普瑞巴林口崩片项目信息
介质体积(ml)900取样体积(ml)0补液体积(ml)0
对照品批号101106-202003对照品来源中检所对照品使用方法直接使用
对照品含量(%)99.4对照品水分(%)0对照品稀释倍数500
标示量(mg)25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%
113.521766817660176571772617654176730.18
213.561762917658176440.12
单位质量响应值RSD%判断
1307.171301.180.33数据可信
供试品溶液-2024081611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%
2min118248-18248100.13891.995.31100.1491.995.31
215672-1567286.00286.00
316528-1652890.69990.70
416253-1625389.19089.19
517239-1723994.60194.60
616640-1664091.31491.31
5min120518-20518112.595105.804.40112.60105.804.40
218315-18315100.506100.51
319515-19515107.091107.09
418303-18303100.440100.44
519470-19470106.844106.84
619555-19555107.311107.31
10min120218-20218110.949105.923.75110.95105.923.75
218321-18321100.539100.54
319584-19584107.470107.47
418541-18541101.746101.75
519533-19533107.190107.19
619615-19615107.640107.64
15min120192-20192110.806105.783.95110.81105.783.95
218380-18380100.863100.86
319570-19570107.393107.39
418302-18302100.435100.43
519588-19588107.492107.49
619623-19623107.684107.68
30min120175-20175110.713105.584.12110.71105.584.12
218281-18281100.319100.32
319559-19559107.332107.33
418242-18242100.105100.11
519564-19564107.360107.36
619618-19618107.656107.66
普瑞巴林口崩片项目信息
介质体积(ml)900取样体积(ml)0补液体积(ml)0
对照品批号101106-202003对照品来源中检所对照品使用方法直接使用
对照品含量(%)99.4对照品水分(%)0对照品稀释倍数500
标示量(mg)25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%
113.521765817631176871763017639176490.14
213.561759417568175810.11
单位质量响应值RSD%判断
1305.401296.530.49数据可信
供试品溶液-2024081611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%
2min115714-1571486.44687.164.8686.4587.164.86
214537-1453779.97179.97
315622-1562285.94085.94
416682-1668291.77191.77
515984-1598487.93187.93
616528-1652890.92490.92
5min117441-1744195.94698.504.3695.9598.504.36
217080-1708093.96193.96
318021-1802199.13799.14
419239-19239105.838105.84
517412-1741295.78795.79
618241-18241100.347100.35
10min117331-1733195.34198.804.4395.3498.804.43
217276-1727695.03995.04
318093-1809399.53399.53
419309-19309106.223106.22
517405-1740595.74895.75
618340-18340100.892100.89
15min117335-1733595.36398.984.5295.3698.984.52
217329-1732995.33095.33
318120-1812099.68299.68
419312-19312106.239106.24
517354-1735495.46895.47
618508-18508101.816101.82
30min117357-1735795.48498.814.3195.4898.824.31
217369-1736995.55095.55
318152-1815299.85899.86
419281-19281106.069106.07
517336-1733695.36995.37
618279-18279100.557100.56
普瑞巴林口崩片项目信息
介质体积(ml)900取样体积(ml)0补液体积(ml)0
对照品批号101106-202003对照品来源中检所对照品使用方法直接使用
对照品含量(%)99.4对照品水分(%)0对照品稀释倍数500
标示量(mg)25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%
113.521764617642176271761517619176300.08
213.561763217599176160.14
单位质量响应值RSD%判断
1303.991299.120.27数据可信
供试品溶液-2024081711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%
2min115926-1592687.57289.315.6387.5789.305.63
216964-1696493.28093.28
315507-1550785.26885.27
416330-1633089.79389.79
517581-1758196.67296.67
615140-1514083.25083.25
5min119140-19140105.245100.802.82105.24100.802.82
218379-18379101.060101.06
317670-1767097.16297.16
418551-18551102.006102.01
518352-18352100.912100.91
617897-1789798.41098.41
10min118588-18588102.209100.702.08102.21100.702.08
218535-18535101.918101.92
317744-1774497.56897.57
418690-18690102.770102.77
518369-18369101.005101.01
617956-1795698.73498.73
15min118561-18561102.061100.591.99102.06100.591.98
218404-18404101.198101.20
317762-1776297.66797.67
418713-18713102.897102.90
518354-18354100.923100.92
617962-1796298.76798.77
30min118554-18554102.022100.442.04102.02100.442.04
218437-18437101.379101.38
317699-1769997.32197.32
418654-18654102.572102.57
518313-18313100.697100.70
617939-1793998.64198.64
普瑞巴林口崩片项目信息
介质体积(ml)900取样体积(ml)0补液体积(ml)0
对照品批号101106-202003对照品来源中检所对照品使用方法直接使用
对照品含量(%)99.4对照品水分(%)0对照品稀释倍数500
标示量(mg)25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%
113.521764817690176741764917643176610.12
213.561769217671176820.09
单位质量响应值RSD%判断
1306.291303.980.13数据可信
供试品溶液-2024081711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%
2min116398-1639889.92093.934.4989.9293.944.49
217527-1752796.11196.11
316224-1622488.96688.97
416908-1690892.71692.72
517465-1746595.77195.77
618258-18258100.119100.12
5min118426-18426101.040101.003.21101.04101.003.21
218956-18956103.947103.95
317641-1764196.73696.74
417754-1775497.35597.36
518946-18946103.892103.89
618784-18784103.003103.00
10min118509-18509101.496101.422.91101.50101.422.91
219049-19049104.457104.46
317848-1784897.87197.87
417833-1783397.78997.79
518927-18927103.788103.79
618802-18802103.102103.10
15min118529-18529101.605101.552.78101.61101.552.78
219049-19049104.457104.46
317935-1793598.34898.35
417859-1785997.93197.93
518963-18963103.985103.99
618775-18775102.954102.95
30min118597-18597101.978101.482.74101.98101.482.74
218928-18928103.793103.79
317973-1797398.55698.56
417780-1778097.49897.50
518946-18946103.892103.89
618810-18810103.146103.15
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