玛巴洛沙韦干混悬剂项目信息
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对照品来源原料药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%
110.879679829679889689439662819686929679770.11
210.859688469674619681540.11
单位质量响应值RSD%判断
89050.3289230.780.15数据可信
供试品溶液-24122301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%
5min1741188-74118875.28280.224.4975.2880.224.49
2816522-81652282.93482.93
3760287-76028777.22277.22
4814057-81405782.68482.68
5777455-77745578.96678.97
6829475-82947584.25084.25
10min1812243-81224382.50086.763.8082.6386.893.80
2877801-87780189.15889.30
3825848-82584883.88184.01
4879573-87957389.33889.48
5839485-83948585.26785.40
6889993-88999390.39790.54
15min1832597-83259784.56788.163.1484.8388.443.14
2888751-88875190.27090.56
3844436-84443685.76986.04
4891405-89140590.54090.83
5855363-85536386.87987.15
6895554-89555490.96191.25
20min1837019-83701985.01688.462.7485.4288.892.75
2888811-88881190.27790.71
3856986-85698687.04487.46
4891876-89187690.58891.03
5856916-85691687.03787.46
6894200-89420090.82491.27
30min1843444-84344485.66988.742.4386.2189.322.44
2889796-88979690.37790.96
3864332-86433287.79088.35
4893410-89341090.74491.33
5858586-85858687.20787.77
6892813-89281390.68391.28
45min1845163-84516385.84388.832.1886.5389.552.18
2885161-88516189.90690.64
3868291-86829188.19288.90
4894103-89410390.81491.55
5863577-86357787.71488.42
6891385-89138590.53891.28
60min1845461-84546185.87488.622.1686.7089.492.17
2885474-88547489.93890.83
3865131-86513187.87188.72
4891822-89182290.58291.47
5858641-85864187.21288.07
6888454-88845490.24091.14
极限1917911-91791193.23294.881.4494.2195.901.44
2942312-94231295.71196.75
3950186-95018696.51097.51
4945236-94523696.00897.05
5922513-92251393.70094.70
6926566-92656694.11195.16
玛巴洛沙韦干混悬剂项目信息
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对照品来源原料药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%
110.879692049675129703589703229690689692930.13
210.859697659706169701900.07
单位质量响应值RSD%判断
89171.3989418.430.20数据可信
供试品溶液-24122302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%
5min1778192-77819278.90478.007.7978.9078.007.78
2685660-68566069.52269.52
3865960-86596087.80487.80
4740469-74046975.08075.08
5754818-75481876.53476.53
6790581-79058180.16180.16
10min1861352-86135287.33686.756.0887.4786.886.09
2780798-78079879.16979.28
3940917-94091795.40495.55
4851012-85101286.28886.41
5833517-83351784.51484.64
6865763-86576387.78487.92
15min1882849-88284989.51689.335.0289.7989.615.02
2817602-81760282.90083.15
3954597-95459796.79197.10
4878637-87863789.08989.36
5864756-86475687.68287.95
6887678-88767890.00690.29
20min1890578-89057890.30090.194.2790.7390.624.27
2836263-83626384.79385.18
3953975-95397596.72897.19
4884798-88479889.71490.13
5877207-87720788.94489.36
6894262-89426290.67391.10
30min1892720-89272090.51790.733.6891.0991.303.69
2851022-85102286.28986.82
3952334-95233496.56197.19
4888740-88874090.11390.68
5884157-88415789.64990.21
6899948-89994891.25091.83
45min1894686-89468690.71690.773.5291.4491.503.54
2856375-85637586.83287.50
3952641-95264196.59397.38
4888903-88890390.13090.85
5884594-88459489.69390.41
6894291-89429190.67691.41
60min1891085-89108590.35190.733.4591.2391.613.46
2855622-85562286.75587.57
3950020-95002096.32797.28
4890133-89013390.25591.12
5884162-88416289.64990.51
6897891-89789191.04191.93
极限1967361-96736198.08599.041.2299.11100.061.25
2963360-96336097.67998.64
3997411-997411101.132102.24
4978564-97856499.221100.24
5975129-97512998.87399.88
6978666-97866699.231100.27
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