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%
111.189890329869659876799880859869559877430.09
211.149852719841019846860.09
单位质量响应值RSD%判断
88349.1188391.920.04数据可信
供试品溶液-24111201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%
5min1849640-84964087.05086.574.3987.0586.574.39
2831156-83115685.15685.16
3902038-90203892.41892.42
4811943-81194383.18883.19
5870572-87057289.19489.19
6804278-80427882.40282.40
10min1918443-91844394.09992.593.4994.2492.733.50
2891506-89150691.33991.48
3949229-94922997.25397.41
4876274-87627489.77989.92
5921268-92126894.38994.54
6865317-86531788.65688.79
15min1928304-92830495.10993.393.1195.4193.693.11
2899094-89909492.11792.41
3951244-95124497.46097.78
4889601-88960191.14491.43
5925742-92574294.84795.15
6875387-87538789.68889.97
20min1926106-92610694.88493.432.9395.3493.882.93
2898868-89886892.09492.54
3949508-94950897.28297.76
4892969-89296991.48991.93
5926454-92645494.92095.38
6877285-87728589.88290.32
30min1923837-92383794.65293.492.8495.2794.102.84
2899549-89954992.16392.76
3949889-94988997.32197.96
4896670-89667091.86892.46
5926798-92679894.95595.58
6877980-87798089.95390.54
极限1973544-97354499.74498.351.82100.5299.111.83
2947307-94730797.05697.81
3972084-97208499.595100.40
4964681-96468198.83699.58
5971412-97141299.526100.31
6930312-93031295.31596.05
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%
111.189848759865259859419851939875149860100.11
211.149811679834289822980.17
单位质量响应值RSD%判断
88194.1088177.560.02数据可信
供试品溶液-24111202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%
5min1812463-81246383.41580.677.2783.4280.677.27
2773372-77337279.40279.40
3708798-70879872.77272.77
4839300-83930086.17186.17
5732700-73270075.22675.23
6847688-84768887.03287.03
10min1889115-88911591.28588.225.7391.4288.355.73
2854628-85462887.74487.88
3789882-78988281.09781.22
4899963-89996392.39992.54
5812282-81228283.39783.52
6909447-90944793.37393.52
15min1897874-89787492.18489.365.0392.4889.645.03
2865720-86572088.88389.16
3807944-80794482.95183.21
4907354-90735493.15893.46
5829759-82975985.19185.46
6913484-91348493.78794.09
20min1893929-89392991.77989.584.5892.2290.014.59
2868337-86833789.15289.58
3815305-81530583.70784.10
4909044-90904493.33193.78
5836252-83625285.85886.26
6912090-91209093.64494.10
30min1894374-89437491.82589.934.2292.4290.514.23
2873416-87341689.67390.25
3822934-82293484.49085.02
4907287-90728793.15193.76
5842404-84240486.48987.04
6915323-91532393.97694.59
极限1961750-96175098.74299.330.8499.49100.060.82
2974068-974068100.007100.73
3961646-96164698.73299.41
4958073-95807398.36599.13
5977923-977923100.403101.10
6971467-97146799.740100.51
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%
111.189958909962479923669942699959409949420.17
211.141005938100313910045380.20
单位质量响应值RSD%判断
88993.0290173.970.94数据可信
供试品溶液-24111203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%
5min1822526-82252683.13478.919.2883.1378.919.28
2712997-71299772.06472.06
3854955-85495586.41286.41
4831498-83149884.04184.04
5672603-67260367.98167.98
6789857-78985779.83379.83
10min1889053-88905389.85886.907.1090.0087.047.11
2801805-80180581.04081.16
3921242-92124293.11293.26
4905236-90523691.49491.63
5768202-76820277.64477.76
6873273-87327388.26488.40
15min1898480-89848090.81188.685.7291.1088.965.73
2831815-83181584.07384.33
3926795-92679593.67393.97
4915110-91511092.49292.78
5800108-80010880.86981.11
6892145-89214590.17190.45
20min1902459-90245991.21389.354.8691.6589.774.87
2845150-84515085.42185.82
3924428-92442893.43493.89
4917084-91708492.69293.14
5817399-81739982.61682.99
6897564-89756490.71991.15
30min1904826-90482691.45389.824.0292.0490.394.03
2858183-85818386.73887.28
3924329-92432993.42494.03
4916053-91605392.58793.19
5833032-83303284.19684.71
6895459-89545990.50691.09
极限1955785-95578596.60397.140.7197.3597.870.67
2968960-96896097.93598.62
3951254-95125496.14596.91
4961335-96133597.16497.92
5967684-96768497.80698.46
6961728-96172897.20497.94
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