氟伐他汀钙项目信息
介质体积(ml)1000取样体积(ml)1.5补液体积(ml)1.5
对照品批号100800-202304对照品来源中检院对照品使用方法直接使用
对照品含量(%)97.3对照品水分(%)0对照品稀释倍数125
标示量(mg)80供试品稀释倍数1系数0.9493
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.661453271145384914542991454047145257314536080.05
210.611455534145427014549020.07
单位质量响应值RSD%判断
136360.98137125.540.40数据可信
供试品溶液-X0734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%
60min1120424-1204248.1347.955.618.137.955.59
2109698-1096987.4107.41
3115750-1157507.8197.82
4127825-1278258.6348.63
5112095-1120957.5727.57
6120704-1207048.1538.15
120min1230170-23017015.54815.341.7715.5615.351.77
2224832-22483215.18715.20
3222847-22284715.05315.06
4224124-22412415.13915.15
5227104-22710415.34015.35
6233316-23331615.76015.77
240min1433447-43344729.27929.862.7929.3129.892.78
2456054-45605430.80630.84
3430899-43089929.10629.14
4428908-42890828.97229.01
5449007-44900730.33030.36
6453999-45399930.66730.70
360min1650093-65009343.91344.263.0943.9944.343.09
2674704-67470445.57545.66
3633777-63377742.81042.89
4631467-63146742.65442.73
5678945-67894545.86245.94
6662516-66251644.75244.83
480min1860183-86018358.10458.483.3458.2558.633.33
2896737-89673760.57360.72
3861636-86163658.20258.34
4822897-82289755.58555.73
5899813-89981360.78160.93
6853329-85332957.64157.79
600min11070885-107088572.33672.013.2372.5772.253.23
21101374-110137474.39674.64
31055865-105586571.32271.55
41007342-100734268.04468.27
51098889-109888974.22874.47
61062305-106230571.75771.99
720min11261968-126196885.24483.862.2885.5884.202.28
21263181-126318185.32685.68
31223568-122356882.65082.99
41191794-119179480.50480.83
51254940-125494084.76985.12
61253097-125309784.64484.99
840min11479796-147979699.95896.403.48100.4396.873.47
21445435-144543597.63798.12
31361948-136194891.99792.46
41385241-138524193.57194.02
51409522-140952295.21195.69
61480867-1480867100.030100.50
960min11479359-147935999.92899.901.38100.55100.521.37
21443745-144374597.52298.15
31473533-147353399.535100.13
41482039-1482039100.109100.70
51490876-1490876100.706101.33
61504482-1504482101.625102.25
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
1080min11477684-147768499.81599.621.46100.58100.381.45
21438242-143824297.15197.92
31465246-146524698.97599.72
41478685-147868599.883100.62
51487387-1487387100.470101.24
61501174-1501174101.402102.17
1200min11466750-146675099.07699.131.4499.99100.041.43
21430169-143016996.60597.52
31461172-146117298.70099.60
41474865-147486599.624100.51
51480472-1480472100.003100.93
61491505-1491505100.748101.67
1320min11467493-146749399.12798.771.42100.1999.821.42
21426268-142626896.34297.40
31453847-145384798.20599.25
41464216-146421698.90599.94
51474194-147419499.579100.65
61486986-1486986100.443101.52
1440min11454045-145404598.21898.481.4599.4399.691.44
21422077-142207796.05997.27
31453667-145366798.19399.38
41461808-146180898.74399.93
51471946-147194699.427100.65
61484336-1484336100.264101.49
极限11460104-146010498.62798.401.4599.9999.761.45
21419890-141989095.91197.26
31448692-144869297.85799.20
41460287-146028798.64099.98
51469833-146983399.285100.66
61481459-1481459100.070101.45
氟伐他汀钙项目信息
介质体积(ml)1000取样体积(ml)1.5补液体积(ml)1.5
对照品批号100800-202304对照品来源中检院对照品使用方法直接使用
对照品含量(%)97.3对照品水分(%)0对照品稀释倍数125
标示量(mg)80供试品稀释倍数1系数0.9493
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.661452243145255714512351450054144978414511750.09
210.611450765145126214510140.03
单位质量响应值RSD%判断
136132.74136759.100.33数据可信
供试品溶液-X0734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%
60min1123975-1239758.3937.904.038.397.904.02
2118716-1187168.0378.04
3113813-1138137.7057.70
4116734-1167347.9027.90
5116951-1169517.9177.92
6109992-1099927.4467.45
120min1237633-23763316.08715.582.9516.1015.592.96
2226938-22693815.36315.37
3222796-22279615.08215.09
4223482-22348215.12915.14
5238089-23808916.11716.13
6231551-23155115.67515.69
240min1465745-46574531.52930.664.2631.5730.704.26
2452399-45239930.62530.66
3420338-42033828.45528.49
4443182-44318230.00130.04
5474674-47467432.13332.17
6461078-46107831.21331.25
360min1697212-69721247.19845.334.9047.2845.414.90
2709094-70909448.00248.08
3625652-62565242.35442.43
4648723-64872343.91544.00
5687083-68708346.51246.60
6649929-64992943.99744.08
480min1907040-90704061.40259.504.5261.5659.654.52
2930560-93056062.99463.15
3831539-83153956.29156.43
4840374-84037456.88957.03
5900220-90022060.94161.09
6863957-86395758.48658.63
600min11108364-110836475.03172.804.2575.2873.044.25
21118796-111879675.73775.98
31031070-103107069.79970.02
41030324-103032469.74869.98
51123163-112316376.03376.28
61040810-104081070.45870.69
720min11307289-130728988.49786.583.6588.8686.933.65
21315463-131546389.05189.41
31231731-123173183.38283.71
41234191-123419183.54983.88
51337832-133783290.56590.92
61247283-124728384.43584.78
840min11480185-1480185100.20199.122.41100.6999.602.42
21478399-1478399100.081100.58
31410911-141091195.51295.97
41445625-144562597.86298.32
51514284-1514284102.510103.01
61456114-145611498.57299.04
960min11476179-147617999.930100.741.03100.57101.361.02
21474187-147418799.795100.44
31484611-1484611100.501101.10
41479658-1479658100.166100.77
51510523-1510523102.255102.90
61503450-1503450101.776102.39
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
1080min11471939-147193999.643100.410.97100.44101.190.97
21468963-146896399.442100.24
31481669-1481669100.302101.05
41475436-147543699.880100.64
51504023-1504023101.815102.62
61497537-1497537101.376102.14
1200min11464556-146455699.14399.970.96100.09100.900.95
21463263-146326399.056100.00
31478068-1478068100.058100.96
41469603-146960399.485100.39
51499596-1499596101.515102.47
61485945-1485945100.591101.51
1320min11456721-145672198.61399.330.8399.70100.410.83
21459308-145930898.78899.88
31469988-146998899.511100.56
41463007-146300799.039100.10
51490176-1490176100.878101.99
61464914-146491499.168100.24
1440min11453455-145345598.39299.280.9399.63100.510.93
21455598-145559898.53799.78
31465734-146573499.223100.42
41460263-146026398.853100.06
51488989-1488989100.797102.06
61475784-147578499.904101.12
极限11451770-145177098.27899.030.9099.66100.400.90
21449683-144968398.13799.52
31463104-146310499.045100.39
41455695-145569598.54499.90
51482323-1482323100.346101.76
61474614-147461499.824101.19
氟伐他汀钙项目信息
介质体积(ml)1000取样体积(ml)1.5补液体积(ml)1.5
对照品批号100800-202304对照品来源中检院对照品使用方法直接使用
对照品含量(%)97.3对照品水分(%)0对照品稀释倍数125
标示量(mg)80供试品稀释倍数1系数0.9493
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.661448807144820114484731447902144704714480860.05
210.611451142145030714507240.05
单位质量响应值RSD%判断
135842.96136731.760.47数据可信
供试品溶液-X0801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%
60min1110335-1103357.4787.335.377.487.345.36
2111085-1110857.5297.53
3117490-1174907.9637.96
4102285-1022856.9326.93
5103949-1039497.0457.05
6104181-1041817.0617.06
120min1234290-23429015.87914.3911.4315.8914.4111.43
2236465-23646516.02616.04
3232629-23262915.76615.78
4187131-18713112.68312.69
5192784-19278413.06613.08
6191047-19104712.94812.96
240min1453742-45374230.75227.5712.4130.7927.6012.41
2455252-45525230.85430.89
3449264-44926430.44930.48
4356864-35686424.18624.22
5366565-36656524.84424.87
6359154-35915424.34124.37
360min1657069-65706944.53240.5011.5144.6140.5811.51
2655601-65560144.43344.51
3667715-66771545.25445.34
4527440-52744035.74735.81
5540791-54079136.65236.72
6536930-53693036.39036.46
480min1843492-84349257.16752.739.4957.3252.879.50
2808296-80829654.78254.93
3875195-87519559.31659.46
4705336-70533647.80447.92
5725505-72550549.17149.29
6710567-71056748.15848.28
600min11000186-100018667.78764.118.0768.0264.328.08
2994361-99436167.39267.62
31044419-104441970.78571.02
4858332-85833258.17358.36
5889105-88910560.25960.45
6889025-88902560.25360.45
720min11194662-119466280.96775.468.0181.3075.778.02
21177466-117746679.80280.13
31205945-120594581.73282.08
41004807-100480768.10068.38
51035752-103575270.19770.48
61062179-106217971.98872.27
840min11330060-133006090.14485.186.5590.6085.616.56
21328427-132842790.03390.48
31331045-133104590.21190.68
41165099-116509978.96479.34
51167366-116736679.11779.51
61219286-121928682.63683.03
960min11463541-146354199.19195.693.3499.7896.243.37
21447415-144741598.09898.68
31445637-144563797.97798.58
41366590-136659092.62093.12
51350284-135028491.51592.03
61397816-139781694.73695.25
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
1080min11497359-1497359101.483101.160.66102.22101.860.66
21498942-1498942101.590102.32
31483867-1483867100.568101.32
41478850-1478850100.228100.87
51492419-1492419101.148101.80
61504564-1504564101.971102.63
1200min11472601-147260199.805100.790.99100.70101.640.96
21491764-1491764101.103101.99
31478373-1478373100.196101.10
41474977-147497799.966100.75
51494908-1494908101.316102.12
61510488-1510488102.372103.18
1320min11486231-1486231100.728100.560.68101.77101.560.67
21489546-1489546100.953101.99
31473278-147327899.850100.90
41470592-147059299.668100.61
51485754-1485754100.696101.65
61496865-1496865101.449102.41
1440min11484612-1484612100.619100.070.57101.81101.220.59
21485720-1485720100.694101.88
31470660-147066099.673100.87
41464182-146418299.234100.32
51479403-1479403100.266101.37
61474468-147446899.931101.05
极限11483589-1483589100.54999.850.68101.89101.150.70
21484557-1484557100.615101.95
31467135-146713599.434100.78
41460730-146073099.000100.24
51477574-1477574100.142101.39
61466219-146621999.372100.64
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