洛索洛芬钠细粒剂项目信息
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100638-202104对照品来源中检所对照品使用方法直接使用
对照品含量(%)87.5对照品水分(%)0对照品稀释倍数200
标示量(mg)60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%
114.831656267165848016589151678483167942716663140.70
214.791653339165776216555500.19
单位质量响应值RSD%判断
112361.02111937.120.27数据可信
供试品溶液-24110501批-pH1.2
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min11661238-166123897.20994.531.4997.2194.531.49
21596519-159651993.42293.42
31599158-159915893.57693.58
41620946-162094694.85194.85
51609333-160933394.17294.17
61605671-160567193.95893.96
15min11759785-1759785102.976101.331.39103.14101.491.39
21699684-169968499.45999.61
31725553-1725553100.973101.13
41715645-1715645100.393100.55
51759462-1759462102.957103.11
61729991-1729991101.232101.39
30min11748916-1748916102.340101.662.12102.67101.982.11
21726713-1726713101.040101.36
31712604-1712604100.215100.54
41702485-170248599.62399.95
51804975-1804975105.620105.95
61727986-1727986101.115101.44
极限11746192-1746192102.180100.651.14102.68101.151.14
21711865-1711865100.172100.66
31710333-1710333100.082100.57
41698564-169856499.39399.88
51742584-1742584101.969102.47
61711073-1711073100.125100.62
洛索洛芬钠细粒剂项目信息
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100638-202104对照品来源中检所对照品使用方法直接使用
对照品含量(%)87.5对照品水分(%)0对照品稀释倍数200
标示量(mg)60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%
114.831651932165501116560951662228165831816567170.24
214.791649255165492816520920.25
单位质量响应值RSD%判断
111713.89111703.310.01数据可信
供试品溶液-24110501批-pH4.5
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min11693529-169352999.48999.320.7199.4999.320.71
21694071-169407199.52199.52
31674515-167451598.37298.37
41710202-1710202100.469100.47
51686696-168669699.08899.09
61685384-168538499.01199.01
15min11718126-1718126100.934101.601.18101.10101.761.18
21723619-1723619101.257101.42
31701352-170135299.949100.11
41749604-1749604102.783102.95
51756100-1756100103.165103.33
61727713-1727713101.497101.66
30min11712151-1712151100.583101.241.04100.92101.571.04
21725695-1725695101.379101.71
31693262-169326299.47399.80
41737354-1737354102.064102.40
51740220-1740220102.232102.57
61731018-1731018101.691102.03
极限11709163-1709163100.408101.161.30100.91101.661.30
21719052-1719052100.988101.49
31689333-168933399.24399.74
41734186-1734186101.878102.39
51755004-1755004103.101103.61
61724946-1724946101.335101.84
洛索洛芬钠细粒剂项目信息
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100638-202104对照品来源中检所对照品使用方法直接使用
对照品含量(%)87.5对照品水分(%)0对照品稀释倍数200
标示量(mg)60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%
114.831650530165911416582961659522165983516574590.24
214.791651174165645116538120.23
单位质量响应值RSD%判断
111763.92111819.610.04数据可信
供试品溶液-24110501批-pH6.8
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min11693333-169333399.40498.018.0299.4098.018.03
21402033-140203382.30382.30
31703259-170325999.98699.99
41743083-1743083102.324102.32
51766135-1766135103.677103.68
61710010-1710010100.383100.38
15min11718686-1718686100.892101.452.11101.06101.612.12
21664144-166414497.69097.83
31732353-1732353101.694101.86
41752049-1752049102.850103.02
51771315-1771315103.981104.15
61730225-1730225101.569101.74
30min11701163-170116399.863101.871.49100.20102.201.49
21739401-1739401102.108102.41
31719315-1719315100.929101.26
41749861-1749861102.722103.06
51775315-1775315104.216104.56
61727145-1727145101.388101.72
极限11698492-169849299.706101.791.44100.21102.291.44
21727079-1727079101.385101.85
31737020-1737020101.968102.47
41746774-1746774102.541103.05
51772197-1772197104.033104.55
61722127-1722127101.094101.60
洛索洛芬钠细粒剂项目信息
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100638-202104对照品来源中检所对照品使用方法直接使用
对照品含量(%)87.5对照品水分(%)0对照品稀释倍数200
标示量(mg)60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%
114.831651792166073116540081653223165692516553360.22
214.791651854165651916541860.20
单位质量响应值RSD%判断
111620.77111844.900.15数据可信
供试品溶液-24110502批-pH6.8
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min11691232-169123299.333100.141.8299.33100.141.82
21687796-168779699.13199.13
31694911-169491199.54999.55
41670195-167019598.09798.10
51750929-1750929102.839102.84
61734581-1734581101.879101.88
15min11702378-170237899.987100.802.03100.15100.972.02
21699706-169970699.830100.00
31696747-169674799.65799.82
41679521-167952198.64598.81
51764717-1764717103.649103.82
61754545-1754545103.051103.22
30min11696928-169692899.667100.541.97100.00100.881.97
21695761-169576199.59999.93
31694479-169447999.52399.86
41676025-167602598.44098.77
51759566-1759566103.346103.69
61748391-1748391102.690103.03
极限11694301-169430199.513100.401.96100.01100.901.96
21695629-169562999.591100.09
31692387-169238799.40199.90
41671797-167179798.19198.68
51751208-1751208102.855103.37
61750795-1750795102.831103.34
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