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%
110.032497392495552497842495852494632496250.06
210.102484612487962486280.10
单位质量响应值RSD%判断
24887.8424616.630.78数据可信
供试品溶液-24101401-低硬度批-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%
5min1174923-17492370.31862.6010.8870.3262.6010.88
2174707-17470770.23270.23
3145985-14598558.68558.69
4131744-13174452.96152.96
5149958-14995860.28360.28
6156986-15698663.10863.11
10min1203446-20344681.78479.276.5282.0079.466.52
2209399-20939984.17884.39
3179729-17972972.25072.43
4194179-19417978.05978.22
5185555-18555574.59274.77
6210891-21089184.77784.97
15min1209808-20980884.34282.715.3584.8083.145.36
2214380-21438086.18086.64
3195107-19510778.43278.83
4203290-20329081.72282.11
5191909-19190977.14777.55
6220030-22003088.45188.89
20min1213946-21394686.00584.644.6886.7185.324.69
2217090-21709087.26987.99
3205303-20530382.53183.16
4206364-20636482.95783.60
5196460-19646078.97679.61
6224212-22421290.13290.84
30min1218784-21878487.95086.933.8888.9287.863.89
2220125-22012588.48989.47
3219987-21998788.43489.31
4211129-21112984.87385.76
5201931-20193181.17582.05
6225479-22547990.64291.62
45min1222605-22260589.48688.703.5890.7289.903.57
2223498-22349889.84591.09
3227496-22749691.45292.59
4215658-21565886.69487.84
5207214-20721483.29984.42
6227499-22749991.45492.71
60min1224614-22461490.29489.753.0191.7991.203.01
2225845-22584590.78992.31
3229663-22966392.32493.74
4220399-22039988.60090.00
5211161-21116184.88686.25
6227849-22784991.59493.12
极限1235396-23539694.62894.130.7596.4095.860.73
2233399-23339993.82595.62
3237001-23700195.27396.97
4232882-23288293.61895.29
5233953-23395394.04895.67
6232283-23228393.37795.18
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%
110.032487022486762482662483202485782485080.09
210.102486162479142482650.20
单位质量响应值RSD%判断
24776.4724580.690.57数据可信
供试品溶液-24101402-低硬度批-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%
5min1172129-17212969.40161.3010.4269.4061.3010.42
2130732-13073252.71052.71
3157113-15711363.34663.35
4163046-16304665.73965.74
5136296-13629654.95354.95
6152947-15294761.66761.67
10min1201488-20148881.23877.925.9081.4578.115.90
2179974-17997472.56472.72
3181197-18119773.05773.25
4206238-20623883.15383.35
5188931-18893176.17576.34
6201759-20175981.34781.53
15min1208416-20841684.03182.075.8784.4882.495.87
2191831-19183177.34477.72
3189341-18934176.34076.75
4221089-22108989.14189.59
5201132-20113281.09481.49
6209565-20956584.49584.92
20min1213750-21375086.18284.075.3486.8984.735.35
2197000-19700079.42880.04
3195351-19535178.76479.40
4224469-22446990.50491.22
5206631-20663183.31283.95
6213820-21382086.21086.89
30min1217804-21780487.81686.423.8888.7887.343.90
2203349-20334981.98882.83
3206350-20635083.19884.07
4225313-22531390.84491.83
5213705-21370586.16487.05
6219596-21959688.53989.48
45min1221888-22188889.46388.682.6790.6989.862.70
2211524-21152485.28486.38
3215345-21534586.82587.95
4227328-22732891.65692.91
5219078-21907888.33089.48
6224485-22448590.51091.72
60min1224614-22461490.56289.831.7792.0691.271.82
2217073-21707387.52288.87
3219557-21955788.52389.91
4227455-22745591.70893.24
5222260-22226089.61391.02
6225764-22576491.02692.50
极限1234893-23489394.70794.571.1296.4796.281.04
2238499-23849996.16097.77
3234708-23470894.63296.28
4230542-23054292.95294.76
5233275-23327594.05495.73
6235357-23535794.89496.64
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%
110.032485292488112486552486172487282486680.05
210.102494782492182493480.08
单位质量响应值RSD%判断
24792.4224687.920.30数据可信
供试品溶液-24101001-低硬度批-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%
5min1118414-11841447.62448.548.5347.6248.548.52
2126172-12617250.74450.74
3131135-13113552.74052.74
4117851-11785147.39847.40
5127912-12791251.44451.44
6102679-10267941.29641.30
10min1164135-16413566.01274.867.6166.1575.017.60
2200468-20046880.62580.78
3201312-20131280.96481.12
4189771-18977176.32276.46
5182490-18249073.39473.55
6178687-17868771.86571.99
15min1176878-17687871.13781.117.2171.4881.487.20
2213700-21370085.94686.34
3215797-21579786.79087.19
4204713-20471382.33282.70
5193254-19325477.72378.10
6205684-20568482.72283.06
20min1185376-18537674.55584.186.7975.1184.806.78
2219513-21951388.28488.94
3221940-22194089.26089.92
4212473-21247385.45386.07
5199375-19937580.18580.79
6217194-21719487.35187.94
30min1195014-19501478.43187.535.9579.2188.395.94
2223735-22373589.98290.90
3225012-22501290.49691.42
4219002-21900288.07988.95
5211463-21146385.04785.89
6231533-23153393.11893.97
45min1202754-20275481.54489.774.7782.5690.904.77
2226900-22690091.25592.44
3228338-22833891.83393.03
4224611-22461190.33491.47
5223191-22319189.76390.87
6233488-23348893.90595.03
60min1214004-21400486.06891.783.1287.3393.183.14
2230800-23080092.82494.28
3230562-23056292.72894.20
4229144-22914492.15893.57
5231262-23126293.00994.38
6233498-23349893.90995.32
极限1235235-23523594.60795.390.6396.1297.070.68
2238598-23859895.96097.70
3237473-23747395.50797.26
4236969-23696995.30596.99
5239030-23903096.13397.79
6235835-23583594.84996.54
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