阿齐沙坦片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号68522100802对照品来源自制对照品使用方法直接使用
对照品含量(%)99.7对照品水分(%)0对照品稀释倍数5000
标示量(mg)20供试品稀释倍数10系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
19.951001421002591005581004341003461003480.16
29.981008021013821010920.41
单位质量响应值RSD%判断
10085.2310129.460.31数据可信
加速6月-供试品溶液-2023111721批-pH1.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min12622-26222.3283.0915.762.333.0915.72
23437-34373.0513.05
33795-37953.3693.37
44284-42843.8033.80
53345-33452.9702.97
63412-34123.0293.03
10min17441-74416.6067.538.146.627.558.17
28450-84507.5027.52
38594-85947.6307.65
49548-95488.4768.50
58161-81617.2457.26
68697-86977.7217.74
15min111350-1135010.07610.846.2310.1310.906.25
211952-1195210.61110.67
312817-1281711.37911.44
413412-1341211.90711.98
511746-1174610.42810.48
611984-1198410.63910.70
20min113861-1386112.30513.184.1612.4113.304.19
214421-1442112.80312.92
314880-1488013.21013.33
415569-1556913.82213.96
515282-1528213.56713.68
615044-1504413.35613.47
30min117617-1761715.64016.132.1715.8116.322.21
218057-1805716.03116.22
318656-1865616.56216.76
418307-1830716.25216.46
517858-1785815.85416.04
618488-1848816.41316.61
45min119570-1957017.37418.012.1817.6318.292.22
220146-2014617.88518.16
320574-2057418.26518.55
420665-2066518.34618.65
520048-2004817.79818.08
620687-2068718.36518.65
60min121130-2113018.75919.401.8219.1219.781.84
222254-2225419.75720.13
321981-2198119.51419.91
422143-2214319.65820.06
521809-2180919.36119.74
621795-2179519.34919.74
极限122055-2205519.58020.102.2920.0420.602.24
223174-2317420.57321.06
322412-2241219.89720.40
422105-2210519.62420.14
522980-2298020.40120.89
623150-2315020.55221.05
阿齐沙坦片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号68522100802对照品来源自制对照品使用方法直接使用
对照品含量(%)99.7对照品水分(%)0对照品稀释倍数5000
标示量(mg)20供试品稀释倍数10系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
19.951002581003051004651002541002031002970.11
29.981003751003751003750.00
单位质量响应值RSD%判断
10080.1010057.620.16数据可信
加速6月-供试品溶液-2023111821批-pH1.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min15346-53464.7644.308.004.764.307.98
24575-45754.0774.08
34446-44463.9623.96
44645-46454.1394.14
54649-46494.1434.14
65274-52744.7004.70
10min19533-95338.4957.978.358.527.998.37
28335-83357.4287.45
37869-78697.0137.03
49211-92118.2098.23
58832-88327.8717.89
69855-98558.7828.81
15min112870-1287011.46911.007.2111.5411.077.21
211557-1155710.29910.36
310918-109189.7309.79
412976-1297611.56411.63
512710-1271011.32711.39
613046-1304611.62611.70
20min115198-1519813.54413.327.1113.6813.447.10
213716-1371612.22312.34
313560-1356012.08412.20
415991-1599114.25114.38
515270-1527013.60813.74
615916-1591614.18414.32
30min118602-1860216.57716.516.2716.7916.716.27
217363-1736315.47315.66
316871-1687115.03515.22
419317-1931717.21517.43
519241-1924117.14717.35
619751-1975117.60117.82
45min121250-2125018.93719.113.8819.2419.413.92
220817-2081718.55118.83
320203-2020318.00418.27
422153-2215319.74220.05
521961-2196119.57119.87
622287-2228719.86120.18
60min120773-2077318.51220.006.2018.9220.406.14
222530-2253020.07820.46
320759-2075918.50018.87
423581-2358121.01521.43
523032-2303220.52520.93
623987-2398721.37621.80
极限122785-2278520.30520.993.1720.8221.503.20
223666-2366621.09021.58
322561-2256120.10620.57
424171-2417121.54022.07
523664-2366421.08921.61
624442-2444221.78222.33
阿齐沙坦片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号68522100802对照品来源自制对照品使用方法直接使用
对照品含量(%)99.7对照品水分(%)0对照品稀释倍数5000
标示量(mg)20供试品稀释倍数10系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
19.951006011005211005781008821003401005840.20
29.989937099629995000.19
单位质量响应值RSD%判断
10108.949969.940.98数据可信
加速6月-供试品溶液-2023111921批-pH1.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min15771-57715.1585.1110.175.165.1110.20
26028-60285.3885.39
35039-50394.5044.50
45231-52314.6764.68
55578-55784.9864.99
66652-66525.9465.95
10min111915-1191510.6509.2313.3810.689.2613.38
212225-1222510.92710.96
39348-93488.3558.38
49004-90048.0488.07
59641-96418.6178.64
69837-98378.7928.83
15min115907-1590714.21812.5410.3714.3112.6310.37
215830-1583014.14914.24
312962-1296211.58611.66
412855-1285511.49011.56
513727-1372712.26912.35
612931-1293111.55811.64
20min118330-1833016.38414.848.4716.5514.998.48
218369-1836916.41916.59
315296-1529613.67213.81
415915-1591514.22514.36
515366-1536613.73413.88
616344-1634414.60914.75
30min121922-2192219.59418.026.5419.8518.256.58
221644-2164419.34619.61
318902-1890216.89517.11
418975-1897516.96017.17
519584-1958417.50517.72
619929-1992917.81318.04
45min124279-2427921.70120.505.5222.0720.835.56
224754-2475422.12622.49
322451-2245120.06720.37
421690-2169019.38719.69
522072-2207219.72820.05
622353-2235319.98020.31
60min125038-2503822.37921.393.7422.8721.833.82
225095-2509522.43022.92
323137-2313720.68021.10
423525-2352521.02721.44
523447-2344720.95721.38
623314-2331420.83821.28
极限125148-2514822.47821.794.5623.0922.364.61
226236-2623623.45024.07
323274-2327420.80321.33
424165-2416521.59922.13
523850-2385021.31821.86
623621-2362121.11321.67
阿齐沙坦片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号68522100802对照品来源自制对照品使用方法直接使用
对照品含量(%)99.7对照品水分(%)0对照品稀释倍数5000
标示量(mg)20供试品稀释倍数10系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
19.9510026010025799917998981002241001110.19
29.981008571007071007820.11
单位质量响应值RSD%判断
10061.4110098.400.26数据可信
加速6月-供试品溶液批-pH1.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min16685-66855.9515.836.025.955.836.03
26647-66475.9175.92
36344-63445.6475.65
46275-62755.5865.59
56120-61205.4485.45
67218-72186.4256.43
10min110933-109339.7329.386.909.779.426.88
211589-1158910.31610.35
310833-108339.6439.67
410026-100268.9258.96
59549-95498.5008.53
610303-103039.1729.21
15min114313-1431312.74112.662.3512.8312.742.37
214736-1473613.11813.21
314372-1437212.79412.88
414056-1405612.51312.59
513759-1375912.24812.33
614084-1408412.53712.62
20min116662-1666214.83215.063.9914.9915.223.98
217610-1761015.67615.84
317650-1765015.71215.87
415918-1591814.17014.32
516541-1654114.72514.87
617140-1714015.25815.41
30min120340-2034018.10618.042.3518.3518.282.35
221145-2114518.82319.07
320215-2021517.99518.24
420050-2005017.84818.08
519737-1973717.57017.80
620130-2013017.92018.16
45min123135-2313520.59520.223.1720.9420.563.14
223632-2363221.03721.39
321985-2198519.57119.91
423287-2328720.73021.06
522119-2211919.69020.02
622122-2212219.69320.03
60min123633-2363321.03820.712.6421.4921.162.61
224198-2419821.54122.01
323070-2307020.53720.99
422515-2251520.04320.49
523413-2341320.84221.28
622769-2276920.26920.72
极限124190-2419021.53421.361.4322.1121.921.45
224475-2447521.78722.38
323776-2377621.16521.73
424196-2419621.53922.09
523701-2370121.09821.65
623615-2361521.02221.58
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