二甲双胍恩格列净片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号DC033-12306002对照品来源中检院对照品使用方法直接使用
对照品含量(%)98.99对照品水分(%)0对照品稀释倍数2000
标示量(mg)5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%
19.899091491151911629125491250911460.16
29.929168191643916620.03
单位质量响应值RSD%判断
9215.989240.120.19数据可信
供试品溶液-F24706批-恩格列净-水
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min144701-4470143.15640.1315.9443.1640.1315.94
230101-3010129.06129.06
342457-4245740.99040.99
442553-4255341.08241.08
539543-3954338.17638.18
650060-5006048.33048.33
10min183424-8342480.54175.4611.9380.6175.5311.94
261458-6145859.33459.38
379349-7934976.60776.67
478854-7885476.12976.20
576600-7660073.95374.02
689283-8928386.19786.28
15min1101239-10123997.74093.597.0397.9593.787.04
283423-8342380.54080.69
398933-9893395.51495.71
498867-9886795.45095.65
597464-9746494.09694.28
6101716-10171698.20198.42
20min1104124-104124100.52598.872.99100.8999.223.00
296295-9629592.96793.25
3104387-104387100.779101.13
4103191-10319199.62599.98
5103669-103669100.086100.43
6102793-10279399.24099.63
30min1103793-103793100.20699.900.60100.74100.410.58
2103513-10351399.935100.37
3103589-103589100.009100.53
4103152-10315299.587100.11
5104306-104306100.701101.21
6102484-10248498.94299.50
45min1104138-104138100.53999.820.66101.24100.500.64
2103681-103681100.098100.70
3103591-103591100.011100.70
4102812-10281299.25999.95
5103795-103795100.208100.89
6102345-10234598.80899.53
60min1103633-103633100.05199.670.62100.92100.510.62
2102994-10299499.434100.20
3103626-103626100.045100.90
4103067-10306799.505100.36
5103938-103938100.346101.19
6102162-10216298.63199.51
极限1104412-104412100.80399.770.87101.84100.780.84
2104097-104097100.499101.43
3103115-10311599.551100.57
4102693-10269399.144100.16
5103690-103690100.106101.12
6102044-10204498.51799.56
二甲双胍恩格列净片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号100664-202106对照品来源中检所对照品对照品使用方法105℃烘干2小时
对照品含量(%)100对照品水分(%)0对照品稀释倍数20
标示量(mg)500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%
110.044660624657044658064650754654304656150.09
210.144674954660314667630.23
单位质量响应值RSD%判断
46376.0046031.850.53数据可信
供试品溶液-F24706批-二甲双胍-水
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1268030-26803052.21049.2512.5252.2149.2512.52
2199161-19916138.79538.79
3256002-25600249.86749.87
4256813-25681350.02550.02
5242338-24233847.20547.21
6294738-29473857.41257.41
10min1437109-43710985.14580.849.5385.2380.929.53
2346106-34610667.41867.48
3419048-41904881.62781.71
4416845-41684581.19881.28
5406225-40622579.12979.21
6464740-46474090.52790.62
15min1504433-50443398.25995.345.0098.4995.565.01
2440731-44073185.85186.03
3497317-49731796.87397.09
4497268-49726896.86497.08
5491320-49132095.70595.92
6505531-50553198.47398.72
20min1512943-51294399.91799.262.01100.3199.642.02
2492759-49275995.98596.31
3524402-524402102.149102.53
4509311-50931199.20999.59
5511057-51105799.54999.92
6506896-50689698.73999.15
30min1511711-51171199.67799.220.54100.2499.770.52
2512170-51217099.766100.25
3509380-50938099.22399.77
4506931-50693198.74699.29
5510798-51079899.499100.04
6505337-50533798.43599.01
45min1509658-50965899.27799.050.51100.0099.760.49
2511118-51111899.561100.21
3508911-50891199.13199.85
4506794-50679498.71999.43
5510308-51030899.404100.11
6504144-50414498.20398.94
60min1509190-50919099.18698.870.54100.0899.740.51
2510463-51046399.434100.25
3507556-50755698.86899.75
4506579-50657998.67799.55
5508838-50883899.11799.98
6502778-50277897.93798.84
极限1514128-514128100.14898.740.88101.2099.780.86
2509226-50922699.193100.17
3504703-50470398.31299.36
4504244-50424498.22299.26
5507600-50760098.87699.91
6501531-50153197.69498.76
二甲双胍恩格列净片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号DC033-12306002对照品来源中检院对照品使用方法直接使用
对照品含量(%)98.99对照品水分(%)0对照品稀释倍数2000
标示量(mg)5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%
19.899146691624914889136591410914710.11
29.929124291028911350.17
单位质量响应值RSD%判断
9248.849187.000.48数据可信
供试品溶液-F24706批-恩格列净-水
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min140425-4042539.07146.9917.5039.0746.9917.50
259467-5946757.47557.48
356740-5674054.84054.84
444016-4401642.54242.54
551471-5147149.74749.75
639583-3958338.25738.26
10min177201-7720174.61585.2010.1574.6885.2810.15
298693-9869395.38895.48
397107-9710793.85593.95
483069-8306980.28780.36
591731-9173188.65988.74
681095-8109578.37978.44
15min197950-9795094.67098.482.2994.8698.702.31
2103620-103620100.150100.40
3104143-104143100.655100.90
4100695-10069597.32397.53
5103310-10331099.850100.08
6101607-10160798.20498.40
20min1106956-106956103.374100.791.31103.72101.171.28
2103794-103794100.318100.74
3103684-103684100.212100.63
4103559-103559100.091100.46
5103310-10331099.850100.25
6104373-104373100.877101.24
30min1108647-108647105.008100.982.05105.53101.542.02
2104286-104286100.793101.38
3103776-103776100.300100.88
4103585-103585100.116100.65
5102494-10249499.06199.62
6104111-104111100.624101.15
45min1108336-108336104.708100.562.07105.40101.282.04
2103616-103616100.146100.90
3103351-10335199.890100.64
4103263-10326399.805100.51
5102313-10231398.88699.62
6103383-10338399.921100.61
60min1107896-107896104.282100.651.98105.15101.541.96
2104132-104132100.645101.57
3103977-103977100.495101.41
4102906-10290699.460100.33
5101788-10178898.37999.27
6104133-104133100.645101.51
极限1108125-108125104.504100.442.07105.55101.492.05
2103489-103489100.023101.11
3103274-10327499.815100.90
4103248-10324899.790100.82
5101889-10188998.47799.53
6103471-103471100.006101.03
二甲双胍恩格列净片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号100664-202106对照品来源中检所对照品对照品使用方法105℃烘干2小时
对照品含量(%)100对照品水分(%)0对照品稀释倍数20
标示量(mg)500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%
110.044654974650804656564643324657004652530.13
210.144629404634974632180.09
单位质量响应值RSD%判断
46339.9445682.251.02数据可信
供试品溶液-F24706批-二甲双胍-水
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1246708-24670848.26056.1314.1648.2656.1314.16
2335828-33582865.69365.69
3328085-32808564.17864.18
4264545-26454551.74951.75
5302053-30205359.08659.09
6244312-24431247.79147.79
10min1411656-41165680.52689.017.9080.6189.107.90
2494942-49494296.81896.93
3493406-49340696.51896.62
4432833-43283384.66984.75
5470250-47025091.98892.09
6427095-42709583.54683.63
15min1493148-49314896.46799.071.5596.6899.311.56
2507932-50793299.35999.63
3511138-51113899.986100.25
4503677-50367798.52798.75
5516281-516281100.992101.24
6506536-50653699.08699.30
20min1526599-526599103.011100.131.44103.39100.541.42
2507624-50762499.29999.74
3510274-51027499.817100.25
4509213-50921399.610100.00
5507111-50711199.19999.62
6510497-51049799.861100.24
30min1530795-530795103.831100.141.87104.38100.711.85
2506950-50695099.16799.77
3510780-51078099.916100.52
4509001-50900199.568100.13
5504023-50402398.59499.18
6509877-50987799.740100.29
45min1528377-528377103.35899.851.77104.08100.591.74
2504883-50488398.76399.53
3507750-50775099.324100.09
4508253-50825399.422100.15
5504172-50417298.62499.37
6509149-50914999.597100.31
60min1526218-526218102.93699.941.68103.83100.841.66
2507999-50799999.372100.30
3514259-514259100.597101.53
4505721-50572198.92799.82
5501870-50187098.17399.09
6509194-50919499.606100.49
极限1527670-527670103.22099.411.95104.28100.481.92
2503464-50346498.48599.58
3505501-50550198.88499.98
4504838-50483898.75499.81
5499991-49999197.80698.88
6507611-50761199.296100.35
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