达格列净片项目信息
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%
112.851055631055471055941057751058551056670.14
212.691056541057191056860.05
单位质量响应值RSD%判断
8223.118328.290.90数据可信
供试品溶液-2025080722批-5mg规格-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%
5min193658-9365890.99489.771.3490.9989.771.33
293564-9356490.90390.90
391345-9134588.74788.75
491379-9137988.78088.78
591133-9113388.54188.54
693325-9332590.67190.67
10min199195-9919596.37494.901.2896.5195.041.28
298528-9852895.72695.86
396919-9691994.16294.30
496493-9649393.74993.88
596318-9631893.57993.71
698625-9862595.82095.96
15min1101057-10105798.18396.421.2698.4696.701.26
299717-9971796.88197.16
398782-9878295.97296.25
498318-9831895.52295.80
597614-9761494.83895.11
699994-9999497.15097.43
20min1101985-10198599.08496.991.4699.5197.411.46
2100141-10014197.29397.72
399010-9901096.19496.61
498613-9861395.80896.23
598280-9828095.48595.90
6100932-10093298.06198.49
30min1103269-103269100.33297.921.46100.9198.491.46
2100903-10090398.03398.60
399917-9991797.07597.64
499602-9960296.76997.33
599455-9945596.62697.18
6101581-10158198.69299.26
45min1103972-103972101.01598.131.77101.7498.841.77
2101101-10110198.22598.94
399588-9958896.75697.46
499831-9983196.99297.70
599425-9942596.59797.30
6102118-10211899.21499.93
极限1103903-103903100.94898.101.79101.8398.961.79
2100874-10087498.00598.87
399505-9950596.67597.53
499781-9978196.94397.79
599458-9945896.62997.48
6102313-10231399.403100.27
达格列净片项目信息
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%
112.851063251062921062261063621061891062790.07
212.691066971066141066560.06
单位质量响应值RSD%判断
8270.748404.731.14数据可信
供试品溶液-2025080722批-5mg规格-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%
5min191553-9155388.28988.031.1888.2988.031.18
292182-9218288.89688.90
392074-9207488.79288.79
491616-9161688.35088.35
589264-8926486.08286.08
691020-9102087.77587.78
10min196713-9671393.26593.220.5993.4093.350.59
296620-9662093.17693.31
397470-9747093.99594.13
496925-9692593.47093.60
596529-9652993.08893.22
695744-9574492.33192.46
15min198446-9844694.93794.920.7295.2195.190.72
298214-9821494.71394.99
398654-9865495.13795.41
499205-9920595.66995.94
598876-9887695.35195.62
697177-9717793.71393.98
20min198929-9892995.40295.530.7595.8295.940.75
298710-9871095.19195.61
399119-9911995.58696.00
499896-9989696.33596.75
599788-9978896.23196.64
697903-9790394.41394.82
30min1100282-10028296.70796.670.9097.2797.230.90
299664-9966496.11196.67
399838-9983896.27996.84
4101536-10153697.91798.48
5101029-10102997.42897.98
699126-9912695.59296.14
45min1100860-10086097.26596.941.0197.9797.651.00
299863-9986396.30397.01
399813-9981396.25596.96
4101866-10186698.23598.94
5101432-10143297.81698.52
699332-9933295.79196.49
极限1100709-10070997.11997.051.0897.9797.901.07
299967-9996796.40397.25
399751-9975196.19597.04
4102167-10216798.52599.38
5101679-10167998.05498.90
699552-9955296.00396.84
达格列净片项目信息
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%
112.852109652113252114582111302110272111810.10
212.692123192125262124220.07
单位质量响应值RSD%判断
16434.3216739.321.31数据可信
供试品溶液-2025080521批-10mg规格-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%
5min1172311-17231183.53084.791.7183.5384.791.71
2176787-17678785.70085.70
3171125-17112582.95582.96
4179377-17937786.95586.96
5174903-17490384.78784.79
6174945-17494584.80784.81
10min1182987-18298788.70590.271.4588.8390.401.45
2186731-18673190.52090.65
3183757-18375789.07989.20
4190296-19029692.24892.38
5185690-18569090.01690.14
6187806-18780691.04191.17
15min1186954-18695490.62892.551.5590.8992.821.55
2190264-19026492.23392.50
3189126-18912691.68191.94
4194746-19474694.40694.67
5190471-19047192.33392.60
6193963-19396394.02694.29
20min1189487-18948791.85693.921.6092.2594.321.60
2192191-19219193.16793.57
3192556-19255693.34493.74
4197750-19775095.86296.27
5193644-19364493.87194.27
6196869-19686995.43595.84
30min1191824-19182492.98995.151.6993.5295.691.69
2193800-19380093.94794.49
3196113-19611395.06895.60
4200222-20022297.06097.61
5195842-19584294.93795.48
6199911-19991196.90997.46
45min1191893-19189393.02395.481.9193.6996.161.90
2193881-19388193.98694.67
3196916-19691695.45896.14
4201108-20110897.49098.19
5196777-19677795.39096.07
6201160-20116097.51598.21
极限1191522-19152292.84395.351.9793.6596.171.97
2193557-19355793.82994.65
3196595-19659595.30296.12
4201007-20100797.44198.29
5196314-19631495.16695.99
6201120-20112097.49698.34
达格列净片项目信息
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%
112.852123332123082121952124512120972122770.07
212.692135302136542135920.05
单位质量响应值RSD%判断
16519.6116831.521.33数据可信
供试品溶液-2025080521批-10mg规格-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%
5min1176296-17629685.00785.060.8785.0185.060.87
2178439-17843986.04186.04
3174923-17492384.34584.35
4177770-17777085.71885.72
5176434-17643485.07485.07
6174534-17453484.15884.16
10min1187162-18716290.24790.320.8690.3790.440.86
2188977-18897791.12291.25
3185649-18564989.51789.64
4186246-18624689.80589.93
5189536-18953691.39191.52
6186252-18625289.80889.93
15min1191963-19196392.56292.770.9192.8293.040.91
2194832-19483293.94594.21
3190262-19026291.74192.00
4191648-19164892.41092.67
5194174-19417493.62893.89
6191550-19155092.36292.62
20min1195140-19514094.09494.200.9594.5094.600.95
2197532-19753295.24795.65
3192544-19254492.84293.24
4195125-19512594.08694.49
5197299-19729995.13595.54
6194541-19454193.80594.20
30min1198122-19812295.53195.531.0696.0796.071.06
2200518-20051896.68797.24
3194662-19466293.86394.40
4198425-19842595.67896.22
5199854-19985496.36796.91
6197137-19713795.05695.60
45min1199260-19926096.08096.110.9996.7796.800.99
2201770-20177097.29097.98
3196000-19600094.50895.19
4199637-19963796.26296.95
5200652-20065296.75197.44
6198675-19867595.79896.48
极限1199316-19931696.10795.960.9696.9496.790.96
2201691-20169197.25298.09
3196279-19627994.64395.46
4199661-19966196.27397.10
5199708-19970896.29697.13
6197470-19747095.21796.04
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