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)360供试品稀释倍数4系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.031669874166989516689281670130166853816694730.05
210.151673961167399916739800.01
单位质量响应值RSD%判断
166447.96164924.140.66数据可信
供试品溶液-ACSB24005批-pH1.2
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min14614-46140.2780.2217.080.280.2217.92
24244-42440.2560.26
33465-34650.2090.21
43190-31900.1920.19
53465-34650.2090.21
63020-30200.1820.18
15min14581-45810.2760.2819.620.280.2818.52
24240-42400.2560.26
34333-43330.2610.26
43945-39450.2380.24
54100-41000.2470.25
66377-63770.3850.38
30min14084-40840.2460.252.520.250.252.04
24216-42160.2540.26
34325-43250.2610.26
44083-40830.2460.25
54055-40550.2450.25
64121-41210.2480.25
45min14144-41440.2500.247.750.250.247.46
23601-36010.2170.22
34446-44460.2680.27
44000-40000.2410.24
53722-37220.2240.23
63870-38700.2330.23
60min13785-37850.2280.2511.240.230.2510.63
23771-37710.2270.23
34985-49850.3010.30
43958-39580.2390.24
53953-39530.2380.24
64045-40450.2440.25
90min14138-41380.2500.237.040.250.236.36
23536-35360.2130.22
34049-40490.2440.25
43835-38350.2310.23
53589-35890.2160.22
63568-35680.2150.22
120min13360-33600.2030.215.140.210.224.88
23424-34240.2060.21
33780-37800.2280.23
43533-35330.2130.22
53281-32810.1980.20
63594-35940.2170.22
极限13933-39330.2370.219.130.240.219.17
23367-33670.2030.21
33581-35810.2160.22
43504-35040.2110.21
52963-29630.1790.18
63364-33640.2030.21
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)360供试品稀释倍数4系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.031673939167416116807141678542167585716766430.18
210.151679164167884116790020.02
单位质量响应值RSD%判断
167162.81165418.920.75数据可信
供试品溶液-ACSB24005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%
5min17520-75200.4520.5611.580.450.5611.57
210033-100330.6030.60
38495-84950.5100.51
49460-94600.5680.57
59753-97530.5860.59
610382-103820.6240.62
15min111485-114850.6900.723.970.690.724.22
212576-125760.7560.76
311470-114700.6890.69
411622-116220.6980.70
512242-122420.7350.74
612226-122260.7350.74
30min112239-122390.7350.7110.350.740.719.92
210534-105340.6330.64
313345-133450.8020.80
410074-100740.6050.61
512056-120560.7240.73
612180-121800.7320.73
45min112351-123510.7420.725.500.750.725.72
211293-112930.6780.68
312553-125530.7540.76
411632-116320.6990.70
511294-112940.6790.68
612779-127790.7680.77
60min111524-115240.6920.708.770.700.718.67
212924-129240.7760.78
311739-117390.7050.71
49936-99360.5970.60
511518-115180.6920.70
612468-124680.7490.75
90min111409-114090.6850.678.940.690.688.72
210785-107850.6480.65
39890-98900.5940.60
410531-105310.6330.64
512403-124030.7450.75
612299-122990.7390.74
120min111541-115410.6930.7210.490.700.7310.54
211630-116300.6990.71
39933-99330.5970.60
413377-133770.8040.81
512791-127910.7680.78
612920-129200.7760.78
极限112477-124770.7500.724.760.760.734.75
211350-113500.6820.69
312558-125580.7540.76
411381-113810.6840.69
511846-118460.7120.72
612541-125410.7530.76
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)360供试品稀释倍数4系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.031686201168582416854271681750167725816832920.23
210.151671737167146016715980.02
单位质量响应值RSD%判断
167825.72164689.461.34数据可信
供试品溶液-ACSB24005批-pH6.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1814742-81474248.96048.800.9248.9648.800.92
2816334-81633449.05649.06
3814549-81454948.94948.95
4800548-80054848.10748.11
5820653-82065349.31549.32
6805882-80588248.42848.43
15min11022602-102260261.45161.010.6061.5361.100.59
21018397-101839761.19861.28
31014677-101467760.97561.06
41014264-101426460.95061.03
51017187-101718761.12661.21
61004706-100470660.37660.46
30min11120655-112065567.34366.990.4667.5367.170.46
21119993-111999367.30467.49
31113317-111331766.90267.09
41114007-111400766.94467.13
51113476-111347666.91267.10
61106751-110675166.50866.69
45min11162951-116295169.88569.820.3970.1870.120.39
21168634-116863470.22770.52
31162430-116243069.85470.15
41161833-116183369.81870.11
51161005-116100569.76870.06
61154671-115467169.38769.68
60min11196843-119684371.92271.660.4672.3372.070.46
21193663-119366371.73172.14
31197719-119771971.97472.39
41195362-119536271.83372.24
51185242-118524271.22571.64
61186178-118617871.28171.69
90min11228138-122813873.80273.860.4874.3374.390.48
21234324-123432474.17474.71
31237430-123743074.36174.89
41228270-122827073.81074.34
51223103-122310373.50074.03
61223007-122300773.49474.02
120min11267265-126726576.15476.061.5876.8176.711.56
21276948-127694876.73577.39
31297090-129709077.94678.60
41262820-126282075.88676.54
51244527-124452774.78775.44
61245559-124555974.84975.50
极限11294307-129430777.77978.763.2678.5679.543.24
21360790-136079081.77482.56
31367174-136717482.15782.94
41296077-129607777.88578.66
51276302-127630276.69777.47
61268933-126893376.25477.03
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