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%
19.682055720298202452030720349203510.60
29.492039620297203460.35
单位质量响应值RSD%判断
2102.382143.941.39数据可信
供试品溶液-25011301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%
5min16539-653927.64929.4112.6227.6529.4112.61
26853-685328.97728.98
38261-826134.93034.93
47736-773632.71132.71
55935-593525.09525.10
66402-640227.07027.07
10min112602-1260253.28656.364.5053.3356.414.50
213349-1334956.44456.49
314359-1435960.71560.77
413557-1355757.32457.38
513084-1308455.32455.37
613023-1302355.06655.11
15min115502-1550265.54868.703.7665.6868.853.77
216627-1662770.30570.45
316970-1697071.75571.91
416434-1643469.48969.64
515497-1549765.52765.66
616461-1646169.60369.74
20min116857-1685771.27774.782.7271.5275.042.72
217959-1795975.93776.20
318214-1821477.01577.29
417628-1762874.53774.80
517499-1749973.99274.24
617952-1795275.90776.16
30min117967-1796775.97179.903.1376.3380.283.13
219556-1955682.69083.08
319102-1910280.77081.18
418989-1898980.29280.68
518441-1844177.97578.34
619324-1932481.70982.09
45min119029-1902980.46182.882.7080.9583.402.70
220243-2024385.59586.12
319762-1976283.56184.10
419767-1976783.58284.11
518893-1889379.88680.38
619914-1991484.20384.72
60min119283-1928381.53584.632.9282.1685.282.91
220965-2096588.64789.31
320311-2031185.88286.56
419812-1981283.77284.44
519656-1965683.11283.74
620062-2006284.82985.49
极限118913-1891379.97184.033.0680.7384.823.06
220485-2048586.61887.43
319895-1989584.12384.95
419918-1991884.22085.02
519510-1951082.49583.26
620520-2052086.76687.56
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%
19.682052720793205102054420528205800.59
29.492004520134200900.32
单位质量响应值RSD%判断
2126.032116.970.31数据可信
供试品溶液-25011301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%
5min12298-22989.72310.7912.849.7210.7812.82
22903-290312.28312.28
32960-296012.52512.52
42508-250810.61210.61
52492-249210.54410.54
62133-21339.0259.03
10min17571-757132.03534.447.3532.0534.467.35
28325-832535.22535.25
37532-753231.87031.89
48366-836635.39935.42
59120-912038.58938.61
67923-792333.52433.54
15min111147-1114747.16647.832.3347.2447.912.33
211138-1113847.12847.21
311122-1112247.06047.13
411360-1136048.06748.14
511808-1180849.96350.04
611251-1125147.60647.68
20min113060-1306055.26053.936.6155.4154.096.58
212529-1252953.01453.17
313021-1302155.09555.25
413202-1320255.86156.02
511155-1115547.20047.37
613509-1350957.16057.31
30min115587-1558765.95364.672.3966.1964.912.38
214715-1471562.26362.51
315304-1530464.75565.00
414976-1497663.36863.62
515525-1552565.69165.93
615595-1559565.98766.23
45min116949-1694971.71671.651.3572.0772.001.35
216593-1659370.21070.56
316742-1674270.84071.19
417059-1705972.18172.54
517212-1721272.82973.18
617048-1704872.13572.49
60min117004-1700471.94974.802.5172.4275.282.50
217276-1727673.09973.57
317741-1774175.06775.54
417911-1791175.78676.26
518100-1810076.58677.06
618038-1803876.32476.80
极限118611-1861178.74876.592.7879.3477.192.76
217768-1776875.18175.77
318194-1819476.98477.58
418193-1819376.98077.58
518556-1855678.51579.12
617282-1728273.12573.73
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