富马酸伏诺拉生片片项目信息
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17570对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.78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0.7485
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
114.811223591227661222561226061225411225060.17
214.851253051236191244620.96
单位质量响应值RSD%判断
8271.848381.280.93数据可信
长期12月-供试品溶液-2023031211批-pH1.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1109826-10982688.66292.183.6588.6692.183.65
2120366-12036697.17197.17
3115296-11529693.07893.08
4113870-11387091.92691.93
5116372-11637293.94693.95
6109353-10935388.28088.28
10min1123635-12363599.810101.152.0599.96101.302.05
2124262-124262100.316100.48
3127733-127733103.118103.27
4122996-12299699.29499.45
5129274-129274104.362104.52
6123879-123879100.007100.15
15min1124783-124783100.736101.631.69101.05101.951.69
2124361-124361100.396100.72
3127513-127513102.940103.27
4123860-12386099.991100.31
5129346-129346104.420104.75
6125451-125451101.276101.59
20min1124430-124430100.451101.201.75100.93101.691.75
2123733-12373399.889100.39
3127000-127000102.526103.02
4123186-12318699.44799.93
5128933-128933104.087104.59
6124874-124874100.810101.29
30min1124253-124253100.309101.151.81100.96101.811.81
2123563-12356399.751100.41
3127137-127137102.637103.31
4123108-12310899.384100.04
5128911-128911104.069104.75
6124773-124773100.728101.38
45min1124162-124162100.235100.951.70101.05101.781.70
2123478-12347899.683100.51
3126885-126885102.433103.27
4122957-12295799.262100.08
5128385-128385103.644104.50
6124439-124439100.459101.28
60min1123444-12344499.655100.571.94100.64101.561.94
2122641-12264199.007100.00
3126564-126564102.174103.19
4122313-12231398.74299.72
5128396-128396103.653104.68
6124079-124079100.168101.15
极限1123623-12362399.800100.471.81100.95101.631.80
2122710-12271099.063100.22
3126311-126311101.970103.15
4122167-12216798.62499.77
5127980-127980103.317104.51
6123903-123903100.026101.18
富马酸伏诺拉生片片项目信息
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17570对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.78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0.7485
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
114.811227791228041226091226371228981227450.10
214.851226131227291226710.07
单位质量响应值RSD%判断
8287.988260.670.24数据可信
长期12月-供试品溶液-2023031212批-pH1.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1107540-10754087.36191.033.7187.3691.033.71
2109292-10929288.78488.78
3111583-11158390.64590.65
4110599-11059989.84689.85
5119234-11923496.86096.86
6114076-11407692.67092.67
10min1122401-12240199.43399.861.3399.58100.011.34
2121107-12110798.38298.53
3121589-12158998.77498.92
4123610-123610100.415100.57
5125639-125639102.064102.23
6123179-123179100.065100.22
15min1124494-124494101.133100.291.24101.44100.611.24
2122676-12267699.65799.97
3121223-12122398.47698.79
4123464-123464100.297100.61
5125677-125677102.094102.43
6123217-123217100.096100.42
20min1124529-124529101.162100.111.12101.64100.601.12
2123000-12300099.920100.40
3121362-12136298.58999.07
4122783-12278399.743100.23
5125144-125144101.661102.16
6122612-12261299.605100.09
30min1123851-123851100.61199.831.12101.26100.491.12
2122220-12222099.28699.93
3121059-12105998.34398.99
4122970-12297099.895100.55
5124953-124953101.506102.18
6122301-12230199.352100.01
45min1123824-123824100.58999.761.07101.41100.581.07
2122504-12250499.517100.33
3120751-12075198.09398.90
4122779-12277999.740100.56
5124545-124545101.175102.02
6122389-12238999.423100.24
60min1123550-123550100.36799.391.24101.35100.381.24
2121584-12158498.76999.75
3120113-12011397.57498.55
4122166-12216699.242100.23
5124449-124449101.097102.11
6122209-12220999.277100.26
极限1123311-123311100.17299.221.12101.32100.371.12
2121545-12154598.73899.88
3120254-12025497.68998.82
4121868-12186899.000100.15
5124100-124100100.813101.99
6121759-12175998.912100.06
富马酸伏诺拉生片片项目信息
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17570对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.78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0.7485
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
114.811231441231151230681229381228451230220.11
214.851224081224201224140.01
单位质量响应值RSD%判断
8306.688243.370.55数据可信
长期12月-供试品溶液-2023031311批-pH1.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min181345-8134566.07688.4014.9666.0888.4014.96
2117437-11743795.39495.39
397379-9737979.10179.10
4123230-123230100.099100.10
5120651-12065198.00498.00
6112910-11291091.71691.72
10min1112255-11225591.18498.764.4191.2998.914.43
2123957-123957100.690100.85
3118180-11818095.99796.13
4126083-126083102.417102.58
5123474-123474100.298100.46
6125536-125536101.973102.13
15min1120555-12055597.926100.431.5598.19100.751.57
2123919-123919100.659100.99
3123312-123312100.166100.46
4125724-125724102.125102.46
5122830-12283099.774100.10
6125513-125513101.954102.28
20min1122410-12241099.433100.831.0899.86101.311.09
2123628-123628100.423100.92
3124545-124545101.168101.63
4125735-125735102.134102.64
5123012-12301299.922100.42
6125448-125448101.901102.39
30min1123274-123274100.135100.760.87100.73101.410.88
2123498-123498100.317100.98
3124416-124416101.063101.69
4125422-125422101.880102.56
5122642-12264299.622100.29
6125001-125001101.538102.20
45min1122858-12285899.797100.480.99100.56101.300.99
2123181-123181100.060100.89
3123960-123960100.692101.49
4125224-125224101.719102.57
5122075-12207599.16199.99
6124877-124877101.437102.27
60min1122851-12285199.791100.250.88100.72101.230.88
2122739-12273999.701100.70
3123618-123618100.415101.38
4124872-124872101.433102.45
5122025-12202599.121100.12
6124376-124376101.030102.03
极限1122301-12230199.34599.970.94100.44101.120.95
2122439-12243999.457100.62
3123396-123396100.234101.37
4124452-124452101.092102.28
5121571-12157198.75299.91
6124270-124270100.944102.11
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