依折麦布匹伐他汀钙片项目信息
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%
110.851293211296241295961293131294081294520.12
210.881309931308011308970.11
单位质量响应值RSD%判断
11931.0612030.970.59数据可信
供试品溶液-24021802批-匹伐他汀钙-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%
5min1120514-12051487.18187.741.6287.1887.741.62
2123371-12337189.24789.25
3122630-12263088.71188.71
4118904-11890486.01686.02
5119324-11932486.32086.32
6123001-12300188.98088.98
10min1127197-12719792.01591.842.0492.1691.992.04
2128956-12895693.28893.44
3130077-13007794.09994.25
4124133-12413389.79989.94
5123644-12364489.44589.59
6127735-12773592.40492.55
15min1126954-12695491.83991.911.9992.1492.211.99
2129076-12907693.37493.68
3130382-13038294.31994.62
4124493-12449390.05990.35
5123901-12390189.63189.92
6127513-12751392.24492.55
20min1126820-12682091.74291.712.0892.1992.172.07
2129007-12900793.32593.78
3130033-13003394.06794.53
4124030-12403089.72490.17
5123456-12345689.30989.75
6127345-12734592.12292.58
30min1126326-12632691.38591.412.0191.9992.012.01
2128345-12834592.84693.46
3129700-12970093.82694.44
4123844-12384489.59090.18
5123144-12314489.08389.67
6126785-12678591.71792.33
45min1125922-12592291.09391.152.0891.8591.912.08
2128098-12809892.66793.44
3129341-12934193.56694.34
4123075-12307589.03389.78
5122887-12288788.89789.64
6126722-12672291.67292.43
60min1125908-12590891.08390.932.1291.9991.842.12
2127827-12782792.47193.40
3128990-12899093.31294.24
4123017-12301788.99189.88
5122161-12216188.37289.26
6126252-12625291.33292.25
极限1125507-12550790.79390.762.0291.8591.822.02
2127531-12753192.25793.34
3128713-12871393.11294.20
4122742-12274288.79289.83
5122376-12237688.52889.56
6125869-12586991.05592.12
依折麦布匹伐他汀钙片项目信息
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ZT-705-231101-1-D对照品来源中检院对照品使用方法直接使用
对照品含量(%)100.0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%
110.933850833863783863153856463860313858910.14
211.003886773878533882650.16
单位质量响应值RSD%判断
35305.6735296.820.02数据可信
供试品溶液-24021802批-依折麦布-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%
5min116942-169424.3194.967.444.324.967.42
220923-209235.3345.33
319386-193864.9424.94
418830-188304.8014.80
520003-200035.1005.10
620584-205845.2485.25
10min130988-309887.9008.061.727.918.071.70
232201-322018.2108.22
331914-319148.1368.14
431608-316088.0588.07
532069-320698.1768.18
630961-309617.8937.90
15min133910-339108.6458.710.998.678.730.99
234182-341828.7158.74
333989-339898.6658.69
434067-340678.6858.71
534813-348138.8768.90
633958-339588.6588.68
20min134577-345778.8158.752.628.858.782.61
234859-348598.8878.92
334702-347028.8478.88
434913-349138.9018.94
534299-342998.7448.78
632535-325358.2958.33
30min135137-351378.9588.624.299.018.674.27
234685-346858.8438.89
333748-337488.6048.65
433550-335508.5548.60
534704-347048.8488.90
631147-311477.9417.99
45min134467-344678.7878.572.388.858.632.36
234108-341088.6968.76
332888-328888.3858.45
432571-325718.3048.37
534311-343118.7488.81
633260-332608.4808.54
60min134758-347588.8628.701.628.948.781.59
234510-345108.7988.88
334312-343128.7488.83
433905-339058.6448.72
533202-332028.4658.55
633947-339478.6558.73
极限134710-347108.8498.711.978.948.801.95
234787-347878.8698.96
334681-346818.8428.94
433798-337988.6178.71
533127-331278.4468.54
633850-338508.6308.72
依折麦布匹伐他汀钙片项目信息
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%
110.851301771297161299391299011297231298910.15
210.881294661298791296720.23
单位质量响应值RSD%判断
11971.5211918.380.32数据可信
供试品溶液-24021802批-匹伐他汀钙-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%
5min1115638-11563883.90585.054.0183.9085.054.01
2116169-11616984.29084.29
3123842-12384289.85889.86
4110660-11066080.29380.29
5121380-12138088.07188.07
6115645-11564583.91083.91
10min1126769-12676991.98191.671.1592.1291.821.15
2124670-12467090.45890.60
3128394-12839493.16093.31
4127516-12751692.52392.66
5125540-12554091.09091.24
6125191-12519190.83690.98
15min1126710-12671091.93991.611.3392.2391.901.32
2124340-12434090.21990.51
3128443-12844393.19693.50
4127824-12782492.74793.03
5125381-12538190.97491.27
6124838-12483890.58090.87
20min1126706-12670691.93691.531.2592.3891.981.25
2124528-12452890.35590.80
3128184-12818493.00893.47
4127435-12743592.46592.91
5125718-12571891.21991.67
6124281-12428190.17690.62
30min1126501-12650191.78791.311.3092.3991.911.29
2123964-12396489.94690.54
3128047-12804792.90993.52
4127051-12705192.18692.78
5125233-12523390.86791.47
6124254-12425490.15690.75
45min1125433-12543391.01290.721.6991.7691.471.68
2124017-12401789.98590.73
3127852-12785292.76793.54
4126684-12668491.92092.67
5121930-12193088.47089.22
6124245-12424590.15090.89
60min1125415-12541590.99990.811.1891.9091.711.18
2123848-12384889.86290.75
3127452-12745292.47793.40
4126206-12620691.57392.48
5124166-12416690.09390.99
6123844-12384489.85990.75
极限1125209-12520990.84990.631.2191.9191.681.21
2123666-12366689.73090.77
3127221-12722192.30993.39
4125711-12571191.21492.27
5124588-12458890.39991.45
6123029-12302989.26890.31
依折麦布匹伐他汀钙片项目信息
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ZT-705-231101-1-D对照品来源中检院对照品使用方法直接使用
对照品含量(%)100.0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%
110.933866413855793866813864443859003862490.13
211.003855913862103859000.12
单位质量响应值RSD%判断
35338.4335081.820.52数据可信
供试品溶液-24021802批-依折麦布-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%
5min120242-202425.1745.187.085.175.187.07
219625-196255.0165.02
321604-216045.5225.52
419024-190244.8634.86
522339-223395.7105.71
618766-187664.7974.80
10min133163-331638.4778.132.738.498.142.73
231050-310507.9377.95
332415-324158.2868.29
431283-312837.9968.00
530974-309747.9177.93
631907-319078.1568.16
15min134056-340568.7058.531.718.738.551.73
232669-326698.3518.37
333879-338798.6608.68
433500-335008.5638.58
532745-327458.3708.39
633353-333538.5258.55
20min135383-353839.0448.673.019.088.703.00
233499-334998.5638.60
334248-342488.7548.79
432528-325288.3158.35
533257-332578.5018.54
634558-345588.8338.87
30min135595-355959.0988.742.569.158.792.55
232898-328988.4098.46
334152-341528.7308.78
434021-340218.6968.75
533971-339718.6838.73
634516-345168.8238.87
45min134455-344558.8078.563.948.878.623.91
232450-324508.2958.36
334565-345658.8358.90
433958-339588.6808.74
531283-312837.9968.06
634135-341358.7258.79
60min134269-342698.7608.711.348.848.791.33
233785-337858.6368.71
333280-332808.5078.59
434370-343708.7858.86
534301-343018.7688.85
634452-344528.8068.89
极限135094-350948.9708.861.309.078.951.30
234758-347588.8858.98
335135-351358.9819.08
434537-345378.8288.92
534368-343688.7858.88
633963-339638.6818.78
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