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%
110.551070181072551067681067061068701069230.21
210.531071051072891071970.13
单位质量响应值RSD%判断
10134.8810180.150.32数据可信
中间条件6月-供试品溶液-2023111721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%
5min14161-41613.6763.0319.023.683.0319.04
22251-22511.9891.99
33276-32762.8942.89
43746-37463.3093.31
53413-34133.0153.02
63702-37023.2703.27
10min17764-77646.8595.8611.426.885.8811.43
26884-68846.0816.09
35409-54094.7784.79
46686-66865.9065.92
56545-65455.7825.80
66512-65125.7535.77
15min110214-102149.0237.928.329.087.978.32
29203-92038.1308.17
37967-79677.0387.08
48606-86067.6027.65
59033-90337.9808.03
68781-87817.7577.81
20min111413-1141310.0829.455.8710.199.555.86
211232-112329.92210.01
39729-97298.5948.68
410350-103509.1439.24
510974-109749.6949.79
610500-105009.2769.37
30min112805-1280511.31211.032.7111.4811.182.76
212951-1295111.44111.59
312052-1205210.64710.78
412257-1225710.82810.97
512498-1249811.04111.19
612370-1237010.92811.07
45min114115-1411512.46912.591.7012.7012.801.68
214009-1400912.37512.58
314194-1419412.53912.73
414100-1410012.45612.66
514452-1445212.76712.98
614637-1463712.93013.14
60min115059-1505913.30313.111.2713.6013.391.28
214932-1493213.19113.47
314923-1492313.18313.44
414509-1450912.81713.09
514785-1478513.06113.34
614839-1483913.10913.39
极限115991-1599114.12613.622.1514.5013.972.18
215594-1559413.77614.13
315211-1521113.43713.77
415421-1542113.62313.97
515126-1512613.36213.71
615171-1517113.40213.75
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%
110.551070291071731075261073471074701073090.20
210.531078571081211079890.18
单位质量响应值RSD%判断
10171.4710255.370.59数据可信
中间条件6月-供试品溶液-2023111821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%
5min12579-25792.2662.6329.992.272.6329.93
22171-21711.9071.91
33103-31032.7262.73
44158-41583.6533.65
52014-20141.7691.77
63910-39103.4353.44
10min16078-60785.3405.5413.215.355.5613.24
24935-49354.3364.35
36027-60275.2955.31
46985-69856.1376.16
56521-65215.7295.74
67280-72806.3966.42
15min18749-87497.6877.889.727.737.939.74
27606-76066.6826.72
38900-89007.8197.86
49539-95398.3818.44
58815-88157.7457.79
610208-102088.9689.02
20min110910-109109.5859.324.309.679.414.38
29824-98248.6318.70
310503-105039.2289.32
410791-107919.4819.58
510498-104989.2239.31
611135-111359.7839.89
30min112394-1239410.88911.043.8211.0311.183.89
212011-1201110.55210.67
312762-1276211.21211.35
412982-1298211.40611.56
512074-1207410.60810.74
613164-1316411.56511.72
45min114380-1438012.63412.203.7612.8312.403.79
212888-1288811.32311.50
313830-1383012.15112.35
414100-1410012.38812.60
513998-1399812.29812.49
614132-1413212.41612.64
60min114734-1473412.94513.072.1213.2113.342.17
214597-1459712.82413.07
315036-1503613.21013.48
414725-1472512.93713.22
514744-1474412.95413.22
615454-1545413.57713.87
极限114807-1480713.00913.482.9613.3513.822.92
215283-1528313.42713.74
314982-1498213.16313.51
415238-1523813.38813.75
515706-1570613.79914.13
616022-1602214.07614.44
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%
110.551066351069461066821065671065971066850.15
210.531072301075671073980.23
单位质量响应值RSD%判断
10112.3210199.240.61数据可信
中间条件6月-供试品溶液-2023111921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%
5min15426-54264.7944.639.574.794.639.56
25417-54174.7864.79
35637-56374.9814.98
44792-47924.2344.23
55727-57275.0605.06
64467-44673.9473.95
10min16399-63995.6545.8812.945.685.9112.92
26121-61215.4085.43
36382-63825.6395.67
45995-59955.2975.32
58342-83427.3717.40
66708-67085.9275.95
15min18791-87917.7678.096.657.838.156.65
28454-84547.4707.53
39470-94708.3678.43
48694-86947.6827.73
510062-100628.8908.96
69457-94578.3568.41
20min110518-105189.2939.485.009.399.585.04
210373-103739.1659.26
310629-106299.3919.50
410146-101468.9659.06
511622-1162210.26910.39
611067-110679.7789.88
30min112045-1204510.64211.184.2410.8011.344.20
212585-1258511.12011.27
312504-1250411.04811.21
412342-1234210.90511.05
512818-1281811.32511.50
613608-1360812.02312.18
45min114041-1404112.40612.653.2312.6212.873.23
213622-1362212.03612.25
314187-1418712.53512.75
414486-1448612.79913.01
514756-1475613.03813.28
614838-1483813.11013.33
60min115090-1509013.33313.521.4713.6113.811.51
215050-1505013.29713.58
315201-1520113.43113.72
415345-1534513.55813.84
515503-1550313.69814.01
615604-1560413.78714.08
极限115273-1527313.49413.872.0013.8514.231.98
215621-1562113.80214.15
315564-1556413.75214.11
416014-1601414.14914.50
515603-1560313.78614.17
616121-1612114.24414.62
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%
110.551048541044031048581051481052441049010.32
210.531067991067321067660.05
单位质量响应值RSD%判断
9943.2210139.221.39数据可信
中间条件6月-供试品溶液批-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%
5min13734-37343.3373.2814.023.343.2814.02
23490-34903.1193.12
34138-41383.6983.70
43301-33012.9502.95
54373-43733.9083.91
63007-30072.6872.69
10min17543-75436.7416.327.966.766.337.95
26850-68506.1226.14
37451-74516.6596.68
46177-61775.5205.54
57600-76006.7926.81
66778-67786.0586.07
15min110096-100969.0238.913.739.088.973.76
29732-97328.6988.75
310232-102329.1449.20
49349-93498.3558.40
510362-103629.2619.32
610077-100779.0069.05
20min112317-1231711.00810.573.0711.1110.673.08
211366-1136610.15810.26
312073-1207310.79010.90
411481-1148110.26110.35
511952-1195210.68210.79
611743-1174310.49510.59
30min113010-1301011.62711.832.4411.7911.992.44
212881-1288111.51211.67
313536-1353612.09712.27
413006-1300611.62311.77
513316-1331611.90112.07
613673-1367312.22012.38
45min115336-1533613.70613.302.2413.9413.532.25
214440-1444012.90513.13
314963-1496313.37213.61
414675-1467513.11513.33
515153-1515313.54213.78
614706-1470613.14313.37
60min115291-1529113.66613.751.8113.9714.051.76
215058-1505813.45713.75
315209-1520913.59213.90
415821-1582114.13914.43
515600-1560013.94214.25
615358-1535813.72514.02
极限115567-1556713.91214.082.1014.3014.462.02
215418-1541813.77914.15
315625-1562513.96414.35
416316-1631614.58214.95
515630-1563013.96914.36
615980-1598014.28114.66
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