氟伐他汀缓释片项目信息
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%
110.991476892147678414681581476313147564814747590.26
210.801467865146238914651270.27
单位质量响应值RSD%判断
134190.99135659.910.77数据可信
中间条件12月-供试品溶液-2024041521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%
240min1476081-47608132.59231.002.5432.5931.002.54
2446010-44601030.53430.53
3449233-44923330.75430.75
4448713-44871330.71930.72
5447617-44761730.64430.64
6449054-44905430.74230.74
480min1937000-93700064.14761.193.2364.2061.243.23
2919683-91968362.96163.01
3863212-86321259.09559.14
4878936-87893660.17260.22
5891309-89130961.01961.06
6872598-87259859.73859.78
720min11268353-126835386.83185.521.7086.9885.661.69
21266945-126694586.73586.87
31255677-125567785.96386.10
41237207-123720784.69984.84
51254432-125443285.87886.02
61212674-121267483.01983.16
960min11501318-1501318102.780101.920.98103.06102.190.98
21468716-1468716100.548100.82
31491730-1491730102.123102.39
41506223-1506223103.116103.38
51475202-1475202100.992101.26
61489398-1489398101.964102.22
1200min11494541-1494541102.316101.870.63102.75102.290.62
21482762-1482762101.510101.93
31486665-1486665101.777102.19
41498194-1498194102.566102.98
51473018-1473018100.842101.26
61493196-1493196102.224102.64
1440min11460794-1460794100.006100.781.02100.59101.351.01
21453991-145399199.540100.11
31477443-1477443101.145101.71
41492724-1492724102.192102.76
51463666-1463666100.202100.77
61483999-1483999101.594102.16
极限11461329-1461329100.042100.610.88100.78101.330.87
21452747-145274799.455100.18
31475038-1475038100.981101.70
41487172-1487172101.811102.54
51462601-1462601100.129100.85
61478639-1478639101.227101.95
氟伐他汀缓释片项目信息
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%
110.991473131147450914785731470080147322714739040.21
210.801458842144183214503370.83
单位质量响应值RSD%判断
134113.19134290.460.10数据可信
中间条件12月-供试品溶液-2024041521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%
240min1453681-45368131.22531.542.9931.2331.542.98
2483604-48360433.28533.28
3460606-46060631.70231.70
4449447-44944730.93430.93
5444611-44461130.60130.60
6457996-45799631.52231.52
480min1873538-87353860.12360.114.1060.1760.164.10
2897423-89742361.76761.82
3871626-87162659.99160.04
4822648-82264856.62056.67
5849986-84998658.50258.55
6925307-92530763.68663.73
720min11219325-121932583.92283.564.2784.0683.694.26
21247826-124782685.88486.03
31236079-123607985.07585.21
41135229-113522978.13478.27
51171015-117101580.59780.73
61274510-127451087.72187.86
960min11523390-1523390104.850102.922.11105.11103.182.11
21507667-1507667103.768104.04
31488847-1488847102.473102.74
41440514-144051499.14699.39
51486726-1486726102.327102.58
61525203-1525203104.975105.25
1200min11522851-1522851104.813103.131.05105.23103.541.05
21501541-1501541103.346103.77
31490169-1490169102.564102.98
41494599-1494599102.869103.27
51476283-1476283101.608102.02
61504591-1504591103.556103.99
1440min11512614-1512614104.109102.181.25104.69102.761.25
21491849-1491849102.679103.26
31476556-1476556101.627102.20
41468117-1468117101.046101.60
51463955-1463955100.759101.32
61494863-1494863102.887103.47
极限11509861-1509861103.919102.321.07104.65103.051.07
21486194-1486194102.290103.03
31474440-1474440101.481102.21
41465239-1465239100.848101.55
51487157-1487157102.356103.07
61497083-1497083103.040103.78
氟伐他汀缓释片项目信息
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%
110.991483091147266814745661468185146245514721930.53
210.801434403144243114384170.40
单位质量响应值RSD%判断
133957.51133186.760.41数据可信
中间条件12月-供试品溶液-2024041721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%
240min1399463-39946327.62431.366.6727.6231.366.67
2467914-46791432.35732.36
3488766-48876633.79933.80
4461336-46133631.90231.90
5459876-45987631.80131.80
6443954-44395430.70030.70
480min1795902-79590255.03861.246.0255.0861.296.02
2919271-91927163.56963.62
3945910-94591065.41165.46
4910795-91079562.98363.03
5883478-88347861.09461.14
6858208-85820859.34759.39
720min11160056-116005680.22084.574.7580.3484.704.75
21258353-125835387.01787.16
31294829-129482989.54089.69
41260385-126038587.15887.30
51210814-121081483.73083.87
61152913-115291379.72679.86
960min11446174-1446174100.006102.701.83100.25102.961.84
21493047-1493047103.247103.52
31516292-1516292104.854105.14
41499735-1499735103.710103.98
51497939-1497939103.585103.85
61457654-1457654100.800101.05
1200min11495414-1495414103.411102.950.71103.81103.370.72
21488287-1488287102.918103.35
31499799-1499799103.714104.15
41491832-1491832103.163103.59
51487662-1487662102.875103.29
61469280-1469280101.603102.01
1440min11487150-1487150102.839102.090.95103.39102.660.96
21472616-1472616101.834102.42
31486569-1486569102.799103.40
41480795-1480795102.400102.98
51481001-1481001102.414102.99
61449802-1449802100.257100.81
极限11478480-1478480102.240101.630.99102.94102.360.99
21464807-1464807101.294102.03
31484076-1484076102.627103.38
41474889-1474889101.991102.73
51472345-1472345101.815102.54
61443280-144328099.806100.51
氟伐他汀缓释片项目信息
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%
110.991489675149131514991831488225148768414912160.32
210.801444575144564614451100.06
单位质量响应值RSD%判断
135688.44133806.480.99数据可信
中间条件12月-供试品溶液-2024041721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%
240min1449912-44991230.84231.914.4830.8431.914.47
2465030-46503031.87831.88
3450847-45084730.90630.91
4455290-45529031.21131.21
5505530-50553034.65534.65
6466410-46641031.97331.97
480min1870217-87021759.65562.724.2259.7062.774.23
2915988-91598862.79262.84
3895283-89528361.37361.42
4890887-89088761.07261.12
5976752-97675266.95867.01
6940772-94077264.49164.54
720min11185178-118517881.24685.023.8781.3885.163.87
21267040-126704086.85787.00
31216824-121682483.41583.55
41206358-120635882.69882.84
51317547-131754790.32090.47
61248326-124832685.57585.72
960min11491932-1491932102.274102.490.76102.53102.760.76
21476289-1476289101.202101.47
31504454-1504454103.133103.40
41505424-1505424103.199103.46
51489743-1489743102.124102.41
61502311-1502311102.986103.26
1200min11497443-1497443102.652102.140.69103.06102.560.68
21469612-1469612100.744101.17
31494048-1494048102.419102.84
41495595-1495595102.525102.94
51491305-1491305102.231102.67
61491617-1491617102.253102.68
1440min11488979-1488979102.072101.350.92102.64101.920.91
21457202-145720299.893100.47
31494059-1494059102.420102.99
41484374-1484374101.756102.33
51470798-1470798100.825101.42
61474954-1474954101.110101.69
极限11484564-1484564101.769101.030.80102.49101.760.79
21457443-145744399.910100.63
31485895-1485895101.860102.59
41470827-1470827100.827101.55
51463764-1463764100.343101.09
61480033-1480033101.458102.19
氟伐他汀缓释片项目信息
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%
110.991473603147116514732951466088146629414700890.26
210.801461639145960214606200.10
单位质量响应值RSD%判断
133766.06135242.590.78数据可信
中间条件12月-供试品溶液-2024041821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%
240min1432712-43271229.71631.983.7829.7231.983.78
2473116-47311632.49132.49
3481956-48195633.09833.10
4461998-46199831.72731.73
5467346-46734632.09532.09
6476881-47688132.74932.75
480min1866190-86619059.48561.241.5559.5361.281.55
2893826-89382661.38361.43
3899086-89908661.74461.79
4892739-89273961.30861.36
5907061-90706162.29262.34
6891232-89123261.20561.25
720min11226517-122651784.23084.732.1984.3684.862.19
21285727-128572788.29688.44
31218884-121888483.70683.85
41210164-121016483.10783.25
51224527-122452784.09384.23
61236545-123654584.91985.06
960min11512489-1512489103.869102.690.88104.13102.960.88
21492745-1492745102.513102.79
31472743-1472743101.139101.41
41497473-1497473102.838103.10
51494419-1494419102.628102.90
61502219-1502219103.164103.43
1200min11505619-1505619103.397102.690.55103.81103.110.54
21485335-1485335102.004102.43
31489461-1489461102.287102.71
41501318-1501318103.102103.52
51499942-1499942103.007103.43
61489865-1489865102.315102.74
1440min11489735-1489735102.306101.690.47102.88102.270.47
21470471-1470471100.983101.56
31482051-1482051101.779102.35
41477535-1477535101.468102.04
51486719-1486719102.099102.68
61478252-1478252101.518102.09
极限11488210-1488210102.202101.660.48102.93102.380.48
21468870-1468870100.873101.60
31478085-1478085101.506102.23
41481789-1481789101.761102.49
51486602-1486602102.091102.82
61478179-1478179101.513102.24
氟伐他汀缓释片项目信息
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%
110.991473155147070014728481471602146808414712780.14
210.801458379146621114622950.38
单位质量响应值RSD%判断
133874.25135397.690.81数据可信
中间条件12月-供试品溶液-2024041821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%
240min1462847-46284731.75531.787.3031.7531.787.30
2439890-43989030.18030.18
3526139-52613936.09736.10
4434599-43459929.81729.82
5470512-47051232.28032.28
6444947-44494730.52730.53
480min1855037-85503758.66260.606.3758.7160.656.37
2848047-84804758.18258.23
3994040-99404068.19868.25
4852669-85266958.49958.54
5889444-88944461.02261.07
6860742-86074259.05359.10
720min11191760-119176081.76383.893.9581.9084.033.95
21217142-121714283.50583.64
31317407-131740790.38390.54
41190007-119000781.64381.78
51222048-122204883.84183.98
61197851-119785182.18182.32
960min11479596-1479596101.511101.921.18101.77102.191.18
21502844-1502844103.106103.36
31511469-1511469103.698103.99
41477551-1477551101.371101.63
51467058-1467058100.651100.92
61474928-1474928101.191101.45
1200min11481430-1481430101.637102.091.14102.05102.511.13
21505416-1505416103.282103.69
31492930-1492930102.426102.87
41501613-1501613103.021103.43
51458572-1458572100.068100.49
61488341-1488341102.111102.52
1440min11468240-1468240100.732101.231.09101.29101.801.09
21489653-1489653102.201102.77
31478489-1478489101.435102.04
41488682-1488682102.134102.70
51446996-144699699.27499.84
61480942-1480942101.603102.17
极限11474675-1474675101.173101.171.19101.89101.891.19
21490015-1490015102.226102.95
31484712-1484712101.862102.62
41479231-1479231101.486102.20
51440724-144072498.84499.56
61478328-1478328101.424102.14
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