普瑞巴林口崩片项目信息
介质体积(ml)900取样体积(ml)0补液体积(ml)0
对照品批号101106-202003对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.4对照品水分(%)0对照品稀释倍数100
标示量(mg)150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%
116.871048151056491056561057321057471055200.38
216.891057081047081052080.68
单位质量响应值RSD%判断
6254.896229.010.30数据可信
供试品溶液-22024121021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%
2min194793-9479390.57287.6810.6390.5787.6810.63
297717-9771793.36693.37
397328-9732892.99492.99
496731-9673192.42492.42
572396-7239669.17369.17
691648-9164887.56787.57
5min1106923-106923102.162101.871.11102.16101.881.11
2105946-105946101.229101.23
3107233-107233102.458102.46
4108552-108552103.719103.72
5105529-105529100.830100.83
6105548-105548100.848100.85
10min1106904-106904102.144102.101.07102.14102.101.07
2106310-106310101.577101.58
3107577-107577102.787102.79
4108723-108723103.882103.88
5105889-105889101.174101.17
6105772-105772101.062101.06
15min1107367-107367102.586102.221.09102.59102.221.10
2105889-105889101.174101.17
3107703-107703102.907102.91
4108769-108769103.926103.93
5106354-106354101.619101.62
6105824-105824101.112101.11
30min1107301-107301102.523102.241.00102.52102.241.00
2106181-106181101.453101.45
3107370-107370102.589102.59
4108803-108803103.959103.96
5106408-106408101.670101.67
6105935-105935101.218101.22
普瑞巴林口崩片项目信息
介质体积(ml)900取样体积(ml)0补液体积(ml)0
对照品批号101106-202003对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.4对照品水分(%)0对照品稀释倍数100
标示量(mg)150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%
116.871053531047001056981055061056641053840.39
216.891048171049171048670.07
单位质量响应值RSD%判断
6246.836208.820.44数据可信
供试品溶液-22024121021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%
2min194915-9491590.89589.245.1690.9089.245.16
296766-9676692.66892.67
393838-9383889.86489.86
498094-9809493.93993.94
584914-8491481.31881.32
690589-9058986.75286.75
5min1106886-106886102.359101.260.70102.36101.260.70
2105463-105463100.996101.00
3106149-106149101.653101.65
4105519-105519101.050101.05
5104697-104697100.263100.26
6105700-105700101.223101.22
10min1107567-107567103.011101.600.79103.01101.600.79
2105661-105661101.186101.19
3106376-106376101.871101.87
4105924-105924101.438101.44
5105093-105093100.642100.64
6105929-105929101.443101.44
15min1107518-107518102.964101.620.92102.96101.620.92
2104695-104695100.261100.26
3106427-106427101.919101.92
4106474-106474101.964101.96
5105376-105376100.913100.91
6106175-106175101.678101.68
30min1107636-107636103.077101.540.96103.08101.540.96
2105907-105907101.421101.42
3106038-106038101.547101.55
4106301-106301101.799101.80
5104488-104488100.063100.06
6105832-105832101.350101.35
普瑞巴林口崩片项目信息
介质体积(ml)900取样体积(ml)0补液体积(ml)0
对照品批号101106-202003对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.4对照品水分(%)0对照品稀释倍数100
标示量(mg)150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%
116.871054481054721052171045531054951052370.38
216.891056541049351052940.49
单位质量响应值RSD%判断
6238.116234.100.05数据可信
供试品溶液-HM1191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%
2min154212-5421251.84657.178.0151.8557.188.01
257649-5764955.13455.13
362011-6201159.30559.31
460100-6010057.47857.48
567861-6786164.90064.90
656860-5686054.37954.38
5min1101218-10121896.80197.981.2096.8097.981.20
2101466-10146697.03997.04
3102452-10245297.98297.98
4103427-10342798.91498.91
5104344-10434499.79199.79
6101799-10179997.35797.36
10min1103900-10390099.366100.441.0799.37100.441.07
2104722-104722100.153100.15
3104598-104598100.034100.03
4106426-106426101.782101.78
5106409-106409101.766101.77
6104090-10409099.54899.55
15min1103130-10313098.630100.581.4698.63100.581.46
2104774-104774100.202100.20
3105085-105085100.500100.50
4106425-106425101.781101.78
5107378-107378102.693102.69
6104207-10420799.66099.66
30min1103100-10310098.601100.601.6398.60100.601.63
2104043-10404399.50399.50
3105130-105130100.543100.54
4106797-106797102.137102.14
5107585-107585102.891102.89
6104473-10447399.91499.91
普瑞巴林口崩片项目信息
介质体积(ml)900取样体积(ml)0补液体积(ml)0
对照品批号101106-202003对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.4对照品水分(%)0对照品稀释倍数100
标示量(mg)150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%
116.871047061047321049881056001047251049500.37
216.891046761049531048140.19
单位质量响应值RSD%判断
6221.106205.680.18数据可信
供试品溶液-HM1191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%
2min169290-6929066.50959.517.6266.5159.517.62
262936-6293660.41060.41
361970-6197059.48359.48
459034-5903456.66556.66
563575-6357561.02361.02
655211-5521152.99553.00
5min1105772-105772101.52798.781.87101.5398.781.87
2101942-10194297.85097.85
3103502-10350299.34899.35
4101516-10151697.44297.44
5104171-10417199.99099.99
6100583-10058396.54696.55
10min1106884-106884102.594101.141.22102.59101.141.22
2104419-104419100.228100.23
3106769-106769102.484102.48
4105406-105406101.175101.18
5105127-105127100.908100.91
6103641-10364199.48199.48
15min1106940-106940102.648101.461.26102.65101.461.26
2104481-104481100.287100.29
3107079-107079102.781102.78
4105475-105475101.242101.24
5106370-106370102.101102.10
6103851-10385199.68399.68
30min1107915-107915103.584101.671.34103.58101.671.34
2105447-105447101.215101.21
3107055-107055102.758102.76
4104741-104741100.537100.54
5106168-106168101.907101.91
6104183-104183100.001100.00
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