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%
113.998490884783849908485085030849120.12
214.038333583893836140.48
单位质量响应值RSD%判断
6069.485959.661.30数据可信
影响因素30天-供试品溶液-X022139批-西格列汀-bzgw(内含0.025%氯化钠)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min123104-2310426.83424.9914.1426.8324.9914.14
226581-2658130.87230.87
319906-1990623.12023.12
419582-1958222.74322.74
518101-1810121.02321.02
621848-2184825.37525.38
10min148992-4899256.90255.796.9856.9555.846.98
251344-5134459.63359.68
344584-4458451.78251.82
446574-4657454.09354.13
544499-4449951.68351.72
652237-5223760.67060.71
15min166036-6603676.69775.452.9176.8475.582.91
265708-6570876.31676.47
361600-6160071.54571.67
467099-6709977.93278.06
564591-6459175.01975.14
664717-6471775.16575.31
20min175587-7558787.79083.893.3288.0684.153.32
273545-7354585.41985.70
369843-6984381.11981.36
472749-7274984.49484.75
572515-7251584.22284.47
669123-6912380.28380.55
30min178020-7802090.61687.252.3691.0387.652.36
276308-7630888.62889.05
373538-7353885.41085.79
474833-7483386.91587.31
574680-7468086.73787.12
673370-7337085.21585.62
45min178340-7834090.98890.501.4891.5591.041.48
279954-7995492.86293.43
376870-7687089.28089.80
477664-7766490.20390.75
577800-7780090.36190.89
676883-7688389.29689.84
60min178350-7835090.99990.811.1691.7291.511.17
279303-7930392.10692.83
377517-7751790.03290.70
478431-7843191.09391.79
578758-7875891.47392.15
676772-7677289.16789.86
极限178155-7815590.77390.981.4291.6491.831.42
279163-7916391.94492.82
377494-7749490.00590.83
478510-7851091.18592.03
579887-7988792.78493.62
676817-7681789.21990.06
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%
119.263980170397806139725233971880397953439764340.10
219.313910342391251039114260.04
单位质量响应值RSD%判断
206460.75202559.611.35数据可信
影响因素30天-供试品溶液-X022139批-二甲双胍-bzgw(内含0.025%氯化钠)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min11413826-141382636.56634.0111.7036.5734.0211.70
21557313-155731340.27740.28
31239087-123908732.04732.05
41207752-120775231.23631.24
51136095-113609529.38329.38
61336482-133648234.56634.57
10min12605733-260573367.39366.355.7267.4566.405.73
22697947-269794769.77869.84
32434362-243436262.96163.01
42498471-249847164.61964.67
52395695-239569561.96162.01
62760224-276022471.38871.45
15min13315014-331501485.73784.611.9385.9184.781.93
23290615-329061585.10685.29
33159077-315907781.70481.86
43335021-333502186.25586.41
53245228-324522883.93284.08
63283788-328378884.93085.11
20min13685660-368566095.32392.252.1995.6492.562.19
23615626-361562693.51293.84
33515473-351547390.92291.22
43571012-357101292.35892.66
53551869-355186991.86392.16
63462195-346219589.54489.86
30min13779093-377909397.74094.981.5898.2195.441.58
23695038-369503895.56696.05
33624824-362482493.75094.20
43651081-365108194.42994.89
53649505-364950594.38894.83
63633717-363371793.98094.45
45min13771141-377114197.53497.580.7498.1798.200.75
23826514-382651498.96699.61
33744927-374492796.85697.46
43760290-376029097.25397.87
53768553-376855397.46798.07
63765759-376575997.39598.02
60min13784286-378428697.87497.730.6698.6798.510.67
23813568-381356898.63199.44
33759844-375984497.24298.01
43782352-378235297.82498.60
53789975-378997598.02198.79
63741805-374180596.77597.56
极限13774251-377425197.61597.670.6598.5898.620.65
23797594-379759498.21899.19
33757341-375734197.17798.10
43779436-377943697.74998.69
53808191-380819198.49299.42
63742219-374221996.78697.73
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%
113.998399883993839008395184062839810.08
214.038254283077828100.46
单位质量响应值RSD%判断
6002.935902.351.20数据可信
影响因素30天-供试品溶液-X022139批-西格列汀-bzgs(内含0.025%氯化钠)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min113692-1369216.06819.7610.9816.0719.7610.97
215829-1582918.57618.58
318375-1837521.56321.56
417473-1747320.50520.50
516984-1698419.93119.93
618680-1868021.92121.92
10min135881-3588142.10747.288.1542.1347.318.15
237740-3774044.28844.32
343004-4300450.46650.50
439431-3943146.27346.31
541000-4100048.11448.15
644681-4468152.43452.47
15min154140-5414063.53468.765.8163.6368.875.82
256660-5666066.49166.60
360412-6041270.89471.01
456508-5650866.31366.42
560385-6038570.86370.98
663438-6343874.44574.57
20min168281-6828180.12981.933.9880.3382.163.98
268270-6827080.11680.33
370209-7020982.39182.63
466290-6629077.79278.01
571979-7197984.46884.70
673876-7387686.69586.94
30min179946-7994693.81892.122.2394.1592.482.23
278161-7816191.72392.07
377814-7781491.31691.69
475518-7551888.62288.97
579328-7932893.09393.46
680244-8024494.16894.56
45min182204-8220496.46895.851.9096.9696.361.88
284445-8444599.09899.60
381497-8149795.63896.17
480548-8054894.52495.02
580096-8009693.99494.52
681268-8126895.36995.92
60min183176-8317697.60895.791.5998.2696.471.57
283249-8324997.69498.36
381182-8118295.26895.96
480475-8047594.43995.10
580283-8028394.21394.90
681395-8139595.51896.23
极限182598-8259896.93095.512.0897.7596.352.06
283897-8389798.45499.28
380805-8080594.82695.67
480213-8021394.13194.95
579210-7921092.95493.80
681630-8163095.79496.66
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%
119.263928379394761839324863930468393507339348050.20
219.313891174391793539045540.49
单位质量响应值RSD%判断
204299.33202203.730.73数据可信
影响因素30天-供试品溶液-X022139批-二甲双胍-bzgs(内含0.025%氯化钠)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1871793-87179322.68627.259.8522.6927.259.85
2989234-98923425.74225.74
31134062-113406229.51029.51
41088275-108827528.31928.32
51053560-105356027.41527.42
61145839-114583929.81729.82
10min11987265-198726551.71257.086.8451.7557.136.84
22075074-207507453.99754.04
32316661-231666160.28460.33
42160111-216011156.21056.26
52235592-223559258.17458.22
62387741-238774162.13362.18
15min12787823-278782372.54477.264.7572.6777.404.76
22881252-288125274.97575.11
33035682-303568278.99479.14
42887989-288798975.15175.29
53049307-304930779.34879.49
63172444-317244482.55382.71
20min13362415-336241587.49689.003.2087.7489.273.20
23342942-334294286.98987.25
33420575-342057589.00989.29
43298580-329858085.83586.10
53512452-351245291.40091.68
63584618-358461893.27893.57
30min13784355-378435598.47697.211.4998.8797.631.50
23702423-370242396.34496.75
33699726-369972696.27396.70
43660849-366084995.26295.67
53769112-376911298.07998.51
63798873-379887398.85399.30
45min13831685-383168599.70799.340.72100.2699.920.71
23860434-3860434100.455101.02
33812807-381280799.21699.81
43800082-380008298.88599.45
53780244-378024498.36998.96
63821265-382126599.436100.05
60min13827496-382749699.59899.390.87100.32100.140.86
23877768-3877768100.906101.64
33809807-380980799.13899.89
43795183-379518398.75799.49
53784082-378408298.46999.22
63823512-382351299.495100.27
极限13847631-3847631100.12299.080.93101.0199.990.91
23844826-3844826100.049100.95
33798719-379871998.84999.77
43788745-378874598.59099.49
53754834-375483497.70798.63
63810898-381089899.166100.11
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%
113.998321083073832368323783279832070.10
214.038266183265829630.52
单位质量响应值RSD%判断
5947.615913.260.41数据可信
影响因素30天-供试品溶液-X022139批-西格列汀-bzgz(内含0.025%氯化钠)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min120228-2022823.82520.918.6623.8320.918.67
216949-1694919.96319.96
316413-1641319.33219.33
417795-1779520.96020.96
516309-1630919.20919.21
618821-1882122.16822.17
10min144364-4436452.25448.745.9252.2948.775.92
240551-4055147.76247.80
338664-3866445.54045.57
443969-4396951.78851.82
538905-3890545.82445.86
641821-4182149.25849.30
15min163219-6321974.46270.443.9374.5970.563.93
259586-5958670.18370.30
357819-5781968.10168.21
461083-6108371.94672.07
556667-5666766.74466.85
660440-6044071.18871.31
20min174822-7482288.12883.324.0488.3883.564.04
271451-7145184.15884.39
368072-6807280.17880.40
472915-7291585.88286.12
567481-6748179.48279.70
669706-6970682.10282.34
30min180135-8013594.38692.052.0094.7892.422.00
279966-7996694.18794.56
376802-7680290.46090.82
478015-7801591.88992.27
577416-7741691.18391.54
676574-7657490.19290.57
45min180605-8060594.93996.070.8695.4996.590.85
281936-8193696.50797.03
380780-8078095.14695.65
481847-8184796.40296.94
582325-8232596.96597.47
681886-8188696.44896.97
60min180368-8036894.66096.011.1795.3796.701.16
281620-8162096.13596.82
380314-8031494.59795.26
482362-8236297.00997.71
582403-8240397.05797.72
682015-8201596.60097.29
极限180525-8052594.84595.860.9195.7296.710.90
281521-8152196.01896.87
380468-8046894.77895.60
481670-8167096.19497.05
582272-8227296.90397.73
681864-8186496.42297.27
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%
119.263924578393139539261243923512392368439258590.09
219.313905461390123239033460.08
单位质量响应值RSD%判断
203834.84202141.170.59数据可信
影响因素30天-供试品溶液-X022139批-二甲双胍-bzgz(内含0.025%氯化钠)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min11229435-122943532.03328.557.6532.0328.557.65
21058296-105829627.57427.57
31022064-102206426.63026.63
41095043-109504328.53228.53
51013346-101334626.40326.40
61155970-115597030.11930.12
10min12375051-237505161.88358.524.6861.9458.564.69
22222114-222211457.89857.94
32123368-212336855.32555.37
42351418-235141861.26761.31
52138727-213872755.72555.77
62264474-226447459.00259.05
15min13170756-317075682.61578.963.3282.7779.103.33
23026479-302647978.85679.00
32922559-292255976.14876.28
43099629-309962980.76280.91
52912374-291237475.88376.02
63051191-305119179.50079.65
20min13617848-361784894.26490.343.2494.5690.623.25
23492626-349262691.00191.28
33352367-335236787.34787.61
43567710-356771092.95893.24
53345513-334551387.16887.43
63427238-342723889.29889.58
30min13807772-380777299.21397.341.5799.6697.771.57
23804796-380479699.13599.56
33672609-367260995.69196.10
43731099-373109997.21597.65
53716661-371666196.83997.25
63683019-368301995.96296.39
45min13834299-383429999.904100.150.69100.52100.740.69
23851856-3851856100.361100.95
33797990-379799098.95899.53
43845616-3845616100.199100.80
53876265-3876265100.997101.57
63856249-3856249100.476101.07
60min13796035-379603598.90799.890.9099.69100.650.89
23839202-3839202100.032100.79
33787773-378777398.69299.43
43854730-3854730100.436101.20
53872593-3872593100.902101.64
63852295-3852295100.373101.13
极限13791722-379172298.79499.700.8999.74100.620.88
23832601-383260199.860100.78
33780528-378052898.50399.40
43836318-383631899.956100.89
53866072-3866072100.732101.64
63852549-3852549100.379101.30
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