盐酸二甲双胍达格列净片项目信息
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%
19.763959746396746439642433954250396480239621010.14
29.793954493396571839601060.21
单位质量响应值RSD%判断
405952.97404505.210.26数据可信
长期6月-供试品溶液-2025081521批-盐酸二甲双胍-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%
5min1242886-2428865.9945.0212.895.995.0212.87
2206080-2060805.0865.09
3215974-2159745.3305.33
4179680-1796804.4344.43
5169639-1696394.1864.19
6205423-2054235.0695.07
10min1363729-3637298.9768.974.259.019.004.27
2354270-3542708.7428.77
3393411-3934119.7089.74
4349893-3498938.6348.66
5358198-3581988.8398.86
6362669-3626698.9508.98
15min1530298-53029813.08612.603.1913.1612.673.20
2491626-49162612.13212.20
3529577-52957713.06913.14
4498589-49858912.30412.37
5502161-50216112.39212.46
6512121-51212112.63812.71
20min1647066-64706615.96815.742.1716.1115.872.19
2622592-62259215.36415.49
3656487-65648716.20016.34
4621704-62170415.34215.47
5636105-63610515.69715.82
6642405-64240515.85315.99
30min1869226-86922621.45020.961.9721.6721.171.98
2830725-83072520.50020.71
3867514-86751421.40821.63
4836901-83690120.65320.86
5837375-83737520.66420.87
6853912-85391221.07221.28
45min11111787-111178727.43627.321.5927.7627.631.61
21097678-109767827.08827.40
31139808-113980828.12828.46
41089913-108991326.89627.20
51102641-110264127.21027.52
61099952-109995227.14427.46
60min11348458-134845833.27732.661.8733.7433.121.88
21296748-129674832.00032.45
31358632-135863233.52834.00
41303554-130355432.16832.61
51316247-131624732.48232.93
61317954-131795432.52432.98
120min11998959-199895949.32949.011.1449.9649.631.14
21949742-194974248.11548.72
32015386-201538649.73550.37
41994908-199490849.22949.83
51979019-197901948.83749.44
61979033-197903348.83849.45
180min12503831-250383161.78860.731.8362.6761.601.82
22395056-239505659.10459.95
32490044-249004461.44862.33
42501176-250117661.72362.57
52452068-245206860.51161.36
62424607-242460759.83360.69
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
240min12876086-287608670.97570.001.4472.1671.171.44
22815141-281514169.47170.61
32876223-287622370.97872.17
42841634-284163470.12471.28
52768175-276817568.31269.47
62843284-284328470.16571.32
360min13382855-338285583.48082.561.8585.0284.071.84
23232189-323218979.76281.25
33412945-341294584.22385.77
43354095-335409582.77184.28
53356577-335657782.83284.33
63333747-333374782.26883.78
480min13668392-366839290.52790.420.9492.4992.350.95
23627671-362767189.52291.41
33718479-371847991.76393.73
43682961-368296190.88692.81
53657855-365785590.26792.18
63629292-362929289.56291.48
600min13832369-383236994.57394.321.1496.9896.701.12
23752947-375294792.61394.95
33791823-379182393.57396.00
43844819-384481994.88097.26
53876856-387685695.67198.03
63834754-383475494.63297.00
720min13975581-397558198.10796.341.36100.9999.201.35
23822109-382210994.32097.12
33938139-393813997.183100.08
43873347-387334795.58498.43
53909939-390993996.48799.33
63905549-390554996.37999.22
极限13939305-393930597.21297.161.58100.59100.491.55
23840582-384058294.77698.04
33958263-395826397.680101.06
44031544-403154499.488102.82
53939399-393939997.214100.54
63913609-391360996.57899.90
盐酸二甲双胍达格列净片项目信息
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%
112.383228232391325073234032535324110.34
212.503247932573325260.21
单位质量响应值RSD%判断
2618.012602.080.44数据可信
长期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%
5min137629-3762992.73190.052.5392.7390.052.53
234960-3496086.15486.15
336591-3659190.17390.17
436714-3671490.47690.48
537175-3717591.61291.61
636183-3618389.16789.17
10min138185-3818594.10191.912.9694.5692.362.96
235217-3521786.78787.22
336913-3691390.96691.42
437817-3781793.19493.65
537861-3786193.30393.76
637781-3778193.10593.55
15min138732-3873295.44992.642.2496.3893.552.24
236306-3630689.47190.34
337077-3707791.37192.28
438086-3808693.85794.78
537507-3750792.43093.35
637843-3784393.25894.17
20min138766-3876695.53392.921.9296.9494.301.93
236758-3675890.58491.90
337021-3702191.23392.60
437832-3783293.23194.62
537990-3799093.62195.01
637875-3787593.33794.71
30min138733-3873395.45292.751.9497.3494.581.94
236860-3686090.83692.60
336915-3691590.97192.79
437984-3798493.60695.46
537344-3734492.02993.88
637979-3797993.59395.44
45min138026-3802693.70992.250.9296.0894.550.95
237063-3706391.33693.56
337253-3725391.80494.08
437618-3761892.70495.03
537260-3726091.82294.14
637372-3737292.09894.41
60min138314-3831494.41991.931.5897.2594.691.59
236536-3653690.03792.71
336992-3699291.16193.89
437408-3740892.18694.97
537233-3723391.75594.53
637347-3734792.03694.81
120min138179-3817994.08692.061.7197.3995.281.72
236523-3652390.00593.13
336796-3679690.67893.87
437938-3793893.49296.74
537268-3726891.84195.07
637444-3744492.27595.51
180min138218-3821894.18291.252.2097.9694.942.18
236015-3601588.75392.33
336566-3656690.11193.75
437769-3776993.07696.79
536841-3684190.78994.48
636768-3676890.60994.30
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
240min138031-3803193.72291.181.9597.9795.321.92
236569-3656990.11994.14
336723-3672390.49894.59
437492-3749292.39396.57
536009-3600988.73992.88
637179-3717991.62295.77
360min137674-3767492.84290.422.1197.5695.012.09
235330-3533087.06591.54
336601-3660190.19894.74
437080-3708091.37896.02
536738-3673890.53595.12
636716-3671690.48195.09
480min137067-3706791.34689.601.3096.5394.641.32
235914-3591488.50593.41
336098-3609888.95893.95
436829-3682990.75995.86
536102-3610288.96894.01
636134-3613489.04794.10
600min136691-3669190.41988.621.9396.0694.121.91
235177-3517786.68892.04
335029-3502986.32491.76
436482-3648289.90495.46
536200-3620089.20994.70
636188-3618889.18094.68
720min137265-3726591.83488.352.1797.9294.292.14
234984-3498486.21391.99
335438-3543887.33293.20
435818-3581888.26894.27
535582-3558287.68693.62
636025-3602588.77894.73
极限136822-3682290.74288.882.0097.2995.261.98
235140-3514086.59792.81
335483-3548387.44293.75
436964-3696491.09297.53
535916-3591688.50994.88
636074-3607488.89995.29
盐酸二甲双胍达格列净片项目信息
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%
19.764030072403319240404854030191403201040331900.11
29.794043817404199040429040.04
单位质量响应值RSD%判断
413236.68412962.610.05数据可信
长期6月-供试品溶液-2025081521批-盐酸二甲双胍-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%
5min1200428-2004284.8524.848.654.854.848.67
2228316-2283165.5275.53
3190361-1903614.6084.61
4209118-2091185.0625.06
5178853-1788534.3304.33
6191772-1917724.6424.64
10min1368451-3684518.9198.622.368.948.652.37
2364482-3644828.8238.85
3349376-3493768.4578.48
4354404-3544048.5798.60
5353723-3537238.5638.58
6347379-3473798.4098.43
15min1520372-52037212.59712.132.7312.6712.202.75
2513627-51362712.43312.51
3488394-48839411.82311.89
4492749-49274911.92812.00
5503678-50367812.19312.26
6488193-48819311.81811.88
20min1636646-63664615.41115.091.6015.5415.221.60
2628097-62809715.20415.34
3609529-60952914.75514.88
4625265-62526515.13615.26
5627029-62702915.17915.30
6614053-61405314.86514.99
30min1859608-85960820.80920.151.7621.0220.351.77
2833079-83307920.16720.38
3820589-82058919.86420.06
4832948-83294820.16320.37
5828211-82821120.04920.25
6819309-81930919.83320.03
45min11113224-111322426.94826.381.2727.2626.681.28
21099759-109975926.62226.93
31080193-108019326.14826.45
41085129-108512926.26826.57
51080540-108054026.15726.46
61079709-107970926.13726.43
60min11333302-133330232.27631.711.1432.7232.151.14
21304920-130492031.58932.03
31306894-130689431.63632.06
41303034-130303431.54331.98
51321346-132134631.98632.42
61291205-129120531.25731.69
120min12047557-204755749.56648.051.6650.1748.641.65
21978963-197896347.90548.51
31973337-197333747.76948.36
41956294-195629447.35647.95
51963652-196365247.53548.13
61989670-198967048.16448.75
180min12474693-247469359.90559.161.1960.7659.991.18
22453056-245305659.38260.22
32469632-246963259.78360.61
42426828-242682858.74759.58
52396801-239680158.02058.85
62442090-244209059.11659.94
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
240min12853677-285367769.08068.401.1570.2469.541.14
22839127-283912768.72769.87
32866744-286674469.39670.52
42785951-278595167.44068.56
52797718-279771867.72568.85
62811371-281137168.05669.18
360min13387020-338702081.99081.331.1083.4982.801.08
23350248-335024881.10082.58
33329920-332992080.60882.08
43312365-331236580.18381.64
53365854-336585481.47882.94
63412012-341201282.59584.06
480min13708318-370831889.76888.770.7491.6890.650.74
23687576-368757689.26691.15
33657047-365704788.52790.40
43631611-363161187.91189.77
53660580-366058088.61390.48
63658084-365808488.55290.43
600min13846692-384669293.11892.900.9195.4895.220.89
23898008-389800894.36096.69
33834240-383424092.81695.13
43820283-382028392.47894.78
53793961-379396191.84194.15
63833507-383350792.79995.12
720min14002355-400235596.88695.151.0999.7197.941.07
23911434-391143494.68597.49
33905765-390576594.54897.33
43879381-387938193.90996.67
53944250-394425095.47998.25
63940848-394084895.39798.18
极限13945588-394558895.51295.220.7398.8298.480.71
23935835-393583595.27698.55
33922512-392251294.95398.21
43979125-397912596.32499.56
53892213-389221394.22097.47
63926378-392637895.04798.30
盐酸二甲双胍达格列净片项目信息
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%
112.383292832923329923288832966329390.13
212.503319633118331570.17
单位质量响应值RSD%判断
2660.662652.560.22数据可信
长期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%
5min137427-3742790.61689.081.3190.6289.081.31
237264-3726490.22190.22
336296-3629687.87887.88
436361-3636188.03588.03
536899-3689989.33789.34
636503-3650388.37988.38
10min137899-3789991.75990.671.7792.2191.121.76
237947-3794791.87592.33
336667-3666788.77689.22
437844-3784491.62592.07
537806-3780691.53391.98
636537-3653788.46188.90
15min138359-3835992.87290.931.9493.7891.821.94
237977-3797791.94792.86
336691-3669188.83489.72
437424-3742490.60991.51
538158-3815892.38693.29
636721-3672188.90789.79
20min137486-3748690.75990.421.5792.1391.771.57
237502-3750290.79792.17
336545-3654588.48089.81
437926-3792691.82493.18
537892-3789291.74293.11
636717-3671788.89790.23
30min138249-3824992.60690.511.7994.4492.311.78
237533-3753390.87292.70
336680-3668088.80790.58
437964-3796491.91693.73
537266-3726690.22692.05
636597-3659788.60690.38
45min137830-3783091.59290.211.2693.8892.471.26
237548-3754890.90993.19
336708-3670888.87591.09
437604-3760491.04493.31
537101-3710189.82792.10
636768-3676889.02091.24
60min137671-3767191.20790.181.4593.9692.891.44
237148-3714889.94092.67
336932-3693289.41792.08
437532-3753290.87093.60
537811-3781191.54694.27
636378-3637888.07690.74
120min138689-3868993.67190.701.7496.8893.861.72
237413-3741390.58293.76
336899-3689989.33792.44
437590-3759091.01094.19
537149-3714989.94393.13
637033-3703389.66292.76
180min137470-3747090.72089.531.2894.4093.151.26
237059-3705989.72593.36
336950-3695089.46193.01
437495-3749590.78094.42
536306-3630687.90291.53
636602-3660288.61892.17
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
240min137412-3741290.58089.730.9694.7193.790.95
237242-3724290.16894.25
337239-3723990.16194.16
437176-3717690.00894.10
536844-3684489.20493.28
636450-3645088.25092.24
360min137407-3740790.56789.331.1195.1593.841.11
236923-3692389.39693.93
336196-3619687.63592.09
437099-3709989.82294.36
537027-3702789.64794.17
636731-3673188.93193.37
480min137175-3717590.00688.361.5695.0493.321.54
236732-3673288.93393.92
335818-3581886.72091.61
436932-3693289.41794.41
536480-3648088.32393.29
635832-3583286.75491.63
600min136500-3650088.37187.491.4393.8692.891.41
236441-3644188.22993.66
335667-3566786.35591.68
436816-3681689.13794.57
535814-3581486.71192.12
635574-3557486.12991.44
720min137018-3701889.62687.311.6995.5593.141.65
235873-3587386.85392.72
335273-3527385.40191.15
436349-3634988.00693.89
536196-3619687.63593.48
635657-3565786.33092.07
极限136560-3656088.51787.222.1094.8993.502.02
235995-3599587.14993.45
335425-3542585.76991.95
437262-3726290.21696.54
535550-3555086.07192.35
635365-3536585.62391.80
盐酸二甲双胍达格列净片项目信息
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%
19.764033345402942340240494030714402560540286270.10
29.794051942404398440479630.14
单位质量响应值RSD%判断
412769.16413479.370.13数据可信
长期6月-供试品溶液-2025081621批-盐酸二甲双胍-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%
5min1199601-1996014.8324.757.134.834.757.09
2185106-1851064.4814.48
3194477-1944774.7074.71
4219052-2190525.3025.30
5178720-1787204.3264.33
6199500-1995004.8294.83
10min1382386-3823869.2569.002.819.289.022.80
2358352-3583528.6748.70
3362833-3628338.7838.81
4380164-3801649.2029.23
5366155-3661558.8638.88
6380054-3800549.2009.22
15min1522677-52267712.65212.663.4812.7212.723.49
2507960-50796012.29612.36
3513286-51328612.42512.49
4527829-52782912.77712.85
5508950-50895012.32012.39
6556386-55638613.46813.54
20min1639199-63919915.47215.551.2915.6115.681.29
2633236-63323615.32815.46
3646064-64606415.63915.77
4656936-65693615.90216.04
5639721-63972115.48515.61
6638581-63858115.45715.59
30min1848623-84862320.54220.350.8420.7520.560.85
2835453-83545320.22320.43
3839092-83909220.31120.52
4849043-84904320.55220.77
5831533-83153320.12820.33
6840627-84062720.34820.56
45min11114945-111494526.98826.771.0127.3027.081.01
21099457-109945726.61326.92
31116117-111611727.01727.33
41105440-110544026.75827.08
51087566-108756626.32526.63
61112747-111274726.93527.25
60min11315399-131539931.84031.770.4832.2932.220.49
21305020-130502031.58932.03
31319367-131936731.93632.38
41319356-131935631.93632.39
51306816-130681631.63332.07
61310007-131000731.71032.16
120min11959358-195935847.42847.851.0548.0448.461.02
22012383-201238348.71149.31
31969816-196981647.68148.29
41974487-197448747.79448.41
51988001-198800148.12148.72
61957390-195739047.38047.99
180min12470137-247013759.79259.400.5560.6460.240.54
22466805-246680559.71160.55
32450417-245041759.31460.16
42458070-245807059.50060.35
52439017-243901759.03859.87
62439791-243979159.05759.90
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
240min12821655-282165568.30068.091.0069.4469.230.98
22849018-284901868.96370.10
32816830-281683068.18469.32
42801791-280179167.82068.97
52765256-276525666.93568.07
62823340-282334068.34169.48
360min13315983-331598380.26681.291.4181.7582.781.38
23439067-343906783.24584.73
33379152-337915281.79583.28
43321391-332139180.39781.88
53366980-336698081.50082.97
63328202-332820280.56282.05
480min13668627-366862788.80289.120.3790.6991.000.37
23705241-370524189.68891.59
33674498-367449888.94490.83
43684850-368485089.19591.08
53672215-367221588.88990.76
63684288-368428889.18191.07
600min13881091-388109193.94593.540.8196.2895.880.79
23860530-386053093.44795.79
33865695-386569593.57295.91
43813911-381391192.31994.65
53856954-385695493.36195.68
63908316-390831694.60496.94
720min13979438-397943896.32695.680.9799.1398.480.95
23983681-398368196.42899.24
33949981-394998195.61298.41
43893679-389367994.25097.05
53922829-392282994.95597.74
63987140-398714096.51299.32
极限13965410-396541095.98695.440.6299.2798.720.60
23930995-393099595.15398.45
33925401-392540195.01898.30
43911476-391147694.68097.95
53950741-395074195.63198.89
63973922-397392296.19299.48
盐酸二甲双胍达格列净片项目信息
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%
112.383288332760329993261732623327760.51
212.503346833317333920.32
单位质量响应值RSD%判断
2647.502671.360.64数据可信
长期6月-供试品溶液-2025081621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%
5min137727-3772791.24790.341.9691.2590.341.96
236103-3610387.31987.32
338331-3833192.70892.71
437387-3738790.42590.42
537227-3722790.03890.04
637334-3733490.29790.30
10min138272-3827292.56593.001.4393.0293.451.43
237753-3775391.31091.75
338339-3833992.72793.19
438938-3893894.17694.63
539251-3925194.93395.38
638146-3814692.26092.71
15min139144-3914494.67494.580.7095.5995.490.70
238685-3868593.56494.46
339076-3907694.51095.44
438931-3893194.15995.08
539417-3941795.33596.26
639366-3936695.21196.12
20min138847-3884793.95694.901.2795.3596.291.26
239059-3905994.46995.83
338832-3883293.92095.32
439603-3960395.78497.18
540073-4007396.92198.32
639011-3901194.35395.74
30min139139-3913994.66294.220.6396.5296.080.62
238560-3856093.26295.10
338974-3897494.26396.13
439266-3926694.96996.84
538884-3888494.04595.93
638908-3890894.10395.96
45min139279-3927995.00194.260.7597.3496.600.74
238520-3852093.16595.46
339208-3920894.82997.17
438965-3896594.24196.59
538758-3875893.74196.10
639118-3911894.61196.94
60min138755-3875593.73393.650.9996.5496.460.98
238017-3801791.94894.71
339132-3913294.64597.46
438756-3875693.73696.55
538702-3870293.60596.43
638968-3896894.24997.05
120min138653-3865393.48794.070.5596.7797.340.55
238713-3871393.63296.86
339180-3918094.76198.05
438987-3898794.29597.58
539062-3906294.47697.77
638768-3876893.76597.04
180min139300-3930095.05293.811.1098.8097.551.08
238016-3801691.94695.64
338757-3875793.73897.50
438951-3895194.20797.97
538802-3880293.84797.61
638888-3888894.05597.80
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
240min138433-3843392.95593.091.0097.1897.310.97
238230-3823092.46496.62
339121-3912194.61998.85
438446-3844692.98697.22
538015-3801591.94496.18
638697-3869793.59397.81
360min138026-3802691.97092.990.9496.6697.670.88
238849-3884993.96198.58
338761-3876193.74898.45
438232-3823292.46897.16
538687-3868793.56998.26
638131-3813192.22496.91
480min137899-3789991.66392.080.4796.8197.230.46
237907-3790791.68296.77
338148-3814892.26597.44
438334-3833492.71597.87
538184-3818492.35297.51
637969-3796991.83296.98
600min137789-3778991.39791.640.8197.0097.240.79
237384-3738490.41795.96
338059-3805992.05097.68
437774-3777491.36196.98
538198-3819892.38698.01
638136-3813692.23697.84
720min137687-3768791.15091.280.6397.2197.340.60
237610-3761090.96496.96
337813-3781391.45597.55
437390-3739090.43296.51
537843-3784391.52897.61
638089-3808992.12398.19
极限137378-3737890.40390.650.5796.9297.170.55
237344-3734490.32196.77
337420-3742090.50597.06
437280-3728090.16696.70
537851-3785191.54798.09
637600-3760090.94097.46
盐酸二甲双胍达格列净片项目信息
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%
19.764066255407466940707314062799405499340658890.19
29.794046236405959940529180.24
单位质量响应值RSD%判断
416586.99413985.500.45数据可信
长期6月-供试品溶液-2025081621批-盐酸二甲双胍-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%
5min1187086-1870864.5054.743.364.514.743.32
2196601-1966014.7344.73
3193918-1939184.6704.67
4196057-1960574.7214.72
5206493-2064934.9724.97
6201350-2013504.8494.85
10min1381173-3811739.1799.262.179.209.292.18
2380840-3808409.1719.19
3381883-3818839.1969.22
4376456-3764569.0659.09
5400103-4001039.6349.66
6387522-3875229.3329.36
15min1522392-52239212.57912.742.3012.6512.812.30
2517883-51788312.47112.54
3529646-52964612.75412.82
4517295-51729512.45612.53
5547432-54743213.18213.26
6538736-53873612.97313.04
20min1627989-62798915.12215.542.1915.2515.672.20
2642307-64230715.46715.60
3646561-64656115.56915.70
4635806-63580615.31015.44
5669446-66944616.12016.26
6648881-64888115.62515.76
30min1836866-83686620.15220.492.6220.3620.702.62
2838594-83859420.19320.40
3865058-86505820.83121.04
4826570-82657019.90420.11
5887360-88736021.36821.59
6849977-84997720.46720.68
45min11102145-110214526.54026.941.3826.8527.261.37
21139974-113997427.45127.76
31126020-112602027.11527.43
41107895-110789526.67826.99
51130546-113054627.22427.55
61106506-110650626.64526.96
60min11313972-131397231.64031.901.7932.0832.351.79
21319907-131990731.78332.23
31329056-132905632.00432.45
41306794-130679431.46831.91
51370350-137035032.99833.46
61309266-130926631.52731.98
120min11961188-196118847.22547.471.2347.8248.081.23
21964606-196460647.30847.91
31989718-198971847.91248.52
41938995-193899546.69147.29
52007804-200780448.34848.98
61965459-196545947.32847.94
180min12420421-242042158.28459.221.6059.1260.061.59
22472447-247244759.53760.38
32510885-251088560.46261.31
42421513-242151358.31059.14
52495393-249539360.08960.96
62435073-243507358.63759.48
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
240min12818301-281830167.86568.071.4968.9969.211.48
22865537-286553769.00270.14
32878233-287823369.30870.46
42776505-277650566.85867.98
52839225-283922568.36969.54
62783563-278356367.02868.17
360min13344934-334493480.54680.450.8582.0181.930.84
23381550-338155081.42882.91
33361051-336105180.93482.43
43309424-330942479.69181.15
53337410-333741080.36581.88
63311146-331114679.73281.20
480min13618026-361802687.12288.893.1988.9990.783.11
23621073-362107387.19589.09
33715625-371562589.47291.38
43919530-391953094.38296.24
53630102-363010287.41389.33
63644504-364450487.76089.63
600min13863011-386301193.02192.631.5195.3394.961.48
23778159-377815990.97893.31
33937340-393734094.81197.16
43799026-379902691.48193.81
53876064-387606493.33695.69
63826540-382654092.14394.45
720min13932229-393222994.68894.401.8197.4697.201.77
23978287-397828795.79798.58
33987303-398730396.01498.84
43871022-387102293.21496.00
53950270-395027095.12397.94
63803414-380341491.58694.36
极限13897312-389731293.84793.910.7097.0997.170.70
23923215-392321594.47197.73
33940759-394075994.89498.20
43870566-387056693.20396.45
53886864-388686493.59696.89
63879667-387966793.42296.65
盐酸二甲双胍达格列净片项目信息
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%
112.383328633260331643302733028331530.38
212.503345933303333810.34
单位质量响应值RSD%判断
2677.952670.480.20数据可信
长期6月-供试品溶液-2025081621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%
5min137742-3774290.77789.745.0690.7889.745.06
238235-3823591.96391.96
338373-3837392.29592.29
433836-3383681.38281.38
539064-3906493.95793.96
636623-3662388.08688.09
10min138675-3867593.02191.974.5393.4792.424.53
238309-3830992.14192.60
339417-3941794.80695.27
434999-3499984.17984.59
539923-3992396.02396.49
638100-3810091.63892.08
15min139431-3943194.83992.575.2795.7693.485.27
238501-3850192.60293.52
339919-3991996.01396.95
434531-3453183.05483.88
539872-3987295.90096.85
638661-3866192.98793.89
20min138700-3870093.08192.175.1394.4793.545.13
238552-3855292.72594.11
339390-3939094.74196.16
434402-3440282.74483.99
539670-3967095.41496.84
639219-3921994.32995.69
30min139027-3902793.86891.815.9995.7393.645.97
238282-3828292.07693.92
339460-3946094.90996.80
433620-3362080.86382.52
539759-3975995.62897.53
638873-3887393.49795.33
45min138750-3875093.20192.374.6795.5394.664.68
239321-3932194.57596.88
339053-3905393.93096.29
434771-3477183.63185.69
539220-3922094.33296.72
639311-3931194.55196.85
60min138759-3875993.22392.185.1496.0294.935.14
238714-3871493.11595.90
339059-3905993.94596.78
434410-3441082.76385.24
539953-3995396.09598.95
639045-3904593.91196.69
120min138616-3861692.87991.405.1496.1494.615.14
238479-3847992.55095.80
338760-3876093.22596.53
434043-3404381.88084.77
539121-3912194.09497.43
638975-3897593.74396.99
180min138282-3828292.07691.685.3195.8095.355.30
238869-3886993.48897.20
339310-3931094.54898.32
434075-3407581.95785.26
539435-3943594.84998.66
638732-3873293.15896.87
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
240min138214-3821491.91291.415.4596.1095.545.42
239516-3951695.04499.22
339161-3916194.19098.43
433935-3393581.62085.33
539078-3907893.99098.27
638127-3812791.70395.88
360min138338-3833892.21090.544.8596.8595.124.85
238530-3853092.67297.32
338209-3820991.90096.61
433933-3393381.61685.74
538541-3854192.69997.45
638310-3831092.14396.78
480min137476-3747690.13789.843.2195.2494.873.30
237498-3749890.19095.30
338374-3837492.29797.47
435016-3501684.22088.75
538084-3808491.60096.81
637658-3765890.57595.67
600min137518-3751890.23889.645.2495.7995.135.21
236867-3686788.67294.24
338813-3881393.35398.99
433645-3364580.92385.87
539024-3902493.86099.53
637757-3775790.81396.36
720min137840-3784091.01388.665.2397.0294.595.20
237765-3776590.83296.84
337567-3756790.35696.46
433129-3312979.68285.04
538356-3835692.25498.40
636502-3650287.79593.80
极限137457-3745790.09188.085.2796.5594.465.24
237497-3749790.18896.65
337303-3730389.72196.27
432712-3271278.67984.43
537726-3772690.73897.34
637032-3703289.06995.51
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