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%
118.152101192100072098602099042097452099270.07
218.172098802096542097670.08
单位质量响应值RSD%判断
11566.2311544.690.14数据可信
供试品溶液-12595119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%
5min13424-34241.6581.613.971.661.613.95
23456-34561.6741.67
33343-33431.6191.62
43144-31441.5231.52
53174-31741.5371.54
63391-33911.6421.64
10min16409-64093.1043.203.933.123.223.94
26775-67753.2813.30
36854-68543.3203.34
46692-66923.2413.26
56180-61802.9933.01
66739-67393.2643.28
15min111340-113405.4935.542.205.555.602.16
211531-115315.5855.64
311911-119115.7695.82
411330-113305.4885.54
511354-113545.4995.55
611201-112015.4255.48
20min115910-159107.7067.722.577.827.842.54
215560-155607.5367.65
315494-154947.5057.62
416610-166108.0458.16
515951-159517.7267.84
616147-161477.8217.94
30min125771-2577112.48212.611.3012.6812.811.29
226354-2635412.76512.97
326464-2646412.81813.02
426103-2610312.64312.85
525621-2562112.41012.61
625854-2585412.52212.72
45min135163-3516317.03117.312.6817.3717.652.62
236355-3635517.60917.95
336911-3691117.87818.22
434282-3428216.60416.95
536272-3627217.56817.90
635466-3546617.17817.52
60min147311-4731122.91523.502.7223.4424.042.68
248645-4864523.56124.10
349648-4964824.04724.59
449607-4960724.02724.56
549418-4941823.93624.47
646536-4653622.54023.07
极限154579-5457926.43526.631.1427.2227.421.13
255646-5564626.95227.75
355855-5585527.05327.86
454799-5479926.54227.34
554295-5429526.29827.09
654722-5472226.50527.29
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%
118.152096782096612098562096582095582096820.06
218.172097182099852098520.09
单位质量响应值RSD%判断
11552.7311549.370.03数据可信
供试品溶液-12595119批
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min11932-19320.9360.918.670.940.918.76
21755-17550.8500.85
32126-21261.0301.03
41885-18850.9130.91
51948-19480.9440.94
61657-16570.8030.80
10min12488-24881.2061.143.701.221.153.72
22367-23671.1471.16
32348-23481.1381.15
42329-23291.1281.14
52312-23121.1201.13
62223-22231.0771.09
15min12824-28241.3681.313.781.391.333.79
22560-25601.2401.26
32786-27861.3501.37
42681-26811.2991.32
52752-27521.3331.36
62619-26191.2691.29
20min13179-31791.5401.536.441.581.576.38
23008-30081.4571.49
33238-32381.5691.61
43015-30151.4611.50
53506-35061.6991.74
62972-29721.4401.48
30min13700-37001.7931.775.841.851.825.72
23401-34011.6481.70
33915-39151.8971.95
43628-36281.7581.81
53855-38551.8681.92
63425-34251.6601.71
45min14838-48382.3442.253.602.422.333.61
24468-44682.1652.24
34853-48532.3512.43
44481-44812.1712.24
54664-46642.2602.34
64605-46052.2312.30
60min15534-55342.6812.641.522.782.731.62
25366-53662.6002.69
35552-55522.6902.79
45402-54022.6172.71
55421-54212.6272.73
65366-53662.6002.69
极限16196-61963.0022.912.333.133.042.30
25914-59142.8662.99
36165-61652.9873.12
46006-60062.9103.04
55946-59462.8813.01
65849-58492.8342.96
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%
118.152107842105322104372106942100032104900.15
218.172108182107652107920.02
单位质量响应值RSD%判断
11597.2511601.100.03数据可信
供试品溶液-12595119批
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1927-9270.4470.407.000.450.407.00
2840-8400.4050.41
3779-7790.3760.38
4778-7780.3750.38
5806-8060.3890.39
6788-7880.3800.38
10min1864-8640.4170.469.490.420.479.16
2970-9700.4680.47
3852-8520.4110.42
41073-10730.5180.52
5951-9510.4590.46
61047-10470.5050.51
15min11100-11000.5310.533.230.540.543.67
21092-10920.5270.54
31102-11020.5320.54
41101-11010.5310.54
51026-10260.4950.50
61132-11320.5460.56
20min11053-10530.5080.554.460.520.564.43
21102-11020.5320.55
31176-11760.5670.58
41118-11180.5390.56
51153-11530.5560.57
61187-11870.5730.59
30min11144-11440.5520.574.980.570.595.26
21239-12390.5980.62
31083-10830.5230.54
41171-11710.5650.59
51201-12010.5800.60
61231-12310.5940.62
45min11165-11650.5620.565.680.590.595.25
21211-12110.5840.61
31234-12340.5950.62
41093-10930.5270.56
51069-10690.5160.54
61191-11910.5750.60
60min11266-12660.6110.615.310.640.645.26
21279-12790.6170.65
31241-12410.5990.63
41344-13440.6490.68
51163-11630.5610.59
61338-13380.6460.68
极限11254-12540.6050.6313.010.650.6712.24
21641-16410.7920.83
31168-11680.5640.60
41282-12820.6190.66
51208-12080.5830.62
61288-12880.6210.66
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%
118.152106362105562102992100392102322103520.12
218.172092372093662093020.05
单位质量响应值RSD%判断
11589.6411519.100.44数据可信
供试品溶液-12595119批
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min11230-12300.5960.622.890.600.622.37
21275-12750.6180.62
31308-13080.6340.63
41296-12960.6280.63
51329-13290.6440.64
61252-12520.6060.61
10min11546-15460.7490.793.960.760.803.70
21659-16590.8040.81
31620-16200.7850.79
41663-16630.8060.81
51573-15730.7620.77
61722-17220.8340.84
15min11759-17590.8520.948.320.870.968.21
21945-19450.9420.96
31982-19820.9600.98
42232-22321.0811.10
51918-19180.9290.94
61836-18360.8890.91
20min11760-17600.8530.987.020.881.016.92
22075-20751.0051.03
32188-21881.0601.09
42048-20480.9921.02
52064-20641.0001.03
62015-20150.9761.00
30min12087-20871.0111.104.561.041.134.76
22308-23081.1181.16
32241-22411.0861.12
42352-23521.1391.18
52365-23651.1461.18
62226-22261.0781.11
45min12550-25501.2351.294.611.281.344.56
22632-26321.2751.32
32499-24991.2111.26
42824-28241.3681.42
52722-27221.3191.37
62735-27351.3251.37
60min13011-30111.4591.433.651.521.503.60
22980-29801.4441.51
32983-29831.4451.51
43097-30971.5001.57
52781-27811.3471.41
62899-28991.4041.47
极限13121-31211.5121.585.271.591.664.98
23246-32461.5721.65
33097-30971.5001.58
43232-32321.5661.65
53289-32891.5931.67
63576-35761.7321.81
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