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%
110.284274836427465242709584270696426592542714130.09
210.284287964428431142861380.07
单位质量响应值RSD%判断
415507.10416939.490.25数据可信
供试品溶液-2025081621批-二甲双胍-pH1.2
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1168824-1688244.0564.488.994.064.488.95
2190805-1908054.5844.58
3184104-1841044.4234.42
4179944-1799444.3234.32
5217448-2174485.2245.22
6178183-1781834.2814.28
10min1352758-3527588.4758.833.048.508.853.02
2374680-3746809.0029.02
3374713-3747139.0039.02
4381477-3814779.1659.19
5358208-3582088.6068.63
6362989-3629898.7218.74
15min1504775-50477512.12812.624.7112.1912.684.67
2507321-50732112.18912.26
3527921-52792112.68412.75
4506684-50668412.17312.24
5567937-56793713.64513.71
6536867-53686712.89912.96
20min1616414-61641414.81015.485.9514.9315.615.90
2621875-62187514.94115.07
3651804-65180415.66015.79
4717289-71728917.23317.36
5618815-61881514.86715.00
6639759-63975915.37115.50
30min1795215-79521519.10619.832.0319.3020.032.04
2826858-82685819.86620.07
3843351-84335120.26220.47
4829086-82908619.91920.13
5820281-82028119.70819.92
6836590-83659020.10020.31
45min11079766-107976625.94226.101.6226.2326.411.62
21078088-107808825.90226.20
31119886-111988626.90627.22
41083062-108306226.02126.34
51088067-108806726.14226.45
61069282-106928225.69026.00
60min11279638-127963830.74431.211.0831.1731.651.09
21283095-128309530.82731.26
31306619-130661931.39231.84
41311649-131164931.51331.96
51308991-130899131.44931.89
61304655-130465531.34531.78
120min11927148-192714846.30147.181.2846.8847.771.28
21975223-197522347.45648.04
31993371-199337147.89248.49
41977934-197793447.52148.12
51968534-196853447.29547.89
61939925-193992546.60847.20
180min12433723-243372358.47258.921.0359.2859.741.03
22421048-242104858.16758.99
32488689-248868959.79260.63
42469232-246923259.32560.16
52460739-246073959.12159.96
62440193-244019358.62759.45
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
240min12766788-276678866.47467.941.1867.5769.061.18
22819794-281979467.74768.86
32858358-285835868.67469.81
42854985-285498568.59369.73
52829657-282965767.98469.11
62836227-283622768.14269.26
360min13319274-331927479.74880.670.6681.1882.130.66
23365899-336589980.86882.32
33384608-338460881.31782.80
43359559-335955980.71682.19
53350504-335050480.49881.97
63366614-336661480.88582.34
480min13623382-362338287.05488.290.7588.8990.160.75
23670546-367054688.18790.04
33702365-370236588.95290.84
43688221-368822188.61290.49
53683387-368338788.49690.37
63681411-368141188.44890.31
600min13815301-381530191.66593.261.4793.9395.571.45
23861092-386109292.76595.06
33902067-390206793.75096.08
43863892-386389292.83295.16
53983188-398318895.69998.01
63865198-386519892.86495.17
720min13834200-383420092.11994.221.5394.8497.001.51
23898643-389864393.66796.43
33924568-392456894.29097.09
44014322-401432296.44799.24
53950791-395079194.92097.71
63908464-390846493.90396.67
极限13885129-388512993.34393.760.6196.5397.000.61
23881111-388111193.24696.48
33904725-390472593.81497.09
43911173-391117393.96897.24
53944078-394407894.75998.03
63887494-388749493.40096.64
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%
112.643194231739315273179831687317390.48
212.643175732021318890.59
单位质量响应值RSD%判断
2511.002522.860.34数据可信
供试品溶液-2025081621批-达格列净-pH1.2
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min135846-3584691.60595.062.2491.6095.062.24
237603-3760396.09596.09
336711-3671193.81593.82
437195-3719595.05295.05
538226-3822697.68797.69
637613-3761396.12096.12
10min137677-3767796.28497.391.3596.7497.871.35
237781-3778196.55097.03
337684-3768496.30296.77
438542-3854298.49498.97
538914-3891499.44599.93
638066-3806697.27897.76
15min137572-3757296.01696.711.7496.9597.671.73
237730-3773096.41997.38
336921-3692194.35295.30
437672-3767296.27197.24
538793-3879399.136100.12
638374-3837498.06599.03
20min137398-3739895.57195.691.0396.9997.131.04
237150-3715094.93796.38
336889-3688994.27095.69
437889-3788996.82698.27
537822-3782296.65498.14
637510-3751095.85797.31
30min136363-3636392.92694.892.3094.8296.822.28
236733-3673393.87195.79
336090-3609092.22894.12
437549-3754995.95797.89
538064-3806497.27399.24
638001-3800197.11299.05
45min137399-3739995.57395.432.1297.9497.832.10
237144-3714494.92297.31
336161-3616192.41094.76
437675-3767596.27998.69
538574-3857498.576101.03
637105-3710594.82297.24
60min137249-3724995.19094.532.8798.0397.402.82
236754-3675493.92596.79
335031-3503189.52292.34
437527-3752795.90198.79
538127-3812797.434100.38
637251-3725195.19598.09
120min137037-3703794.64894.703.2597.9698.053.19
237469-3746995.75299.09
334830-3483089.00892.27
437636-3763696.17999.55
538388-3838898.101101.53
636981-3698194.50597.88
180min137290-3729095.29594.373.7499.0898.193.66
236943-3694394.40898.22
334426-3442687.97691.69
437953-3795396.989100.84
538332-3833297.958101.88
636619-3661993.58097.42
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
240min136742-3674293.89493.794.1798.1698.094.07
236973-3697394.48598.77
333787-3378786.34390.49
437893-3789396.836101.18
537991-3799197.086101.50
636825-3682594.10798.42
360min136727-3672793.85692.764.7398.5997.524.60
237097-3709794.80299.56
332909-3290984.09988.68
437203-3720395.07399.90
537557-3755795.977100.87
636300-3630092.76597.55
480min136175-3617592.44691.884.8497.6597.104.70
236757-3675793.93399.16
332573-3257383.24188.24
436939-3693994.39899.70
537370-3737095.499100.88
635905-3590591.75697.00
600min136201-3620192.51291.925.6498.1897.605.46
236680-3668093.73699.44
332278-3227882.48787.90
436856-3685694.18699.96
538281-3828197.827103.68
635510-3551090.74696.45
720min135442-3544290.57290.935.7096.7097.075.52
236112-3611292.28598.45
332018-3201881.82287.65
437560-3756095.985102.23
537388-3738895.545101.89
634962-3496289.34695.51
极限135882-3588291.69790.125.5498.2896.725.36
235738-3573891.32997.96
331554-3155480.63686.88
436467-3646793.19299.91
537033-3703394.638101.46
634909-3490989.21095.82
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%
110.284266936426759242663054264121426486442659640.04
210.284342972434481843438950.04
单位质量响应值RSD%判断
414977.04422557.881.29数据可信
供试品溶液-2025081621批-二甲双胍-pH1.2
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1182206-1822064.3514.186.654.354.186.62
2178888-1788884.2724.27
3165781-1657813.9593.96
4158669-1586693.7893.79
5174178-1741784.1604.16
6191045-1910454.5624.56
10min1366643-3666438.7568.532.948.788.552.96
2360356-3603568.6068.63
3341828-3418288.1638.18
4357574-3575748.5398.56
5348379-3483798.3208.34
6368824-3688248.8088.83
15min1507378-50737812.11711.891.1012.1811.951.09
2498403-49840311.90311.97
3498353-49835311.90111.96
4490645-49064511.71711.78
5496159-49615911.84911.91
6496298-49629811.85211.92
20min1631403-63140315.07914.842.2515.2114.962.23
2607569-60756914.51014.63
3613389-61338914.64914.77
4642058-64205815.33315.45
5608236-60823614.52614.65
6625938-62593814.94815.07
30min1863096-86309620.61219.952.0120.8120.151.99
2840736-84073620.07820.27
3827573-82757319.76419.96
4815549-81554919.47719.67
5841544-84154420.09720.29
6824524-82452419.69119.89
45min11068035-106803525.50625.551.7825.8125.851.75
21073017-107301725.62525.92
31069779-106977925.54825.84
41094877-109487726.14726.44
51077919-107791925.74226.04
61036823-103682324.76125.06
60min11298319-129831931.00630.901.8431.4431.321.82
21294717-129471730.92031.34
31319700-131970031.51631.94
41268223-126822330.28730.71
51263572-126357230.17630.60
61317579-131757931.46631.89
120min11944905-194490546.44745.901.5747.0346.481.55
21950921-195092146.59147.17
31917769-191776945.79946.38
41937699-193769946.27546.85
51910886-191088645.63546.21
61869075-186907544.63645.22
180min12400497-240049757.32857.860.5658.1558.670.55
22426369-242636957.94558.76
32439246-243924658.25359.06
42432015-243201558.08058.89
52416527-241652757.71058.51
62421369-242136957.82658.63
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
240min12782343-278234366.44766.361.0867.5567.461.06
22797181-279718166.80167.90
32785707-278570766.52767.62
42741811-274181165.47966.58
52745832-274583265.57566.67
62819247-281924767.32868.42
360min13298971-329897178.78579.751.5480.2281.181.52
23403435-340343581.27982.72
33368693-336869380.45081.88
43304704-330470478.92180.35
53279715-327971578.32579.74
63380702-338070280.73682.17
480min13661546-366154687.44388.031.1589.2889.861.14
23723340-372334088.91990.76
33717508-371750888.78090.61
43672870-367287087.71489.53
53618685-361868586.42088.23
63721852-372185288.88490.72
600min13822135-382213591.27992.021.4193.5594.291.38
23855069-385506992.06594.35
33825067-382506791.34993.63
43909910-390991093.37595.63
53783780-378378090.36392.61
63923135-392313593.69195.97
720min13871941-387194192.46892.551.5995.1995.281.56
23934878-393487893.97196.72
33955036-395503694.45297.19
43832655-383265591.53094.26
53792160-379216090.56393.26
63864345-386434592.28795.03
极限13892731-389273192.96492.791.9296.1595.981.88
23893039-389303992.97296.19
33961602-396160294.60997.81
43837489-383748991.64594.83
53767786-376778689.98193.13
63960554-396055494.58497.79
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%
112.643172832016317943178831725318100.38
212.643226232459323600.44
单位质量响应值RSD%判断
2516.612560.131.22数据可信
供试品溶液-2025081621批-达格列净-pH1.2
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min136410-3641092.26692.431.2492.2792.431.25
236593-3659392.73092.73
336640-3664092.84992.85
435650-3565090.34190.34
536546-3654692.61192.61
637014-3701493.79793.80
10min137560-3756095.18195.150.6895.6495.620.68
237366-3736694.68995.15
337450-3745094.90295.37
437451-3745194.90495.36
537415-3741594.81395.28
638048-3804896.41796.89
15min137233-3723394.35295.391.0295.2996.331.01
237400-3740094.77595.71
337441-3744194.87995.82
438310-3831097.08198.01
537690-3769095.51096.45
637777-3777795.73196.68
20min137342-3734294.62895.391.1196.0496.801.09
237309-3730994.54595.96
338052-3805296.42797.84
437882-3788295.99797.41
537168-3716894.18795.60
638096-3809696.53997.97
30min137350-3735094.64895.261.1396.5397.161.11
237534-3753495.11597.00
338018-3801896.34198.24
437302-3730294.52796.42
537154-3715494.15296.04
638200-3820096.80298.71
45min136245-3624591.84894.772.7094.2097.142.64
236929-3692993.58295.94
337765-3776595.70098.08
439043-3904398.939101.30
537759-3775995.68598.04
636642-3664292.85495.25
60min136717-3671793.04495.272.3695.8698.112.30
236948-3694893.63096.46
338719-3871998.118100.97
437500-3750095.02997.89
537025-3702593.82596.66
638657-3865797.961100.82
120min136734-3673493.08793.682.3996.3797.002.30
237225-3722594.33297.63
337023-3702393.82097.17
438148-3814896.671100.00
537217-3721794.31197.62
635449-3544989.83193.18
180min136419-3641992.28994.481.6496.0398.271.60
236838-3683893.35197.12
337490-3749095.00398.82
438193-3819396.785100.60
537479-3747994.97598.75
637283-3728394.47998.28
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
240min136350-3635092.11493.651.3896.3297.911.35
236726-3672693.06797.30
337066-3706693.92998.22
437103-3710394.02398.32
536671-3667192.92897.18
637829-3782995.862100.13
360min135825-3582590.78493.801.7895.4598.531.73
237174-3717494.20298.90
337153-3715394.14998.91
437436-3743694.86699.64
536796-3679693.24597.96
637710-3771095.561100.31
480min136324-3632492.04893.691.3097.1798.881.28
236690-3669092.97698.15
337255-3725594.40899.64
437592-3759295.262100.51
536678-3667892.94698.13
637285-3728594.48499.71
600min136116-3611691.52192.902.3597.1098.562.25
236060-3606091.37997.01
336127-3612791.54997.25
438212-3821296.833102.55
536312-3631292.01897.66
637127-3712794.08399.78
720min135952-3595291.10691.111.1897.1497.241.12
235985-3598591.18997.28
336371-3637192.16898.33
436459-3645992.39198.60
535555-3555590.10096.21
635409-3540989.73095.90
极限135618-3561890.25991.032.1996.7597.612.08
235590-3559090.18896.74
336563-3656392.65499.28
436551-3655192.62499.29
534640-3464087.78194.34
636566-3656692.66299.28
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