布洛芬混悬液项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)0
对照品批号100179-202308对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.9对照品水分(%)0对照品稀释倍数50
标示量(mg)200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%
111.252649898266719126657312673016267264126656950.36
211.202654404265714626557750.08
单位质量响应值RSD%判断
236950.67237122.770.06数据可信
影响因素30天-供试品溶液-250226083批-pH7.2
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min12636413-2636413100.00196.024.03100.0096.024.03
22556035-255603596.95396.95
32485945-248594594.29494.29
42377722-237772290.18990.19
52644821-2644821100.320100.32
62488294-248829494.38394.38
10min12651786-2651786100.58497.533.73101.1498.063.73
22590032-259003298.24298.78
32537127-253712796.23596.76
42423324-242332491.91992.42
52692158-2692158102.116102.67
62533567-253356796.10096.62
15min12669681-2669681101.26397.663.93102.3898.743.93
22593462-259346298.37299.46
32530823-253082395.99697.05
42437516-243751692.45793.47
52705249-2705249102.612103.74
62511385-251138595.25996.32
20min12642673-2642673100.23997.274.03101.9298.884.03
22598274-259827498.555100.19
32507210-250721095.10196.69
42430678-243067892.19893.72
52707837-2707837102.711104.41
62499180-249918094.79696.38
30min12635141-263514199.95396.473.94102.1998.633.94
22576837-257683797.74299.92
32501964-250196494.90297.02
42411351-241135191.46593.50
52668242-2668242101.209103.47
62466815-246681593.56895.68
极限12548594-254859496.67095.873.0699.4698.563.07
22563139-256313997.22299.94
32500977-250097794.86497.51
42417439-241743991.69594.24
52644773-2644773100.318103.15
62489675-248967594.43597.07
布洛芬混悬液项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)0
对照品批号100179-202308对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.9对照品水分(%)0对照品稀释倍数50
标示量(mg)200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%
111.252657474266980526824372676944267889426731110.37
211.202636669264284026397540.17
单位质量响应值RSD%判断
237609.87235692.320.58数据可信
影响因素30天-供试品溶液-250226083批-pH7.2
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min12439019-243901992.66693.942.0192.6793.952.01
22440322-244032292.71692.72
32408980-240898091.52591.53
42532501-253250196.21896.22
52505076-250507695.17695.18
62510070-251007095.36695.37
10min12576957-257695797.90797.732.5298.4298.262.51
22633185-2633185100.043100.56
32484331-248433194.38894.90
42604972-260497298.97199.51
52632198-2632198100.006100.53
62502657-250265795.08495.61
15min12582164-258216498.10597.172.3299.1698.232.31
22512075-251207595.44296.51
32507826-250782695.28096.31
42611423-261142399.216100.30
52634346-2634346100.087101.17
62497630-249763094.89395.95
20min12565975-256597597.49096.312.4799.0997.922.46
22501776-250177695.05196.65
32477316-247731694.12195.68
42595353-259535398.606100.24
52607449-260744999.065100.71
62462294-246229493.55195.14
30min12536366-253636696.36595.702.3898.5197.842.36
22472474-247247493.93796.07
32476873-247687394.10496.19
42584751-258475198.203100.39
52589732-258973298.392100.58
62453770-245377093.22795.33
极限12530308-253030896.13595.182.6798.8297.862.65
22459012-245901293.42696.08
32471057-247105793.88496.49
42569594-256959497.627100.36
52584899-258489998.209100.95
62416505-241650591.81194.43
布洛芬混悬液项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)0
对照品批号100179-202308对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.9对照品水分(%)0对照品稀释倍数50
标示量(mg)200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%
111.252632276266737826770032670642267118226636960.68
211.202659128266370826614180.13
单位质量响应值RSD%判断
236772.98237626.610.26数据可信
影响因素30天-供试品溶液-250226083批-pH7.2
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min12618530-261853099.25596.672.5899.2696.672.58
22433345-243334592.23692.24
32565112-256511297.23097.23
42526598-252659895.77095.77
52598334-259833498.49098.49
62559977-255997797.03697.04
10min12646573-2646573100.31899.061.94100.8799.601.94
22517321-251732195.41995.93
32626475-262647599.556100.10
42600134-260013498.55899.09
52649745-2649745100.438100.99
62640298-2640298100.080100.62
15min12670819-2670819101.23799.252.02102.35100.342.02
22532066-253206695.97897.02
32594135-259413598.33099.42
42601725-260172598.61899.70
52652222-2652222100.532101.64
62659926-2659926100.824101.92
20min12651277-2651277100.49698.922.12102.17100.562.11
22511275-251127595.19096.77
32614559-261455999.105100.74
42583848-258384897.94099.57
52642009-2642009100.145101.81
62654640-2654640100.624102.28
30min12656708-2656708100.70298.492.09102.93100.672.09
22508030-250803095.06797.17
32605117-260511798.747100.94
42564107-256410797.19299.36
52619393-261939399.288101.51
62635946-263594699.915102.13
极限12657908-2657908100.74898.032.23103.54100.772.22
22496333-249633394.62397.26
32604340-260434098.717101.46
42552301-255230196.74599.46
52578081-257808197.722100.49
62628364-262836499.628102.40
布洛芬混悬液项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)0
对照品批号100179-202308对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.9对照品水分(%)0对照品稀释倍数50
标示量(mg)200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%
111.252640771265759826793212682391267822926676620.68
211.202666106269271426794100.71
单位质量响应值RSD%判断
237125.51239233.040.63数据可信
影响因素30天-供试品溶液-250226083批-pH7.2
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min12642315-264231599.74693.574.6199.7593.574.61
22437099-243709992.00092.00
32501312-250131294.42494.42
42373101-237310189.58489.58
52349523-234952388.69488.69
62569252-256925296.98896.99
10min12732331-2732331103.14496.744.50103.7097.264.50
22574579-257457997.18997.70
32588561-258856197.71798.24
42430742-243074291.76092.26
52433673-243367391.87092.36
62615967-261596798.75299.29
15min12755613-2755613104.02396.724.75105.1597.784.74
22559753-255975396.63097.68
32597695-259769598.06299.13
42440251-244025192.11993.13
52423729-242372991.49592.50
62595935-259593597.99699.08
20min12749685-2749685103.80096.964.35105.5098.554.35
22592138-259213897.85299.44
32565559-256555996.84998.46
42453880-245388092.63394.15
52447544-244754492.39493.91
62601935-260193598.22299.85
30min12749542-2749542103.79496.344.70106.0898.484.70
22583224-258322497.51699.65
32566381-256638196.88099.03
42433339-243333991.85893.89
52419685-241968591.34293.37
62560283-256028396.65098.83
极限12717882-2717882102.59995.574.79105.4698.244.78
22544575-254457596.05798.73
32553113-255311396.37999.07
42417621-241762191.26493.81
52380314-238031489.85692.39
62576756-257675697.27299.99
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