佩玛贝特片项目信息
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DHX240702对照品来源ZZ对照品使用方法直接使用
对照品含量(%)99.74对照品水分(%)0对照品稀释倍数100000
标示量(mg)0.1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%
1 10.262145521388215762150321483214810.32
2 10.282135321408213800.19
单位质量响应值RSD%判断
2093.662079.770.48数据可信
供试品溶液-2025041421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%
5min18791-879137.81740.226.3937.8240.226.38
210246-1024644.07744.08
39323-932340.10640.11
49802-980242.16742.17
59258-925839.82639.83
68679-867937.33637.34
10min114040-1404060.39862.503.7460.4662.563.74
215475-1547566.57166.64
314531-1453162.51062.58
414787-1478763.61163.68
514090-1409060.61360.68
614247-1424761.28861.35
15min116712-1671271.89274.842.5072.0675.022.50
217773-1777376.45676.64
317304-1730474.43974.61
417646-1764675.91076.09
517828-1782876.69376.86
617126-1712673.67373.84
20min118890-1889081.26282.021.3381.5582.321.33
219130-1913082.29482.61
318891-1889181.26681.56
419266-1926682.87983.18
519435-1943583.60683.90
618788-1878880.82381.11
30min120931-2093190.04289.041.5790.4689.481.57
221140-2114090.94191.39
320385-2038587.69388.12
420881-2088189.82790.27
520424-2042487.86188.30
620431-2043187.89188.31
45min122278-2227895.83694.411.6396.4194.991.63
222318-2231896.00896.61
321599-2159992.91593.49
422013-2201394.69695.29
522035-2203594.79195.37
621438-2143892.22392.79
60min122473-2247396.67596.711.2197.4097.451.22
222679-2267997.56198.32
322196-2219695.48396.22
422764-2276497.92798.68
522660-2266097.48098.22
622111-2211195.11895.84
90min122950-2295098.72798.521.6899.6299.421.68
223506-23506101.119102.04
322542-2254296.97297.86
422885-2288598.44799.36
523083-2308399.299100.20
622449-2244996.57297.45
极限122901-2290198.51698.431.4399.5799.491.43
223381-23381100.581101.67
322609-2260997.26098.31
423089-2308999.325100.40
522820-2282098.16899.23
622481-2248196.70997.75
佩玛贝特片项目信息
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DHX240702对照品来源ZZ对照品使用方法直接使用
对照品含量(%)99.74对照品水分(%)0对照品稀释倍数100000
标示量(mg)0.1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%
1 10.262146621309215002126921405213900.47
2 10.282135821378213680.07
单位质量响应值RSD%判断
2084.802078.600.22数据可信
供试品溶液-PN4A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%
5min110381-1038144.76535.6024.2944.7635.6024.28
25226-522622.53522.54
38608-860837.11937.12
48978-897838.71538.71
59865-986542.53942.54
66478-647827.93427.93
10min115798-1579868.12464.156.6668.2064.216.67
213351-1335157.57257.61
314943-1494364.43764.50
415367-1536766.26566.33
515758-1575867.95168.02
614039-1403960.53860.59
15min118294-1829478.88776.314.8879.0776.474.90
216337-1633770.44870.58
318011-1801177.66677.84
418300-1830078.91379.09
518337-1833779.07279.26
616894-1689472.85073.00
20min119647-1964784.72183.372.3085.0483.662.32
218626-1862680.31880.57
319237-1923782.95383.25
419759-1975985.20485.51
519672-1967284.82985.14
619056-1905682.17382.44
30min120952-2095290.34890.611.2190.8191.041.22
220665-2066589.11189.50
320829-2082989.81890.26
421375-2137592.17392.62
521170-2117091.28991.75
621083-2108390.91391.32
45min121549-2154992.92394.081.0793.5394.661.07
221799-2179994.00194.53
321839-2183994.17394.76
421820-2182094.09194.69
522231-2223195.86496.47
621664-2166493.41993.98
60min121991-2199194.82995.921.0695.6096.661.05
222386-2238696.53297.22
322319-2231996.24396.99
422590-2259097.41298.17
522186-2218695.67096.44
621993-2199394.83795.55
90min122354-2235496.39497.640.7597.3298.540.73
222626-2262697.56798.42
322784-2278498.24899.15
422782-2278298.24099.16
522555-2255597.26198.19
622755-2275598.12398.99
极限122276-2227696.05896.700.6597.1497.760.65
222305-2230596.18397.20
322324-2232496.26597.33
422630-2263097.58498.67
522530-2253097.15398.24
622484-2248496.95597.99
佩玛贝特片项目信息
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DHX240702对照品来源ZZ对照品使用方法直接使用
对照品含量(%)99.74对照品水分(%)0对照品稀释倍数100000
标示量(mg)0.1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%
1 10.262142321357213782141921434214020.16
2 10.282134221294213180.16
单位质量响应值RSD%判断
2085.962073.740.42数据可信
供试品溶液-2025041421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%
5min116967-1696773.23055.1020.8273.2355.1020.81
212516-1251654.01954.02
39995-999543.13943.14
410421-1042144.97744.98
514713-1471363.50263.50
611983-1198351.71951.72
10min122161-2216195.64783.428.5295.7783.518.53
218813-1881381.19781.29
317851-1785177.04577.12
418077-1807778.02178.10
520371-2037187.92288.03
618688-1868880.65880.74
15min122898-2289898.82889.725.6199.1189.955.63
220286-2028687.55587.78
319796-1979685.44085.64
419997-1999786.30786.51
521353-2135392.16092.41
620395-2039588.02588.25
20min123110-2311099.74392.274.97100.1992.654.99
220694-2069489.31689.69
320263-2026387.45687.80
421008-2100890.67191.02
522186-2218695.75596.16
621014-2101490.69791.06
30min123248-23248100.33994.503.99100.9595.034.01
221469-2146992.66193.18
320605-2060588.93289.42
421990-2199094.90995.41
522243-2224396.00196.57
621814-2181494.15094.67
45min123095-2309599.67996.262.34100.4696.952.36
221951-2195194.74195.42
321799-2179994.08594.72
422664-2266497.81898.48
522451-2245196.89997.62
621858-2185894.34095.02
60min123015-2301599.33397.072.58100.2897.922.60
222268-2226896.10996.94
321559-2155993.04993.84
423108-2310899.735100.56
522730-2273098.10398.99
622267-2226796.10596.94
90min122904-2290498.85497.952.1799.9798.962.17
222600-2260097.54298.53
322113-2211395.44096.39
423532-23532101.565102.55
522661-2266197.80598.86
622356-2235696.48997.48
极限122757-2275798.22098.422.2799.5099.592.24
222683-2268397.90099.06
322465-2246596.95998.07
423790-23790102.678103.83
522789-2278998.35899.57
622331-2233196.38197.53
佩玛贝特片项目信息
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DHX240702对照品来源ZZ对照品使用方法直接使用
对照品含量(%)99.74对照品水分(%)0对照品稀释倍数100000
标示量(mg)0.1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%
1 10.262124921169212582122021215212220.17
2 10.282130921239212740.24
单位质量响应值RSD%判断
2068.422069.460.04数据可信
供试品溶液-PN4A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%
5min111790-1179051.15440.2422.0051.1540.2422.00
210787-1078746.80246.80
37693-769333.37833.38
410703-1070346.43846.44
57593-759332.94432.94
67078-707830.71030.71
10min118618-1861880.77974.009.9680.8674.079.96
218072-1807278.41078.49
315662-1566267.95368.01
417356-1735675.30375.38
518290-1829079.35679.41
614340-1434062.21862.27
15min121575-2157593.60887.435.9593.8387.625.96
220591-2059189.33989.55
319934-1993486.48986.66
419654-1965485.27485.48
520993-2099391.08391.27
618160-1816078.79278.95
20min122229-2222996.44691.823.7296.8292.163.73
220978-2097891.01891.38
321297-2129792.40292.72
420778-2077890.15090.50
521730-2173094.28194.62
619966-1996686.62786.91
30min122587-2258797.99994.772.1498.5495.262.17
221844-2184494.77695.28
321798-2179894.57695.04
421602-2160293.72694.22
522045-2204595.64896.14
621182-2118291.90392.33
45min122439-2243997.35795.731.1898.0696.381.21
222053-2205395.68296.35
321868-2186894.88095.50
421851-2185194.80695.46
522324-2232496.85897.51
621851-2185194.80695.39
60min122466-2246697.47496.870.6298.3497.680.64
222315-2231596.81997.65
322175-2217596.21296.99
422253-2225396.55097.36
522521-2252197.71398.53
622237-2223796.48197.22
90min122136-2213696.04396.590.5697.0797.560.54
222265-2226596.60297.59
322099-2209995.88296.83
422303-2230396.76797.74
522407-2240797.21898.20
622362-2236297.02397.93
极限122560-2256097.88296.710.7899.0797.840.80
222351-2235196.97598.12
322165-2216596.16897.27
422054-2205495.68796.82
522331-2233196.88998.03
622277-2227796.65497.72
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