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 10.262117621207212672116521098211830.30
2 10.282122521355212900.44
单位质量响应值RSD%判断
2064.622071.010.22数据可信
供试品溶液-2025041421批-水
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min112333-1233353.53952.709.9853.5452.709.98
212891-1289155.96155.96
312226-1222653.07453.07
49791-979142.50442.50
513208-1320857.33757.34
612387-1238753.77353.77
10min118430-1843080.00779.953.6380.1080.043.64
218808-1880881.64881.74
318912-1891282.09982.19
417100-1710074.23374.30
518707-1870781.20981.30
618543-1854380.49780.59
15min120792-2079290.26090.121.4890.4890.351.50
220920-2092090.81691.05
321089-2108991.55091.78
420194-2019487.66487.86
520872-2087290.60890.84
620697-2069789.84890.07
20min121992-2199295.47095.651.0095.8496.030.99
221795-2179594.61595.00
322390-2239097.19897.58
422188-2218896.32196.66
521864-2186494.91495.30
621977-2197795.40595.78
30min122852-2285299.20398.901.2199.7499.431.21
222702-2270298.55299.09
323305-23305101.170101.71
422572-2257297.98898.49
522589-2258998.06198.60
622666-2266698.39698.93
45min123543-23543102.203100.691.63102.90101.391.62
222732-2273298.68299.38
323653-23653102.680103.39
423318-23318101.226101.89
523117-23117100.354101.06
622810-2281099.02199.72
60min123543-23543102.203101.231.18103.07102.101.18
222926-2292699.524100.39
323648-23648102.659103.54
423329-23329101.274102.11
523390-23390101.539102.41
623080-23080100.193101.05
90min123468-23468101.877100.761.30102.92101.791.30
222992-2299299.811100.84
323657-23657102.698103.75
423124-23124100.384101.39
523163-23163100.553101.59
622855-2285599.216100.24
极限123348-23348101.356100.411.28102.56101.611.27
222839-2283999.147100.35
323602-23602102.459103.68
423092-23092100.245101.41
522874-2287499.299100.51
623026-2302699.958101.15
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 10.262124421269212342141321340213000.36
2 10.282113121195211630.22
单位质量响应值RSD%判断
2076.022058.660.60数据可信
供试品溶液-PN4A批-水
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min15354-535423.24824.7554.6523.2524.7554.65
25520-552023.96923.97
33868-386816.79616.80
44987-498721.65421.65
52778-277812.06312.06
611698-1169850.79550.79
10min115275-1527566.32762.7317.4766.3762.7817.50
215048-1504865.34165.38
312577-1257754.61254.64
414130-1413061.35561.39
511160-1116048.45948.48
618496-1849680.31380.40
15min120025-2002586.95282.959.0687.1083.099.09
219540-1954084.84684.99
317735-1773577.00977.13
419414-1941484.29984.44
516510-1651071.68971.79
621393-2139392.89293.11
20min121373-2137392.80591.205.4093.1091.485.43
221232-2123292.19392.48
320348-2034888.35588.60
421655-2165594.03094.31
519093-1909382.90583.13
622315-2231596.89697.27
30min122264-2226496.67496.731.7297.1297.161.77
222199-2219996.39296.84
322221-2222196.48896.88
422532-2253297.83898.27
521651-2165194.01294.37
622794-2279498.97699.51
45min122682-2268298.48998.890.6399.1099.490.65
222684-2268498.49899.10
322606-2260698.15998.71
422798-2279898.99399.59
522922-2292299.531100.05
622959-2295999.692100.39
60min122711-2271198.61598.940.9099.3999.700.90
222634-2263498.28199.05
322554-2255497.93398.65
422770-2277098.87199.63
523104-23104100.322101.00
622944-2294499.627100.49
90min122566-2256697.98698.930.9798.9299.860.95
222739-2273998.73799.67
322631-2263198.26899.15
422691-2269198.52899.46
523162-23162100.574101.42
622913-2291399.492100.52
极限122630-2263098.26398.810.9099.3799.900.89
222679-2267998.47699.57
322812-2281299.054100.10
422463-2246397.53898.63
522995-2299599.848100.86
622957-2295799.683100.88
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 10.262131521329212702138921293213190.22
2 10.282148821348214180.47
单位质量响应值RSD%判断
2077.882083.460.19数据可信
供试品溶液-2025041421批-pH5.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min15288-528822.81418.1926.9722.8118.1926.96
24476-447619.31119.31
32318-231810.00110.00
45058-505821.82221.82
53409-340914.70714.71
64748-474820.48420.48
10min111874-1187451.22844.9614.6051.2744.9914.61
210785-1078546.53046.56
37943-794334.26834.29
411910-1191051.38351.42
59449-944940.76640.79
610561-1056145.56345.60
15min115714-1571467.79562.269.9267.9262.379.93
214628-1462863.10963.22
311995-1199551.75051.82
415403-1540366.45366.58
513511-1351158.29058.38
615338-1533866.17366.28
20min117631-1763176.06572.326.6376.3072.536.65
217196-1719674.18974.40
315098-1509865.13765.30
417808-1780876.82977.06
515671-1567167.60967.80
617172-1717274.08574.31
30min119426-1942683.80982.203.1784.1782.533.20
219338-1933883.43083.77
318079-1807977.99878.27
419674-1967484.87985.24
518570-1857080.11680.42
619233-1923382.97783.32
45min120326-2032687.69287.871.8388.2088.341.86
220659-2065989.12989.61
319957-1995786.10086.50
420878-2087890.07490.58
519951-1995186.07486.51
620437-2043788.17188.65
60min121169-2116991.32990.732.3091.9891.342.32
221141-2114191.20891.83
320800-2080089.73790.28
421675-2167593.51294.16
520227-2022787.26587.84
621174-2117491.35191.98
90min121452-2145292.55092.441.9693.3593.211.98
221389-2138992.27893.06
321079-2107990.94191.63
422177-2217795.67896.49
520994-2099490.57491.30
621473-2147392.64193.42
极限121911-2191194.53094.151.7595.4995.061.77
221688-2168893.56894.50
321573-2157393.07293.92
422558-2255897.32298.29
521594-2159493.16394.04
621607-2160793.21994.15
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 10.262146221380214322145421434214320.15
2 10.282151921456214880.21
单位质量响应值RSD%判断
2088.892090.270.05数据可信
供试品溶液-PN4A批-pH5.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min15289-528922.72119.3333.2322.7219.3333.22
25805-580524.93824.94
34662-466220.02720.03
44821-482120.71020.71
54848-484820.82620.83
61568-15686.7366.74
10min112901-1290155.42149.2917.8255.4649.3217.83
212419-1241953.35153.39
311182-1118248.03748.07
411948-1194851.32751.36
512879-1287955.32755.36
67514-751432.27932.29
15min116548-1654871.08865.669.6871.2265.789.70
216083-1608369.09169.22
314437-1443762.02062.13
415742-1574267.62667.75
516236-1623669.74869.87
612664-1266454.40354.47
20min118451-1845179.26374.525.6779.5174.745.70
217837-1783776.62676.87
316812-1681272.22272.44
417435-1743574.89975.13
517874-1787476.78577.03
615673-1567367.32967.49
30min120261-2026187.03983.223.2687.4283.573.27
219375-1937583.23383.61
318346-1834678.81279.15
419525-1952583.87784.23
519609-1960984.23884.61
619122-1912282.14682.41
45min121465-2146592.21188.752.6792.7489.232.66
220298-2029887.19887.71
319875-1987585.38185.85
420666-2066688.77989.28
520638-2063888.65989.17
621007-2100790.24490.65
60min122027-2202794.62591.143.5395.3191.783.51
221214-2121491.13391.79
319918-1991885.56586.18
421174-2117490.96191.61
521093-2109390.61391.27
621873-2187393.96494.52
90min122619-2261997.16992.593.4298.0193.383.40
221436-2143692.08792.90
320567-2056788.35389.11
421371-2137191.80792.60
521150-2115090.85891.67
622182-2218295.29196.00
极限122499-2249996.65393.353.4997.6594.293.47
221597-2159792.77893.74
320463-2046387.90788.81
421928-2192894.20095.15
521431-2143192.06593.03
622456-2245696.46897.34
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 10.262143621363214062132221401213860.21
2 10.282143221365213980.23
单位质量响应值RSD%判断
2084.412081.520.10数据可信
供试品溶液-2025041421批-pH5.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min13130-313013.48917.1816.1113.4917.1816.12
24264-426418.37618.38
33288-328814.17014.17
44025-402517.34617.35
54598-459819.81519.82
64608-460819.85819.86
10min19882-988242.58746.848.6442.6146.878.65
211358-1135848.94848.98
39848-984842.44042.46
410623-1062345.78045.81
511243-1124348.45248.49
612266-1226652.86152.89
15min113037-1303756.18363.116.5856.2863.226.58
215204-1520465.52265.63
314162-1416261.03261.13
414610-1461062.96263.07
515052-1505264.86764.98
615800-1580068.09168.21
20min115656-1565667.47073.424.2067.6673.634.21
217151-1715173.91374.13
317013-1701373.31873.51
417271-1727174.43074.64
517463-1746375.25775.48
617670-1767076.15076.38
30min118677-1867780.48983.092.2580.7983.422.26
219157-1915782.55882.90
319325-1932583.28283.60
418991-1899181.84282.18
519709-1970984.93785.28
619818-1981885.40685.77
45min120176-2017686.94989.201.6787.3889.681.68
220484-2048488.27788.76
320706-2070689.23389.69
420718-2071889.28589.76
520963-2096390.34190.83
621147-2114791.13491.64
60min120686-2068689.14791.861.9689.7392.481.97
221006-2100690.52691.16
321273-2127391.67792.28
421474-2147492.54393.16
521650-2165093.30293.94
621806-2180693.97494.63
90min121503-2150392.66893.991.4693.4094.761.48
221524-2152492.75993.54
321642-2164293.26794.03
421801-2180193.95294.73
522119-2211995.32396.12
622263-2226395.94396.76
极限121982-2198294.73294.961.4795.6195.891.47
221471-2147192.53093.46
321912-2191294.43195.34
422245-2224595.86696.80
522277-2227796.00496.96
622317-2231796.17697.15
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 10.262138321466214262140821476214320.19
2 10.282139021433214120.15
单位质量响应值RSD%判断
2088.892082.880.21数据可信
供试品溶液-PN4A批-pH5.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min13846-384616.55116.7516.7316.5516.7516.74
23279-327914.11114.11
34605-460519.81819.82
44635-463519.94719.95
53921-392116.87416.87
63067-306713.19913.20
10min111916-1191651.28149.1010.5751.3149.1310.57
210745-1074546.24146.26
312986-1298655.88555.92
410970-1097047.20947.24
512224-1222452.60652.63
69615-961541.37841.40
15min116175-1617569.60967.225.4269.7267.335.43
215621-1562167.22567.33
316528-1652871.12871.25
415044-1504464.74264.85
516101-1610169.29169.41
614246-1424661.30861.40
20min118289-1828978.70776.573.7878.9476.793.79
217987-1798777.40777.62
318501-1850179.61979.86
417304-1730474.46874.69
517978-1797877.36877.60
616697-1669771.85672.05
30min120025-2002586.17885.162.1286.5485.512.14
219691-1969184.74085.08
320293-2029387.33187.71
419146-1914682.39582.74
520057-2005786.31586.68
619517-1951783.99284.30
45min121059-2105990.62890.421.5491.1390.911.54
221035-2103590.52491.01
321350-2135091.88092.40
420409-2040987.83088.31
521208-2120891.26991.77
621002-2100290.38290.84
60min121662-2166293.22392.671.6193.8893.311.63
221519-2151992.60793.24
321917-2191794.32095.00
421001-2100190.37891.01
521826-2182693.92894.58
621273-2127391.54992.15
90min122105-2210595.12993.751.6995.9494.551.70
221841-2184193.99394.78
322022-2202294.77295.61
421304-2130491.68292.46
522086-2208695.04795.86
621353-2135391.89392.65
极限122049-2204994.88894.090.9095.8695.040.92
221881-2188194.16595.11
322111-2211195.15596.15
421601-2160192.96093.89
521841-2184193.99394.96
621701-2170193.39094.30
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