达格列净二甲双胍缓释片项目信息
介质体积(ml)1000取样体积(ml)5补液体积(ml)5
对照品批号100664-202106对照品来源中检院对照品使用方法直接使用
对照品含量(%)100对照品水分(%)0对照品稀释倍数50
标示量(mg)1000供试品稀释倍数5系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.354257847425834542569124258692425838442580360.02
210.474304015431359843088060.16
单位质量响应值RSD%判断
411404.44411538.300.03数据可信
供试品溶液-2025081521批-二甲双胍-水
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1181148-1811484.4024.726.534.404.726.52
2184708-1847084.4894.49
3182291-1822914.4304.43
4208693-2086935.0725.07
5203112-2031124.9364.94
6204616-2046164.9734.97
10min1411264-4112649.9959.145.8110.029.165.82
2382371-3823719.2939.32
3363444-3634448.8338.85
4348751-3487518.4768.50
5365279-3652798.8778.90
6385292-3852929.3649.39
15min1537428-53742813.06112.855.9913.1312.925.96
2533674-53367412.97013.04
3525949-52594912.78212.85
4480239-48023911.67111.74
5516584-51658412.55512.62
6577698-57769814.04014.11
20min1682824-68282416.59516.155.1916.7316.285.18
2706671-70667117.17417.31
3662464-66246416.10016.23
4604152-60415214.68314.81
5655982-65598215.94216.07
6675005-67500516.40516.55
30min1914130-91413022.21621.384.5522.4421.604.56
2904288-90428821.97722.20
3874489-87448921.25321.46
4812021-81202119.73519.93
5859618-85961820.89121.10
6914090-91409022.21522.44
45min11171036-117103628.46028.083.4928.7928.403.50
21173218-117321828.51328.84
31164620-116462028.30428.62
41087381-108738126.42726.72
51132882-113288227.53227.85
61203715-120371529.25429.59
60min11407134-140713434.19834.062.7534.6734.522.75
21404751-140475134.14034.61
31445245-144524535.12435.58
41345009-134500932.68833.12
51369745-136974533.28933.74
61436766-143676634.91835.40
120min12114456-211445651.38850.522.1152.0351.152.13
22094430-209443050.90151.54
32090723-209072350.81151.45
41993616-199361648.45149.04
52074124-207412450.40751.03
62104887-210488751.15551.81
180min12639551-263955164.14962.972.8965.0563.852.89
22591701-259170162.98663.88
32678572-267857265.09765.99
42464442-246444259.89360.73
52554784-255478462.08962.96
62616687-261668763.59364.51
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
240min12991392-299139272.70071.312.1273.9272.522.13
22946289-294628971.60472.82
32961838-296183871.98273.20
42824849-282484968.65269.79
52902588-290258870.54271.72
62979355-297935572.40773.64
360min13436440-343644083.51683.681.3085.1085.241.32
23446548-344654883.76285.33
33469242-346924284.31385.89
43358162-335816281.61483.09
53471769-347176984.37485.91
63477308-347730884.50986.10
480min13820825-382082592.85892.051.4694.8694.021.48
23810662-381066292.61194.60
33765791-376579191.52093.52
43709571-370957190.15492.04
53753432-375343291.22093.18
63864321-386432193.91595.93
600min13915907-391590795.16895.610.8397.6498.050.85
23947283-394728395.93198.38
33961428-396142896.27598.73
43876082-387608294.20196.54
53954538-395453896.10798.52
63949536-394953695.98698.47
720min14021826-402182697.74397.191.46100.69100.101.47
23993538-399353897.05599.99
33987938-398793896.91999.85
43930928-393092895.53398.34
53959589-395958996.23099.12
64099635-409963599.634102.60
极限13988003-398800396.92196.611.23100.35100.011.25
23966795-396679596.40599.82
34007943-400794397.405100.82
43895343-389534394.66997.95
53955839-395583996.13999.51
64037496-403749698.123101.59
达格列净二甲双胍缓释片项目信息
介质体积(ml)1000取样体积(ml)5补液体积(ml)5
对照品批号101568-202301对照品来源中检院对照品使用方法直接使用
对照品含量(%)80.4对照品水分(%)0对照品稀释倍数12500
标示量(mg)5供试品稀释倍数5系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
112.002979529759299152985429854298350.21
212.022986529950299080.21
单位质量响应值RSD%判断
2486.252488.190.06数据可信
供试品溶液-2025081521批-达格列净-水
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min138795-38795100.32598.013.60100.3298.013.60
238247-3824798.90898.91
338694-38694100.064100.06
435182-3518290.98190.98
538485-3848599.52399.52
638004-3800498.27998.28
10min139675-39675102.60098.693.01103.1099.183.01
238084-3808498.48698.98
338442-3844299.41299.91
436131-3613193.43693.89
538262-3826298.94699.44
638389-3838999.27599.77
15min139244-39244101.48698.522.79102.5099.512.79
238196-3819698.77699.76
339306-39306101.646102.64
436547-3654794.51195.43
537490-3749096.95097.94
637810-3781097.77798.77
20min138655-3865599.96398.731.80101.48100.201.81
238776-38776100.276101.76
338395-3839599.290100.80
436869-3686995.34496.74
538192-3819298.765100.24
638172-3817298.714100.19
30min138914-38914100.63298.132.22102.65100.102.22
237938-3793898.109100.09
338277-3827798.985100.99
436781-3678195.11696.99
537135-3713596.03298.00
638625-3862599.885101.86
45min138024-3802498.33197.541.46100.86100.001.48
238236-3823698.879101.35
338230-3823098.864101.36
436884-3688495.38397.73
537287-3728796.42598.88
637639-3763997.33599.80
60min138515-3851599.60198.581.44102.62101.541.44
237795-3779597.739100.71
338996-38996100.845103.84
437789-3778997.723100.55
537516-3751697.01799.95
638121-3812198.582101.54
120min138578-3857899.76497.901.13103.28101.351.15
237912-3791298.041101.50
338065-3806598.437101.93
437439-3743996.818100.13
537667-3766797.408100.83
637493-3749396.958100.41
180min138779-38779100.28397.791.99104.30101.721.98
237538-3753897.074101.02
338768-38768100.255104.24
437151-3715196.07399.87
537315-3731596.497100.40
637347-3734796.580100.51
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
240min138255-3825598.92896.621.44103.44101.041.44
237109-3710995.965100.40
337726-3772697.560102.05
437069-3706995.861100.14
536769-3676995.08599.47
637252-3725296.334100.75
360min137312-3731296.49095.940.70101.50100.840.68
236670-3667094.82999.74
337334-3733496.547101.52
437268-3726896.376101.13
537029-3702995.758100.62
636972-3697295.610100.51
480min138050-3805098.39896.501.28103.89101.881.26
237085-3708595.903101.29
337071-3707195.866101.33
437214-3721496.236101.47
536755-3675595.049100.39
637715-3771597.532102.91
600min137329-3732996.53495.710.93102.52101.580.90
236650-3665094.778100.64
337290-3729096.433102.37
437332-3733296.541102.26
536635-3663594.739100.56
636831-3683195.246101.11
720min137757-3775797.64095.591.86104.11101.941.79
236575-3657594.584100.92
336713-3671394.941101.36
437004-3700495.693101.90
536005-3600593.11099.40
637738-3773897.591103.93
极限137151-3715196.07394.571.41103.03101.391.35
235948-3594892.96299.77
336780-3678095.114102.01
436860-3686095.321102.00
535918-3591892.88599.64
636752-3675295.041101.87
达格列净二甲双胍缓释片项目信息
介质体积(ml)1000取样体积(ml)5补液体积(ml)5
对照品批号100664-202106对照品来源中检院对照品使用方法直接使用
对照品含量(%)100对照品水分(%)0对照品稀释倍数50
标示量(mg)1000供试品稀释倍数5系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.354309611431644843113844310775430890743114250.07
210.474337916433669443373050.02
单位质量响应值RSD%判断
416562.80414260.270.40数据可信
供试品溶液-2025081621批-二甲双胍-水
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1184893-1848934.4514.619.074.454.619.07
2217911-2179115.2465.25
3174762-1747624.2074.21
4182223-1822234.3874.39
5208720-2087205.0245.02
6181230-1812304.3634.36
10min1405063-4050639.7519.357.679.779.377.68
2430502-43050210.36310.39
3356384-3563848.5798.60
4367169-3671698.8398.86
5406313-4063139.7819.81
6364141-3641418.7668.79
15min1541497-54149713.03512.552.8513.1112.622.86
2518302-51830212.47712.55
3499577-49957712.02612.09
4516142-51614212.42512.49
5534220-53422012.86012.93
6517197-51719712.45012.52
20min1664444-66444415.99515.852.3916.1315.982.35
2656639-65663915.80715.95
3639425-63942515.39315.52
4679887-67988716.36716.49
5641914-64191415.45315.59
6668547-66854716.09416.22
30min1856808-85680820.62620.621.7720.8420.831.78
2885516-88551621.31721.54
3845298-84529820.34920.55
4844871-84487120.33820.55
5855884-85588420.60320.82
6850115-85011520.46520.67
45min11132080-113208027.25227.123.6727.5727.433.64
21202264-120226428.94229.27
31122282-112228227.01627.32
41115681-111568126.85727.17
51079120-107912025.97726.30
61106900-110690026.64626.96
60min11378656-137865633.18832.601.2733.6433.051.27
21370360-137036032.98833.46
31348732-134873232.46832.91
41349014-134901432.47432.92
51331714-133171432.05832.51
61347554-134755432.43932.88
120min12023841-202384148.71948.871.7649.3449.481.75
22062006-206200649.63850.27
32028272-202827248.82649.43
42064143-206414349.68950.30
51965963-196596347.32647.93
62036993-203699349.03649.64
180min12535114-253511461.02760.890.9761.8961.750.96
22542635-254263561.20862.09
32492752-249275260.00760.85
42507995-250799560.37461.23
52558178-255817861.58262.43
62540105-254010561.14762.00
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
240min12902828-290282869.87969.591.1071.0570.751.10
22925126-292512670.41671.61
32878418-287841869.29170.44
42898131-289813169.76670.92
52833966-283396668.22169.37
62906920-290692069.97771.13
360min13371021-337102181.15082.320.8082.6783.830.79
23445821-344582182.95084.49
33440456-344045682.82184.31
43416236-341623682.23883.75
53411990-341199082.13683.63
63432708-343270882.63584.14
480min13843814-384381492.53190.381.7694.4692.301.73
23780160-378016090.99992.96
33702484-370248489.12991.03
43807622-380762291.66093.58
53716108-371610889.45791.36
63676718-367671888.50990.43
600min13856040-385604092.82593.270.9195.2195.640.90
23937267-393726794.78197.19
33892801-389280193.71096.06
43853095-385309592.75495.13
53843877-384387792.53294.88
63863002-386300292.99395.36
720min13891695-389169593.68494.671.2196.5497.511.20
24014239-401423996.63499.52
33919010-391901094.34197.16
43964362-396436295.43398.27
53907296-390729694.05996.87
63899174-389917493.86496.69
极限13886997-388699793.57194.801.6496.8998.111.60
24000038-400003896.29299.66
34036324-403632497.165100.46
43919544-391954494.35497.67
53881434-388143493.43796.72
63903666-390366693.97297.27
达格列净二甲双胍缓释片项目信息
介质体积(ml)1000取样体积(ml)5补液体积(ml)5
对照品批号101568-202301对照品来源中检院对照品使用方法直接使用
对照品含量(%)80.4对照品水分(%)0对照品稀释倍数12500
标示量(mg)5供试品稀释倍数5系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
112.002994829787300462978729822298780.39
212.023023430165302000.17
单位质量响应值RSD%判断
2489.832512.480.65数据可信
供试品溶液-2025081621批-达格列净-水
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min138932-38932100.120101.344.41100.12101.344.42
239294-39294101.051101.05
336863-3686394.79994.80
442041-42041108.115108.12
540465-40465104.062104.06
638832-3883299.86399.86
10min139292-39292101.046101.312.61101.55101.822.61
240161-40161103.281103.79
337713-3771396.98597.46
440621-40621104.464105.00
539685-39685102.056102.58
638904-38904100.048100.55
15min138791-3879199.757100.792.02100.76101.812.03
239141-39141100.657101.68
338123-3812398.04099.00
440463-40463104.057105.12
539606-39606101.853102.88
639041-39041100.400101.40
20min138902-38902100.043100.792.18101.55102.312.19
239726-39726102.162103.69
338231-3823198.31799.77
440303-40303103.646105.23
539717-39717102.139103.68
638272-3827298.42399.92
30min138350-3835098.623100.441.76100.63102.461.75
239696-39696102.085104.12
338765-3876599.691101.63
439161-39161100.709102.81
539986-39986102.831104.88
638373-3837398.682100.68
45min138257-3825798.384100.783.13100.88103.303.07
241443-41443106.577109.12
338893-38893100.020102.46
439669-39669102.015104.62
538620-3862099.318101.88
638246-3824698.356100.84
60min139109-39109100.575100.421.06103.57103.451.08
239009-39009100.318103.40
338787-3878799.747102.69
439555-39555101.722104.84
539410-39410101.349104.41
638424-3842498.814101.79
120min138914-38914100.074100.721.43103.57104.251.42
239164-39164100.717104.30
339215-39215100.848104.29
440223-40223103.440107.06
538753-3875399.660103.23
638714-3871499.559103.03
180min138883-3888399.994100.421.17103.99104.451.16
238736-3873699.616103.70
338961-38961100.195104.14
439303-39303101.074105.21
539833-39833102.437106.50
638579-3857999.212103.18
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
240min138604-3860499.27699.950.74103.77104.480.76
238935-38935100.128104.71
338922-38922100.094104.54
439349-39349101.192105.84
538823-3882399.840104.42
638560-3856099.163103.63
360min138004-3800497.73399.781.56102.72104.821.52
238238-3823898.335103.42
339188-39188100.778105.72
439455-39455101.465106.62
539315-39315101.105106.18
638610-3861099.292104.25
480min139098-39098100.54799.632.04106.03105.161.99
238388-3838898.721104.30
338572-3857299.194104.64
439902-39902102.615108.27
538938-38938100.135105.72
637541-3754196.543102.00
600min138121-3812198.03498.811.29104.02104.841.24
238346-3834698.613104.68
339086-39086100.516106.46
438905-38905100.051106.22
538312-3831298.526104.61
637766-3776697.121103.06
720min137638-3763896.79298.181.86103.26104.701.82
238173-3817398.168104.73
338388-3838898.721105.17
439315-39315101.105107.78
538300-3830098.495105.07
637249-3724995.792102.22
极限137480-3748096.38698.142.12103.34105.162.01
238020-3802097.775104.83
339406-39406101.339108.28
438832-3883299.863107.04
537926-3792697.533104.60
637313-3731395.956102.86
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