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%
114.037911179021790227906979054790550.05
214.067844678427784360.02
单位质量响应值RSD%判断
5634.715578.660.71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%
5min115281-1528119.03819.0418.8819.0419.0418.89
218109-1810922.56122.56
315211-1521118.95118.95
411745-1174514.63314.63
512461-1246115.52515.52
618910-1891023.55923.56
10min136413-3641345.36649.9014.1945.4049.9414.19
245223-4522356.34256.38
341443-4144351.63351.66
433563-3356341.81541.84
535889-3588944.71344.74
647805-4780559.55959.60
15min152778-5277865.75473.6712.6265.8673.7812.63
266514-6651482.86883.00
358344-5834472.68972.81
452788-5278865.76765.86
554297-5429767.64767.75
670050-7005087.27387.41
20min164988-6498880.96688.548.0981.1888.788.11
278731-7873198.08898.36
369812-6981286.97787.22
467638-6763884.26884.47
567545-6754584.15284.37
677687-7768796.78897.07
30min175803-7580394.44198.462.6894.7998.852.70
281683-81683101.766102.20
377448-7744896.49096.87
479528-7952899.08199.43
579287-7928798.78199.13
680444-80444100.223100.67
45min179612-7961299.186101.161.6899.70101.701.67
282273-82273102.501103.10
379523-7952399.07599.62
481928-81928102.071102.58
582676-82676103.003103.52
681144-81144101.095101.71
60min179430-7943098.959101.301.8299.63102.011.82
282266-82266102.493103.27
379673-7967399.26299.97
482122-82122102.313102.99
583076-83076103.502104.19
681271-81271101.253102.03
极限179984-7998499.650101.881.57100.49102.761.57
282769-82769103.119104.06
380593-80593100.408101.28
482264-82264102.490103.34
583302-83302103.783104.65
681724-81724101.817102.77
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%
19.594310636431049143139354309185431142343111340.05
29.624320183432167743209300.03
单位质量响应值RSD%判断
449544.73449161.120.07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%
5min11109977-110997726.12926.0215.7326.1326.0215.74
21283299-128329930.20930.21
31097353-109735325.83125.83
4897031-89703121.11621.12
5928391-92839121.85421.85
61316734-131673430.99631.00
10min12260037-226003753.20157.3211.2053.2457.3611.21
22691753-269175363.36363.41
32507702-250770259.03159.07
42124797-212479750.01750.05
52228027-222802752.44752.48
62796573-279657365.83165.88
15min13056341-305634171.94578.479.6172.0878.619.61
23637818-363781885.63385.79
33321291-332129178.18278.32
43068036-306803672.22172.34
53111832-311183273.25273.38
63806436-380643689.60289.76
20min13613862-361386285.06990.615.7385.3290.885.75
24131023-413102397.24397.54
33835874-383587490.29590.57
43702918-370291887.16687.40
53705402-370540287.22487.47
64105707-410570796.64796.96
30min14051678-405167895.37598.251.6495.7798.671.65
24237963-423796399.761100.22
34146246-414624697.60298.02
44212375-421237599.15899.54
54176529-417652998.31498.71
64218175-421817599.29599.77
45min14196022-419602298.773100.181.0599.33100.771.04
24265757-4265757100.415101.04
34220306-422030699.34599.93
44295979-4295979101.126101.68
54312293-4312293101.510102.07
64244653-424465399.918100.56
60min14197973-419797398.819100.260.9899.54101.010.97
24264747-4264747100.391101.19
34234858-423485899.687100.44
44295280-4295280101.110101.83
54312619-4312619101.518102.24
64249680-4249680100.036100.84
极限14200114-420011498.870100.290.8699.75101.210.85
24264347-4264347100.382101.34
34248512-4248512100.009100.93
44288788-4288788100.957101.84
54305046-4305046101.340102.23
64255668-4255668100.177101.15
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%
114.037888478925788437888278848788760.05
214.068002580058800420.03
单位质量响应值RSD%判断
5621.955692.890.89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%
5min112201-1220115.06516.8411.8515.0616.8411.85
215140-1514018.69418.69
312672-1267215.64615.65
415616-1561619.28119.28
514375-1437517.74917.75
611809-1180914.58114.58
10min133440-3344041.28947.4711.3641.3147.5011.36
245732-4573256.46656.50
337605-3760546.43146.46
440539-4053950.05450.09
538368-3836847.37347.40
634986-3498643.19843.22
15min152679-5267965.04372.579.9865.1472.689.97
269440-6944085.73885.86
355543-5554368.58068.68
459862-5986273.91274.03
559353-5935373.28473.39
655794-5579468.89068.99
20min167590-6759083.45487.236.6183.6687.466.62
279581-7958198.26098.53
367615-6761583.48583.70
469256-6925685.51185.75
571891-7189188.76589.00
667967-6796783.92084.13
30min178617-7861797.06995.862.0797.4196.242.08
279925-7992598.68499.12
376121-7612193.98894.34
475797-7579793.58893.97
576987-7698795.05795.44
678378-7837896.77497.13
45min180441-8044199.32297.541.7299.8298.081.71
280168-8016898.98499.58
377788-7778896.04696.56
477397-7739795.56396.10
578191-7819196.54397.08
680019-8001998.80199.31
60min180557-8055799.46597.741.69100.1398.441.68
279861-7986198.60599.37
378211-7821196.56897.24
477479-7747995.66496.36
578297-7829796.67497.37
680571-8057199.482100.16
极限181101-81101100.13699.520.92100.97100.380.90
280433-8043399.312100.24
380272-8027299.11399.95
479736-7973698.45199.31
580243-8024399.07799.94
681808-81808101.009101.85
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%
19.594305347430464043122164306922430854743075340.08
29.624396358439801643971870.03
单位质量响应值RSD%判断
449169.34457088.051.24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%
5min1923831-92383121.56723.389.3021.5723.389.30
21091334-109133425.47825.48
3939406-93940621.93121.93
41113749-111374926.00126.00
51044086-104408624.37524.37
6896684-89668420.93320.93
10min12134452-213445249.83054.908.7049.8754.948.70
22687761-268776162.74762.79
32308152-230815253.88553.92
42460333-246033357.43757.48
52355334-235533454.98655.03
62163920-216392050.51850.55
15min13088135-308813572.09477.527.5672.2177.657.56
23780990-378099088.26988.42
33179693-317969374.23174.36
43357448-335744878.38178.52
53356119-335611978.35078.48
63159860-315986073.76873.89
20min13733345-373334587.15689.524.8487.4089.784.85
24188746-418874697.78898.08
33716882-371688286.77287.02
43776993-377699388.17588.44
53884763-388476390.69190.95
63705945-370594586.51786.76
30min14183007-418300797.65496.281.4798.0496.691.47
24200184-420018498.05598.51
34066642-406664294.93795.33
44053619-405361994.63395.05
54101123-410112395.74296.16
64140286-414028696.65697.04
45min14254856-425485699.33197.671.1299.8898.241.11
24207986-420798698.23798.86
34143809-414380996.73997.29
44137400-413740096.58997.16
54152562-415256296.94397.52
64205107-420510798.17098.72
60min14263764-426376499.53997.921.06100.2598.661.05
24197712-419771297.99798.78
34166804-416680497.27697.99
44144791-414479196.76297.50
54167360-416736097.28998.02
64226957-422695798.68099.39
极限14265437-426543799.57898.570.71100.4699.460.69
24201858-420185898.09499.04
34213654-421365498.36999.25
44197616-419761697.99598.89
54200790-420079098.06998.97
64253888-425388899.309100.18
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%
114.037889978963789987890778985789500.06
214.067878378854788180.07
单位质量响应值RSD%判断
5627.235605.830.27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%
5min114102-1410217.53818.0214.0117.5418.0214.00
213521-1352116.81616.82
312227-1222715.20615.21
413876-1387617.25717.26
518194-1819422.62722.63
615020-1502018.68018.68
10min137061-3706146.09147.479.3546.1247.509.35
237931-3793147.17347.20
333005-3300541.04741.07
439617-3961749.27049.30
543922-4392254.62454.66
637501-3750146.63846.67
15min155634-5563469.19071.005.9969.3071.115.99
257597-5759771.63171.74
351614-5161464.19064.28
461135-6113576.03176.14
560116-6011674.76474.89
656442-5644270.19570.30
20min169261-6926186.13786.453.7886.3686.673.78
270117-7011787.20287.43
365219-6521981.11081.31
473142-7314290.96491.20
568561-6856185.26685.52
670756-7075687.99688.22
30min179856-7985699.31498.371.8699.6898.741.86
280781-80781100.464100.84
377703-7770396.63696.97
480068-8006899.57799.97
576973-7697395.72896.12
679188-7918898.48398.86
45min180518-80518100.137100.821.70100.67101.361.69
283171-83171103.436103.98
381885-81885101.837102.33
480509-80509100.126100.68
579126-7912698.40698.96
681214-81214101.002101.54
60min180123-8012399.646100.621.78100.34101.321.76
283167-83167103.431104.14
381878-81878101.828102.49
480241-8024199.792100.51
579123-7912398.40299.12
680914-80914100.629101.33
极限179702-7970299.122100.501.7999.99101.371.77
283055-83055103.292104.18
381971-81971101.944102.78
480062-8006299.570100.46
579320-7932098.64799.53
680730-80730100.401101.27
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%
19.594305725430725643168724307257431411943102460.12
29.624326119432852143273200.04
单位质量响应值RSD%判断
449452.14449825.360.06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%
5min11020745-102074524.01324.7510.4124.0124.7410.41
2999520-99952023.51323.51
3933063-93306321.95021.95
41029005-102900524.20724.21
51254425-125442529.51029.51
61074524-107452425.27825.28
10min12287550-228755053.81455.197.7953.8555.237.79
22349557-234955755.27355.31
32086438-208643849.08349.12
42426049-242604957.07257.11
52639311-263931162.08962.14
62286986-228698653.80153.84
15min13187637-318763774.98876.374.9075.1276.504.90
23288198-328819877.35477.49
32989552-298955270.32970.45
43411634-341163480.25880.39
53405382-340538280.11180.26
63195402-319540275.17175.30
20min13784910-378491089.03989.122.8789.2989.382.88
23817220-381722089.79990.06
33601348-360134884.72184.96
43934894-393489492.56792.84
53766687-376668788.61088.90
63824554-382455489.97290.23
30min14201761-420176198.84598.140.9799.2598.550.97
24226162-422616299.41999.83
34137581-413758197.33697.71
44190445-419044598.57999.00
54123167-412316796.99797.43
64152742-415274297.69298.10
45min14215466-421546699.16899.711.0199.74100.280.99
24303946-4303946101.249101.82
34277705-4277705100.632101.17
44199947-419994798.80399.39
54205150-420515098.92599.52
64228325-422832599.470100.04
60min14200627-420062798.81999.421.0599.55100.151.03
24292358-4292358100.977101.72
34270952-4270952100.473101.18
44187947-418794798.52099.27
54198557-419855798.77099.53
64205637-420563798.93799.67
极限14181311-418131198.36499.211.1799.26100.111.15
24292282-4292282100.975101.89
34264756-4264756100.327101.20
44174225-417422598.19899.11
54194864-419486498.68399.61
64195105-419510598.68999.59
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