玛巴洛沙韦片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号115240801对照品来源原料对照品使用方法直接使用
对照品含量(%)100.6对照品水分(%)0对照品稀释倍数250
标示量(mg)40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%
111.119758149761999761349757919755229758920.03
211.279784429781759783080.02
单位质量响应值RSD%判断
87839.0686806.390.84数据可信
供试品溶液-24111801批-pH1.2(内含0.16%CTAB)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1159927-15992716.58316.3736.3616.5816.3736.35
2211708-21170821.95221.95
3163861-16386116.99016.99
4166827-16682717.29817.30
548488-484885.0285.03
6196401-19640120.36420.36
10min1445905-44590546.23544.2719.5146.2644.3019.51
2489675-48967550.77350.81
3429947-42994744.58044.61
4447753-44775346.42746.46
5263842-26384227.35727.37
6484618-48461850.24950.28
15min1577868-57786859.91858.1511.5560.0258.2511.58
2605336-60533662.76662.89
3562345-56234558.30858.41
4576858-57685859.81359.92
5433797-43379744.98045.03
6608905-60890563.13663.25
20min1663306-66330668.77766.857.2268.9867.057.24
2670312-67031269.50369.73
3646118-64611866.99567.19
4657491-65749168.17468.38
5552585-55258557.29657.43
6678664-67866470.36970.59
30min1764915-76491579.31277.183.6879.6377.493.72
2749132-74913277.67678.02
3743828-74382877.12677.44
4755393-75539378.32578.64
5690920-69092071.64071.86
6762197-76219779.03179.37
45min1840023-84002387.10085.432.1187.5585.872.15
2827374-82737485.78986.26
3826494-82649485.69786.14
4830373-83037386.10086.55
5789952-78995281.90982.25
6829478-82947886.00786.48
60min1883843-88384391.64489.831.6392.2490.421.66
2859900-85990089.16189.78
3870076-87007690.21690.80
4873610-87361090.58391.18
5842437-84243787.35187.83
6868474-86847490.05090.67
90min1927326-92732696.15394.241.3396.9094.971.35
2902844-90284493.61494.38
3910648-91064894.42395.16
4914911-91491194.86595.61
5891660-89166092.45493.08
6905704-90570493.91194.68
极限1951178-95117898.62697.710.8099.5498.600.77
2936428-93642897.09698.02
3948795-94879598.37999.27
4939857-93985797.45298.35
5945922-94592298.08198.86
6932117-93211796.64997.57
玛巴洛沙韦片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号115240801对照品来源原料对照品使用方法直接使用
对照品含量(%)100.6对照品水分(%)0对照品稀释倍数250
标示量(mg)40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%
111.119755759754479757059772199783639764620.14
211.279809709803059806380.05
单位质量响应值RSD%判断
87890.3787013.130.71数据可信
供试品溶液-24111801批-pH4.5(内含0.16%CTAB)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1137479-13747914.23416.9610.8714.2316.9610.88
2177988-17798818.42818.43
3184387-18438719.09019.09
4155712-15571216.12116.12
5173550-17355017.96817.97
6153544-15354415.89715.90
10min1399424-39942441.35442.964.5541.3842.984.56
2425218-42521844.02544.06
3432940-43294044.82444.86
4386802-38680240.04740.07
5432474-43247444.77644.81
6412469-41246942.70542.73
15min1556053-55605357.57057.922.8057.6658.022.81
2560862-56086258.06858.17
3572552-57255259.27959.39
4531376-53137655.01555.11
5575314-57531459.56559.67
6560168-56016857.99658.09
20min1646667-64666766.95266.652.2867.1466.842.28
2642657-64265766.53766.74
3654558-65455867.76967.97
4616882-61688263.86864.05
5658631-65863168.19168.39
6642840-64284066.55666.75
30min1737189-73718976.32476.131.5776.6276.431.57
2729464-72946475.52475.84
3744202-74420277.05077.37
4717511-71751174.28774.58
5750162-75016277.66777.98
6733178-73317875.90976.21
45min1809574-80957483.81883.380.9884.2583.820.99
2797775-79777582.59783.03
3813332-81333284.20784.65
4796951-79695182.51282.93
5814184-81418484.29684.74
6800449-80044982.87483.31
60min1850403-85040388.04687.670.8288.6188.250.82
2837510-83751086.71187.29
3854212-85421288.44089.03
4844109-84410987.39487.95
5853542-85354288.37188.96
6841139-84113987.08687.66
90min1891805-89180592.33292.060.6093.0592.780.60
2881972-88197291.31492.03
3894705-89470592.63293.37
4889597-88959792.10492.80
5893285-89328592.48593.22
6883465-88346591.46992.18
极限1911887-91188794.41195.330.9695.2896.200.95
2917956-91795695.04095.91
3926005-92600595.87396.76
4935045-93504596.80997.66
5921089-92108995.36496.25
6912598-91259894.48595.35
玛巴洛沙韦片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号115240801对照品来源原料对照品使用方法直接使用
对照品含量(%)100.6对照品水分(%)0对照品稀释倍数250
标示量(mg)40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%
111.119819759813029786259782229789919798230.18
211.279838139848199843160.08
单位质量响应值RSD%判断
88192.8987339.490.69数据可信
供试品溶液-24111801批-pH6.8(内含0.1%CTAB)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1178120-17812018.37518.837.9118.3818.837.91
2196232-19623220.24420.24
3161031-16103116.61216.61
4193361-19336119.94819.95
5194571-19457120.07320.07
6172026-17202617.74717.75
10min1427075-42707544.05843.773.8044.0943.813.80
2437853-43785345.17045.20
3400439-40043941.31041.34
4433612-43361244.73344.77
5438360-43836045.22245.26
6408552-40855242.14742.18
15min1554517-55451757.20657.482.0957.3157.582.09
2564615-56461558.24758.36
3541787-54178755.89255.99
4564691-56469158.25558.36
5571259-57125958.93359.04
6546242-54624256.35256.45
20min1633701-63370165.37465.601.2365.5765.801.23
2635844-63584465.59665.80
3625256-62525664.50364.69
4640924-64092466.12066.32
5647734-64773466.82267.03
6631679-63167965.16665.36
30min1717642-71764274.03474.650.7674.3474.960.76
2720657-72065774.34574.66
3718145-71814574.08674.38
4726351-72635174.93275.25
5729544-72954475.26275.58
6729253-72925375.23275.53
45min1784042-78404280.88481.400.5381.3281.840.53
2784184-78418480.89981.34
3788839-78883981.37981.80
4790954-79095481.59782.04
5793529-79352981.86382.31
6792753-79275381.78382.21
60min1825407-82540785.15185.200.3985.7285.770.38
2820346-82034684.62985.20
3829126-82912685.53586.09
4828521-82852185.47386.05
5825097-82509785.11985.70
6826642-82664285.27985.84
90min1864431-86443189.17789.160.5689.8989.870.55
2859490-85949088.66789.38
3870729-87072989.82790.53
4868593-86859389.60790.32
5858757-85875788.59289.31
6863677-86367789.09989.81
极限1899902-89990292.83692.570.4893.6993.440.47
2894474-89447492.27793.14
3898202-89820292.66193.51
4898582-89858292.70093.57
5890494-89049491.86692.74
6902478-90247893.10293.96
玛巴洛沙韦片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号115240801对照品来源原料对照品使用方法直接使用
对照品含量(%)100.6对照品水分(%)0对照品稀释倍数250
标示量(mg)40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%
111.119731759730189727369735039732689731400.03
211.279712019734569723280.17
单位质量响应值RSD%判断
87591.3686275.781.08数据可信
供试品溶液-24111801批-pH6.8(内含0.16%CTAB)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1180895-18089518.84115.8827.1518.8415.8827.16
288817-888179.2519.25
3126758-12675813.20213.20
4207470-20747021.60921.61
5156666-15666616.31716.32
6154152-15415216.05616.06
10min1461525-46152548.07045.5711.3548.1045.5911.35
2340030-34003035.41635.43
3431658-43165844.95944.98
4463550-46355048.28148.32
5471341-47134149.09249.12
6456897-45689747.58847.61
15min1611616-61161663.70362.416.1063.8162.516.11
2526920-52692054.88154.96
3603537-60353762.86162.96
4606254-60625463.14463.26
5628983-62898365.51165.62
6617654-61765464.33164.44
20min1691934-69193472.06871.473.8972.2971.683.90
2634972-63497266.13566.30
3690877-69087771.95872.16
4686923-68692371.54671.77
5711760-71176074.13374.35
6700868-70086872.99973.21
30min1778070-77807081.03980.702.0081.3881.032.02
2746449-74644977.74678.02
3779655-77965581.20581.53
4769537-76953780.15180.49
5788651-78865182.14282.48
6786599-78659981.92882.26
45min1838818-83881887.36787.411.3287.8487.871.34
2820612-82061285.47085.88
3845927-84592788.10788.56
4832942-83294286.75587.23
5846997-84699788.21988.70
6850104-85010488.54289.01
60min1870397-87039790.65690.950.9191.2791.550.93
2862064-86206489.78890.34
3879881-87988191.64492.25
4868509-86850990.45991.08
5874319-87431991.06491.69
6883941-88394192.06692.69
90min1901972-90197293.94494.090.7694.7194.850.76
2898068-89806893.53894.24
3905793-90579394.34295.10
4896750-89675093.40194.17
5902220-90222093.97094.75
6915673-91567395.37196.14
极限1925206-92520696.36496.320.5297.2997.230.52
2925764-92576496.42297.28
3924528-92452896.29497.21
4921087-92108795.93596.86
5918948-91894895.71396.65
6932940-93294097.17098.10
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