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%
19.912392672388982395762391622395482392900.12
29.992371472375442373460.12
单位质量响应值RSD%判断
24146.3223758.361.15数据可信
供试品溶液-2095120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%
5min1189953-18995378.91368.8016.0178.9168.8016.00
2116709-11670948.48548.49
3176139-17613973.17473.17
4155506-15550664.60364.60
5181098-18109875.23575.23
6174282-17428272.40372.40
10min1212525-21252588.29083.857.6488.5384.067.65
2174426-17442672.46372.61
3195739-19573981.31781.54
4208014-20801486.41686.61
5217526-21752690.36890.59
6202782-20278284.24384.46
15min1216714-21671490.03187.185.4490.5387.645.46
2192008-19200879.76780.13
3203088-20308884.37084.83
4215794-21579489.64890.10
5223924-22392493.02693.52
6207578-20757886.23586.71
20min1221638-22163892.07689.214.4692.8589.934.49
2201965-20196583.90384.51
3207499-20749986.20286.92
4219277-21927791.09591.82
5227311-22731194.43395.21
6210678-21067887.52388.25
30min1223263-22326392.75190.453.5793.8091.433.60
2209458-20945887.01687.87
3210636-21063687.50688.48
4220572-22057291.63392.63
5228918-22891895.10196.16
6213443-21344388.67289.66
45min1225233-22523393.57091.572.9394.9092.832.96
2214853-21485389.25890.37
3214861-21486189.26190.50
4221899-22189992.18593.45
5230236-23023695.64896.99
6215466-21546689.51290.77
60min1226605-22660594.14091.852.7595.7593.392.78
2215890-21589089.68891.07
3218208-21820890.65192.16
4222313-22231392.35793.90
5229429-22942995.31396.94
6214170-21417088.97490.50
极限1229466-22946695.32892.782.8397.2294.602.85
2217520-21752090.36692.02
3227055-22705594.32796.10
4221538-22153892.03593.86
5229617-22961795.39197.31
6214865-21486589.26391.06
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%
19.912376052379812382272380552384362380610.13
29.992383322379762381540.11
单位质量响应值RSD%判断
24022.3023839.240.55数据可信
供试品溶液-2095120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%
5min1181366-18136675.41068.0611.0675.4168.0611.06
2177108-17710873.64073.64
3146787-14678761.03261.03
4180625-18062575.10275.10
5154714-15471464.32864.33
6141532-14153258.84758.85
10min1206380-20638085.81080.625.8786.0480.835.88
2202259-20225984.09784.32
3198158-19815882.39282.57
4196091-19609181.53281.76
5183909-18390976.46776.66
6176644-17664473.44773.62
15min1216533-21653390.03284.155.2790.5284.595.29
2207973-20797386.47386.95
3206764-20676485.97086.40
4201961-20196183.97384.44
5194763-19476380.98081.40
6186265-18626577.44777.84
20min1221299-22129992.01485.865.2992.7786.555.30
2211560-21156087.96488.70
3212065-21206588.17488.86
4204532-20453285.04285.76
5199207-19920782.82883.49
6190272-19027279.11379.74
30min1229084-22908495.25188.555.1496.2889.505.14
2216081-21608189.84490.84
3218847-21884790.99491.95
4208284-20828486.60287.58
5208288-20828886.60487.52
6197179-19717981.98582.85
45min1232195-23219596.54490.404.7297.8691.634.73
2219617-21961791.31492.58
3223873-22387393.08494.31
4211604-21160487.98389.22
5214709-21470989.27490.45
6202579-20257984.23085.34
60min1232498-23249896.67091.474.1298.2892.964.13
2220684-22068491.75893.30
3226312-22631294.09895.60
4214876-21487689.34390.84
5219175-21917591.13192.57
6206373-20637385.80887.17
极限1235255-23525597.81694.203.1199.7195.973.12
2222439-22243992.48894.30
3233582-23358297.12198.91
4221228-22122891.98493.75
5228752-22875295.11396.83
6218090-21809090.67992.30
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