苯磺酸美洛加巴林片项目信息
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D405-1-240701对照品来源原料对照品使用方法直接使用
对照品含量(%)99.66对照品水分(%)0.00对照品稀释倍数2000
标示量(mg)2.5供试品稀释倍数1系数0.5695
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
119.231010891013501015801011701014461013270.20
219.221013571017341015460.27
单位质量响应值RSD%判断
5269.215283.350.19数据可信
供试品溶液-YAB2147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%
5min182544-82544159.825156.173.86159.83156.173.86
278658-78658152.301152.30
375325-75325145.847145.85
481268-81268157.355157.35
583430-83430161.541161.54
682724-82724160.174160.17
10min1103795-103795200.972206.092.08201.24206.352.08
2108161-108161209.426209.68
3105300-105300203.886204.13
4107151-107151207.470207.73
5109537-109537212.090212.36
6104677-104677202.680202.95
15min1103969-103969201.309206.031.98201.91206.641.98
2108587-108587210.251210.85
3105602-105602204.471205.05
4106786-106786206.764207.37
5109023-109023211.095211.72
6104483-104483202.304202.91
20min1103376-103376200.161205.492.00201.10206.442.00
2108080-108080209.269210.22
3105512-105512204.297205.22
4106572-106572206.349207.30
5108846-108846210.752211.73
6104386-104386202.117203.06
30min1103680-103680200.750205.132.03202.02206.422.02
2108438-108438209.962211.26
3104811-104811202.940204.20
4106119-106119205.472206.77
5108546-108546210.171211.50
6104075-104075201.514202.79
45min1103173-103173199.768204.842.01201.37206.482.00
2107955-107955209.027210.68
3105408-105408204.095205.70
4105900-105900205.048206.69
5108454-108454209.993211.67
6103878-103878201.133202.75
极限1102954-102954199.344205.812.01201.28207.782.00
2107403-107403207.958209.96
3104807-104807202.932204.87
4106010-106010205.261207.24
5108331-108331209.755211.78
6108243-108243209.585211.53
苯磺酸美洛加巴林片项目信息
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D405-1-240701对照品来源原料对照品使用方法直接使用
对照品含量(%)99.66对照品水分(%)0.00对照品稀释倍数2000
标示量(mg)2.5供试品稀释倍数1系数0.5695
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
119.231011551009911012761009701015851011950.25
219.221006271006721006500.04
单位质量响应值RSD%判断
5262.355236.730.35数据可信
供试品溶液-YAB2147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%
5min172819-72819141.714153.599.84141.71153.599.84
292711-92711180.426180.43
374197-74197144.396144.40
473291-73291142.633142.63
583100-83100161.722161.72
677403-77403150.635150.64
10min1105453-105453205.224204.330.96205.46204.580.95
2103540-103540201.501201.80
3106090-106090206.463206.70
4105878-105878206.051206.29
5104164-104164202.715202.98
6104836-104836204.023204.27
15min1105678-105678205.661204.350.96206.24204.940.95
2103491-103491201.405202.04
3106115-106115206.512207.10
4105604-105604205.517206.10
5104152-104152202.692203.30
6104972-104972204.288204.88
20min1105630-105630205.568204.101.09206.49205.041.08
2103128-103128200.699201.67
3106211-106211206.699207.63
4105571-105571205.453206.38
5104238-104238202.859203.80
6104474-104474203.318204.25
30min1105929-105929206.150203.841.03207.41205.121.02
2103021-103021200.491201.80
3105636-105636205.580206.85
4105158-105158204.649205.92
5104115-104115202.620203.90
6104590-104590203.544204.81
45min1108981-108981212.089204.422.03213.70206.042.01
2102816-102816200.092201.73
3105407-105407205.134206.75
4104907-104907204.161205.77
5103794-103794201.995203.62
6104331-104331203.040204.65
极限1105936-105936206.164203.251.25208.12205.201.24
2102485-102485199.448201.42
3105572-105572205.455207.41
4104829-104829204.009205.96
5103450-103450201.326203.28
6104359-104359203.095205.04
苯磺酸美洛加巴林片项目信息
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D405-1-240701对照品来源原料对照品使用方法直接使用
对照品含量(%)99.66对照品水分(%)0.00对照品稀释倍数2000
标示量(mg)2.5供试品稀释倍数1系数0.5695
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
119.231014371011431013311012491012831012890.11
219.221008451008741008600.03
单位质量响应值RSD%判断
5267.245247.660.27数据可信
供试品溶液-YAB2147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%
5min178058-78058151.681155.854.15151.68155.854.15
282971-82971161.228161.23
379170-79170153.842153.84
482952-82952161.191161.19
583016-83016161.315161.32
675058-75058145.851145.85
10min1104071-104071202.229204.231.51202.48204.491.51
2102598-102598199.367199.64
3104997-104997204.028204.28
4105888-105888205.760206.03
5107047-107047208.012208.28
6105997-105997205.972206.21
15min1104822-104822203.688204.801.53204.28205.401.53
2102552-102552199.277199.88
3105413-105413204.837205.43
4106084-106084206.141206.75
5107163-107163208.237208.85
6106338-106338206.634207.22
20min1104604-104604203.265204.651.43204.19205.591.43
2102795-102795199.749200.68
3105303-105303204.623205.56
4105847-105847205.680206.64
5107128-107128208.169209.13
6106223-106223206.411207.34
30min1104109-104109202.303204.281.51203.57205.561.50
2102667-102667199.501200.77
3105117-105117204.262205.54
4105713-105713205.420206.72
5107220-107220208.348209.66
6105919-105919205.820207.09
45min1104055-104055202.198204.251.64203.80205.881.63
2102365-102365198.914200.51
3105320-105320204.656206.28
4105632-105632205.262206.90
5107362-107362208.624210.28
6105941-105941205.863207.48
极限1104468-104468203.000203.831.30204.94205.791.30
2102576-102576199.324201.25
3104850-104850203.743205.70
4105267-105267204.553206.54
5106665-106665207.270209.27
6105542-105542205.087207.05
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