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%
111.252642694264288026423402642495264337526427570.02
211.202643456264428526438700.03
单位质量响应值RSD%判断
234911.73236059.820.35数据可信
影响因素30天-供试品溶液-2025110251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%
5min12440206-244020693.16993.950.9093.1793.960.90
22465417-246541794.13294.13
32482426-248242694.78194.78
42431203-243120392.82592.83
52459116-245911693.89193.89
62486260-248626094.92894.93
10min12463287-246328794.05094.700.8694.5795.220.86
22493517-249351795.20595.73
32497175-249717595.34495.87
42450155-245015593.54994.06
52473697-247369794.44894.97
62503818-250381895.59896.13
15min12461111-246111193.96794.680.8395.0195.730.83
22494493-249449395.24296.29
32488799-248879995.02596.08
42449771-244977193.53494.57
52482023-248202394.76695.81
62502849-250284995.56196.62
20min12456642-245664293.79794.400.9195.3695.970.91
22489687-248968795.05896.64
32489456-248945695.05096.63
42434588-243458892.95594.51
52477183-247718394.58196.15
62487104-248710494.96096.55
30min12443778-244377893.30693.680.8095.3995.780.80
22445863-244586393.38595.49
32480603-248060394.71296.82
42426269-242626992.63794.71
52455356-245535693.74895.85
62470211-247021194.31596.43
极限12414288-241428892.18093.010.8494.7895.620.84
22455299-245529993.74596.37
32450061-245006193.54596.18
42406605-240660591.88694.47
52442934-244293493.27395.89
62446475-244647593.40996.05
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%
111.252643417264656326438262644792264446926446130.05
211.202646559264779026471740.04
单位质量响应值RSD%判断
235076.71236354.820.39数据可信
影响因素30天-供试品溶液-2025110251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%
5min12604076-260407699.32999.675.9099.3399.665.90
22471303-247130394.26594.26
32496116-249611695.21195.21
42832165-2832165108.029108.03
52770344-2770344105.671105.67
62503389-250338995.48895.49
10min12665555-2665555101.674101.236.05102.23101.796.05
22480069-248006994.59995.12
32533255-253325596.62897.16
42869224-2869224109.443110.04
52820652-2820652107.590108.18
62555456-255545697.47498.00
15min12664021-2664021101.616101.356.37102.73102.476.36
22505967-250596795.58796.64
32527840-252784096.42197.49
42899417-2899417110.594111.80
52821346-2821346107.617108.80
62524038-252403896.27697.35
20min12665176-2665176101.660100.536.08103.34102.216.08
22462492-246249293.92895.51
32511799-251179995.80997.41
42846344-2846344108.570110.39
52798281-2798281106.737108.52
62529668-252966896.49198.10
30min12643201-2643201100.82199.644.59103.07101.884.62
22474068-247406894.37096.47
32534740-253474096.68498.82
42710946-2710946103.405105.83
52782292-2782292106.127108.50
62527947-252794796.42598.57
极限12625400-2625400100.14299.716.21102.95102.506.20
22451255-245125593.50096.13
32476921-247692194.47997.15
42851240-2851240108.757111.76
52759357-2759357105.252108.22
62519747-251974796.11298.79
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%
111.252648802264558626472082645129264509426463640.07
211.202649439264825126488450.04
单位质量响应值RSD%判断
235232.36236504.020.39数据可信
影响因素30天-供试品溶液-2025110251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%
5min12526158-252615896.29595.162.1696.2995.162.16
22394128-239412891.26291.26
32500179-250017995.30495.30
42499266-249926695.27095.27
52550445-255044597.22097.22
62508223-250822395.61195.61
10min12517507-251750795.96595.692.0196.5096.222.01
22417418-241741892.15092.66
32498610-249861095.24595.77
42526392-252639296.30496.83
52561796-256179697.65398.19
62540606-254060696.84597.38
15min12499641-249964195.28495.481.1296.3596.541.13
22454305-245430593.55694.57
32525562-252556296.27297.33
42507108-250710895.56996.63
52533770-253377096.58597.67
62508984-250898495.64096.71
20min12478489-247848994.47895.271.6296.0896.861.62
22431256-243125692.67794.22
32509253-250925395.65097.24
42500390-250039095.31296.91
52542512-254251296.91898.54
62533162-253316296.56298.16
30min12487050-248705094.80494.511.6896.9396.631.68
22406062-240606291.71793.77
32493236-249323695.04097.16
42503149-250314995.41897.54
52525480-252548096.26998.43
62461106-246110693.81595.95
极限12466894-246689494.03694.561.2996.6897.201.29
22425337-242533792.45195.01
32500555-250055595.31997.97
42498695-249869595.24897.90
52513380-251338095.80898.50
62478509-247850994.47897.14
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%
111.252650337264882026484002649483264827526490630.04
211.202648503264664226475720.05
单位质量响应值RSD%判断
235472.27236390.360.28数据可信
影响因素30天-供试品溶液-2025110251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%
5min12490851-249085194.92393.902.3294.9293.902.32
22403572-240357291.59791.60
32421014-242101492.26292.26
42469817-246981794.12194.12
52437819-243781992.90292.90
62560894-256089497.59297.59
10min12526822-252682296.29495.282.0696.8295.802.06
22424127-242412792.38092.89
32489794-248979494.88395.40
42502131-250213195.35395.88
52479183-247918394.47894.99
62578787-257878798.27498.82
15min12498826-249882695.22794.772.0696.2995.822.06
22459084-245908493.71294.73
32453340-245334093.49494.53
42464353-246435393.91394.97
52459774-245977493.73994.78
62585752-258575298.54099.63
20min12477246-247724694.40593.861.8496.0095.431.84
22397275-239727591.35792.90
32454248-245424893.52895.09
42467543-246754394.03595.61
52445194-244519493.18394.74
62535589-253558996.62898.26
30min12490665-249066594.91694.862.5897.0396.962.55
22424003-242400392.37694.43
32575964-257596498.167100.25
42467113-246711394.01896.12
52424123-242412392.38094.46
62553118-255311897.29699.47
极限12472572-247257294.22693.652.2696.8796.272.25
22401366-240136691.51394.08
32437328-243732892.88395.51
42444293-244429393.14995.77
52428531-242853192.54895.14
62559941-255994197.556100.27
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