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%
118.102027472027012025952032232028112028150.12
218.032025952025062025500.04
单位质量响应值RSD%判断
11205.2511234.050.19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%
5min15319-53192.6532.815.472.652.815.54
25522-55222.7552.75
35543-55432.7652.77
45400-54002.6942.69
56035-60353.0113.01
66006-60062.9963.00
10min18499-84994.2404.272.094.274.302.08
28310-83104.1454.18
38607-86074.2944.32
48448-84484.2144.24
58680-86804.3304.36
68811-88114.3954.43
15min111609-116095.7915.993.115.876.073.10
211884-118845.9286.00
311984-119845.9786.06
411775-117755.8745.95
512078-120786.0256.11
612687-126876.3296.41
20min115419-154197.6927.842.347.837.992.34
215692-156927.8287.97
315759-157597.8618.01
415430-154307.6977.84
515629-156297.7967.94
616420-164208.1918.34
30min123211-2321111.57911.681.1111.8111.911.12
223580-2358011.76311.99
323317-2331711.63211.86
423331-2333111.63911.87
523162-2316211.55411.79
623843-2384311.89412.14
45min134321-3432117.12117.271.6317.4817.631.63
233987-3398716.95417.31
334338-3433817.12917.49
434592-3459217.25617.61
534864-3486417.39217.76
635594-3559417.75618.13
60min145522-4552222.70822.780.6023.2523.340.62
245622-4562222.75823.31
345997-4599722.94523.50
445232-4523222.56423.11
545865-4586522.88023.44
645778-4577822.83623.41
极限150773-5077325.32825.610.9826.1326.420.97
250989-5098925.43626.24
351380-5138025.63126.44
451209-5120925.54526.34
552221-5222126.05026.86
651480-5148025.68126.51
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%
118.102028902025992027322025332020422025590.16
218.032033422028332030880.18
单位质量响应值RSD%判断
11191.1011263.890.46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%
5min14596-45962.2912.126.122.292.126.04
23908-39081.9481.95
34478-44782.2322.23
44044-40442.0162.02
54275-42752.1312.13
64176-41762.0822.08
10min16979-69793.4793.622.633.503.642.63
27102-71023.5403.56
37434-74343.7063.73
47271-72713.6253.65
57441-74413.7093.73
67385-73853.6813.70
15min111566-115665.7665.942.095.836.002.07
211715-117155.8405.90
312101-121016.0326.10
412238-122386.1016.16
511885-118855.9255.99
612001-120015.9836.05
20min115060-150607.5077.822.227.647.952.17
215540-155407.7477.87
315808-158087.8808.01
415901-159017.9278.06
516015-160157.9848.11
615834-158347.8938.02
30min123133-2313311.53211.932.3711.7412.152.35
223665-2366511.79712.01
324155-2415512.04112.26
424844-2484412.38512.60
523821-2382111.87512.09
623998-2399811.96312.18
45min136316-3631618.10418.392.8818.4418.742.83
237106-3710618.49718.84
336559-3655918.22518.58
438934-3893419.40919.76
536018-3601817.95518.31
636446-3644618.16818.52
60min144418-4441822.14223.174.1822.6823.734.13
246088-4608822.97523.52
346581-4658123.22123.78
450106-5010624.97825.55
545340-4534022.60223.15
646397-4639723.12923.68
极限151085-5108525.46626.294.0926.2527.104.04
252513-5251326.17826.98
352020-5202025.93226.75
456993-5699328.41129.26
551439-5143925.64226.44
652391-5239126.11726.93
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%
118.102014872009952008602007372007072009570.16
218.032014382011772013080.10
单位质量响应值RSD%判断
11102.6011165.170.40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%
5min13937-39371.9792.094.911.982.094.87
24123-41232.0732.07
33964-39641.9931.99
44163-41632.0932.09
54483-44832.2542.25
64276-42762.1502.15
10min17095-70953.5673.693.083.593.723.05
27421-74213.7303.75
37153-71533.5963.62
47209-72093.6243.65
57612-76123.8263.85
67594-75943.8173.84
15min110582-105825.3195.472.535.385.542.54
210764-107645.4115.48
310776-107765.4175.48
410833-108335.4465.51
510990-109905.5255.59
611378-113785.7205.79
20min114236-142367.1567.393.327.287.523.26
214389-143897.2337.36
314390-143907.2347.36
414957-149577.5197.64
514686-146867.3837.51
615542-155427.8137.94
30min121699-2169910.90811.272.9211.1111.482.90
222099-2209911.10911.31
322529-2252911.32511.53
421971-2197111.04511.25
522760-2276011.44111.65
623510-2351011.81812.03
45min133057-3305716.61817.142.5416.9417.482.55
233907-3390717.04517.37
333926-3392617.05417.38
433549-3354916.86517.20
534698-3469817.44217.78
635484-3548417.83818.19
60min143675-4367521.95522.422.8822.4622.942.87
243898-4389822.06722.58
343950-4395022.09322.61
444802-4480222.52223.04
544142-4414222.19022.72
647091-4709123.67224.22
极限149234-4923424.75025.023.0725.5025.793.04
249533-4953324.90025.66
347542-4754223.89924.66
449768-4976825.01825.79
550380-5038025.32626.10
652207-5220726.24427.05
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