叶酸片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号100074-202217对照品来源中检院对照品使用方法直接使用
对照品含量(%)91.2对照品水分(%)0对照品稀释倍数25000
标示量(mg)0.4供试品稀释倍数2系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.111229952122876012290101228612122888112290430.05
210.141227687122593212268100.11
单位质量响应值RSD%判断
121567.06120987.180.34数据可信
供试品溶液-24092301批-pH4.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1111615-11161515.10815.533.7215.1115.533.71
2119698-11969816.20216.20
3118377-11837716.02416.02
4112796-11279615.26815.27
5116990-11699015.83615.84
6108889-10888914.73914.74
10min1206248-20624827.91826.197.2528.0926.377.21
2193667-19366726.21526.39
3198042-19804226.80726.99
4201041-20104127.21327.38
5195741-19574126.49626.67
6166349-16634922.51722.68
15min1256458-25645834.71433.699.0835.1934.169.02
2254280-25428034.41934.89
3257860-25786034.90435.38
4261139-26113935.34835.82
5260659-26065935.28335.75
6203133-20313327.49627.91
20min1299394-29939440.52639.2410.5441.3940.0810.46
2297034-29703440.20741.06
3304365-30436541.19942.06
4300998-30099840.74341.61
5309442-30944241.88642.75
6228206-22820630.89031.61
30min1352883-35288347.76646.6410.5649.0847.9210.49
2351546-35154647.58548.89
3360336-36033648.77550.10
4363902-36390249.25850.58
5367270-36727049.71451.04
6271373-27137336.73337.80
45min1412598-41259855.84954.5510.4657.6956.3510.41
2405741-40574154.92156.75
3425663-42566357.61859.48
4427987-42798757.93259.80
5427210-42721057.82759.71
6318968-31896843.17644.65
60min1447774-44777460.61160.0910.5363.0862.4910.48
2444624-44462460.18462.62
3473793-47379364.13366.64
4471452-47145263.81666.32
5473544-47354464.09966.62
6352423-35242347.70449.65
90min1507571-50757168.70567.909.2271.8470.979.23
2493929-49392966.85869.97
3535424-53542472.47575.69
4529010-52901071.60774.82
5530842-53084271.85575.09
6413034-41303455.90858.39
极限1551058-55105874.59174.764.3678.4978.584.58
2548257-54825774.21278.06
3577998-57799878.23882.26
4570755-57075577.25881.27
5556751-55675175.36279.40
6509190-50919068.92472.03
叶酸片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号100074-202217对照品来源中检院对照品使用方法直接使用
对照品含量(%)91.2对照品水分(%)0对照品稀释倍数25000
标示量(mg)0.4供试品稀释倍数2系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.111224835122281912227921222553122235512230710.09
210.141219912121816712190400.11
单位质量响应值RSD%判断
120976.36120220.910.45数据可信
供试品溶液-24092401批-pH4.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1109707-10970714.93415.385.1214.9315.385.12
2116242-11624215.82315.82
3115487-11548715.72015.72
4106688-10668814.52314.52
5121678-12167816.56316.56
6108088-10808814.71314.71
10min1189052-18905225.73426.4512.3725.9026.6212.27
2187662-18766225.54525.72
3183309-18330924.95225.13
4240753-24075332.77232.93
5194164-19416426.43026.61
6171141-17114123.29623.46
15min1225527-22552730.69932.226.6931.1532.686.66
2244623-24462333.29933.76
3248427-24842733.81634.27
4240577-24057732.74833.27
5250814-25081434.14134.62
6210018-21001828.58829.01
20min1277867-27786737.82437.907.7838.6238.727.72
2289657-28965739.42940.26
3291240-29124039.64440.47
4283075-28307538.53339.42
5292929-29292939.87440.73
6235757-23575732.09232.83
30min1326790-32679044.48345.269.0745.7046.508.98
2354718-35471848.28549.55
3347277-34727747.27248.54
4335623-33562345.68647.00
5355108-35510848.33849.64
6275280-27528037.47238.57
45min1376717-37671751.28053.0410.2252.9954.7810.10
2422300-42230057.48459.29
3401549-40154954.66056.45
4390042-39004253.09354.92
5428416-42841658.31760.15
6318679-31867943.37944.89
60min1409427-40942755.73258.2110.6458.0160.5510.52
2464870-46487063.27965.72
3439251-43925159.79262.19
4427488-42748858.19160.61
5475791-47579164.76667.25
6349056-34905647.51449.51
90min1463523-46352363.09665.1010.0665.9968.089.98
2523829-52382971.30574.45
3488090-48809066.44069.50
4475241-47524164.69167.75
5524332-52433271.37374.58
6394309-39430953.67456.20
极限1526348-52634871.64872.744.1275.2576.444.32
2554407-55440775.46779.41
3543268-54326873.95177.75
4526108-52610871.61575.40
5557305-55730575.86279.86
6498664-49866467.87971.00
叶酸片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号100074-202217对照品来源中检院对照品使用方法直接使用
对照品含量(%)91.2对照品水分(%)0对照品稀释倍数25000
标示量(mg)0.4供试品稀释倍数2系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.111219342121716412169431217104121638212173870.10
210.141216218121436812152930.11
单位质量响应值RSD%判断
120414.14119851.380.34数据可信
供试品溶液-24092402批-pH4.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1728633-72863399.56799.600.9699.5799.600.96
2736182-736182100.599100.60
3733572-733572100.242100.24
4716520-71652097.91297.91
5726425-72642599.26699.27
6731823-731823100.003100.00
10min1713345-71334597.47880.8747.3698.5881.9846.73
2722915-72291598.78699.90
3650771-65077188.92890.04
422592-225923.0874.18
5716686-71668697.93599.04
6724528-72452899.006100.12
15min1705871-70587196.45797.380.8198.6599.381.00
2722062-72206298.669100.88
3714584-71458497.64899.75
4709647-70964796.97398.10
5708968-70896896.88099.07
6714605-71460597.65099.86
20min1702814-70281496.03996.741.1899.3099.831.41
2714774-71477497.674100.99
3712636-71263697.381100.57
4699707-69970795.61597.81
5699438-69943895.57898.85
6718351-71835198.162101.46
30min1697337-69733795.29195.740.5599.6299.900.76
2706072-70607296.484100.88
3703777-70377796.171100.44
4699191-69919195.54498.81
5696114-69611495.12499.45
6701237-70123795.824100.21
45min1686712-68671293.83994.840.7499.23100.070.94
2701520-70152095.862101.33
3694968-69496894.967100.30
4691138-69113894.44498.77
5693003-69300394.699100.09
6696944-69694495.237100.69
60min1675667-67566792.33093.390.6598.7699.670.88
2686680-68668093.835100.37
3686271-68627193.779100.17
4680551-68055192.99798.37
5685761-68576193.709100.15
6685629-68562993.691100.20
90min1664580-66458090.81592.751.0998.27100.061.11
2682973-68297393.328100.90
3685570-68557093.683101.12
4679132-67913292.80399.21
5681098-68109893.072100.55
6678937-67893792.776100.33
极限1669539-66953991.49292.510.6599.96100.860.87
2678761-67876192.752101.37
3681611-68161193.142101.62
4674156-67415692.12399.56
5678562-67856292.725101.24
6679226-67922692.816101.40
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