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%
114.138082180610805438078480689806890.15
214.148096680953809600.02
单位质量响应值RSD%判断
5710.475725.600.19数据可信
供试品溶液-2024050721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%
5min110123-1012312.36616.1720.0812.3716.1720.07
212151-1215114.84314.84
314956-1495618.27018.27
413154-1315416.06916.07
511492-1149214.03814.04
617527-1752721.41121.41
10min130323-3032337.04243.9514.6037.0643.9714.61
233082-3308240.41240.44
341034-4103450.12650.16
436099-3609944.09844.12
531896-3189638.96338.99
643416-4341653.03653.07
15min149566-4956660.54966.679.5460.6366.779.55
252061-5206163.59763.69
359419-5941972.58572.70
454623-5462366.72666.83
549672-4967260.67860.77
662098-6209875.85875.98
20min162720-6272076.61780.935.2276.8081.145.24
264913-6491379.29679.49
370331-7033185.91586.15
466762-6676281.55581.77
562607-6260776.47976.67
670165-7016585.71285.96
30min175277-7527791.95792.831.3592.2793.181.36
275453-7545392.17292.50
377749-7774994.97695.35
476625-7662593.60393.95
575059-7505991.69092.01
675797-7579792.59292.99
45min179402-7940296.99695.671.2497.4696.171.22
277370-7737094.51495.00
379086-7908696.61097.15
479022-7902296.53297.03
577823-7782395.06795.54
677195-7719594.30094.85
60min180099-8009997.84796.311.3998.4796.981.37
278020-7802095.30895.95
379376-7937696.96497.66
479784-7978497.46298.13
578489-7848995.88096.51
677297-7729794.42495.13
极限181617-8161799.70297.691.38100.4998.511.34
279065-7906596.58497.38
379811-7981197.49598.35
480324-8032498.12298.95
580473-8047398.30499.09
678524-7852495.92396.79
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 4373383437421443837284377022437952743775750.10
218.924367308437094143691240.06
单位质量响应值RSD%判断
229793.96230926.220.35数据可信
供试品溶液-2024050721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%
5min1846474-84647419.43424.3716.5319.4324.3716.53
2996263-99626322.87322.87
31157454-115745426.57426.57
41064437-106443724.43824.44
5955688-95568821.94221.94
61349511-134951130.98430.98
10min12082221-208222147.80655.1611.8547.8455.2011.85
22283566-228356652.42952.47
32633947-263394760.47360.52
42389173-238917354.85354.89
52189556-218955650.27050.31
62836983-283698365.13565.19
15min13068980-306898070.46176.377.3870.5776.507.39
23233905-323390574.24774.37
33529884-352988481.04381.19
43325578-332557876.35276.48
53105520-310552071.30071.42
63695299-369529984.84185.00
20min13681778-368177884.53088.533.9484.7688.793.96
23815720-381572087.60587.85
34019634-401963492.28792.57
43865315-386531588.74489.00
53711021-371102185.20285.44
64043203-404320392.82893.13
30min14205098-420509896.54597.510.7096.9297.920.72
24247784-424778497.52597.92
34293148-429314898.56799.00
44254177-425417797.67298.08
54227289-422728997.05597.44
64255087-425508797.69398.15
45min14364500-4364500100.20599.450.45100.74100.020.43
24320797-432079799.20299.76
34335626-433562699.542100.14
44336774-433677499.568100.14
54324220-432422099.28099.82
64307593-430759398.89899.52
60min14387307-4387307100.72999.950.65101.43100.680.63
24340656-434065699.657100.38
34338548-433854899.609100.37
44385081-4385081100.677101.41
54353205-435320599.946100.65
64315215-431521599.07399.86
极限14408704-4408704101.220100.120.77102.09101.020.74
24352941-435294199.940100.83
34329863-432986399.410100.34
44361246-4361246100.130101.03
54389124-4389124100.770101.65
64322534-432253499.241100.19
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%
114.138043080429804718050480354804380.07
214.148065980793807260.12
单位质量响应值RSD%判断
5692.715709.050.21数据可信
供试品溶液-2024050721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%
5min112794-1279415.67616.1517.4015.6816.1517.41
216858-1685820.65520.66
311429-1142914.00314.00
414700-1470018.01118.01
510521-1052112.89112.89
612785-1278515.66515.66
10min136073-3607344.19944.8713.7044.2244.9013.70
244883-4488354.99355.03
331592-3159238.70838.73
439950-3995048.94948.98
532433-3243339.73939.76
634817-3481742.66042.69
15min155703-5570368.25069.0810.0568.3569.1810.06
265838-6583880.66880.79
350256-5025661.57661.66
459870-5987073.35673.47
552351-5235164.14364.23
654260-5426066.48266.58
20min168407-6840783.81682.905.0684.0383.125.08
272996-7299689.43989.70
362835-6283576.98977.18
469049-6904984.60384.84
565705-6570580.50580.70
666964-6696482.04882.26
30min177914-7791495.46495.181.3795.8295.531.37
277172-7717294.55594.96
376117-7611793.26393.58
477217-7721794.61094.99
578644-7864496.35996.69
679006-7900696.80297.15
45min179534-7953497.44997.121.1597.9697.631.11
277749-7774995.26295.83
380285-8028598.37098.84
478776-7877696.52197.05
579300-7930097.16397.65
679928-7992897.93298.44
60min179652-7965297.59497.321.2498.2798.001.20
277613-7761395.09695.82
380231-8023198.30398.94
479260-7926097.11497.81
579520-7952097.43298.08
680296-8029698.38399.05
极限180292-8029298.37897.981.2599.2298.821.21
278253-7825395.88096.76
381146-8114699.425100.23
479695-7969597.64798.50
579830-7983097.81298.63
680591-8059198.74599.58
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 4370571437050043803444374870437393643740440.10
218.924361007436545543632310.08
单位质量响应值RSD%判断
229608.61230614.750.31数据可信
供试品溶液-2024050721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%
5min11037181-103718123.83824.0912.9623.8424.0912.96
21262727-126272729.02229.02
3939587-93958721.59521.60
41141350-114135026.23326.23
5891183-89118320.48320.48
61017198-101719823.37923.38
10min12387052-238705254.86455.7310.5954.9055.7710.59
22853324-285332465.58065.63
32192996-219299650.40350.44
42598787-259878759.73059.77
52211207-221120750.82250.86
62304149-230414952.95853.00
15min13357451-335745177.16778.147.8477.3078.287.84
23864561-386456188.82288.98
33149041-314904172.37772.50
43545079-354507981.48081.62
53205084-320508473.66573.78
63277966-327796675.34075.47
20min13921534-392153490.13289.883.6390.3990.143.64
24147216-414721695.31995.62
33734697-373469785.83886.08
43966180-396618091.15891.44
53813593-381359387.65187.89
63880514-388051489.18989.44
30min14295745-429574598.73399.000.7999.1499.410.78
24287823-428782398.55199.02
34270787-427078798.15998.54
44292850-429285098.66699.10
54334087-433408799.614100.00
64362197-4362197100.260100.66
45min14346414-434641499.897100.180.98100.47100.760.95
24297479-429747998.77399.40
34420844-4420844101.608102.16
44354647-4354647100.086100.68
54343324-434332499.826100.38
64390695-4390695100.915101.48
60min14344172-434417299.846100.181.03100.59100.931.00
24294487-429448798.70499.50
34424440-4424440101.691102.41
44359264-4359264100.193100.95
54341359-434135999.781100.50
64389440-4389440100.886101.62
极限14350722-435072299.996100.120.99100.90101.020.96
24294419-429441998.70299.66
34423477-4423477101.668102.55
44352849-4352849100.045100.97
54337310-433731099.688100.57
64376651-4376651100.592101.50
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