比拉斯汀口崩片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)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%
111.133797483791253798533790153794693794420.10
211.173780113786763783440.13
单位质量响应值RSD%判断
34091.8233871.440.46数据可信
加速6月-供试品溶液-2024122021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%
5min1379291-379291100.05499.651.12100.0599.651.12
2375121-37512198.95498.95
3375004-37500498.92398.92
4379904-379904100.216100.22
5372952-37295298.38298.38
6384361-384361101.391101.39
10min1382927-382927101.013100.860.93101.18101.020.93
2380080-380080100.262100.43
3379155-379155100.018100.18
4383923-383923101.276101.44
5379578-379578100.130100.29
6388428-388428102.464102.63
15min1383549-383549101.177100.741.08101.51101.081.08
2380773-380773100.445100.78
3375273-37527398.99499.33
4383130-383130101.067101.40
5381020-381020100.510100.84
6387718-387718102.277102.62
20min1382556-382556100.915100.700.97101.42101.200.97
2379826-379826100.195100.69
3377906-37790699.689100.19
4381934-381934100.751101.26
5379755-379755100.176100.67
6388438-388438102.467102.98
30min1381928-381928100.750100.420.92101.42101.080.92
2379035-37903599.987100.65
3375823-37582399.13999.80
4382178-382178100.816101.49
5378997-37899799.977100.64
6385999-385999101.824102.50
极限1377204-37720499.50499.920.92100.34100.750.92
2375581-37558199.07599.91
3376701-37670199.371100.20
4379178-379178100.024100.86
5378619-37861999.877100.71
6385298-385298101.639102.49
比拉斯汀口崩片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)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%
111.133801303801213806333803733804453803400.06
211.173808343799163803750.18
单位质量响应值RSD%判断
34172.5134053.270.25数据可信
中间条件6月-供试品溶液-2024122021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%
5min1381983-381983100.376100.400.87100.38100.400.87
2383938-383938100.889100.89
3385852-385852101.392101.39
4380603-380603100.013100.01
5376419-37641998.91498.91
6383599-383599100.800100.80
10min1381282-381282100.192101.341.30100.36101.511.30
2389835-389835102.439102.61
3391133-391133102.780102.95
4383953-383953100.893101.06
5378942-37894299.57799.74
6388844-388844102.179102.35
15min1382130-382130100.414101.341.17100.75101.671.17
2387168-387168101.738102.08
3392377-392377103.107103.45
4384618-384618101.068101.40
5379715-37971599.780100.11
6387837-387837101.914102.25
20min1380021-38002199.860100.931.09100.36101.441.09
2386128-386128101.465101.97
3388492-388492102.086102.60
4384858-384858101.131101.63
5378054-37805499.34399.84
6387113-387113101.724102.23
30min1378420-37842099.439100.651.07100.11101.321.07
2384096-384096100.931101.61
3387918-387918101.935102.62
4382414-382414100.489101.16
5378368-37836899.426100.09
6386909-386909101.670102.35
极限1379675-37967599.769100.310.89100.60101.150.89
2381709-381709100.304101.15
3386589-386589101.586102.44
4379577-37957799.743100.58
5377928-37792899.310100.14
6384960-384960101.158102.01
比拉斯汀口崩片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)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%
111.133792793797833806353801613798583799430.14
211.173829143807503818320.41
单位质量响应值RSD%判断
34136.8434183.710.10数据可信
加速6月-供试品溶液-3L77C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%
5min1376761-37676198.86695.992.1398.8795.992.13
2361624-36162494.89494.89
3371502-37150297.48697.49
4361488-36148894.85894.86
5355397-35539793.26093.26
6368029-36802996.57596.57
10min1383000-383000100.50397.162.09100.6797.322.09
2365965-36596596.03396.19
3374157-37415798.18398.35
4365917-36591796.02096.18
5361165-36116594.77394.93
6371254-37125497.42197.58
15min1381859-381859100.20497.081.98100.5497.401.98
2364932-36493295.76296.08
3373599-37359998.03698.36
4367815-36781596.51896.84
5360970-36097094.72295.04
6370506-37050697.22597.55
20min1382027-382027100.24896.852.24100.7597.332.24
2363273-36327395.32795.80
3373485-37348598.00698.50
4365324-36532495.86596.34
5359020-35902094.21194.68
6371300-37130097.43397.92
30min1379882-37988299.68596.771.92100.3597.411.92
2364504-36450495.65096.29
3373686-37368698.05998.71
4365839-36583996.00096.64
5360062-36006294.48495.11
6368631-36863196.73397.38
极限1379685-37968599.63396.931.78100.4797.741.78
2370718-37071897.28098.08
3371343-37134397.44498.26
4365139-36513995.81696.61
5360196-36019694.51995.30
6369264-36926496.89997.71
比拉斯汀口崩片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)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%
111.133826013830243822013829653821923825970.11
211.173813263806703809980.13
单位质量响应值RSD%判断
34375.2934109.040.55数据可信
中间条件6月-供试品溶液-3L77C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%
5min1372765-37276597.58595.493.1397.5895.483.13
2344536-34453690.19590.19
3371076-37107697.14397.14
4374004-37400497.90997.91
5358347-35834793.81093.81
6367785-36778596.28196.28
10min1374922-37492298.15098.111.3898.3198.271.38
2365703-36570395.73695.89
3374558-37455898.05498.22
4379104-37910499.24499.41
5373974-37397497.90198.06
6380361-38036199.57399.73
15min1374898-37489898.14398.221.5698.4798.541.56
2366320-36632095.89896.21
3372138-37213897.42197.75
4379885-37988599.44999.78
5374991-37499198.16898.49
6382889-382889100.235100.56
20min1374666-37466698.08298.151.5398.5798.641.54
2365111-36511195.58196.05
3375771-37577198.37298.86
4378332-37833299.04299.54
5373515-37351597.78198.26
6382245-382245100.067100.56
30min1372374-37237497.48297.821.6398.1498.471.63
2363469-36346995.15195.78
3372588-37258897.53898.19
4379873-37987399.446100.11
5373814-37381497.85998.51
6379841-37984199.437100.10
极限1373939-37393997.89297.611.2798.7198.421.27
2364413-36441395.39896.19
3371982-37198297.38098.19
4376660-37666098.60499.43
5372514-37251497.51998.33
6377688-37768898.87499.70
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