磷酸奥司他韦干混悬剂项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号101096-202404对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.6对照品水分(%)0对照品稀释倍数100
标示量(mg)75供试品稀释倍数1系数0.7612
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
19.911524099152282215232371521978152047515225220.10
29.931519458152062515200420.06
单位质量响应值RSD%判断
153634.91153075.730.26数据可信
供试品溶液-2024111821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%
5min11661221-166122198.553100.022.3898.55100.022.38
21648498-164849897.79897.80
31651415-165141597.97197.97
41748980-1748980103.759103.76
51690808-1690808100.308100.31
61715026-1715026101.745101.74
10min11663259-166325998.67499.372.5499.77100.482.53
21638751-163875197.22098.31
31622399-162239996.25097.34
41733658-1733658102.850104.00
51680833-168083399.716100.83
61710954-1710954101.503102.63
15min11652656-165265698.04599.482.20100.24101.692.18
21622349-162234996.24798.41
31706064-1706064101.213103.37
41718196-1718196101.933104.23
51663308-166330898.677100.90
61698246-1698246100.749103.01
20min11633250-163325096.89397.562.35100.17100.882.34
21608976-160897695.45398.69
31601722-160172295.02398.31
41697762-1697762100.721104.15
51643197-164319797.484100.80
61681693-168169399.767103.15
30min11617786-161778695.97696.372.48100.33100.772.46
21594995-159499594.62498.92
31569697-156969793.12397.46
41676537-167653799.462104.01
51624710-162471096.387100.79
61662700-166270098.641103.13
极限11599400-159940094.88595.622.03100.31101.102.04
21579433-157943393.70199.05
31582987-158298793.91299.28
41656759-165675998.288103.94
51605732-160573295.261100.73
61646824-164682497.699103.28
磷酸奥司他韦干混悬剂项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号101096-202404对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.6对照品水分(%)0对照品稀释倍数100
标示量(mg)75供试品稀释倍数1系数0.7612
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
19.911523942152472215235231524680152367415241080.04
29.931522204151963215209180.12
单位质量响应值RSD%判断
153794.95153163.950.30数据可信
供试品溶液-2024111821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%
5min11563843-156384392.70195.711.9792.7095.711.97
21648342-164834297.71097.71
31595961-159596194.60594.60
41619563-161956396.00496.00
51614864-161486495.72595.73
61645201-164520197.52497.52
10min11599095-159909594.79197.271.8495.8298.341.84
21646357-164635797.59298.68
31615829-161582995.78396.83
41648454-164845497.71698.78
51685591-168559199.918100.98
61650417-165041797.83398.92
15min11586287-158628794.03196.341.8896.1198.481.87
21627349-162734996.46598.64
31596094-159609494.61396.73
41636860-163686097.02999.18
51670514-167051499.024101.20
61633837-163383796.85099.02
20min11578629-157862993.57795.441.8196.7198.651.80
21609971-160997195.43598.68
31579957-157995793.65696.82
41617654-161765495.89199.12
51657029-165702998.225101.50
61616749-161674995.83799.08
30min11564343-156434392.73194.431.8196.9098.711.80
21591326-159132694.33098.63
31562920-156292092.64696.85
41603797-160379795.06999.37
51640580-164058097.250101.62
61595275-159527594.56498.88
极限11555462-155546292.20493.711.8597.4099.041.84
21608111-160811195.325100.68
31543050-154305091.46896.71
41580249-158024993.67399.03
51618985-161898595.970101.42
61579137-157913793.60898.97
磷酸奥司他韦干混悬剂项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号101096-202404对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.6对照品水分(%)0对照品稀释倍数100
标示量(mg)75供试品稀释倍数1系数0.7612
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
19.911529114152987015270281525339152859215279890.12
29.931525178152329215242350.09
单位质量响应值RSD%判断
154186.58153497.990.32数据可信
供试品溶液-2024111921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%
5min11645891-164589197.33598.502.4797.3398.502.47
21616509-161650995.59795.60
31702824-1702824100.701100.70
41676678-167667899.15599.16
51720312-1720312101.736101.74
61631813-163181396.50296.50
10min11647686-164768697.44198.681.9598.5299.771.95
21636985-163698596.80897.87
31701730-1701730100.637101.76
41685345-168534599.668100.77
51704762-1704762100.816101.95
61635150-163515096.69997.77
15min11627428-162742896.24397.512.0298.4199.702.02
21617235-161723595.64097.78
31682863-168286399.521101.76
41666538-166653898.556100.76
51685681-168568199.688101.94
61613730-161373095.43397.58
20min11610822-161082295.26196.542.0798.4999.812.08
21597961-159796194.50097.70
31666175-166617598.534101.88
41659900-165990098.163101.47
51662629-166262998.324101.68
61597226-159722694.45797.66
30min11589276-158927693.98695.221.9998.2899.571.99
21580343-158034393.45897.71
31643264-164326497.179101.62
41627293-162729396.235100.63
51644927-164492797.278101.73
61576057-157605793.20597.46
极限11581492-158149293.52694.321.7598.8699.731.76
21574373-157437393.10598.39
31623854-162385496.031101.55
41606589-160658995.010100.47
51625362-162536296.120101.65
61558102-155810292.14397.44
磷酸奥司他韦干混悬剂项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号101096-202404对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.6对照品水分(%)0对照品稀释倍数100
标示量(mg)75供试品稀释倍数1系数0.7612
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
19.911525586152662315256341526052152415915256110.06
29.931518760151917215189660.02
单位质量响应值RSD%判断
153946.62152967.370.46数据可信
供试品溶液-2024111921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%
5min11463572-146357286.77096.606.2986.7796.606.30
21637327-163732797.07297.07
31660440-166044098.44298.44
41781773-1781773105.635105.64
51601656-160165694.95794.96
61631315-163131596.71596.72
10min11569010-156901093.02197.724.3093.9998.804.31
21644390-164439097.49098.57
31657450-165745098.26599.36
41775082-1775082105.239106.41
51597660-159766094.72095.78
61646211-164621197.59898.67
15min11570560-157056093.11396.703.7395.1198.863.76
21625999-162599996.40098.56
31643191-164319197.41999.60
41740409-1740409103.183105.53
51579213-157921393.62695.73
61627507-162750796.48998.65
20min11558641-155864192.40795.683.6395.4498.913.66
21607671-160767195.31398.55
31623079-162307996.22799.50
41719557-1719557101.947105.44
51561186-156118692.55895.71
61612542-161254295.60298.83
30min11550277-155027791.91194.643.5595.9798.943.58
21586808-158680894.07798.37
31602190-160219094.98999.33
41700522-1700522100.818105.44
51542546-154254691.45295.63
61595232-159523294.57698.87
极限11541257-154125791.37693.653.4696.4699.003.49
21569869-156986993.07298.41
31584427-158442793.93599.33
41680128-168012899.609105.35
51523026-152302690.29595.49
61578744-157874493.59898.94
磷酸奥司他韦干混悬剂项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号101096-202404对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.6对照品水分(%)0对照品稀释倍数100
标示量(mg)75供试品稀释倍数1系数0.7612
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
19.911550899154922115491941548802154182115479870.23
29.931534879153731115360950.12
单位质量响应值RSD%判断
156204.54154692.350.69数据可信
供试品溶液-2024112021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%
5min11753027-1753027102.60199.803.34102.6099.803.34
21769372-1769372103.558103.56
31686423-168642398.70398.70
41608920-160892094.16794.17
51715288-1715288100.392100.39
61698319-169831999.39999.40
10min11751579-1751579102.516100.112.87103.66101.222.88
21773691-1773691103.810104.96
31689649-168964998.89299.99
41634359-163435995.65696.70
51712464-1712464100.227101.34
61700698-170069899.538100.64
15min11743813-1743813102.06299.182.69104.34101.402.70
21744253-1744253102.088104.39
31678012-167801298.211100.41
41623397-162339795.01497.12
51694753-169475399.190101.42
61683649-168364998.541100.75
20min11724704-1724704100.94398.492.17104.36101.822.20
21725502-1725502100.990104.43
31663398-166339897.355100.64
41631809-163180995.50698.67
51675043-167504398.037101.37
61676640-167664098.130101.44
30min11703048-170304899.67697.961.67104.21102.381.65
21704427-170442799.757104.32
31643018-164301896.162100.53
41687137-168713798.745102.97
51656277-165627796.938101.36
61648260-164826096.469100.86
极限11684348-168434898.58195.982.51104.22101.492.50
21684490-168449098.590104.26
31626253-162625395.181100.62
41575176-157517692.19297.52
51637852-163785295.860101.36
61631179-163117995.470100.94
磷酸奥司他韦干混悬剂项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号101096-202404对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.6对照品水分(%)0对照品稀释倍数100
标示量(mg)75供试品稀释倍数1系数0.7612
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
19.911540555154206715447451539449154156115416750.13
29.931534864153590815353860.05
单位质量响应值RSD%判断
155567.61154620.950.44数据可信
供试品溶液-2024112021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%
5min11696257-169625799.50495.825.8199.5095.825.82
21521367-152136789.24589.24
31520140-152014089.17389.17
41636911-163691196.02296.02
51751903-1751903102.768102.77
61673838-167383898.18998.19
10min11711353-1711353100.38997.645.83101.4998.715.82
21549132-154913290.87391.86
31613436-161343694.64595.64
41609559-160955994.41895.48
51824462-1824462107.024108.17
61679260-167926098.50799.60
15min11693423-169342399.33796.444.68101.5698.584.70
21531405-153140589.83391.83
31610164-161016494.45396.50
41611339-161133994.52296.64
51752491-1752491102.802105.13
61664908-166490897.66599.85
20min11673313-167331398.15895.274.85101.4898.494.87
21513367-151336788.77591.77
31577555-157755592.54195.63
41596758-159675893.66796.83
51737797-1737797101.940105.41
61645848-164584896.54799.82
30min11655016-165501697.08494.244.78101.5098.524.80
21497921-149792187.86991.86
31558567-155856791.42795.55
41582167-158216792.81197.02
51715520-1715520100.634105.24
61629946-162994695.61499.96
极限11635577-163557795.94493.244.47101.4498.574.50
21491878-149187887.51592.48
31548560-154856090.84095.98
41559567-155956791.48596.72
51692283-169228399.271104.99
61609046-160904694.38899.79
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