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%
110.204164296416538541681534165644416256741652090.05
210.274145369415109941482340.10
单位质量响应值RSD%判断
408353.82403917.620.78数据可信
加速6月-供试品溶液-2025081621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%
5min1188231-1882314.6354.847.804.634.847.83
2204019-2040195.0245.02
3209292-2092925.1535.15
4213847-2138475.2665.27
5190289-1902894.6854.69
6173174-1731744.2644.26
10min1408090-40809010.0489.304.5610.079.324.56
2380720-3807209.3749.40
3383223-3832239.4369.46
4362589-3625898.9288.95
5365034-3650348.9889.01
6366349-3663499.0219.04
15min1503410-50341012.39512.503.2312.4712.573.22
2526973-52697312.97613.05
3523845-52384512.89912.97
4506192-50619212.46412.53
5481726-48172611.86211.93
6504397-50439712.42012.49
20min1648071-64807115.95715.672.9716.0915.802.98
2650515-65051516.01816.15
3655740-65574016.14616.28
4635008-63500815.63615.77
5606201-60620114.92715.05
6623581-62358115.35415.48
30min1816026-81602620.09320.773.0920.3120.983.07
2864309-86430921.28221.50
3856875-85687521.09921.32
4838310-83831020.64220.85
5811441-81144119.98020.18
6874472-87447221.53221.74
45min11073689-107368926.43726.992.9626.7527.312.96
21121494-112149427.61527.94
31142084-114208428.12228.45
41097080-109708027.01327.33
51051673-105167325.89526.20
61091569-109156926.87827.19
60min11291193-129119331.79332.302.5832.2432.762.58
21355466-135546633.37633.84
31343760-134376033.08733.55
41319809-131980932.49832.95
51267597-126759731.21231.64
61294076-129407631.86432.31
120min11902768-190276846.85248.061.6947.4648.671.68
21992670-199267049.06649.69
31981559-198155948.79249.42
41952874-195287448.08648.70
51948527-194852747.97948.57
61931460-193146047.55848.17
180min12392037-239203758.89959.871.5359.7460.721.54
22486760-248676061.23262.11
32451857-245185760.37261.25
42433611-243361159.92360.78
52388326-238832658.80859.64
62435241-243524159.96360.81
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
240min12773459-277345968.29169.101.4969.4370.251.50
22851804-285180470.22071.40
32861955-286195570.47071.65
42805810-280581069.08870.24
52765429-276542968.09369.21
62778997-277899768.42769.57
360min13325879-332587981.89381.411.0783.3782.901.07
23341452-334145282.27783.81
33344305-334430582.34783.87
43264049-326404980.37181.87
53278182-327818280.71982.18
63283226-328322680.84382.33
480min13585680-358568088.29089.242.5690.1891.142.52
23743121-374312192.16794.11
33681512-368151290.65092.59
43471961-347196185.49087.39
53613098-361309888.96590.83
63649464-364946489.86191.75
600min13751575-375157592.37594.322.7594.7096.672.70
23923601-392360196.61199.01
33848659-384865994.76697.16
43705176-370517691.23393.56
53977419-397741997.936100.25
63776174-377617492.98195.32
720min13872689-387268995.35795.422.3898.1598.242.34
23927162-392716296.69999.58
33980348-398034898.008100.87
43709365-370936591.33694.12
53902644-390264496.09598.90
63860028-386002895.04697.85
极限13844320-384432094.65995.261.7597.9398.561.73
23967952-396795297.703101.07
33877995-387799595.48898.84
43761519-376151992.62095.86
53894211-389421195.88799.17
63866868-386686895.21498.49
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6250
标示量(mg)10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%
112.613561035606355923555935373355480.29
212.743525335277352650.05
单位质量响应值RSD%判断
2819.032768.051.30数据可信
加速6月-供试品溶液-2025081621批-达格列净-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%
5min137359-3735986.02487.052.3586.0287.052.35
238801-3880189.34589.34
337973-3797387.43887.44
438127-3812787.79387.79
536267-3626783.51083.51
638301-3830188.19488.19
10min136987-3698785.16887.762.1685.6088.192.15
239088-3908890.00690.45
338194-3819487.94788.38
438076-3807687.67588.11
537411-3741186.14486.56
638914-3891489.60590.05
15min136167-3616783.28087.052.6684.1487.922.65
238812-3881289.37090.27
337902-3790287.27588.15
437743-3774386.90987.79
537334-3733485.96786.82
638858-3885889.47690.37
20min140494-4049493.24389.272.3594.5290.582.31
238825-3882589.40090.74
338207-3820787.97789.29
438393-3839388.40589.72
537925-3792587.32888.61
638769-3876989.27190.61
30min136513-3651384.07687.732.7685.8289.482.73
238708-3870889.13190.92
337605-3760586.59188.34
438296-3829688.18289.94
537852-3785287.16088.87
639614-3961491.21793.00
45min137135-3713585.50988.171.6787.6790.361.67
238801-3880189.34591.58
338495-3849588.64090.83
438427-3842788.48490.68
538026-3802687.56089.71
638851-3885189.46091.70
60min137217-3721785.69887.961.6988.2890.591.68
239225-3922590.32193.00
338129-3812987.79890.43
438217-3821788.00090.64
538061-3806187.64190.23
638344-3834488.29390.98
120min136733-3673384.58387.571.9787.6090.641.92
238608-3860888.90092.04
337608-3760886.59889.67
438328-3832888.25691.33
538719-3871989.15692.18
638176-3817687.90691.03
180min136922-3692285.01887.631.8988.4691.141.87
238829-3882989.40992.99
337591-3759186.55990.06
438336-3833688.27491.79
537977-3797787.44890.92
638672-3867289.04892.61
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
240min136856-3685684.86687.391.5388.7391.351.52
238473-3847388.59092.62
338309-3830988.21292.15
438233-3823388.03792.00
537955-3795587.39791.31
637896-3789687.26191.27
360min136894-3689484.95486.470.9489.2490.860.96
237872-3787287.20691.67
337560-3756086.48790.86
437652-3765286.69991.10
537543-3754386.44890.79
637806-3780687.05491.50
480min136423-3642383.86986.192.7188.5891.012.63
238693-3869389.09694.00
337599-3759986.57791.38
436174-3617483.29688.13
537309-3730985.90990.69
638383-3838388.38293.27
600min136035-3603582.97686.152.6088.1191.402.51
238463-3846388.56793.92
337636-3763686.66291.90
436474-3647483.98789.24
538274-3827488.13193.34
637601-3760186.58291.91
720min136559-3655984.18285.212.5689.7390.892.45
237630-3763086.64992.44
337630-3763086.64992.32
435268-3526881.21086.88
537311-3731185.91491.56
637625-3762586.63792.40
极限136076-3607683.07084.672.1689.0490.782.10
237765-3776586.95993.19
336674-3667484.44790.55
435665-3566582.12488.20
537123-3712385.48191.56
637331-3733185.96092.15
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%
110.204148086415580241613374157393416297941571190.15
210.274165810418195241738810.28
单位质量响应值RSD%判断
407560.69406414.900.20数据可信
加速6月-供试品溶液-2025081621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%
5min1221865-2218655.4514.8912.105.454.8912.10
2233073-2330735.7275.73
3180197-1801974.4284.43
4179964-1799644.4224.42
5201399-2013994.9494.95
6176844-1768444.3454.35
10min1381259-3812599.3688.793.659.408.813.68
2360153-3601538.8498.88
3348491-3484918.5638.58
4347000-3470008.5268.55
5359974-3599748.8458.87
6348631-3486318.5668.59
15min1533391-53339113.10612.403.1013.1812.473.11
2509710-50971012.52412.60
3488453-48845312.00212.07
4497694-49769412.22912.29
5499909-49990912.28312.35
6498898-49889812.25812.32
20min1640452-64045215.73615.411.8215.8815.541.86
2626169-62616915.38515.52
3610018-61001814.98915.11
4622640-62264015.29915.42
5639209-63920915.70615.84
6623478-62347815.31915.45
30min1851710-85171020.92720.491.7721.1520.701.78
2844920-84492020.76020.97
3813669-81366919.99320.19
4828367-82836720.35420.56
5822619-82261920.21220.42
6842409-84240920.69920.90
45min11114799-111479927.39226.741.6027.7127.051.60
21098060-109806026.98027.30
31070080-107008026.29326.59
41087263-108726326.71527.02
51069020-106902026.26726.58
61091224-109122426.81227.12
60min11333772-133377232.77231.891.5433.2332.331.55
21307423-130742332.12432.58
31280249-128024931.45731.89
41288299-128829931.65532.09
51285165-128516531.57832.02
61291187-129118731.72632.17
120min11986480-198648048.80947.722.1449.4348.332.13
21980747-198074748.66949.28
31943636-194363647.75748.35
41887204-188720446.37046.97
51957646-195764648.10148.70
61898354-189835446.64447.24
180min12592292-259229263.69560.742.5864.5661.582.56
22454626-245462660.31261.17
32460670-246067060.46161.29
42421806-242180659.50660.33
52420173-242017359.46660.31
62482284-248228460.99261.82
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
240min12827738-282773869.48069.751.1670.6770.901.13
22831049-283104969.56170.72
32854295-285429570.13271.26
42874590-287459070.63171.76
52782571-278257168.37069.51
62861790-286179070.31671.45
360min13376942-337694282.97482.500.7584.5184.000.75
23368974-336897482.77884.28
33354507-335450782.42383.90
43364169-336416982.66084.14
53309203-330920381.31082.79
63373149-337314982.88184.37
480min13709923-370992391.15690.440.8393.1092.340.83
23694360-369436090.77392.69
33660915-366091589.95291.84
43640029-364002989.43891.33
53663334-366333490.01191.90
63715975-371597591.30593.21
600min13844753-384475394.46995.211.9596.8797.571.91
24021918-402191898.822101.19
33842729-384272994.41996.76
43815794-381579493.75796.10
53839593-383959394.34296.68
63884626-388462695.44897.81
720min13892603-389260395.64496.661.3498.5299.501.30
23920393-392039396.32799.19
33932772-393277296.63199.45
43963530-396353097.387100.19
53874692-387469295.20498.01
64020255-402025598.781101.62
极限13912186-391218696.12695.730.7199.4899.040.70
23894191-389419195.68399.03
33865010-386501094.96698.26
43927397-392739796.49999.79
53861432-386143294.87998.16
63915609-391560996.21099.54
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6250
标示量(mg)10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%
112.613537435368354393545735504354280.17
212.743547035462354660.02
单位质量响应值RSD%判断
2809.522783.830.65数据可信
加速6月-供试品溶液-2025081621批-达格列净-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%
5min137345-3734585.89185.341.7485.8985.341.74
237428-3742886.08286.08
336410-3641083.74083.74
436612-3661284.20584.20
538117-3811787.66687.67
636719-3671984.45184.45
10min139281-3928190.34387.221.9990.7787.651.99
238081-3808187.58388.01
337752-3775286.82787.25
437211-3721185.58286.00
537956-3795687.29687.73
637262-3726285.70086.12
15min139420-3942090.66388.081.8191.5488.941.80
238731-3873189.07889.95
337550-3755086.36287.21
438171-3817187.79088.64
537709-3770986.72887.60
638206-3820687.87188.72
20min138358-3835888.22088.070.8089.5589.370.80
238206-3820687.87189.18
337877-3787787.11488.40
438223-3822387.91089.20
538816-3881689.27490.58
638263-3826388.00289.29
30min138420-3842088.36387.991.5590.1489.731.52
238520-3852088.59390.35
337797-3779786.93088.65
438372-3837288.25389.98
537370-3737085.94887.70
639060-3906089.83591.57
45min137870-3787087.09887.581.6889.3289.761.64
238543-3854388.64690.84
337724-3772486.76288.92
438599-3859988.77590.94
537066-3706685.24987.43
638669-3866988.93691.12
60min138499-3849988.54587.181.2191.2089.811.20
238261-3826187.99790.64
337568-3756886.40488.99
437928-3792887.23289.84
537234-3723485.63588.25
637955-3795587.29489.92
120min138122-3812287.67886.691.4990.7789.741.46
238477-3847788.49491.57
337511-3751186.27289.29
437053-3705385.21988.27
537845-3784587.04190.08
637139-3713985.41788.48
180min140300-4030092.68788.962.3096.2292.462.24
238383-3838388.27891.80
338486-3848688.51591.97
438275-3827588.03091.50
537695-3769586.69690.17
638950-3895089.58293.07
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
240min138020-3802087.44388.201.4191.4492.141.34
238300-3830088.08792.05
338377-3837788.26492.16
438908-3890889.48593.40
537538-3753886.33590.24
638949-3894989.58093.52
360min138403-3840388.32487.841.1392.7692.211.11
238270-3827088.01892.42
337740-3774086.79991.14
438513-3851388.57792.94
537581-3758186.43390.77
638636-3863688.86093.24
480min138310-3831088.11087.231.4792.9992.051.43
238015-3801587.43292.28
337318-3731885.82990.60
437658-3765886.61191.42
537479-3747986.19990.97
638793-3879389.22194.05
600min137566-3756686.39986.941.1691.7292.201.12
238345-3834588.19193.47
337519-3751986.29191.49
437615-3761586.51291.75
537400-3740086.01791.22
638370-3837088.24893.52
720min137225-3722585.61586.442.0191.3692.121.91
237299-3729985.78591.51
337390-3739085.99491.62
438195-3819587.84693.52
536642-3664284.27489.91
638743-3874389.10694.82
极限137202-3720285.56285.231.5791.7491.351.50
237013-3701385.12791.28
336394-3639483.70389.76
437789-3778986.91293.02
536396-3639683.70889.76
637551-3755186.36492.52
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