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%
19.991012051015241014211019091011101014340.31
29.891017241017461017350.02
单位质量响应值RSD%判断
10153.5510286.650.93数据可信
中间条件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%
5min12527-25272.2193.0838.792.223.0838.82
23076-30762.7012.70
33489-34893.0633.06
43051-30512.6792.68
56195-61955.4395.44
62692-26922.3642.36
10min17478-74786.5668.0616.096.588.0816.11
28525-85257.4857.50
39555-95558.3898.41
49595-95958.4258.44
511702-1170210.27510.30
68232-82327.2287.24
15min110941-109419.60611.2110.299.6611.2810.35
212310-1231010.80810.86
313326-1332611.70011.76
413433-1343311.79411.86
514679-1467912.88812.98
611946-1194610.48910.54
20min114083-1408312.36513.666.1512.4713.786.21
215177-1517713.32613.44
316645-1664514.61514.74
415888-1588813.95014.08
516421-1642114.41814.58
615104-1510413.26213.37
30min117227-1722715.12616.514.5415.3016.714.61
218905-1890516.59916.79
319276-1927616.92517.13
419318-1931816.96117.17
519563-1956317.17717.42
618517-1851716.25816.44
45min121026-2102618.46118.941.9618.7219.232.03
221220-2122018.63118.91
322112-2211219.41519.72
421968-2196819.28819.59
521650-2165019.00919.34
621457-2145718.84019.12
60min121653-2165319.01219.662.8319.3720.052.88
222575-2257519.82120.21
322700-2270019.93120.34
423016-2301620.20820.61
522852-2285220.06420.50
621539-2153918.91219.29
极限122822-2282220.03821.022.5120.5021.522.59
223957-2395721.03521.53
324224-2422421.26921.79
424360-2436021.38821.91
524460-2446021.47622.03
623806-2380620.90221.39
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%
19.991004091009681009081005531009031007480.25
29.891009711007771008740.14
单位质量响应值RSD%判断
10084.8810199.600.80数据可信
中间条件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%
5min12660-26602.3532.6022.052.352.6022.08
24122-41223.6473.65
33181-31812.8142.81
42629-26292.3262.33
52721-27212.4072.41
62297-22972.0322.03
10min18749-87497.7417.5011.387.757.5211.42
210092-100928.9298.95
38883-88837.8597.87
47664-76646.7816.79
57953-79537.0367.05
67542-75426.6736.68
15min112747-1274711.27811.064.0911.3311.114.14
213378-1337811.83611.91
312289-1228910.87310.93
412469-1246911.03211.08
512152-1215210.75110.80
611946-1194610.56910.62
20min116062-1606214.21113.714.2314.3313.834.26
216404-1640414.51314.65
315641-1564113.83813.96
415172-1517213.42313.54
514914-1491413.19513.31
614767-1476713.06513.17
30min118898-1889816.72016.641.5616.9216.831.61
219320-1932017.09317.31
318523-1852316.38816.58
418839-1883916.66816.85
518697-1869716.54216.73
618559-1855916.42016.60
45min121337-2133718.87819.172.5319.1719.462.47
221303-2130318.84819.16
321953-2195319.42319.71
422583-2258319.98020.26
521098-2109818.66618.94
621755-2175519.24819.52
60min123583-2358320.86520.321.9021.2620.711.88
222797-2279720.17020.59
323157-2315720.48820.88
422979-2297920.33120.72
522259-2225919.69420.07
622997-2299720.34620.72
极限123029-2302920.37520.973.1120.8921.472.98
222638-2263820.02920.56
324347-2434721.54122.05
423839-2383921.09121.59
523818-2381821.07321.56
624523-2452321.69722.19
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%
19.991005651009631007171005011007481006990.18
29.899972399151994370.41
单位质量响应值RSD%判断
10079.9810054.300.19数据可信
中间条件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%
5min12428-24282.1642.3612.812.162.3612.82
22231-22311.9891.99
32477-24772.2082.21
42985-29852.6612.66
52663-26632.3742.37
63107-31072.7692.77
10min18131-81317.2477.4110.977.267.4210.97
27492-74926.6786.69
38033-80337.1607.17
49579-95798.5388.55
57370-73706.5696.58
69249-92498.2448.26
15min110926-109269.73910.508.799.7910.568.78
211139-111399.9289.98
311417-1141710.17610.23
412654-1265411.27911.34
511088-110889.8839.93
613467-1346712.00312.06
20min113611-1361112.13212.935.9212.2413.045.93
214075-1407512.54512.65
314528-1452812.94913.06
415838-1583814.11714.24
513815-1381512.31412.42
615170-1517013.52113.65
30min117915-1791515.96815.965.5616.1416.145.58
216489-1648914.69714.87
317955-1795516.00416.18
419402-1940217.29317.50
517243-1724315.36915.54
618417-1841716.41516.62
45min121441-2144119.11118.672.1419.3718.942.15
220675-2067518.42818.68
320872-2087218.60418.87
421019-2101918.73519.03
520260-2026018.05818.32
621394-2139419.06919.36
60min129276-2927626.09421.1611.4826.4621.5411.26
222451-2245120.01120.37
323034-2303420.53120.90
422975-2297520.47820.88
522427-2242719.99020.35
622311-2231119.88620.29
极限128095-2809525.04221.568.2725.5622.058.15
222971-2297120.47420.94
322516-2251620.06920.56
423838-2383821.24721.76
523645-2364521.07521.54
624035-2403521.42321.93
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%
19.991018381021571019081017001012351017680.34
29.89999961001481000720.11
单位质量响应值RSD%判断
10186.9910118.500.48数据可信
中间条件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%
5min15986-59865.2905.486.905.295.486.91
26031-60315.3305.33
35700-57005.0385.04
46899-68996.0976.10
56079-60795.3735.37
66496-64965.7415.74
10min111284-112849.97310.406.1910.0010.436.18
212800-1280011.31311.34
310811-108119.5559.58
412096-1209610.69110.72
511407-1140710.08210.11
612212-1221210.79310.82
15min115401-1540113.61214.073.8113.7014.153.81
216957-1695714.98715.08
315279-1527913.50413.58
415735-1573513.90714.00
516009-1600914.14914.23
616104-1610414.23314.32
20min118088-1808815.98616.332.6716.1516.492.68
218695-1869516.52316.70
317983-1798315.89416.05
418890-1889016.69516.87
518055-1805515.95716.12
619125-1912516.90317.07
30min120465-2046518.08718.621.6118.3418.881.59
221210-2121018.74619.01
321075-2107518.62618.87
421328-2132818.85019.11
521397-2139718.91119.16
620957-2095718.52218.79
45min122132-2213219.56020.191.7819.9120.551.78
223083-2308320.40120.77
322754-2275420.11020.46
423116-2311620.43020.80
523253-2325320.55120.91
622740-2274020.09820.47
60min123544-2354420.80821.172.3621.2721.642.32
223699-2369920.94521.43
323823-2382321.05521.51
424869-2486921.97922.46
524381-2438121.54822.02
623386-2338620.66921.15
极限123709-2370920.95421.372.7421.5321.962.68
225264-2526422.32922.93
324067-2406721.27121.85
424209-2420921.39622.00
524480-2448021.63622.23
623356-2335620.64221.24
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