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%
114.038427684403843478443084397843710.08
214.068319183313832520.11
单位质量响应值RSD%判断
6013.615921.191.10数据可信
供试品溶液-2024031621批-50mg/850mg规格-西格列汀-0.02mol/L氯化钠溶液
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min114215-1421516.64016.5019.0916.6416.5019.08
213535-1353515.84415.84
319214-1921422.49222.49
411863-1186313.88713.89
511966-1196614.00714.01
613758-1375816.10516.11
10min138247-3824744.77246.5110.8844.8046.5410.88
236054-3605442.20542.23
347006-4700655.02555.06
436933-3693343.23443.26
537190-3719043.53543.56
642966-4296650.29650.32
15min157945-5794567.83070.738.4467.9370.848.45
255214-5521464.63364.73
368314-6831479.96880.10
457610-5761067.43867.53
558333-5833368.28568.38
665128-6512876.23976.35
20min171243-7124383.39786.375.6283.6186.605.63
269293-6929381.11481.32
379177-7917792.68592.95
471997-7199784.28084.49
572260-7226084.58784.80
678740-7874092.17392.41
30min183146-8314697.33198.532.0197.6998.902.02
281167-8116795.01495.35
385417-8541799.989100.41
485121-8512199.64399.99
585071-8507199.58499.93
685095-8509599.612100.00
45min185856-85856100.503100.630.67101.02101.160.64
286853-86853101.670102.17
385645-85645100.256100.84
485880-85880100.531101.05
586351-86351101.082101.60
685212-8521299.749100.31
60min186139-86139100.834100.621.09101.52101.321.06
287660-87660102.615103.28
385331-8533199.888100.64
485641-85641100.251100.93
585965-85965100.631101.32
684998-8499899.499100.22
极限187037-87037101.885101.011.37102.74101.881.34
288110-88110103.141103.98
385391-8539199.959100.88
486032-86032100.709101.56
586352-86352101.084101.94
684796-8479699.262100.15
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10
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%
19.593693101369542536994523700047370121436978480.10
29.623671770367693936743540.10
单位质量响应值RSD%判断
385594.16381949.480.68数据可信
供试品溶液-2024031621批-50mg/850mg规格-二甲双胍-0.02mol/L氯化钠溶液
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1861185-86118523.73723.6013.8023.7423.6013.80
2836146-83614623.04723.05
31077507-107750729.69929.70
4760537-76053720.96320.96
5750794-75079420.69420.69
6850074-85007423.43123.43
10min11897829-189782952.31054.838.7752.3554.878.77
21850030-185003050.99251.03
32275010-227501062.70662.76
41878255-187825551.77051.81
51897591-189759152.30352.34
62137237-213723758.90958.95
15min12635491-263549172.64276.797.0172.7776.927.01
22595801-259580171.54871.67
33069830-306983084.61484.77
42688628-268862874.10774.23
52741327-274132775.55975.68
62984749-298474982.26982.41
20min13099280-309928085.42589.424.7585.6789.684.76
23108135-310813585.66985.91
33433396-343339694.63594.93
43195200-319520088.06988.31
53191475-319147587.96688.21
63438785-343878594.78395.06
30min13486368-348636896.09598.571.6896.4898.981.70
23513427-351342796.84097.23
33617933-361793399.721100.17
43617381-361738199.706100.10
53600452-360045299.23999.63
63621004-362100499.806100.24
45min13573512-357351298.49799.880.8499.05100.460.83
23664378-3664378101.001101.55
33617969-361796999.722100.34
43633384-3633384100.147100.70
53638339-3638339100.283100.84
63615471-361547199.653100.25
60min13586536-358653698.85699.920.8999.57100.660.88
23683855-3683855101.538102.25
33615365-361536599.650100.44
43621081-362108199.808100.53
53629324-3629324100.035100.76
63613981-361398199.612100.38
极限13586232-358623298.84799.891.0699.73100.801.04
23695215-3695215101.851102.74
33602206-360220699.287100.24
43625357-362535799.926100.82
53629938-3629938100.052100.95
63605828-360582899.387100.32
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%
114.038361083599833948360283415835240.14
214.068319183449833200.22
单位质量响应值RSD%判断
5953.245926.030.33数据可信
供试品溶液-2024031621批-50mg/850mg规格-西格列汀-0.03mol/L氯化钠溶液
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min110563-1056312.42214.4917.0412.4214.4917.04
213412-1341215.77315.77
311541-1154113.57213.57
416088-1608818.92018.92
510775-1077512.67112.67
611571-1157113.60813.61
10min134124-3412440.13043.888.6040.1543.908.61
241871-4187149.24149.27
337865-3786544.53044.55
440214-4021447.29247.32
534761-3476140.87940.90
635018-3501841.18141.20
15min155212-5521264.93068.764.7865.0268.864.78
262639-6263973.66473.77
359000-5900069.38469.48
460391-6039171.02071.13
557603-5760367.74267.83
655976-5597665.82865.92
20min170777-7077783.23485.333.6683.4385.543.66
277137-7713790.71490.94
374371-7437187.46187.67
471573-7157384.17084.40
570967-7096783.45883.66
670522-7052282.93483.14
30min182432-8243296.94197.172.4097.2897.532.40
285209-85209100.206100.59
384401-8440199.25699.61
480059-8005994.15094.52
580864-8086495.09795.44
682808-8280897.38397.72
45min184187-8418799.00499.061.3199.5099.581.31
285358-85358100.382100.93
385353-85353100.376100.90
482593-8259397.13097.66
583369-8336998.04398.54
684536-8453699.41599.92
60min184572-8457299.45799.131.40100.1299.811.40
285305-85305100.319101.04
385616-85616100.685101.38
482459-8245996.97297.66
583454-8345498.14298.81
684359-8435999.20799.87
极限184771-8477199.69199.270.84100.52100.110.84
284820-8482099.749100.63
385397-85397100.427101.29
483521-8352198.22199.07
584054-8405498.84899.67
683895-8389598.66199.49
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10
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%
19.593661003366087036624793659856366366236615740.05
29.623677013368030036786560.07
单位质量响应值RSD%判断
381811.68382396.670.11数据可信
供试品溶液-2024031621批-50mg/850mg规格-二甲双胍-0.03mol/L氯化钠溶液
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1678203-67820318.77421.0614.0418.7721.0614.04
2814692-81469222.55322.55
3707943-70794319.59819.60
4954678-95467826.42826.43
5688027-68802719.04619.05
6721264-72126419.96619.97
10min11729207-172920747.86951.517.0547.9051.557.05
22042523-204252356.54256.58
31854119-185411951.32751.36
41998871-199887155.33455.38
51765691-176569148.87948.91
61774625-177462549.12649.16
15min12555809-255580970.75274.303.7870.8674.423.78
22824643-282464378.19478.33
32705564-270556474.89775.02
42755659-275565976.28476.42
52675430-267543074.06374.18
62587437-258743771.62771.74
20min13108065-310806586.03987.862.5886.2788.102.58
23307023-330702391.54791.81
33234607-323460789.54289.79
43152446-315244687.26887.53
53146751-314675187.11087.35
63093638-309363885.64085.87
30min13482293-348229396.39996.881.4796.7797.281.47
23552406-355240698.34098.75
33569145-356914598.80399.20
43432876-343287695.03195.44
53473861-347386196.16696.55
63488220-348822096.56396.94
45min13566328-356632898.72598.200.7399.2698.760.73
23561653-356165398.59699.17
33579252-357925299.08399.64
43511116-351111697.19797.76
53530955-353095597.74698.29
63535405-353540597.86998.41
60min13552404-355240498.34098.300.7199.0499.010.71
23555354-355535498.42299.16
33590886-359088699.405100.13
43516895-351689597.35798.09
53556354-355635498.44999.15
63532845-353284597.79898.50
极限13542547-354254798.06798.090.5898.9398.970.57
23546360-354636098.17399.08
33571657-357165798.87399.76
43526311-352631197.61898.51
53557631-355763198.48599.35
63516189-351618997.33798.20
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%
114.038320383517831338334883289832980.18
214.068325683263832600.01
单位质量响应值RSD%判断
5937.135921.760.19数据可信
供试品溶液-X003810批-50mg/850mg规格-西格列汀-0.025mol/L氯化钠溶液
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min116171-1617119.05020.5116.0419.0520.5116.04
220580-2058024.24424.24
313074-1307415.40115.40
416283-1628319.18219.18
519899-1989923.44123.44
618469-1846921.75721.76
10min136331-3633142.79946.849.8142.8346.889.82
243637-4363751.40551.45
334333-3433340.44540.47
439522-3952246.55846.59
544116-4411651.97052.01
640636-4063647.87047.91
15min153860-5386063.44868.037.1563.5568.147.15
261165-6116572.05472.18
352450-5245061.78761.88
457034-5703467.18767.30
563072-6307274.30074.43
658891-5889169.37569.49
20min166536-6653678.38181.764.4478.5981.984.45
271159-7115983.82784.07
365423-6542377.07077.27
468703-6870380.93481.16
573536-7353686.62786.88
671050-7105083.69983.93
30min176674-7667490.32492.972.0790.6693.332.08
279852-7985294.06894.45
377946-7794691.82292.15
477952-7795291.82992.19
580251-8025194.53894.93
680834-8083495.22495.60
45min181665-8166596.20396.700.6496.6997.220.67
282684-8268497.40497.95
381889-8188996.46796.94
481376-8137695.86396.37
582542-8254297.23697.79
682373-8237397.03797.57
60min182583-8258397.28596.980.5397.9497.650.54
282697-8269797.41998.12
381605-8160596.13396.77
482015-8201596.61697.28
582628-8262897.33898.05
682400-8240097.06997.76
极限182468-8246897.14997.030.3797.9697.870.39
282765-8276597.49998.37
382060-8206096.66997.47
481957-8195796.54797.38
582458-8245897.13798.01
682473-8247397.15598.01
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10
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%
19.593663762366444436524893653496365044436569270.19
29.623683004367825736806300.10
单位质量响应值RSD%判断
381327.11382601.870.24数据可信
供试品溶液-X003810批-50mg/850mg规格-二甲双胍-0.025mol/L氯化钠溶液
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1944163-94416326.14727.6613.9426.1527.6613.93
21155285-115528531.99331.99
3778900-77890021.57021.57
4945616-94561626.18726.19
51126401-112640131.19331.19
61041791-104179128.85028.85
10min11842604-184260451.02755.168.2051.0755.208.21
22155876-215587659.70259.76
31769465-176946549.00149.04
41977200-197720054.75454.80
52172926-217292660.17460.23
62032492-203249256.28556.33
15min12528551-252855170.02374.405.6770.1574.545.68
22812071-281207177.87478.03
32499358-249935869.21469.33
42657470-265747073.59373.73
52875290-287529079.62579.78
62746721-274672176.06476.21
20min12986747-298674782.71186.033.6482.9686.293.65
23170029-317002987.78788.07
32976591-297659182.43082.66
43077924-307792485.23685.49
53262165-326216590.33990.62
63165840-316584087.67187.94
30min13342013-334201392.55094.981.6992.9395.391.71
23460363-346036395.82796.26
33402770-340277094.23294.60
43400448-340044894.16894.57
53479367-347936796.35496.79
63493864-349386496.75597.17
45min13495412-349541296.79897.680.6497.3498.240.65
23549086-354908698.28498.87
33532348-353234897.82198.35
43504129-350412997.03997.60
53547218-354721898.23298.83
63534342-353434297.87698.45
60min13519857-351985797.47597.780.3898.1798.500.41
23540988-354098898.06098.81
33524965-352496597.61698.31
43515092-351509297.34398.06
53550475-355047598.32399.08
63532961-353296197.83898.58
极限13506005-350600597.09197.770.4697.9598.660.48
23538946-353894698.00398.92
33526416-352641697.65698.51
43520668-352066897.49798.38
53550380-355038098.32099.24
63540178-354017898.03898.94
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