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%
110.184301198430827742879214298541430245142996780.18
210.194219010423528642271480.28
单位质量响应值RSD%判断
422365.23414832.971.28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%
5min1166572-1665723.9804.277.823.984.277.81
2165814-1658143.9613.96
3189432-1894324.5264.53
4178331-1783314.2614.26
5200621-2006214.7934.79
6170614-1706144.0764.08
10min1335416-3354168.0138.595.848.038.625.86
2337802-3378028.0708.09
3360177-3601778.6058.63
4368320-3683208.8008.82
5391879-3918799.3629.39
6364662-3646628.7128.73
15min1462347-46234711.04612.115.4411.1112.185.44
2490573-49057311.72011.78
3536594-53659412.82012.89
4513029-51302912.25712.32
5531843-53184312.70612.78
6507889-50788912.13412.20
20min1589286-58928614.07915.214.6414.1915.344.65
2629558-62955815.04115.16
3629032-62903215.02815.16
4653418-65341815.61115.74
5677977-67797716.19816.33
6641426-64142615.32415.45
30min1784041-78404118.73220.334.3618.9220.534.35
2879167-87916721.00421.20
3846492-84649220.22420.43
4852054-85205420.35720.56
5890490-89049021.27521.49
6852532-85253220.36820.57
45min11061852-106185225.36926.723.6025.6527.023.60
21098951-109895126.25526.55
31115282-111528226.64526.95
41134988-113498827.11627.42
51183422-118342228.27328.59
61116310-111631026.67026.97
60min11291123-129112330.84632.072.8331.2532.502.84
21317529-131752931.47731.91
31324645-132464531.64732.09
41360690-136069032.50832.95
51395276-139527633.33533.80
61364281-136428132.59433.03
120min11929271-192927146.09247.921.9846.6548.522.00
22013948-201394848.11648.70
32005123-200512347.90548.50
42016809-201680948.18448.79
52029908-202990848.49749.13
62040553-204055348.75149.35
180min12264599-226459954.10459.524.5754.8960.364.55
22574414-257441461.50662.33
32513692-251369260.05560.89
42516509-251650960.12260.97
52557169-255716961.09461.97
62522324-252232460.26161.10
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
240min12824575-282457567.48268.661.0368.5469.801.05
22905048-290504869.40570.54
32898644-289864469.25270.39
42871229-287122968.59769.74
52859258-285925868.31169.49
62884778-288477868.92170.07
360min13302372-330237278.89781.701.8980.3083.181.89
23432234-343223482.00083.48
33427839-342783981.89583.38
43441230-344123082.21583.70
53415924-341592481.61083.13
63499159-349915983.59985.09
480min13642691-364269187.02889.061.3488.8290.941.36
23715229-371522988.76190.65
33712467-371246788.69590.59
43745472-374547289.48491.38
53778005-377800590.26192.19
63771627-377162790.10892.02
600min13900736-390073693.19393.771.1295.4296.101.11
23999306-399930695.54897.88
33872138-387213892.51094.85
43908239-390823993.37295.72
53923981-392398193.74896.13
63944856-394485694.24796.60
720min13963377-396337794.69096.002.3797.3898.802.32
24014036-401403695.90098.71
33904330-390433093.27996.08
44188648-4188648100.072102.89
54020602-402060296.05798.90
64017795-401779595.99098.82
极限13938503-393850394.09595.530.8597.2698.800.87
23992624-399262495.38898.68
34003387-400338795.64598.91
44041764-404176496.56299.88
54004912-400491295.68299.01
64009089-400908995.78299.09
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%
112.653273732669326713263632847327120.26
212.623256332401324820.36
单位质量响应值RSD%判断
2585.932573.850.34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%
5min133459-3345983.41890.764.8983.4290.764.89
235819-3581989.30289.30
336122-3612290.05790.06
438765-3876596.64796.65
537331-3733193.07293.07
636937-3693792.08992.09
10min135860-3586089.40494.613.5589.8295.063.55
236866-3686691.91292.36
338293-3829395.47095.92
439507-3950798.49798.98
538296-3829695.47795.94
638861-3886196.88697.35
15min136778-3677891.69394.262.3592.5695.192.36
237427-3742793.31194.22
338168-3816895.15896.09
439237-3923797.82398.80
537132-3713292.57593.52
638108-3810895.00995.95
20min137432-3743293.32394.851.8794.6596.251.87
238067-3806794.90696.28
337866-3786694.40595.81
439269-3926997.90399.37
538315-3831595.52596.93
637316-3731693.03494.45
30min137020-3702092.29695.852.5094.0997.722.48
239700-3970098.978100.82
338479-3847995.93497.81
439286-3928697.94699.90
538172-3817295.16897.05
638004-3800494.74996.63
45min137762-3776294.14694.951.5196.4097.301.52
237568-3756893.66296.00
337987-3798794.70797.06
439171-3917197.659100.10
538174-3817495.17397.53
637834-3783494.32696.68
60min138022-3802294.79494.921.7397.5297.751.72
237693-3769393.97496.78
337702-3770293.99696.83
439243-3924397.838100.77
537429-3742993.31696.15
638356-3835695.62798.46
120min137829-3782994.31394.291.8497.5197.591.81
237909-3790994.51397.79
338255-3825595.37598.67
438746-3874696.599100.02
536713-3671391.53194.83
637473-3747393.42696.73
180min135169-3516987.68193.953.6191.3597.723.53
238831-3883196.811100.56
338349-3834995.61099.39
438724-3872496.544100.45
537473-3747393.42697.18
637552-3755293.62397.40
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
240min138030-3803094.81494.222.0798.9298.462.01
237897-3789794.48398.72
338340-3834095.58799.84
438596-3859696.225100.61
536407-3640790.76894.99
637469-3746993.41697.66
360min137081-3708192.44893.861.8297.0398.571.80
237680-3768093.94298.65
337904-3790494.50099.23
438392-3839295.717100.59
536614-3661491.28495.96
638212-3821295.26899.98
480min137166-3716692.66092.870.9697.7098.050.99
237127-3712792.56397.74
337242-3724292.85098.05
437920-3792094.54099.89
536857-3685791.89097.03
637187-3718792.71397.90
600min137524-3752493.55392.511.7499.0698.161.66
237798-3779894.23699.88
336827-3682791.81597.48
437498-3749893.48899.31
536026-3602689.81895.41
636973-3697392.17997.83
720min137271-3727192.92292.343.0098.8998.442.89
236733-3673391.58197.69
336325-3632590.56396.69
439173-3917397.664103.95
536277-3627790.44496.49
636435-3643590.83896.95
极限136730-3673091.57391.601.9598.0198.171.91
236577-3657791.19297.76
336973-3697392.17998.76
438003-3800394.747101.52
536014-3601489.78896.29
636143-3614390.11096.68
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