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%
110.204154135415203941604644165999415755141580380.14
210.274164450416616441653070.03
单位质量响应值RSD%判断
407650.78405580.040.37数据可信
加速6月-供试品溶液-WK2170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%
5min1122958-1229583.0242.938.543.022.938.49
2128763-1287633.1673.17
3107559-1075592.6452.65
4117681-1176812.8942.89
5130308-1303083.2053.20
6106969-1069692.6312.63
10min1294419-2944197.2416.775.217.266.795.22
2278924-2789246.8606.88
3266651-2666516.5586.57
4255470-2554706.2836.30
5287115-2871157.0617.08
6268891-2688916.6136.63
15min1420508-42050810.34210.053.0710.3910.103.08
2414829-41482910.20210.25
3394777-3947779.7099.75
4398105-3981059.7919.84
5423507-42350710.41510.47
6399703-3997039.8309.88
20min1527883-52788312.98212.741.8913.0912.841.91
2519712-51971212.78112.88
3516757-51675712.70912.80
4500379-50037912.30612.40
5525966-52596612.93513.04
6517413-51741312.72512.82
30min1708451-70845117.42317.492.4517.5917.652.44
2725337-72533717.83918.00
3692756-69275617.03717.20
4699176-69917617.19517.35
5738672-73867218.16618.33
6702871-70287117.28617.44
45min1938718-93871823.08623.050.9723.3423.300.98
2941452-94145223.15423.41
3944824-94482423.23623.48
4919707-91970722.61922.86
5942502-94250223.17923.44
6936468-93646823.03123.28
60min11149364-114936428.26728.031.4328.6428.391.44
21151419-115141928.31728.69
31121377-112137727.57827.94
41117202-111720227.47627.83
51154803-115480328.40128.78
61143569-114356928.12428.48
120min11766390-176639043.44243.252.0343.9543.752.01
21788273-178827343.98044.49
31760222-176022243.29043.79
41743400-174340042.87643.37
51697038-169703841.73642.25
61795953-179595344.16944.67
180min12228936-222893654.81754.920.7155.5555.640.71
22247817-224781755.28256.01
32240506-224050655.10255.82
42213423-221342354.43655.14
52216427-221642754.51055.24
62250415-225041555.34556.07
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
240min12633394-263339464.76464.301.0565.7765.301.04
22622679-262267964.50165.51
32590576-259057663.71164.70
42600577-260057763.95764.94
52585142-258514263.57764.58
62655421-265542165.30666.30
360min13218596-321859679.15678.141.1580.4879.461.13
23170007-317000777.96179.29
33174383-317438378.06979.38
43189631-318963178.44479.74
53112736-311273676.55377.87
63199400-319940078.68480.01
480min13646663-364666389.68487.151.8991.4188.861.86
23480113-348011385.58887.31
33548271-354827187.26488.96
43499225-349922586.05887.75
53490318-349031885.83987.54
63596587-359658788.45290.17
600min13758576-375857692.43691.471.4694.6193.621.44
23729673-372967391.72593.87
33737095-373709591.90894.04
43611741-361174188.82590.95
53727982-372798291.68493.81
63751386-375138692.25994.42
720min13865246-386524695.06093.491.0797.6996.091.05
23744218-374421892.08394.69
33811918-381191893.74896.34
43814696-381469693.81696.38
53780264-378026492.97095.56
63791692-379169293.25195.87
极限13839881-383988194.43694.230.8997.5497.300.87
23776144-377614492.86895.94
33830056-383005694.19497.26
43817236-381723693.87996.91
53850111-385011194.68797.74
63876647-387664795.34098.43
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 12.613529135341354433546335507354090.26
2 12.743557535780356780.41
单位质量响应值RSD%判断
2808.012800.470.20数据可信
加速6月-供试品溶液-WK2170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%
5min125303-2530358.03758.183.1058.0458.183.09
225224-2522457.85657.86
326296-2629660.31460.31
424689-2468956.62956.63
526272-2627260.25960.26
624414-2441455.99856.00
10min132829-3282975.29979.515.9675.5979.805.94
232165-3216573.77674.07
336674-3667484.11884.42
433834-3383477.60477.89
535262-3526280.88081.18
637233-3723385.40085.68
15min133628-3362877.13282.535.5877.8083.225.56
234046-3404678.09078.75
337481-3748185.96986.69
435507-3550781.44182.11
536390-3639083.46784.17
638849-3884989.10789.81
20min133861-3386177.66682.856.4178.7283.956.38
233823-3382377.57978.63
338429-3842988.14489.30
435471-3547181.35982.44
535774-3577482.05483.18
639359-3935990.27791.43
30min133791-3379177.50682.875.5278.9584.395.51
234059-3405978.12079.56
337560-3756086.15087.74
435901-3590182.34583.83
536533-3653383.79585.33
638934-3893489.30290.91
45min133311-3331176.40583.016.2378.2384.946.20
234079-3407978.16679.99
338576-3857688.48190.50
436157-3615782.93284.83
536195-3619583.02084.97
638822-3882289.04591.10
60min133699-3369977.29583.015.6279.5085.365.61
234346-3434678.77981.00
337800-3780086.70189.17
435977-3597782.51984.83
536232-3623283.10485.47
639094-3909489.66992.16
120min133391-3339176.58882.836.7879.1885.586.71
234425-3442578.96081.57
338059-3805987.29590.19
436722-3672284.22886.95
534407-3440778.91881.70
639659-3965990.96593.91
180min132993-3299375.67582.696.3178.6585.866.27
234252-3425278.56381.57
337882-3788286.88990.22
435962-3596282.48585.63
536019-3601982.61685.79
639191-3919189.89193.29
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
240min133270-3327076.31182.576.0179.6786.155.98
234112-3411278.24281.64
337629-3762986.30990.08
436179-3617982.98386.54
535703-3570381.89185.48
639089-3908989.65793.51
360min133484-3348476.80182.396.2180.5486.396.17
233709-3370977.31781.11
337541-3754186.10790.31
436219-3621983.07587.05
535347-3534781.07485.07
639233-3923389.98894.28
480min133697-3369777.29082.046.0281.4186.455.99
233377-3337776.55680.73
337420-3742085.82990.46
435924-3592482.39886.79
535248-3524880.84785.25
638945-3894589.32794.07
600min132565-3256574.69381.005.8679.2085.825.84
233965-3396577.90582.46
336945-3694584.74089.80
434560-3456079.26984.07
535594-3559481.64186.45
638263-3826387.76392.96
720min132495-3249574.53380.215.5979.4285.445.59
232911-3291175.48780.44
336488-3648883.69289.18
435406-3540681.21086.41
535067-3506780.43285.65
637466-3746685.93591.57
极限132322-3232274.13681.887.2279.3987.507.08
233017-3301775.73081.06
336937-3693784.72190.63
435453-3545381.31886.92
537867-3786786.85592.47
638581-3858188.49294.55
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%
110.204153940416299241570434140346415386141536360.20
210.274146380414945241479160.06
单位质量响应值RSD%判断
407219.22403886.660.59数据可信
加速6月-供试品溶液-WK2170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%
5min1101677-1016772.5073.0614.412.513.0614.36
2125413-1254133.0923.09
3152115-1521153.7513.75
4108667-1086672.6802.68
5132391-1323913.2653.26
6124237-1242373.0633.06
10min1254713-2547136.2816.424.436.296.434.43
2269300-2693006.6406.66
3244272-2442726.0236.04
4252331-2523316.2226.24
5273878-2738786.7536.77
6267166-2671666.5886.60
15min1402319-4023199.9209.913.809.969.953.80
2403345-4033459.9469.99
3398974-3989749.8389.89
4377422-3774229.3079.35
5425343-42534310.48810.54
6403090-4030909.9399.99
20min1514886-51488612.69612.365.4912.7912.465.45
2514594-51459412.68912.79
3501772-50177212.37312.47
4491787-49178712.12712.22
5532715-53271513.13613.24
6452971-45297111.16911.27
30min1703631-70363117.35017.243.0317.5117.403.02
2733198-73319818.07918.24
3676372-67637216.67816.84
4678281-67828116.72516.88
5708354-70835417.46717.63
6694187-69418717.11717.27
45min1939232-93923223.16023.191.6523.4023.441.66
2958158-95815823.62623.88
3937166-93716623.10923.35
4942325-94232523.23623.47
5953129-95312923.50223.76
6913774-91377422.53222.77
60min11142197-114219728.16428.191.5128.5228.551.51
21164786-116478628.72129.09
31153492-115349228.44328.80
41121432-112143227.65228.00
51152548-115254828.42028.79
61124745-112474527.73428.09
120min11744711-174471143.02143.391.3143.5243.891.31
21790351-179035144.14744.66
31731110-173111042.68643.19
41764295-176429543.50443.99
51781344-178134443.92544.44
61746732-174673243.07143.56
180min12209046-220904654.47154.601.4555.1955.321.46
22241911-224191155.28156.02
32165159-216515953.38954.10
42208217-220821754.45055.16
52256978-225697855.65356.39
62205401-220540154.38155.09
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
240min12631704-263170464.89364.151.2265.8865.141.20
22618987-261898764.57965.59
32637095-263709565.02666.01
42582996-258299663.69264.67
52571529-257152963.40964.42
62566144-256614463.27664.25
360min13134251-313425177.28578.431.4478.6079.741.43
23247072-324707280.06781.40
33134870-313487077.30078.61
43179104-317910478.39179.69
53219875-321987579.39680.73
63167862-316786278.11379.41
480min13445027-344502784.94885.682.8686.6587.382.79
23502271-350227186.35988.09
33563310-356331087.86489.56
43560814-356081487.80389.49
53295500-329550081.26182.99
63481070-348107085.83787.52
600min13746161-374616192.37391.181.5894.5093.321.55
23746939-374693992.39294.56
33738876-373887692.19494.33
43604392-360439288.87791.01
53694575-369457591.10193.23
63656818-365681890.17092.28
720min13805721-380572193.84293.891.3496.4396.481.30
23794222-379422293.55896.19
33875839-387583995.57198.16
43858901-385890195.15397.73
53751695-375169592.51095.10
63759335-375933592.69895.26
极限13854717-385471795.05094.221.0798.1097.271.03
23826968-382696894.36697.46
33778212-377821293.16496.23
43880588-388058895.68898.74
53794303-379430393.56096.61
63790364-379036493.46396.49
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 12.613538535415352093537935272353320.25
2 12.743517035451353100.57
单位质量响应值RSD%判断
2801.902771.590.77数据可信
加速6月-供试品溶液-WK2170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%
5min123903-2390355.17154.519.5455.1754.519.54
224339-2433956.17856.18
321129-2112948.76948.77
420921-2092148.28948.29
526845-2684561.96261.96
624564-2456456.69756.70
10min135489-3548981.91479.784.3682.1980.054.36
233539-3353977.41377.69
332250-3225074.43774.68
434891-3489180.53380.77
534668-3466880.01980.33
636555-3655584.37484.66
15min137073-3707385.57082.993.0886.2683.663.08
235090-3509080.99381.66
334313-3431379.19979.82
436640-3664084.57085.21
535711-3571182.42683.14
636896-3689685.16185.87
20min137298-3729886.08981.734.8387.2082.814.76
234821-3482180.37281.44
334911-3491180.57981.59
437021-3702185.45086.52
535757-3575782.53283.65
632637-3263775.33176.46
30min137423-3742386.37783.513.4987.9285.003.46
236210-3621083.57885.05
334240-3424079.03180.45
437514-3751486.58788.08
535283-3528381.43882.97
636417-3641784.05585.56
45min137768-3776887.17484.132.8289.1586.052.80
235518-3551881.98083.87
335494-3549481.92583.74
437603-3760386.79388.72
535819-3581982.67584.62
636504-3650484.25686.18
60min137802-3780287.25284.592.9389.6686.922.90
235881-3588182.81885.12
335927-3592782.92485.14
438137-3813788.02590.39
535603-3560382.17784.53
636549-3654984.36086.71
120min137491-3749186.53483.903.8989.3886.663.84
235397-3539781.70184.42
334381-3438179.35681.99
438243-3824388.27091.07
535917-3591782.90185.67
636667-3666784.63287.40
180min136974-3697485.34182.944.1488.6286.124.08
235004-3500480.79483.92
333727-3372777.84780.88
437922-3792287.52990.77
535623-3562382.22385.40
636358-3635883.91987.11
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
240min137560-3756086.69483.523.5490.4087.113.49
235185-3518581.21284.74
335208-3520881.26584.69
437792-3779287.22990.91
534894-3489480.54084.13
636459-3645984.15287.77
360min136432-3643284.09083.813.4088.2387.823.35
235959-3595982.99886.93
334471-3447179.56483.39
438234-3823488.24992.37
535972-3597283.02887.02
636804-3680484.94988.98
480min136068-3606883.25081.774.8287.8186.194.67
234646-3464679.96884.32
334842-3484280.42084.64
437921-3792187.52792.08
532893-3289375.92280.33
636179-3617983.50687.97
600min136938-3693885.25881.852.5890.2486.682.59
234870-3487080.48585.23
334463-3446379.54584.17
435901-3590182.86487.86
534844-3484480.42585.21
635749-3574982.51487.39
720min136066-3606683.24581.473.7088.6586.723.62
234194-3419478.92484.08
334470-3447079.56284.59
437428-3742886.38991.80
534103-3410378.71483.91
635513-3551381.96987.26
极限136508-3650884.26581.544.1390.0987.204.05
234313-3431379.19984.75
333500-3350077.32382.74
437408-3740886.34392.18
534647-3464779.97085.55
635595-3559582.15887.86
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