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%
111.071839971841621841971832061837101838540.23
211.051834351834371834360.01
单位质量响应值RSD%判断
16608.3116600.540.04数据可信
供试品溶液-3208批-pH6.8
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min1109795-10979559.27359.783.5359.2759.783.53
2106970-10697057.74857.75
3111387-11138760.13360.13
4109339-10933959.02759.03
5118136-11813663.77663.78
6108775-10877558.72358.72
10min1146435-14643579.05476.313.9479.1576.413.93
2132523-13252371.54371.64
3136523-13652373.70373.80
4145084-14508478.32478.42
5144659-14465978.09578.20
6142923-14292377.15877.26
15min1165004-16500489.07887.252.4389.3187.482.43
2157451-15745185.00185.22
3157932-15793285.26185.48
4163168-16316888.08788.32
5166769-16676990.03190.27
6159344-15934486.02386.25
20min1175945-17594594.98592.981.5895.3693.361.58
2170082-17008291.82092.18
3169049-16904991.26291.63
4172789-17278993.28193.66
5174725-17472594.32694.71
6170848-17084892.23392.60
30min1186614-186614100.74596.992.25101.2897.522.24
2175580-17558094.78895.30
3175766-17576694.88895.41
4180450-18045097.41797.95
5179364-17936496.83197.37
6180225-18022597.29697.82
45min1192685-192685104.02299.142.93104.7399.832.92
2180723-18072397.56498.23
3177497-17749795.82396.50
4185015-18501599.881100.58
5180418-18041897.40098.10
6185511-185511100.149100.83
60min1193986-193986104.72599.663.20105.60100.523.19
2179433-17943396.86897.70
3178978-17897896.62297.46
4186496-186496100.681101.54
5180894-18089497.65798.52
6187861-187861101.418102.27
极限1194812-194812105.170100.023.05106.22101.043.04
2179310-17931096.80297.79
3181027-18102797.72998.72
4186009-186009100.418101.45
5182610-18261098.58399.61
6187887-187887101.432102.45
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%
111.071853501854871852501854661849831853070.12
211.051834231835391834810.05
单位质量响应值RSD%判断
16739.5716604.620.58数据可信
供试品溶液-3208批-pH6.8
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min1108969-10896958.59057.343.1258.5957.343.12
2109290-10929058.76258.76
3104803-10480356.35056.35
4110181-11018159.24159.24
5101764-10176454.71654.72
6104872-10487256.38756.39
10min1144020-14402077.43673.865.1977.5373.965.19
2143946-14394677.39677.49
3133164-13316471.59971.69
4143315-14331577.05777.16
5129046-12904669.38569.48
6130720-13072070.28570.38
15min1162501-16250187.37385.422.0687.6085.642.07
2161330-16133086.74386.97
3159919-15991985.98486.20
4159479-15947985.74885.97
5153759-15375982.67282.88
6156283-15628384.02984.24
20min1172952-17295292.99291.502.1193.3691.862.11
2171972-17197292.46592.84
3173784-17378493.43993.80
4170580-17058091.71692.09
5164678-16467888.54388.89
6167058-16705889.82390.17
30min1182525-18252598.13996.052.6298.6796.562.62
2181910-18191097.80898.33
3181570-18157097.62598.14
4180398-18039896.99597.52
5172086-17208692.52693.02
6173316-17331693.18793.69
45min1187951-187951101.05698.143.60101.7598.813.60
2188543-188543101.375102.06
3184494-18449499.19899.87
4185623-18562399.805100.49
5174508-17450893.82894.47
6174022-17402293.56794.22
60min1188529-188529101.36798.743.71102.2399.583.70
2189828-189828102.066102.92
3186331-186331100.185101.03
4187155-187155100.628101.48
5174721-17472193.94394.75
6175302-17530294.25595.07
极限1188827-188827101.52799.752.44102.56100.752.45
2191580-191580103.008104.04
3184416-18441699.156100.16
4187268-187268100.689101.71
5180651-18065197.13198.09
6180379-18037996.98597.95
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%
111.071840221836301836521838351834401837160.13
211.051832501832061832280.02
单位质量响应值RSD%判断
16595.8416581.720.07数据可信
供试品溶液-3128批-pH6.8
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min1109727-10972759.29359.961.8759.2959.961.87
2107703-10770358.19958.20
3112584-11258460.83660.84
4111686-11168660.35160.35
5113415-11341561.28661.29
6110605-11060559.76759.77
10min1135986-13598673.48274.572.1073.5874.672.09
2137152-13715274.11274.21
3134269-13426972.55472.66
4139894-13989475.59475.69
5138283-13828374.72374.83
6142407-14240776.95277.05
15min1161526-16152687.28388.321.5887.5088.541.58
2163125-16312588.14788.37
3160026-16002686.47286.69
4163132-16313288.15188.38
5166386-16638689.90990.14
6166434-16643489.93590.16
20min1170149-17014991.94393.131.5092.3193.501.50
2172959-17295993.46193.83
3169399-16939991.53791.90
4172029-17202992.95893.33
5172824-17282493.38893.76
6176723-17672395.49595.87
30min1175037-17503794.58495.171.5195.1095.691.51
2177995-17799596.18296.71
3172718-17271893.33193.85
4175945-17594595.07595.60
5174756-17475694.43294.96
6180235-18023597.39397.93
45min1178655-17865596.53995.982.0297.2296.662.02
2178254-17825496.32297.01
3172674-17267493.30793.98
4178196-17819696.29196.98
5174811-17481194.46295.15
6183104-18310498.94399.64
60min1177234-17723495.77196.121.7296.6196.971.71
2179247-17924796.85997.70
3173534-17353493.77294.60
4178711-17871196.56997.42
5176091-17609195.15396.00
6182499-18249998.61699.48
极限1170186-17018691.96394.362.2792.9695.362.24
2178585-17858596.50197.51
3177902-17790296.13297.12
4172019-17201992.95393.96
5178064-17806496.22097.23
6170949-17094992.37593.40
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%
111.071838311840241837831845791843961841230.20
211.051839301834141836720.20
单位质量响应值RSD%判断
16632.6116621.900.05数据可信
供试品溶液-3128批-pH6.8
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min1112162-11216260.46861.253.0460.4761.253.04
2116440-11644062.77562.77
3109879-10987959.23759.24
4111679-11167960.20860.21
5112397-11239760.59560.59
6119101-11910164.20964.21
10min1135315-13531572.95075.722.6273.0575.832.62
2144874-14487478.10478.21
3138770-13877074.81374.91
4137929-13792974.36074.46
5142787-14278776.97977.08
6143089-14308977.14177.25
15min1158866-15886685.64788.862.3585.8789.082.35
2169158-16915891.19691.43
3163518-16351888.15588.38
4162620-16262087.67187.90
5168130-16813090.64190.87
6166611-16661189.82290.06
20min1167391-16739190.24394.062.5990.6194.442.59
2179704-17970496.88197.27
3173496-17349693.53493.90
4173167-17316793.35793.73
5179094-17909496.55296.93
6173986-17398693.79894.18
30min1170850-17085092.10895.892.7092.6296.422.70
2183544-18354498.95199.50
3176482-17648295.14495.67
4177779-17777995.84396.37
5182986-18298698.65099.19
6175500-17550094.61595.16
45min1176560-17656095.18697.202.3695.8697.892.35
2185270-18527099.882100.59
3177670-17767095.78596.47
4180106-18010697.09897.78
5185720-185720100.124100.83
6176443-17644395.12395.82
60min1174112-17411293.86697.442.6194.6998.302.61
2185635-185635100.079100.96
3178109-17810996.02196.87
4179954-17995497.01697.86
5186641-186641100.621101.49
6180000-18000097.04197.90
极限1172077-17207792.76995.512.8893.7596.532.86
2173829-17382993.71494.76
3172681-17268193.09594.10
4183562-18356298.96199.97
5178082-17808296.00797.05
6182750-18275098.52399.54
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