氟伐他汀钠缓释片项目信息
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100800-202103对照品来源中检院对照品使用方法直接使用
对照品含量(%)93.4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%
110.921413299141366014133911413012141382314134370.03
211.251476039147659014763140.03
单位质量响应值RSD%判断
129435.62131227.910.98数据可信
长期6月-供试品溶液-2024041521批-pH4.5
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
240min1268399-26839918.26016.438.3318.2616.438.32
2250827-25082717.06517.06
3211188-21118814.36814.37
4239692-23969216.30716.31
5227497-22749715.47715.48
6251112-25111217.08417.08
480min1497009-49700933.81329.428.9433.8429.458.93
2457576-45757631.13031.16
3390923-39092326.59626.62
4415705-41570528.28228.31
5407729-40772927.73927.76
6425678-42567828.96028.99
720min1666271-66627145.32938.9110.8345.4138.9810.82
2632957-63295743.06243.13
3517620-51762035.21535.28
4531974-53197436.19236.26
5533446-53344636.29236.36
6549352-54935237.37437.44
1440min1787183-78718353.55557.365.6653.7057.485.63
2826708-82670856.24456.38
3892153-89215360.69660.81
4794328-79432854.04154.16
5861917-86191758.63958.76
6896253-89625360.97561.10
极限11054198-105419871.72061.4611.2671.9561.6711.24
21001312-100131268.12268.34
3817737-81773755.63355.84
4807586-80758654.94355.14
5853340-85334058.05558.26
6885889-88588960.27060.49
氟伐他汀钠缓释片项目信息
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100800-202103对照品来源中检院对照品使用方法直接使用
对照品含量(%)93.4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%
110.921413147141358014126121413600141403914133960.04
211.251465069146612714655980.06
单位质量响应值RSD%判断
129431.87130275.380.46数据可信
长期6月-供试品溶液-2024041521批-pH4.5
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
240min1154464-15446410.54714.7814.8810.5514.7814.87
2245204-24520416.74316.74
3226962-22696215.49715.50
4221583-22158315.13015.13
5214726-21472614.66214.66
6235813-23581316.10216.10
480min1419693-41969328.65728.785.9528.6728.805.94
2454090-45409031.00631.03
3449615-44961530.70030.72
4392857-39285726.82526.85
5403754-40375427.56927.59
6409349-40934927.95127.97
720min1599762-59976240.95239.7511.2641.0139.8111.25
2704339-70433948.09348.16
3574433-57443339.22339.29
4523135-52313535.72035.78
5546769-54676937.33437.40
6544193-54419337.15837.22
1440min1947739-94773964.71359.156.7564.8359.286.72
2809672-80967255.28555.43
3895651-89565161.15661.28
4844054-84405457.63357.75
5901985-90198561.58961.71
6798644-79864454.53254.65
极限11082536-108253673.91764.9013.3574.1365.1213.31
21115610-111561076.17576.40
3875522-87552259.78260.00
4813314-81331455.53455.74
5845957-84595757.76357.97
6970270-97027066.25166.45
氟伐他汀钠缓释片项目信息
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100800-202103对照品来源中检院对照品使用方法直接使用
对照品含量(%)93.4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%
110.921415204141374314147631414827141485414146780.04
211.251473921147359114737560.02
单位质量响应值RSD%判断
129549.27131000.530.79数据可信
长期6月-供试品溶液-2024041721批-pH4.5
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
240min1230449-23044915.68514.737.4915.6814.737.51
2237802-23780216.18516.19
3205742-20574214.00314.00
4222815-22281515.16515.17
5197835-19783513.46513.46
6203838-20383813.87413.87
480min1406689-40668927.68026.762.4527.7026.782.44
2390181-39018126.55626.58
3385614-38561426.24626.27
4397251-39725127.03827.06
5399102-39910227.16427.18
6380525-38052525.89925.92
720min1530737-53073736.12335.802.2636.1935.862.25
2512830-51283034.90434.97
3510569-51056934.75034.81
4530100-53010036.08036.14
5530169-53016936.08436.15
6541326-54132636.84436.90
1440min1825088-82508856.15758.216.7656.2858.336.74
2764694-76469452.04652.16
3839765-83976557.15657.27
4889993-88999360.57460.69
5927826-92782663.14963.26
6884429-88442960.19660.31
极限1850933-85093357.91660.947.2258.1261.147.21
2804857-80485754.78054.97
3870905-87090559.27559.47
4922065-92206562.75762.97
5979473-97947366.66566.87
6943525-94352564.21864.42
氟伐他汀钠缓释片项目信息
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100800-202103对照品来源中检院对照品使用方法直接使用
对照品含量(%)93.4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%
110.921408085140757014081341408863140996914085240.07
211.251468381146721814678000.06
单位质量响应值RSD%判断
128985.71130471.110.81数据可信
长期6月-供试品溶液-2024041721批-pH4.5
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
240min1156535-15653510.69913.3810.4810.7013.3810.48
2208050-20805014.22014.22
3190168-19016812.99813.00
4208733-20873314.26714.27
5201924-20192413.80113.80
6209057-20905714.28914.29
480min1363848-36384824.86826.192.7424.8826.212.75
2391271-39127126.74326.76
3392389-39238926.81926.84
4380402-38040226.00026.02
5384089-38408926.25226.27
6387172-38717226.46326.48
720min1505610-50561034.55835.172.1834.6135.232.19
2517851-51785135.39435.46
3519761-51976135.52535.58
4518647-51864735.44935.51
5497331-49733133.99234.05
6528559-52855936.12636.19
1440min1797764-79776454.52658.2811.8054.6358.3911.78
2803479-80347954.91755.03
3860915-86091558.84258.96
4806451-80645155.12055.23
5795444-79544454.36754.48
61051843-105184371.89272.01
极限1823197-82319756.26460.7710.7756.4560.9610.75
2855979-85597958.50558.70
3904224-90422461.80262.00
4843631-84363157.66157.86
5831760-83176056.85057.04
61075537-107553773.51173.73
氟伐他汀钠缓释片项目信息
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100800-202103对照品来源中检院对照品使用方法直接使用
对照品含量(%)93.4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%
110.921426015142624214255771425371142505414256520.04
211.251472180147069114714360.08
单位质量响应值RSD%判断
130554.21130794.310.13数据可信
长期6月-供试品溶液-2024041821批-pH4.5
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
240min1150007-15000710.17813.3618.8210.1813.3618.81
2225579-22557915.30615.31
3217718-21771814.77314.77
4217787-21778714.77714.78
5221679-22167915.04115.04
6148348-14834810.06610.07
480min1303098-30309820.56626.0411.0420.5826.0611.05
2414345-41434528.11428.14
3420469-42046928.53028.55
4389430-38943026.42326.45
5395319-39531926.82326.85
6379898-37989825.77725.79
720min1414726-41472628.14035.9112.3528.1935.9712.34
2579283-57928339.30539.37
3592283-59228340.18740.25
4508803-50880334.52334.58
5517000-51700035.07935.14
6563448-56344838.23138.28
1440min1793595-79359553.84759.305.1153.9459.425.11
2887260-88726060.20260.33
3861248-86124858.43758.56
4925462-92546262.79462.91
5894913-89491360.72160.84
6881378-88137859.80359.91
极限1807127-80712754.76560.916.9954.9361.116.99
2922973-92297362.62562.84
3850477-85047757.70657.92
4978901-97890166.42066.63
5885613-88561360.09060.30
6940846-94084663.83864.04
氟伐他汀钠缓释片项目信息
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100800-202103对照品来源中检院对照品使用方法直接使用
对照品含量(%)93.4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%
110.921411835141157914120881411944141191414118720.02
211.251468264146783114680480.03
单位质量响应值RSD%判断
129292.31130493.160.66数据可信
长期6月-供试品溶液-2024041821批-pH4.5
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
240min1204364-20436413.95015.366.1513.9515.366.15
2220506-22050615.05215.05
3234760-23476016.02516.03
4220395-22039515.04415.04
5244852-24485216.71416.71
6225630-22563015.40215.40
480min1433371-43337129.58228.036.8629.6028.066.85
2383787-38378726.19826.22
3413636-41363628.23528.26
4391468-39146826.72226.74
5453657-45365730.96730.99
6388253-38825326.50326.53
720min1656522-65652244.81538.3811.7344.8838.4411.72
2515861-51586135.21335.28
3536861-53686136.64736.71
4514288-51428835.10635.17
5635770-63577043.39943.47
6513913-51391335.08035.14
1440min1796093-79609354.34256.517.5654.4756.637.56
2820539-82053956.01156.13
3808244-80824455.17255.29
4761113-76111351.95552.07
5944442-94444264.46964.61
6836713-83671357.11557.23
极限1967810-96781066.06464.7713.4766.2864.9813.44
2849198-84919857.96758.17
31116708-111670876.22876.43
4806366-80636655.04455.24
51079733-107973373.70473.94
6873456-87345659.62359.82
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