达格列净二甲双胍缓释片项目信息
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1250
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%
112.588002179969799608019479934800160.14
212.618045380254803540.18
单位质量响应值RSD%判断
6360.576372.240.13数据可信
供试品溶液-250402101批-达格列净-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%
5min186962-8696287.85889.895.7587.8689.895.75
282590-8259083.44183.44
394152-9415295.12295.12
492422-9242293.37493.37
593724-9372494.69094.69
683999-8399984.86484.86
10min193334-9333494.29696.732.2094.4396.862.21
294534-9453495.50895.63
398733-9873399.75099.89
495744-9574496.73196.87
597751-9775198.75898.90
694350-9435095.32295.45
15min194094-9409495.06497.511.9595.3497.791.95
295506-9550696.49096.76
399251-99251100.274100.57
496148-9614897.13997.42
598182-9818299.19499.48
695924-9592496.91297.18
20min193908-9390894.87697.651.9195.2998.071.91
295846-9584696.83497.25
399154-99154100.176100.62
496571-9657197.56698.00
598182-9818299.19499.63
696238-9623897.23097.65
30min194152-9415295.12297.861.7295.6898.441.72
296728-9672897.72598.28
399304-99304100.327100.92
496772-9677297.76998.35
597486-9748698.49099.08
696744-9674497.74198.30
45min194246-9424695.21797.991.6995.9298.711.69
297083-9708398.08398.79
399189-99189100.211100.95
496708-9670897.70498.43
597884-9788498.89399.63
696810-9681097.80798.52
60min194207-9420795.17897.911.8596.0298.781.85
296867-9686797.86598.72
399721-99721100.748101.64
496818-9681897.81698.69
597515-9751598.52099.40
696337-9633797.33098.18
120min196801-9680197.798100.791.6398.78101.801.64
2100132-100132101.164102.16
3101703-101703102.751103.80
499487-99487100.512101.53
5100287-100287101.320102.35
6100144-100144101.176102.18
180min196891-9689197.889100.541.5899.02101.701.58
299797-99797100.825101.98
3101686-101686102.734103.93
499008-99008100.028101.20
5100008-100008101.038102.22
699704-99704100.731101.88
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
240min197011-9701198.011100.481.5299.29101.801.52
299610-99610100.636101.94
3101612-101612102.659104.01
498873-9887399.892101.21
599663-99663100.690102.03
699959-99959100.989102.29
360min196134-9613497.125100.071.6698.55101.531.66
299496-99496100.521101.97
3101014-101014102.055103.56
498551-9855199.566101.03
599276-99276100.299101.79
699807-99807100.835102.29
480min195849-9584996.83799.281.5098.41100.901.50
298553-9855399.568101.17
3100292-100292101.325102.99
497774-9777498.781100.40
598174-9817499.186100.82
698971-9897199.991101.60
600min195041-9504196.02098.351.2597.74100.111.25
297957-9795798.966100.72
398313-9831399.326101.14
497116-9711698.11799.88
597500-9750098.505100.29
698147-9814799.158100.91
720min194662-9466295.63798.071.4197.5099.981.41
297645-9764598.651100.55
398771-9877199.789101.75
496676-9667697.67299.58
597334-9733498.337100.27
697308-9730898.311100.22
极限194464-9446495.43797.961.5997.44100.021.59
297427-9742798.431100.48
399121-99121100.142102.25
496227-9622797.21899.28
597263-9726398.265100.35
697277-9727798.279100.33
达格列净二甲双胍缓释片项目信息
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100664-202106对照品来源中检院对照品使用方法直接使用
对照品含量(%)100.0对照品水分(%)0对照品稀释倍数10
标示量(mg)1000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%
110.271174839117361711720731173185117310511733640.09
210.251173433117316311732980.02
单位质量响应值RSD%判断
114251.61114468.100.14数据可信
供试品溶液-250402101批-二甲双胍-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%
5min148430-484304.2354.518.364.234.518.37
248334-483344.2264.23
356576-565764.9474.95
453609-536094.6884.69
555900-559004.8884.89
646613-466134.0764.08
10min1117797-11779710.30110.303.7110.3110.313.70
2116041-11604110.14710.15
3120231-12023110.51310.52
4118740-11874010.38310.39
5123469-12346910.79710.80
6110495-1104959.6629.67
15min1168996-16899614.77814.732.8214.8014.762.82
2165834-16583414.50114.52
3170291-17029114.89114.91
4170358-17035814.89714.92
5174683-17468315.27515.30
6160731-16073114.05514.08
20min1210282-21028218.38818.382.7018.4318.422.71
2207264-20726418.12418.17
3211463-21146318.49118.54
4210262-21026218.38618.43
5219499-21949919.19419.24
6202196-20219617.68117.72
30min1276241-27624124.15524.231.4724.2324.301.48
2277132-27713224.23324.30
3278005-27800524.31024.38
4278511-27851124.35424.43
5282644-28264424.71524.79
6270184-27018423.62623.69
45min1355859-35585931.11831.221.2431.2331.331.24
2357685-35768531.27731.38
3357017-35701731.21931.33
4357599-35759931.27031.38
5363908-36390831.82131.93
6350119-35011930.61630.72
60min1422819-42281936.97337.051.1037.1337.201.11
2425255-42525537.18637.34
3425166-42516637.17837.33
4422954-42295436.98537.14
5430096-43009637.60937.77
6415871-41587136.36536.51
120min1630986-63098655.17655.200.6655.3955.410.66
2633473-63347355.39355.60
3629360-62936055.03355.25
4629541-62954155.04955.26
5637972-63797255.78656.00
6625992-62599254.73954.94
180min1770555-77055567.38067.210.5767.6767.510.57
2772824-77282467.57867.87
3764509-76450966.85167.15
4766913-76691367.06167.36
5773714-77371467.65667.96
6763461-76346166.76067.05
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
240min1875165-87516576.52776.380.4076.9276.780.40
2875683-87568376.57376.97
3869515-86951576.03376.43
4871883-87188376.24076.63
5878363-87836376.80777.21
6870332-87033276.10576.49
360min11018352-101835289.04888.850.3689.5689.360.36
21020642-102064289.24889.76
31011209-101120988.42488.93
41012833-101283388.56689.07
51018127-101812789.02889.55
61015485-101548588.79789.30
480min11105298-110529896.65196.240.3797.2996.880.37
21102943-110294396.44597.09
31094507-109450795.70796.35
41098364-109836496.04596.69
51103502-110350296.49497.14
61098965-109896596.09796.73
600min11149270-1149270100.496100.120.30101.28100.910.30
21147336-1147336100.327101.11
31141894-114189499.851100.64
41143040-114304099.951100.74
51147269-1147269100.321101.12
61141126-114112699.784100.56
720min11167865-1167865102.122101.800.25103.06102.740.25
21166777-1166777102.027102.96
31160151-1160151101.447102.38
41164346-1164346101.814102.75
51164012-1164012101.785102.73
61161921-1161921101.602102.53
极限11168782-1168782102.202101.700.29103.29102.790.29
21164665-1164665101.842102.93
31159992-1159992101.434102.52
41159976-1159976101.432102.52
51162178-1162178101.625102.72
61162585-1162585101.660102.74
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