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 9.231966519661196731969619664196720.08
2 9.221972919663196960.24
单位质量响应值RSD%判断
2131.312136.230.17数据可信
供试品溶液-24122801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%
5min16191-619126.04524.177.3026.0524.177.30
25531-553123.26923.27
35905-590524.84224.84
45036-503621.18621.19
56071-607125.54025.54
65741-574124.15224.15
10min111920-1192050.14749.733.8250.1949.773.82
211662-1166249.06149.10
312583-1258352.93652.98
411259-1125947.36647.40
511557-1155748.61948.66
611940-1194050.23150.27
15min115150-1515063.73563.331.7963.8663.451.80
214730-1473061.96862.09
315361-1536164.62364.75
414818-1481862.33862.45
515340-1534064.53464.66
614925-1492562.78862.91
20min116470-1647069.28869.253.5869.5269.483.57
216445-1644569.18369.41
317037-1703771.67371.91
416623-1662369.93270.15
515352-1535264.58564.82
616844-1684470.86271.09
30min117830-1783075.01075.371.7275.3675.711.72
217429-1742973.32373.66
318269-1826976.85677.21
417787-1778774.82975.16
517963-1796375.56975.91
618209-1820976.60476.95
45min118706-1870678.69579.001.5579.1779.471.54
218267-1826776.84877.31
319023-1902380.02880.51
418885-1888579.44879.91
518738-1873878.82979.29
619059-1905980.18080.65
60min119007-1900779.96180.301.1780.5780.901.16
218790-1879079.04879.64
319358-1935881.43882.06
419271-1927181.07281.66
518906-1890679.53680.13
619189-1918980.72781.33
极限118980-1898079.84881.151.7580.5981.881.74
218765-1876578.94379.66
319458-1945881.85882.61
419479-1947981.94782.67
519424-1942481.71582.44
619628-1962882.57483.32
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 9.231967119703196861961619569196490.29
2 9.221962519618196220.03
单位质量响应值RSD%判断
2128.822128.200.03数据可信
供试品溶液-24122801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%
5min12996-299612.63510.1115.9712.6410.1115.99
22629-262911.08711.09
32028-20288.5538.55
42191-21919.2409.24
52504-250410.56010.56
62037-20378.5918.59
10min17457-745731.44931.805.3731.4731.825.37
28079-807934.07234.09
36843-684328.85928.87
47536-753631.78231.80
57634-763432.19532.21
67698-769832.46532.48
15min110467-1046744.14345.085.6244.2245.165.61
210292-1029243.40543.48
310152-1015242.81442.88
410450-1045044.07144.14
511755-1175549.57549.65
611025-1102546.49646.56
20min112371-1237152.17253.078.9852.3253.228.97
213461-1346156.76956.92
310690-1069045.08345.22
412006-1200650.63350.77
513569-1356957.22557.38
613405-1340556.53356.68
30min114723-1472362.09261.877.6962.3362.107.68
215160-1516063.93564.18
313766-1376658.05658.26
413136-1313655.39955.62
516373-1637369.05069.30
614858-1485862.66162.90
45min116535-1653569.73369.614.8270.0769.944.82
216286-1628668.68369.03
315619-1561965.87066.18
415897-1589767.04367.36
517865-1786575.34275.71
616828-1682870.96971.31
60min117614-1761474.28474.476.4774.7474.926.47
218346-1834677.37177.83
316141-1614168.07268.49
416677-1667770.33270.76
519313-1931381.44981.94
617851-1785175.28375.75
极限117783-1778374.99775.496.7375.5776.076.71
218508-1850878.05478.65
316726-1672670.53971.07
417780-1778074.98475.53
519905-1990583.94684.57
616698-1669870.42171.01
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 9.231941319440194191945619478194410.14
2 9.221969919643196710.21
单位质量响应值RSD%判断
2106.282133.510.91数据可信
供试品溶液-24122801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%
5min116817-1681771.21475.2910.5971.2175.2910.59
220018-2001884.76984.77
315015-1501563.58363.58
419238-1923881.46681.47
518790-1879079.56979.57
616794-1679471.11671.12
10min120566-2056687.08991.426.7887.2191.556.78
223392-2339299.05699.20
319510-1951082.61782.72
423020-2302097.48197.62
521433-2143390.76190.89
621613-2161391.52391.64
15min121228-2122889.89394.374.7990.1694.654.80
223739-23739100.526100.83
321212-2121289.82590.07
423377-2337798.99399.29
521954-2195492.96793.25
622206-2220694.03494.31
20min121230-2123089.90194.594.5390.3195.034.54
223394-2339499.06599.54
321301-2130190.20290.60
423595-2359599.916100.38
522041-2204193.33593.77
622466-2246695.13595.56
30min121173-2117389.66095.764.9190.2296.354.91
223807-23807100.814101.45
321780-2178092.23092.77
423852-23852101.004101.63
522082-2208293.50994.10
622992-2299297.36297.95
45min121387-2138790.56696.134.8291.2896.884.83
223771-23771100.661101.47
321767-2176792.17592.87
423959-23959101.457102.26
522088-2208893.53494.28
623232-2323298.37999.13
60min121412-2141290.67296.655.0591.5497.565.05
223919-23919101.288102.26
321882-2188292.66293.51
424272-24272102.783103.75
522264-2226494.28095.19
623195-2319598.22299.13
极限121312-2131290.24896.295.5291.2697.375.52
223722-23722100.454101.60
321647-2164791.66792.67
424043-24043101.813102.95
521868-2186892.60393.67
623844-23844100.970102.05
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