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%
112.204303900430047343014794297963430371543015060.06
29.654396494439504343957680.03
单位质量响应值RSD%判断
352582.46455520.0018.02数据不可信!(响应值差异过大,请重新称样测定!)
长期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%
5min1191890-1918904.8274.818.564.834.808.58
2182682-1826824.5964.60
3195757-1957574.9254.92
4210330-2103305.2915.29
5163567-1635674.1154.11
6201839-2018395.0785.08
10min1368067-3680679.2609.415.279.289.435.29
2360136-3601369.0609.08
3400863-40086310.08510.11
4359183-3591839.0369.06
5358681-3586819.0249.04
6397093-3970939.99010.02
15min1520130-52013013.08512.883.4913.1612.953.48
2503711-50371112.67212.74
3528045-52804513.28413.36
4496295-49629512.48612.56
5489728-48972812.32012.39
6533317-53331713.41713.49
20min1642135-64213516.15516.154.9116.2916.294.90
2624693-62469315.71615.85
3675418-67541816.99217.13
4620096-62009615.60015.73
5606049-60604915.24715.37
6684158-68415817.21217.35
30min1845701-84570121.27621.282.2821.4921.492.30
2842660-84266021.19921.41
3870589-87058921.90222.13
4818498-81849820.59120.80
5833060-83306020.95821.16
6863522-86352221.72421.95
45min11105289-110528927.80627.672.2628.1328.002.27
21100308-110030827.68128.00
31132979-113297928.50328.84
41058717-105871726.63526.95
51090176-109017627.42627.73
61112572-111257227.99028.33
60min11316276-131627633.11433.052.1933.5833.512.20
21297943-129794332.65333.11
31344263-134426333.81834.30
41271369-127136931.98532.43
51305498-130549832.84333.29
61346203-134620333.86734.34
120min11972107-197210749.61349.591.9350.2450.211.93
21963303-196330349.39250.01
32032196-203219651.12551.77
41915833-191583348.19848.81
51958054-195805449.26049.87
61984623-198462349.92850.57
180min12529089-252908963.62662.011.9064.5062.891.90
22430604-243060461.14862.01
32511478-251147863.18364.09
42428351-242835161.09161.94
52419574-241957460.87161.73
62470662-247066262.15663.05
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
240min12846273-284627371.60571.151.0572.8072.331.03
22875635-287563572.34473.51
32814315-281431570.80172.02
42804124-280412470.54571.70
52797104-279710470.36871.53
62831401-283140171.23172.44
360min13330684-333068483.79284.921.3585.3486.461.34
23425854-342585486.18687.72
33437808-343780886.48788.06
43347277-334727784.20985.72
53344166-334416684.13185.64
63367311-336731184.71386.28
480min13743999-374399994.19093.431.4096.1695.401.40
23727462-372746293.77495.74
33785476-378547695.23397.24
43652604-365260491.89193.82
53655222-365522291.95693.89
63719009-371900993.56195.55
600min13896907-389690798.03797.810.92100.48100.240.93
23870824-387082497.38099.81
33927654-392765498.810101.29
43854621-385462196.97399.36
53848047-384804796.80799.20
63928908-392890898.842101.30
720min14007924-4007924100.830100.001.09103.76102.921.09
24014127-4014127100.986103.90
33991802-3991802100.424103.40
43914284-391428498.474101.35
53926807-392680798.789101.67
63994572-3994572100.494103.44
极限13968996-396899699.850100.352.74103.29103.772.67
23973918-397391899.974103.40
33970164-397016499.880103.36
43874181-387418197.465100.83
53947372-394737299.306102.68
64197678-4197678105.603109.05
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)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%
113.811663716504166141653316559165690.34
215.901656416560165620.02
单位质量响应值RSD%判断
1199.781041.649.98数据不可信!(响应值差异过大,请重新称样测定!)
长期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%
5min118391-183910.5300.533.450.530.533.66
218025-180250.5200.52
319169-191690.5530.55
418907-189070.5450.55
517468-174680.5040.50
618870-188700.5440.54
10min118856-188560.5440.542.050.550.551.89
218666-186660.5380.54
319168-191680.5530.56
418924-189240.5460.55
518147-181470.5230.53
619135-191350.5520.55
15min118943-189430.5460.551.620.550.551.48
219078-190780.5500.56
319383-193830.5590.56
418943-189430.5460.55
518514-185140.5340.54
619267-192670.5560.56
20min119094-190940.5510.552.900.560.562.87
219093-190930.5510.56
319952-199520.5750.58
419276-192760.5560.56
518195-181950.5250.53
619186-191860.5530.56
30min119009-190090.5480.561.330.560.571.33
219389-193890.5590.57
319575-195750.5650.58
419215-192150.5540.57
518945-189450.5460.56
619431-194310.5600.57
45min118995-189950.5480.551.450.560.561.49
219321-193210.5570.57
319609-196090.5660.58
418848-188480.5440.56
519108-191080.5510.56
619002-190020.5480.56
60min118958-189580.5470.561.330.560.571.43
219493-194930.5620.58
319392-193920.5590.58
419028-190280.5490.57
519284-192840.5560.57
619618-196180.5660.58
120min119020-190200.5490.561.890.570.581.80
219545-195450.5640.58
319714-197140.5690.59
418741-187410.5400.56
519302-193020.5570.58
619369-193690.5590.58
180min119302-193020.5570.561.260.580.581.31
219439-194390.5610.58
319593-195930.5650.59
419072-190720.5500.57
518934-189340.5460.57
619256-192560.5550.58
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
240min118921-189210.5460.551.630.570.581.70
219831-198310.5720.60
319144-191440.5520.58
419139-191390.5520.58
519192-191920.5530.58
619096-190960.5510.58
360min118627-186270.5370.552.240.560.582.44
219758-197580.5700.60
319550-195500.5640.59
419114-191140.5510.58
519042-190420.5490.58
618848-188480.5440.57
480min119280-192800.5560.551.690.590.581.70
219555-195550.5640.59
319231-192310.5550.59
418737-187370.5400.57
518831-188310.5430.57
618904-189040.5450.58
600min118560-185600.5350.551.570.570.581.55
219336-193360.5580.59
319246-192460.5550.59
418782-187820.5420.57
519025-190250.5490.58
618867-188670.5440.58
720min118972-189720.5470.541.420.580.581.31
219283-192830.5560.59
318995-189950.5480.58
418635-186350.5370.57
518936-189360.5460.58
618557-185570.5350.57
极限118534-185340.5350.541.650.570.581.71
219186-191860.5530.59
318788-187880.5420.58
418465-184650.5330.57
518614-186140.5370.57
619192-191920.5530.59
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%
112.204271829427135142919674279517428063642790600.20
29.654332065432704743295560.09
单位质量响应值RSD%判断
350742.62448658.6517.33数据不可信!(响应值差异过大,请重新称样测定!)
长期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%
5min1224629-2246295.7065.218.685.715.218.66
2202486-2024865.1435.14
3220248-2202485.5945.59
4198458-1984585.0415.04
5209112-2091125.3115.31
6175059-1750594.4464.45
10min1372929-3729299.4729.403.629.509.433.63
2363796-3637969.2409.27
3385239-3852399.7859.81
4380844-3808449.6739.70
5370248-3702489.4049.43
6347677-3476778.8318.85
15min1539913-53991313.71413.322.0513.7913.402.06
2516091-51609113.10913.18
3526373-52637313.37013.45
4520566-52056613.22213.30
5533028-53302813.53913.61
6511311-51131112.98713.05
20min1642457-64245716.31816.252.3116.4616.392.30
2624007-62400715.85015.99
3644711-64471116.37616.52
4660384-66038416.77416.91
5646130-64613016.41216.55
6621181-62118115.77815.91
30min1837198-83719821.26521.311.5021.4921.531.51
2839099-83909921.31321.53
3848806-84880621.56021.79
4849235-84923521.57021.79
5843625-84362521.42821.65
6815376-81537620.71020.92
45min11093447-109344727.77327.921.2528.1128.251.24
21122576-112257628.51328.84
31108382-110838228.15328.49
41091085-109108527.71328.04
51093608-109360827.77728.11
61086015-108601527.58527.90
60min11324098-132409833.63233.431.3834.1033.901.38
21306592-130659233.18733.65
31347837-134783734.23534.71
41315494-131549433.41333.88
51308230-130823033.22933.70
61295646-129564632.90933.36
120min11984347-198434750.40250.130.7451.0450.760.75
21968573-196857350.00150.63
31991110-199111050.57451.22
41973818-197381850.13550.77
51975022-197502250.16550.80
61948893-194889349.50150.12
180min12435735-243573561.86762.350.6962.7663.240.69
22480376-248037663.00163.88
32465048-246504862.61263.51
42453181-245318162.31063.20
52456618-245661862.39863.28
62437704-243770461.91762.78
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
240min12862124-286212472.69772.261.3873.9073.461.35
22834807-283480772.00473.20
32814698-281469871.49372.70
42820147-282014771.63172.83
52820790-282079071.64772.85
62916874-291687474.08875.26
360min13361429-336142985.38085.610.7386.9487.170.72
23402874-340287486.43287.99
33367215-336721585.52787.10
43365622-336562285.48687.04
53391874-339187486.15387.71
63333911-333391184.68186.22
480min13677252-367725293.40194.601.7795.3996.581.74
23805187-380518796.65198.64
33810050-381005096.77498.77
43680584-368058493.48695.47
53704994-370499494.10696.09
63668039-366803993.16795.13
600min13900567-390056799.07499.091.03101.53101.551.02
23968453-3968453100.798103.27
33911824-391182499.360101.84
43865374-386537498.180100.63
53906178-390617899.216101.67
63855748-385574897.935100.37
720min13979902-3979902101.089101.350.72104.04104.310.71
24041363-4041363102.650105.63
33976860-3976860101.011103.99
43997671-3997671101.540104.48
53989077-3989077101.322104.28
63957203-3957203100.512103.43
极限13960557-3960557100.597100.981.32104.06104.441.29
24004873-4004873101.723105.21
34013389-4013389101.939105.42
43896641-389664198.974102.42
54036818-4036818102.534105.99
63941090-3941090100.103103.53
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)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%
113.811644316452165471651816461164840.28
215.901650216657165800.67
单位质量响应值RSD%判断
1193.631042.779.54数据不可信!(响应值差异过大,请重新称样测定!)
长期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%
5min118594-185940.5370.532.480.540.532.57
218852-188520.5450.54
318268-182680.5280.53
418920-189200.5470.55
518210-182100.5260.53
617735-177350.5120.51
10min118633-186330.5380.541.570.540.541.93
219069-190690.5510.55
319012-190120.5490.55
419136-191360.5530.56
518751-187510.5420.54
618381-183810.5310.53
15min119136-191360.5530.551.560.560.561.51
219657-196570.5680.57
318959-189590.5480.55
418966-189660.5480.55
518834-188340.5440.55
618964-189640.5480.55
20min119030-190300.5500.550.660.560.560.93
219063-190630.5510.56
318816-188160.5440.55
418884-188840.5460.55
518976-189760.5480.56
619191-191910.5540.56
30min119190-191900.5540.550.760.570.560.97
219224-192240.5550.57
319185-191850.5540.57
419112-191120.5520.56
518842-188420.5440.56
618993-189930.5490.56
45min118982-189820.5480.551.570.560.561.49
219258-192580.5560.57
318981-189810.5480.56
418901-189010.5460.56
518743-187430.5420.56
619575-195750.5660.58
60min119042-190420.5500.551.240.570.571.45
219286-192860.5570.57
319282-192820.5570.57
419217-192170.5550.57
518645-186450.5390.55
619129-191290.5530.57
120min119454-194540.5620.551.030.580.571.11
219056-190560.5510.57
319173-191730.5540.57
419114-191140.5520.57
518864-188640.5450.56
619239-192390.5560.57
180min119296-192960.5580.551.110.580.580.96
219293-192930.5570.58
318917-189170.5470.57
418911-189110.5460.57
518978-189780.5480.57
619353-193530.5590.58
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
240min119339-193390.5590.552.060.580.582.03
219305-193050.5580.58
318765-187650.5420.57
418958-189580.5480.57
518816-188160.5440.57
619808-198080.5720.60
360min119083-190830.5510.550.870.580.580.96
219180-191800.5540.58
318821-188210.5440.57
418938-189380.5470.57
518738-187380.5410.57
619014-190140.5490.58
480min118638-186380.5380.552.270.570.582.03
219438-194380.5620.59
319062-190620.5510.58
418874-188740.5450.58
518273-182730.5280.56
619253-192530.5560.59
600min119138-191380.5530.541.960.590.581.71
219332-193320.5590.59
318570-185700.5370.57
418528-185280.5350.57
518459-184590.5330.57
618936-189360.5470.58
720min118827-188270.5440.541.410.580.581.31
218874-188740.5450.58
318456-184560.5330.57
418909-189090.5460.58
518403-184030.5320.57
619060-190600.5510.59
极限118727-187270.5410.541.800.580.581.46
218782-187820.5430.58
318672-186720.5390.58
417918-179180.5180.56
518453-184530.5330.57
618808-188080.5430.58
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