磷酸西格列汀片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号101546-202101对照品来源中检院对照品使用方法直接使用
对照品含量(%)96.5对照品水分(%)0对照品稀释倍数200
标示量(mg)50供试品稀释倍数1系数0.8061
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
112.711722041715561718721714541726301719430.29
212.641735531740411737970.20
单位质量响应值RSD%判断
13528.1713749.761.15数据可信
长期24月-供试品溶液-2022030401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%
5min1161069-16106982.68380.803.2582.6880.803.25
2153643-15364378.87178.87
3156728-15672880.45580.45
4162967-16296783.65883.66
5149519-14951976.75476.75
6160447-16044782.36482.36
10min1171077-17107787.82188.091.0687.9688.221.06
2174347-17434789.49989.63
3170009-17000987.27387.41
4173263-17326388.94389.08
5171080-17108087.82287.95
6169828-16982887.18087.32
15min1176560-17656090.63590.642.2090.9290.922.20
2182994-18299493.93894.22
3174176-17417689.41289.69
4178092-17809291.42291.71
5176078-17607890.38890.66
6171505-17150588.04188.32
20min1177512-17751291.12491.892.1191.5692.322.10
2185369-18536995.15895.59
3175844-17584490.26890.70
4180347-18034792.58093.02
5179894-17989492.34792.77
6175077-17507789.87490.30
30min1178630-17863091.69893.702.0992.2994.292.08
2189081-18908197.06397.66
3180064-18006492.43493.01
4183686-18368694.29494.89
5183641-18364194.27094.85
6180118-18011892.46293.04
45min1184643-18464394.78596.002.1895.5296.742.18
2194188-19418899.685100.44
3184563-18456394.74495.48
4188641-18864196.83797.59
5187201-18720196.09896.83
6182863-18286393.87194.60
极限1186404-18640495.68996.751.8396.5997.651.83
2193988-19398899.582100.51
3185776-18577695.36696.26
4189601-18960197.33098.24
5190198-19019897.63698.53
6184856-18485694.89495.78
磷酸西格列汀片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号101546-202101对照品来源中检院对照品使用方法直接使用
对照品含量(%)96.5对照品水分(%)0对照品稀释倍数200
标示量(mg)50供试品稀释倍数1系数0.8061
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
112.711738531736551737831734061738481737090.11
212.641737981736791737380.05
单位质量响应值RSD%判断
13667.1113745.090.41数据可信
长期24月-供试品溶液-2022030501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%
5min1156971-15697180.18077.317.2680.1877.317.26
2160957-16095782.21682.22
3142403-14240372.73972.74
4164667-16466784.11184.11
5145343-14534374.24174.24
6137752-13775270.36370.36
10min1169967-16996786.81986.212.5786.9586.342.58
2173666-17366688.70888.85
3166075-16607584.83184.95
4172314-17231488.01788.16
5168825-16882586.23586.36
6161784-16178482.63982.76
15min1173912-17391288.83489.001.4089.1189.271.40
2177063-17706390.44390.73
3175311-17531189.54889.81
4175148-17514889.46589.75
5174089-17408988.92489.19
6169844-16984486.75687.01
20min1176299-17629990.05390.331.3790.4890.751.37
2179776-17977691.82992.26
3178140-17814090.99391.41
4177369-17736990.60091.04
5176813-17681390.31690.73
6172593-17259388.16088.56
30min1180231-18023192.06192.381.3092.6492.951.31
2183866-18386693.91894.51
3181944-18194492.93693.50
4181533-18153392.72693.31
5180720-18072092.31192.88
6176813-17681390.31690.86
45min1183077-18307793.51593.731.1394.2594.461.14
2186225-18622595.12395.87
3184930-18493094.46295.18
4183089-18308993.52194.26
5183600-18360093.78294.50
6180092-18009291.99092.69
极限1185917-18591794.96694.981.0795.8595.861.07
2187450-18745095.74996.65
3186887-18688795.46196.34
4185127-18512794.56295.46
5187800-18780095.92896.80
6182458-18245893.19994.05
磷酸西格列汀片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号101546-202101对照品来源中检院对照品使用方法直接使用
对照品含量(%)96.5对照品水分(%)0对照品稀释倍数200
标示量(mg)50供试品稀释倍数1系数0.8061
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
112.711732111735631735191735371736991735060.11
212.641738781741111739940.10
单位质量响应值RSD%判断
13651.1413765.350.59数据可信
长期24月-供试品溶液-2022030601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%
5min1166511-16651185.04178.845.6585.0478.845.66
2157199-15719980.28580.28
3144301-14430173.69873.70
4144900-14490074.00474.00
5153229-15322978.25778.26
6160079-16007981.75681.76
10min1177088-17708890.44387.611.8990.5887.741.89
2170769-17076987.21587.35
3169001-16900186.31386.44
4167946-16794685.77485.90
5172726-17272688.21588.35
6171705-17170587.69387.83
15min1181496-18149692.69490.581.3092.9990.861.31
2175820-17582089.79590.07
3176549-17654990.16790.43
4175950-17595089.86290.13
5178626-17862691.22891.51
6175686-17568689.72790.01
20min1183274-18327493.60291.931.1094.0592.361.10
2178311-17831191.06791.50
3179821-17982191.83992.26
4178759-17875991.29691.71
5181387-18138792.63893.07
6178446-17844691.13691.57
30min1184691-18469194.32693.420.7594.9394.000.75
2181833-18183392.86693.45
3183359-18335993.64594.22
4182143-18214393.02493.59
5184178-18417894.06494.65
6181327-18132792.60893.19
45min1187419-18741995.71994.950.8596.4895.690.85
2184787-18478794.37595.11
3186052-18605295.02195.75
4184832-18483294.39895.12
5188122-18812296.07896.82
6184292-18429294.12294.86
极限1190903-19090397.49896.331.0098.4297.231.00
2187230-18723095.62296.52
3189082-18908296.56897.45
4188010-18801096.02196.90
5190447-19044797.26598.17
6186074-18607495.03295.93
磷酸西格列汀片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号101546-202101对照品来源中检院对照品使用方法直接使用
对照品含量(%)96.5对照品水分(%)0对照品稀释倍数200
标示量(mg)50供试品稀释倍数1系数0.8061
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
112.711743741744451741981740201741801742430.10
212.641747551746671747110.04
单位质量响应值RSD%判断
13709.1313822.070.59数据可信
长期24月-供试品溶液-U028516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%
5min1122219-12221962.16066.9210.0362.1666.9210.02
2129748-12974865.98965.99
3136493-13649369.41969.42
4153038-15303877.83477.83
5133406-13340667.84967.85
6114543-11454358.25658.26
10min1151251-15125176.92581.585.8377.0381.705.84
2157934-15793480.32480.43
3170261-17026186.59486.71
4170752-17075286.84386.97
5163438-16343883.12483.24
6148838-14883875.69875.80
15min1165530-16553084.18887.733.6584.4287.973.65
2172781-17278187.87588.12
3180855-18085591.98292.24
4174777-17477788.89089.16
5176218-17621889.62389.87
6164755-16475583.79384.02
20min1171589-17158987.26990.772.7087.6491.172.71
2180588-18058891.84692.24
3184300-18430093.73494.15
4178947-17894791.01191.43
5181525-18152592.32292.72
6173935-17393588.46288.83
30min1178484-17848490.77693.722.2191.2994.262.22
2186962-18696295.08895.63
3189168-18916896.21096.78
4182546-18254692.84293.42
5187001-18700195.10895.66
6181488-18148892.30492.81
45min1182553-18255392.84595.662.2693.5196.362.26
2191389-19138997.33998.04
3193106-19310698.21298.94
4184747-18474793.96194.69
5190763-19076397.02197.73
6185919-18591994.55795.22
极限1185288-18528894.23697.242.3095.0698.102.30
2194012-19401298.67399.54
3196225-19622599.799100.69
4186914-18691495.06395.95
5194259-19425998.79999.67
6190419-19041996.84697.67
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