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%
1 12.037970479492791327951379629794940.28
2 12.077937678999791880.34
单位质量响应值RSD%判断
6607.986560.730.51数据可信
供试品溶液-25042203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%
5min185462-8546283.48687.554.7083.4987.544.69
290884-9088488.78288.78
384555-8455582.60082.60
494623-9462392.43592.43
588400-8840086.35686.36
693781-9378191.61291.61
10min196807-9680794.56896.211.3594.6996.341.35
298059-9805995.79195.92
397612-9761295.35595.48
4100622-10062298.29598.43
599128-9912896.83696.97
698668-9866896.38696.52
15min199087-9908796.79597.751.3397.0698.031.33
299465-9946597.16597.44
398567-9856796.28896.55
4102249-10224999.884100.17
5100664-10066498.33698.61
6100377-10037798.05698.34
20min199655-9965597.35097.951.5297.7698.371.52
299241-9924196.94697.37
399578-9957897.27597.69
4103291-103291100.902101.34
5100288-10028897.96998.39
699543-9954397.24197.67
30min199790-9979097.48298.541.8098.0499.111.79
2100071-10007197.75798.32
399653-9965397.34897.91
4103734-103734101.335101.92
599437-9943797.13797.71
6102539-102539100.168100.74
45min1100327-10032798.00798.541.5898.7199.261.58
2100479-10047998.15598.87
399724-9972497.41898.12
4104076-104076101.669102.41
5100444-10044498.12198.84
6100215-10021597.89798.62
60min1100635-10063598.30898.621.8899.1699.481.88
299968-9996897.65698.52
399669-9966997.36498.21
4104758-104758102.335103.23
5100402-10040298.08098.94
6100301-10030197.98198.85
120min1103983-103983101.578101.681.86102.58102.691.86
2103936-103936101.532102.54
3102704-102704100.329101.32
4107874-107874105.379106.42
5103159-103159100.773101.78
6102852-102852100.473101.49
180min1103972-103972101.568101.281.55102.72102.451.55
2102948-102948100.567101.73
3102683-102683100.308101.45
4106792-106792104.322105.53
5102611-102611100.238101.40
6103079-103079100.695101.86
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
240min1103375-103375100.984101.021.54102.29102.341.54
2102929-102929100.549101.86
3102200-10220099.836101.13
4106551-106551104.087105.45
5102563-102563100.191101.50
6102874-102874100.495101.82
360min1102535-102535100.164100.401.44101.62101.871.44
2102391-102391100.023101.49
3101860-10186099.504100.95
4105745-105745103.300104.82
5102021-10202199.662101.12
6102134-10213499.772101.24
480min1102153-10215399.79199.731.53101.40101.351.53
2101152-10115298.813100.43
3101154-10115498.815100.41
4105164-105164102.732104.40
5101234-10123498.893100.50
6101712-10171299.360100.98
600min1101473-10147399.12699.141.35100.88100.901.35
2100429-10042998.10699.87
3100927-10092798.593100.34
4104185-104185101.776103.60
5100834-10083498.502100.26
6101048-10104898.711100.48
720min1100883-10088398.55098.891.38100.45100.811.38
2102436-102436100.067101.97
3100063-10006397.74999.64
4103451-103451101.059103.04
5100360-10036098.03999.95
6100189-10018997.87299.79
极限1100974-10097498.63998.361.35100.69100.421.35
299394-9939497.09599.15
3100275-10027597.95699.99
4103169-103169100.783102.91
5100665-10066598.337100.39
699637-9963797.33399.40
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%
1 10.131065775106738410657641067663106945510672080.15
2 10.161065004106146710632360.24
单位质量响应值RSD%判断
105351.23104649.210.48数据可信
供试品溶液-25042203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%
5min149516-495164.7164.6913.564.724.6913.57
244511-445114.2394.24
343759-437594.1684.17
456291-562915.3615.36
542947-429474.0904.09
658222-582225.5455.55
10min1106168-10616810.11110.271.4810.1210.281.47
2107863-10786310.27310.28
3105934-10593410.08910.10
4109684-10968410.44610.45
5108127-10812710.29810.30
6109498-10949810.42810.44
15min1155249-15524914.78615.171.9214.8115.191.91
2160586-16058615.29415.32
3156414-15641414.89714.92
4158979-15897915.14115.16
5160616-16061615.29715.32
6163583-16358315.57915.60
20min1196168-19616818.68318.751.2518.7318.791.27
2194771-19477118.55018.59
3194678-19467818.54118.58
4200121-20012119.05919.11
5199727-19972719.02219.07
6195663-19566318.63518.68
30min1258558-25855824.62524.931.9824.7025.001.98
2259416-25941624.70724.78
3258210-25821024.59224.66
4267912-26791225.51625.59
5257612-25761224.53524.61
6268833-26883325.60325.68
45min1335144-33514431.91932.151.2032.0332.271.21
2342165-34216532.58732.70
3333352-33335231.74831.86
4342542-34254232.62332.74
5338391-33839132.22832.34
6334116-33411631.82131.93
60min1397760-39776037.88237.931.2538.0438.091.25
2395830-39583037.69837.86
3395684-39568437.68537.84
4408285-40828538.88539.05
5396782-39678237.78937.95
6395372-39537237.65537.82
120min1596137-59613756.77556.792.4056.9957.012.40
2592309-59230956.41156.63
3583431-58343155.56555.78
4602254-60225457.35857.58
5582526-58252655.47955.69
6621118-62111859.15559.37
180min1712922-71292267.89867.860.8568.2068.160.86
2707918-70791867.42167.72
3706212-70621267.25967.55
4722957-72295768.85469.16
5710146-71014667.63467.93
6715265-71526568.12168.43
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
240min1797020-79702075.90776.170.7076.3176.580.70
2798922-79892276.08876.49
3795355-79535575.74976.15
4810675-81067577.20877.62
5800062-80006276.19776.60
6796890-79689075.89576.30
360min1918993-91899387.52487.900.7188.0488.410.71
2927437-92743788.32888.84
3918563-91856387.48387.99
4932689-93268988.82889.35
5915138-91513887.15787.67
6924693-92469388.06788.59
480min1993346-99334694.60594.580.5595.2595.230.55
2992916-99291694.56495.21
3987967-98796794.09394.73
41001214-100121495.35596.01
5986582-98658293.96194.61
6996656-99665694.92095.58
600min11029415-102941598.04098.000.3698.8398.800.37
21028787-102878797.98198.77
31025414-102541497.65998.44
41035114-103511498.58399.39
51025123-102512397.63298.42
61030386-103038698.13398.93
720min11044447-104444799.47299.580.70100.41100.510.70
21057033-1057033100.671101.61
31037147-103714798.77799.71
41050121-1050121100.012100.96
51039091-103909198.96299.89
61045373-104537399.560100.50
极限11044146-104414699.44399.460.26100.53100.550.26
21045772-104577299.598100.69
31041084-104108499.152100.23
41048735-104873599.880100.98
51043642-104364299.395100.48
61042764-104276499.312100.41
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