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%
1 14.228718487216872998721087241872300.05
2 14.218750987603875560.08
单位质量响应值RSD%判断
6134.326161.580.32数据可信
加速6月-供试品溶液-X022139批-西格列汀-0.025molNACL
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min119094-1909421.69427.1318.9721.6927.1318.97
222964-2296426.09126.09
327301-2730131.01831.02
429962-2996234.04234.04
518595-1859521.12721.13
625354-2535428.80628.81
10min143684-4368449.63257.8311.5949.6757.8811.59
247853-4785354.36954.41
356268-5626863.92963.98
457388-5738865.20265.26
545620-4562051.83251.87
654598-5459862.03262.08
15min162346-6234670.83577.566.8470.9577.706.85
265719-6571974.66774.80
374957-7495785.16385.32
469934-6993479.45679.62
565156-6515674.02874.15
671458-7145881.18881.34
20min172560-7256082.44085.993.5382.6886.273.54
272945-7294582.87783.14
379450-7945090.26890.57
475656-7565685.95786.26
575807-7580786.12986.37
677713-7771388.29488.58
30min177030-7703087.51890.002.0587.8990.422.07
277971-7797188.58888.98
380802-8080291.80492.25
478441-7844189.12289.56
580136-8013691.04791.44
680915-8091591.93292.37
45min180151-8015191.06492.721.4691.5893.281.46
280972-8097291.99792.54
381612-8161292.72493.33
481043-8104392.07892.67
583536-8353694.91095.45
682319-8231993.52894.11
60min181197-8119792.25393.381.0692.9294.101.05
282116-8211693.29793.99
381723-8172392.85093.61
481906-8190693.05893.80
583736-8373695.13895.84
682466-8246693.69594.44
极限182728-8272893.99294.640.9394.8295.510.91
283757-8375795.16196.01
382507-8250793.74194.65
482963-8296394.25995.16
584599-8459996.11896.98
683212-8321294.54295.44
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%
119.003923842392688639291133928378392829139273020.06
219.023929318392970239295100.01
单位质量响应值RSD%判断
206700.11206598.840.04数据可信
加速6月-供试品溶液-X022139批-二甲双胍-0.025molNACL
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min11155179-115517929.56535.7416.2129.5635.7416.21
21345711-134571134.44134.44
31579288-157928840.41940.42
41688049-168804943.20343.20
51131612-113161228.96228.96
61478101-147810137.82937.83
10min12330710-233071059.65067.849.9959.7067.909.99
22499367-249936763.96764.02
32927462-292746274.92374.99
42918256-291825674.68874.76
52422099-242209961.98962.04
62806078-280607871.81771.88
15min13123387-312338779.93886.376.1280.0986.546.13
23253218-325321883.26083.42
33676171-367617194.08594.28
43422876-342287687.60287.80
53242025-324202582.97483.13
63530529-353052990.35890.54
20min13513345-351334589.91893.403.3890.2093.723.39
23519244-351924490.06990.37
33835503-383550398.16398.51
43644854-364485493.28493.63
53660180-366018093.67693.97
63723741-372374195.30295.64
30min13700349-370034994.70496.932.0095.1497.402.02
23715726-371572695.09795.55
33878424-387842499.26199.77
43752385-375238596.03696.53
53813669-381366997.60498.05
63863064-386306498.86899.36
45min13802930-380293097.32998.921.2997.9299.551.30
23824550-382455097.88398.49
33903217-390321799.896100.57
43842559-384255998.34399.00
53931371-3931371100.616101.23
63886059-388605999.457100.11
60min13847153-384715398.46199.430.8099.21100.230.81
23865695-386569598.93699.71
33904609-390460999.931100.78
43866319-386631998.95299.77
53931585-3931585100.622101.40
63894648-389464899.677100.50
极限13881576-388157699.342100.090.73100.26101.060.73
23905157-390515799.946100.88
33917414-3917414100.259101.27
43891581-389158199.598100.58
53962957-3962957101.425102.37
63906711-390671199.985100.97
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%
1 14.228715287285873168719087352872590.10
2 14.218747487236873550.20
单位质量响应值RSD%判断
6136.366147.430.13数据可信
加速6月-供试品溶液-2024050521批-西格列汀-0.025molNACL
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min112313-1231314.00316.4617.4014.0016.4617.39
215131-1513117.20817.21
316586-1658618.86318.86
417981-1798120.44920.45
511585-1158513.17513.18
613259-1325915.07915.08
10min136750-3675041.79547.0710.1941.8247.1010.19
240455-4045546.00846.04
346190-4619052.53152.56
446981-4698153.43053.46
538403-3840343.67543.70
639568-3956845.00045.02
15min155409-5540963.01570.838.0063.1170.948.01
260002-6000268.23968.34
368391-6839177.77977.90
467856-6785677.17177.29
560805-6080569.15269.25
661226-6122669.63169.73
20min166793-6679375.96283.736.5576.1683.956.55
271289-7128981.07581.29
380461-8046191.50691.75
477599-7759988.25188.50
572963-7296382.97983.19
672645-7264582.61782.83
30min175391-7539185.74091.163.8586.0691.523.87
277682-7768288.34688.70
382432-8243293.74894.15
483417-8341794.86895.27
581866-8186693.10493.45
680129-8012991.12991.48
45min181283-8128392.44194.711.9392.9195.231.95
282156-8215693.43493.94
383275-8327594.70795.26
486026-8602697.83598.39
583365-8336594.80995.31
683570-8357095.04295.55
60min182337-8233793.64095.491.7394.2696.171.74
284359-8435995.93996.60
383244-8324494.67195.39
486591-8659198.47899.20
583503-8350394.96695.63
683763-8376395.26295.93
极限183701-8370195.19196.341.6595.9797.181.66
285264-8526496.96997.79
383876-8387695.39096.26
487332-8733299.321100.20
584072-8407295.61396.43
684040-8404095.57796.40
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%
119.003919001391815839197423918812391736239186150.03
219.023923782392519439244880.03
单位质量响应值RSD%判断
206242.89206334.810.04数据可信
加速6月-供试品溶液-2024050521批-二甲双胍-0.025molNACL
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1817012-81701220.94723.8013.8120.9523.8013.81
2965497-96549724.75324.75
31041547-104154726.70326.70
41098746-109874628.17028.17
5775537-77553719.88319.88
6872308-87230822.36422.36
10min12020752-202075251.80856.888.5751.8456.928.58
22160811-216081155.39955.44
32414974-241497461.91561.96
42491179-249117963.86963.92
52075566-207556653.21353.25
62148731-214873155.08955.13
15min12825087-282508772.42978.976.2772.5579.116.27
22978204-297820476.35576.49
33322569-332256985.18485.33
43296254-329625484.50984.66
53018310-301831077.38377.51
63041795-304179577.98578.11
20min13282156-328215684.14890.094.8884.3990.364.88
23419712-341971287.67487.94
33766886-376688696.57596.86
43648669-364866993.54493.84
53485813-348581389.36989.62
63481505-348150589.25989.52
30min13608714-360871492.52096.312.6192.9096.732.63
23672210-367221094.14894.55
33831869-383186998.24198.69
43859011-385901198.93799.39
53809424-380942497.66698.07
63758101-375810196.35096.76
45min13815236-381523697.81598.961.1598.3599.541.17
23827095-382709598.11998.68
33854422-385442298.81999.43
43941330-3941330101.048101.66
53856135-385613598.86399.43
63866146-386614699.12099.69
60min13850611-385061198.72299.540.9899.42100.280.99
23892210-389221099.788100.52
33861337-386133798.99799.78
43953538-3953538101.361102.14
53859313-385931398.94599.67
63878148-387814899.428100.16
极限13875596-387559699.36299.990.91100.23100.900.92
23910653-3910653100.261101.15
33863836-386383699.061100.00
43960212-3960212101.532102.48
53912778-3912778100.316101.21
63878245-387824599.430100.33
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