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%
112.312001342010042005512002492005442004960.17
212.272010781998952004860.42
单位质量响应值RSD%判断
16287.2516339.530.23数据可信
供试品溶液-WA3063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%
5min1147246-14724672.57075.385.2272.5775.385.22
2144525-14452571.22971.23
3146646-14664672.27472.27
4157720-15772077.73277.73
5164654-16465481.14981.15
6156890-15689077.32377.32
10min1164115-16411580.88487.694.7580.9987.804.75
2189033-18903393.16593.27
3174178-17417885.84385.95
4177025-17702587.24687.36
5182137-18213789.76689.89
6181009-18100989.21089.33
15min1170186-17018683.87690.404.5784.1190.644.56
2195503-19550396.35396.60
3180415-18041588.91789.15
4181672-18167289.53789.78
5186501-18650191.91792.17
6186203-18620391.77092.02
20min1174416-17441685.96192.074.1586.3292.454.15
2197988-19798897.57897.97
3185057-18505791.20591.58
4184639-18463990.99991.38
5189046-18904693.17193.57
6189693-18969393.49093.88
30min1179096-17909688.26794.123.7988.7594.643.79
2201277-20127799.19999.74
3190783-19078394.02794.53
4188623-18862392.96293.48
5193298-19329895.26795.80
6192719-19271994.98195.51
45min1181474-18147489.43995.503.5990.0696.163.58
2202894-20289499.996100.68
3195012-19501296.11196.76
4192957-19295795.09895.76
5194780-19478095.99796.67
6195511-19551196.35797.03
60min1182939-18293990.16196.203.5290.9197.003.52
2203869-203869100.476101.31
3196746-19674696.96697.76
4193911-19391195.56996.37
5196481-19648196.83597.66
6197206-19720697.19398.01
极限1194019-19401995.62297.711.7796.5198.661.78
2204097-204097100.589101.58
3200130-20013098.63499.57
4196112-19611296.65397.60
5197240-19724097.20998.18
6197899-19789997.53498.49
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%
112.312001622009742003501996942000722002500.24
212.271994872004631999750.35
单位质量响应值RSD%判断
16267.2616297.880.14数据可信
供试品溶液-WC2484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%
5min1112609-11260955.60458.0810.4055.6058.0810.40
2139128-13912868.69968.70
3116271-11627157.41257.41
4103527-10352751.12051.12
5111687-11168755.14955.15
6122538-12253860.50760.51
10min1164312-16431281.13485.633.3881.2285.723.38
2174926-17492686.37586.48
3171658-17165884.76184.85
4171161-17116184.51684.59
5177009-17700987.40387.49
6181461-18146189.60289.69
15min1177970-17797087.87889.982.5388.0890.192.54
2184583-18458391.14391.38
3179553-17955388.66088.87
4179335-17933588.55288.76
5181478-18147889.61089.82
6190383-19038394.00794.23
20min1182383-18238390.05792.002.2190.3992.352.22
2189509-18950993.57693.95
3184320-18432091.01491.36
4183928-18392890.82091.16
5184630-18463091.16791.51
6193122-19312295.36095.73
30min1185106-18510691.40293.251.8191.8793.741.82
2192768-19276895.18595.69
3186239-18623991.96192.44
4186564-18656492.12292.59
5189482-18948293.56294.05
6192916-19291695.25895.77
45min1186916-18691692.29594.491.5792.9095.121.58
2193513-19351395.55396.21
3189504-18950493.57394.19
4190004-19000493.82094.43
5194089-19408995.83796.46
6194184-19418495.88496.54
60min1189694-18969493.66795.231.3394.4196.001.33
2194999-19499996.28797.08
3190947-19094794.28695.05
4192321-19232194.96495.72
5196607-19660797.08197.85
6192589-19258995.09795.89
极限1195718-19571896.64296.840.9497.5397.760.93
2197493-19749397.51898.46
3195184-19518496.37897.28
4195915-19591596.73997.63
5198841-19884198.18499.10
6193587-19358795.58996.53
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%
112.312002682002551994692000161997411999500.18
212.272007171997802002480.34
单位质量响应值RSD%判断
16242.8916320.130.34数据可信
供试品溶液-WK2927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%
5min1117577-11757758.06153.6916.0258.0653.6916.02
2122265-12226560.37660.38
383598-8359841.28241.28
491290-9129045.08045.08
5111227-11122754.92554.93
6126416-12641662.42662.43
10min1168548-16854883.23178.709.4383.3278.789.44
2162376-16237680.18480.27
3140727-14072769.49369.55
4140441-14044169.35269.42
5173978-17397885.91386.00
6170155-17015584.02584.12
15min1179005-17900588.39584.147.8588.6184.347.86
2170550-17055084.22084.43
3153497-15349775.79975.97
4154763-15476376.42476.60
5184248-18424890.98491.20
6180245-18024589.00889.23
20min1183066-18306690.40186.327.1190.7586.657.12
2174284-17428486.06486.40
3159721-15972178.87379.15
4160123-16012379.07179.36
5188692-18869293.17993.53
6182942-18294290.33990.69
30min1188419-18841993.04488.756.2793.5289.206.28
2179087-17908788.43688.90
3166274-16627482.10982.51
4166037-16603781.99182.40
5191261-19126194.44794.93
6187285-18728592.48492.97
45min1192151-19215194.88791.304.9895.5191.895.00
2184325-18432591.02291.62
3174231-17423186.03886.56
4173511-17351185.68286.21
5194640-19464096.11696.75
6190482-19048294.06394.69
60min1196224-19622496.89893.174.3497.6693.894.36
2187657-18765792.66893.40
3180079-18007988.92689.58
4177902-17790287.85188.51
5196591-19659197.07997.85
6193549-19354995.57796.35
极限1197320-19732097.43997.920.5198.3598.780.49
2200100-20010098.81299.69
3198310-19831097.92898.71
4198427-19842797.98698.77
5197456-19745697.50798.43
6198133-19813397.84198.75
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