美阿沙坦钾片项目信息
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%
118.122635232635642635762633422634632634940.04
218.092632282634722633500.07
单位质量响应值RSD%判断
14541.6114557.770.08数据可信
供试品溶液-24111901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%
5min12219-22190.8540.8916.030.850.8816.22
22215-22150.8520.85
31670-16700.6420.64
42746-27461.0561.06
52477-24770.9530.95
62502-25020.9620.96
10min15347-53472.0572.085.532.062.085.67
25512-55122.1202.13
34914-49141.8901.89
45826-58262.2412.25
55342-53422.0552.06
65498-54982.1152.12
15min110774-107744.1444.264.434.164.284.43
211022-110224.2404.26
310336-103363.9763.99
411628-116284.4734.49
511088-110884.2654.28
611582-115824.4554.47
20min113990-139905.3825.553.905.425.593.88
214458-144585.5625.60
314092-140925.4215.46
415489-154895.9586.00
514522-145225.5865.63
614049-140495.4045.45
30min123096-230968.8848.951.838.959.021.85
223802-238029.1569.23
322687-226878.7278.79
423432-234329.0149.09
523654-236549.0999.17
622990-229908.8448.92
45min134256-3425613.17713.172.1813.3013.292.19
235082-3508213.49513.62
333765-3376512.98813.10
435128-3512813.51313.64
533897-3389713.03913.16
633279-3327912.80212.92
60min145796-4579617.61617.951.9117.8118.141.92
247368-4736818.22118.42
346683-4668317.95818.14
448000-4800018.46418.67
546405-4640517.85118.05
645734-4573417.59317.78
极限149614-4961419.08520.072.7319.3720.362.71
252918-5291820.35620.65
353619-5361920.62620.91
452914-5291420.35520.66
552363-5236320.14320.44
651614-5161419.85520.14
美阿沙坦钾片项目信息
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%
118.122630422626162622502622452619082624120.17
218.092618612620282619440.05
单位质量响应值RSD%判断
14481.9014480.040.01数据可信
供试品溶液-24112001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%
5min12779-27791.0740.9711.711.070.9711.71
22835-28351.0961.10
32381-23810.9200.92
42164-21640.8360.84
52209-22090.8540.85
62665-26651.0301.03
10min15926-59262.2902.155.072.302.155.07
25520-55202.1332.14
35433-54332.1002.10
45286-52862.0432.05
55281-52812.0412.05
65863-58632.2662.27
15min111678-116784.5144.344.164.534.364.13
211919-119194.6074.62
311094-110944.2884.30
410806-108064.1774.19
510796-107964.1734.19
611068-110684.2784.30
20min115263-152635.8995.604.295.945.644.29
214698-146985.6815.72
314977-149775.7895.83
413672-136725.2845.32
513874-138745.3625.40
614458-144585.5885.63
30min123414-234149.0498.921.739.138.991.70
222468-224688.6848.76
323417-234179.0519.12
423360-233609.0299.10
523038-230388.9048.97
622749-227498.7928.87
45min132990-3299012.75113.202.7712.8813.322.73
233919-3391913.11013.23
335832-3583213.84913.97
434438-3443813.31013.43
533938-3393813.11713.24
633823-3382313.07313.19
60min145671-4567117.65218.031.5817.8518.221.56
245973-4597317.76817.96
347274-4727418.27118.47
447499-4749918.35818.55
546999-4699918.16518.36
646460-4646017.95718.15
极限152494-5249420.28920.251.5620.5820.551.54
251590-5159019.93920.23
352427-5242720.26320.56
452520-5252020.29920.59
551576-5157619.93420.23
653800-5380020.79421.09
美阿沙坦钾片项目信息
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%
118.122621102623002620622619122620492620870.06
218.092639102632762635930.18
单位质量响应值RSD%判断
14463.9614571.200.53数据可信
供试品溶液-24111901批-磷酸盐溶液(pH6.8)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1758-7580.2920.3112.610.290.3113.68
2816-8160.3150.31
3763-7630.2940.29
4655-6550.2530.25
5873-8730.3370.34
6948-9480.3650.37
10min11123-11230.4330.465.840.430.465.74
21151-11510.4440.45
31203-12030.4640.47
41183-11830.4560.46
51189-11890.4580.46
61326-13260.5110.51
15min11447-14470.5580.583.870.560.583.70
21447-14470.5580.56
31477-14770.5690.57
41583-15830.6100.61
51462-14620.5640.57
61551-15510.5980.60
20min11764-17640.6800.683.780.690.693.50
21683-16830.6490.66
31707-17070.6580.67
41816-18160.7000.71
51842-18420.7100.72
61831-18310.7060.71
30min12476-24760.9550.952.850.970.962.80
22542-25420.9800.99
32398-23980.9240.94
42532-25320.9760.99
52390-23900.9210.93
62402-24020.9260.94
45min13226-32261.2441.263.721.261.283.68
23271-32711.2611.28
33138-31381.2101.23
43239-32391.2491.27
53501-35011.3501.37
63304-33041.2741.29
60min14211-42111.6231.672.161.651.702.04
24343-43431.6741.70
34457-44571.7181.74
44416-44161.7021.73
54378-43781.6881.71
64260-42601.6421.67
极限14811-48111.8551.881.631.891.921.62
24870-48701.8781.91
34891-48911.8861.92
44937-49371.9031.94
54803-48031.8521.89
65015-50151.9331.97
美阿沙坦钾片项目信息
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%
118.122620892622742619412622042620412621100.06
218.092628812629312629060.02
单位质量响应值RSD%判断
14465.2314533.220.34数据可信
供试品溶液-24112001批-磷酸盐溶液(pH6.8)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min115594-155946.0202.17132.746.022.17132.68
214896-148965.7505.75
3784-7840.3030.30
4884-8840.3410.34
5842-8420.3250.33
6718-7180.2770.28
10min11244-12440.4800.495.100.510.504.01
21181-11810.4560.49
31305-13050.5040.51
41234-12340.4760.48
51242-12420.4790.48
61365-13650.5270.53
15min11646-16460.6350.624.020.670.633.96
21496-14960.5770.61
31635-16350.6310.64
41655-16550.6390.64
51554-15540.6000.60
61637-16370.6320.64
20min11900-19000.7330.703.710.770.723.88
21711-17110.6600.70
31874-18740.7230.73
41818-18180.7020.71
51797-17970.6940.70
61788-17880.6900.70
30min12486-24860.9600.973.241.001.002.96
22487-24870.9601.00
32685-26851.0361.05
42544-25440.9820.99
52478-24780.9570.97
62472-24720.9540.97
45min13215-32151.2411.283.611.291.313.08
23301-33011.2741.32
33376-33761.3031.32
43376-33761.3031.32
53162-31621.2211.24
63491-34911.3481.36
60min14250-42501.6411.682.441.701.721.68
24242-42421.6371.69
34530-45301.7491.77
44390-43901.6951.72
54367-43671.6861.71
64353-43531.6801.70
极限14925-49251.9011.901.171.971.951.41
24918-49181.8981.96
34959-49591.9141.95
45009-50091.9341.97
54839-48391.8681.90
64901-49011.8921.93
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