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%
110.209322193684936919340393563935120.22
210.109400793785938960.17
单位质量响应值RSD%判断
9167.849296.630.99数据可信
供试品溶液-2024092321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%
5min136414-3641435.14141.7227.7135.1441.7227.72
249556-4955647.82447.82
329847-2984728.80428.80
456992-5699255.00055.00
531823-3182330.71130.71
654730-5473052.81752.82
10min172817-7281770.27277.4215.4470.3377.4915.45
287344-8734484.29184.37
365830-6583063.52963.58
494867-9486791.55191.64
569302-6930266.88066.93
691179-9117987.99288.08
15min192919-9291989.67192.235.0889.8592.435.11
298387-9838794.94895.17
388623-8862385.52585.68
4101012-10101297.48197.73
592782-9278289.53989.70
699691-9969196.20696.44
20min198294-9829494.85895.331.7295.1895.681.76
298973-9897395.51395.89
395829-9582992.47992.78
4100697-10069797.17797.58
598807-9880795.35395.67
6100105-10010596.60697.00
30min199297-9929795.82696.240.7096.3196.750.73
298902-9890295.44595.98
399448-9944895.97296.42
4100795-10079597.27297.84
599627-9962796.14596.62
6100294-10029496.78897.34
45min199767-9976796.28096.330.7996.9297.000.82
299357-9935795.88496.58
398542-9854295.09895.71
4100706-10070697.18697.92
5100209-10020996.70697.34
6100337-10033796.83097.55
60min199604-9960496.12296.200.7196.9397.040.73
298867-9886795.41196.27
398904-9890495.44796.22
4100625-10062597.10898.00
5100092-10009296.59397.39
6100033-10003396.53697.42
极限1102061-10206198.49498.690.7599.4699.690.74
2101035-10103597.50398.52
3102019-10201998.45399.38
4102456-10245698.87599.93
5103255-10325599.646100.60
6102789-10278999.196100.24
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%
110.19 4665354659904671824655534668254664170.14
210.094648284650454649360.04
单位质量响应值RSD%判断
45772.0346078.890.48数据可信
供试品溶液-2024092321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%
5min1231392-23139245.34651.9222.7145.3551.9222.70
2298865-29886558.56958.57
3196561-19656138.52038.52
4332166-33216665.09565.10
5207765-20776540.71640.72
6322758-32275863.25263.25
10min1411968-41196880.73486.8912.1080.8186.9812.11
2474301-47430192.95093.05
3380775-38077574.62174.69
4505790-50579099.12199.23
5395620-39562077.53077.60
6491823-49182396.38396.49
15min1500153-50015398.01699.422.7198.2399.662.74
2514996-514996100.925101.18
3487089-48708995.45695.64
4520329-520329101.970102.24
5500042-50004297.99498.19
6521438-521438102.187102.45
20min1515905-515905101.103101.260.49101.48101.660.50
2514099-514099100.749101.17
3514586-514586100.844101.19
4516014-516014101.124101.57
5519905-519905101.887102.25
6519721-519721101.851102.29
30min1513910-513910100.712101.290.78101.25101.860.76
2512320-512320100.400100.99
3523330-523330102.558103.07
4514872-514872100.900101.51
5517570-517570101.429101.96
6519206-519206101.750102.36
45min1514235-514235100.776101.160.57101.49101.890.55
2512348-512348100.406101.16
3517039-517039101.325102.01
4514699-514699100.867101.65
5519740-519740101.854102.55
6519022-519022101.714102.49
60min1514011-514011100.732100.900.57101.61101.800.55
2510190-51019099.983100.91
3515926-515926101.107101.96
4513617-513617100.655101.60
5517871-517871101.488102.36
6517648-517648101.444102.39
极限1511837-511837100.306100.690.60101.35101.760.59
2509360-50936099.820100.91
3514452-514452100.818101.84
4513049-513049100.543101.66
5516657-516657101.250102.29
6517504-517504101.416102.53
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%
110.209512095180954139562595521953720.23
210.109600196639963200.47
单位质量响应值RSD%判断
9350.209536.631.40数据可信
供试品溶液-2024092321批-恩格列净-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%
5min148585-4858545.84043.2519.1045.8443.2419.10
249243-4924346.46146.46
349681-4968146.87546.87
456875-5687553.66253.66
533620-3362031.72131.72
637003-3700334.91334.91
10min185670-8567080.83179.1312.9080.9179.2012.91
290370-9037085.26585.34
392917-9291787.66887.75
493387-9338788.11288.20
568681-6868164.80164.85
672195-7219568.11768.17
15min198058-9805892.51992.073.8492.7392.273.86
299958-9995894.31194.53
3102361-10236196.57996.80
497766-9776692.24392.48
591355-9135586.19486.36
695984-9598490.56290.73
20min198998-9899893.40694.061.8893.7794.421.89
2101113-10111395.40195.78
3102796-10279696.98997.37
498228-9822892.67993.07
598096-9809692.55592.86
698902-9890293.31593.64
30min1100293-10029394.62894.541.7295.1595.051.72
2101320-10132095.59796.13
3102752-10275296.94897.49
497701-9770192.18292.73
599578-9957893.95394.41
699545-9954593.92294.40
45min1100779-10077995.08694.881.6395.7695.551.63
2101014-10101495.30896.00
3103244-10324497.41298.12
498295-9829592.74293.44
599766-9976694.13094.75
6100240-10024094.57895.21
60min1100518-10051894.84094.881.4195.6895.701.41
2101250-10125095.53196.38
3102674-10267496.87497.74
498439-9843992.87893.73
599798-9979894.16194.93
6100659-10065994.97395.77
极限1101293-10129395.57196.351.2296.5797.341.23
2102815-10281597.00798.02
3104123-10412398.24199.27
4100643-10064394.95895.97
5101522-10152295.78796.72
6102312-10231296.53397.48
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%
110.19 4740304732404719404722774729924728960.18
210.094744074739724741900.07
单位质量响应值RSD%判断
46407.8546996.040.90数据可信
供试品溶液-2024092321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%
5min1298835-29883557.59154.7915.9657.5954.7915.96
2301489-30148958.10358.10
3304829-30482958.74658.75
4341218-34121865.75965.76
5221003-22100342.59242.59
6238351-23835145.93545.93
10min1478108-47810892.14189.5610.8492.2489.6510.84
2494753-49475395.34895.45
3506546-50654697.62197.72
4505777-50577797.47397.58
5392260-39226075.59675.67
6410876-41087679.18479.26
15min1525726-525726101.31799.802.86101.57100.042.88
2528954-528954101.940102.20
3533708-533708102.856103.12
4514250-51425099.10699.38
5493428-49342895.09395.29
6511054-51105498.49098.70
20min1525731-525731101.318100.781.44101.74101.181.45
2527689-527689101.696102.12
3533768-533768102.867103.30
4513105-51310598.88599.32
5517742-51774299.779100.13
6519459-519459100.110100.48
30min1523751-523751100.937100.661.23101.52101.231.24
2526623-526623101.490102.09
3531061-531061102.346102.95
4512514-51251498.77199.37
5519092-519092100.039100.56
6520746-520746100.358100.90
45min1523676-523676100.922100.641.34101.68101.381.34
2526352-526352101.438102.20
3532034-532034102.533103.31
4511954-51195498.66399.43
5517618-51761899.755100.44
6521539-521539100.511101.22
60min1521867-521867100.574100.381.41101.50101.291.41
2525721-525721101.316102.25
3530955-530955102.325103.27
4509917-50991798.27199.20
5516354-51635499.511100.37
6520331-520331100.278101.15
极限1519991-519991100.212100.081.38101.30101.161.38
2523816-523816100.949102.05
3529414-529414102.028103.14
4508394-50839497.97799.07
5515834-51583499.411100.43
6518525-51852599.930100.97
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