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101566-202301对照品来源中检所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1000
标示量(mg)10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%
19.855451775463645456655463465469075460920.13
29.895460445461505460970.02
单位质量响应值RSD%判断
55440.8155217.090.29数据可信
中间条件12月-供试品溶液-2024053011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%
5min1385448-38544862.69965.393.1062.7065.403.10
2396207-39620764.44964.45
3406717-40671766.15866.16
4418093-41809368.00968.01
5393264-39326463.97063.97
6412402-41240267.08367.08
10min1508630-50863082.73685.422.0182.8485.532.01
2515008-51500883.77383.88
3530996-53099686.37486.48
4531721-53172186.49286.61
5533184-53318486.73086.84
6531250-53125086.41586.53
15min1543956-54395688.48289.811.4688.7290.061.46
2542597-54259788.26188.51
3557336-55733690.65990.91
4555839-55583990.41590.67
5563117-56311791.59991.85
6550012-55001289.46789.72
20min1559755-55975591.05291.601.3991.4492.001.39
2553920-55392090.10390.50
3561320-56132091.30791.71
4564495-56449591.82392.23
5577391-57739193.92194.32
6561950-56195091.40991.81
30min1574692-57469293.48293.471.1794.0294.031.17
2564810-56481091.87492.42
3574795-57479593.49994.06
4571636-57163692.98593.55
5585289-58528995.20695.77
6576596-57659693.79194.35
45min1585043-58504395.16694.851.2995.8695.561.29
2572743-57274393.16593.86
3581021-58102194.51195.22
4577359-57735993.91694.63
5591092-59109296.14996.87
6591497-59149796.21596.93
60min1585425-58542595.22895.511.2596.0896.381.25
2577672-57767293.96794.82
3584928-58492895.14796.02
4584075-58407595.00895.88
5592095-59209596.31397.19
6598824-59882497.40798.28
极限1595534-59553496.87298.240.9997.8999.270.99
2598630-59863097.37698.38
3611134-61113499.410100.44
4608629-60862999.002100.03
5606165-60616598.60199.64
6603645-60364598.19199.23
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101566-202301对照品来源中检所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1000
标示量(mg)10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%
19.855423695417765425925413285422445420620.10
29.895413565418415415980.07
单位质量响应值RSD%判断
55031.6854762.180.35数据可信
中间条件12月-供试品溶液-2024053011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%
5min1393686-39368664.54366.343.9064.5466.343.90
2424032-42403269.51869.52
3386240-38624063.32263.32
4422716-42271669.30269.30
5395673-39567364.86864.87
6405634-40563466.50166.50
10min1518072-51807284.93588.853.0185.0488.963.01
2564708-56470892.58192.70
3540212-54021288.56588.67
4549331-54933190.06090.18
5530529-53052986.97787.09
6548977-54897790.00290.11
15min1543852-54385289.16294.022.7789.4194.282.77
2587666-58766696.34596.61
3574669-57466994.21494.47
4584290-58429095.79196.06
5570206-57020693.48293.74
6580398-58039895.15395.41
20min1552420-55242090.56695.612.7790.9696.032.77
2596694-59669497.82598.26
3584635-58463595.84896.26
4594308-59430897.43497.86
5581291-58129195.30095.71
6589796-58979696.69497.11
30min1558980-55898091.64296.642.6992.1997.212.69
2600737-60073798.48899.08
3589209-58920996.59897.17
4600035-60003598.37298.96
5589126-58912696.58497.15
6598580-59858098.13498.71
45min1568153-56815393.14697.272.2193.8598.012.21
2601729-60172998.65099.41
3592805-59280597.18797.92
4603351-60335198.91699.67
5593438-59343897.29198.02
6600397-60039798.43299.18
60min1577506-57750694.67997.701.6895.5498.601.69
2601471-60147198.60899.53
3594163-59416397.41098.30
4605709-60570999.303100.22
5595585-59558597.64398.53
6601283-60128398.57799.49
极限1598899-59889998.18699.160.6599.20100.220.67
2603587-60358798.955100.04
3602864-60286498.83699.89
4610323-610323100.059101.14
5606303-60630399.400100.45
6606881-60688199.495100.57
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101566-202301对照品来源中检所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1000
标示量(mg)10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%
19.855409555405715411115413205414085410730.07
29.895478605473455476020.07
单位质量响应值RSD%判断
54931.2755369.260.57数据可信
中间条件12月-供试品溶液批-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%
5min1392642-39264264.07662.833.0164.0862.833.01
2374845-37484561.17261.17
3369540-36954060.30660.31
4389565-38956563.57463.57
5400593-40059365.37465.37
6382967-38296762.49862.50
10min1538627-53862787.90084.702.2888.0184.812.28
2519175-51917584.72684.83
3507608-50760882.83882.94
4513526-51352683.80483.91
5509073-50907383.07783.19
6526196-52619685.87285.98
15min1575302-57530293.88590.652.5894.1490.892.58
2564993-56499392.20392.45
3541106-54110688.30588.54
4554571-55457190.50290.75
5537670-53767087.74487.99
6559073-55907391.23791.48
20min1589859-58985996.26192.962.9596.6793.362.94
2581316-58131694.86795.26
3552857-55285790.22290.61
4572389-57238993.41093.81
5546383-54638389.16689.56
6575052-57505293.84594.24
30min1602648-60264898.34894.823.2898.9295.383.27
2598680-59868097.70098.26
3561833-56183391.68792.22
4578353-57835394.38394.94
5556485-55648590.81591.36
6588318-58831896.00996.57
45min1609436-60943699.45696.072.81100.1996.782.81
2599705-59970597.86898.59
3570698-57069893.13493.82
4585040-58504095.47496.18
5568963-56896392.85193.54
6598127-59812797.61098.33
60min1615386-615386100.42796.992.75101.3397.862.75
2605726-60572698.85099.73
3578417-57841794.39495.24
4587972-58797295.95396.82
5574941-57494193.82694.67
6603616-60361698.50699.38
极限1618251-618251100.89498.401.71101.9699.431.72
2611047-61104799.719100.76
3589431-58943196.19197.19
4596703-59670397.37898.41
5599848-59984897.89198.90
6602477-60247798.32099.36
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101566-202301对照品来源中检所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1000
标示量(mg)10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%
19.855489335486135453455478635475285476560.26
29.895561355558975560160.04
单位质量响应值RSD%判断
55599.5956220.020.79数据可信
中间条件12月-供试品溶液批-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%
5min1396598-39659863.84458.8311.9663.8458.8311.95
2359905-35990557.93757.94
3378715-37871560.96560.96
4383258-38325861.69661.70
5393913-39391363.41263.41
6280385-28038545.13645.14
10min1514970-51497082.89979.176.8283.0179.276.83
2490465-49046578.95479.05
3510593-51059382.19482.30
4507060-50706081.62681.73
5502257-50225780.85380.96
6425615-42561568.51568.59
15min1538488-53848886.68585.492.4686.9385.722.46
2524226-52422684.38984.62
3550089-55008988.55388.79
4537207-53720786.47986.72
5520931-52093183.85984.10
6515488-51548882.98283.17
20min1550571-55057188.63088.482.8089.0288.852.78
2535904-53590486.26986.64
3567224-56722491.31191.70
4556863-55686389.64390.03
5526985-52698584.83385.21
6560306-56030690.19790.52
30min1560071-56007190.15991.063.6190.7091.583.58
2550573-55057388.63089.14
3576557-57655792.81393.35
4571093-57109391.93492.47
5538950-53895086.75987.28
6596660-59666096.04996.53
45min1575211-57521192.59792.793.8593.2893.473.82
2564526-56452690.87791.54
3583941-58394194.00294.70
4585487-58548794.25194.94
5541748-54174887.21087.88
6607694-60769497.82698.46
60min1582937-58293793.84093.573.4994.6894.393.46
2570677-57067791.86792.68
3588102-58810294.67295.52
4588921-58892194.80495.65
5548288-54828888.26389.07
6608528-60852897.96098.76
极限1592803-59280395.42995.721.1896.4396.701.17
2593427-59342795.52996.49
3592435-59243595.36996.38
4596371-59637196.00397.00
5585700-58570094.28595.24
6606918-60691897.70198.67
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