420640.24940.28
342433-4243349.93049.97
433604-3360439.54139.57
541347-4134748.65248.68
632737-3273738.52138.54
15min154148-5414863.71464.227.0263.8264.327.03
252858-5285862.19762.29
358488-5848868.82168.94
451017-5101760.03060.12
559985-5998570.58370.69
650971-5097159.97660.06
20min166213-6621377.91178.614.9478.1278.824.95
265304-6530476.84177.04
369053-6905381.25381.49
463444-6344474.65374.84
572305-7230585.07985.31
664541-6454175.94476.13
30min174436-7443687.58788.981.8287.9289.321.84
275296-7529688.59988.92
377358-7735891.02591.40
474108-7410887.20187.52
577213-7721390.85491.23
675319-7531988.62688.94
45min177292-7729290.94791.750.7291.4392.240.74
278455-7845592.31692.79
378616-7861692.50593.03
477828-7782891.57892.04
578283-7828392.11392.64
677393-7739391.06691.53
60min178858-7885892.79092.750.7993.4393.390.81
278827-7882792.75393.38
378992-7899292.94893.62
478711-7871192.61793.23
579739-7973993.82794.50
677797-7779791.54292.16
极限180041-8004194.18293.860.6894.9794.650.68
280600-8060094.84095.62
379730-7973093.81694.65
479289-7928993.29794.07
579824-7982493.92794.76
679103-7910393.07893.85
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%
119.533974682398130139767163976984397661839772600.07
219.553971069398291439769920.22
单位质量响应值RSD%判断
203648.75203426.700.08数据可信
影响因素30天-供试品溶液-X022139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%
5min11038306-103830626.98026.1613.4226.9826.1613.41
2922824-92282423.97923.98
31242037-124203732.27432.27
4925211-92521124.04124.04
51045551-104555127.16827.17
6866637-86663722.51922.52
10min12157762-215776256.06855.839.1356.1155.889.13
22027551-202755152.68552.72
32400050-240005062.36462.42
41994688-199468851.83151.87
52368947-236894761.55661.60
61943392-194339250.49850.54
15min12911217-291121775.64775.875.5875.7876.005.59
22838895-283889573.76773.90
33086032-308603280.18980.35
42765915-276591571.87172.00
53147435-314743581.78581.93
62768949-276894971.95072.07
20min13374030-337403087.67288.253.6887.9488.513.69
23333324-333332486.61586.87
33472022-347202290.21990.51
43263887-326388784.81085.06
53608657-360865793.76994.05
63324533-332453386.38686.63
30min13671551-367155195.40396.601.4795.8197.001.49
23711131-371113196.43296.83
33793022-379302298.56099.00
43657393-365739395.03695.42
53772278-377227898.02198.46
63699320-369932096.12596.51
45min13798966-379896698.71498.590.4099.2899.160.42
23806054-380605498.89899.45
33808618-380861898.96599.57
43775278-377527898.09998.64
53801121-380112198.77099.37
63775606-377560698.10798.65
60min13817824-381782499.20499.060.6499.9499.790.65
23831213-383121399.552100.27
33818859-381885999.231100.00
43790292-379029298.48999.20
53838494-383849499.741100.51
63776131-377613198.12198.83
极限13821301-382130199.29598.890.56100.1999.780.57
23831559-383155999.561100.45
33815250-381525099.137100.07
43775363-377536398.10198.97
53801951-380195198.79299.73
63787901-378790198.42799.30
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