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%
118.102058502049222061282058562060652057640.24
218.032053672041052047360.44
单位质量响应值RSD%判断
11368.1811355.300.09数据可信
加速6月-供试品溶液-12521472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%
5min15778-57782.8462.983.152.852.983.08
26079-60792.9952.99
36050-60502.9802.98
46282-62823.0953.09
55884-58842.8992.90
66205-62053.0573.06
10min19205-92054.5344.492.864.574.532.79
28715-87154.2934.33
38983-89834.4254.46
49153-91534.5094.54
59169-91694.5174.55
69502-95024.6814.71
15min111803-118035.8145.911.645.905.991.63
211729-117295.7785.86
312135-121355.9786.06
411944-119445.8845.97
512126-121265.9736.06
612211-122116.0156.10
20min114839-148397.3107.441.287.467.591.25
214919-149197.3497.49
315338-153387.5567.70
415113-151137.4457.59
515256-152567.5157.66
615168-151687.4727.62
30min121911-2191110.79411.101.4011.0211.331.40
222733-2273311.19811.43
322522-2252211.09511.33
422752-2275211.20811.44
522634-2263411.15011.38
622642-2264211.15411.39
45min134113-3411316.80416.951.2517.1517.301.23
234004-3400416.75117.10
334930-3493017.20717.56
434262-3426216.87817.23
534973-3497317.22817.58
634173-3417316.83417.19
60min145733-4573322.52822.610.9423.0623.150.94
245480-4548022.40422.94
346364-4636422.83923.39
446450-4645022.88223.43
545867-4586722.59423.14
645451-4545122.39022.94
极限151516-5151625.37725.520.8226.1626.310.81
251258-5125825.25026.04
352313-5231325.77026.57
452088-5208825.65926.46
552102-5210225.66626.46
651533-5153325.38626.18
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%
118.102066102051682053892056832054742056650.28
218.032041952038342040140.13
单位质量响应值RSD%判断
11362.7111315.250.30数据可信
长期6月-供试品溶液-12521472批
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min15077-50772.5062.475.032.512.475.07
25099-50992.5172.52
34702-47022.3212.32
44821-48212.3802.38
55407-54072.6692.67
64887-48872.4122.41
10min19532-95324.7054.672.284.734.702.30
29399-93994.6394.67
39293-92934.5874.61
49283-92834.5824.61
59864-98644.8694.90
69430-94304.6554.68
15min113805-138056.8146.721.716.896.801.73
213565-135656.6966.78
313477-134776.6526.73
413283-132836.5566.63
513928-139286.8756.96
613687-136876.7566.83
20min117486-174868.6318.652.218.798.802.18
217742-177428.7578.91
317544-175448.6608.81
416870-168708.3278.48
518036-180368.9039.06
617446-174468.6118.76
30min125934-2593412.80112.651.2613.0512.901.26
225810-2581012.74012.99
325121-2512112.40012.65
425415-2541512.54512.79
525910-2591012.78913.05
625534-2553412.60412.85
45min136967-3696718.24718.231.1118.6418.621.13
237047-3704718.28618.68
336874-3687418.20118.59
436470-3647018.00218.38
537634-3763418.57618.98
636602-3660218.06718.46
60min146446-4644622.92623.240.8223.5223.830.81
246875-4687523.13723.73
347090-4709023.24423.83
447124-4712423.26023.84
547415-4741523.40424.01
647504-4750423.44824.04
极限151988-5198825.66126.030.9126.5126.880.87
252503-5250325.91526.77
352867-5286726.09526.94
453026-5302626.17427.01
552607-5260725.96726.83
653369-5336926.34327.19
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%
118.102048602052612050182053852054982052040.13
218.032043982044202044090.01
单位质量响应值RSD%判断
11337.2411337.160.01数据可信
中间条件6月-供试品溶液-12521472批
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min14887-48872.4132.495.172.412.495.16
25306-53062.6192.62
35026-50262.4812.48
44987-49872.4622.46
54674-46742.3072.31
65368-53682.6502.65
10min17883-78833.8924.073.813.924.103.82
28517-85174.2054.23
38281-82814.0884.12
48298-82984.0974.12
57873-78733.8873.91
68627-86274.2594.29
15min112028-120285.9385.993.216.016.063.23
212580-125806.2106.29
312196-121966.0216.09
412213-122136.0296.10
511427-114275.6415.71
612321-123216.0836.16
20min116961-169618.3738.472.248.518.612.25
217754-177548.7658.91
317199-171998.4918.63
417124-171248.4548.59
516601-166018.1958.33
617324-173248.5528.70
30min123996-2399611.84612.111.8812.0812.341.90
224908-2490812.29612.54
324816-2481612.25112.49
424737-2473712.21212.45
523872-2387211.78512.01
624807-2480712.24712.49
45min135500-3550017.52517.511.3817.8917.881.37
235712-3571217.63018.01
336199-3619917.87018.24
434760-3476017.16017.53
535162-3516217.35917.71
635454-3545417.50317.88
60min146091-4609122.75422.901.2523.3123.461.24
247029-4702923.21723.79
346963-4696323.18423.75
445600-4560022.51223.07
546610-4661023.01023.56
645971-4597122.69523.26
极限152482-5248225.90926.111.5426.7226.931.52
253768-5376826.54427.38
353531-5353126.42727.25
451503-5150325.42626.24
553052-5305226.19026.99
653034-5303426.18127.00
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