美阿沙坦钾片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号D211-4R701-2402002对照品来源自制工作对照品对照品使用方法直接使用
对照品含量(%)99.5对照品水分(%)0对照品稀释倍数1000
标示量(mg)80供试品稀释倍数5系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
118.102053012058472051702053352056762054660.14
218.032059502060352059920.03
单位质量响应值RSD%判断
11351.7111424.960.46数据可信
加速6月-供试品溶液-12461045批-磷酸盐溶液（pH7.8）
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min15845-58452.8732.905.702.872.905.74
26289-62893.0913.09
35598-55982.7512.75
45584-55842.7442.74
56344-63443.1183.12
65752-57522.8272.83
10min18715-87154.2834.254.604.324.294.58
28871-88714.3604.39
38808-88084.3294.36
48426-84264.1414.17
59121-91214.4834.52
67987-79873.9253.96
15min112546-125466.1665.795.076.255.875.07
212346-123466.0686.15
311636-116365.7195.80
411118-111185.4645.54
511884-118845.8415.92
611145-111455.4775.55
20min116312-163128.0177.385.998.167.525.95
215807-158077.7697.92
314564-145647.1587.30
414153-141536.9567.09
515096-150967.4197.57
614137-141376.9487.08
30min124217-2421711.90210.736.5012.1410.956.45
222673-2267311.14311.38
321709-2170910.66910.89
420677-2067710.16210.38
521219-2121910.42810.66
620449-2044910.05010.26
45min135321-3532117.35915.796.2217.7316.146.18
233660-3366016.54316.90
331949-3194915.70216.04
430694-3069415.08515.41
531053-3105315.26115.61
630095-3009514.79115.12
60min147844-4784423.51421.146.6924.0821.666.66
244768-4476822.00222.55
342609-4260920.94121.46
441283-4128320.28920.78
541683-4168320.48621.00
639857-3985719.58820.08
极限152353-5235325.73023.466.3226.5524.226.30
250127-5012724.63625.42
347828-4782823.50624.25
445523-4552322.37323.09
546225-4622522.71823.46
644379-4437921.81122.52
美阿沙坦钾片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号D211-4R701-2402002对照品来源自制工作对照品对照品使用方法直接使用
对照品含量(%)99.5对照品水分(%)0对照品稀释倍数1000
标示量(mg)80供试品稀释倍数5系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
118.102060212054602059572058022059962058470.12
218.032059592060602060100.04
单位质量响应值RSD%判断
11372.7611425.960.34数据可信
长期6月-供试品溶液-12461045批
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min14192-41922.0582.065.012.062.065.11
23900-39001.9151.91
34053-40531.9901.99
44454-44542.1872.19
54129-41292.0272.03
64397-43972.1592.16
10min17264-72643.5673.583.313.593.603.36
27053-70533.4633.48
37065-70653.4693.49
47707-77073.7843.81
57302-73023.5853.61
67390-73903.6283.65
15min111640-116405.7155.862.575.785.932.57
211636-116365.7135.77
311832-118325.8095.87
412436-124366.1066.17
512085-120855.9346.00
612034-120345.9095.97
20min115173-151737.4507.662.077.587.782.06
215496-154967.6087.73
315580-155807.6507.77
416146-161467.9278.06
515701-157017.7097.84
615463-154637.5927.72
30min122916-2291611.25111.411.2811.4611.631.28
223122-2312211.35311.56
323494-2349411.53511.75
423669-2366911.62111.84
523314-2331411.44711.66
622978-2297811.28211.50
45min135753-3575317.55417.582.0617.8917.922.04
235906-3590617.62917.96
336462-3646217.90218.24
436344-3634417.84418.20
535915-3591517.63417.97
634408-3440816.89417.23
60min144015-4401521.61122.061.2222.1422.591.22
245241-4524122.21322.74
345053-4505322.12022.66
445499-4549922.33922.89
545200-4520022.19222.73
644537-4453721.86722.39
极限150667-5066724.87725.181.0225.6525.961.02
251691-5169125.37926.16
350947-5094725.01425.80
452005-5200525.53426.33
551465-5146525.26926.05
650907-5090724.99525.76
美阿沙坦钾片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号D211-4R701-2402002对照品来源自制工作对照品对照品使用方法直接使用
对照品含量(%)99.5对照品水分(%)0对照品稀释倍数1000
标示量(mg)80供试品稀释倍数5系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
118.102062532058172059082062642057172059920.13
218.032052152048602050380.13
单位质量响应值RSD%判断
11380.7711372.050.06数据可信
中间条件6月-供试品溶液-12461045批
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min13995-39951.9652.217.931.972.217.92
24322-43222.1262.13
34834-48342.3782.38
44236-42362.0842.08
54832-48322.3772.38
64736-47362.3302.33
10min17426-74263.6533.745.833.683.765.83
27685-76853.7813.80
38139-81394.0044.03
47620-76203.7493.77
57896-78963.8853.91
66847-68473.3693.39
15min111151-111515.4865.723.315.555.793.30
211369-113695.5935.66
312243-122436.0236.09
411573-115735.6945.76
511871-118715.8405.91
611564-115645.6895.75
20min115033-150337.3967.541.317.527.671.35
215257-152577.5067.63
315583-155837.6667.80
415216-152167.4867.61
515442-154427.5977.73
615468-154687.6107.74
30min122033-2203310.84011.182.2811.0511.402.29
222629-2262911.13311.34
323407-2340711.51611.74
422874-2287411.25311.46
523147-2314711.38811.61
622302-2230210.97211.18
45min135775-3577517.60017.751.3817.9318.091.38
236360-3636017.88818.22
336853-3685318.13118.48
436025-3602517.72318.06
536073-3607317.74718.09
635408-3540817.42017.75
60min144880-4488022.08022.332.3122.6022.862.31
245182-4518222.22822.76
347352-4735223.29623.85
444922-4492222.10022.63
545589-4558922.42922.97
644363-4436321.82522.35
极限150776-5077624.98025.410.9325.7526.190.92
252242-5224225.70226.48
351697-5169725.43326.24
451721-5172125.44526.22
551752-5175225.46126.25
651705-5170525.43726.21
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