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%
110.204216244422022542242154238090422092242239390.20
210.274217649420956642136080.14
单位质量响应值RSD%判断
414111.67410283.150.66数据可信
中间条件6月-供试品溶液-2025081922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%
5min1212756-2127565.1625.006.135.165.006.13
2216747-2167475.2585.26
3183891-1838914.4614.46
4199055-1990554.8294.83
5215716-2157165.2335.23
6208051-2080515.0475.05
10min1377993-3779939.1709.502.749.209.522.71
2393310-3933109.5429.57
3386313-3863139.3729.39
4384805-3848059.3369.36
5399768-3997689.6999.72
6407232-4072329.8809.90
15min1526324-52632412.76912.841.6312.8412.911.62
2540194-54019413.10613.18
3521459-52145912.65112.72
4532344-53234412.91512.99
5518142-51814212.57112.65
6536066-53606613.00513.08
20min1633397-63339715.36715.861.9515.5015.991.95
2655186-65518615.89516.03
3651009-65100915.79415.93
4670920-67092016.27716.41
5649092-64909215.74715.88
6662244-66224416.06716.21
30min1840316-84031620.38720.962.2320.6021.182.22
2885802-88580221.49021.71
3849005-84900520.59720.81
4851176-85117620.65020.87
5880971-88097121.37321.59
6875781-87578121.24721.47
45min11138667-113866727.62527.230.7927.9427.550.78
21121620-112162027.21127.54
31118256-111825627.13027.44
41115195-111519527.05527.38
51115547-111554727.06427.39
61125507-112550727.30627.63
60min11316251-131625131.93332.471.4132.3932.921.39
21344136-134413632.61033.07
31326797-132679732.18932.64
41323855-132385532.11832.57
51356258-135625832.90433.36
61362224-136222433.04933.51
120min11948548-194854847.27348.261.4947.8948.891.47
21972754-197275447.86048.49
32036849-203684949.41550.03
41989430-198943048.26548.88
51986035-198603548.18348.81
62002747-200274748.58849.22
180min12405107-240510758.35059.791.5359.2060.651.51
22459575-245957559.67160.54
32463896-246389659.77660.63
42519701-251970161.13061.99
52455151-245515159.56460.43
62483886-248388660.26161.13
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
240min12777591-277759167.38668.721.1268.5369.881.11
22854316-285431669.24870.41
32834401-283440168.76569.92
42845162-284516269.02670.19
52817713-281771368.36069.52
62865320-286532069.51570.69
360min13286940-328694079.74481.341.3681.2282.841.35
23396299-339629982.39783.91
33354497-335449781.38382.88
43389795-338979582.23983.75
53308752-330875280.27381.78
63379835-337983581.99783.52
480min13639212-363921288.29088.851.2690.1790.761.25
23689089-368908989.50091.42
33637844-363784488.25790.16
43717357-371735790.18692.11
53594858-359485887.21489.12
63696343-369634389.67691.61
600min13785354-378535491.83693.231.4594.1595.581.44
23862089-386208993.69796.07
33832082-383208292.96995.32
43896586-389658694.53496.90
53774088-377408891.56293.90
63906857-390685794.78397.16
720min13809855-380985592.43094.781.9995.2197.601.96
23927051-392705195.27398.11
33886582-388658294.29197.11
43936063-393606395.49298.33
53849137-384913793.38396.18
64032425-403242597.830100.68
极限13899401-389940194.60295.611.7797.8498.901.74
23927975-392797595.29698.61
33872289-387228993.94597.23
44035394-403539497.902101.22
53891285-389128594.40597.67
64018845-401884597.500100.84
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%
1 12.611659516552165371675016752166370.64
212.741677216651167120.52
单位质量响应值RSD%判断
1319.351311.770.41数据可信
中间条件6月-供试品溶液-2025081922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%
5min117322-1732284.69187.734.1684.6987.734.16
217773-1777386.89686.90
316906-1690682.65782.66
418601-1860190.94490.94
518240-1824089.17989.18
618819-1881992.01092.01
10min118230-1823089.13089.341.6289.5589.781.62
218092-1809288.45688.89
318027-1802788.13888.55
418849-1884992.15792.61
518207-1820789.01889.46
618229-1822989.12589.59
15min118075-1807588.37289.881.4389.2490.761.43
218581-1858190.84691.72
318146-1814688.72089.57
418574-1857490.81291.73
518235-1823589.15590.05
618690-1869091.37992.28
20min117890-1789087.46890.013.3188.7891.343.28
217907-1790787.55188.88
318555-1855590.71992.02
419420-1942094.94896.32
517972-1797287.86989.21
618711-1871191.48292.84
30min118270-1827089.32690.691.7691.0792.481.75
218503-1850390.46592.23
318196-1819688.96490.72
418526-1852690.57792.42
518703-1870391.44393.22
619098-1909893.37495.19
45min118351-1835189.72290.801.3991.9293.041.37
218271-1827189.33191.55
318916-1891692.48494.68
418763-1876391.73694.03
518431-1843190.11392.35
618703-1870391.44393.73
60min118125-1812588.61790.381.6291.2693.081.61
218451-1845190.21192.88
318253-1825389.24391.90
418457-1845790.24093.00
518670-1867091.28193.97
618960-1896092.69995.44
120min117974-1797487.87989.981.9290.9793.121.91
218390-1839089.91393.03
318090-1809088.44691.55
418734-1873491.59494.80
518351-1835189.72292.86
618880-1888092.30895.52
180min117964-1796487.83089.891.8291.3693.481.79
218377-1837789.84993.42
318363-1836389.78093.33
418972-1897292.75896.42
518210-1821089.03292.62
618421-1842190.06493.73
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
240min117829-1782987.17089.952.1091.1393.992.06
218079-1807988.39292.41
318348-1834889.70793.70
418595-1859590.91595.04
518765-1876591.74695.78
618771-1877191.77595.89
360min117935-1793587.68888.961.4592.0993.451.41
218276-1827689.35593.81
318396-1839689.94294.39
418255-1825589.25293.84
517821-1782187.13191.62
618488-1848890.39294.97
480min117827-1782787.16089.261.8792.0094.201.85
218093-1809388.46093.37
318130-1813088.64193.54
418804-1880491.93796.97
518199-1819988.97993.91
618483-1848390.36795.40
600min117600-1760086.05088.762.4191.3394.142.35
218263-1826389.29294.64
317722-1772286.64791.98
418611-1861190.99396.48
518092-1809288.45693.83
618635-1863591.11096.59
720min117336-1733684.75987.992.6590.4693.822.53
218021-1802188.10893.90
318548-1854890.68596.46
418019-1801988.09994.04
517591-1759186.00691.82
618469-1846990.29996.24
极限117445-1744585.29287.971.9891.4294.241.94
217966-1796687.83994.08
317757-1775786.81893.04
418441-1844190.16296.55
518245-1824589.20495.45
618098-1809888.48594.87
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%
110.204196676422406042290054222997422784142201160.32
210.274266029429240542792170.44
单位质量响应值RSD%判断
413736.86416671.570.50数据可信
中间条件6月-供试品溶液-2025081922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%
5min1188036-1880364.5294.946.734.534.946.72
2195985-1959854.7204.72
3204160-2041604.9174.92
4212034-2120345.1075.11
5228031-2280315.4925.49
6203172-2031724.8934.89
10min1365741-3657418.8099.032.898.839.052.86
2367138-3671388.8428.87
3386861-3868619.3179.34
4362540-3625408.7328.76
5382156-3821569.2049.23
6384450-3844509.2599.28
15min1499780-49978012.03712.412.9812.1012.482.99
2502912-50291212.11312.18
3524640-52464012.63612.71
4501576-50157612.08012.15
5534243-53424312.86712.94
6527289-52728912.70012.77
20min1625803-62580315.07215.472.3815.2015.612.40
2631457-63145715.20915.34
3652876-65287615.72415.86
4629305-62930515.15715.29
5661302-66130215.92716.07
6653993-65399315.75115.89
30min1830443-83044320.00120.361.4120.2020.571.43
2831055-83105520.01620.22
3853377-85337720.55320.77
4847931-84793120.42220.63
5858420-85842020.67520.89
6851513-85151320.50920.72
45min11079864-107986426.00826.531.7326.3126.841.72
21084222-108422226.11326.42
31105230-110523026.61926.94
41107197-110719726.66726.97
51099547-109954726.48226.80
61132943-113294327.28727.60
60min11284216-128421630.93031.601.8631.3632.051.85
21346591-134659132.43232.87
31328586-132858631.99932.45
41285285-128528530.95631.40
51315165-131516531.67632.13
61313512-131351231.63632.09
120min11927422-192742246.42247.551.3147.0148.151.31
21985000-198500047.80848.41
31996746-199674648.09148.70
41978354-197835447.64848.24
51964245-196424547.30947.92
61994199-199419948.03048.64
180min12390537-239053757.57658.991.2158.3959.821.21
22468078-246807859.44360.28
32463065-246306559.32360.17
42461524-246152459.28560.12
52448040-244804058.96159.81
62463471-246347159.33260.18
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
240min12772109-277210966.76667.791.4267.8768.931.40
22839122-283912268.38069.51
32834729-283472968.27469.42
42867723-286772369.06970.20
52807832-280783267.62668.77
62766825-276682566.63967.79
360min13325955-332595580.10581.090.9281.5582.560.91
23353379-335337980.76682.24
33363007-336300780.99782.48
43419624-341962482.36183.84
53374761-337476181.28182.76
63363399-336339981.00782.49
480min13617079-361707987.11789.251.9688.9691.121.93
23747193-374719390.25192.13
33819025-381902591.98193.87
43718544-371854489.56191.45
53679300-367930088.61590.50
63651528-365152887.94689.83
600min13861343-386134393.00093.501.0695.2895.821.04
23924407-392440794.51996.85
33896514-389651493.84796.20
43833923-383392392.33994.67
53930052-393005294.65596.99
63845708-384570892.62394.95
720min13860155-386015592.97194.931.0695.7197.721.05
23949814-394981495.13197.93
33962209-396220995.42998.25
43978223-397822395.81598.61
53951338-395133895.16797.97
63947555-394755595.07697.86
极限13952050-395205095.18494.981.1998.3998.251.15
23997849-399784996.28899.57
33984036-398403695.95599.25
43920211-392021194.41897.69
53938778-393877894.86598.14
63868505-386850593.17296.44
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%
1 12.611673716647166961694516791167630.69
212.741640316711165571.32
单位质量响应值RSD%判断
1329.341299.611.60数据可信
中间条件6月-供试品溶液-2025081922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%
5min117300-1730084.66385.762.4984.6685.762.49
217303-1730384.67884.68
317271-1727184.52184.52
417157-1715783.96483.96
517854-1785487.37587.37
618262-1826289.37189.37
10min117590-1759086.08387.311.4686.5187.741.47
217613-1761386.19586.62
317872-1787287.46387.89
417785-1778587.03787.46
517871-1787187.45887.89
618309-1830989.60190.05
15min117885-1788587.52687.571.5488.3888.431.54
217682-1768286.53387.39
317994-1799488.06088.92
417679-1767986.51887.37
517727-1772786.75387.63
618391-1839190.00390.90
20min118203-1820389.08287.610.9590.3788.910.93
217893-1789387.56588.85
317970-1797087.94289.24
417742-1774286.82688.11
517770-1777086.96388.27
617833-1783387.27288.62
30min118625-1862591.14888.911.8692.8890.651.84
217944-1794487.81589.54
318011-1801188.14389.88
417739-1773986.81288.53
518210-1821089.11790.86
618482-1848290.44892.23
45min118469-1846990.38488.691.9292.5890.881.90
217779-1777987.00889.17
317770-1777086.96389.14
418150-1815088.82390.98
517981-1798187.99690.18
618591-1859190.98193.21
60min118300-1830089.55788.031.7292.2090.661.67
218339-1833989.74892.35
318043-1804388.29990.91
417531-1753185.79488.39
517792-1779287.07189.70
617919-1791987.69390.38
120min118722-1872291.62288.931.9994.7192.001.94
218078-1807888.47191.52
317771-1777186.96890.03
418249-1824989.30892.34
517820-1782087.20890.27
618395-1839590.02293.15
180min118545-1854590.75688.802.4894.3192.312.41
218106-1810688.60892.10
317437-1743785.33488.83
418202-1820289.07892.55
517902-1790287.60991.11
618676-1867691.39794.97
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
240min118429-1842990.18887.891.9994.1991.851.91
218055-1805588.35892.29
317668-1766886.46490.38
418271-1827189.41593.34
517507-1750785.67689.61
617830-1783087.25791.29
360min118554-1855490.80088.532.2995.2692.922.22
218026-1802688.21692.59
317596-1759686.11290.46
418461-1846190.34594.71
517620-1762086.22990.60
618278-1827889.45093.92
480min118239-1823989.25989.090.9694.1793.930.88
218285-1828589.48494.30
318481-1848190.44395.22
418153-1815388.83893.66
518100-1810088.57893.38
617972-1797287.95292.87
600min118527-1852790.66887.952.4196.0293.232.32
217995-1799588.06593.33
317312-1731284.72289.96
417666-1766686.45491.72
518057-1805788.36893.61
618267-1826789.39694.75
720min118056-1805688.36387.221.5594.1792.951.52
217780-1778087.01292.72
317506-1750685.67191.33
417911-1791187.65393.35
517515-1751585.71691.40
618171-1817188.92694.73
极限118112-1811288.63787.221.9694.8993.381.88
218072-1807288.44194.58
317185-1718584.10190.19
417712-1771286.68092.81
517825-1782587.23393.34
618023-1802388.20294.45
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