左氨氯地平叶酸片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号100546-202105 对照品来源中检院对照品使用方法直接使用
对照品含量(%)97.3对照品水分(%)0对照品稀释倍数5000
标示量(mg)2.5供试品稀释倍数2系数0.7210
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
116.141834681826361828561828561827811829190.18
216.011829511823361826440.24
单位质量响应值RSD%判断
11333.2711408.120.47数据可信
供试品溶液-24052301批-左氨氯地平-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%
5min1214776-214776190.816187.882.12190.82187.882.12
2217100-217100192.880192.88
3211898-211898188.259188.26
4205511-205511182.584182.58
5212631-212631188.910188.91
6206940-206940183.854183.85
10min1217112-217112192.891188.472.07195.01190.562.07
2215662-215662191.603193.75
3211596-211596187.990190.08
4206589-206589183.542185.57
5214439-214439190.516192.62
6207409-207409184.271186.31
15min1213185-213185189.402186.791.85193.67190.971.85
2213600-213600189.771194.04
3209820-209820186.413190.59
4204494-204494181.681185.75
5213491-213491189.674193.89
6206848-206848183.772187.86
20min1211914-211914188.273185.131.96194.64191.391.96
2211981-211981188.332194.71
3208158-208158184.936191.19
4202779-202779180.157186.24
5211299-211299187.727194.05
6204141-204141181.367187.50
30min1210749-210749187.238183.662.01195.70191.972.01
2209937-209937186.516194.99
3206271-206271183.259191.57
4201040-201040178.612186.70
5209781-209781186.378194.79
6202540-202540179.945188.09
45min1208201-208201184.974181.931.90195.51192.281.90
2207351-207351184.219194.76
3205252-205252182.354192.70
4199044-199044176.839186.91
5207800-207800184.618195.10
6200968-200968178.548188.69
极限1200875-200875178.465176.061.85191.06188.441.85
2199795-199795177.506190.10
3199374-199374177.132189.50
4193539-193539171.948183.99
5201811-201811179.297191.83
6193640-193640172.038184.17
左氨氯地平叶酸片项目信息
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20000
标示量(mg)0.8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%
116.781888331885311887331886291888741887200.08
216.841874951877641876300.11
单位质量响应值RSD%判断
11246.7211141.920.67数据可信
供试品溶液-24052301批-叶酸-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%
5min1203180-203180186.226180.043.02186.23180.043.02
2204204-204204187.164187.16
3191583-191583175.597175.60
4191721-191721175.723175.72
5191610-191610175.621175.62
6196282-196282179.903179.90
10min1206070-206070188.875182.393.41190.94184.393.40
2208336-208336190.952193.03
3192866-192866176.773178.72
4193278-193278177.150179.10
5194321-194321178.106180.06
6199092-199092182.479184.48
15min1204929-204929187.829182.213.21192.00186.243.21
2208040-208040190.680194.88
3193239-193239177.114181.03
4192608-192608176.536180.46
5195482-195482179.170183.10
6198474-198474181.913185.94
20min1205877-205877188.698181.973.25194.95188.023.24
2206689-206689189.442195.76
3192772-192772176.686182.57
4191728-191728175.729181.61
5195889-195889179.543185.46
6198295-198295181.748187.80
30min1206088-206088188.891182.753.04197.24190.823.05
2207085-207085189.805198.23
3194458-194458178.232186.08
4192215-192215176.176184.01
5197628-197628181.137189.05
6198858-198858182.265190.33
45min1206073-206073188.877184.382.52199.33194.492.55
2207607-207607190.283200.82
3197071-197071180.627190.45
4194409-194409178.187187.98
5200914-200914184.149194.08
6200955-200955184.187194.28
极限1203706-203706186.708188.660.78199.26200.810.71
2207178-207178189.890202.54
3207975-207975190.621202.45
4205945-205945188.760200.53
5205768-205768188.598200.57
6204444-204444187.384199.52
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