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%
110.342143121577214242152621580215080.36
210.352187921783218310.32
单位质量响应值RSD%判断
2080.082109.280.99数据可信
供试品溶液-24082001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%
5min18129-812934.83835.3314.9334.8435.3314.94
29425-942540.39240.39
39825-982542.10642.11
48073-807334.59834.60
57531-753132.27532.28
66476-647627.75427.75
10min113652-1365258.50860.107.5358.5760.167.54
214732-1473263.13663.20
315586-1558666.79666.87
414294-1429461.25961.32
513142-1314256.32256.38
612742-1274254.60854.65
15min116283-1628369.78369.537.1869.9469.697.19
216959-1695972.68072.85
317993-1799377.11277.29
416078-1607868.90569.06
514723-1472363.09863.25
615310-1531065.61365.75
20min117668-1766875.71974.665.5875.9974.935.60
218194-1819477.97378.27
318750-1875080.35680.67
417154-1715473.51673.79
516219-1621969.50969.76
616537-1653770.87271.12
30min118629-1862979.83779.305.5080.2479.705.51
218945-1894581.19281.62
320031-2003185.84686.29
418622-1862279.80780.20
517113-1711373.34073.71
617676-1767675.75376.12
45min119211-1921182.33181.654.4882.8682.184.49
219530-1953083.69984.26
320310-2031087.04187.63
418941-1894181.17481.70
517849-1784976.49476.99
618472-1847279.16479.66
60min119358-1935882.96182.664.9883.6383.334.99
219683-1968384.35485.05
320750-2075088.92789.66
419275-1927582.60683.27
517848-1784876.49077.11
618814-1881480.63081.25
极限119661-1966184.26084.195.5985.0784.995.58
219704-1970484.44485.28
320843-2084389.32690.21
420851-2085189.36090.16
518287-1828778.37279.12
618516-1851679.35380.11
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%
110.342184321794217712171921831217920.23
210.352219222326222590.43
单位质量响应值RSD%判断
2107.542150.631.44数据可信
供试品溶液-24101102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%
5min17335-733530.92933.2919.7130.9333.2919.70
27283-728330.71030.71
35780-578024.37224.37
47826-782632.99933.00
58768-876836.97136.97
610379-1037943.76443.76
10min113090-1309055.19560.208.8155.2560.268.81
213461-1346156.76056.81
313064-1306455.08655.13
415125-1512563.77663.83
514819-1481962.48662.55
616103-1610367.90067.97
15min117441-1744173.54272.424.1773.6972.574.18
216364-1636469.00169.15
316230-1623068.43668.57
417722-1772274.72774.89
517331-1733173.07873.24
617956-1795675.71375.90
20min119023-1902380.21378.093.8780.4878.363.88
217853-1785375.27975.54
317735-1773574.78275.03
418739-1873979.01579.30
518198-1819876.73477.02
619568-1956882.51182.82
30min120976-2097688.44882.483.6888.8582.893.67
219256-1925681.19581.58
319107-1910780.56780.94
419403-1940381.81582.23
519049-1904980.32280.74
619579-1957982.55783.01
45min122375-2237594.34786.464.6494.8987.014.62
220313-2031385.65286.17
319753-1975383.29183.80
420397-2039786.00686.56
519896-1989683.89484.44
620298-2029885.58986.18
60min122468-2246894.73988.213.7995.4488.903.77
220835-2083587.85388.52
320362-2036285.85986.50
420768-2076887.57188.27
520304-2030485.61486.30
620786-2078687.64688.38
极限122833-2283396.27888.784.4797.1489.624.44
221050-2105088.76089.57
320832-2083287.84088.63
420638-2063887.02287.87
520049-2004984.53985.37
620929-2092988.24989.13
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%
110.342155621616215052147121524215340.26
210.352174321814217780.24
单位质量响应值RSD%判断
2082.592104.150.73数据可信
供试品溶液-24092301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%
5min16814-681429.22032.6115.9229.2232.6115.92
28372-837235.90135.90
38117-811734.80734.81
46097-609726.14526.15
56873-687329.47329.47
69348-934840.08640.09
10min113501-1350157.89561.675.1357.9461.725.14
214888-1488863.84363.90
315046-1504664.52164.58
413810-1381059.22059.26
513861-1386159.43959.49
615185-1518565.11765.18
15min117233-1723373.89975.723.0274.0475.883.03
217736-1773676.05676.22
318020-1802077.27477.44
416816-1681672.11172.25
517922-1792276.85377.00
618221-1822178.13678.31
20min118332-1833278.61280.611.8878.8880.891.89
218691-1869180.15180.44
319117-1911781.97882.27
418713-1871380.24580.51
518628-1862879.88180.16
619305-1930582.78483.09
30min119853-1985385.13485.620.8785.5386.040.88
219914-1991485.39685.82
320218-2021886.69987.13
419829-1982985.03185.43
519838-1983885.07085.48
620150-2015086.40886.85
45min120512-2051287.96088.540.7688.5089.100.78
220630-2063088.46689.03
320818-2081889.27289.85
420554-2055488.14088.68
520509-2050987.94788.50
620863-2086389.46590.05
60min120695-2069588.74589.741.2689.4390.451.27
220609-2060988.37689.09
321253-2125391.13791.86
420849-2084989.40590.09
520948-2094889.83090.53
621207-2120790.94091.68
极限120753-2075388.99390.261.5389.8391.121.53
220764-2076489.04189.90
321180-2118090.82491.70
420796-2079689.17890.01
521314-2131491.39992.25
621488-2148892.14593.03
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