比拉斯汀片项目信息
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D1BSF0200923对照品来源自制对照品使用方法直接使用
对照品含量(%)99.6对照品水分(%)0对照品稀释倍数500
标示量(mg)20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%
111.053852033856273858443851003856823854910.09
211.053856173854303855240.04
单位质量响应值RSD%判断
34886.0634889.050.01数据可信
供试品溶液-2024122121批-pH1.0
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min1394107-394107101.262101.421.20101.26101.421.20
2396212-396212101.803101.80
3389972-389972100.199100.20
4399042-399042102.530102.53
5388619-38861999.85299.85
6400274-400274102.846102.85
10min1402057-402057103.304103.401.39103.47103.561.39
2404027-404027103.811103.98
3396345-396345101.837102.00
4408304-408304104.910105.08
5395527-395527101.627101.79
6408194-408194104.881105.05
15min1406659-406659104.487103.701.64104.83104.041.64
2404971-404971104.053104.40
3396230-396230101.807102.14
4411730-411730105.790106.14
5394949-394949101.478101.81
6407049-407049104.587104.93
20min1399172-399172102.563102.831.26103.08103.351.26
2401609-401609103.189103.71
3395198-395198101.542102.05
4405952-405952104.305104.83
5393984-393984101.230101.74
6405395-405395104.162104.68
30min1397415-397415102.112102.711.20102.80103.401.20
2400748-400748102.968103.66
3394046-394046101.246101.92
4405590-405590104.212104.91
5395912-395912101.726102.40
6404796-404796104.008104.70
极限1397035-397035102.014102.391.32102.87103.241.32
2400137-400137102.811103.67
3393464-393464101.097101.94
4404334-404334103.889104.76
5391973-391973100.713101.56
6403971-403971103.796104.66
比拉斯汀片项目信息
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D1BSF0200923对照品来源自制对照品使用方法直接使用
对照品含量(%)99.6对照品水分(%)0对照品稀释倍数500
标示量(mg)20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%
111.053872843866633859983855413847453860460.26
211.053867043863973865500.06
单位质量响应值RSD%判断
34936.2934981.900.10数据可信
供试品溶液-2024122221批-pH1.0
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min1398168-398168102.096101.341.44102.10101.351.44
2391264-391264100.326100.33
3389088-38908899.76899.77
4404930-404930103.830103.83
5394920-394920101.263101.26
6393064-393064100.787100.79
10min1405792-405792104.051102.701.71104.22102.861.71
2395288-395288101.357101.52
3395925-395925101.521101.69
4411993-411993105.641105.81
5397478-397478101.919102.09
6396551-396551101.681101.85
15min1400146-400146102.603101.831.46102.95102.171.46
2393833-393833100.984101.32
3390893-390893100.230100.57
4407229-407229104.419104.77
5395668-395668101.455101.79
6395055-395055101.298101.64
20min1399143-399143102.346101.741.47102.86102.251.47
2392987-392987100.767101.27
3389642-38964299.910100.41
4406233-406233104.164104.69
5398218-398218102.109102.62
6394425-394425101.136101.64
30min1401705-401705103.003101.711.45103.69102.391.45
2392039-392039100.524101.20
3390275-390275100.072100.74
4405237-405237103.908104.61
5395861-395861101.504102.18
6394881-394881101.253101.93
极限1398100-398100102.078101.311.46102.94102.161.45
2390918-390918100.237101.08
3388370-38837099.584100.42
4404634-404634103.754104.62
5394252-394252101.092101.94
6394245-394245101.090101.93
比拉斯汀片项目信息
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D1BSF0200923对照品来源自制对照品使用方法直接使用
对照品含量(%)99.6对照品水分(%)0对照品稀释倍数500
标示量(mg)20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%
111.053848343857263850243852423853863852420.09
211.053869743870913870320.03
单位质量响应值RSD%判断
34863.5335025.520.33数据可信
供试品溶液-2024122321批-pH1.0
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min1397064-397064101.856100.941.62101.86100.941.62
2399494-399494102.479102.48
3384273-38427398.57598.57
4399980-399980102.604102.60
5391258-391258100.366100.37
6388819-38881999.74199.74
10min1404088-404088103.658102.211.68103.83102.381.68
2404216-404216103.690103.86
3388820-38882099.74199.91
4404324-404324103.718103.89
5394496-394496101.197101.36
6394624-394624101.230101.40
15min1402915-402915103.357101.841.65103.70102.171.65
2403244-403244103.441103.78
3387610-38761099.43199.76
4401762-401762103.061103.40
5392860-392860100.777101.11
6393542-393542100.952101.29
20min1401668-401668103.037101.791.49103.55102.301.49
2402143-402143103.159103.67
3388246-38824699.594100.09
4401896-401896103.095103.61
5393953-393953101.058101.56
6392933-392933100.796101.30
30min1400101-400101102.635101.621.42103.32102.301.42
2402106-402106103.149103.84
3389245-38924599.850100.51
4401097-401097102.890103.58
5392874-392874100.781101.45
6391409-391409100.405101.08
极限1400574-400574102.756101.391.67103.61102.241.66
2401885-401885103.092103.95
3385783-38578398.96299.79
4400191-400191102.658103.52
5392423-392423100.665101.51
6390651-390651100.211101.05
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