地拉罗司颗粒项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号2.0对照品来源EP对照品使用方法直接使用
对照品含量(%)99.9对照品水分(%)0对照品稀释倍数100
标示量(mg)90供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.251706372170498817060921705434170320617052180.08
210.311706660170598317063220.03
单位质量响应值RSD%判断
166362.73165501.650.37数据可信
供试品溶液-2批-pH4.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1-0.0000.00-0.000.00-
2-0.0000.00
3-0.0000.00
4-0.0000.00
5-0.0000.00
6-0.0000.00
15min16234-62340.3750.4513.540.380.4513.11
28322-83220.5010.50
37001-70010.4220.42
47870-78700.4740.47
56431-64310.3870.39
68622-86220.5190.52
30min19874-98740.5940.586.620.600.586.39
210101-101010.6080.61
39806-98060.5900.59
49305-93050.5600.56
510343-103430.6230.62
68566-85660.5160.52
45min110519-105190.6330.5814.020.630.5813.78
210067-100670.6060.61
39343-93430.5630.56
47095-70950.4270.43
510812-108120.6510.65
610182-101820.6130.61
60min111010-110100.6630.6316.100.670.6315.71
210993-109930.6620.66
37544-75440.4540.46
49389-93890.5650.57
512287-122870.7400.74
611085-110850.6670.67
90min111679-116790.7030.714.670.710.724.31
211859-118590.7140.72
311743-117430.7070.71
412936-129360.7790.78
511714-117140.7050.71
611315-113150.6810.69
120min110100-101000.6080.6613.450.610.6613.35
211382-113820.6850.69
312692-126920.7640.77
410002-100020.6020.61
58905-89050.5360.54
612263-122630.7380.74
极限110966-109660.6600.6612.050.670.6711.88
28900-89000.5360.54
312895-128950.7760.78
411397-113970.6860.69
510310-103100.6210.63
611395-113950.6860.69
地拉罗司颗粒项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号2.0对照品来源EP对照品使用方法直接使用
对照品含量(%)99.9对照品水分(%)0对照品稀释倍数100
标示量(mg)90供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.251706657170633617073601703909170684217062210.08
210.311703550170431517039320.04
单位质量响应值RSD%判断
166460.59165269.840.51数据可信
供试品溶液-2批-pH4.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1-0.0000.00-0.000.00-
2-0.0000.00
3-0.0000.00
4-0.0000.00
5-0.0000.00
6-0.0000.00
15min17990-79900.4810.4418.290.480.4417.91
24759-47590.2870.29
37120-71200.4290.43
48331-83310.5020.50
57892-78920.4750.48
68205-82050.4940.49
30min17816-78160.4710.5911.720.470.5911.95
29616-96160.5790.58
310000-100000.6020.60
410579-105790.6370.64
59737-97370.5860.59
611229-112290.6760.68
45min18360-83600.5040.5913.070.510.5912.73
210329-103290.6220.62
311457-114570.6900.69
410716-107160.6450.65
58410-84100.5070.51
69230-92300.5560.56
60min111732-117320.7070.6012.350.710.6012.57
29490-94900.5720.57
310367-103670.6240.63
410866-108660.6540.66
58600-86000.5180.52
68786-87860.5290.53
90min112229-122290.7370.6612.260.740.6712.14
210640-106400.6410.64
38555-85550.5150.52
411633-116330.7010.70
511124-111240.6700.67
612044-120440.7250.73
120min112617-126170.7600.6614.040.760.6613.84
29039-90390.5440.55
311385-113850.6860.69
411623-116230.7000.71
512100-121000.7290.73
69091-90910.5480.55
极限112017-120170.7240.6710.170.730.689.76
212600-126000.7590.76
39625-96250.5800.59
410863-108630.6540.66
510205-102050.6150.62
611706-117060.7050.71
地拉罗司颗粒项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号2.0对照品来源EP对照品使用方法直接使用
对照品含量(%)99.9对照品水分(%)0对照品稀释倍数100
标示量(mg)90供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.251727611172505017259361716335172223217234330.26
210.311712455171552017139880.13
单位质量响应值RSD%判断
168139.80166245.200.81数据可信
供试品溶液-2批-pH4.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min17792-77920.4660.4514.080.470.4613.82
27156-71560.4280.43
38352-83520.4990.50
48556-85560.5110.51
55648-56480.3370.34
68001-80010.4780.48
15min110202-102020.6100.5421.550.610.5421.61
210170-101700.6080.61
311650-116500.6960.70
48236-82360.4920.49
56452-64520.3860.39
67541-75410.4510.45
30min110308-103080.6160.609.650.620.609.72
211106-111060.6640.67
310288-102880.6150.62
410370-103700.6200.62
58340-83400.4980.50
69455-94550.5650.57
45min111525-115250.6890.5519.880.690.5519.71
29548-95480.5710.57
310256-102560.6130.62
49523-95230.5690.57
58068-80680.4820.48
66256-62560.3740.38
60min112587-125870.7520.678.250.760.688.27
211523-115230.6890.69
311120-111200.6640.67
410766-107660.6430.65
59783-97830.5850.59
611436-114360.6830.69
90min111843-118430.7080.6417.200.710.6517.19
211128-111280.6650.67
312442-124420.7430.75
412321-123210.7360.74
58220-82200.4910.49
68721-87210.5210.53
120min110862-108620.6490.6119.260.660.6219.29
212318-123180.7360.74
37783-77830.4650.47
412566-125660.7510.76
58790-87900.5250.53
69153-91530.5470.55
极限110299-102990.6150.649.130.620.658.87
211834-118340.7070.71
311746-117460.7020.71
411040-110400.6600.67
59216-92160.5510.56
610539-105390.6300.64
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