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%
110.302499012498392498842498402494662497860.08
210.332500142500102500120.01
单位质量响应值RSD%判断
24251.0724202.520.15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%
5min1234723-23472396.40192.742.4996.4092.742.49
2224126-22412692.04992.05
3226090-22609092.85692.86
4222939-22293991.56291.56
5218171-21817189.60389.60
6228777-22877793.95993.96
10min1240755-24075598.87994.432.8199.1794.712.81
2227274-22727493.34293.62
3230287-23028794.58094.86
4226804-22680493.14993.42
5221749-22174991.07391.34
6232647-23264795.54995.83
15min1240794-24079498.89594.592.7599.4895.152.75
2228673-22867393.91794.47
3231009-23100994.87695.44
4227064-22706493.25693.81
5221874-22187491.12491.67
6232462-23246295.47396.04
20min1240570-24057098.80394.452.7799.6995.292.77
2228763-22876393.95494.79
3230257-23025794.56795.41
4226578-22657893.05693.89
5221513-22151390.97691.79
6232087-23208795.31996.17
30min1239387-23938798.31793.992.7799.5095.122.77
2227969-22796993.62794.75
3229521-22952194.26595.40
4225706-22570692.69893.81
5220167-22016790.42391.51
6230339-23033994.60195.74
45min1238094-23809497.78693.652.7699.2695.062.76
2227139-22713993.28794.69
3228682-22868293.92095.33
4224584-22458492.23793.63
5219270-21927090.05591.41
6230431-23043194.63996.06
60min1237209-23720997.42293.272.7099.1994.962.70
2226218-22621892.90894.59
3227448-22744893.41495.11
4224000-22400091.99793.67
5218672-21867289.80991.44
6229065-22906594.07895.79
极限1236884-23688497.28993.072.8599.3595.042.85
2226020-22602092.82794.79
3227195-22719593.31095.29
4223535-22353591.80693.75
5217229-21722989.21791.12
6228748-22874893.94795.94
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%
110.302509732507952506672506172504972507100.08
210.332508842509842509340.03
单位质量响应值RSD%判断
24340.7824291.770.15数据可信
供试品溶液-2185663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%
5min1222440-22244091.02190.971.4691.0290.971.46
2218482-21848289.40189.40
3223136-22313691.30591.31
4226936-22693692.86092.86
5224057-22405791.68291.68
6218792-21879289.52889.53
10min1227353-22735393.03193.061.3293.3093.341.32
2227384-22738493.04493.31
3226966-22696692.87393.15
4230817-23081794.44894.73
5229831-22983194.04594.32
6222216-22221690.92991.20
15min1227668-22766893.16093.181.3193.7193.731.31
2227486-22748693.08593.63
3227622-22762293.14193.69
4230928-23092894.49495.06
5230147-23014794.17494.73
6222439-22243991.02091.56
20min1227196-22719692.96793.041.2593.8093.871.25
2226848-22684892.82493.65
3227094-22709492.92593.76
4230552-23055294.34095.19
5229939-22993994.08994.93
6222604-22260491.08891.90
30min1224823-22482391.99692.521.4193.1193.631.41
2225909-22590992.44093.55
3226139-22613992.53493.64
4229621-22962193.95995.09
5229178-22917893.77894.90
6220884-22088490.38491.47
45min1224661-22466191.92992.141.3293.3293.531.32
2225331-22533192.20493.59
3225182-22518292.14393.53
4228709-22870993.58695.00
5227173-22717392.95794.36
6219987-21998790.01791.38
60min1224444-22444491.84192.011.4593.5093.681.44
2224562-22456291.88993.55
3224477-22447791.85493.52
4227764-22776493.19994.89
5228542-22854293.51795.20
6219376-21937689.76791.40
极限1222271-22227190.95191.421.3692.8993.361.36
2224060-22406091.68393.62
3223587-22358791.49093.43
4226874-22687492.83594.81
5225563-22556392.29894.26
6218178-21817889.27791.17
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%
110.302537992537832538822539132535462537850.06
210.332502282502932502600.02
单位质量响应值RSD%判断
24639.3224226.521.20数据可信
供试品溶液-2180621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%
5min1206644-20664484.15990.723.6784.1690.723.67
2224302-22430291.35191.35
3225543-22554391.85691.86
4223539-22353991.04091.04
5229147-22914793.32493.32
6227404-22740492.61492.61
10min1235725-23572596.00394.261.3396.2694.541.32
2228132-22813292.91193.18
3229740-22974093.56593.84
4234608-23460895.54895.82
5231292-23129294.19794.48
6229214-22921493.35193.63
15min1235202-23520295.79094.671.8696.3395.231.85
2228343-22834392.99693.55
3229898-22989893.63094.19
4239789-23978997.65898.22
5231848-23184894.42494.99
6229641-22964193.52594.08
20min1234992-23499295.70494.441.8496.5395.281.83
2228080-22808092.88993.72
3229326-22932693.39794.23
4239004-23900497.33898.19
5231123-23112394.12994.97
6228873-22887393.21294.05
30min1234029-23402995.31294.111.8496.4395.231.83
2226942-22694292.42693.54
3228842-22884293.20094.32
4238165-23816596.99798.14
5230262-23026293.77894.91
6228214-22821492.94494.06
45min1233609-23360995.14193.931.9196.5495.341.89
2226784-22678492.36293.75
3227659-22765992.71894.11
4238059-23805996.95398.39
5229879-22987993.62295.03
6227833-22783392.78994.19
60min1232284-23228494.60193.551.8696.2995.241.85
2225622-22562291.88893.55
3227286-22728692.56694.24
4237101-23710196.56398.29
5228720-22872093.15094.84
6227176-22717692.52194.20
极限1230782-23078293.99093.161.6195.9695.121.61
2224829-22482991.56593.51
3226670-22667092.31594.27
4235030-23503095.72097.74
5228405-22840593.02294.99
6226691-22669192.32494.28
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%
110.302507252509432506832507302505482507260.06
210.332513242513972513600.03
单位质量响应值RSD%判断
24342.3324333.010.03数据可信
供试品溶液-24082102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%
5min1227832-22783293.14591.437.7193.1491.437.71
2230058-23005894.05594.05
3235330-23533096.21096.21
4188850-18885077.20877.21
5230354-23035494.17694.18
6229431-22943193.79993.80
10min1230635-23063594.29195.082.9794.5795.362.98
2234736-23473695.96796.25
3241121-24112198.57898.87
4220393-22039390.10490.34
5235403-23540396.24096.52
6233116-23311695.30595.59
15min1231077-23107794.47296.121.4695.0396.681.47
2235517-23551796.28796.86
3241253-24125398.63299.22
4234284-23428495.78396.28
5235258-23525896.18196.75
6233203-23320395.34195.91
20min1228095-22809593.25295.701.7394.1096.551.73
2234477-23447795.86296.72
3240543-24054398.34199.22
4234008-23400895.67096.46
5235012-23501296.08096.94
6232391-23239195.00995.86
30min1230338-23033894.16995.691.3495.2996.821.34
2234022-23402295.67696.82
3239795-23979598.03699.21
4232912-23291295.22296.30
5233821-23382195.59396.74
6233411-23341195.42696.56
45min1228356-22835693.35995.201.5294.7796.621.52
2233293-23329395.37796.81
3239116-23911697.75899.23
4232687-23268795.13096.49
5232372-23237295.00196.44
6231267-23126794.54995.97
60min1228344-22834493.35494.951.5395.0496.651.53
2232576-23257695.08496.80
3238547-23854797.52599.29
4231783-23178394.76096.41
5232621-23262195.10396.82
6229545-22954593.84595.55
极限1228201-22820193.29694.631.4295.2696.621.42
2231115-23111594.48796.49
3237774-23777497.20999.26
4230402-23040294.19696.13
5231041-23104194.45796.46
6230258-23025894.13796.13
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