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%
114.058363083677836988369683669836740.04
214.128334083373833560.03
单位质量响应值RSD%判断
5955.445903.400.63数据可信
供试品溶液-2024050521批-西格列汀-0.025mol(内含%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%
5min112183-1218314.35214.5312.9614.3514.5312.96
213184-1318415.53115.53
313586-1358616.00516.00
410281-1028112.11212.11
510625-1062512.51712.52
614157-1415716.67816.68
10min135179-3517941.44342.179.8441.4742.209.84
238766-3876645.66845.69
337680-3768044.38944.42
435804-3580442.17942.20
529190-2919034.38734.41
638157-3815744.95144.98
15min156783-5678366.89366.207.8166.9966.307.81
258056-5805668.39368.49
357840-5784068.13868.24
459293-5929369.85069.94
547392-4739255.83055.91
657808-5780868.10168.20
20min169334-6933481.67981.305.6181.8881.505.61
268965-6896581.24481.46
370826-7082683.43783.65
471849-7184984.64284.85
561490-6149072.43872.61
671590-7159084.33784.55
30min178726-7872692.74392.772.4593.0893.122.46
277675-7767591.50591.86
379254-7925493.36593.72
479548-7954893.71194.06
575781-7578189.27489.57
681530-8153096.04696.40
45min180560-8056094.90496.451.3595.4096.941.32
282118-8211896.73997.24
381142-8114295.58996.10
481207-8120795.66696.17
583441-8344198.29898.74
682768-8276897.50598.02
60min180344-8034494.64996.561.5395.3097.211.51
282163-8216396.79297.46
381389-8138995.88096.55
481168-8116895.62096.28
583761-8376198.67599.28
682957-8295797.72798.41
极限180244-8024494.53196.421.5795.3497.241.55
281980-8198096.57697.40
381001-8100195.42396.25
481290-8129095.76496.59
583763-8376398.67799.45
682812-8281297.55798.40
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%
119.013930241393105239322053932872393108239314900.03
218.913927469392938339284260.04
单位质量响应值RSD%判断
206811.68207743.310.32数据可信
供试品溶液-2024050521批-二甲双胍-0.025mol(内含%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%
5min1824746-82474621.04421.1410.7721.0421.1410.78
2867181-86718122.12722.13
3896654-89665422.87922.88
4711022-71102218.14218.14
5736066-73606618.78118.78
6934626-93462623.84823.85
10min11995961-199596150.92951.068.0050.9651.108.00
22119477-211947754.08054.12
32077816-207781653.01753.06
41993288-199328850.86050.89
51696656-169665643.29243.32
62124515-212451554.20954.25
15min12933177-293317774.84273.526.3074.9673.646.30
22943467-294346775.10575.23
32938033-293803374.96675.09
43007767-300776776.74676.86
52515060-251506064.17464.28
62950958-295095875.29675.43
20min13441320-344132087.80886.494.7888.0586.734.78
23359776-335977685.72785.98
33444204-344420487.88288.13
43521572-352157289.85690.10
53078963-307896378.56278.77
63491942-349194289.10089.36
30min13786600-378660096.61895.462.1497.0195.852.15
23683194-368319493.98094.37
33752316-375231695.74396.14
43784624-378462496.56896.96
53611637-361163792.15492.50
63829007-382900797.70098.10
45min13835364-383536497.86297.920.6698.4198.470.64
23820507-382050797.48398.03
33806015-380601597.11497.67
43829736-382973697.71998.27
53865886-386588698.64199.14
63868767-386876798.71599.28
60min13830175-383017597.73097.980.7598.4598.690.73
23820706-382070697.48898.20
33812000-381200097.26697.99
43825771-382577197.61898.33
53878434-387843498.96199.62
63873388-387338898.83399.56
极限13822286-382228697.52997.790.7698.4198.660.74
23810107-381010797.21898.09
33803506-380350697.04997.93
43822144-382214497.52598.40
53872793-387279398.81799.64
63864333-386433398.60299.50
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%
114.058379583724836368357683546836550.13
214.128354683539835420.01
单位质量响应值RSD%判断
5954.095916.570.45数据可信
供试品溶液-2024050621批-西格列汀-0.025mol(内含%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%
5min115009-1500917.66414.6216.7417.6614.6216.73
211197-1119713.17713.18
313788-1378816.22716.23
49160-916010.78010.78
512064-1206414.19814.20
613296-1329615.64815.65
10min138666-3866645.50542.759.0545.5342.789.05
235364-3536441.61941.64
338448-3844845.24845.28
430389-3038935.76435.78
535993-3599342.35942.38
639099-3909946.01446.04
15min156011-5601165.91766.205.8266.0266.305.82
255816-5581665.68865.78
358233-5823368.53268.63
450424-5042459.34259.42
556924-5692466.99267.09
660118-6011870.75170.85
20min168604-6860480.73882.254.7380.9582.464.74
270849-7084983.38083.58
371691-7169184.37184.59
464749-6474976.20176.38
568933-6893381.12581.33
674523-7452387.70487.92
30min178102-7810291.91694.221.7392.2794.561.74
280322-8032294.52894.87
381450-8145095.85696.21
478785-7878592.71993.02
580220-8022094.40894.75
681490-8149095.90396.27
45min182483-8248397.07196.730.5697.5797.240.53
282082-8208296.59997.10
381769-8176996.23196.75
482974-8297497.64998.11
581988-8198896.48996.99
681883-8188396.36596.89
60min182844-8284497.49696.600.7998.1697.260.77
281809-8180996.27896.94
381600-8160096.03296.71
482962-8296297.63598.26
581557-8155795.98296.64
681708-8170896.15996.85
极限182785-8278597.42796.560.9198.2597.380.88
281811-8181196.28197.10
381323-8132395.70696.54
483141-8314197.84698.63
581508-8150895.92496.74
681698-8169896.14897.00
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%
119.013926464392429739225563921158391939839227750.07
218.913930165393232739312460.04
单位质量响应值RSD%判断
206353.24207892.440.53数据可信
供试品溶液-2024050621批-二甲双胍-0.025mol(内含%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%
5min1982056-98205625.07721.1014.7325.0821.1014.74
2780514-78051419.93019.93
3909769-90976923.23123.23
4643947-64394716.44316.44
5760079-76007919.40919.41
6881890-88189022.51922.52
10min12139002-213900254.62051.747.8454.6651.777.84
21999532-199953251.05851.09
32134310-213431054.50054.54
41735354-173535444.31244.34
51998804-199880451.04051.07
62150255-215025554.90754.94
15min12880010-288001073.54173.724.8573.6773.844.85
22866284-286628473.19173.31
32978288-297828876.05176.18
42635813-263581367.30667.41
52917074-291707474.48874.61
63044988-304498877.75477.88
20min13366634-336663485.96787.513.6786.2287.753.68
23446413-344641388.00488.24
33505125-350512589.50489.76
43239515-323951582.72182.93
53396029-339602986.71886.96
63608126-360812692.13492.39
30min13715529-371552994.87696.781.2395.2797.171.24
23791545-379154596.81797.20
33836452-383645297.96498.37
43757698-375769895.95396.30
53808074-380807497.23997.63
63831673-383167397.84298.25
45min13853133-385313398.39098.400.5498.9598.950.51
23845881-384588198.20598.75
33838470-383847098.01698.58
43893905-389390599.43199.94
53846920-384692098.23198.78
63841818-384181898.10198.68
60min13854802-385480298.43398.280.5399.1599.000.50
23834476-383447697.91498.63
33833987-383398797.90198.63
43886554-388655499.24399.92
53846760-384676098.22798.94
63837516-383751697.99198.73
极限13851793-385179398.35698.090.6299.2498.970.59
23828085-382808597.75098.63
33822935-382293597.61998.51
43883796-388379699.173100.02
53838858-383885898.02698.90
63823489-382348997.63398.54
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%
114.058332783386833578342883420833840.06
214.128323583206832200.03
单位质量响应值RSD%判断
5934.805893.770.50数据可信
供试品溶液-2024050721批-西格列汀-0.025mol(内含%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%
5min110424-1042412.31116.3326.5712.3116.3326.59
219938-1993823.54823.55
311781-1178113.91413.91
416629-1662919.64019.64
511560-1156013.65313.65
612644-1264414.93314.93
10min135299-3529941.69046.3415.2441.7146.3715.24
249155-4915558.05558.09
335185-3518541.55541.58
444096-4409652.08052.11
534900-3490041.21941.24
636796-3679643.45843.48
15min155964-5596466.09770.8010.0566.1970.9110.06
271009-7100983.86684.00
357172-5717267.52367.62
462854-6285474.23474.35
555582-5558265.64565.74
657113-5711367.45467.55
20min170401-7040183.14886.066.1583.3586.296.17
281549-8154996.31496.59
371870-7187084.88285.09
473317-7331786.59186.83
569119-6911981.63381.83
670970-7097083.82084.03
30min178360-7836092.54894.691.9192.8995.061.92
281568-8156896.33696.77
381149-8114995.84196.19
480163-8016394.67795.06
578274-7827492.44692.78
681535-8153596.29796.65
45min181568-8156896.33697.531.0496.8398.061.01
281731-8173196.52997.13
383889-8388999.07899.58
482612-8261297.56998.11
582728-8272897.70698.20
682960-8296097.98098.49
60min181879-8187996.70497.641.0897.3698.321.05
281529-8152996.29097.05
383954-8395499.15499.83
482510-8251097.44998.16
583146-8314698.20098.85
682989-8298998.01598.69
极限181637-8163796.41897.591.1597.2398.431.12
281427-8142796.17097.09
383847-8384799.02899.86
482561-8256197.50998.38
583149-8314998.20499.02
683132-8313298.18499.02
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%
119.013921237392319739234113925324392568739237710.05
218.913930361393130039308300.02
单位质量响应值RSD%判断
206405.63207870.440.51数据可信
供试品溶液-2024050721批-二甲双胍-0.025mol(内含%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%
5min1727336-72733618.57123.3522.0118.5723.3522.01
21251971-125197131.96731.97
3795918-79591820.32220.32
41064209-106420927.17327.17
5805956-80595620.57920.58
6841820-84182021.49421.49
10min11993613-199361350.90355.4312.6150.9355.4612.62
22620489-262048966.90966.96
31980962-198096250.58050.61
42401186-240118661.31061.36
51978381-197838150.51450.55
62050202-205020252.34852.38
15min12890913-289091373.81477.738.1473.9377.868.15
23498463-349846389.32789.49
32923789-292378974.65474.77
43165912-316591280.83680.98
52863373-286337373.11173.23
62923296-292329674.64174.76
20min13461445-346144588.38290.544.8788.6290.804.88
23882730-388273099.13899.45
33485665-348566589.00089.24
43564453-356445391.01291.29
53410453-341045387.08087.32
63470862-347086288.62288.87
30min13768147-376814796.21397.511.3696.6097.921.38
23880615-388061599.08499.56
33833545-383354597.88398.27
43820228-382022897.54397.98
53748521-374852195.71296.10
63862321-386232198.61799.01
45min13872278-387227898.87299.500.4799.42100.080.45
23880166-388016699.07399.72
33922286-3922286100.148100.70
43900752-390075299.599100.20
53900678-390067899.597100.14
63905654-390565499.724100.28
60min13876681-387668198.98499.470.5099.70100.210.47
23869790-386979098.80899.62
33919266-3919266100.071100.79
43893158-389315899.405100.17
53909715-390971599.827100.54
63905422-390542299.718100.44
极限13861287-386128798.59199.300.5699.47100.210.54
23864655-386465598.67799.65
33909297-390929799.817100.70
43888203-388820399.278100.21
53907046-390704699.759100.64
63903754-390375499.675100.57
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