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%
114.138212683119830708302883099828880.52
2 13.547918479116791500.07
单位质量响应值RSD%判断
5866.105845.640.25数据可信
长期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%
5min110914-1091413.01913.4810.0913.0213.4810.08
210924-1092413.03013.03
310229-1022912.20112.20
410292-1029212.27712.28
512834-1283415.30915.31
612596-1259615.02515.02
10min135044-3504441.80141.526.9241.8241.556.92
234325-3432540.94440.97
334194-3419440.78840.81
431385-3138537.43737.46
535036-3503641.79241.82
638876-3887646.37246.40
15min156407-5640767.28465.305.7867.3865.405.78
253927-5392764.32664.42
355863-5586366.63566.72
451072-5107260.92061.00
551718-5171861.69161.79
659501-5950170.97471.08
20min168929-6892982.22081.053.7682.4281.253.76
267741-6774180.80381.00
368768-6876882.02882.23
466422-6642279.23079.41
564133-6413376.50076.70
671682-7168285.50485.72
30min178372-7837293.48493.462.3493.8293.802.34
279697-7969795.06595.40
376906-7690691.73692.07
478457-7845793.58693.90
575822-7582290.44290.77
680881-8088196.47796.84
45min181662-8166297.40998.490.9097.9098.980.88
282727-8272798.67999.17
383337-8333799.40799.90
483468-8346899.563100.04
582268-8226898.13198.61
681958-8195897.76298.29
60min181991-8199197.80198.540.8798.4699.200.85
282834-8283498.80799.46
382978-8297898.97899.63
483408-8340899.491100.13
582957-8295798.95399.59
681502-8150297.21897.90
极限182072-8207297.89898.810.9998.7299.630.97
282769-8276998.72999.55
383418-8341899.503100.32
482935-8293598.92799.73
584016-84016100.217101.02
681824-8182497.60298.45
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%
118.973894181390945439118523910259391064739072790.19
218.543774938379615037855440.40
单位质量响应值RSD%判断
205971.48204182.520.62数据可信
长期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%
5min1757708-75770819.54119.927.5919.5419.927.57
2749885-74988519.33919.34
3716106-71610618.46818.47
4721084-72108418.59718.60
5850453-85045321.93321.93
6839664-83966421.65521.65
10min12005718-200571851.72750.745.7951.7650.775.78
21936324-193632449.93849.97
31954211-195421150.39950.43
41803393-180339346.50946.54
51950012-195001250.29150.33
62154055-215405555.55355.59
15min12921112-292111275.33573.444.8875.4573.564.87
22816492-281649272.63772.75
32913829-291382975.14775.26
42684477-268447769.23369.34
52705629-270562969.77869.90
63044317-304431778.51378.64
20min13433760-343376088.55687.343.0288.8087.583.03
23395172-339517287.56187.80
33427326-342732688.39188.63
43316397-331639785.53085.75
53226877-322687783.22183.46
63520316-352031690.78991.05
30min13811598-381159898.30197.542.0698.6997.932.06
23828447-382844798.73599.12
33738619-373861996.41996.81
43773338-377333897.31497.68
53659252-365925294.37294.75
63882279-3882279100.124100.53
45min13893270-3893270100.407100.961.04100.96101.511.03
23950883-3950883101.893102.44
33964583-3964583102.246102.79
43934792-3934792101.478102.01
53875596-387559699.951100.48
63869703-386970399.799100.38
60min13895343-3895343100.461100.690.88101.18101.410.86
23918203-3918203101.050101.77
33933859-3933859101.454102.17
43936764-3936764101.529102.23
53897129-3897129100.507101.21
63844833-384483399.15899.90
极限13891952-3891952100.373100.961.21101.26101.841.19
23945708-3945708101.760102.64
33952152-3952152101.926102.81
43934894-3934894101.481102.35
53934977-3934977101.483102.35
63828760-382876098.74499.65
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%
114.138301683004830268295382483828960.29
2 13.547947979409794440.07
单位质量响应值RSD%判断
5866.675867.360.01数据可信
长期6月-供试品溶液-2024050621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%
5min114202-1420216.90815.818.8516.9115.818.86
212929-1292915.39315.39
312836-1283615.28215.28
413297-1329715.83115.83
511515-1151513.70913.71
614898-1489817.73717.74
10min138602-3860245.95842.978.1245.9943.008.12
235721-3572142.52842.55
334679-3467941.28741.31
436688-3668843.67943.71
531364-3136437.34137.36
639514-3951447.04447.07
15min157160-5716068.05266.066.9768.1666.166.97
253977-5397764.26364.36
355154-5515465.66465.76
457799-5779968.81368.91
548857-4885758.16758.25
659979-5997971.40871.52
20min168563-6856381.62880.124.8381.8580.334.84
265741-6574178.26878.47
366813-6681379.54579.75
469610-6961082.87583.09
561942-6194273.74673.93
671106-7110684.65684.88
30min178100-7810092.98392.132.0193.3492.482.03
276838-7683891.48091.81
376714-7671491.33291.67
478845-7884593.87094.22
574887-7488789.15789.46
678940-7894093.98394.35
45min182491-8249198.21097.190.6898.7297.680.69
281422-8142296.93897.42
381551-8155197.09197.58
482073-8207397.71398.22
581301-8130196.79497.25
680970-8097096.39996.92
60min182004-8200497.63196.920.7198.3097.570.72
280804-8080496.20296.85
381348-8134896.85097.50
481993-8199397.61798.29
580684-8068496.05996.67
681597-8159797.14697.83
极限182468-8246898.18397.151.1399.0297.961.14
280722-8072296.10496.91
381082-8108296.53397.34
483023-8302398.84499.68
581113-8111396.57097.34
681179-8117996.64897.50
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%
118.973912651391865739059753912927390397739108370.16
218.543770025378529937776620.29
单位质量响应值RSD%判断
206159.04203757.390.83数据可信
长期6月-供试品溶液-2024050621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%
5min1950123-95012324.51823.197.0224.5223.197.01
2865933-86593322.34622.35
3879354-87935422.69222.69
4905495-90549523.36723.37
5807147-80714720.82920.83
6984329-98432925.40125.40
10min12196761-219676156.68853.027.0556.7353.067.05
22014909-201490951.99552.03
31999118-199911851.58851.63
42075579-207557953.56153.60
51824580-182458047.08447.12
62217285-221728557.21857.26
15min12946667-294666776.04074.555.5576.1774.685.55
22825722-282572272.91973.04
32876444-287644474.22774.35
42995691-299569177.30577.43
52615294-261529467.48867.60
63074595-307459579.34179.48
20min13417379-341737988.18686.703.4288.4586.953.42
23296546-329654685.06885.31
33346812-334681286.36586.61
43435264-343526488.64888.91
53171830-317183081.85082.08
63490816-349081690.08290.35
30min13755990-375599096.92496.281.3797.3396.671.38
23709659-370965995.72996.12
33711062-371106295.76596.16
43783291-378329197.62998.03
53649083-364908394.16694.53
63776269-377626997.44897.87
45min13891015-3891015100.40999.950.57100.98100.500.58
23860780-386078099.629100.18
33843103-384310399.17299.72
43903871-3903871100.741101.31
53864554-386455499.726100.24
63875910-3875910100.019100.60
60min13899711-3899711100.63399.540.87101.37100.270.88
23820289-382028998.58499.30
33833217-383321798.91799.63
43895133-3895133100.515101.25
53838271-383827199.04899.73
63858563-385856399.571100.32
极限13891862-3891862100.43199.870.96101.34100.750.95
23831772-383177298.88099.76
33845717-384571799.240100.12
43932212-3932212101.472102.37
53867136-386713699.793100.64
63850962-385096299.375100.29
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%
114.138268882350823148265982818825660.27
2 13.547963179651796410.02
单位质量响应值RSD%判断
5843.315881.910.47数据可信
长期6月-供试品溶液-2024050721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%
5min113598-1359816.20216.4913.9716.2016.4913.96
216057-1605719.13119.13
312501-1250114.89514.89
411590-1159013.80913.81
512983-1298315.46915.47
616311-1631119.43419.43
10min139626-3962647.21347.1911.5547.2447.2211.54
244250-4425052.72252.75
338852-3885246.29146.32
433507-3350739.92239.95
536069-3606942.97543.00
645318-4531853.99554.03
15min162232-6223274.14771.166.2674.2571.266.27
263107-6310775.19075.31
358934-5893470.21870.32
455761-5576166.43766.53
554963-5496365.48665.58
663349-6334975.47875.60
20min173678-7367887.78584.575.1288.0184.795.13
272709-7270986.63086.88
370478-7047883.97284.19
467067-6706779.90880.11
566484-6648479.21379.42
675445-7544589.89090.14
30min179274-7927494.45294.371.6394.8394.741.65
280865-8086596.34896.74
378691-7869193.75894.12
478659-7865993.71994.05
577333-7733392.14092.48
680401-8040195.79596.19
45min181455-8145597.05197.791.0697.5898.311.06
282596-8259698.41098.96
380962-8096296.46396.98
483129-8312999.04599.53
581541-8154197.15397.65
682768-8276898.61599.17
60min180969-8096996.47297.841.2897.1798.521.27
282749-8274998.59399.31
381355-8135596.93297.61
483519-8351999.510100.16
581275-8127596.83697.49
682817-8281798.67499.40
极限181365-8136596.94497.750.9797.8098.600.97
281890-8189097.56998.45
381083-8108396.60897.45
483048-8304898.94999.77
581966-8196697.66098.48
682900-8290098.77299.66
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%
118.973880641390010239025983905854387897738936340.33
218.543800655377359637871260.51
单位质量响应值RSD%判断
205252.19204267.850.34数据可信
长期6月-供试品溶液-2024050721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%
5min1918255-91825523.71823.9611.1823.7223.9611.17
21056192-105619227.28127.28
3854873-85487322.08122.08
4801828-80182820.71120.71
5886586-88658622.90022.90
61047043-104704327.04527.04
10min12212544-221254457.14956.849.2957.1956.889.29
22430002-243000262.76662.81
32191642-219164256.60956.65
41910496-191049649.34749.38
52042540-204254052.75852.80
62416709-241670962.42262.47
15min13170995-317099581.90579.434.8382.0479.564.83
23235497-323549783.57183.72
33055297-305529778.91779.05
42879634-287963474.38074.50
52921142-292114275.45275.58
63188152-318815282.34882.50
20min13604795-360479593.11090.473.9293.3890.743.93
23595853-359585392.87993.17
33510875-351087590.68490.95
43329961-332996186.01186.25
53337802-333780286.21486.47
63636637-363663793.93394.22
30min13841179-384117999.21698.841.0299.6499.261.04
23862498-386249899.766100.21
33849807-384980799.43999.85
43780038-378003897.63798.02
53774750-377475097.50097.90
63851720-385172099.48899.93
45min13916610-3916610101.164101.220.39101.76101.810.40
23917133-3917133101.178101.79
33905484-3905484100.877101.46
43935941-3935941101.663102.21
53900702-3900702100.753101.31
63937622-3937622101.707102.32
60min13884712-3884712100.340101.170.59101.10101.920.58
23922651-3922651101.320102.10
33922739-3922739101.322102.07
43948644-3948644101.992102.71
53896956-3896956100.657101.38
63925697-3925697101.399102.18
极限13897170-3897170100.662100.960.20101.59101.880.19
23904540-3904540100.852101.80
33905986-3905986100.890101.81
43917285-3917285101.182102.07
53911393-3911393101.029101.92
63915356-3915356101.132102.08
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