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%
110.174173639417173641705864170316417038441713320.04
210.104151767415451841531420.05
单位质量响应值RSD%判断
410160.47411202.180.18数据可信
供试品溶液-2025070821批-二甲双胍-pH4.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1160651-1606513.9123.468.603.913.468.58
2153156-1531563.7293.73
3131689-1316893.2073.21
4132256-1322563.2203.22
5133556-1335563.2523.25
6141081-1410813.4353.44
10min1308851-3088517.5207.788.697.547.808.68
2299501-2995017.2937.31
3374235-3742359.1139.13
4321333-3213337.8247.84
5305208-3052087.4327.45
6307910-3079107.4987.51
15min1442861-44286110.78410.813.1410.8410.863.12
2433997-43399710.56810.62
3444259-44425910.81810.88
4435786-43578610.61110.67
5470812-47081211.46411.52
6435141-43514110.59610.65
20min1572764-57276413.94713.762.7214.0613.872.73
2552215-55221513.44613.55
3592244-59224414.42114.54
4560496-56049613.64813.76
5551713-55171313.43413.54
6561338-56133813.66813.78
30min1771489-77148918.78618.620.6918.9718.800.70
2764289-76428918.61018.79
3768843-76884318.72118.91
4759660-75966018.49818.67
5766765-76676518.67118.85
6758093-75809318.45918.64
45min1981318-98131823.89524.501.3124.1724.771.29
21013241-101324124.67224.94
31019211-101921124.81825.10
41006803-100680324.51524.78
51010795-101079524.61324.88
61005702-100570224.48924.76
60min11195554-119555429.11229.491.0929.5129.881.09
21220823-122082329.72730.12
31228639-122863929.91730.32
41214936-121493629.58329.98
51209655-120965529.45529.85
61196584-119658429.13729.53
120min11836207-183620744.71145.532.0445.2546.072.02
21820113-182011344.31944.86
31892297-189229746.07746.63
41917413-191741346.68947.23
51856616-185661645.20845.75
61896060-189606046.16946.71
180min12356756-235675657.38757.041.1858.1557.811.17
22298555-229855555.96956.73
32321430-232143056.52657.31
42374930-237493057.82958.60
52351539-235153957.26058.03
62351732-235173257.26458.03
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
240min12711405-271140566.02266.442.7867.0767.492.75
22642397-264239764.34265.38
32864134-286413469.74170.81
42745443-274544366.85167.91
52727219-272721966.40767.46
62680908-268090865.28066.33
360min13287981-328798180.06279.291.3581.4480.671.32
23275616-327561679.76181.12
33194789-319478977.79379.21
43255311-325531179.26680.66
53308473-330847380.56181.95
63214377-321437778.26979.65
480min13585419-358541987.30486.931.2789.0888.711.24
23515451-351545185.60187.36
33517700-351770085.65587.46
43583146-358314687.24989.04
53586568-358656887.33289.12
63631672-363167288.43190.20
600min13802905-380290592.60093.090.9894.8295.310.97
23794948-379494892.40694.60
33877432-387743294.41596.65
43790376-379037692.29594.52
53862576-386257694.05396.28
63810602-381060292.78795.00
720min13938364-393836495.89895.141.5698.5897.831.52
23855108-385510893.87196.52
33838064-383806493.45696.16
43995535-399553597.29199.98
53942329-394232995.99598.69
63875137-387513794.35997.04
极限13908532-390853295.17295.100.9998.3398.250.98
23852211-385221193.80196.92
33874409-387440994.34197.51
43962776-396277696.49399.67
53921789-392178995.49598.67
63912697-391269795.27398.42
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%
112.373023630277306923024730374303650.63
212.363044930268303580.43
单位质量响应值RSD%判断
2454.732456.150.05数据可信
供试品溶液-2025070821批-达格列净-pH4.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min132140-3214084.19085.502.1684.1985.502.16
233675-3367588.21188.21
332496-3249685.12385.12
431704-3170483.04883.05
532677-3267785.59785.60
633148-3314886.83186.83
10min134220-3422089.63991.801.9690.0692.221.96
234939-3493991.52291.96
336069-3606994.48294.91
434510-3451090.39990.81
535606-3560693.27093.70
634923-3492391.48091.91
15min134681-3468190.84792.111.8391.7293.001.83
235160-3516092.10193.00
336079-3607994.50995.41
434391-3439190.08790.95
535747-3574793.63994.53
634918-3491891.46792.36
20min135777-3577793.71893.400.9495.0494.740.92
236047-3604794.42595.78
335187-3518792.17293.54
435640-3564093.35994.68
535351-3535192.60293.96
635922-3592294.09795.45
30min135709-3570993.53994.421.6595.3396.241.63
236665-3666596.04497.87
336266-3626694.99896.83
435023-3502391.74293.53
536408-3640895.37097.20
636202-3620294.83196.65
45min134688-3468890.86593.922.3593.1296.202.32
237067-3706797.09799.41
336009-3600994.32596.63
435116-3511691.98694.23
536135-3613594.65596.96
636108-3610894.58596.88
60min134640-3464090.73993.542.6893.4596.302.63
237475-3747598.165100.96
335683-3568393.47196.25
435175-3517592.14194.84
535583-3558393.20995.99
635698-3569893.51196.28
120min134861-3486191.31894.331.9594.4997.551.90
235962-3596294.20297.49
336198-3619894.82098.07
436614-3661495.91099.07
535641-3564193.36196.60
636788-3678896.36699.60
180min135009-3500991.70693.811.9295.3397.511.89
236470-3647095.53399.29
335240-3524092.31196.03
435408-3540892.75196.39
536096-3609694.55398.26
636656-3665696.02099.74
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
240min135221-3522192.26194.021.3496.3498.191.33
236482-3648295.56499.80
336413-3641395.38499.56
435775-3577593.71297.82
535631-3563193.33597.52
635839-3583993.88098.08
360min135277-3527792.40893.472.2696.9598.102.19
236692-3669296.114100.83
334989-3498991.65396.31
434855-3485591.30295.88
536619-3661995.923100.57
635665-3566593.42498.09
480min134515-3451590.41291.982.0395.4297.081.97
235679-3567993.46198.66
334513-3451390.40695.52
434628-3462890.70895.74
535125-3512592.01097.14
636229-3622994.902100.03
600min134544-3454490.48892.942.7595.9598.502.66
235997-3599794.29499.96
336076-3607694.501100.07
434033-3403389.14994.63
536525-3652595.677101.26
635702-3570293.52199.13
720min134601-3460190.63792.061.8796.5598.091.81
235895-3589594.027100.16
334360-3436090.00696.05
435073-3507391.87397.80
535947-3594794.163100.23
634992-3499291.66197.74
极限134203-3420389.59492.754.0795.9699.243.88
238185-38185100.025106.63
335519-3551993.04299.53
434473-3447390.30296.69
535117-3511791.98998.53
634955-3495591.56498.10
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%
110.174201946420840842092314209557420714542072570.08
210.104203970420353642037530.01
单位质量响应值RSD%判断
413692.92416213.170.43数据可信
供试品溶液-2025070821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%
5min1159120-1591203.8354.1621.003.834.1621.07
2171527-1715274.1344.13
3151478-1514783.6513.65
4245103-2451035.9075.91
5151595-1515953.6533.65
6157052-1570523.7853.78
10min1323522-3235227.7977.772.867.827.792.82
2325156-3251567.8367.86
3337982-3379828.1458.16
4312646-3126467.5357.56
5313730-3137307.5617.58
6321203-3212037.7417.76
15min1472194-47219411.38012.2412.9211.4412.3012.86
2482428-48242811.62611.69
3640584-64058415.43815.50
4483607-48360711.65511.72
5495578-49557811.94312.00
6472880-47288011.39611.45
20min1589402-58940214.20414.9913.7214.3215.1113.62
2591786-59178614.26214.38
3615827-61582714.84114.98
4565725-56572513.63413.76
5792549-79254919.10019.22
6575925-57592513.87913.99
30min1778266-77826618.75618.761.7518.9418.961.73
2791462-79146219.07419.26
3795708-79570819.17619.39
4762550-76255018.37718.57
5764339-76433918.42018.63
6778789-77878918.76818.95
45min11096627-109662726.42825.122.8426.7125.412.81
21013055-101305524.41424.70
31045868-104586825.20525.51
41039060-103906025.04125.33
51041073-104107325.08925.39
61019197-101919724.56224.84
60min11272671-127267130.67130.302.2631.0830.722.25
21263595-126359530.45230.86
31296593-129659331.24731.68
41213847-121384729.25329.66
51239642-123964229.87530.30
61258171-125817130.32130.72
120min11898421-189842145.75145.951.8746.3246.521.86
21931253-193125346.54247.10
31959528-195952847.22347.81
41861485-186148544.86145.42
51878333-187833345.26745.84
61912285-191228546.08546.64
180min12401253-240125357.86957.461.8358.6658.261.82
22372649-237264957.17957.97
32464749-246474959.39960.22
42353857-235385756.72657.51
52350377-235037756.64357.45
62362631-236263156.93857.72
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
240min12771701-277170166.79666.860.9967.8867.941.00
22798649-279864967.44668.52
32814904-281490467.83768.96
42752891-275289166.34367.41
52762836-276283666.58367.67
62744680-274468066.14567.21
360min13330347-333034780.25980.151.1581.6881.571.15
23336553-333655380.40981.82
33388113-338811381.65183.11
43320399-332039980.01981.42
53271996-327199678.85380.27
63307749-330774979.71581.11
480min13620315-362031587.24789.624.7289.0791.444.62
24063604-406360497.93099.75
33654418-365441888.06989.94
43596327-359632786.66988.47
53644770-364477087.83789.65
63732703-373270389.95691.75
600min13853171-385317192.85993.341.1795.1195.601.16
23887830-388783093.69496.00
33881286-388128693.53695.85
43799275-379927591.56093.79
53879994-387999493.50595.76
63936459-393645994.86697.11
720min13976217-397621795.82496.643.8098.5499.373.71
23897361-389736193.92496.70
34296027-4296027103.531106.31
43940977-394097794.97597.66
53895384-389538493.87696.60
64054334-405433497.707100.43
极限13808948-380894891.79394.592.1194.9997.812.06
23930051-393005194.71297.96
33973561-397356195.76099.05
43845332-384533292.67095.83
54025263-402526397.006100.20
63967916-396791695.62498.83
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%
112.373078031086309893062730778308520.60
212.363109930995310470.24
单位质量响应值RSD%判断
2494.102511.890.51数据可信
供试品溶液-2025070821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%
5min133996-3399687.36186.602.3087.3686.602.30
234072-3407287.55787.56
333848-3384886.98186.98
434589-3458988.88588.89
532355-3235583.14483.14
633330-3333085.65085.65
10min135380-3538090.91889.542.0191.3589.972.01
235262-3526290.61591.05
334982-3498289.89590.33
435495-3549591.21391.66
533985-3398587.33387.75
633951-3395187.24687.67
15min135626-3562691.55091.242.2292.4492.122.21
235535-3553591.31692.21
336643-3664394.16395.05
435726-3572691.80792.71
534204-3420487.89688.75
635302-3530290.71791.58
20min135061-3506190.09892.102.1191.4593.442.09
235851-3585192.12893.48
336579-3657993.99995.35
436446-3644693.65795.02
536318-3631893.32894.62
634790-3479089.40290.72
30min135947-3594792.37591.482.1194.1793.282.10
235945-3594592.37094.18
336178-3617892.96994.79
436221-3622193.07994.91
534507-3450788.67490.43
634798-3479889.42291.19
45min136843-3684394.67791.852.6896.9494.112.63
234406-3440688.41590.68
335813-3581392.03194.32
436699-3669994.30796.60
535772-3577291.92594.13
634931-3493189.76491.98
60min136234-3623493.11292.601.9095.8595.311.89
235443-3544391.08093.79
336961-3696194.98197.73
436559-3655993.94896.71
535149-3514990.32492.99
635854-3585492.13694.80
120min136082-3608292.72292.291.0895.9295.471.09
235696-3569691.73094.90
336135-3613592.85896.08
436412-3641293.57096.80
535305-3530590.72593.84
635855-3585592.13895.26
180min135885-3588592.21691.872.0795.8895.502.04
235049-3504990.06793.69
336515-3651593.83597.52
436612-3661294.08497.79
534825-3482589.49293.06
635610-3561091.50995.09
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
240min135606-3560691.49992.621.5795.6296.721.55
236031-3603192.59196.67
336147-3614792.88997.05
437032-3703295.16399.34
535404-3540490.98094.99
636039-3603992.61196.65
360min135713-3571391.77492.611.8296.3697.171.80
235865-3586592.16496.70
336510-3651093.82298.44
437110-3711095.364100.01
535297-3529790.70595.17
635744-3574491.85396.36
480min135355-3535590.85492.813.8795.9097.833.66
238788-3878899.676104.68
335046-3504690.06095.15
436054-3605492.65097.78
535198-3519890.45095.37
636252-3625293.15998.12
600min135367-3536790.88491.501.4296.3896.991.36
235330-3533090.78996.29
335346-3534690.83096.37
436003-3600392.51998.11
535144-3514490.31195.69
636446-3644693.65799.09
720min135279-3527990.65892.475.3996.6198.415.10
234513-3451388.69094.64
339610-39610101.788107.78
435925-3592592.31898.37
534292-3429288.12293.95
636278-3627893.22599.12
极限133414-3341485.86689.412.0592.2795.821.90
234698-3469889.16595.56
334944-3494489.79796.30
435226-3522690.52297.03
535296-3529690.70296.97
635178-3517890.39996.76
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