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%
110.354276091428009742866414284858428484342825060.11
210.474291439428997542907070.03
单位质量响应值RSD%判断
413768.70409809.650.68数据可信
供试品溶液-2025081621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%
5min1194835-1948354.7324.686.664.734.686.65
2192622-1926224.6784.68
3207205-2072055.0325.03
4204667-2046674.9704.97
5182478-1824784.4314.43
6173772-1737724.2204.22
10min1346617-3466178.4188.623.028.448.653.05
2368322-3683228.9458.97
3353835-3538358.5938.62
4365295-3652958.8718.90
5355965-3559658.6458.67
6340279-3402798.2648.28
15min1507471-50747112.32412.242.7712.3912.302.76
2522897-52289712.69812.77
3493326-49332611.98012.05
4511160-51116012.41312.48
5505041-50504112.26512.33
6483181-48318111.73411.80
20min1597790-59779014.51715.093.2914.6415.223.28
2624796-62479615.17315.30
3614279-61427914.91815.05
4637243-63724315.47515.61
5651066-65106615.81115.94
6603106-60310614.64614.77
30min1811377-81137719.70419.940.8119.9020.150.83
2825379-82537920.04420.25
3819996-81999619.91320.12
4822767-82276719.98120.19
5830615-83061520.17120.38
6817597-81759719.85520.05
45min11084165-108416526.32926.331.5026.6326.631.50
21110502-111050226.96827.28
31078357-107835726.18826.49
41077580-107758026.16926.48
51092285-109228526.52626.83
61062255-106225525.79726.09
60min11266253-126625330.75131.311.6131.1831.741.61
21308170-130817031.76932.21
31260529-126052930.61231.04
41305089-130508931.69432.13
51302743-130274331.63732.08
61291726-129172631.36931.79
120min11985749-198574948.22447.081.6248.8147.671.60
21930029-193002946.87047.47
31900336-190033646.14946.74
41918513-191851346.59147.19
51964551-196455147.70948.31
61931890-193189046.91647.50
180min12426093-242609358.91758.600.4759.7459.420.47
22403870-240387058.37859.21
32398343-239834358.24359.06
42420486-242048658.78159.61
52421601-242160158.80859.64
62406792-240679258.44959.26
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
240min12775969-277596967.41467.260.7268.5368.380.71
22768754-276875467.23968.37
32757977-275797766.97768.09
42738407-273840766.50267.63
52795044-279504467.87769.01
62782577-278257767.57468.68
360min13317005-331700580.55379.920.9282.0181.370.91
23286225-328622579.80581.27
33259161-325916179.14880.59
43260879-326087979.19080.65
53334550-333455080.97982.45
63286906-328690679.82281.27
480min13634420-363442088.26188.490.4690.1290.350.46
23632057-363205788.20490.07
33622817-362281787.98089.82
43650843-365084388.66090.51
53665987-366598789.02890.90
63657341-365734188.81890.66
600min13893263-389326394.54793.281.1896.8595.581.15
23806807-380680792.44894.75
33854515-385451593.60695.88
43880338-388033894.23396.53
53838354-383835493.21495.53
63773825-377382591.64793.93
720min13922386-392238695.25495.580.3998.0398.350.39
23936291-393629195.59298.36
33935113-393511395.56498.31
43933845-393384595.53398.30
53964620-396462096.28099.07
63923384-392338495.27998.02
极限13903322-390332294.79295.060.6498.0498.300.61
23951849-395184995.97099.21
33935686-393568695.57798.80
43909081-390908194.93198.18
53883597-388359794.31397.58
63902420-390242094.77097.99
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%
112.002994329965299702970430014299190.42
212.022982629789298080.09
单位质量响应值RSD%判断
2493.252479.870.39数据可信
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%
5min137168-3716896.14397.903.1996.1497.903.19
238040-3804098.39998.40
338818-38818100.412100.41
436429-3642994.23294.23
539607-39607102.452102.45
637013-3701395.74395.74
10min139467-39467102.09099.761.83102.57100.251.83
238959-38959100.776101.27
337917-3791798.08198.58
437612-3761297.29297.76
538987-38987100.849101.36
638465-3846599.49899.98
15min140479-40479104.708101.522.19105.70102.512.18
239513-39513102.209103.21
338494-3849499.573100.57
438131-3813198.63499.59
539757-39757102.840103.86
639109-39109101.164102.14
20min139150-39150101.270101.642.52102.79103.142.51
239078-39078101.084102.59
338481-3848199.540101.03
438497-3849799.581101.03
541173-41173106.503108.03
639378-39378101.860103.34
30min139744-39744102.807101.111.62104.83103.121.61
238716-38716100.148102.16
338842-38842100.474102.46
438130-3813098.632100.58
539488-39488102.145104.21
639616-39616102.476104.47
45min140386-40386104.468101.572.23107.00104.082.21
239464-39464102.083104.60
338520-3852099.641102.13
437967-3796798.210100.65
539648-39648102.559105.13
639618-39618102.481104.98
60min139232-39232101.482100.391.82104.54103.411.81
238470-3847099.511102.53
337924-3792498.099101.09
438205-3820598.826101.76
539358-39358101.808104.90
639672-39672102.621105.64
120min140392-40392104.483100.422.73108.05103.942.68
238028-3802898.368101.89
337851-3785197.910101.39
437880-3788097.985101.41
539461-39461102.075105.67
639316-39316101.700105.23
180min139791-39791102.928100.431.75107.02104.451.73
238258-3825898.963102.98
338263-3826398.976102.94
438251-3825198.945102.86
538948-38948100.748104.85
639441-39441102.023106.06
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
240min139320-39320101.71099.412.08106.31103.932.06
237960-3796098.192102.70
337907-3790798.055102.52
437354-3735496.625101.04
538855-38855100.507105.12
639182-39182101.353105.90
360min139001-39001100.88598.322.27106.00103.342.24
237441-3744196.850101.85
337349-3734996.612101.57
436959-3695995.603100.50
538527-3852799.659104.77
638783-38783100.321105.38
480min138392-3839299.31098.161.65104.92103.671.64
237379-3737996.689102.17
337583-3758397.217102.65
437246-3724696.345101.72
538303-3830399.079104.69
638771-38771100.290105.85
600min139003-39003100.89097.861.97107.00103.861.94
237080-3708095.916101.88
337944-3794498.151104.07
436978-3697895.652101.51
538132-3813298.637104.74
637855-3785597.921103.98
720min138236-3823698.90697.941.31105.52104.441.33
237343-3734396.596103.04
337714-3771497.556103.97
437252-3725296.361102.69
538264-3826498.979105.58
638375-3837599.266105.81
极限138066-3806698.46697.051.26105.58104.041.26
237266-3726696.397103.33
337697-3769797.512104.41
436834-3683495.279102.09
537292-3729296.464103.56
637966-3796698.208105.25
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%
110.354294988429394942957024293873429414242945310.02
210.474299321429862542989730.02
单位质量响应值RSD%判断
414930.53410599.140.75数据可信
供试品溶液-2025081621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%
5min1182944-1829444.4324.778.424.434.778.46
2211985-2119855.1365.14
3203111-2031114.9214.92
4212949-2129495.1595.16
5199053-1990534.8234.82
6171409-1714094.1534.15
10min1387334-3873349.3849.566.389.419.586.39
2427473-42747310.35710.38
3400293-4002939.6989.72
4416564-41656410.09210.12
5371384-3713848.9989.02
6363329-3633298.8038.82
15min1509495-50949512.34412.501.9112.4112.581.95
2528814-52881412.81212.89
3520415-52041512.60812.68
4524154-52415412.69912.78
5510309-51030912.36412.43
6503326-50332612.19412.26
20min1683104-68310416.55015.952.4416.6816.092.39
2643486-64348615.59015.73
3661697-66169716.03116.17
4638048-63804815.45815.60
5661667-66166716.03116.16
6662532-66253216.05216.18
30min1818232-81823219.82420.361.7020.0420.571.69
2854370-85437020.69920.92
3832768-83276820.17620.39
4856640-85664020.75420.97
5838726-83872620.32020.53
6840463-84046320.36220.57
45min11101808-110180826.69426.631.9427.0126.941.93
21120662-112066227.15127.47
31077121-107712126.09626.41
41115624-111562427.02927.35
51110138-111013826.89627.21
61069071-106907125.90126.21
60min11302899-130289931.56631.651.1032.0132.101.11
21331681-133168132.26332.72
31308292-130829231.69732.14
41298481-129848131.45931.91
51308110-130811031.69232.14
61288862-128886231.22631.66
120min11968630-196863047.69547.610.8748.3048.220.86
21975772-197577247.86848.49
31943711-194371147.09147.70
41962230-196223047.54048.15
51990132-199013248.21648.82
61950507-195050747.25647.85
180min12434331-243433158.97859.190.5759.8260.030.55
22424185-242418558.73259.59
32436837-243683759.03959.88
42452531-245253159.41960.27
52448144-244814459.31260.16
62461844-246184459.64460.47
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
240min12821487-282148768.35868.520.4569.5069.660.44
22817084-281708468.25169.40
32813067-281306768.15469.29
42837577-283757768.74869.90
52838084-283808468.76069.90
62842812-284281268.87470.00
360min13356977-335697781.33181.251.2482.8182.741.21
23307279-330727980.12781.62
33384310-338431081.99383.47
43297710-329771079.89581.39
53389160-338916082.11183.60
63386405-338640582.04483.52
480min13724417-372441790.23389.451.3892.1291.341.35
23614451-361445187.56989.46
33653320-365332088.51190.40
43688128-368812889.35491.25
53748973-374897390.82892.73
63724201-372420190.22892.11
600min13897171-389717194.41994.680.7596.7697.010.73
23861227-386122793.54895.88
33895426-389542694.37796.71
43919986-391998694.97297.31
53937025-393702595.38497.74
63935604-393560495.35097.68
720min13990231-399023196.67396.131.0199.4898.940.98
24005803-400580397.05199.85
33896292-389629294.39897.20
43955146-395514695.82398.64
53964988-396498896.06298.89
63995306-399530696.79699.61
极限14120861-412086199.83896.082.36103.1399.372.29
23858411-385841193.48096.77
33917474-391747494.91198.18
43917054-391705494.90198.19
54023024-402302497.468100.78
63957891-395789195.89099.18
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%
112.002994829741299462995529973299130.33
212.022996029989299740.07
单位质量响应值RSD%判断
2492.752493.680.03数据可信
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%
5min138555-3855599.46498.642.5599.4698.642.55
238829-38829100.171100.17
339106-39106100.886100.89
438928-38928100.427100.43
537005-3700595.46695.47
636992-3699295.43295.43
10min139687-39687102.385101.192.11102.88101.682.11
239476-39476101.840102.34
339489-39489101.874102.38
440213-40213103.742104.24
537976-3797697.97198.45
638492-3849299.30299.78
15min139267-39267101.301101.560.34102.31102.560.33
239314-39314101.422102.43
339442-39442101.753102.77
439373-39373101.575102.60
539585-39585102.122103.09
639222-39222101.185102.16
20min139566-39566102.072101.840.76103.59103.340.76
239734-39734102.506104.02
339830-39830102.754104.28
439237-39237101.224102.75
539045-39045100.728102.21
639437-39437101.740103.22
30min138660-3866099.735100.860.92101.76102.880.89
238819-38819100.145102.18
338919-38919100.403102.44
439478-39478101.845103.88
539165-39165101.038103.02
639529-39529101.977103.97
45min139180-39180101.077101.381.26103.60103.901.23
239047-39047100.734103.26
338623-3862399.640102.18
440091-40091103.427105.97
539317-39317101.430103.92
639528-39528101.974104.47
60min138974-38974100.545101.310.71103.58104.340.69
239787-39787102.643105.68
339139-39139100.971104.01
439278-39278101.330104.39
539161-39161101.028104.02
639284-39284101.345104.35
120min139195-39195101.115101.180.69104.65104.720.66
239262-39262101.288104.84
338721-3872199.893103.43
439324-39324101.448105.02
539298-39298101.381104.88
639526-39526101.969105.48
180min138929-38929100.429100.521.32104.47104.561.27
238284-3828498.765102.82
339016-39016100.654104.69
439045-39045100.728104.80
538666-3866699.751103.76
639835-39835102.766106.79
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
240min138459-3845999.217100.461.26103.76105.001.21
238668-3866899.756104.30
338749-3874999.965104.51
439245-39245101.244105.82
538740-3874099.942104.45
639789-39789102.648107.19
360min138366-3836698.97799.911.34104.01104.951.28
238144-3814498.404103.45
339192-39192101.108106.15
438471-3847199.248104.33
538703-3870399.846104.85
639492-39492101.882106.93
480min138462-3846299.22499.641.41104.76105.181.34
238016-3801698.074103.61
338312-3831298.837104.39
438667-3866799.753105.33
538662-3866299.740105.24
639611-39611102.189107.75
600min137990-3799098.00799.611.22104.03105.651.17
238227-3822798.618104.65
338550-3855099.451105.50
438910-38910100.380106.46
538699-3869999.836105.84
639294-39294101.371107.44
720min137741-3774197.36498.301.30103.88104.841.24
238188-3818898.518105.04
337607-3760797.019103.56
438236-3823698.641105.22
537869-3786997.695104.20
638979-38979100.558107.14
极限139040-39040100.71698.471.55107.72105.501.44
237314-3731496.263103.28
337838-3783897.615104.64
438021-3802198.087105.16
538359-3835998.959105.95
638444-3844499.178106.26
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