达格列净片项目信息
介质体积(ml)1000取样体积(ml)0补液体积(ml)0
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%
112.451013681012281012981011561011941012490.09
212.581038601036881037740.12
单位质量响应值RSD%判断
8132.458249.131.01数据可信
供试品溶液-STGC批-水
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
2min16116-61166.0045.1829.506.005.1829.47
26359-63596.2426.24
33685-36853.6173.62
44349-43494.2694.27
53738-37383.6693.67
67387-73877.2517.25
5min165441-6544164.24059.2611.1964.2459.2611.19
264497-6449763.31363.31
364883-6488363.69263.69
447551-4755146.67846.68
559548-5954858.45558.45
660313-6031359.20659.21
10min187212-8721285.61189.773.5585.6189.773.55
289118-8911887.48287.48
392040-9204090.35090.35
496725-9672594.94994.95
591139-9113989.46689.47
692435-9243590.73890.74
15min192145-9214590.45394.353.5390.4594.353.53
293581-9358191.86391.86
394571-9457192.83592.83
4101503-10150399.63999.64
597863-9786396.06696.07
697021-9702195.24095.24
20min194743-9474393.00496.873.8893.0096.873.89
295611-9561193.85693.86
396109-9610994.34494.34
499227-9922797.40597.41
5102722-102722100.836100.84
6103690-103690101.786101.79
30min196073-9607394.30996.391.8894.3196.391.88
296872-9687295.09395.09
396899-9689995.12095.12
4100818-10081898.96798.97
599243-9924397.42197.42
699246-9924697.42497.42
极限197719-9771995.92597.071.5895.9297.071.58
297910-9791096.11296.11
398243-9824396.43996.44
4101701-10170199.83499.83
598042-9804296.24296.24
699719-9971997.88897.89
达格列净片项目信息
介质体积(ml)1000取样体积(ml)0补液体积(ml)0
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%
112.451032791039011022111026301023711028780.69
212.581027211028321027760.08
单位质量响应值RSD%判断
8263.298169.790.81数据可信
供试品溶液-STGC批-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%
2min17940-79407.7707.7116.697.777.7116.68
26585-65856.4446.44
36664-66646.5216.52
410058-100589.8429.84
58599-85998.4158.41
67416-74167.2577.26
5min161131-6113159.81961.627.9459.8261.627.94
259786-5978658.50358.50
355455-5545554.26554.27
468387-6838766.92066.92
566779-6677965.34665.35
666301-6630164.87964.88
10min186394-8639484.54083.313.0584.5483.313.05
280635-8063578.90578.91
384258-8425882.45082.45
488365-8836586.46986.47
585262-8526283.43383.43
685897-8589784.05484.05
15min191779-9177989.81088.132.5389.8188.132.53
286853-8685384.99084.99
389081-8908187.17087.17
493412-9341291.40891.41
589613-8961387.69087.69
689627-8962787.70487.70
20min194568-9456892.53990.732.0592.5490.732.04
289834-8983487.90787.91
392100-9210090.12490.12
494723-9472392.69192.69
591625-9162589.65989.66
693469-9346991.46491.46
30min197913-9791395.81293.092.3395.8193.082.33
291651-9165189.68589.68
394638-9463892.60892.61
497098-9709895.01595.01
594993-9499392.95592.95
694475-9447592.44892.45
极限1100961-10096198.79597.671.4298.7997.671.41
297666-9766695.57195.57
3101733-10173399.55099.55
499620-9962097.48397.48
599501-9950197.36697.37
699414-9941497.28197.28
达格列净片项目信息
介质体积(ml)1000取样体积(ml)0补液体积(ml)0
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%
112.451026451025321022811024371027731025340.19
212.581030821029541030180.09
单位质量响应值RSD%判断
8235.668189.030.41数据可信
供试品溶液-STGC批-pH4.5
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
2min110851-1085110.6239.0418.4410.629.0418.43
29727-97279.5239.52
37327-73277.1737.17
410936-1093610.70710.71
57003-70036.8566.86
69589-95899.3889.39
5min170757-7075769.27363.178.5869.2763.178.58
264294-6429462.94562.95
359528-5952858.27958.28
469794-6979468.33068.33
556824-5682455.63255.63
665964-6596464.58064.58
10min189295-8929587.42285.693.3487.4285.693.34
290098-9009888.20888.21
385383-8538383.59283.59
490552-9055288.65288.65
583271-8327181.52481.52
686564-8656484.74884.75
15min192113-9211390.18190.262.1290.1890.262.12
295409-9540993.40793.41
390305-9030588.41188.41
492177-9217790.24390.24
590114-9011488.22488.22
693049-9304991.09791.10
20min193625-9362591.66192.382.1491.6692.382.14
297330-9733095.28895.29
392310-9231090.37390.37
494635-9463592.65092.65
592317-9231790.38090.38
695920-9592093.90893.91
30min195664-9566493.65794.792.4493.6694.792.44
2100073-10007397.97497.97
394312-9431292.33392.33
497671-9767195.62295.62
594510-9451092.52792.53
698682-9868296.61296.61
极限197828-9782895.77697.721.8095.7897.721.80
2101777-10177799.64299.64
398425-9842596.36096.36
4101027-10102798.90898.91
598348-9834896.28596.28
6101455-10145599.32799.33
达格列净片项目信息
介质体积(ml)1000取样体积(ml)0补液体积(ml)0
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%
112.451037531026351030121030001031341031070.40
212.581036361025451030900.75
单位质量响应值RSD%判断
8281.698194.750.75数据可信
供试品溶液-STGC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%
2min13816-38163.7246.8229.153.726.8229.18
25105-51054.9824.98
38354-83548.1538.15
48044-80447.8517.85
57696-76967.5117.51
68891-88918.6778.68
5min149726-4972648.53153.3111.6848.5353.3111.68
249008-4900847.83047.83
349088-4908847.90847.91
457040-5704055.66955.67
558401-5840156.99757.00
664480-6448062.93062.93
10min182451-8245180.46982.864.4380.4782.864.43
286505-8650584.42684.43
379944-7994478.02378.02
483186-8318681.18781.19
590412-9041288.23988.24
686904-8690484.81584.82
15min188069-8806985.95288.673.8585.9588.673.85
293361-9336191.11791.12
386868-8686884.78084.78
488399-8839986.27486.27
595347-9534793.05593.06
693054-9305490.81890.82
20min191286-9128689.09291.053.8189.0991.053.81
295430-9543093.13693.14
388468-8846886.34286.34
491220-9122089.02889.03
598101-9810195.74395.74
695232-9523292.94392.94
30min197875-9787595.52393.853.5195.5293.853.51
297335-9733594.99695.00
391188-9118888.99689.00
492762-9276290.53390.53
599640-9964097.24597.25
698160-9816095.80195.80
极限1100996-10099698.56998.282.1898.5798.282.18
2103766-103766101.272101.27
398396-9839696.03196.03
4100142-10014297.73597.74
5102531-102531100.067100.07
698347-9834795.98395.98
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