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%
113.677719577196772037720977241772090.03
213.887727977342773100.06
单位质量响应值RSD%判断
5648.065569.880.99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%
5min118963-1896323.61623.5610.6423.6223.5610.64
219420-1942024.18524.19
321401-2140126.65326.65
416800-1680020.92320.92
516346-1634620.35720.36
620560-2056025.60525.61
10min148627-4862760.56062.124.4260.6062.154.42
251974-5197464.72864.77
348989-4898961.01061.05
449813-4981362.03762.07
546974-4697458.50158.53
652883-5288365.86065.90
15min168587-6858785.41887.032.5185.5687.172.51
269606-6960686.68786.83
369765-6976586.88587.03
470645-7064587.98188.12
567843-6784384.49184.62
672842-7284290.71790.87
20min179422-7942298.91199.440.9599.1999.720.95
280514-80514100.271100.56
380156-8015699.825100.12
478504-7850497.76898.05
580318-80318100.027100.30
680158-8015899.828100.13
30min180999-80999100.875100.621.46101.32101.071.45
282362-82362102.573103.03
381207-81207101.134101.59
478794-7879498.12998.58
581034-81034100.919101.36
680369-80369100.091100.56
45min181013-81013100.893100.341.63101.51100.961.63
282351-82351102.559103.19
380838-80838100.675101.30
478358-7835897.58698.20
580778-80778100.600101.21
680092-8009299.746100.38
60min180907-80907100.761100.301.80101.54101.091.78
282265-82265102.452103.25
380864-80864100.707101.50
478025-7802597.17297.95
581234-81234101.168101.94
679929-7992999.543100.35
极限181021-81021100.903100.622.17101.85101.572.16
283740-83740104.289105.26
381150-81150101.063102.02
478402-7840297.64198.58
580363-80363100.083101.03
680068-8006899.716100.68
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%
19.384168431416820341692724168600416838041685770.01
29.494213671421419742139340.01
单位质量响应值RSD%判断
444411.19444039.410.06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%
5min11315009-131500931.31230.858.5931.3130.858.58
21274474-127447430.34730.35
31434545-143454534.15934.16
41193094-119309428.40928.41
51154415-115441527.48827.49
61401593-140159333.37433.37
10min12811826-281182666.95468.193.1467.0168.243.14
22909613-290961369.28269.33
32848951-284895167.83867.89
42889182-288918268.79668.84
52730486-273048665.01765.06
62993262-299326271.27471.33
15min13672467-367246787.44788.892.2787.6189.052.27
23702904-370290488.17288.34
33737369-373736988.99289.16
43790700-379070090.26290.42
53630250-363025086.44286.60
63864300-386430092.01592.19
20min14094109-409410997.48798.040.4997.8098.350.49
24124794-412479498.21798.53
34132603-413260398.40398.72
44092408-409240897.44697.76
54120405-412040598.11398.41
64139741-413974198.57398.90
30min14141461-414146198.61498.660.7099.0999.140.70
24175977-417597799.43699.91
34176800-417680099.45699.94
44105357-410535797.75598.23
54120418-412041898.11398.57
64141152-414115298.60799.10
45min14149071-414907198.79598.560.7799.4399.200.77
24177838-417783899.480100.12
34167147-416714799.22699.87
44093669-409366997.47698.11
54117905-411790598.05398.68
64129093-412909398.32098.98
60min14140260-414026098.58698.570.8399.3999.370.83
24176009-417600999.437100.25
34165676-416567699.191100.00
44077948-407794897.10297.90
54143412-414341298.66199.45
64133498-413349898.42599.24
极限14136917-413691798.50698.531.1299.4799.501.12
24211895-4211895100.291101.27
34166493-416649399.210100.19
44085752-408575297.28898.25
54098234-409823497.58598.54
64127161-412716198.27499.26
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%
113.677737977190772077718377235772390.11
213.887741677416774160.00
单位质量响应值RSD%判断
5650.265577.520.92数据可信
供试品溶液-X022139批-西格列汀
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min127342-2734234.02132.8010.7434.0232.8010.74
225246-2524631.41331.41
324944-2494431.03831.04
422764-2276428.32528.33
526713-2671333.23933.24
631131-3113138.73638.74
10min154735-5473568.10666.824.0668.1666.874.07
252036-5203664.74864.80
351769-5176964.41664.47
452308-5230865.08665.13
553877-5387767.03967.09
657471-5747171.51171.58
15min171653-7165389.15788.032.6089.3388.192.60
269456-6945686.42386.58
369411-6941186.36786.53
469315-6931586.24886.40
570653-7065387.91388.08
673985-7398592.05992.24
20min177814-7781496.82396.221.3397.1496.541.33
276028-7602894.60194.91
377504-7750496.43896.74
476924-7692495.71696.02
576722-7672295.46495.78
678991-7899198.28898.62
30min179374-7937498.76497.671.2399.2498.141.24
277781-7778196.78297.24
379014-7901498.31698.78
477352-7735296.24896.71
577803-7780396.81097.28
679632-7963299.08599.59
45min178281-7828197.40497.381.0498.0598.011.05
277240-7724096.10996.73
378917-7891798.19698.82
477662-7766296.63497.25
578012-7801297.07097.70
679438-7943898.84499.51
60min178259-7825997.37797.171.5398.1897.971.53
277657-7765796.62897.41
378724-7872497.95698.75
476420-7642095.08995.87
577578-7757896.53097.33
679938-7993899.466100.30
极限177966-7796697.01297.110.9697.9898.070.97
277889-7788996.91797.86
378458-7845897.62598.58
476974-7697495.77896.72
577753-7775396.74797.70
679210-7921098.56099.56
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%
19.384208879420815342084824215491420923742100480.08
29.494214931421796442164480.06
单位质量响应值RSD%判断
448832.41444304.320.72数据可信
供试品溶液-X022139批-二甲双胍
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min11773224-177322442.00340.588.9342.0040.588.93
21652256-165225639.13739.14
31637157-163715738.78038.78
41513008-151300835.83935.84
51738518-173851841.18041.18
61964551-196455146.53546.53
10min13123217-312321773.98072.783.1074.0572.853.10
22993828-299382870.91570.98
32984936-298493670.70570.77
43013581-301358171.38371.44
53089711-308971173.18673.25
63230458-323045876.52076.60
15min13861869-386186991.47790.501.8191.6790.691.82
23765288-376528889.18989.37
33772812-377281289.36789.55
43764413-376441389.16889.35
53822985-382298590.55690.75
63936899-393689993.25493.46
20min14111480-411148097.38996.830.9297.7397.160.93
24037302-403730295.63295.96
34104533-410453397.22597.56
44067561-406756196.34996.68
54065347-406534796.29696.64
64139987-413998798.06498.42
30min14176318-417631898.92597.720.9499.4398.220.94
24093866-409386696.97297.46
34153169-415316998.37798.87
44083951-408395196.73797.22
54096998-409699897.04697.55
64147317-414731798.23898.76
45min14117021-411702197.52097.390.7998.1998.060.79
24078464-407846496.60797.26
34151755-415175598.34399.00
44072962-407296296.47797.13
54107678-410767897.29997.96
64141955-414195598.11198.80
60min14128066-412806697.78297.231.0798.6298.061.07
24088135-408813596.83697.65
34146679-414667998.22399.04
44034037-403403795.55596.36
54086221-408622196.79197.62
64145420-414542098.19399.04
极限14109818-410981897.35097.090.8298.3598.070.83
24081290-408129096.67497.65
34138491-413849198.02999.01
44050920-405092095.95596.92
54081020-408102096.66897.65
64130341-413034197.83698.85
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