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%
114.138267582718827128268182736827040.04
214.148312383084831040.04
单位质量响应值RSD%判断
5853.085877.230.30数据可信
供试品溶液-2024050621批-西格列汀-pH6.8
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min111912-1191214.18614.8416.5614.1914.8416.56
214686-1468617.49017.49
314977-1497717.83717.84
412619-1261915.02815.03
59912-991211.80511.80
610679-1067912.71812.72
10min137083-3708344.16444.258.8444.1944.288.85
240810-4081048.60248.63
340061-4006147.71047.74
437911-3791145.15045.17
531894-3189437.98438.00
635187-3518741.90641.93
15min158514-5851469.68768.144.8269.7868.244.82
258251-5825169.37369.48
360766-6076672.36972.48
456093-5609366.80366.90
552600-5260062.64362.73
657090-5709067.99168.08
20min171626-7162685.30283.882.8085.5284.092.81
270565-7056584.03984.26
373448-7344887.47287.70
469247-6924782.46982.68
567733-6773380.66680.85
669977-6997783.33883.54
30min180497-8049795.86793.841.1396.2294.201.12
278729-7872993.76294.13
378220-7822093.15593.53
478023-7802392.92193.27
578804-7880493.85194.17
678517-7851793.50993.85
45min181581-8158197.15895.081.3197.6795.581.29
279616-7961694.81895.34
378693-7869393.71994.25
479239-7923994.36994.87
580494-8049495.86496.34
679377-7937794.53395.03
60min181903-8190397.54295.361.3698.2296.031.34
279653-7965394.86295.54
379062-7906294.15894.85
479464-7946494.63795.30
580850-8085096.28896.93
679496-7949694.67595.33
极限182547-8254798.30996.061.5799.1596.881.55
280560-8056095.94296.78
379118-7911894.22595.07
479825-7982595.06795.89
581711-8171197.31398.11
680189-8018995.50096.31
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%
119.05 3977079398086039808183977425397990239792170.05
218.923955148395413239546400.02
单位质量响应值RSD%判断
208882.78209019.030.05数据可信
供试品溶液-2024050621批-二甲双胍-pH6.8
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min1848433-84843321.47522.1613.8921.4722.1613.89
2992365-99236525.11825.12
31035942-103594226.22126.22
4875384-87538422.15722.16
5717223-71722318.15418.15
6782562-78256219.80819.81
10min12153968-215396854.52055.037.5954.5655.077.60
22329692-232969258.96859.01
32352404-235240459.54259.59
42222375-222237556.25156.29
51916112-191611248.49948.53
62070189-207018952.39952.43
15min13090152-309015278.21677.414.2778.3477.544.27
23105266-310526678.59878.74
33246942-324694282.18482.33
43020038-302003876.44176.57
52847548-284754872.07572.19
63040058-304005876.94877.07
20min13601425-360142591.15790.492.7591.4190.752.76
23576586-357658690.52890.80
33745526-374552694.80495.08
43541086-354108689.63089.89
53449162-344916287.30387.53
63537005-353700589.52689.77
30min13904321-390432198.82497.780.6899.2398.190.68
23854844-385484497.57197.99
33884973-388497398.33498.77
43848007-384800797.39897.81
53850255-385025597.45597.83
63835802-383580297.08997.49
45min13938339-393833999.68598.450.76100.2699.020.75
23880550-388055098.22298.81
33893703-389370398.55599.16
43872107-387210798.00898.58
53899480-389948098.70199.24
63852268-385226897.50698.07
60min13943187-394318799.80798.610.81100.5599.350.81
23882399-388239998.26999.02
33910848-391084898.98999.75
43877216-387721698.13798.87
53908425-390842598.92799.63
63854420-385442097.56098.28
极限13941813-394181399.77398.550.77100.6899.450.76
23884956-388495698.33399.25
33891180-389118098.49199.42
43871892-387189298.00398.90
53912362-391236299.02799.90
63859183-385918397.68198.57
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%
114.138259182625826008248082628825850.08
214.148311983218831680.09
单位质量响应值RSD%判断
5844.665881.750.45数据可信
供试品溶液-2024050621批-西格列汀-pH6.8
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min116647-1664719.83213.0029.9519.8313.0029.95
29260-926011.03211.03
36945-69458.2748.27
49953-995311.85711.86
511950-1195014.23714.24
610716-1071612.76612.77
10min144629-4462953.16839.8219.0253.2039.8419.02
230145-3014535.91335.93
325878-2587830.83030.84
432179-3217938.33638.36
535691-3569142.52042.54
632027-3202738.15538.18
15min165935-6593578.55163.4813.5378.6763.5613.54
249889-4988959.43559.51
344350-4435052.83652.90
452270-5227062.27162.36
555492-5549266.11066.20
651750-5175061.65261.74
20min174838-7483889.15879.577.2889.4179.767.31
265222-6522277.70277.88
359985-5998571.46371.62
466906-6690679.70879.90
568409-6840981.49981.70
665375-6537577.88478.07
30min178942-7894294.04792.021.3894.4592.351.42
276831-7683191.53291.84
375655-7565590.13190.40
477418-7741892.23192.55
577234-7723492.01292.35
677386-7738692.19392.51
45min180091-8009195.41694.860.7795.9795.340.76
279439-7943994.63995.10
380612-8061296.03796.46
479195-7919594.34894.82
579005-7900594.12294.62
679418-7941894.61495.09
60min180301-8030195.66695.470.9296.3896.110.90
279914-7991495.20595.82
381532-8153297.13397.72
479589-7958994.81895.45
579590-7959094.81995.47
679911-7991195.20195.83
极限181217-8121796.75797.381.2097.6398.171.16
282005-8200597.69698.47
383592-8359299.587100.33
481397-8139796.97297.76
580939-8093996.42697.23
681263-8126396.81297.60
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%
119.05 3961821396579539664893960896396447439638950.07
218.923951282395360239524420.05
单位质量响应值RSD%判断
208078.48208902.850.28数据可信
供试品溶液-2024050621批-二甲双胍-pH6.8
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min11121238-112123828.44319.6825.5628.4419.6825.55
2680003-68000317.25017.25
3530275-53027513.45213.45
4709239-70923917.99117.99
5831837-83183721.10121.10
6781330-78133019.82019.82
10min12515412-251541263.80950.1615.4463.8650.2015.44
21827042-182704246.34746.38
31606505-160650540.75340.78
41915537-191553748.59248.62
52074335-207433552.62052.66
61925472-192547248.84448.88
15min13439378-343937887.24872.7811.3087.4072.9011.31
22712060-271206068.79868.90
32471068-247106862.68462.77
42827540-282754071.72771.84
52967264-296726475.27175.39
62797347-279734770.96171.08
20min13750353-375035395.13686.366.0995.4486.606.12
23319759-331975984.21384.43
33124005-312400579.24879.44
43405027-340502786.37686.61
53481794-348179488.32488.57
63345939-334593984.87785.11
30min13888516-388851698.64196.021.5699.1096.401.60
23739783-373978394.86895.23
33721871-372187194.41494.74
43781999-378199995.93996.31
53805370-380537096.53296.93
63773755-377375595.73096.10
45min13917343-391734399.37298.100.8599.9998.640.86
23833752-383375297.25297.77
33895107-389510798.80899.29
43845836-384583697.55898.09
53865086-386508698.04798.60
63846302-384630297.57098.10
60min13917257-391725799.37098.580.83100.1699.290.84
23851340-385134097.69898.38
33930794-393079499.714100.36
43861893-386189397.96698.66
53890544-389054498.69399.41
63865653-386565398.06198.76
极限13921695-392169599.48399.080.84100.4499.940.83
23888667-388866798.64599.49
33964096-3964096100.558101.37
43885247-388524798.55899.42
53899268-389926898.91499.80
63874776-387477698.29399.15
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