普瑞巴林口崩片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)0
对照品批号D5385-22-019M1对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.8对照品水分(%)0对照品稀释倍数200
标示量(mg)75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%
116.635445154549544845447254510544930.07
216.755423354219542260.02
单位质量响应值RSD%判断
3276.793237.370.86数据可信
供试品溶液-24052301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%
2min152020-5202095.64089.074.6295.6489.064.62
246071-4607184.70384.70
349259-4925990.56490.56
446740-4674085.93385.93
549502-4950291.01191.01
647072-4707286.54386.54
5min156172-56172103.274103.422.02103.43103.572.02
257451-57451105.625105.77
355231-55231101.543101.69
455273-55273101.621101.76
557831-57831106.324106.48
655545-55545102.121102.27
10min156287-56287103.485103.732.05103.82104.052.05
257726-57726106.131106.45
355347-55347101.757102.08
455513-55513102.062102.37
557966-57966106.572106.90
655671-55671102.352102.67
15min156297-56297103.503103.822.00104.01104.311.99
257772-57772106.215106.71
355421-55421101.893102.38
455560-55560102.148102.63
557964-57964106.568107.07
655802-55802102.593103.08
30min156283-56283103.478103.822.05104.15104.492.04
257813-57813106.291106.96
355369-55369101.797102.46
455624-55624102.266102.92
558002-58002106.638107.32
655740-55740102.479103.14
普瑞巴林口崩片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)0
对照品批号D5385-22-019M1对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.8对照品水分(%)0对照品稀释倍数200
标示量(mg)75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%
116.631089611089741090321089211090071089790.04
216.751088261088171088220.01
单位质量响应值RSD%判断
6553.166496.840.62数据可信
供试品溶液-2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%
2min1100428-10042892.16592.036.0692.1692.036.06
2101464-10146493.11593.12
388809-8880981.50281.50
4101913-10191393.52793.53
5107003-10700398.19998.20
6102093-10209393.69393.69
5min1117585-117585107.910108.570.75108.06108.730.75
2118027-118027108.316108.47
3118748-118748108.977109.11
4118899-118899109.116109.27
5119462-119462109.633109.80
6117133-117133107.495107.65
10min1117855-117855108.158108.820.81108.49109.160.81
2118159-118159108.437108.77
3119190-119190109.383109.70
4119044-119044109.249109.59
5119897-119897110.032110.38
6117339-117339107.684108.02
15min1117523-117523107.853108.780.78108.37109.300.78
2118159-118159108.437108.95
3119190-119190109.383109.88
4118970-118970109.181109.70
5119786-119786109.930110.46
6117583-117583107.908108.42
30min1117618-117618107.940108.760.86108.63109.460.86
2118258-118258108.528109.22
3119009-119009109.217109.90
4118881-118881109.099109.80
5120039-120039110.162110.88
6117270-117270107.621108.32
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