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%
110.224130724413792141283844130180413561941325660.10
210.414134610413599141353000.03
单位质量响应值RSD%判断
404360.67397243.041.26数据可信
加速6月-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%
5min1162787-1627874.0624.429.314.064.429.33
2154731-1547313.8613.86
3197526-1975264.9294.93
4190431-1904314.7524.75
5174015-1740154.3424.34
6184262-1842624.5984.60
10min1345260-3452608.6159.053.838.649.083.84
2367751-3677519.1769.20
3376368-3763689.3919.42
4370001-3700019.2329.26
5345376-3453768.6188.64
6372524-3725249.2959.32
15min1491695-49169512.26912.654.9512.3312.724.95
2505533-50553312.61412.68
3516681-51668112.89212.96
4551272-55127213.75513.83
5479900-47990011.97412.04
6496419-49641912.38712.46
20min1609757-60975715.21515.191.3215.3415.321.31
2593816-59381614.81714.95
3610257-61025715.22715.36
4616934-61693415.39415.53
5608462-60846215.18215.31
6613780-61378015.31515.45
30min1834979-83497920.83420.341.6721.0420.541.67
2803447-80344720.04820.25
3816962-81696220.38520.60
4826066-82606620.61220.83
5800352-80035219.97020.17
6808213-80821320.16620.37
45min11061364-106136426.48326.681.2326.7926.991.23
21065760-106576026.59326.90
31067820-106782026.64426.96
41092982-109298227.27227.59
51072149-107214926.75227.05
61054760-105476026.31826.63
60min11266080-126608031.59131.881.7732.0332.321.77
21266375-126637531.59932.03
31300927-130092732.46132.91
41310692-131069232.70433.16
51266645-126664531.60532.04
61254724-125472431.30831.75
120min11936964-193696448.33147.883.5248.9348.483.48
21950792-195079248.67649.27
31952774-195277448.72649.34
41964609-196460949.02149.64
51922675-192267547.97448.57
61784344-178434444.52345.12
180min12390277-239027759.64259.921.4060.4860.761.40
22437564-243756460.82261.66
32413023-241302360.21061.06
42436817-243681760.80361.67
52375627-237562759.27760.11
62355259-235525958.76859.59
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
240min12744326-274432668.47669.391.9169.6170.531.90
22764950-276495068.99170.13
32842859-284285970.93572.09
42830286-283028670.62171.79
52799059-279905969.84270.97
62704652-270465267.48668.60
360min13271450-327145081.62982.031.3483.1183.521.34
23275531-327553181.73183.22
33365254-336525483.97085.48
43295378-329537882.22683.75
53286373-328637382.00183.48
63231883-323188380.64282.09
480min13531631-353163188.12190.372.2790.0192.272.26
23625170-362517090.45592.35
33742374-374237493.38095.31
43693366-369336692.15794.09
53583522-358352289.41691.30
63554671-355467188.69690.55
600min13759917-375991793.81795.311.5296.1497.661.53
23825777-382577795.46197.81
33897882-389788297.26099.66
43872600-387260096.62999.02
53806480-380648094.97997.31
63755427-375542793.70596.00
720min13873845-387384596.66097.261.5099.46100.081.50
23916539-391653997.725100.55
33972894-397289499.131102.01
43951155-395115598.589101.46
53841536-384153695.85498.66
63831133-383113395.59498.36
极限13809889-380988995.06496.791.7498.34100.101.73
23917564-391756497.751101.06
33963465-396346598.896102.27
43930438-393043898.072101.44
53850570-385057096.07999.37
63803214-380321494.89898.14
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%
112.563534635404355453552735324354290.29
212.793541135383353970.06
单位质量响应值RSD%判断
2820.782767.551.35数据可信
加速6月-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%
5min136887-3688784.91982.643.1584.9282.643.15
234782-3478280.07380.07
334252-3425278.85378.85
436849-3684984.83284.83
535996-3599682.86882.87
636617-3661784.29884.30
10min137945-3794587.35585.391.9187.7885.801.92
236626-3662684.31884.72
336448-3644883.90984.30
437806-3780687.03587.46
536347-3634783.67684.09
637369-3736986.02986.45
15min137903-3790387.25885.521.6788.1286.361.67
236494-3649484.01584.84
337208-3720885.65886.47
437831-3783187.09387.95
536508-3650884.04784.88
636934-3693485.02885.88
20min137520-3752086.37785.411.2987.6786.681.29
236417-3641783.83785.08
336739-3673984.57985.82
437358-3735886.00487.30
536954-3695485.07486.33
637621-3762186.60987.89
30min137985-3798587.44785.701.5889.1887.401.58
236981-3698185.13686.80
336901-3690184.95286.62
437449-3744986.21387.94
536371-3637183.73185.41
637678-3767886.74088.45
45min137478-3747886.28085.731.1288.4587.861.13
236921-3692184.99887.08
336645-3664584.36286.45
437789-3778986.99689.15
537162-3716285.55287.65
637450-3745086.21588.36
60min137133-3713385.48685.031.1588.0887.581.15
236490-3649084.00586.52
336927-3692785.01187.52
437418-3741886.14288.73
536375-3637583.74186.27
637269-3726985.79988.37
120min137758-3775886.92484.832.3389.9587.812.26
237271-3727185.80388.74
336962-3696285.09288.03
437340-3734085.96288.98
536394-3639483.78486.73
635366-3536681.41884.42
180min137393-3739386.08485.141.4489.5488.541.42
237417-3741786.13989.50
336528-3652884.09387.45
436989-3698985.15488.61
536165-3616583.25786.62
637411-3741186.12689.54
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
240min136989-3698985.15485.410.8189.0489.240.80
236728-3672884.55388.34
337354-3735485.99489.78
437495-3749586.31990.20
536843-3684384.81888.60
637192-3719285.62189.46
360min137002-3700285.18484.251.0389.5088.501.01
236229-3622983.40587.62
336785-3678584.68488.90
436423-3642383.85188.16
536157-3615783.23987.44
636980-3698085.13389.40
480min136325-3632583.62684.021.1788.3788.701.13
236286-3628683.53688.17
336943-3694385.04889.68
436822-3682284.77089.50
535833-3583382.49387.11
636775-3677584.66189.36
600min136674-3667484.42983.840.8389.5988.930.84
236189-3618983.31288.36
336456-3645683.92788.99
436749-3674984.60289.75
535948-3594882.75887.79
636480-3648083.98289.10
720min136625-3662584.31683.101.2189.9088.611.19
236035-3603582.95888.42
336001-3600182.88088.36
436308-3630883.58689.16
535335-3533581.34686.79
636264-3626483.48589.02
极限136045-3604582.98182.470.9688.9988.400.95
235794-3579482.40388.28
336091-3609183.08788.98
436028-3602882.94288.93
535171-3517180.96986.82
635821-3582182.46588.42
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%
110.224145610413632941370714138164413671641387780.10
210.414258171435372743059491.57
单位质量响应值RSD%判断
404968.49413635.831.50数据可信
加速6月-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%
5min1168142-1681424.1084.248.064.114.258.07
2200798-2007984.9064.91
3170909-1709094.1764.18
4163589-1635893.9974.00
5163565-1635653.9974.00
6175048-1750484.2774.28
10min1348890-3488908.5258.845.218.558.865.21
2379406-3794069.2719.30
3391165-3911659.5589.58
4347582-3475828.4938.51
5353205-3532058.6308.65
6349381-3493818.5378.56
15min1501783-50178312.26112.421.4412.3212.481.45
2516320-51632012.61612.69
3502607-50260712.28112.35
4502176-50217612.27012.33
5508612-50861212.42812.49
6517722-51772212.65012.71
20min1614175-61417515.00715.442.4715.1315.572.46
2635594-63559415.53015.66
3646518-64651815.79715.93
4618478-61847815.11215.24
5624647-62464715.26315.39
6652795-65279515.95116.08
30min1823322-82332220.11820.381.5320.3220.581.52
2842633-84263320.58920.80
3819269-81926920.01820.23
4827697-82769720.22420.42
5852623-85262320.83321.04
6838408-83840820.48620.69
45min11066774-106677426.06626.821.7226.3727.121.70
21097878-109787826.82627.14
31108351-110835127.08227.39
41092635-109263526.69827.00
51123556-112355627.45427.76
61095427-109542726.76627.08
60min11269350-126935031.01632.001.7531.4532.441.74
21336610-133661032.65933.11
31304566-130456631.87732.32
41311035-131103532.03532.47
51324111-132411132.35432.80
61312921-131292132.08132.52
120min11925103-192510347.03947.881.1147.6248.481.12
21974606-197460648.24948.86
31964143-196414347.99348.60
41959167-195916747.87148.47
51987285-198728548.55849.16
61946872-194687247.57148.17
180min12431913-243191359.42359.860.8060.2460.700.80
22469718-246971860.34661.20
32434539-243453959.48760.33
42432108-243210859.42860.26
52457312-245731260.04360.89
62474058-247405860.45361.29
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
240min12788329-278832968.13268.740.8069.2569.880.81
22841957-284195769.44270.60
32806938-280693868.58669.73
42787984-278798468.12369.25
52826914-282691469.07470.22
62827011-282701169.07770.22
360min13319326-331932681.10681.490.5982.5682.980.59
23322575-332257581.18682.69
33361950-336195082.14883.63
43315011-331501181.00182.47
53354749-335474981.97283.47
63336984-333698481.53883.03
480min13679308-367930889.90290.171.1291.7792.061.11
23742195-374219591.43993.35
33654468-365446889.29591.19
43651388-365138889.22091.10
53741338-374133891.41893.32
63672621-367262189.73991.64
600min13827341-382734193.51993.720.8895.8396.060.87
23863300-386330094.39896.76
33780847-378084792.38394.72
43817600-381760093.28195.60
53866705-386670594.48196.84
63858801-385880194.28896.63
720min13883513-388351394.89296.853.3797.6799.663.29
24234155-4234155103.460106.30
33910081-391008195.54198.34
43930173-393017396.03298.82
53916124-391612495.68998.52
63907739-390773995.48498.30
极限13956631-395663196.67996.101.0199.9399.390.98
23919278-391927895.76699.12
33927231-392723195.96099.24
43863877-386387794.41297.68
53976339-397633997.160100.47
63953534-395353496.60399.90
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%
112.563555835551353543551735460354880.24
212.793690736743368250.32
单位质量响应值RSD%判断
2825.482879.201.34数据可信
加速6月-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%
5min136564-3656482.45982.492.4182.4682.492.41
238087-3808785.89385.89
335772-3577280.67380.67
435645-3564580.38680.39
536563-3656382.45782.46
636842-3684283.08683.09
10min137228-3722883.95683.661.3284.3784.071.31
236643-3664382.63783.07
336497-3649782.30882.71
436943-3694383.31483.72
537554-3755484.69185.10
637706-3770685.03485.45
15min136876-3687683.16284.491.7183.9985.321.71
237417-3741784.38285.23
337325-3732584.17584.99
436741-3674182.85883.68
538330-3833086.44187.28
638106-3810685.93686.78
20min137402-3740284.34984.070.7885.6085.320.78
236977-3697783.39084.65
337324-3732484.17385.41
436874-3687483.15884.39
537579-3757984.74886.02
637517-3751784.60885.88
30min136938-3693883.30283.611.4784.9785.281.46
237028-3702883.50585.19
336399-3639982.08783.74
436660-3666082.67584.32
537820-3782085.29186.98
637594-3759484.78286.47
45min137255-3725584.01784.081.0486.1086.171.04
237072-3707283.60485.70
336720-3672082.81184.88
437206-3720683.90785.97
537739-3773985.10987.23
637696-3769685.01287.13
60min136653-3665382.66083.761.1085.1786.271.09
237671-3767184.95587.47
336791-3679182.97185.45
437026-3702683.50185.98
537150-3715083.78086.32
637557-3755784.69887.24
120min137264-3726484.03783.580.6786.9686.510.66
236928-3692883.28086.22
336844-3684483.09085.99
436970-3697083.37486.27
537465-3746584.49187.45
636890-3689083.19486.16
180min137771-3777185.18183.721.4688.5287.071.43
237158-3715883.79887.16
336457-3645782.21785.53
436546-3654682.41885.73
537181-3718183.85087.24
637638-3763884.88188.26
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
240min137330-3733084.18683.450.8787.9587.220.86
237021-3702183.48987.27
336667-3666782.69186.41
436587-3658782.51186.24
537079-3707983.62087.42
637333-3733384.19388.00
360min137363-3736384.26182.900.9788.4587.090.94
236378-3637882.03986.23
336751-3675182.88187.02
436426-3642682.14886.29
536836-3683683.07287.29
636810-3681083.01487.24
480min137104-3710483.67782.831.3688.2887.421.32
237147-3714783.77488.38
336081-3608181.37085.92
436214-3621481.66986.22
537206-3720683.90788.54
636613-3661382.56987.21
600min136192-3619281.62081.311.3786.6586.331.34
236172-3617281.57586.60
335248-3524879.49184.45
435793-3579380.72085.68
536216-3621681.67486.73
636711-3671182.79087.85
720min135746-3574680.61481.973.3786.0587.393.17
238783-3878387.46392.89
335611-3561180.31085.66
435833-3583380.81086.17
535734-3573480.58786.05
636387-3638782.06087.53
极限136215-3621581.67281.091.3987.5186.921.34
235713-3571380.54086.41
335696-3569680.50186.26
435225-3522579.43985.21
536580-3658082.49588.36
636315-3631581.89787.78
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