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%
110.174066954407554040665534053994406648640659050.19
210.134128664413610741323860.13
单位质量响应值RSD%判断
399794.00407935.441.43数据可信
中间条件6月-供试品溶液-2025081721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%
5min1189574-1895744.6944.9315.684.694.9315.71
2165191-1651914.0914.09
3197653-1976534.8954.89
4174706-1747064.3264.33
5251440-2514406.2266.23
6216426-2164265.3595.36
10min1349516-3495168.6558.984.738.689.004.71
2347124-3471248.5968.62
3364137-3641379.0179.04
4388975-3889759.6329.65
5375926-3759269.3099.34
6349148-3491488.6468.67
15min1498410-49841012.34212.592.9712.4112.662.97
2492845-49284512.20412.27
3520077-52007712.87912.95
4531316-53131613.15713.23
5510180-51018012.63412.71
6496970-49697012.30712.38
20min1632080-63208015.65215.701.5815.7815.831.60
2614536-61453615.21815.34
3641710-64171015.89116.02
4638950-63895015.82215.96
5638989-63898915.82315.96
6636802-63680215.76915.90
30min1822784-82278420.37521.042.4720.5821.252.44
2876856-87685621.71421.91
3853959-85395921.14721.36
4852678-85267821.11521.33
5864113-86411321.39821.62
6827447-82744720.49020.70
45min11095628-109562827.13127.571.6427.4427.891.63
21104696-110469627.35627.67
31126258-112625827.89028.21
41142508-114250828.29228.61
51114398-111439827.59627.92
61097526-109752627.17827.49
60min11326478-132647832.84833.160.9633.2933.620.94
21355805-135580533.57434.02
31354663-135466333.54634.00
41329957-132995732.93433.40
51332978-133297833.00933.47
61335088-133508833.06133.51
120min11972906-197290648.85649.361.0149.4649.981.01
21997853-199785349.47350.09
31984189-198418949.13549.76
42023817-202381750.11650.74
52006018-200601849.67650.31
61973764-197376448.87749.49
180min12474212-247421261.27060.762.3862.1261.622.33
22550004-255000463.14664.01
32388068-238806859.13660.01
42410075-241007559.68160.56
52427433-242743360.11160.99
62471343-247134361.19962.06
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
240min12824955-282495569.95570.220.8671.1171.390.85
22865139-286513970.95072.13
32842891-284289170.39971.57
42860314-286031470.83172.01
52810922-281092269.60870.79
62810088-281008869.58770.75
360min13357890-335789083.15283.411.2484.6684.931.23
23440528-344052885.19986.73
33311942-331194282.01583.53
43377040-337704083.62785.16
53358081-335808183.15784.68
63364115-336411583.30784.82
480min13659910-365991090.63191.511.1692.5693.451.14
23767756-376775693.30295.26
33711313-371131391.90493.83
43687796-368779691.32293.27
53698420-369842091.58593.53
63647596-364759690.32692.26
600min13897792-389779296.52296.490.3898.9098.890.37
23886573-388657396.24498.67
33883579-388357996.17098.56
43922627-392262797.13799.54
53887539-388753996.26898.67
63901622-390162296.61799.00
720min13951385-395138597.84997.991.17100.71100.871.15
24037006-403700699.970102.87
33965744-396574498.205101.07
43953458-395345897.901100.79
53894420-389442096.43999.32
63940672-394067297.584100.45
极限13956116-395611697.96698.150.50101.32101.520.49
23978292-397829298.516101.92
33976357-397635798.468101.83
43985932-398593298.705102.08
53936007-393600797.468100.83
63949251-394925197.796101.15
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 12.613351033305332013336933134333040.45
2 12.693380833533336700.58
单位质量响应值RSD%判断
2641.082653.270.33数据可信
中间条件6月-供试品溶液-2025081721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%
5min136604-3660488.93989.931.3488.9489.931.34
236367-3636788.36488.36
337341-3734190.73090.73
437727-3772791.66891.67
536938-3693889.75189.75
637095-3709590.13290.13
10min137640-3764091.45791.860.7691.9092.310.77
237365-3736590.78891.23
337777-3777791.79092.24
438030-3803092.40492.86
538175-3817592.75793.21
637847-3784791.96092.41
15min138269-3826992.98592.461.5793.8993.371.56
237994-3799492.31793.21
338625-3862593.85094.76
438501-3850193.54994.47
536959-3695989.80290.71
637977-3797792.27693.19
20min138198-3819892.81292.261.1994.1893.631.17
237603-3760391.36792.72
338015-3801592.36893.75
438054-3805492.46393.85
537339-3733990.72592.09
638612-3861293.81895.19
30min137009-3700989.92391.691.2091.7593.521.17
238336-3833693.14894.96
337807-3780791.86293.71
437609-3760991.38193.23
538030-3803092.40494.22
637619-3761991.40693.25
45min137488-3748891.08792.120.9793.3794.410.96
237918-3791892.13294.41
338413-3841393.33595.64
438275-3827593.00095.31
537631-3763191.43593.71
637759-3775991.74694.04
60min137480-3748091.06891.771.7793.8094.521.73
238563-3856393.69996.44
338626-3862693.85296.62
437615-3761591.39694.17
537053-3705390.03092.76
637279-3727990.58093.34
120min137430-3743090.94690.700.7594.1493.910.73
237062-3706290.05293.26
337116-3711690.18393.42
437684-3768491.56494.79
537080-3708090.09693.28
637605-3760591.37294.58
180min137261-3726190.53690.342.2894.1894.012.19
238591-3859193.76797.43
336724-3672489.23192.92
436606-3660688.94492.63
536273-3627388.13591.77
637639-3763991.45495.12
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
240min136788-3678889.38790.541.2893.4994.651.25
237478-3747891.06395.19
337808-3780891.86596.00
437693-3769391.58595.72
536660-3666089.07593.15
637139-3713990.23994.36
360min136792-3679289.39690.150.8193.9494.720.79
237449-3744990.99395.58
336777-3677789.36093.96
437422-3742290.92795.52
536973-3697389.83694.36
637198-3719890.38394.96
480min136152-3615287.84189.961.4592.8394.981.39
237672-3767291.53496.57
337328-3732890.69995.74
436920-3692089.70794.75
537319-3731990.67795.65
636762-3676289.32394.35
600min137440-3744090.97190.211.1496.4095.681.08
236872-3687289.59195.09
337325-3732590.69196.19
437699-3769991.60097.09
536622-3662288.98394.41
636811-3681189.44294.92
720min136470-3647088.61489.231.4294.5095.151.37
237151-3715190.26996.21
337232-3723290.46596.41
437102-3710290.14996.10
535925-3592587.29093.16
636467-3646788.60794.53
极限136714-3671489.20788.960.8995.5495.320.86
236874-3687489.59595.99
337048-3704890.01896.42
436424-3642488.50294.90
536172-3617287.89094.19
636435-3643588.52994.89
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%
110.174067741406953040671994061224406292440657240.09
210.134108575410319241058840.10
单位质量响应值RSD%判断
399776.20405319.250.98数据可信
中间条件6月-供试品溶液-2025081721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%
5min1257707-2577076.4026.368.696.406.368.69
2288535-2885357.1687.17
3232212-2322125.7695.77
4265862-2658626.6056.60
5262932-2629326.5326.53
6229524-2295245.7025.70
10min1414618-41461810.30010.447.8610.3310.477.83
2414765-41476510.30410.34
3400182-4001829.9429.97
4471353-47135311.71011.74
5377080-3770809.3689.40
6442825-44282511.00111.03
15min1537602-53760213.35613.874.6013.4413.954.56
2539916-53991613.41313.50
3598053-59805314.85714.94
4535781-53578113.31013.40
5559260-55926013.89413.97
6579245-57924514.39014.47
20min1694632-69463217.25717.004.1117.4117.164.08
2709665-70966517.63017.78
3638125-63812515.85316.01
4713571-71357117.72717.89
5680554-68055416.90717.06
6670140-67014016.64816.80
30min1870212-87021221.61921.681.6821.8621.921.68
2874133-87413321.71621.96
3847035-84703521.04321.27
4879729-87972921.85522.10
5874877-87487721.73521.97
6891193-89119322.14022.38
45min11093635-109363527.16928.052.4827.5128.402.46
21173448-117344829.15229.50
31113002-111300227.65027.99
41146013-114601328.47028.83
51130218-113021828.07828.42
61118063-111806327.77628.13
60min11317299-131729932.72633.411.4633.2133.891.43
21355845-135584533.68334.18
31355177-135517733.66734.14
41322000-132200032.84233.34
51357741-135774133.73034.21
61360179-136017933.79134.28
120min11956520-195652048.60650.294.0549.2550.944.01
22168165-216816553.86454.53
32072493-207249351.48752.13
41961969-196196948.74149.40
51983239-198323949.27049.92
62003791-200379149.78050.44
180min12449567-244956760.85460.811.0461.7461.711.05
22489793-248979361.85462.79
32412495-241249559.93360.83
42455098-245509860.99261.90
52437129-243712960.54561.44
62441706-244170660.65961.57
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
240min12802116-280211669.61368.741.4670.8069.941.44
22805395-280539569.69470.94
32801270-280127069.59270.79
42728940-272894067.79569.01
52744021-274402168.17069.37
62719066-271906667.55068.76
360min13240690-324069080.50881.451.3882.0583.001.37
23331599-333159982.76784.36
33337128-333712882.90484.45
43264608-326460881.10382.65
53232282-323228280.29981.84
63265274-326527481.11982.67
480min13522861-352286187.51888.992.2689.4690.962.22
23588401-358840189.14691.15
33593560-359356089.27591.24
43503679-350367987.04289.00
53554225-355422588.29790.24
63730839-373083992.68594.64
600min13639834-363983490.42491.891.2392.8094.291.23
23739772-373977292.90795.36
33717859-371785992.36394.77
43693532-369353291.75894.15
53652165-365216590.73193.11
63749380-374938093.14695.56
720min13775520-377552093.79593.950.8996.6396.810.89
23797164-379716494.33397.25
33801698-380169894.44597.32
43737391-373739192.84895.70
53750925-375092593.18496.02
63826922-382692295.07297.95
极限13740265-374026592.91993.841.9596.2297.181.91
23869389-386938996.12799.52
33787935-378793594.10397.45
43669379-366937991.15894.47
53751972-375197293.21096.51
63845657-384565795.53798.89
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 12.613332033621333013346333435334280.39
2 12.693385433907338800.12
单位质量响应值RSD%判断
2650.912669.820.51数据可信
中间条件6月-供试品溶液-2025081721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%
5min136529-3652988.31889.051.6188.3289.041.61
236977-3697789.40189.40
336527-3652788.31388.31
436965-3696589.37289.37
536133-3613387.36087.36
637849-3784991.50991.51
10min137438-3743890.51590.490.9990.9690.940.99
237435-3743590.50890.96
337969-3796991.79992.24
437505-3750590.67791.12
536811-3681189.00089.44
637408-3740890.44390.90
15min137587-3758790.87690.410.8091.7791.310.79
237546-3754690.77791.68
337685-3768591.11392.01
437475-3747590.60591.51
537162-3716289.84890.73
636910-3691089.23990.15
20min137890-3789091.60890.431.5692.9691.781.54
237590-3759090.88392.24
337049-3704989.57590.93
437790-3779091.36792.72
537719-3771991.19592.53
636380-3638087.95889.31
30min137713-3771391.18090.670.6192.9992.470.61
237483-3748390.62492.43
337397-3739790.41692.22
437837-3783791.48093.29
537320-3732090.23092.02
637264-3726490.09591.89
45min136638-3663888.58189.530.7790.8491.780.75
237185-3718589.90492.16
336749-3674988.85091.11
437395-3739590.41292.68
537088-3708889.66991.91
637119-3711989.74491.99
60min136429-3642988.07689.741.5090.7892.441.45
236684-3668488.69391.40
338026-3802691.93794.64
437055-3705589.58992.31
537184-3718489.90192.59
637328-3732890.25092.94
120min137215-3721589.97691.732.8893.1294.882.79
239910-3991096.49299.65
338547-3854793.19796.36
437210-3721089.96493.13
537442-3744290.52593.66
637315-3731590.21893.36
180min136802-3680288.97889.241.2692.5792.851.22
236888-3688889.18692.82
336623-3662388.54592.17
437825-3782591.45195.07
536765-3676588.88892.48
636562-3656288.39891.99
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
240min137040-3704089.55387.921.9293.5991.971.84
235803-3580386.56290.64
337080-3708089.65093.72
436775-3677588.91392.99
536053-3605387.16791.20
635428-3542885.65689.70
360min136280-3628087.71687.831.9992.2092.321.91
235963-3596386.94991.46
337572-3757290.83995.36
436518-3651888.29192.81
536217-3621787.56392.03
635402-3540285.59390.06
480min135706-3570686.32886.771.2291.2591.701.14
235482-3548285.78690.74
336057-3605787.17792.15
435491-3549185.80890.77
535951-3595186.92091.83
636639-3663988.58493.48
600min134571-3457183.58485.001.2788.9490.371.21
234993-3499384.60489.98
335378-3537885.53590.94
435881-3588186.75192.14
534960-3496084.52489.87
635166-3516685.02290.36
720min135263-3526385.25784.471.1691.0390.261.10
234511-3451183.43989.24
335158-3515885.00390.84
435296-3529685.33791.16
535045-3504584.73090.49
634356-3435683.06488.83
极限134718-3471883.93984.620.7990.1490.840.75
235364-3536485.50191.72
335233-3523385.18491.44
434740-3474083.99290.24
534819-3481984.18390.37
635123-3512384.91891.10
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