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%
1 10.284248708423863642427384254530425091842471060.16
2 10.284245276423888542420800.11
单位质量响应值RSD%判断
413142.61412653.700.09数据可信
供试品溶液-2025081521批-二甲双胍-pH1.2
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1186773-1867734.5234.049.014.524.048.98
2165972-1659724.0204.02
3161222-1612223.9053.90
4183174-1831744.4364.44
5153941-1539413.7283.73
6150521-1505213.6453.65
10min1344414-3444148.3418.445.878.368.465.87
2389640-3896409.4379.46
3339056-3390568.2128.23
4338673-3386738.2028.22
5335560-3355608.1278.15
6343464-3434648.3188.34
15min1498268-49826812.06811.932.5112.1311.992.53
2503043-50304312.18312.25
3485720-48572011.76411.82
4483800-48380011.71711.78
5476223-47622311.53411.59
6507737-50773712.29712.36
20min1625898-62589815.15915.072.3815.2815.192.37
2614123-61412314.87315.00
3617900-61790014.96515.08
4648895-64889515.71615.84
5605644-60564414.66814.79
6619746-61974615.01015.13
30min1866489-86648920.98619.953.1821.1920.143.17
2815585-81558519.75319.96
3818221-81822119.81720.01
4840016-84001620.34420.54
5791858-79185819.17819.37
6809050-80905019.59419.79
45min11083817-108381726.24926.181.6426.5526.481.63
21080430-108043026.16726.47
31073875-107387526.00826.30
41113550-111355026.96927.27
51073686-107368626.00426.29
61061268-106126825.70326.00
60min11304551-130455131.59531.291.6032.0331.721.60
21295035-129503531.36531.80
31273476-127347630.84231.27
41323772-132377232.06132.50
51288103-128810331.19731.61
61267796-126779630.70531.13
120min11964284-196428447.57347.341.0348.1747.931.05
21958330-195833047.42948.02
31943793-194379347.07747.65
41988143-198814348.15148.75
51931570-193157046.78147.35
61942851-194285147.05447.63
180min12472293-247229359.87759.421.4560.7160.241.45
22471372-247137259.85460.68
32435029-243502958.97459.79
42505257-250525760.67561.51
52427575-242757558.79459.60
62409625-240962558.35959.17
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
240min12837864-283786468.73068.341.7769.8669.451.76
22780125-278012567.33268.46
32777606-277760667.27168.38
42908960-290896070.45271.59
52831832-283183268.58469.68
62793164-279316467.64868.75
360min13384044-338404481.95881.091.9283.4382.551.90
23267790-326779079.14380.60
33310154-331015480.16981.61
43445806-344580683.45484.95
53369571-336957181.60883.05
63312059-331205980.21581.66
480min13696047-369604789.51589.202.4691.4091.062.43
23551599-355159986.01687.87
33645251-364525188.28590.13
43830281-383028192.76694.68
53676922-367692289.05290.90
63697918-369791889.56091.40
600min13873932-387393293.82393.302.9096.1695.612.85
23646426-364642688.31390.60
33843049-384304993.07595.36
43977386-397738696.32998.70
53911761-391176194.73997.04
63861261-386126193.51695.81
720min13938668-393866895.39194.994.1598.1997.764.08
23660132-366013288.64591.37
33880988-388098893.99496.75
44165784-4165784100.891103.75
53968268-396826896.10898.88
63917670-391767094.88297.64
极限13904778-390477894.57094.534.0897.8597.794.00
23630087-363008787.91791.09
33869572-386957293.71796.94
44106129-410612999.447102.81
54001043-400104396.901100.15
63908125-390812594.65197.88
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%
112.643143231420314223148231412314340.09
212.643160631523315640.19
单位质量响应值RSD%判断
2486.872497.150.30数据可信
供试品溶液-2025081521批-达格列净-pH1.2
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min134781-3478189.77292.882.2789.7792.882.28
235479-3547991.57391.57
335929-3592992.73592.73
436255-3625593.57693.58
536257-3625793.58293.58
637201-3720196.01896.02
10min135459-3545991.52294.002.3691.9794.462.36
235640-3564091.98992.45
336109-3610993.20093.66
436476-3647694.14794.61
537237-3723796.11196.58
637593-3759397.03097.51
15min136141-3614193.28294.761.4894.1995.691.49
236337-3633793.78894.71
336584-3658494.42695.36
436655-3665594.60995.55
536867-3686795.15696.10
637690-3769097.28098.25
20min135641-3564191.99294.351.6393.3695.761.63
236217-3621793.47894.87
336321-3632193.74795.15
437105-3710595.77097.18
537121-3712195.81297.24
636934-3693495.32996.78
30min136131-3613193.25694.492.1595.0996.372.13
236103-3610393.18495.04
336076-3607693.11494.98
437275-3727596.20998.10
536169-3616993.35495.26
637901-3790197.82599.75
45min135444-3544491.48394.912.2793.7897.262.26
236344-3634493.80696.13
336515-3651594.24796.58
437375-3737596.46798.84
537245-3724596.13298.50
637708-3770897.32799.74
60min135326-3532691.17994.552.4293.9497.382.39
236519-3651994.25897.05
335952-3595292.79495.60
437540-3754096.89399.75
536935-3693595.33198.18
637531-3753196.87099.77
120min135417-3541791.41394.962.7094.6398.262.67
236491-3649194.18597.45
336476-3647694.14797.42
437564-3756496.955100.29
536542-3654294.31797.64
638263-3826398.759102.15
180min135951-3595192.79295.392.3996.4699.172.37
236836-3683695.07698.81
336346-3634693.81197.55
437926-3792697.889101.71
536554-3655494.34898.15
638139-3813998.439102.32
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
240min135510-3551091.65394.793.0995.7999.043.04
235962-3596292.82097.03
335936-3593692.75396.96
438065-3806598.248102.56
536761-3676194.88299.15
638116-3811698.380102.75
360min135374-3537491.30293.762.9295.8998.482.87
235291-3529191.08895.76
335678-3567892.08796.76
437522-3752296.847101.65
536440-3644094.05498.80
637650-3765097.177102.04
480min134968-3496890.25593.424.1395.3098.614.02
234723-3472389.62294.75
335517-3551791.67296.81
437874-3787497.755103.04
535858-3585892.55297.77
638217-3821798.640103.99
600min134863-3486389.98492.804.2495.4898.464.12
233689-3368986.95392.53
335561-3556191.78597.38
437217-3721796.059101.84
536708-3670894.746100.42
637680-3768097.254103.10
720min134635-3463589.39592.175.3095.3498.305.11
233008-3300885.19691.20
335160-3516090.75096.80
438132-3813298.421104.68
535817-3581792.44698.60
637511-3751196.818103.15
极限134343-3434388.64191.595.1995.0498.185.00
232716-3271684.44290.88
334978-3497890.28096.79
437520-3752096.841103.59
536083-3608393.13299.75
637275-3727596.209103.02
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%
1 10.284253561425772242596654254328425463242559820.07
2 10.284266341425594242611420.18
单位质量响应值RSD%判断
414006.03414507.980.09数据可信
供试品溶液-2025081521批-二甲双胍-pH1.2
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1168186-1681864.0604.1314.784.064.1214.84
2219404-2194045.2965.30
3156269-1562693.7723.77
4162358-1623583.9193.92
5171619-1716194.1434.14
6147631-1476313.5643.56
10min1381464-3814649.2088.746.859.238.766.85
2401279-4012799.6879.71
3341367-3413678.2408.26
4355148-3551488.5738.59
5357457-3574578.6298.65
6336346-3363468.1198.14
15min1519617-51961712.54312.385.3112.6112.455.31
2520306-52030612.56012.63
3533580-53358012.88012.94
4538388-53838812.99613.06
5502368-50236812.12712.19
6463814-46381411.19611.25
20min1755016-75501618.22615.847.7418.3515.967.68
2645549-64554915.58315.72
3633075-63307515.28215.41
4652079-65207915.74115.87
5641267-64126715.48015.60
6609053-60905314.70214.82
30min1838730-83873020.24720.150.6620.4720.360.67
2836571-83657120.19520.41
3841485-84148520.31320.51
4825957-82595719.93820.14
5832279-83227920.09120.29
6833450-83345020.11920.31
45min11393195-139319533.63127.6110.8733.9527.9210.77
21097003-109700326.48126.80
31126860-112686027.20227.50
41102685-110268526.61826.92
51083060-108306026.14526.45
61059531-105953125.57725.87
60min11291724-129172431.18231.561.8931.6732.011.86
21288509-128850931.10431.55
31329078-132907832.08332.52
41337872-133787232.29632.73
51320431-132043131.87532.31
61277924-127792430.84931.26
120min11974702-197470247.66947.721.5748.3148.321.56
21962118-196211847.36547.97
32001182-200118248.30848.91
42014273-201427348.62449.22
51983096-198309647.87148.46
61926569-192656946.50747.08
180min12467088-246708859.55559.941.0360.4460.780.99
22445170-244517059.02559.87
32504201-250420160.45061.29
42500025-250002560.35061.19
52473024-247302459.69860.53
62509417-250941760.57661.38
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
240min12892463-289246369.82369.351.1471.0070.501.14
22837640-283764068.50069.64
32883986-288398669.61870.76
42920560-292056070.50171.65
52866185-286618569.18970.32
62837538-283753868.49769.60
360min13362298-336229881.16582.321.0982.7083.811.05
23399286-339928682.05783.54
33374801-337480181.46682.96
43450958-345095883.30584.80
53434257-343425782.90284.38
63440372-344037283.04984.50
480min13735794-373579490.18190.620.7192.1292.520.71
23774251-377425191.10993.00
33749382-374938290.50992.41
43795897-379589791.63193.55
53746436-374643690.43892.33
63723369-372336989.88191.74
600min13902060-390206094.19493.323.8196.5895.673.72
23886831-388683193.82796.17
33999821-399982196.55498.90
43921053-392105394.65397.03
53576890-357689086.34588.69
63908309-390830994.34596.66
720min14018307-401830797.00095.983.6199.8698.803.53
23963582-396358295.67998.49
34073989-407398998.345101.18
44066844-406684498.172101.02
54038901-403890197.498100.27
63694896-369489689.19391.98
极限14028554-402855497.24897.861.96100.59101.161.92
23996322-399632296.47099.76
34194992-4194992101.265104.59
44095331-409533198.860102.20
53983691-398369196.16599.43
64025348-402534897.170100.40
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%
112.643147731557315463148831557315250.13
212.643170731618316620.20
单位质量响应值RSD%判断
2494.072504.910.31数据可信
供试品溶液-2025081521批-达格列净-pH1.2
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min134340-3434088.36992.475.2888.3792.475.28
237718-3771897.06197.06
337662-3766296.91796.92
436572-3657294.11294.11
536326-3632693.47993.48
632989-3298984.89284.89
10min136789-3678994.67195.242.7195.1195.702.72
237938-3793897.62798.11
337603-3760396.76597.25
437157-3715795.61896.09
537455-3745596.38596.85
635129-3512990.39990.82
15min136722-3672294.49895.913.4995.4196.853.49
237844-3784497.38698.36
339122-39122100.674101.64
437280-3728095.93496.88
537475-3747596.43697.39
635192-3519290.56191.44
20min139051-39051100.49296.482.84101.8897.902.82
237605-3760596.77198.23
337396-3739696.23397.70
436702-3670294.44795.88
538161-3816198.20199.63
636032-3603292.72394.05
30min137943-3794397.64096.481.6899.5398.381.69
237865-3786597.44099.38
338171-3817198.227100.18
436808-3680894.72096.62
537508-3750896.52198.44
636661-3666194.34196.13
45min140130-40130103.26897.303.67105.6599.683.62
237850-3785097.40199.83
338267-3826798.474100.92
437146-3714695.58997.96
537525-3752596.56598.97
635944-3594492.49694.76
60min137117-3711795.51595.171.5798.4198.041.60
237050-3705095.34298.26
337563-3756396.66299.60
437057-3705795.36098.21
537238-3723895.82698.71
635864-3586492.29095.02
120min137819-3781997.32195.902.13100.6999.242.14
237425-3742596.30799.70
337954-3795497.669101.09
436956-3695695.10098.43
537628-3762896.830100.20
635815-3581592.16495.35
180min137708-3770897.03696.011.21100.8999.831.22
237397-3739796.235100.11
337764-3776497.180101.09
436580-3658094.13397.94
537403-3740396.251100.10
636999-3699995.21198.86
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
240min138031-3803197.86796.042.07102.21100.342.06
237639-3763996.858101.22
337447-3744796.364100.76
437826-3782697.339101.61
537092-3709295.45099.78
635889-3588992.35596.48
360min136625-3662594.24994.681.2999.0899.461.28
237539-3753996.601101.44
336678-3667894.38599.26
436311-3631193.44198.20
537175-3717595.664100.47
636419-3641993.71998.31
480min136649-3664994.31093.881.7699.6299.141.75
237488-3748896.469101.79
336627-3662794.25499.60
435965-3596592.55097.78
536523-3652393.98699.27
635640-3564091.71496.77
600min136387-3638793.63691.544.3099.4197.274.08
236586-3658694.14899.96
337035-3703595.304101.12
435212-3521290.61296.30
532798-3279884.40090.16
635425-3542591.16196.67
720min136550-3655094.05692.034.40100.3098.224.24
236454-3645493.809100.09
336699-3669994.439100.73
435540-3554091.45797.60
536667-3666794.357100.54
632677-3267784.08990.06
极限136388-3638893.63993.452.26100.35100.102.21
236628-3662894.256101.00
337769-3776997.193103.96
435802-3580292.13198.73
535676-3567691.80798.46
635626-3562691.67898.07
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