磷酸奥司他韦干混悬剂项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号101096-202404对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.6对照品水分(%)0对照品稀释倍数100
标示量(mg)75供试品稀释倍数1系数0.7612
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
19.861515858152105715146651518042151804415175330.17
29.931519790151817515189820.08
单位质量响应值RSD%判断
153908.01152968.980.44数据可信
供试品溶液-2024111821批-pH1.0
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min11710436-1710436101.41899.122.27101.4299.122.27
21683543-168354399.82499.82
31680688-168068899.65499.65
41608025-160802595.34695.35
51700020-1700020100.801100.80
61647052-164705297.66097.66
10min11712992-1712992101.570100.561.86102.70101.661.85
21687137-1687137100.037101.15
31672639-167263999.177100.28
41649607-164960797.81198.87
51728009-1728009102.460103.58
61724936-1724936102.278103.36
15min11696753-1696753100.60799.621.74102.86101.841.73
21669724-166972499.004101.22
31657618-165761898.286100.50
41639221-163922197.19699.34
51711551-1711551101.484103.74
61706118-1706118101.162103.38
20min11676098-167609899.38298.291.80102.76101.611.80
21652915-165291598.008101.33
31634266-163426696.902100.20
41612767-161276795.62798.85
51687346-1687346100.049103.44
61682412-168241299.757103.10
30min11658427-165842798.33497.131.67102.81101.551.66
21623478-162347896.262100.67
31618074-161807495.942100.32
41601310-160131094.94899.24
51663819-166381998.654103.15
61663738-166373898.649103.10
极限11627038-162703896.47395.961.66102.04101.451.65
21612728-161272895.625101.10
31599178-159917894.821100.27
41578945-157894593.62298.97
51648341-164834197.736103.33
61643717-164371797.462103.01
磷酸奥司他韦干混悬剂项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号101096-202404对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.6对照品水分(%)0对照品稀释倍数100
标示量(mg)75供试品稀释倍数1系数0.7612
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
19.861516143151829715207141516425152215015187460.18
29.931515942151843015171860.12
单位质量响应值RSD%判断
154031.03152788.120.58数据可信
供试品溶液-2024111821批-pH1.0
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min11715357-1715357101.73099.113.13101.7399.113.13
21715514-1715514101.739101.74
31697692-1697692100.682100.68
41686962-1686962100.046100.05
51615536-161553695.81095.81
61595919-159591994.64794.65
10min11717177-1717177101.83899.262.82102.97100.362.82
21706208-1706208101.187102.32
31704431-1704431101.082102.20
41685898-168589899.983101.09
51613716-161371695.70296.77
61615133-161513395.78696.84
15min11689275-1689275100.18398.052.65102.44100.252.66
21685737-168573799.973102.23
31682663-168266399.791102.03
41666259-166625998.818101.04
51602094-160209495.01397.14
61593426-159342694.49996.61
20min11674874-167487499.32997.212.58102.70100.502.59
21670456-167045699.067102.43
31667284-166728498.879102.23
41649810-164981097.843101.16
51593770-159377094.51997.70
61578194-157819493.59596.76
30min11652142-165214297.98196.062.39102.46100.442.40
21647541-164754197.708102.17
31644823-164482397.547102.00
41630499-163049996.697101.11
51583432-158343293.90698.14
61560050-156005092.51996.73
极限11636919-163691997.07894.313.21102.6599.763.18
21622925-162292596.248101.80
31620019-162001996.076101.61
41605614-160561495.222100.70
51549320-154932091.88397.16
61507049-150704989.37694.61
磷酸奥司他韦干混悬剂项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号101096-202404对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.6对照品水分(%)0对照品稀释倍数100
标示量(mg)75供试品稀释倍数1系数0.7612
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
19.861518508152166615189411516326152241515195710.17
29.931519518151884915191840.04
单位质量响应值RSD%判断
154114.71152989.330.52数据可信
供试品溶液-2024111921批-pH1.0
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min11512591-151259189.62194.766.5189.6294.766.51
21665851-166585198.70298.70
31433639-143363984.94384.94
41669308-166930898.90798.91
51696216-1696216100.501100.50
61618037-161803795.86995.87
10min11663752-166375298.57898.782.1699.5799.832.19
21714438-1714438101.581102.68
31604562-160456295.07196.01
41677901-167790199.416100.51
51679081-167908199.486100.60
61662967-166296798.53199.60
15min11657632-165763298.21598.121.74100.31100.271.78
21699284-1699284100.683102.91
31611001-161100195.45297.45
41663071-166307198.537100.74
51661170-166117098.425100.65
61643698-164369897.38999.55
20min11645609-164560997.50397.011.72100.69100.251.75
21678613-167861399.458102.80
31593767-159376794.43197.49
41643543-164354397.380100.68
51640147-164014797.179100.49
61622037-162203796.10699.35
30min11618851-161885195.91795.861.61100.18100.181.65
21658468-165846898.265102.71
31580470-158047093.64397.75
41625767-162576796.327100.71
51621125-162112596.052100.45
61602455-160245594.94699.26
极限11603606-160360695.01494.641.62100.35100.021.66
21632913-163291396.750102.29
31555594-155559492.16997.32
41601008-160100894.860100.31
51606306-160630695.174100.64
61583963-158396393.85099.21
磷酸奥司他韦干混悬剂项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号101096-202404对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.6对照品水分(%)0对照品稀释倍数100
标示量(mg)75供试品稀释倍数1系数0.7612
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
19.861515240151524015170131516222151688115161190.06
29.931514040151521715146280.06
单位质量响应值RSD%判断
153764.60152530.510.57数据可信
供试品溶液-2024111921批-pH1.0
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min11616913-161691396.05697.603.9596.0697.603.95
21709331-1709331101.546101.55
31684230-1684230100.055100.05
41629240-162924096.78896.79
51685628-1685628100.138100.14
61532514-153251491.04291.04
10min11638540-163854097.34099.322.3998.41100.412.40
21714525-1714525101.854102.98
31710467-1710467101.613102.73
41628490-162849096.74397.82
51698025-1698025100.874101.99
61641201-164120197.49998.51
15min11614872-161487295.93498.272.5498.08100.462.55
21700951-1700951101.048103.31
31694561-1694561100.668102.91
41605664-160566495.38797.54
51677828-167782899.674101.91
61631065-163106596.89698.99
20min11600988-160098895.11097.162.4698.32100.442.46
21679357-167935799.765103.15
31674716-167471699.490102.85
41589243-158924394.41297.62
51659138-165913898.564101.91
61609422-160942295.61198.78
30min11581050-158105093.92596.002.4298.20100.372.43
21657794-165779498.484102.98
31650528-165052898.053102.52
41570845-157084593.31997.58
51644697-164469797.706102.14
61591438-159143894.54298.78
极限11564163-156416392.92294.992.4098.24100.422.40
21645384-164538497.747103.33
31628591-162859196.749102.30
41555219-155521992.39197.69
51624338-162433896.497102.02
61576140-157614093.63398.92
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