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%
110.601802411807381799711803771798441802340.20
210.671802981804301803640.06
单位质量响应值RSD%判断
17003.2116903.840.42数据可信
加速6月-供试品溶液-2025073121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%
5min1105814-10581455.94957.001.7255.9557.001.72
2106953-10695356.55156.55
3110272-11027258.30658.31
4109754-10975458.03258.03
5107838-10783857.01957.02
6106238-10623856.17356.17
10min1147352-14735277.91278.940.9478.0079.030.95
2149942-14994279.28179.38
3151383-15138380.04380.14
4149114-14911478.84378.94
5149702-14970279.15479.25
6148264-14826478.39478.49
15min1168918-16891889.31490.461.0689.5490.691.05
2172135-17213591.01591.24
3172908-17290891.42491.65
4170446-17044690.12290.35
5172881-17288191.41091.64
6169235-16923589.48289.71
20min1180164-18016495.26196.210.9995.6396.590.99
2183219-18321996.87697.25
3183416-18341696.98097.36
4180253-18025395.30895.69
5184075-18407597.32997.71
6180672-18067295.52995.90
30min1187905-18790599.354100.521.0699.88101.061.06
2191981-191981101.509102.05
3191081-191081101.033101.58
4187977-18797799.39299.93
5192477-192477101.771102.31
6189264-189264100.072100.60
45min1190276-190276100.607101.480.88101.30102.180.88
2193604-193604102.367103.08
3193028-193028102.062102.78
4190003-190003100.463101.17
5193634-193634102.383103.09
6191003-191003100.992101.69
60min1189928-189928100.423101.550.99101.29102.430.98
2193845-193845102.494103.37
3193213-193213102.160103.04
4190311-190311100.626101.50
5194158-194158102.660103.54
6190925-190925100.950101.82
极限1189885-189885100.401101.300.96101.43102.350.96
2193397-193397102.258103.31
3192292-192292101.673102.73
4189539-189539100.218101.26
5193788-193788102.464103.52
6190652-190652100.806101.84
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%
110.601792051789161793271792331803061793970.30
210.671794781794551794660.01
单位质量响应值RSD%判断
16924.2516819.680.44数据可信
加速6月-供试品溶液-2025080121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%
5min1100992-10099253.65753.506.3953.6653.506.39
299574-9957452.90452.90
395683-9568350.83650.84
495150-9515050.55350.55
599917-9991753.08653.09
6112901-11290159.98459.98
10min1146465-14646577.81776.663.8377.9176.753.83
2145619-14561977.36777.46
3136903-13690372.73772.82
4140310-14031074.54774.63
5143454-14345476.21776.31
6152922-15292281.24881.35
15min1167924-16792489.21888.361.8389.4488.581.83
2167345-16734588.91189.13
3160423-16042385.23385.44
4166139-16613988.27088.48
5167068-16706888.76388.98
6168934-16893489.75589.99
20min1178155-17815594.65494.001.3595.0294.371.35
2178441-17844194.80695.17
3172190-17219091.48591.83
4178172-17817294.66395.02
5177718-17771894.42294.79
6176896-17689693.98594.37
30min1185289-18528998.44497.701.6598.9798.221.64
2185113-18511398.35198.87
3179485-17948595.36195.86
4187410-18741099.571100.08
5185110-18511098.34998.87
6180929-18092996.12896.67
45min1187509-18750999.62498.681.80100.3199.361.79
2186610-18661099.14699.83
3182251-18225196.83097.49
4189651-189651100.762101.44
5187306-18730699.516100.20
6181055-18105596.19596.90
60min1187546-18754699.64398.601.83100.5099.451.82
2186620-18662099.151100.00
3181457-18145796.40897.23
4189494-189494100.678101.53
5187050-18705099.380100.23
6181361-18136196.35797.22
极限1187122-18712299.41898.721.44100.4499.741.43
2186982-18698299.344100.36
3182297-18229796.85597.84
4188699-188699100.256101.27
5187134-18713499.424100.44
6182649-18264997.04298.06
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%
110.601798331796291793621794111800031796480.16
210.671795561799451797500.16
单位质量响应值RSD%判断
16947.9216846.300.43数据可信
加速6月-供试品溶液-2025080122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%
5min1117783-11778362.48562.972.2362.4962.972.23
2123153-12315365.33465.33
3118438-11843862.83362.83
4118801-11880163.02563.03
5114959-11495960.98760.99
6119075-11907563.17063.17
10min1155506-15550682.49783.751.1282.6083.861.12
2160263-16026385.02185.13
3158837-15883784.26584.37
4158752-15875284.21984.32
5156381-15638182.96283.06
6157516-15751683.56483.67
15min1169453-16945389.89691.601.3890.1491.851.38
2176538-17653893.65593.91
3173777-17377792.19092.44
4172380-17238091.44991.69
5172437-17243791.47991.72
6171427-17142790.94491.19
20min1174132-17413292.37994.991.5492.7795.391.54
2182324-18232496.72597.13
3180256-18025695.62896.03
4179195-17919595.06595.46
5179996-17999695.49095.88
6178421-17842194.65495.05
30min1178449-17844994.66997.041.5895.2197.601.57
2187116-18711699.26799.83
3183799-18379997.50798.07
4182185-18218596.65197.21
5184056-18405697.64398.20
6181884-18188496.49197.05
45min1178870-17887094.89297.721.7695.6098.441.75
2188310-18831099.900100.63
3185134-18513498.21598.94
4183529-18352997.36498.08
5186255-18625598.81099.52
6183096-18309697.13497.85
60min1179229-17922995.08397.861.6295.9498.741.62
2187653-18765399.552100.45
3185458-18545898.38799.27
4184470-18447097.86398.74
5186611-18661198.99999.88
6183411-18341197.30198.18
极限1183681-18368197.44599.301.1598.46100.341.15
2189590-189590100.579101.65
3187240-18724099.333100.38
4187427-18742799.432100.47
5189093-189093100.316101.36
6186071-18607198.71299.75
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%
110.601805791802041803631803471803091803600.08
210.671804681808271806480.15
单位质量响应值RSD%判断
17015.0916930.460.36数据可信
中间条件6月-供试品溶液-2025073121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%
5min1110877-11087758.55958.192.0058.5658.192.00
2110379-11037958.29658.30
3107804-10780456.93656.94
4110185-11018558.19358.19
5113831-11383160.11960.12
6108003-10800357.04157.04
10min1153729-15372981.19180.251.7981.2980.351.79
2153245-15324580.93581.03
3150357-15035779.41079.50
4151334-15133479.92680.02
5155311-15531182.02682.13
6147749-14774978.03378.13
15min1173884-17388491.83690.691.5492.0790.921.54
2173753-17375391.76692.00
3170234-17023489.90890.14
4169480-16948089.51089.74
5174495-17449592.15892.40
6168411-16841188.94589.17
20min1183642-18364296.98995.541.4497.3895.921.44
2182611-18261196.44596.83
3179421-17942194.76095.14
4177622-17762293.81094.19
5183305-18330596.81197.20
6178786-17878694.42594.80
30min1191310-191310101.03999.321.51101.5999.861.51
2190512-190512100.618101.16
3187629-18762999.09599.63
4184117-18411797.24097.78
5189242-18924299.947100.50
6185519-18551997.98198.51
45min1193567-193567102.231100.431.62102.95101.141.61
2192666-192666101.755102.47
3189478-189478100.072100.77
4185483-18548397.96298.66
5191711-191711101.251101.97
6188082-18808299.334100.03
60min1193313-193313102.097100.391.50102.98101.271.50
2192425-192425101.628102.51
3189463-189463100.064100.93
4186056-18605698.26499.13
5191586-191586101.185102.07
6187676-18767699.12099.98
极限1193665-193665102.283100.761.44103.34101.801.44
2192398-192398101.614102.67
3190040-190040100.368101.40
4186829-18682998.67299.70
5193148-193148102.010103.07
6188572-18857299.593100.62
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%
110.601805561812501805751810281801681807150.24
210.671810321809311809820.04
单位质量响应值RSD%判断
17048.5816961.760.37数据可信
中间条件6月-供试品溶液-2025080121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%
5min199092-9909252.23555.539.1452.2455.529.14
298105-9810551.71551.71
395201-9520150.18450.18
4105914-10591455.83155.83
5115608-11560860.94160.94
6118090-11809062.25062.25
10min1142054-14205474.88276.676.2474.9776.766.24
2140755-14075574.19774.28
3133663-13366370.45970.54
4143836-14383675.82175.91
5154598-15459881.49481.60
6157782-15778283.17383.28
15min1161970-16197085.38086.923.3285.5987.133.33
2162736-16273685.78485.99
3157803-15780383.18483.38
4164349-16434986.63486.85
5169547-16954789.37589.61
6172884-17288491.13491.38
20min1172116-17211690.72992.012.2391.0892.372.24
2174640-17464092.05992.41
3168879-16887989.02289.36
4174895-17489592.19492.56
5176361-17636192.96693.35
6180380-18038095.08595.48
30min1181588-18158895.72296.011.1896.2396.531.18
2184001-18400196.99497.50
3179498-17949894.62095.11
4182090-18209095.98696.50
5180457-18045795.12695.67
6185168-18516897.60998.16
45min1185232-18523297.64397.521.2398.3198.201.23
2188005-18800599.10499.77
3182487-18248796.19696.84
4185617-18561797.84698.52
5182201-18220196.04596.74
6186479-18647998.30099.02
60min1186728-18672898.43198.121.2499.2698.961.23
2189109-18910999.686100.52
3184624-18462497.32298.13
4186943-18694398.54599.39
5182451-18245196.17797.04
6186975-18697598.56199.44
极限1187820-18782099.00798.790.73100.0099.790.73
2188883-18888399.567100.57
3185731-18573197.90698.87
4188310-18831099.265100.27
5185701-18570197.89098.91
6187959-18795999.080100.12
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%
110.601804261810061811021809561814021809780.20
210.671811191813381812280.09
单位质量响应值RSD%判断
17073.4016984.820.37数据可信
中间条件6月-供试品溶液-2025080122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%
5min1111414-11141458.64860.896.5158.6560.896.51
2108197-10819756.95556.95
3107584-10758456.63256.63
4120090-12009063.21563.21
5124996-12499665.79765.80
6121769-12176964.09964.10
10min1151553-15155379.77781.663.8679.8781.763.86
2148746-14874678.29978.39
3149239-14923978.55978.65
4158945-15894583.66883.77
5162507-16250785.54385.65
6159776-15977684.10684.21
15min1167191-16719188.00989.702.7388.2489.942.73
2165207-16520786.96487.19
3167364-16736488.10088.33
4173240-17324091.19391.44
5177548-17754893.46193.71
6171863-17186390.46890.72
20min1175929-17592992.60893.261.9792.9993.651.97
2172788-17278890.95591.33
3176012-17601292.65293.02
4179006-17900694.22894.62
5183016-18301696.33996.75
6176251-17625192.77893.18
30min1182004-18200495.80695.871.6496.3496.411.65
2178859-17885994.15194.67
3181909-18190995.75696.28
4183267-18326796.47197.02
5187200-18720098.54199.11
6179525-17952594.50195.05
45min1185032-18503297.40096.971.6398.0997.671.63
2181293-18129395.43296.11
3184611-18461197.17997.86
4184466-18446697.10297.82
5189094-18909499.538100.27
6180820-18082095.18395.89
60min1185827-18582797.81997.231.4298.6798.101.42
2182632-18263296.13796.97
3185463-18546397.62798.48
4184627-18462797.18798.06
5188597-18859799.277100.18
6181141-18114195.35296.22
极限1187267-18726798.57798.181.1699.5999.201.16
2184716-18471697.23498.23
3185721-18572197.76398.77
4186085-18608597.95498.99
5190464-190464100.260101.32
6184811-18481197.28498.31
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