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%
110.002135021422213012125821401213460.32
210.082138821314213510.25
单位质量响应值RSD%判断
2134.602118.150.55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%
5min16170-617026.04727.965.9626.0527.965.96
26824-682428.80828.81
36379-637926.93026.93
46558-655827.68527.69
56505-650527.46227.46
67298-729830.80930.81
10min112283-1228351.85455.254.0351.9055.304.03
213515-1351557.05557.10
312993-1299354.85154.90
412922-1292254.55254.60
513010-1301054.92354.97
613806-1380658.28458.33
15min115174-1517464.05967.973.3164.1968.113.31
216545-1654569.84769.99
316085-1608567.90568.04
415957-1595767.36467.50
516163-1616368.23468.37
616681-1668170.42170.57
20min116831-1683171.05475.062.9671.2975.312.96
218396-1839677.66177.92
317941-1794175.74075.99
417724-1772474.82475.07
517742-1774274.90075.15
618049-1804976.19676.46
30min118606-1860678.54782.802.7978.9083.182.80
220078-2007884.76185.15
319882-1988283.93484.31
419496-1949682.30482.68
519585-1958582.68083.06
620034-2003484.57684.97
45min120249-2024985.48388.852.1385.9789.362.13
221439-2143990.50791.04
321405-2140590.36490.88
420864-2086488.08088.59
521061-2106188.91189.42
621261-2126189.75690.29
60min120876-2087688.13091.622.1788.7692.282.17
222182-2218293.64494.32
321958-2195892.69893.36
421472-2147290.64691.30
521757-2175791.85092.51
621965-2196592.72893.41
90min121634-2163491.33093.952.1092.1194.762.10
222872-2287296.55797.39
322515-2251595.05095.87
421808-2180892.06592.87
522209-2220993.75894.57
622488-2248894.93695.77
极限121945-2194592.64394.301.7793.5795.271.77
222756-2275696.06797.07
322658-2265895.65396.63
421794-2179492.00692.97
522306-2230694.16795.14
622559-2255995.23596.23
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%
110.002141221385213732143721341213900.18
210.082133721206212720.44
单位质量响应值RSD%判断
2139.002110.320.96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%
5min16380-638026.95628.5711.1626.9628.5711.15
27141-714130.17230.17
36587-658727.83127.83
47939-793933.54333.54
55696-569624.06624.07
66833-683328.87028.87
10min112939-1293954.66955.023.9554.7155.063.95
213436-1343656.76956.82
312430-1243052.51952.57
413679-1367957.79657.85
513196-1319655.75555.80
612447-1244752.59052.64
15min116282-1628268.79467.762.3068.9367.902.30
216165-1616568.30068.44
315579-1557965.82465.96
416414-1641469.35269.50
516213-1621368.50268.64
615571-1557165.79065.93
20min118004-1800476.07074.492.1376.3274.742.13
217975-1797575.94776.21
317473-1747373.82674.07
417759-1775975.03475.30
517565-1756574.21574.46
617000-1700071.82872.07
30min119482-1948282.31482.301.2382.6982.681.23
219397-1939781.95582.34
319749-1974983.44383.81
419714-1971483.29583.69
519439-1943982.13382.50
619092-1909280.66781.03
45min121234-2123489.71788.621.8890.2389.141.87
220893-2089388.27688.80
321582-2158291.18791.69
420991-2099188.69089.22
520651-2065187.25487.76
620502-2050286.62487.12
60min121989-2198992.90792.422.0393.5793.082.02
221895-2189592.51093.18
322595-2259595.46796.13
421734-2173491.82992.51
521799-2179992.10492.76
621224-2122489.67590.32
90min122549-2254995.27393.982.2896.0994.802.27
222233-2223393.93894.76
323044-2304497.36498.18
422036-2203693.10593.94
522039-2203993.11893.92
621561-2156191.09991.89
极限122558-2255895.31194.992.4396.2995.962.41
222389-2238994.59795.58
323422-2342298.96299.94
422146-2214693.57094.56
522580-2258095.40496.37
621799-2179992.10493.05
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%
110.002127521394211402133021248212770.45
210.082138021168212740.71
单位质量响应值RSD%判断
2127.702110.520.58数据可信
供试品溶液-SI4S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%
5min16382-638227.03528.8010.3927.0328.8010.40
25909-590925.03125.03
37020-702029.73729.74
47900-790033.46533.47
57158-715830.32230.32
66429-642927.23427.23
10min113156-1315655.73056.274.4755.7856.324.47
212268-1226851.96852.01
313479-1347957.09857.15
413936-1393659.03459.09
513749-1374958.24258.29
613108-1310855.52755.57
15min116214-1621468.68468.983.8068.8269.123.80
215330-1533064.93965.07
316954-1695471.81971.96
416545-1654570.08670.24
516817-1681771.23871.39
615842-1584267.10867.25
20min117490-1749074.08976.382.9074.3476.642.91
217315-1731573.34873.58
318461-1846178.20378.47
418449-1844978.15278.42
518477-1847778.27078.54
617993-1799376.22076.47
30min119569-1956982.89683.582.5183.2783.962.52
218843-1884379.82180.18
320064-2006484.99385.39
419731-1973183.58283.98
520238-2023885.73086.13
619934-1993484.44284.82
45min120864-2086488.38288.331.3688.9088.861.37
220431-2043186.54887.04
321133-2113389.52190.06
420832-2083288.24688.79
521182-2118289.72990.27
620669-2066987.55688.07
60min121565-2156591.35190.880.8292.0191.550.81
221480-2148090.99191.63
321653-2165391.72492.41
421144-2114489.56890.26
521388-2138890.60291.29
621493-2149391.04691.71
90min121721-2172192.01292.150.8592.8392.970.86
221575-2157591.39492.18
321930-2193092.89893.74
421549-2154991.28492.12
522003-2200393.20794.05
621736-2173692.07692.89
极限121641-2164191.67392.590.9592.6493.570.94
221975-2197593.08894.03
322184-2218493.97494.97
421791-2179192.30993.30
521654-2165491.72892.72
621900-2190092.77193.74
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%
110.002149521239213402142721438213880.47
210.082135821385213720.09
单位质量响应值RSD%判断
2138.802120.240.62数据可信
供试品溶液-SI4S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%
5min16819-681928.74529.4513.1628.7429.4513.16
25638-563823.76623.77
36970-697029.38129.38
46528-652827.51827.52
58282-828234.91234.91
67685-768532.39532.40
10min112818-1281854.03356.302.1554.0856.352.15
213383-1338356.41556.45
313575-1357557.22457.27
413298-1329856.05656.10
513484-1348456.84056.90
613582-1358257.25457.31
15min115554-1555465.56668.042.0465.7068.192.04
216481-1648169.47469.61
316317-1631768.78368.93
416323-1632368.80868.95
516024-1602467.54867.70
616152-1615268.08768.24
20min117459-1745973.59776.201.7773.8476.461.77
218299-1829977.13877.39
318128-1812876.41776.68
418041-1804176.05076.30
518261-1826176.97777.24
618277-1827777.04577.31
30min119225-1922581.04183.861.8181.4184.241.81
220145-2014584.91985.30
320028-2002884.42684.81
419973-1997384.19484.57
520208-2020885.18585.58
619787-1978783.41083.80
45min120588-2058886.78788.891.4087.2989.411.41
221244-2124489.55290.07
321343-2134389.96990.50
421007-2100788.55389.07
521363-2136390.05490.59
620976-2097688.42288.95
60min121077-2107788.84890.171.7289.5090.841.71
221698-2169891.46692.13
320855-2085587.91288.59
421337-2133789.94490.61
521762-2176291.73592.42
621621-2162191.14191.82
90min121775-2177591.79092.630.9092.5993.460.90
222140-2214093.32994.15
322119-2211993.24094.06
421906-2190692.34393.16
522180-2218093.49894.34
621731-2173191.60592.43
极限121106-2110688.97092.672.2089.9293.642.19
222479-2247994.75895.73
322373-2237394.31195.29
421977-2197792.64293.61
521995-2199592.71893.71
621971-2197192.61793.60
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