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%
113.677718177232771977724677251772210.05
213.887717577192771840.02
单位质量响应值RSD%判断
5648.945560.811.12数据可信
供试品溶液-2024031621批-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%
5min114937-1493718.61614.7213.9918.6214.7214.00
211009-1100913.72113.72
311451-1145114.27214.27
410641-1064113.26213.26
510573-1057313.17713.18
612264-1226415.28515.28
10min140063-4006349.93144.866.5249.9644.886.52
234780-3478043.34743.37
334914-3491443.51443.54
435454-3545444.18744.21
533472-3347241.71741.74
637268-3726846.44846.47
15min159093-5909373.64969.304.8873.7669.404.89
254578-5457868.02168.12
354357-5435767.74667.84
455597-5559769.29169.39
551746-5174664.49264.58
658274-5827472.62872.73
20min172824-7282490.76288.534.3691.0088.754.36
271263-7126388.81689.02
369627-6962786.77786.99
470270-7027087.57987.79
566531-6653182.91983.12
675703-7570394.35094.57
30min181815-81815101.967102.001.76102.36102.361.76
283930-83930104.603104.96
382838-82838103.242103.60
480669-80669100.539100.90
579943-7994399.63499.97
681830-81830101.986102.37
45min181968-81968102.158102.212.02102.72102.742.01
285076-85076106.032106.56
382045-82045102.254102.78
480834-80834100.745101.27
580339-80339100.128100.63
681772-81772101.914102.47
60min181872-81872102.038102.001.80102.77102.701.80
284459-84459105.263105.97
382122-82122102.350103.05
480721-80721100.604101.30
580248-80248100.014100.68
681609-81609101.711102.43
极限181723-81723101.853101.861.87102.75102.731.86
284434-84434105.232106.11
382049-82049102.259103.13
480566-80566100.411101.27
580060-8006099.780100.62
681530-81530101.612102.50
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%
19.384165424417952941804884180615418125841774630.17
29.494211936421205242119940.01
单位质量响应值RSD%判断
445358.53443834.980.25数据可信
供试品溶液-2024031621批-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%
5min11090620-109062025.94821.7210.2125.9521.7210.21
2869400-86940020.68420.68
3889205-88920521.15621.16
4839449-83944919.97219.97
5854038-85403820.31920.32
6934433-93443322.23222.23
10min12422110-242211057.62653.174.7557.6753.214.75
22187898-218789852.05452.09
32176110-217611051.77351.81
42210459-221045952.59052.62
52125137-212513750.56050.59
62287735-228773554.42954.47
15min13276145-327614577.94574.983.3578.0875.113.36
23104561-310456173.86373.98
33088674-308867473.48573.61
43181964-318196475.70475.83
53002456-300245671.43371.55
63255848-325584877.46277.59
20min13834910-383491091.23990.382.9191.5190.632.91
23805657-380565790.54390.79
33746763-374676389.14289.39
43798943-379894390.38390.63
53634860-363486086.47986.72
63971949-397194994.49994.76
30min14145947-414594798.63999.521.3099.0699.921.29
24262739-4262739101.417101.81
34239455-4239455100.864101.26
44163826-416382699.06499.46
54134377-413437798.36498.74
64152175-415217598.78799.20
45min14140190-414019098.50299.401.5099.0999.971.49
24301387-4301387102.337102.90
34181127-418112799.476100.04
44162636-416263699.03699.60
54137751-413775198.44498.99
64145748-414574898.63499.21
60min14137555-413755598.43999.171.2799.1999.901.26
24269555-4269555101.580102.31
34179029-417902999.426100.15
44157031-415703198.90399.63
54130353-413035398.26898.98
64135883-413588398.39999.14
极限14132558-413255898.32099.041.2999.2399.941.29
24265958-4265958101.494102.40
34174403-417440399.316100.21
44147441-414744198.67499.57
54122718-412271898.08698.96
64133779-413377998.34999.26
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%
113.677730877360772967734877340773300.04
213.887719177214772020.03
单位质量响应值RSD%判断
5656.915562.101.20数据可信
供试品溶液-X022139批-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%
5min116424-1642420.45320.774.5420.4520.774.55
216232-1623220.21420.21
317681-1768122.01822.02
415558-1555819.37419.37
517082-1708221.27221.27
617099-1709921.29321.29
10min140218-4021850.08349.123.0250.1249.163.03
239516-3951649.20949.24
339810-3981049.57549.61
437149-3714946.26246.29
540484-4048450.41550.45
639508-3950849.19949.23
15min157799-5779971.97771.922.7572.0972.042.75
256926-5692670.89071.01
358895-5889573.34273.46
455107-5510768.62568.73
559582-5958274.19774.32
658205-5820572.48372.60
20min170758-7075888.11588.481.7688.3588.711.76
270037-7003787.21787.45
372434-7243490.20290.44
469251-6925186.23886.46
571956-7195689.60789.85
671863-7186389.49189.73
30min178711-7871198.01997.350.9998.4097.740.99
278309-7830997.51897.90
378173-7817397.34997.74
476666-7666695.47295.84
578613-7861397.89798.29
678589-7858997.86798.25
45min178990-7899098.36697.461.2198.9198.001.21
278468-7846897.71698.26
378141-7814197.30997.86
476449-7644995.20295.73
578583-7858397.85998.41
678926-7892698.28698.84
60min178672-7867297.97097.570.4498.6898.280.45
278317-7831797.52898.23
378218-7821897.40598.12
477758-7775896.83297.52
578557-7855797.82798.55
678602-7860297.88398.60
极限178669-7866997.96697.061.1798.8497.931.17
278237-7823797.42898.30
377868-7786896.96997.85
476191-7619194.88195.73
578123-7812397.28798.17
678558-7855897.82898.71
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%
19.384175998417523041769644177534417809941767650.03
29.494208556421147642100160.05
单位质量响应值RSD%判断
445284.12443626.550.27数据可信
供试品溶液-X022139批-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%
5min11165522-116552227.73827.993.6027.7427.993.59
21155421-115542127.49827.50
31228356-122835629.23429.23
41108728-110872826.38726.39
51195380-119538028.44928.45
61203792-120379228.64928.65
10min12435866-243586657.97257.122.5358.0257.172.53
22407344-240734457.29357.34
32411778-241177857.39857.45
42282263-228226354.31654.36
52453289-245328958.38658.43
62411029-241102957.38157.43
15min13261955-326195577.63277.652.3577.7777.792.35
23227121-322712176.80376.94
33307447-330744778.71578.86
43131810-313181074.53574.67
53349704-334970479.72079.87
63297009-329700978.46678.61
20min13822588-382258890.97591.221.4091.2591.491.40
23788137-378813790.15590.42
33882904-388290492.41092.69
43754956-375495689.36589.62
53871779-387177992.14592.42
63877625-387762592.28492.56
30min14116762-411676297.97697.490.8398.4097.910.84
24104808-410480897.69198.11
34087861-408786197.28897.72
44031455-403145595.94596.35
54114720-411472097.92798.36
64121370-412137098.08598.51
45min14112283-411228397.86997.380.9898.4697.970.99
24100012-410001297.57798.16
34082674-408267497.16497.76
44016240-401624095.58396.15
54111652-411165297.85498.45
64128478-412847898.25498.85
60min14099391-409939197.56297.440.4198.3198.190.42
24094671-409467197.45098.19
34078078-407807897.05597.81
44071100-407110096.88997.62
54107602-410760297.75898.52
64114093-411409397.91298.67
极限14098715-409871597.54697.060.9698.4697.980.96
24093171-409317197.41498.32
34069116-406911696.84297.76
44004373-400437395.30196.19
54092495-409249597.39898.32
64112628-411262897.87798.80
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