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%
110.002108521154211132108721092211060.14
210.082088320972209280.31
单位质量响应值RSD%判断
2110.602076.191.17数据可信
供试品溶液-2025041421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%
5min12793-279311.97712.8316.2511.9812.8416.26
22418-241810.36910.37
33329-332914.27614.28
43483-348314.93614.94
52489-248910.67410.67
63445-344514.77314.77
10min17010-701030.06131.856.7430.0831.886.74
27493-749332.13332.15
37393-739331.70431.73
48098-809834.72734.75
56748-674828.93828.96
67826-782633.56133.59
15min110464-1046444.87343.513.2944.9443.593.28
210181-1018143.66043.73
39830-983042.15442.23
410185-1018543.67743.76
59694-969441.57141.64
610529-1052945.15245.23
20min112238-1223852.48150.653.5052.6350.803.50
211780-1178050.51750.66
311642-1164249.92550.07
412013-1201351.51651.67
511095-1109547.57947.71
612104-1210451.90652.06
30min114727-1472763.15461.362.6463.3961.592.64
213907-1390759.63859.87
313994-1399460.01160.24
414338-1433861.48661.73
514098-1409860.45760.67
614787-1478763.41263.65
45min116902-1690272.48269.993.0272.8270.323.02
216310-1631069.94370.27
315959-1595968.43868.77
416477-1647770.65971.00
515568-1556866.76167.08
616706-1670671.64171.99
60min117699-1769975.89974.923.8876.3675.373.87
216498-1649870.74971.19
317853-1785376.56077.00
417186-1718673.70074.16
517141-1714173.50773.93
618451-1845179.12479.59
90min119861-1986185.17182.971.7485.7683.541.74
219197-1919782.32382.89
319350-1935082.98083.55
419014-1901481.53982.12
519044-1904481.66782.22
619616-1961684.12084.72
极限120628-2062888.46084.553.4089.1985.263.39
218775-1877580.51481.21
319730-1973084.60985.32
419593-1959384.02284.74
519283-1928382.69283.38
620282-2028286.97687.72
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%
110.002120121148211312097821012210940.45
210.082088020936209080.19
单位质量响应值RSD%判断
2109.402074.211.19数据可信
供试品溶液-2025041421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%
5min12705-270511.60912.3511.9111.6112.3511.92
23116-311613.37313.37
33292-329214.12814.13
42620-262011.24411.24
52424-242410.40310.40
63115-311513.36813.37
10min16760-676029.01129.006.8029.0329.026.79
25895-589525.29925.32
37139-713930.63830.66
46687-668728.69828.72
56952-695229.83529.85
67107-710730.50130.52
15min19901-990142.49141.513.4042.5641.583.39
29456-945640.58240.65
39749-974941.83941.91
49879-987942.39742.46
59938-993842.65042.72
69105-910539.07539.15
20min111687-1168750.15650.693.3650.2950.823.35
212469-1246953.51253.64
311925-1192551.17851.32
411671-1167150.08850.22
511857-1185750.88651.02
611260-1126048.32448.46
30min113360-1336057.33658.583.7057.5658.803.69
213080-1308056.13456.36
314431-1443161.93262.16
414023-1402360.18160.40
513695-1369558.77459.00
613312-1331257.13057.35
45min116295-1629569.93267.964.9770.2568.284.96
216025-1602568.77369.09
316356-1635670.19470.53
416161-1616169.35769.68
515912-1591268.28868.61
614265-1426561.22061.53
60min117959-1795977.07375.271.7877.5175.701.77
217431-1743174.80775.24
317719-1771976.04376.49
417706-1770675.98876.42
517121-1712173.47773.91
617296-1729674.22874.64
90min119489-1948983.63981.932.0684.2082.492.06
218944-1894481.30181.85
319342-1934283.00983.59
419049-1904981.75182.31
519322-1932282.92383.48
618402-1840278.97479.51
极限119850-1985085.18984.052.1785.8984.742.16
218983-1898381.46882.16
320171-2017186.56687.28
419399-1939983.25383.95
519757-1975784.79085.49
619342-1934283.00983.68
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%
110.002108721083212532111321269211610.44
210.082121021107211580.35
单位质量响应值RSD%判断
2116.102099.010.58数据可信
供试品溶液-SI4S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%
5min14260-426018.14517.9112.1218.1417.9112.12
23348-334814.26014.26
34825-482520.55120.55
44591-459119.55519.55
54166-416617.74417.74
64045-404517.22917.23
10min19223-922339.28438.825.6139.3138.855.61
28316-831635.42135.44
39288-928839.56139.59
49718-971841.39241.42
58712-871237.10737.14
69431-943140.17040.20
15min112229-1222952.08750.834.7452.1850.924.74
211175-1117547.59847.68
312206-1220651.98952.09
412472-1247253.12253.22
511255-1125547.93948.03
612267-1226752.24952.34
20min113649-1364958.13557.952.8758.3258.132.88
213163-1316356.06556.23
313998-1399859.62259.81
414102-1410260.06560.26
513219-1321956.30456.48
613495-1349557.48057.66
30min115636-1563666.59966.822.6066.8867.102.60
215343-1534365.35165.61
315785-1578567.23367.52
416366-1636669.70870.00
515212-1521264.79365.06
615790-1579067.25567.53
45min117566-1756674.81974.562.2675.2174.952.27
216849-1684971.76572.13
317817-1781775.88876.29
417844-1784476.00376.41
517222-1722273.35473.73
617738-1773875.55275.94
60min118898-1889880.49379.662.6281.0180.182.63
218048-1804876.87277.36
318732-1873279.78680.31
419492-1949283.02383.56
518375-1837578.26578.76
618674-1867479.53980.06
90min120065-2006585.46384.073.1286.1184.713.11
219333-1933382.34582.96
320095-2009585.59186.25
420307-2030786.49487.17
519945-1994584.95285.58
618678-1867879.55680.20
极限120164-2016485.88585.922.6186.6886.702.62
219293-1929382.17582.92
320154-2015485.84286.64
420930-2093089.14889.96
520130-2013085.74086.51
620362-2036286.72887.51
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%
110.002107020952211382100720970210270.37
210.082109721139211180.15
单位质量响应值RSD%判断
2102.702095.040.26数据可信
供试品溶液-SI4S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%
5min14806-480620.55518.8811.3420.5518.8811.33
23718-371815.90115.90
34911-491121.00421.00
44082-408217.45817.46
54836-483620.68320.68
64134-413417.68117.68
10min19565-956540.90839.924.9740.9439.964.97
28683-868337.13637.16
39921-992142.43142.47
49177-917739.24939.28
59668-966841.34941.38
68995-899538.47138.50
15min112098-1209851.74250.983.6751.8451.073.66
211369-1136948.62448.71
311367-1136748.61548.72
412100-1210051.75051.84
512340-1234052.77752.88
612240-1224052.34952.44
20min113660-1366058.42258.592.4758.6158.772.47
213189-1318956.40856.58
313566-1356658.02058.21
413634-1363458.31158.49
514006-1400659.90260.09
614136-1413660.45860.64
30min115932-1593268.13967.632.0268.4367.912.01
215878-1587867.90868.17
316220-1622069.37169.65
415270-1527065.30865.59
515901-1590168.00768.30
615675-1567567.04067.32
45min117863-1786376.39875.912.1176.8076.302.09
217989-1798976.93777.31
318198-1819877.83178.23
417298-1729873.98274.37
517291-1729173.95274.36
617850-1785076.34276.74
60min118762-1876280.24380.442.1580.7780.962.14
218824-1882480.50881.01
319224-1922482.21982.75
418900-1890080.83381.34
519074-1907481.57782.11
618062-1806277.24977.77
90min120075-2007585.85985.491.9886.5286.141.96
220007-2000785.56886.21
319965-1996585.38886.05
420357-2035787.06587.71
519245-1924582.30982.97
620277-2027786.72287.37
极限120598-2059888.09587.552.0388.9088.352.02
219900-1990085.11085.89
320837-2083789.11889.93
420718-2071888.60989.40
519993-1999385.50886.31
620776-2077688.85789.65
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