叶酸片项目信息
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2000
标示量(mg)5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%
110.17 9930499331993569928799271993100.04
210.129983899877998580.03
单位质量响应值RSD%判断
9765.009867.390.74数据可信
供试品溶液-23FA175批-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%
5min1119326-11932699.77997.812.2499.7897.812.24
2115284-11528496.40096.40
3114645-11464595.86595.87
4116068-11606897.05597.06
5121111-121111101.272101.27
6115395-11539596.49296.49
10min1119785-119785100.16398.512.10100.3398.672.10
2115617-11561796.67896.84
3116082-11608297.06797.23
4117077-11707797.89998.06
5121852-121852101.892102.06
6116401-11640197.33497.49
15min1119554-11955499.97098.412.27100.3098.742.27
2115354-11535496.45896.78
3116205-11620597.17097.49
4116827-11682797.69098.01
5122230-122230102.208102.55
6115983-11598396.98497.31
20min1119436-11943699.87199.062.40100.3799.552.39
2115482-11548296.56597.05
3121334-121334101.459101.94
4116596-11659697.49797.98
5121971-121971101.991102.50
6115947-11594796.95497.44
30min1119080-11908099.57498.142.23100.2498.802.23
2115238-11523896.36197.00
3115794-11579496.82697.48
4116356-11635697.29697.95
5121927-121927101.954102.63
6115808-11580896.83897.48
45min1119058-11905899.55597.932.37100.3998.752.37
2114674-11467495.88996.69
3115477-11547796.56197.37
4116242-11624297.20198.01
5121839-121839101.881102.73
6115396-11539696.49397.30
极限1118984-11898499.49397.792.27100.4998.782.27
2114894-11489496.07397.04
3115252-11525296.37397.35
4116091-11609197.07498.05
5121397-121397101.511102.53
6115094-11509496.24197.21
叶酸片项目信息
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2000
标示量(mg)5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%
110.17 9936499339992719930499212992980.06
210.129905299238991450.14
单位质量响应值RSD%判断
9763.829796.940.24数据可信
供试品溶液-23FA175批-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%
5min1120244-120244100.913101.983.59100.91101.983.59
2114603-11460396.17996.18
3122758-122758103.023103.02
4122963-122963103.195103.19
5120577-120577101.192101.19
6127922-127922107.356107.36
10min1120442-120442101.079102.553.48101.25102.723.48
2115670-11567097.07497.23
3123447-123447103.601103.77
4123450-123450103.603103.78
5121570-121570102.026102.19
6128589-128589107.916108.10
15min1120174-120174100.854102.593.43101.19102.933.43
2115590-11559097.00797.33
3123265-123265103.448103.79
4123625-123625103.750104.09
5122535-122535102.836103.17
6128244-128244107.627107.99
20min1119906-119906100.629102.243.60101.13102.753.60
2115082-11508296.58197.06
3123078-123078103.291103.81
4123149-123149103.351103.87
5121334-121334101.828102.34
6128409-128409107.765108.30
30min1119575-119575100.351102.053.63101.02102.743.63
2114864-11486496.39897.04
3122795-122795103.054103.74
4123395-123395103.557104.25
5120891-120891101.456102.14
6128106-128106107.511108.23
45min1119403-119403100.207102.033.61101.05102.883.61
2114834-11483496.37397.18
3122591-122591102.883103.74
4124378-124378104.382105.24
5120669-120669101.270102.12
6127589-127589107.077107.97
极限1119442-119442100.240101.773.52101.25102.803.52
2114463-11446396.06197.03
3122426-122426102.744103.78
4122641-122641102.924103.96
5121227-121227101.738102.76
6127423-127423106.938108.01
叶酸片项目信息
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2000
标示量(mg)5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%
110.17 2485082486972485532487402487042486400.05
210.122488142487042487590.04
单位质量响应值RSD%判断
24448.3824580.930.39数据可信
供试品溶液-AM222092批-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%
5min1292573-29257397.96098.610.8397.9698.610.83
2297865-29786599.73299.73
3294674-29467498.66498.66
4297024-29702499.45099.45
5292143-29214397.81697.82
6292831-29283198.04698.05
10min1295686-29568699.00299.661.0399.1799.821.03
2300744-300744100.696100.86
3299470-299470100.269100.43
4300860-300860100.735100.90
5294356-29435698.55798.72
6294719-29471998.67998.84
15min1294919-29491998.74699.611.1099.0799.941.10
2301093-301093100.813101.15
3299329-299329100.222100.55
4300852-300852100.732101.07
5294315-29431598.54398.87
6294583-29458398.63398.96
20min1294728-29472898.68299.321.0199.1799.811.02
2300390-300390100.577101.08
3298011-29801199.781100.28
4299310-299310100.216100.72
5293322-29332298.21198.70
6293969-29396998.42798.92
30min1294219-29421998.51199.201.3399.1799.861.33
2300554-300554100.632101.30
3298397-29839799.910100.57
4299951-299951100.430101.10
5290779-29077997.35998.01
6293766-29376698.35999.02
45min1293516-29351698.27699.671.4399.10100.501.42
2299267-299267100.201101.04
3298216-29821699.849100.68
4299470-299470100.269101.11
5292023-29202397.77698.59
6303562-303562101.639102.46
极限1292828-29282898.04598.910.9399.0399.900.94
2298841-298841100.059101.06
3296582-29658299.302100.30
4297969-29796999.767100.77
5292519-29251997.94298.92
6293693-29369398.33599.32
叶酸片项目信息
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2000
标示量(mg)5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%
110.17 2486712483802485142484972486162485360.05
210.122475432476802476120.04
单位质量响应值RSD%判断
24438.1524467.590.09数据可信
供试品溶液-AM222092批-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%
5min1293636-29363698.56498.951.7298.5698.951.72
2290486-29048697.50697.51
3288502-28850296.84096.84
4300955-300955101.020101.02
5294876-29487698.98098.98
6300294-300294100.799100.80
10min1298499-298499100.196100.061.73100.36100.231.73
2293595-29359598.55098.71
3290898-29089897.64597.81
4303714-303714101.947102.11
5298517-298517100.202100.37
6303426-303426101.850102.02
15min1296349-29634999.47499.671.7799.81100.001.77
2291818-29181897.95398.28
3290526-29052697.52097.84
4303236-303236101.786102.12
5297274-29727499.785100.12
6302440-302440101.519101.86
20min1292784-29278498.27899.401.8898.7799.901.88
2293851-29385198.63699.13
3289535-28953597.18797.67
4303160-303160101.761102.27
5294745-29474598.93699.43
6302703-302703101.607102.11
30min1295069-29506999.04599.451.7099.71100.121.70
2292364-29236498.13798.79
3289752-28975297.26097.91
4302115-302115101.410102.09
5296396-29639699.490100.15
6301971-301971101.361102.04
45min1295217-29521799.09499.311.5099.92100.141.50
2292157-29215798.06798.89
3289991-28999197.34098.15
4301545-301545101.218102.07
5296282-29628299.452100.28
6299951-299951100.683101.53
极限1293456-29345698.50399.011.5899.49100.011.58
2292475-29247598.17499.16
3288373-28837396.79797.77
4300993-300993101.033102.05
5295220-29522099.095100.09
6299366-299366100.487101.50
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