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%
113.588228481589818738184281723818620.32
213.558122381731814770.45
单位质量响应值RSD%判断
6028.136013.060.18数据可信
供试品溶液-2024050521批-西格列汀-zjtj3y(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%
5min115706-1570618.22216.3118.4418.2216.3118.43
211720-1172013.59713.60
311565-1156513.41813.42
412073-1207314.00714.01
515647-1564718.15318.15
617626-1762620.44920.45
10min143360-4336050.30646.7411.8650.3446.7711.86
234905-3490540.49640.52
336515-3651542.36442.39
436937-3693742.85442.88
543350-4335050.29450.32
646679-4667954.15654.19
15min162881-6288172.95470.216.9273.0770.316.93
255211-5521164.05564.15
356821-5682165.92366.02
458695-5869568.09768.19
563929-6392974.17074.28
665543-6554376.04276.17
20min174630-7463086.58583.644.4886.8283.864.49
268429-6842979.39179.59
369143-6914380.21980.42
470198-7019881.44381.65
574057-7405785.92086.16
676084-7608488.27288.52
30min179535-7953592.27692.172.7492.6692.532.75
277431-7743189.83590.16
378497-7849791.07191.41
477346-7734689.73690.08
580947-8094793.91494.29
682897-8289796.17696.57
45min180730-8073093.66294.550.9094.2095.070.91
281526-8152694.58695.06
381430-8143094.47494.96
481038-8103894.01994.51
581415-8141594.45794.99
682855-8285596.12796.69
60min181612-8161294.68595.751.5295.3896.421.52
283981-8398197.43498.07
380707-8070793.63594.28
482255-8225595.43196.08
583691-8369197.09797.79
682914-8291496.19696.91
极限182029-8202995.16995.300.7096.0296.130.71
281994-8199495.12995.93
381331-8133194.35995.16
482057-8205795.20296.01
583069-8306996.37697.23
682376-8237695.57296.45
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%
119.123929017392525239172283926688391599539228360.15
219.143896082390210838990950.11
单位质量响应值RSD%判断
205169.25203714.470.51数据可信
供试品溶液-2024050521批-二甲双胍-zjtj3y(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%
5min11000289-100028925.87723.7614.7625.8823.7614.76
2797904-79790420.64220.64
3795927-79592720.59120.59
4811032-81103220.98120.98
5988040-98804025.56025.56
61116323-111632328.87928.88
10min12343811-234381160.63456.909.7660.6856.949.77
21972780-197278051.03651.07
32009858-200985851.99552.03
42049432-204943253.01953.05
52338649-233864960.50160.54
62482876-248287664.23264.28
15min13167634-316763481.94679.035.3382.0979.175.33
22862756-286275674.05974.18
32899809-289980975.01875.14
42983580-298358077.18577.31
53152032-315203281.54381.69
63264395-326439584.45084.60
20min13619760-361976093.64390.993.4693.9291.253.48
23385562-338556287.58487.83
33385590-338559087.58587.83
43482630-348263090.09590.35
53548187-354818791.79192.07
63680441-368044195.21395.51
30min13809212-380921298.54498.222.0798.9898.642.09
23743815-374381596.85297.24
33722772-372277296.30896.70
43736708-373670896.66897.07
53842116-384211699.39599.83
63926280-3926280101.572102.03
45min13866865-3866865100.035100.090.60100.64100.670.61
23878658-3878658100.340100.89
33852228-385222899.657100.21
43871422-3871422100.153100.72
53838147-383814799.29299.89
63905680-3905680101.040101.66
60min13879262-3879262100.356100.861.09101.12101.611.08
23956673-3956673102.359103.08
33845873-384587399.492100.21
43884667-3884667100.496101.23
53942894-3942894102.002102.77
63883405-3883405100.463101.26
极限13865058-386505899.989100.000.49100.92100.920.51
23856613-385661399.770100.66
33837451-383745199.274100.16
43889507-3889507100.621101.52
53861608-386160899.899100.83
63883762-3883762100.473101.43
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%
113.588179781176820158154781496816060.39
213.558122481119811720.10
单位质量响应值RSD%判断
6009.285990.550.23数据可信
供试品溶液-2024050621批-西格列汀-zjtj3y(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%
5min114981-1498117.44117.1019.0317.4417.1019.04
217910-1791020.85120.85
312121-1212114.11114.11
415521-1552118.06918.07
516929-1692919.70919.71
610655-1065512.40412.40
10min140510-4051047.16148.3512.7847.1948.3812.79
247444-4744455.23455.27
338403-3840344.70844.73
446023-4602353.57953.61
543668-4366850.83850.87
633148-3314838.59138.61
15min160341-6034170.24871.288.2370.3671.398.23
267950-6795079.10779.23
359940-5994069.78169.88
463643-6364374.09274.21
562714-6271473.01173.13
652797-5279761.46661.55
20min174174-7417486.35385.205.4486.5885.435.46
279143-7914392.13792.40
372372-7237284.25584.47
474044-7404486.20186.44
572600-7260084.52084.76
666786-6678677.75277.94
30min182069-8206995.54493.571.3895.9193.941.39
281190-8119094.52094.93
379245-7924592.25692.61
479433-7943392.47592.86
580571-8057193.80094.18
679745-7974592.83893.16
45min184017-8401797.81295.851.3298.3496.381.33
283327-8332797.00897.58
381382-8138294.74495.25
481508-8150894.89195.43
581685-8168595.09795.63
682084-8208495.56196.03
60min183748-8374897.49895.481.1998.1996.161.19
282466-8246696.00696.74
381459-8145994.83495.50
481597-8159794.99495.69
581015-8101594.31795.01
681792-8179295.22195.85
极限184092-8409297.89995.471.3898.7596.321.38
281553-8155394.94395.83
380734-8073493.99094.81
481687-8168795.09995.96
582234-8223495.73696.59
681740-8174095.16195.95
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%
119.123927722393300739108073915060391818439209560.24
219.143888237387147638798560.31
单位质量响应值RSD%判断
205070.92202709.300.82数据可信
供试品溶液-2024050621批-二甲双胍-zjtj3y(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%
5min1964022-96402225.00724.8815.1825.0124.8815.18
21132594-113259429.38029.38
3822617-82261721.33921.34
41007694-100769426.14026.14
51073410-107341027.84527.84
6754933-75493319.58319.58
10min12207036-220703657.25258.6810.9057.2958.7210.90
22524415-252441565.48465.53
32114559-211455954.85354.89
42473295-247329564.15864.20
52380742-238074261.75861.80
61872841-187284148.58248.61
15min13046197-304619779.02080.106.3379.1680.246.34
23334639-333463986.50286.66
33046816-304681679.03679.16
43203463-320346383.09983.25
53140990-314099081.47981.63
62755524-275552471.48071.59
20min13574230-357423092.71792.074.1392.9992.344.14
23751555-375155597.31797.62
33536609-353660991.74192.00
43598304-359830493.34293.63
53537271-353727191.75892.04
63298298-329829885.55985.79
30min13806981-380698198.75598.280.6899.1898.710.70
23815745-381574598.98299.45
33763662-376366297.63198.04
43773303-377330397.88198.33
53812716-381271698.90499.34
63760511-376051197.54997.92
45min13866594-3866594100.30199.670.42100.89100.260.43
23849452-384945299.857100.49
33818879-381887999.06399.64
43845930-384593099.765100.37
53838361-383836199.569100.17
63834131-383413199.459100.00
60min13859025-3859025100.10599.740.49100.86100.500.51
23872669-3872669100.459101.25
33828942-382894299.324100.06
43851545-385154599.911100.68
53830461-383046199.364100.13
63827888-382788899.297100.00
极限13850427-385042799.88299.590.74100.80100.510.74
23811019-381101998.86099.82
33825536-382553699.236100.14
43852614-385261499.939100.88
53883589-3883589100.742101.68
63812035-381203598.88699.76
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%
113.588221881899815478155881978818400.36
213.558154681365814560.16
单位质量响应值RSD%判断
6026.516011.510.18数据可信
供试品溶液-2024050721批-西格列汀-zjtj3y(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%
5min111003-1100312.76913.955.8712.7713.955.87
212874-1287414.94014.94
311527-1152713.37713.38
412587-1258714.60714.61
511796-1179613.68913.69
612352-1235214.33414.33
10min134047-3404739.51141.853.9039.5341.873.91
238047-3804744.15344.18
336438-3643842.28642.31
436887-3688742.80742.83
535052-3505240.67840.70
635884-3588441.64341.67
15min152477-5247760.89965.093.8360.9965.183.83
258951-5895168.41268.51
355773-5577364.72464.82
456997-5699766.14566.24
555503-5550364.41164.50
656812-5681265.93066.02
20min167165-6716577.94580.052.4778.1380.252.48
271707-7170783.21683.43
368451-6845179.43779.64
469053-6905380.13680.34
567447-6744778.27278.47
670043-7004381.28581.49
30min179014-7901491.69592.941.5692.0193.281.57
281268-8126894.31194.66
379707-7970792.50092.83
479618-7961892.39692.74
578938-7893891.60791.94
681975-8197595.13295.47
45min182642-8264295.90697.291.0396.3897.781.03
284390-8439097.93498.44
385063-8506398.71599.20
483225-8322596.58297.08
584029-8402997.51598.00
683636-8363697.05997.56
60min183139-8313996.48297.190.9797.1197.840.97
283694-8369497.12697.80
383508-8350896.91197.56
482848-8284896.14596.80
584242-8424297.76298.41
685076-8507698.73099.39
极限183716-8371697.15297.070.7997.9497.880.78
284265-8426597.78998.62
383859-8385997.31898.13
482856-8285696.15496.97
584316-8431697.84898.65
682836-8283696.13196.95
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%
119.123933354390433839295373936393393034539267930.33
219.143927896391543239216640.23
单位质量响应值RSD%判断
205376.20204893.630.17数据可信
供试品溶液-2024050721批-二甲双胍-zjtj3y(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%
5min1763910-76391019.69521.095.1719.7021.095.17
2865252-86525222.30822.31
3787804-78780420.31120.31
4856116-85611622.07322.07
5790944-79094420.39220.39
6844133-84413321.76421.76
10min11944661-194466150.13851.772.9450.1751.812.95
22101962-210196254.19354.23
32018459-201845952.04052.07
42036503-203650352.50652.54
51948259-194825950.23050.26
61998698-199869851.53151.57
15min12744277-274427770.75473.732.8470.8773.852.84
22991825-299182577.13677.26
32864535-286453573.85473.97
42879580-287958074.24274.37
52819028-281902872.68172.80
62858566-285856673.70073.82
20min13338008-333800886.06187.122.0486.3087.362.04
23489672-348967289.97190.23
33367721-336772186.82787.07
43380066-338006687.14687.39
53287069-328706984.74884.99
63411341-341134187.95288.20
30min13762254-376225496.99997.631.2097.3898.021.20
23832125-383212598.80199.21
33755649-375564996.82997.22
43766735-376673597.11597.51
53748254-374825496.63897.02
63855233-385523399.39699.79
45min13917281-3917281100.996100.770.89101.54101.320.89
23955394-3955394101.979102.55
33934532-3934532101.441101.99
43889205-3889205100.272100.83
53896054-3896054100.449100.99
63858508-385850899.481100.04
60min13937182-3937182101.509101.050.89102.22101.770.89
23931860-3931860101.372102.11
33904086-3904086100.656101.37
43882229-3882229100.092100.81
53887412-3887412100.226100.93
63973666-3973666102.450103.17
极限13912681-3912681100.878100.650.88101.75101.540.87
23927569-3927569101.261102.17
33950433-3950433101.851102.74
43884830-3884830100.159101.05
53894637-3894637100.412101.29
63852967-385296799.338100.23
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%
113.588156381742820188127881981817160.38
213.558196181636817980.29
单位质量响应值RSD%判断
6017.386036.750.23数据可信
供试品溶液-X022139批-西格列汀-zjtj3y(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%
5min120840-2084024.15221.659.4324.1521.659.44
219618-1961822.73622.74
317587-1758720.38220.38
418517-1851721.46021.46
519629-1962922.74922.75
615880-1588018.40418.40
10min148137-4813755.78850.646.3655.8350.676.36
243221-4322150.09150.13
341366-4136647.94147.97
443840-4384050.80850.84
545184-4518452.36652.40
640395-4039546.81646.85
15min167156-6715677.83072.164.5877.9672.284.58
261953-6195371.80071.92
360882-6088270.55970.67
462335-6233572.24372.36
562793-6279372.77472.90
658485-5848567.78167.89
20min174963-7496386.87884.201.8387.1484.441.83
273006-7300684.61084.85
372572-7257284.10784.34
472221-7222183.70083.94
572203-7220383.67983.93
670948-7094882.22582.45
30min181358-8135894.28993.171.1394.7093.561.14
280934-8093493.79894.18
381077-8107793.96494.34
479778-7977892.45892.84
580258-8025893.01593.40
678972-7897291.52491.88
45min182499-8249995.61295.560.6896.1896.100.69
282401-8240195.49896.04
383125-8312596.33796.87
482103-8210395.15395.69
582978-8297896.16796.71
681612-8161294.58495.10
60min182732-8273295.88295.430.9596.6196.120.95
282611-8261195.74296.44
382821-8282195.98596.67
482906-8290696.08396.78
582100-8210095.14995.85
680864-8086493.71794.39
极限182612-8261295.74395.580.3996.6396.440.38
282004-8200495.03895.90
382577-8257795.70296.55
482563-8256395.68696.54
582194-8219495.25896.12
682871-8287196.04396.87
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%
119.123913827391896339287673920040392262639208450.14
219.143917911392426339210870.12
单位质量响应值RSD%判断
205065.12204863.480.07数据可信
供试品溶液-X022139批-二甲双胍-zjtj3y(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%
5min11242691-124269132.06629.388.0932.0729.388.10
21184953-118495330.57630.58
31082541-108254127.93327.93
41140716-114071629.43529.43
51193841-119384130.80530.81
6986247-98624725.44925.45
10min12519556-251955665.01460.205.1865.0760.255.18
22326196-232619660.02460.08
32222050-222205057.33757.38
42352652-235265260.70760.76
52391612-239161261.71261.76
62185478-218547856.39356.44
15min13326625-332662585.83980.613.9286.0080.753.92
23109542-310954280.23880.39
33058939-305893978.93279.07
43142295-314229581.08381.23
53149256-314925681.26281.42
62956061-295606176.27776.41
20min13647638-364763894.12291.321.7394.4391.601.74
23556697-355669791.77692.06
33525022-352502290.95891.23
43504116-350411690.41990.70
53532265-353226591.14591.43
63468387-346838789.49789.76
30min13845804-384580499.23698.520.6399.7098.960.64
23825087-382508798.70199.14
33837534-383753499.02299.45
43807352-380735298.24498.68
53813173-381317398.39498.84
63779053-377905397.51397.93
45min13892030-3892030100.429100.030.83101.06100.630.84
23891130-3891130100.405101.01
33905903-3905903100.787101.38
43883208-3883208100.201100.80
53871159-387115999.890100.50
63815119-381511998.44499.02
60min13868269-386826999.81599.760.69100.61100.530.69
23877354-3877354100.050100.82
33880653-3880653100.135100.89
43888231-3888231100.331101.10
53868299-386829999.816100.59
63814425-381442598.42699.17
极限13877846-3877846100.063100.000.46101.02100.930.46
23891863-3891863100.424101.36
33883077-3883077100.198101.12
43888452-3888452100.336101.27
53844960-384496099.214100.15
63865642-386564299.748100.65
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