盐酸奥洛他定口崩片项目信息
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101098-202303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2000
标示量(mg)5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%
111.292332102326262325292326232317952325570.22
211.312317362319792318580.08
单位质量响应值RSD%判断
20598.4920500.270.34数据可信
供试品溶液-24091901批-水
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1217589-21758995.10794.741.7795.1194.741.77
2217101-21710194.89494.89
3220605-22060596.42696.43
4219984-21998496.15496.15
5215182-21518294.05594.06
6210045-21004591.81091.81
10min1222795-22279597.38396.971.7597.5497.121.75
2223204-22320497.56297.72
3225587-22558798.60398.76
4224461-22446198.11198.27
5220104-22010496.20796.36
6214888-21488893.92794.08
15min1223747-22374797.79997.401.7398.1297.721.73
2224160-22416097.97998.30
3226660-22666099.07299.40
4225679-22567998.64398.97
5220466-22046696.36596.68
6216285-21628594.53794.85
20min1224790-22479098.25597.721.6798.7498.201.67
2225053-22505398.37098.85
3226906-22690699.18099.67
4226093-22609398.82499.31
5221737-22173796.92097.40
6216863-21686394.79095.26
30min1225506-22550698.56897.931.6999.2298.571.69
2225469-22546998.55299.20
3227391-22739199.392100.05
4226717-22671799.09799.75
5221637-22163796.87797.52
6217499-21749995.06895.69
45min1225642-22564298.62798.111.7099.4498.921.70
2225821-22582198.70599.52
3227977-22797799.648100.47
4227170-22717099.295100.11
5222422-22242297.22098.02
6217754-21775495.17995.96
60min1225572-22557298.59798.171.6299.5799.141.63
2225808-22580898.70099.68
3227989-22798999.653100.64
4227402-22740299.397100.38
5222548-22254897.27598.24
6218260-21826095.40196.34
极限1225873-22587398.72898.241.6199.8799.381.61
2226281-22628198.907100.05
3227890-22789099.610100.76
4227447-22744799.416100.57
5222600-22260097.29898.42
6218465-21846595.49096.59
盐酸奥洛他定口崩片项目信息
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101098-202303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2000
标示量(mg)5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%
111.292320892323052322652322672321012322050.05
211.312304572307222305900.09
单位质量响应值RSD%判断
20567.3220388.150.62数据可信
供试品溶液-1批-水
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1196607-19660786.23888.403.3786.2488.403.36
2205028-20502889.93289.93
3193008-19300884.65984.66
4205341-20534190.06990.07
5211197-21119792.63892.64
6198041-19804186.86786.87
10min1205979-20597990.34992.593.4890.4992.743.48
2214299-21429993.99894.15
3201451-20145188.36388.50
4215941-21594194.71894.87
5221293-22129397.06697.22
6207534-20753491.03191.18
15min1209730-20973091.99494.273.5392.2994.573.53
2218266-21826695.73896.04
3204764-20476489.81690.10
4219971-21997196.48696.79
5225344-22534498.84399.16
6211483-21148392.76393.06
20min1211514-21151492.77795.293.6393.2295.743.63
2220634-22063496.77797.24
3207085-20708590.83491.27
4222748-22274897.70498.17
5228045-228045100.028100.51
6213387-21338793.59894.05
30min1213948-21394893.84496.323.6494.4596.933.64
2223084-22308497.85298.48
3209066-20906691.70392.29
4224729-22472998.57399.20
5230729-230729101.205101.85
6215943-21594394.71995.33
45min1215415-21541594.48897.233.6295.2598.013.62
2225319-22531998.83299.62
3210903-21090392.50993.25
4227047-22704799.590100.39
5232433-232433101.952102.77
6218936-21893696.03296.80
60min1217043-21704395.20297.833.7496.1298.773.74
2226567-22656799.379100.33
3211466-21146692.75693.65
4227966-22796699.993100.95
5234618-234618102.911103.90
6220524-22052496.72997.65
极限1217527-21752795.41498.183.5796.4999.283.57
2227197-22719799.656100.78
3212516-21251693.21694.27
4227966-22796699.993101.12
5234876-234876103.024104.18
6222883-22288397.76398.85
盐酸奥洛他定口崩片项目信息
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101098-202303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2000
标示量(mg)5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%
111.292321572322262322132322642321252321970.03
211.312318322321852320080.11
单位质量响应值RSD%判断
20566.6120513.530.19数据可信
供试品溶液-24091901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%
5min1227989-22798999.69897.982.4199.7097.982.41
2220539-22053996.44096.44
3220580-22058096.45896.46
4228913-228913100.102100.10
5216848-21684894.82694.83
6229554-229554100.382100.38
10min1232477-232477101.66099.752.51101.8399.912.51
2225119-22511998.44398.60
3223767-22376797.85298.01
4234224-234224102.424102.59
5220451-22045196.40296.56
6232584-232584101.707101.87
15min1231931-231931101.42299.702.45101.76100.022.45
2224904-22490498.34998.67
3224639-22463998.23398.56
4233972-233972102.314102.65
5220026-22002696.21696.53
6232436-232436101.642101.98
20min1231836-231836101.38099.492.55101.8899.992.54
2223847-22384797.88798.38
3223759-22375997.84898.34
4233861-233861102.266102.77
5219757-21975796.09896.58
6232057-232057101.477101.98
30min1231229-231229101.11599.252.50101.7999.912.50
2223466-22346697.72098.37
3223239-22323997.62198.27
4233125-233125101.944102.62
5219318-21931895.90696.55
6231434-231434101.204101.88
45min1230284-230284100.70199.022.46101.5499.852.46
2223263-22326397.63198.45
3222970-22297097.50398.32
4232391-232391101.623102.47
5218647-21864795.61396.41
6231130-231130101.071101.92
60min1229650-229650100.42498.842.48101.4399.832.48
2222811-22281197.43498.41
3222446-22244697.27498.25
4232089-232089101.491102.51
5218311-21831195.46696.42
6230866-230866100.956101.97
极限1229341-229341100.28998.592.47101.4799.752.47
2221996-22199697.07798.22
3221819-22181997.00098.14
4231425-231425101.200102.39
5217966-21796695.31596.43
6230198-230198100.664101.84
盐酸奥洛他定口崩片项目信息
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101098-202303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2000
标示量(mg)5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%
111.292319752323632322072322372319622321490.08
211.312310722315492313100.15
单位质量响应值RSD%判断
20562.3620451.810.39数据可信
供试品溶液-1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%
5min1216197-21619794.69498.283.0194.6998.283.01
2236396-236396103.541103.54
3224844-22484498.48198.48
4223676-22367697.97097.97
5220572-22057296.61096.61
6224603-22460398.37698.38
10min1220675-22067596.655100.723.1996.81100.883.19
2242737-242737106.318106.49
3230556-230556100.983101.15
4230693-230693101.043101.21
5225855-22585598.92499.09
6229218-229218100.397100.56
15min1220962-22096296.781100.733.2397.10101.063.23
2243158-243158106.503106.85
3230604-230604101.004101.34
4230689-230689101.041101.37
5225848-22584898.92199.25
6228614-228614100.133100.46
20min1220757-22075796.691100.673.1397.17101.173.13
2242362-242362106.154106.68
3230381-230381100.906101.41
4230698-230698101.045101.55
5225766-22576698.88599.38
6229103-229103100.347100.84
30min1220440-22044096.552100.413.1897.19101.083.18
2242045-242045106.015106.72
3229970-229970100.726101.40
4230115-230115100.790101.46
5224693-22469398.41599.07
6228272-22827299.983100.65
45min1219910-21991096.320100.323.1597.12101.153.15
2241539-241539105.794106.67
3229615-229615100.571101.41
4229829-229829100.665101.50
5224794-22479498.45999.28
6228564-228564100.111100.94
60min1218934-21893495.89399.933.2696.86100.933.26
2241217-241217105.653106.71
3228838-228838100.231101.24
4228736-228736100.186101.19
5223832-22383298.03899.02
6227297-22729799.556100.55
极限1218311-21831195.62099.693.2796.74100.853.27
2240617-240617105.390106.62
3227965-22796599.848101.02
4228476-228476100.072101.24
5223145-22314597.73798.88
6227069-22706999.456100.62
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