匹伐他汀钙依折麦布片项目信息
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101245-202102对照品来源中检院对照品使用方法直接使用
对照品含量(%)96.3对照品水分(%)0对照品稀释倍数5000
标示量(mg)2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%
110.781283261285011283231283841283491283770.06
210.771286301290871288580.26
单位质量响应值RSD%判断
11908.8111964.530.34数据可信
加速6月-供试品溶液-2024061321批-匹伐他汀钙-pH4.5(内含0.1%Tween)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1111151-11115180.70588.505.6580.7188.505.65
2127721-12772192.73692.74
3118997-11899786.40286.40
4130706-13070694.90494.90
5120656-12065687.60787.61
6122072-12207288.63588.63
10min1130724-13072494.91797.211.7195.0597.361.72
2134397-13439797.58497.74
3133119-13311996.65696.80
4137762-137762100.027100.19
5133899-13389997.22297.37
6133401-13340196.86197.01
15min1133345-13334596.82097.881.4297.1198.191.42
2134477-13447797.64297.96
3134569-13456997.70998.01
4138551-138551100.600100.92
5134336-13433697.53997.85
6133566-13356696.98097.29
20min1133737-13373797.10597.971.4097.5698.441.41
2134323-13432397.53098.01
3135027-13502798.04198.51
4138584-138584100.624101.12
5134513-13451397.66898.14
6133359-13335996.83097.30
30min1133322-13332296.80397.911.3597.4298.541.35
2133965-13396597.27097.91
3135090-13509098.08798.72
4138347-138347100.452101.11
5134062-13406297.34197.97
6134288-13428897.50598.14
45min1132753-13275396.39097.511.3597.1798.311.35
2133599-13359997.00497.81
3134820-13482097.89198.69
4137649-13764999.945100.77
5134013-13401397.30598.10
6132951-13295196.53497.33
60min1132646-13264696.31297.381.5297.2598.341.52
2133348-13334896.82297.79
3134452-13445297.62498.58
4138026-138026100.219101.21
5133630-13363097.02797.98
6132616-13261696.29197.25
极限1133519-13351996.94697.411.3498.0498.531.34
2133538-13353896.96098.09
3134277-13427797.49798.62
4137604-13760499.912101.07
5133570-13357096.98398.10
6132440-13244096.16397.28
匹伐他汀钙依折麦布片项目信息
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DSMF-387-240606对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.75对照品水分(%)0对照品稀释倍数1000
标示量(mg)10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%
111.163866453865313861593861223859383862790.08
211.123864373865333864850.02
单位质量响应值RSD%判断
34612.8134755.850.30数据可信
加速6月-供试品溶液-2024061321批-依折麦布-pH4.5(内含0.1%Tween)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1149999-14999938.82539.4111.7238.8339.4111.72
2170786-17078644.20544.21
3162602-16260242.08742.09
4146198-14619837.84137.84
5120910-12091031.29631.30
6163087-16308742.21342.21
10min1285006-28500673.77074.144.6573.8374.204.65
2305427-30542779.05579.13
3288473-28847374.66774.74
4270457-27045770.00470.07
5273293-27329370.73870.79
6295865-29586576.58076.65
15min1333091-33309186.21687.431.8886.4087.621.89
2346298-34629889.63489.84
3340512-34051288.13788.33
4333405-33340586.29786.48
5330506-33050685.54785.72
6342949-34294988.76788.97
20min1352876-35287691.33792.611.2891.6792.951.29
2363682-36368294.13494.49
3361342-36134293.52893.87
4355105-35510591.91492.24
5353422-35342291.47891.79
6360420-36042093.29093.64
30min1368498-36849895.38096.490.9395.8696.980.94
2375747-37574797.25797.77
3375474-37547497.18697.68
4371146-37114696.06696.54
5369595-36959595.66496.13
6376337-37633797.40997.91
45min1375160-37516097.10597.790.5397.7598.440.55
2380510-38051098.49099.16
3379061-37906198.11498.77
4376919-37691997.56098.20
5376320-37632097.40598.03
6378871-37887198.06598.73
60min1376983-37698397.57798.130.5398.3898.940.55
2382305-38230598.95499.79
3379535-37953598.23799.06
4377799-37779997.78898.59
5377740-37774097.77398.56
6380382-38038298.45699.28
极限1378004-37800497.84198.320.5198.8199.290.52
2382851-38285199.095100.10
3380696-38069698.53899.52
4378424-37842497.95098.91
5378310-37831097.92098.87
6380759-38075998.55499.55
匹伐他汀钙依折麦布片项目信息
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101245-202102对照品来源中检院对照品使用方法直接使用
对照品含量(%)96.3对照品水分(%)0对照品稀释倍数5000
标示量(mg)2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%
110.781285741285051281511285861285941284820.15
210.771294271299841297060.31
单位质量响应值RSD%判断
11918.5512043.270.74数据可信
长期6月-供试品溶液-2024061321批-匹伐他汀钙-pH4.5(内含0.1%Tween)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1106329-10632976.92181.7610.6376.9281.7610.63
2121013-12101387.54387.54
3103317-10331774.74274.74
4120270-12027087.00687.01
5128857-12885793.21893.22
698347-9834771.14671.15
10min1135098-13509897.73397.360.9797.8697.490.98
2134858-13485897.55997.70
3132738-13273896.02596.15
4133506-13350696.58196.73
5136464-13646498.72198.88
6134805-13480597.52197.64
15min1139387-139387100.83598.951.26101.1399.251.25
2135000-13500097.66297.97
3137014-13701499.11999.40
4134755-13475597.48597.79
5136917-13691799.04999.37
6137621-13762199.55899.84
20min1138541-138541100.22398.861.20100.6899.321.19
2135034-13503497.68698.16
3137886-13788699.750100.20
4134467-13446797.27697.74
5136428-13642898.69599.18
6137560-13756099.51499.96
30min1138559-138559100.23698.761.22100.8699.381.20
2134600-13460097.37298.01
3137576-13757699.525100.14
4134518-13451897.31397.94
5136470-13647098.72599.37
6137354-13735499.36599.98
45min1138340-138340100.07898.511.30100.8799.301.28
2134272-13427297.13597.93
3137591-13759199.536100.32
4134128-13412897.03197.82
5135673-13567398.14998.96
6137051-13705199.14599.92
60min1137656-13765699.58398.261.21100.5499.221.19
2133892-13389296.86097.82
3137223-13722399.270100.22
4133910-13391096.87397.83
5135704-13570498.17199.15
6136580-13658098.80599.75
极限1137464-13746499.44498.071.14100.5799.191.13
2133783-13378396.78197.90
3136767-13676798.940100.05
4133820-13382096.80897.92
5135281-13528197.86599.01
6136254-13625498.56999.68
匹伐他汀钙依折麦布片项目信息
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DSMF-387-240606对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.75对照品水分(%)0对照品稀释倍数1000
标示量(mg)10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%
111.163863643860333861633860643860013861250.04
211.123875403878933877160.07
单位质量响应值RSD%判断
34599.0134866.550.55数据可信
长期6月-供试品溶液-2024061321批-依折麦布-pH4.5(内含0.1%Tween)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min147963-4796312.39719.8257.6812.4019.8257.67
2158328-15832840.92440.92
348131-4813112.44112.44
491209-9120923.57523.58
573167-7316718.91218.91
641301-4130110.67510.68
10min1199425-19942551.54758.7619.4551.5758.7919.47
2290874-29087475.18475.25
3174448-17444845.09145.11
4255965-25596566.16166.20
5246828-24682863.79963.83
6196348-19634850.75150.77
15min1306388-30638879.19480.905.9279.3081.035.96
2336552-33655286.99187.18
3282450-28245073.00773.10
4322245-32224583.29383.44
5321813-32181383.18183.32
6308402-30840279.71579.82
20min1342071-34207188.41889.312.6088.6689.582.64
2357240-35724092.33892.68
3330723-33072385.48485.70
4348900-34890090.18390.47
5349929-34992990.44990.73
6344258-34425888.98389.22
30min1366209-36620994.65794.790.9595.0495.200.98
2368149-36814995.15895.65
3360946-36094693.29693.66
4366504-36650494.73395.17
5371685-37168596.07296.50
6366814-36681494.81395.20
45min1376483-37648397.31297.280.6197.8697.850.58
2373291-37329196.48797.14
3375288-37528897.00397.52
4375396-37539697.03197.63
5379787-37978798.16698.75
6377897-37789797.67898.22
60min1377953-37795397.69297.640.5898.4098.370.56
2375140-37514096.96597.78
3377685-37768597.62398.30
4376070-37607097.20697.96
5381411-38141198.58699.34
6378156-37815697.74598.45
极限1378799-37879997.91197.860.7598.7898.760.73
2374214-37421496.72697.70
3378140-37814097.74198.58
4377484-37748497.57198.49
5382611-38261198.89699.81
6380463-38046398.34199.21
匹伐他汀钙依折麦布片项目信息
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101245-202102对照品来源中检院对照品使用方法直接使用
对照品含量(%)96.3对照品水分(%)0对照品稀释倍数5000
标示量(mg)2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%
110.781291171290081288981290271291191290340.08
210.771290621293701292160.17
单位质量响应值RSD%判断
11969.7611997.770.17数据可信
中间条件6月-供试品溶液-2024061321批-匹伐他汀钙-pH4.5(内含0.1%Tween)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1126742-12674291.66481.1217.0791.6681.1217.07
2104866-10486675.84275.84
3120091-12009186.85386.85
4131107-13110794.82094.82
578341-7834156.65956.66
6111811-11181180.86580.87
10min1133715-13371596.70796.772.3896.8696.902.40
2134498-13449897.27397.40
3133885-13388596.83096.97
4138387-138387100.086100.24
5128421-12842192.87892.97
6133868-13386896.81796.95
15min1134432-13443297.22597.811.7497.5498.101.75
2136021-13602198.37498.66
3132752-13275296.01096.32
4139189-139189100.666100.99
5133185-13318596.32396.57
6135828-13582898.23598.53
20min1131345-13134594.99397.442.2995.4797.902.30
2136162-13616298.47698.93
3132620-13262095.91596.38
4139509-139509100.897101.39
5132568-13256895.87796.29
6136175-13617598.48698.95
30min1133746-13374696.72997.581.9297.3698.201.93
2135918-13591898.30098.92
3132607-13260795.90596.53
4138805-138805100.388101.05
5132037-13203795.49396.06
6136444-13644498.68099.30
45min1133279-13327996.39197.462.0697.1998.242.06
2136079-13607998.41699.20
3131862-13186295.36696.15
4138758-138758100.354101.18
5132108-13210895.54496.27
6136443-13644398.68099.47
60min1131964-13196495.44097.182.4296.4098.122.42
2135520-13552098.01298.96
3131398-13139895.03195.98
4139101-139101100.602101.60
5131456-13145695.07395.96
6136739-13673998.89499.85
极限1132685-13268595.96297.072.1997.0898.182.19
2134769-13476997.46998.58
3131002-13100294.74595.85
4138055-13805599.845101.01
5131653-13165395.21596.26
6137149-13714999.190100.31
匹伐他汀钙依折麦布片项目信息
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DSMF-387-240606对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.75对照品水分(%)0对照品稀释倍数1000
标示量(mg)10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%
111.163855653858203856223852923860183856630.08
211.123859633858373859000.03
单位质量响应值RSD%判断
34557.6234703.240.30数据可信
中间条件6月-供试品溶液-2024061321批-依折麦布-pH4.5(内含0.1%Tween)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1153338-15333839.75125.1543.6339.7525.1543.62
260279-6027915.62715.63
397849-9784925.36625.37
484842-8484221.99421.99
546811-4681112.13512.14
6139037-13903736.04436.04
10min1280719-28071972.77363.7415.4472.8463.7815.45
2238912-23891261.93561.96
3257332-25733266.71066.75
4218578-21857856.66456.70
5189923-18992349.23549.26
6289788-28978875.12475.18
15min1334164-33416486.62883.075.2886.8283.225.31
2315763-31576381.85881.99
3324003-32400383.99484.15
4307960-30796079.83579.97
5297426-29742677.10477.21
6343269-34326988.98989.17
20min1346490-34649089.82490.012.6490.1690.292.67
2345467-34546789.55889.82
3349566-34956690.62190.91
4343542-34354289.05989.32
5335145-33514586.88287.11
6362995-36299594.10294.44
30min1367368-36736895.23695.571.4295.7296.011.45
2366583-36658395.03295.45
3371018-37101896.18296.63
4367735-36773595.33195.74
5361874-36187493.81294.19
6377435-37743597.84698.34
45min1373640-37364096.86298.051.0797.5098.641.08
2380119-38011998.54199.11
3378973-37897398.24498.85
4380210-38021098.56599.14
5373049-37304996.70997.24
6383239-38323999.350100.00
60min1370390-37039096.01998.271.4696.8299.031.46
2378657-37865798.16298.90
3380916-38091698.74899.52
4384648-38464899.716100.45
5375373-37537397.31198.00
6384438-38443899.661100.48
极限1374699-37469997.13698.441.2098.1099.361.21
2376517-37651797.60898.51
3380303-38030398.58999.52
4382719-38271999.215100.12
5377165-37716597.77698.63
6386957-386957100.314101.30
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