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%
110.184201465423172242442354208272421714942205690.42
210.194282274429267942874760.18
单位质量响应值RSD%判断
414594.20420753.291.05数据可信
供试品溶液-2025081521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%
5min1155832-1558323.7313.805.153.733.805.14
2160131-1601313.8343.83
3160294-1602943.8383.84
4144838-1448383.4683.47
5169581-1695814.0604.06
6161928-1619283.8773.88
10min1341493-3414938.1778.192.238.208.212.19
2348795-3487958.3518.37
3344637-3446378.2528.27
4350253-3502538.3868.40
5329760-3297607.8967.92
6337680-3376808.0858.10
15min1472642-47264211.31711.713.8211.3811.773.79
2524671-52467112.56212.62
3490391-49039111.74211.80
4479573-47957311.48311.54
5478571-47857111.45911.52
6488001-48800111.68411.74
20min1594308-59430814.23014.592.0514.3514.712.05
2622564-62256414.90615.03
3625069-62506914.96615.09
4608561-60856114.57114.69
5598100-59810014.32114.44
6607538-60753814.54714.66
30min1802404-80240419.21219.571.9419.4019.761.95
2845316-84531620.24020.44
3817362-81736219.57019.76
4815894-81589419.53519.72
5802096-80209619.20519.39
6820622-82062219.64919.84
45min11079054-107905425.83626.001.5126.1226.291.52
21111272-111127226.60826.91
31070383-107038325.62925.92
41100500-110050026.35026.64
51073128-107312825.69425.98
61080160-108016025.86326.15
60min11280171-128017130.65231.041.8531.0631.461.85
21331594-133159431.88332.32
31288218-128821830.84431.26
41287680-128768030.83131.25
51271023-127102330.43330.85
61320204-132020431.61032.03
120min11929770-192977046.20546.471.0846.7747.051.08
21959131-195913146.90847.50
31939893-193989346.44847.02
41950309-195030946.69747.27
51905806-190580645.63246.20
61960996-196099646.95347.53
180min12449051-244905158.63958.451.0759.4459.261.07
22480516-248051659.39260.22
32428290-242829058.14258.95
42458205-245820558.85859.66
52410940-241094057.72658.52
62421183-242118357.97158.78
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
240min12775170-277517066.44767.321.2067.5468.421.20
22868218-286821868.67569.80
32780631-278063166.57867.68
42806142-280614267.18968.29
52818623-281862367.48868.57
62821008-282100867.54568.65
360min13387086-338708681.09880.370.6082.5281.810.59
23359862-335986280.44781.91
33338341-333834179.93181.36
43365248-336524880.57682.01
53331132-333113279.75981.18
63359322-335932280.43481.87
480min13678349-367834988.07288.330.9589.9090.160.95
23746174-374617489.69691.57
33671808-367180887.91689.75
43671144-367114487.90089.74
53651679-365167987.43489.25
63714427-371442788.93690.78
600min13853067-385306792.25693.120.5494.5295.400.53
23898634-389863493.34795.66
33891086-389108693.16695.44
43913416-391341693.70195.98
53880382-388038292.91095.17
63897796-389779693.32795.61
720min13925590-392559093.99294.911.1596.7297.651.13
23998693-399869395.74298.53
33963740-396374094.90697.64
43899553-389955393.36996.12
53972579-397257995.11797.84
64022591-402259196.31599.07
极限14012074-401207496.06395.400.5599.2698.620.52
23979347-397934795.27998.54
33955873-395587394.71797.93
44005600-400560095.90899.12
53986082-398608295.44098.64
63966762-396676294.97898.21
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%
112.653206732362323103210132565322810.64
212.623259832940327690.74
单位质量响应值RSD%判断
2551.862596.591.23数据可信
供试品溶液-2025081521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%
5min135873-3587389.64092.332.2689.6492.332.26
235919-3591989.75589.75
337538-3753893.80093.80
437662-3766294.11094.11
537517-3751793.74893.75
637196-3719692.94692.95
10min138257-3825795.59796.560.9596.0497.030.95
238454-3845496.08996.54
339060-3906097.60398.07
438902-3890297.20897.68
538939-3893997.30197.77
638255-3825595.59296.06
15min137488-3748893.67596.961.7494.6097.901.74
239132-3913297.78398.71
339022-3902297.50898.47
439048-3904897.57398.53
539374-3937498.38899.34
638746-3874696.81997.76
20min137629-3762994.02895.811.3095.4297.241.30
237858-3785894.60096.02
338514-3851496.23997.68
438476-3847696.14497.59
538931-3893197.28198.73
638643-3864396.56197.99
30min137573-3757393.88896.081.2495.7597.991.24
238534-3853496.28998.18
338374-3837495.88997.81
438518-3851896.24998.17
538940-3894097.30399.24
638766-3876696.86998.78
45min138167-3816795.37296.271.1297.7198.661.11
238056-3805695.09597.47
338228-3822895.52497.93
438834-3883497.03999.44
539102-3910297.708100.13
638767-3876796.87199.27
60min137325-3732593.26895.541.3996.0898.411.38
238039-3803995.05297.90
338314-3831495.73998.62
438630-3863096.52999.42
538244-3824495.56498.47
638854-3885497.08999.97
120min137345-3734593.31894.881.1196.6098.231.11
237660-3766094.10597.43
337950-3795094.83098.19
438136-3813695.29498.67
538214-3821495.48998.88
638526-3852696.26999.63
180min137858-3785894.60095.240.8698.3499.060.85
237837-3783794.54798.34
338206-3820695.46999.30
438610-3861096.479100.33
538336-3833695.79499.66
637828-3782894.52598.37
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
240min136947-3694792.32394.351.4896.5498.651.45
237663-3766394.11298.38
337622-3762294.01098.32
438038-3803895.05099.38
538632-3863296.534100.88
637645-3764594.06798.39
360min137981-3798194.90794.290.9799.5999.060.94
237171-3717192.88397.62
337790-3779094.43099.21
437981-3798194.90799.72
538067-3806795.12299.95
637408-3740893.47598.26
480min136889-3688992.17893.610.8197.3398.850.81
237682-3768294.16099.36
337604-3760493.96599.22
437392-3739293.43598.72
537694-3769494.19099.49
637506-3750693.72098.98
600min136683-3668391.66493.071.2397.2898.781.21
236797-3679791.94997.62
337434-3743493.54099.27
437645-3764594.06799.82
537802-3780294.460100.23
637122-3712292.76198.48
720min136367-3636790.87491.911.5196.9598.081.46
236419-3641991.00497.14
336810-3681091.98198.17
436278-3627890.65296.87
537725-3772594.267100.51
637089-3708992.67898.87
极限136686-3668691.67192.131.3898.2098.761.33
236418-3641891.00197.59
336727-3672791.77498.43
437286-3728693.17099.84
537677-3767794.147100.86
636417-3641790.99997.65
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%
110.184222439423357342204374215305423497742253460.21
210.194264639426415542643970.01
单位质量响应值RSD%判断
415063.46418488.420.59数据可信
供试品溶液-2025081521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%
5min1159095-1590953.8174.408.973.824.408.96
2181018-1810184.3434.34
3171395-1713954.1124.11
4193606-1936064.6454.65
5188806-1888064.5304.53
6205194-2051944.9234.92
10min1347903-3479038.3488.755.628.378.785.61
2376035-3760359.0239.04
3378455-3784559.0819.10
4345295-3452958.2858.31
5347600-3476008.3408.36
6393475-3934759.4419.47
15min1511481-51148112.27312.512.7912.3312.572.81
2524803-52480312.59212.66
3513571-51357112.32312.39
4508840-50884012.20912.27
5520611-52061112.49212.56
6548337-54833713.15713.23
20min1609120-60912014.61515.454.5514.7415.584.52
2683054-68305416.38916.52
3626832-62683215.04015.17
4623798-62379814.96715.09
5672368-67236816.13316.26
6649434-64943415.58315.72
30min1837792-83779220.10220.682.0020.3020.882.01
2886323-88632321.26721.48
3860688-86068820.65120.85
4848619-84861920.36220.56
5872870-87287020.94421.15
6864391-86439120.74020.96
45min11099505-109950526.38226.842.9726.6827.152.95
21140003-114000327.35327.67
31141044-114104427.37827.68
41066573-106657325.59125.89
51155685-115568527.73028.04
61109988-110998826.63326.95
60min11295897-129589731.09432.263.2231.5232.703.20
21366224-136622432.78133.24
31328090-132809031.86632.31
41318664-131866431.64032.07
51418774-141877434.04234.49
61338325-133832532.11232.56
120min11954594-195459446.89947.791.9047.4848.391.89
22022523-202252348.52949.15
32003936-200393648.08348.68
41972918-197291847.33847.93
52043502-204350249.03249.65
61952043-195204346.83847.45
180min12401297-240129757.61758.832.1158.4359.682.10
22496656-249665659.90560.77
32516478-251647860.38161.22
42435822-243582258.44559.27
52471830-247183059.30960.18
62389637-238963757.33758.18
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
240min12731681-273168165.54467.162.1066.6568.302.09
22780570-278057066.71767.88
32841591-284159168.18169.33
42788033-278803366.89668.01
52892751-289275169.40970.57
62758936-275893666.19867.33
360min13233925-323392577.59579.811.8779.0381.291.86
23315638-331563879.55681.05
33364853-336485380.73782.22
43298585-329858579.14780.60
53417295-341729581.99583.50
63328267-332826779.85981.32
480min13527512-352751284.64088.022.3686.4689.882.34
23654613-365461387.68989.58
33728657-372865789.46691.35
43678273-367827388.25790.10
53780561-378056190.71192.63
63639525-363952587.32789.19
600min13788237-378823790.89592.361.2793.1494.671.27
23816825-381682591.58193.91
33859157-385915792.59794.93
43825645-382564591.79394.08
53921141-392114194.08496.46
63884306-388430693.20095.50
720min13820534-382053491.67095.343.0594.3798.113.01
23955309-395530994.90497.69
33960262-396026295.02397.82
43946921-394692194.70397.45
54194015-4194015100.632103.48
63963048-396304895.09097.86
极限13780405-378040590.70793.121.5593.8696.371.56
23874516-387451692.96696.23
33918322-391832294.01797.29
43910787-391078793.83697.06
53950047-395004794.77898.12
63852135-385213592.42995.67
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%
112.653221732179322553241932511323160.45
212.623283432915328740.18
单位质量响应值RSD%判断
2554.622604.911.38数据可信
供试品溶液-2025081521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%
5min136897-3689792.00292.271.9792.0092.281.97
238269-3826995.42395.42
336474-3647490.94790.95
436359-3635990.66190.66
537424-3742493.31693.32
636615-3661591.29991.30
10min138703-3870396.50594.752.9496.9795.212.92
238515-3851596.03796.51
339214-3921497.77998.23
437310-3731093.03293.49
536130-3613090.09090.56
638111-3811195.02995.49
15min138614-3861496.28396.160.8197.2397.090.80
238321-3832195.55396.51
338515-3851596.03796.98
438411-3841195.77796.70
538357-3835795.64396.56
639159-3915997.64298.57
20min137584-3758493.71594.871.2195.1496.291.18
237850-3785094.37895.81
337529-3752993.57895.00
438362-3836295.65597.05
538649-3864996.37197.77
638319-3831995.54896.97
30min138207-3820795.26995.551.3697.1697.441.32
237510-3751093.53195.44
337988-3798894.72296.61
438640-3864096.34898.22
538671-3867196.42698.30
638899-3889996.99498.89
45min137789-3778994.22694.431.5196.6096.801.48
237746-3774694.11996.49
338146-3814695.11697.48
436853-3685391.89294.25
538491-3849195.97798.34
638205-3820595.26497.65
60min137167-3716792.67594.622.0095.5297.461.95
237779-3777994.20197.05
337221-3722192.81095.65
437798-3779894.24997.07
538966-3896697.161100.00
638751-3875196.62599.48
120min137246-3724692.87292.990.5596.1896.300.54
237509-3750993.52896.84
336979-3697992.20795.51
437222-3722292.81296.10
537529-3752993.57896.90
637268-3726892.92796.27
180min136811-3681191.78892.171.0795.5695.951.01
237330-3733093.08296.87
337501-3750193.50897.27
436997-3699792.25196.00
536484-3648490.97294.77
636661-3666191.41495.22
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
240min136344-3634490.62391.130.8994.8595.370.84
236022-3602289.82094.07
336902-3690292.01596.25
436801-3680191.76395.98
536643-3664391.36995.62
636576-3657691.20295.47
360min136076-3607689.95591.181.4994.6395.871.43
236200-3620090.26494.96
336941-3694192.11296.81
436017-3601789.80894.48
536827-3682791.82896.53
637333-3733393.08997.81
480min135825-3582589.32990.691.2894.4695.841.22
236166-3616690.17995.33
335936-3593689.60694.76
436540-3654091.11296.23
536816-3681691.80096.96
636936-3693692.09997.28
600min136517-3651791.05591.161.4496.6396.761.37
236191-3619190.24295.84
336193-3619390.24795.85
436406-3640690.77896.35
536454-3645490.89796.52
637591-3759193.73399.38
720min135923-3592389.57391.081.6995.6097.141.62
236385-3638590.72596.78
336042-3604289.87095.92
436216-3621690.30496.33
537262-3726292.91298.99
637330-3733093.08299.20
极限135200-3520087.77188.890.7994.2595.400.74
235574-3557488.70395.21
335745-3574589.13095.63
436047-3604789.88396.36
535585-3558588.73195.27
635740-3574089.11795.70
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