盐酸司来吉兰片项目信息
介质体积(ml)500取样体积(ml)1.5补液体积(ml)1.5
对照品批号101298-201801对照品来源中检院对照品使用方法减压干燥3h
对照品含量(%)99.5对照品水分(%)0对照品稀释倍数1000
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%
110.172479222476292478362476092476972477390.06
210.082477752475792476770.06
单位质量响应值RSD%判断
24359.7824571.130.62数据可信
供试品溶液-24092701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%
5min179867-7986732.48234.537.0332.4834.547.03
288279-8827935.90335.90
376914-7691431.28131.28
483932-8393234.13534.14
587163-8716335.44935.45
693330-9333037.95837.96
10min1117688-11768847.86455.8411.6347.9655.9511.61
2140077-14007756.97057.08
3143012-14301258.16358.26
4157549-15754964.07664.18
5118671-11867148.26448.37
6146844-14684459.72259.84
15min1142882-14288258.11163.598.7358.3563.878.73
2159249-15924964.76765.05
3160300-16030065.19565.46
4172958-17295870.34370.64
5137235-13723555.81456.07
6165559-16555967.33367.63
20min1156528-15652863.66068.147.3664.0868.607.36
2169095-16909568.77269.24
3169041-16904168.75069.21
4179913-17991373.17173.68
5149985-14998560.99961.42
6180627-18062773.46273.96
30min1171937-17193769.92773.396.2070.5374.056.21
2179813-17981373.13173.81
3180750-18075073.51274.18
4189313-18931376.99477.72
5165064-16506467.13267.73
6195817-19581779.63980.35
45min1182088-18208874.05677.315.0374.8778.195.06
2189102-18910276.90877.81
3188634-18863476.71877.61
4197360-19736080.26781.22
5178769-17876972.70673.51
6204541-20454183.18884.14
60min1188733-18873376.75879.713.9977.8080.834.02
2196060-19606079.73880.87
3194049-19404978.92080.04
4201927-20192782.12483.32
5187392-18739276.21377.23
6207794-20779484.51185.71
极限1215692-21569287.72389.011.0688.9990.361.11
2222034-22203490.30291.67
3217615-21761588.50589.86
4220946-22094689.85991.30
5217926-21792688.63189.88
6218859-21885989.01190.47
盐酸司来吉兰片项目信息
介质体积(ml)500取样体积(ml)1.5补液体积(ml)1.5
对照品批号101298-201801对照品来源中检院对照品使用方法减压干燥3h
对照品含量(%)99.5对照品水分(%)0对照品稀释倍数1000
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%
110.172443972446142444972445522449522446020.09
210.082446212446522446360.01
单位质量响应值RSD%判断
24051.3324269.440.64数据可信
供试品溶液-24092702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%
5min1177022-17702272.90571.4418.6372.9071.4418.63
2207486-20748685.45185.45
3200073-20007382.39882.40
4147222-14722260.63260.63
5123396-12339650.81950.82
6185531-18553176.40976.41
10min1236488-23648897.39591.595.6997.6191.815.71
2235844-23584497.13097.39
3228623-22862394.15694.40
4211307-21130787.02587.21
5210017-21001786.49386.65
6212095-21209587.34987.58
15min1242801-24280199.99593.985.06100.5194.475.08
2239712-23971298.72399.27
3232167-23216795.61696.15
4219024-21902490.20390.65
5217940-21794089.75690.17
6217509-21750989.57990.07
20min1243484-243484100.27695.054.60101.0995.824.62
2241938-24193899.640100.48
3234833-23483396.71497.53
4222150-22215091.49092.20
5221120-22112091.06691.75
6221169-22116991.08691.85
30min1243868-243868100.43496.143.98101.5597.204.01
2243028-243028100.089101.23
3238141-23814198.07699.18
4226914-22691493.45294.44
5224362-22436292.40193.36
6224359-22435992.40093.43
45min1245320-245320101.03297.373.47102.4598.723.50
2244970-244970100.888102.33
3240772-24077299.159100.56
4231157-23115795.20096.47
5228380-22838094.05695.29
6227967-22796793.88695.20
60min1246072-246072101.34298.322.93103.0699.952.97
2245892-245892101.268103.01
3242534-24253499.885101.58
4235404-23540496.94998.50
5231213-23121395.22396.74
6231236-23123695.23296.82
极限1247177-247177101.797102.331.46103.82104.261.49
2249548-249548102.774104.82
3254286-254286104.725106.72
4250078-250078102.992104.84
5244808-244808100.822102.62
6244888-244888100.855102.73
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