依折麦布瑞舒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RSF-703-230318-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(%)98.9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0.96
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.944698554698604697184695654692714696540.06
210.894683704688444686070.08
单位质量响应值RSD%判断
42929.9843030.950.17数据可信
加速6月-供试品溶液-CLB05410批-瑞舒伐他汀钙-pH7.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1452470-45247089.95682.476.7689.9682.476.76
2392446-39244678.02278.02
3427359-42735984.96384.96
4379313-37931375.41175.41
5435328-43532886.54886.55
6402010-40201079.92479.92
10min1489054-48905497.22996.031.1997.3896.171.19
2478888-47888895.20895.34
3480493-48049395.52795.67
4490686-49068697.55497.68
5482788-48278895.98396.13
6476296-47629694.69394.83
15min1494546-49454698.32198.211.3698.6398.501.35
2499391-49939199.28499.57
3485696-48569696.56296.86
4503878-503878100.176100.46
5490058-49005897.42997.73
6490330-49033097.48397.77
20min1494661-49466198.34498.251.4098.8298.721.39
2499606-49960699.32799.78
3485166-48516696.45696.92
4504299-504299100.260100.72
5490462-49046297.50997.98
6490992-49099297.61498.07
30min1493606-49360698.13498.001.4598.7798.631.44
2498471-49847199.10199.72
3484176-48417696.25996.88
4503560-503560100.113100.74
5488891-48889197.19797.83
6488922-48892297.20397.82
45min1491723-49172397.76097.801.4298.5698.581.41
2497528-49752898.91499.70
3483318-48331896.08996.87
4502379-50237999.878100.67
5488446-48844697.10897.90
6488058-48805897.03197.81
60min1491892-49189297.79397.671.4098.7698.621.39
2497264-49726498.86199.81
3482437-48243795.91496.86
4500862-50086299.577100.53
5487477-48747796.91697.87
6487705-48770596.96197.90
极限1491248-49124897.66597.501.4498.7998.621.43
2496318-49631898.67399.79
3481603-48160395.74896.85
4500548-50054899.514100.64
5486566-48656696.73497.85
6486212-48621296.66497.77
依折麦布瑞舒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%
110.664232654231534231324227274225604229670.08
210.544217614222904220260.09
单位质量响应值RSD%判断
39677.9540040.420.65数据可信
加速6月-供试品溶液-CLB05410批-依折麦布-pH7.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1207951-20795146.95535.6728.4146.9635.6828.41
294455-9445521.32821.33
3184890-18489041.74841.75
4177594-17759440.10140.10
5172258-17225838.89638.90
6110793-11079325.01725.02
10min1395088-39508889.21184.627.0289.2984.687.03
2323834-32383473.12273.16
3380691-38069185.96086.03
4391794-39179488.46788.53
5385519-38551987.05087.11
6371584-37158483.90383.95
15min1446326-446326100.78099.900.86101.01100.100.88
2438418-43841898.99599.15
3439870-43987099.32299.54
4439189-43918999.16999.38
5447191-447191100.976101.19
6443552-443552100.154100.34
20min1446770-446770100.880100.120.78101.28100.490.78
2440945-44094599.56599.89
3440826-44082699.53899.92
4439637-43963799.27099.65
5447781-447781101.109101.49
6444421-444421100.350100.70
30min1445809-445809100.66399.890.75101.23100.430.76
2440275-44027599.41499.90
3439909-43990999.33199.88
4438852-43885299.09399.64
5446835-446835100.895101.44
6442747-44274799.972100.49
45min1444492-444492100.36699.670.79101.10100.370.80
2439150-43915099.16099.81
3439070-43907099.14299.85
4437522-43752298.79299.50
5446359-446359100.788101.50
6441835-44183599.766100.45
60min1444587-444587100.38899.570.80101.29100.430.80
2438982-43898299.12299.94
3438307-43830798.97099.84
4436907-43690798.65399.53
5445432-445432100.578101.46
6441500-44150099.690100.54
极限1444157-444157100.29099.360.77101.36100.400.78
2438057-43805798.91399.90
3437602-43760298.81099.85
4436282-43628298.51299.55
5444029-444029100.262101.31
6440177-44017799.392100.41
依折麦布瑞舒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RSF-703-230318-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(%)98.9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0.96
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.944685824685994687044697124690404689270.11
210.894680704679694680200.02
单位质量响应值RSD%判断
42863.5342977.040.19数据可信
长期6月-供试品溶液-CLB05410批-瑞舒伐他汀钙-pH7.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1299653-29965359.65874.3015.8859.6674.3015.88
2449373-44937389.46589.47
3437202-43720287.04287.04
4334888-33488866.67366.67
5345409-34540968.76768.77
6372579-37257974.17774.18
10min1445952-44595288.78493.903.7588.8894.033.76
2490773-49077397.70897.86
3483457-48345796.25196.40
4480475-48047595.65795.77
5474977-47497794.56394.68
6454280-45428090.44290.57
15min1493036-49303698.15897.831.9998.4198.112.00
2497843-49784399.11599.43
3496837-49683798.91599.22
4493307-49330798.21298.48
5495429-49542998.63598.91
6471794-47179493.92994.20
20min1500155-50015599.57698.341.5299.9998.781.51
2498094-49809499.16599.64
3494907-49490798.53199.00
4494210-49421098.39298.83
5496875-49687598.92399.36
6479315-47931595.42795.86
30min1499428-49942899.43198.431.01100.0199.041.01
2497561-49756199.05999.70
3495209-49520998.59199.23
4493331-49333198.21798.82
5495779-49577998.70499.31
6485191-48519196.59697.19
45min1512681-512681102.06998.672.04102.8199.442.02
2497177-49717798.98399.79
3494377-49437798.42599.22
4492385-49238598.02998.79
5495553-49555398.65999.43
6481449-48144995.85196.60
60min1497785-49778599.10498.041.15100.0298.971.15
2496221-49622198.79299.76
3492964-49296498.14499.11
4491718-49171897.89698.82
5494029-49402998.35699.29
6481845-48184595.93096.84
极限1496498-49649898.84897.741.1999.9398.841.19
2494760-49476098.50199.64
3491904-49190497.93399.06
4488886-48888697.33298.42
5493403-49340398.23199.33
6480268-48026895.61696.69
依折麦布瑞舒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%
110.664221484221174221524227134222934222850.06
210.544214684213804214240.02
单位质量响应值RSD%判断
39613.9839983.300.66数据可信
长期6月-供试品溶液-CLB05410批-依折麦布-pH7.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1137290-13729031.04738.3811.1631.0538.3811.16
2178147-17814740.28740.29
3173500-17350039.23639.24
4162292-16229236.70136.70
5173018-17301839.12739.13
6193970-19397043.86543.87
10min1326382-32638273.80981.466.5073.8681.526.49
2390104-39010488.21988.29
3378993-37899385.70785.77
4360897-36089781.61481.68
5362877-36287782.06282.13
6341918-34191877.32277.40
15min1440251-44025199.56099.171.0299.7399.361.02
2441671-44167199.881100.10
3439956-43995699.49399.70
4440031-44003199.51099.71
5439601-43960199.41399.61
6429536-42953697.13797.34
20min1441851-44185199.92299.990.61100.26100.350.60
2442478-442478100.063100.44
3438873-43887399.24899.62
4442749-442749100.125100.49
5446671-446671101.012101.38
6440261-44026199.56299.93
30min1440877-44087799.701100.010.58100.21100.540.57
2441824-44182499.916100.46
3438766-43876699.22499.76
4441707-44170799.889100.42
5445679-445679100.787101.32
6444609-444609100.545101.08
45min1453457-453457102.546100.231.25103.22100.931.23
2441369-44136999.813100.53
3438134-43813499.08199.79
4440959-44095999.720100.42
5445193-445193100.677101.38
6440180-44018099.544100.24
60min1439646-43964699.42399.560.51100.27100.430.51
2440351-44035199.582100.46
3437051-43705198.83699.71
4440356-44035699.584100.45
5444056-444056100.420101.29
6440084-44008499.522100.39
极限1438741-43874199.21899.280.59100.23100.320.59
2439103-43910399.300100.35
3435992-43599298.59799.63
4437750-43775098.994100.02
5443750-443750100.351101.39
6438833-43883399.239100.27
依折麦布瑞舒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RSF-703-230318-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(%)98.9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0.96
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.944691064687124684654685944683634686480.07
210.894695894697774696830.03
单位质量响应值RSD%判断
42838.0343129.750.48数据可信
中间条件6月-供试品溶液-CLB05410批-瑞舒伐他汀钙-pH7.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1403250-40325080.16579.2110.8380.1679.2110.83
2438759-43875987.22487.22
3336427-33642766.88166.88
4440907-44090787.65187.65
5356689-35668970.90970.91
6414777-41477782.45682.46
10min1480915-48091595.60496.110.7295.7496.240.73
2486546-48654696.72496.87
3484281-48428196.27496.38
4488239-48823997.06097.21
5481239-48123995.66995.79
6479454-47945495.31495.45
15min1493229-49322998.05298.391.7598.3598.681.75
2506959-506959100.782101.09
3495918-49591898.58798.86
4501227-50122799.64299.95
5489899-48989997.39097.67
6482255-48225595.87196.17
20min1493558-49355898.11898.381.7798.5798.841.78
2506553-506553100.701101.18
3496737-49673798.75099.19
4501194-50119499.636100.11
5489550-48955097.32197.76
6481704-48170495.76196.22
30min1492569-49256997.92198.271.8098.5498.891.80
2506241-506241100.639101.28
3496239-49623998.65199.25
4500755-50075599.548100.19
5489248-48924897.26197.86
6480958-48095895.61396.23
45min1493377-49337798.08298.181.7998.8698.961.79
2505390-505390100.470101.28
3495771-49577198.55899.32
4500209-50020999.440100.25
5487900-48790096.99397.76
6480545-48054595.53196.31
60min1491776-49177697.76398.001.7298.7198.941.72
2504417-504417100.276101.25
3494378-49437898.28199.21
4499144-49914499.228100.20
5487381-48738196.89097.82
6480607-48060795.54396.48
极限1489741-48974197.35997.711.7398.4798.831.73
2503633-503633100.121101.27
3492829-49282997.97399.07
4497351-49735198.872100.01
5485948-48594896.60597.69
6479656-47965695.35496.45
依折麦布瑞舒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%
110.664223174219044218334219544215164219050.07
210.544230084230804230440.02
单位质量响应值RSD%判断
39578.3340137.001.00数据可信
中间条件6月-供试品溶液-CLB05410批-依折麦布-pH7.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1193057-19305743.59540.019.5743.6040.019.58
2162800-16280036.76336.76
3156264-15626435.28735.29
4175512-17551239.63339.63
5175156-17515639.55339.55
6200294-20029445.22945.23
10min1374319-37431984.52785.613.8984.6085.683.89
2364211-36421182.24482.31
3368856-36885683.29383.35
4374250-37425084.51184.58
5389312-38931287.91287.98
6403778-40377891.17991.25
15min1438626-43862699.04899.741.5899.2699.951.58
2447943-447943101.152101.35
3432010-43201097.55497.75
4449402-449402101.482101.69
5445604-445604100.624100.84
6436610-43661098.59398.82
20min1445843-445843100.678100.331.37101.06100.701.37
2450165-450165101.654102.02
3437536-43753698.80299.16
4450074-450074101.633102.01
5445958-445958100.704101.08
6436146-43614698.48898.88
30min1444838-444838100.451100.131.34101.00100.681.34
2449709-449709101.551102.09
3437494-43749498.79399.32
4448980-448980101.386101.93
5444381-444381100.348100.90
6435174-43517498.26998.82
45min1445814-445814100.671100.081.37101.39100.801.36
2449137-449137101.422102.13
3437083-43708398.70099.39
4448734-448734101.331102.05
5443795-443795100.215100.93
6434720-43472098.16698.89
60min1444494-444494100.37399.901.31101.25100.771.31
2448333-448333101.240102.11
3435882-43588298.42999.28
4447588-447588101.072101.96
5443231-443231100.088100.97
6434774-43477498.17899.06
极限1442464-44246499.91599.621.30100.96100.661.29
2447362-447362101.021102.06
3434889-43488998.20499.22
4446403-446403100.804101.86
5442105-44210599.834100.88
6433769-43376997.95199.00
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