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%
117.952021012020082021132023632020822021330.07
217.942023072023902023480.03
单位质量响应值RSD%判断
11260.8911279.150.12数据可信
供试品溶液-24100801批-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%
5min15197-51972.5812.543.522.582.543.50
25118-51182.5422.54
35195-51952.5802.58
44817-48172.3922.39
55033-50332.4992.50
65344-53442.6542.65
10min18472-84724.2074.162.164.224.172.10
28224-82244.0844.10
38478-84784.2104.22
48141-81414.0434.06
58617-86174.2794.29
68291-82914.1174.13
15min111144-111445.5345.521.515.575.561.50
211003-110035.4645.50
311429-114295.6765.71
410989-109895.4575.49
511135-111355.5305.57
611006-110065.4665.50
20min117836-178368.8589.091.958.939.161.94
217995-179958.9379.00
318739-187399.3069.38
418377-183779.1269.19
518658-186589.2669.33
618250-182509.0639.13
30min123537-2353711.68911.661.3611.8111.781.37
223008-2300811.42611.54
323816-2381611.82711.95
423223-2322311.53311.65
523793-2379311.81611.94
623479-2347911.66011.78
45min140014-4001419.87220.061.1420.0520.241.14
240578-4057820.15220.33
341029-4102920.37620.56
439784-3978419.75719.94
540660-4066020.19220.38
640236-4023619.98220.16
60min147139-4713923.41023.621.5823.7023.921.57
247069-4706923.37523.67
348349-4834924.01124.31
447914-4791423.79524.09
548345-4834524.00924.31
646555-4655523.12023.41
极限152924-5292426.28325.682.1526.7126.112.13
251777-5177725.71326.14
353103-5310326.37226.81
450385-5038525.02225.44
550897-5089725.27625.71
651160-5116025.40725.83
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%
117.952064632065632063992063362056092062740.19
217.942041042043112042080.08
单位质量响应值RSD%判断
11491.5911382.830.68数据可信
供试品溶液-24101601批-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%
5min14171-41712.0412.072.592.042.072.51
24059-40591.9861.99
34378-43782.1422.14
44290-42902.0992.10
54249-42492.0792.08
64269-42692.0892.09
10min18365-83654.0944.181.994.104.191.99
28458-84584.1394.15
38853-88534.3324.34
48544-85444.1814.19
58595-85954.2064.22
68457-84574.1394.15
15min111287-112875.5235.581.235.565.611.22
211417-114175.5875.62
311491-114915.6235.66
411290-112905.5255.56
511263-112635.5125.55
611613-116135.6835.72
20min117740-177408.6818.590.908.758.660.89
217601-176018.6138.68
317532-175328.5808.65
417580-175808.6038.67
517270-172708.4518.52
617630-176308.6288.69
30min122201-2220110.86411.141.5510.9811.261.54
222898-2289811.20611.32
323224-2322411.36511.48
422741-2274111.12911.24
522568-2256811.04411.16
622953-2295311.23211.35
45min139567-3956719.36319.541.2019.5419.711.19
239821-3982119.48719.66
339813-3981319.48319.66
439814-3981419.48419.66
539662-3966219.40919.58
640876-4087620.00320.18
60min146700-4670022.85322.770.6523.1323.060.62
246591-4659122.80023.08
346954-4695422.97823.26
446545-4654522.77823.06
546315-4631522.66522.95
646096-4609622.55822.85
极限150169-5016924.55124.882.0224.9625.291.98
252221-5222125.55525.97
349682-4968224.31324.73
451750-5175025.32525.73
550069-5006924.50224.91
651160-5116025.03625.45
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%
117.952041252043792044662044572048542044560.13
217.942060722060612060660.01
单位质量响应值RSD%判断
11390.3111486.400.60数据可信
供试品溶液-24101602批-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%
5min13107-31071.5201.6616.251.521.6616.23
22546-25461.2461.25
34166-41662.0382.04
43600-36001.7621.76
53651-36511.7861.79
63280-32801.6051.60
10min16395-63953.1293.468.973.143.479.01
26185-61853.0263.03
37799-77993.8163.83
47336-73363.5903.60
57437-74373.6393.65
67233-72333.5393.55
15min18855-88554.3334.707.774.364.737.83
28522-85224.1704.19
310417-104175.0975.13
49884-98844.8364.87
510106-101064.9454.98
69844-98444.8174.85
20min111157-111575.4595.977.185.516.037.20
211121-111215.4425.49
313282-132826.4996.56
412549-125496.1406.20
512696-126966.2126.27
612420-124206.0776.13
30min124622-2462212.04813.287.1612.1313.377.16
224853-2485312.16112.24
329012-2901214.19614.29
428215-2821513.80613.90
528738-2873814.06214.15
627450-2745013.43213.52
45min132347-3234715.82816.935.1715.9817.095.18
232295-3229515.80215.95
336262-3626217.74417.92
435470-3547017.35617.52
535733-3573317.48517.65
635483-3548317.36217.53
60min139036-3903619.10120.024.7919.3420.284.81
238339-3833918.76018.99
343733-4373321.39921.67
441397-4139720.25620.52
541788-4178820.44820.71
641223-4122320.17120.43
极限144690-4469021.86822.955.1622.2123.325.18
243460-4346021.26621.60
349329-4932924.13724.53
447953-4795323.46423.84
549251-4925124.09924.48
646785-4678522.89323.26
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%
117.952016302018222022552023322023892020860.17
217.942060632063512062070.10
单位质量响应值RSD%判断
11258.2711494.261.47数据可信
供试品溶液-24101603批-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%
5min13059-30591.5051.7711.521.511.7711.46
23826-38261.8831.88
33192-31921.5711.57
43628-36281.7851.79
54184-41842.0592.06
63653-36531.7971.80
10min18488-84884.1764.192.294.184.202.34
28596-85964.2294.24
38215-82154.0424.05
48465-84654.1654.17
58813-88134.3364.35
68491-84914.1784.19
15min110254-102545.0455.635.225.085.675.20
211776-117765.7945.83
311474-114745.6465.68
411657-116575.7365.77
511828-118285.8205.86
611690-116905.7525.79
20min112655-126556.2276.975.386.297.045.35
214554-145547.1617.23
314501-145017.1357.20
414698-146987.2327.30
514439-144397.1047.17
614172-141726.9737.04
30min128254-2825413.90214.523.4014.0014.623.39
230524-3052415.01915.12
329173-2917314.35414.46
430670-3067015.09115.20
529819-2981914.67214.78
628587-2858714.06614.17
45min133849-3384916.65518.234.8116.8318.424.79
238282-3828218.83619.03
337687-3768718.54318.73
438248-3824818.81919.01
538191-3819118.79118.98
636081-3608117.75317.94
60min140364-4036419.86021.654.7120.1221.944.71
245042-4504222.16222.46
343481-4348121.39421.68
445570-4557022.42222.72
546024-4602422.64522.94
643508-4350821.40721.69
极限145573-4557322.42323.983.6522.8024.393.64
249749-4974924.47824.90
348692-4869223.95824.36
450823-5082325.00625.42
548394-4839423.81124.23
649249-4924924.23224.63
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