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1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.121724886172382517234641724464172554017244360.05
210.241723444172462717240360.05
单位质量响应值RSD%判断
170398.81168362.890.85数据可信
供试品溶液-ACSB24025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%
5min1868356-86835612.80412.720.9112.8012.720.90
2874323-87432312.89212.89
3860973-86097312.69512.70
4853069-85306912.57912.58
5856005-85600512.62212.62
6863554-86355412.73312.73
15min11047888-104788815.45215.470.8115.4715.490.81
21063239-106323915.67815.70
31046759-104675915.43515.46
41037154-103715415.29315.31
51049432-104943215.47415.50
61051374-105137415.50315.52
30min11138290-113829016.78516.790.7616.8316.830.77
21151691-115169116.98217.03
31138122-113812216.78216.83
41128326-112832616.63816.68
51130225-113022516.66616.71
61143336-114333616.85916.91
45min11180383-118038317.40517.491.1717.4817.571.17
21212666-121266617.88117.96
31180454-118045417.40617.48
41172684-117268417.29217.37
51186495-118649517.49517.57
61185915-118591517.48717.56
60min11217728-121772817.95618.072.3818.0618.172.37
21282817-128281718.91619.02
31206419-120641917.78917.89
41203866-120386617.75117.85
51218236-121823617.96318.07
61222775-122277518.03018.13
90min11299857-129985719.16718.842.4119.3018.982.40
21326629-132662919.56219.70
31245636-124563618.36718.50
41252459-125245918.46818.60
51278705-127870518.85518.99
61264508-126450818.64618.78
120min11337591-133759119.72319.522.2019.8919.692.19
21377291-137729120.30920.48
31315099-131509919.39219.56
41307963-130796319.28619.45
51301504-130150419.19119.36
61305421-130542119.24919.41
极限11457595-145759521.49320.694.2321.6920.884.18
21460054-146005421.52921.73
31378887-137888720.33220.53
41330012-133001219.61219.81
51447035-144703521.33721.53
61344291-134429119.82220.02
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1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.121727377172569617263231728087172735017269670.06
210.241763250176504817641490.08
单位质量响应值RSD%判断
170648.91172280.180.68数据可信
供试品溶液-ACSB24025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%
5min1886430-88643012.91212.661.3712.9112.661.37
2879738-87973812.81412.81
3857622-85762212.49212.49
4857033-85703312.48412.48
5865190-86519012.60212.60
6868009-86800912.64312.64
15min11066876-106687615.54015.311.4015.5615.341.39
21068257-106825715.56015.58
31045904-104590415.23515.26
41041331-104133115.16815.19
51031262-103126215.02115.04
61054289-105428915.35715.38
30min11150399-115039916.75716.620.7016.8016.660.69
21150442-115044216.75716.80
31139489-113948916.59816.64
41133022-113302216.50416.55
51132632-113263216.49816.54
61140731-114073116.61616.66
45min11193841-119384117.39017.260.6117.4617.330.61
21193627-119362717.38617.46
31182455-118245517.22417.30
41179666-117966617.18317.26
51178125-117812517.16117.23
61179969-117996917.18717.26
60min11219552-121955217.76417.630.7417.8717.730.74
21222554-122255417.80817.91
31208209-120820917.59917.70
41202326-120232617.51317.62
51201947-120194717.50817.61
61205550-120555017.56017.66
90min11253013-125301318.25118.171.2918.3918.311.28
21278183-127818318.61818.75
31239552-123955218.05518.19
41236405-123640518.01018.14
51240087-124008718.06318.19
61238939-123893918.04618.18
120min11244393-124439318.12618.461.6918.2918.621.67
21307553-130755319.04619.21
31266210-126621018.44418.61
41264635-126463518.42118.58
51262255-126225518.38618.55
61257557-125755718.31818.48
极限11333162-133316219.41919.121.8919.6119.321.87
21350683-135068319.67419.87
31310262-131026219.08519.28
41290414-129041418.79618.99
51287946-128794618.76018.95
61304027-130402718.99419.19
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1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.121738707173459717354491735772173496817358990.10
210.241765300176542717653640.01
单位质量响应值RSD%判断
171531.52172398.830.36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%
5min1834298-83429812.11712.002.1912.1212.002.19
2845655-84565512.28212.28
3800622-80062211.62811.63
4838601-83860112.17912.18
5832686-83268612.09312.09
6807762-80776211.73111.73
15min11023525-102352514.86514.751.5914.8914.781.58
21034908-103490815.03015.05
3998142-99814214.49614.52
41022215-102221514.84614.87
51022423-102242314.84914.87
6994023-99402314.43714.46
30min11114739-111473916.19016.111.1016.2316.151.10
21125555-112555516.34716.39
31095507-109550715.91015.95
41108613-110861316.10116.15
51115413-111541316.20016.24
61094437-109443715.89515.94
45min11161137-116113716.86416.751.4816.9416.821.48
21170669-117066917.00217.07
31142632-114263216.59516.66
41160768-116076816.85816.93
51162299-116229916.88116.95
61124230-112423016.32816.40
60min11186460-118646017.23117.200.9617.3317.300.96
21199310-119931017.41817.52
31174607-117460717.05917.16
41190129-119012917.28517.38
51187862-118786217.25217.35
61167891-116789116.96217.06
90min11224132-122413217.77917.751.1017.9117.881.11
21237793-123779317.97718.11
31212669-121266917.61217.74
41235013-123501317.93718.07
51220890-122089017.73117.86
61202239-120223917.46117.59
120min11237366-123736617.97118.251.9318.1318.411.93
21296926-129692618.83619.00
31251192-125119218.17218.33
41265118-126511818.37418.53
51259977-125997718.29918.46
61228090-122809017.83617.99
极限11298941-129894118.86518.882.8019.0519.072.78
21352819-135281919.64819.84
31292381-129238118.77018.96
41304941-130494118.95219.14
51312477-131247719.06219.25
61240293-124029318.01318.20
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