贝派度酸片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号BEMA-231010D对照品来源自制对照品使用方法直接使用
对照品含量(%)99.72对照品水分(%)0对照品稀释倍数50
标示量(mg)180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%
19.662880472881712883842883552881812882280.05
210.693186773187523187140.02
单位质量响应值RSD%判断
29837.2729814.220.06数据可信
供试品溶液-24062701批-pH6.6
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min1116308-11630838.88736.757.5038.8936.757.50
2112295-11229537.54537.54
3115193-11519338.51438.51
4115469-11546938.60638.61
595529-9552931.93931.94
6104693-10469335.00335.00
10min1232611-23261177.77278.051.7478.2078.461.76
2232150-23215077.61878.03
3235061-23506178.59179.02
4239646-23964680.12480.55
5227255-22725575.98176.34
6233915-23391578.20878.60
15min1266787-26678789.19890.601.0490.4991.871.04
2269334-26933490.05091.33
3271442-27144290.75492.06
4274105-27410591.64592.96
5270193-27019390.33791.54
6273945-27394591.59192.85
20min1280468-28046893.77295.401.0896.0697.681.05
2283617-28361794.82597.11
3284979-28497995.28097.59
4286149-28614995.67298.01
5287753-28775396.20898.41
6289082-28908296.65298.93
30min1288596-28859696.49098.201.2099.82101.541.15
2292310-29231097.732101.07
3293157-29315798.015101.38
4292773-29277397.886101.29
5298078-29807899.660102.93
6297356-29735699.419102.77
45min1290695-29069597.19299.031.27101.59103.471.22
2294314-29431498.402102.82
3296336-29633699.078103.53
4295152-29515298.682103.17
5301090-301090100.667105.05
6299640-299640100.182104.64
60min1290977-29097797.28699.181.28102.77104.711.22
2294675-29467598.522104.04
3296796-29679699.231104.79
4295945-29594598.947104.53
5301699-301699100.871106.37
6299744-299744100.217105.78
极限1297352-29735299.417100.400.90105.98107.030.86
2299217-299217100.041106.65
3298988-29898899.964106.62
4298933-29893399.946106.63
5304132-304132101.684108.30
6303090-303090101.336108.02
贝派度酸片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号BEMA-231010D对照品来源自制对照品使用方法直接使用
对照品含量(%)99.72对照品水分(%)0对照品稀释倍数50
标示量(mg)180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%
19.662883342884062883882882252882972883300.03
210.693175043176843175940.05
单位质量响应值RSD%判断
29847.8329709.450.33数据可信
供试品溶液-24062702批-pH6.6
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min180337-8033726.90323.6114.9026.9023.6014.89
278816-7881626.39326.39
370090-7009023.47123.47
464081-6408121.45921.46
576637-7663725.66425.66
652993-5299317.74617.75
10min1219334-21933473.44973.012.1873.7573.272.22
2220505-22050573.84174.13
3220383-22038373.80074.06
4216614-21661472.53872.78
5222142-22214274.38974.67
6209087-20908770.01870.21
15min1265550-26555088.92588.900.6490.0489.970.67
2265212-26521288.81289.93
3265987-26598789.07290.15
4267303-26730389.51290.56
5266396-26639689.20990.32
6262378-26237887.86388.84
20min1284558-28455895.29195.150.5697.3997.220.55
2282200-28220094.50196.60
3283201-28320194.83696.91
4286863-28686396.06398.10
5284473-28447395.26297.37
6283597-28359794.96996.92
30min1296194-29619499.18799.070.95102.35102.190.89
2292674-29267498.009101.16
3292508-29250897.953101.08
4299410-299410100.264103.37
5296419-29641999.263102.42
6297933-29793399.770102.78
45min1299230-299230100.204100.111.09104.47104.331.03
2296471-29647199.280103.52
3294243-29424398.534102.75
4302920-302920101.440105.66
5299056-299056100.146104.41
6301816-301816101.070105.19
60min1298507-29850799.962100.071.09105.34105.401.03
2296670-29667099.347104.69
3294166-29416698.508103.82
4303284-303284101.562106.91
5299159-299159100.180105.56
6301203-301203100.865106.10
极限1298728-298728100.036100.340.87106.52106.780.82
2296844-29684499.405105.85
3298737-298737100.039106.44
4304057-304057101.820108.30
5298182-29818299.853106.34
6301255-301255100.882107.24
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