盐酸二甲双胍片项目信息
介质体积(ml)1000取样体积(ml)1.5补液体积(ml)1.5
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(%)100.0对照品水分(%)0对照品稀释倍数10
标示量(mg)1000供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.079598339625389645579632389630949626520.19
210.059576069578179577120.02
单位质量响应值RSD%判断
95596.0395294.730.23数据可信
供试品溶液-24112601批-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%
5min136826-368263.8583.9812.453.863.9812.45
236865-368653.8623.86
335328-353283.7013.70
445890-458904.8084.81
540708-407084.2654.27
632314-323143.3863.39
10min180468-804688.4318.638.838.448.648.85
278147-781478.1888.19
379804-798048.3618.37
487802-878029.1999.21
594029-940299.8529.86
673951-739517.7487.75
15min1122921-12292112.87913.025.1312.9013.045.13
2120795-12079512.65612.67
3122199-12219912.80312.82
4127923-12792313.40313.42
5134943-13494314.13814.16
6116716-11671612.22912.25
20min1157799-15779916.53316.564.0016.5716.604.00
2155046-15504616.24516.28
3155407-15540716.28216.32
4160384-16038416.80416.84
5169208-16920817.72817.77
6150736-15073615.79315.83
30min1212563-21256322.27122.222.9722.3322.292.97
2209404-20940421.94022.00
3209085-20908521.90621.97
4212196-21219622.23222.30
5223859-22385923.45423.52
6205591-20559121.54021.60
45min1278163-27816329.14429.032.4129.2429.122.41
2274050-27405028.71328.81
3273520-27352028.65728.75
4274829-27482928.79428.89
5289920-28992030.37630.48
6271780-27178028.47528.57
60min1332199-33219934.80534.902.4134.9435.042.41
2326913-32691334.25134.39
3340784-34078435.70535.84
4327227-32722734.28434.43
5345001-34500136.14736.30
6326312-32631234.18834.32
120min1493393-49339351.69451.402.0951.8951.592.09
2483730-48373050.68150.87
3486497-48649750.97151.16
4483183-48318350.62450.82
5510161-51016153.45153.65
6486613-48661350.98451.17
180min1606473-60647363.54262.981.4563.8163.241.45
2594397-59439762.27662.54
3598493-59849362.70562.97
4592516-59251662.07962.35
5615780-61578064.51764.80
6598832-59883262.74163.00
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
240min1696369-69636972.96072.291.2873.3272.651.28
2682371-68237171.49471.85
3687857-68785772.06872.43
4681020-68102071.35271.72
5704129-70412973.77374.15
6688008-68800872.08472.44
360min1814820-81482085.37184.541.0685.8485.011.06
2806889-80688984.54085.01
3804277-80427784.26684.74
4794258-79425883.21683.69
5817739-81773985.67686.17
6803209-80320984.15484.62
480min1913800-91380095.74194.571.0996.3495.161.09
2893738-89373893.63994.23
3901453-90145394.44795.04
4891514-89151493.40694.00
5914693-91469395.83496.45
6900442-90044294.34194.93
600min1957322-957322100.30198.761.12101.0599.501.12
2935463-93546398.01198.74
3941161-94116198.60899.35
4928857-92885797.31898.05
5951919-95191999.735100.50
6940890-94089098.57999.31
720min1973575-973575102.004100.471.15102.90101.361.15
2953138-95313899.862100.74
3957669-957669100.337101.22
4943695-94369598.87399.75
5969661-969661101.594102.51
6956094-956094100.172101.05
极限1976836-976836102.345100.721.45103.39101.761.45
2952634-95263499.810100.84
3958980-958980100.474101.51
4944891-94489198.998100.03
5979783-979783102.654103.72
6955098-955098100.068101.10
盐酸二甲双胍片项目信息
介质体积(ml)1000取样体积(ml)1.5补液体积(ml)1.5
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(%)100.0对照品水分(%)0对照品稀释倍数10
标示量(mg)1000供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.079522439525959526939525319518969523920.04
210.059563079561619562340.02
单位质量响应值RSD%判断
94577.1695147.660.43数据可信
供试品溶液-25010702批-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%
5min142475-424754.4784.523.094.484.523.11
244754-447544.7184.72
342664-426644.4984.50
444189-441894.6584.66
541186-411864.3424.34
642204-422044.4494.45
10min194172-941729.9279.831.959.939.831.94
295192-9519210.03510.04
392059-920599.7059.71
495105-9510510.02610.03
591468-914689.6429.65
691298-912989.6249.63
15min1135773-13577314.31314.211.4614.3314.231.44
2137542-13754214.49914.52
3133042-13304214.02514.05
4136028-13602814.34014.36
5133552-13355214.07914.10
6132656-13265613.98414.01
20min1169179-16917917.83417.721.0517.8817.771.05
2170027-17002717.92417.97
3167710-16771017.67917.72
4169689-16968917.88817.93
5166113-16611317.51117.55
6166138-16613817.51417.56
30min1223049-22304923.51323.321.0623.5823.391.06
2223835-22383523.59623.67
3220485-22048523.24323.31
4222746-22274623.48123.55
5218882-21888223.07423.14
6218284-21828423.01123.08
45min1287396-28739630.29630.000.9430.4030.100.93
2287388-28738830.29630.40
3284031-28403129.94230.05
4285527-28552730.09930.20
5282182-28218229.74729.85
6281055-28105529.62829.73
60min1341004-34100435.94836.113.8536.1036.263.83
2339845-33984535.82535.98
3368634-36863438.86039.01
4337954-33795435.62635.78
5333744-33374435.18235.33
6333814-33381435.19035.34
120min1496653-49665352.35651.690.8752.5651.900.87
2493213-49321351.99352.20
3490424-49042451.69951.91
4489891-48989151.64351.85
5487003-48700351.33851.54
6484799-48479951.10651.31
180min1605924-60592463.87563.020.8264.1663.300.82
2599628-59962863.21163.49
3597685-59768563.00663.29
4597812-59781263.01963.30
5593943-59394362.61262.89
6591861-59186162.39262.67
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
240min1693092-69309273.06472.130.7973.4472.500.79
2686711-68671172.39172.77
3683664-68366472.07072.45
4683897-68389772.09472.47
5680712-68071271.75872.13
6677269-67726971.39671.77
360min1805043-80504384.86584.200.6885.3584.680.68
2800918-80091884.43084.92
3801068-80106884.44684.93
4799720-79972084.30484.79
5796043-79604383.91684.40
6789331-78933183.20983.69
480min1900529-90052994.93194.110.6995.5594.720.69
2894713-89471394.31894.93
3886716-88671693.47594.09
4898361-89836194.70295.31
5890167-89016793.83994.44
6885783-88578393.37693.98
600min1938528-93852898.93798.180.6499.6998.930.64
2932500-93250098.30199.06
3924166-92416697.42398.18
4937419-93741998.82099.57
5929875-92987598.02498.77
6925718-92571897.58698.33
720min1955201-955201100.694100.000.58101.60100.900.58
2948078-94807899.943100.85
3940827-94082799.179100.08
4954634-954634100.634101.54
5946839-94683999.813100.71
6945849-94584999.708100.60
极限1953853-953853100.55299.940.56101.61100.990.56
2948958-948958100.036101.09
3939911-93991199.082100.13
4952128-952128100.370101.42
5949596-949596100.103101.15
6943809-94380999.493100.53
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