替普瑞酮胶囊项目信息
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3A5724009091对照品来源原料药对照品使用方法直接使用
对照品含量(%)98.4对照品水分(%)0对照品稀释倍数2000
标示量(mg)50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%
1111.75386865390115385425382055387555386400.06
2111.65425285420265422770.07
单位质量响应值RSD%判断
4822.204859.110.54数据可信
供试品溶液-25061802批-pH6.8(内含5%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1235430-23543043.07355.1014.2243.0755.1014.22
2316224-31622457.85457.85
3281585-28158551.51751.52
4365969-36596966.95566.96
5300951-30095155.06055.06
6306943-30694356.15656.16
10min1363268-36326866.46167.996.4566.5368.086.46
2388234-38823471.02971.13
3343148-34314862.78062.87
4404744-40474474.04974.16
5381495-38149569.79669.89
6348822-34882263.81863.91
15min1396247-39624772.49573.396.1772.6873.606.18
2422786-42278677.35077.56
3375772-37577268.74968.94
4438998-43899880.31680.55
5392472-39247271.80472.01
6380676-38067669.64669.85
20min1425109-42510977.77578.554.1478.0878.884.16
2446372-44637281.66582.01
3412782-41278275.52075.82
4455937-45593783.41583.78
5422044-42204477.21477.54
6413972-41397275.73776.05
30min1469986-46998685.98585.953.7486.4286.413.75
2490283-49028389.69990.18
3463325-46332584.76785.20
4490808-49080889.79590.30
5449429-44942982.22482.68
6454905-45490583.22683.67
45min1506498-50649892.66592.743.1693.2493.343.17
2526668-52666896.35596.98
3510275-51027593.35693.93
4521004-52100495.31995.98
5489557-48955789.56690.16
6487453-48745389.18189.76
60min1529339-52933996.84496.573.2097.5797.323.20
2547776-547776100.217101.01
3534049-53404997.70698.43
4540501-54050198.88699.70
5509049-50904993.13293.87
6506234-50623492.61793.35
90min1547626-547626100.190100.582.74101.08101.502.74
2570554-570554104.385105.34
3558607-558607102.199103.09
4556021-556021101.726102.71
5534605-53460597.80898.71
6531108-53110897.16898.05
极限1554198-554198101.392102.522.19102.45103.602.20
2580676-580676106.236107.37
3566605-566605103.662104.72
4561383-561383102.707103.86
5553578-553578101.279102.34
6545676-54567699.833100.88
替普瑞酮胶囊项目信息
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3A5724009091对照品来源原料药对照品使用方法直接使用
对照品含量(%)98.4对照品水分(%)0对照品稀释倍数2000
标示量(mg)50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%
1111.75435365430775423905429405429735429830.08
2111.65451685454665453170.04
单位质量响应值RSD%判断
4861.084886.350.37数据可信
供试品溶液-25061802批-pH4.0(内含5%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1245620-24562044.63242.5217.6844.6342.5217.69
2252793-25279345.93545.94
3287750-28775052.28752.29
4191175-19117534.73934.74
5248561-24856145.16645.17
6178025-17802532.34932.35
10min1331515-33151560.24057.017.7660.3157.087.77
2327522-32752259.51459.59
3336216-33621661.09461.18
4281647-28164751.17851.24
5321215-32121558.36858.44
6284319-28431951.66451.72
15min1375316-37531668.19965.125.5568.3765.295.57
2365542-36554266.42366.60
3379826-37982669.01869.21
4328822-32882259.75059.89
5359760-35976065.37265.54
6341042-34104261.97162.11
20min1405180-40518073.62570.444.9173.9170.714.93
2399734-39973472.63672.92
3403719-40371973.36073.66
4359145-35914565.26065.50
5387266-38726670.37070.65
6370714-37071467.36367.61
30min1443751-44375180.63477.664.3481.0578.054.36
2435799-43579979.18979.60
3442775-44277580.45780.88
4397257-39725772.18672.54
5431861-43186178.47478.87
6412778-41277875.00675.36
45min1483090-48309087.78385.604.0988.3386.124.10
2496705-49670590.25790.80
3477306-47730686.73287.29
4442375-44237580.38480.86
5469540-46954085.32085.85
6457375-45737583.11083.59
60min1505131-50513191.78890.534.1592.4891.204.15
2532315-53231596.72797.42
3501320-50132091.09591.80
4471058-47105885.59686.20
5493583-49358389.68990.36
6486003-48600388.31288.93
90min1531210-53121096.52696.343.6097.3797.153.60
2563087-563087102.319103.17
3530994-53099496.48797.34
4505369-50536991.83192.58
5519467-51946794.39395.21
6530898-53089896.47097.24
极限1550239-55023999.984100.072.47100.99101.042.49
2576941-576941104.836105.86
3546496-54649699.304100.32
4537996-53799697.76098.66
5549126-54912699.782100.76
6543352-54335298.73399.66
替普瑞酮胶囊项目信息
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3A5724009091对照品来源原料药对照品使用方法直接使用
对照品含量(%)98.4对照品水分(%)0对照品稀释倍数2000
标示量(mg)50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%
1111.75482545471345461865451625463295466130.22
2111.65477975489735483850.16
单位质量响应值RSD%判断
4893.584913.840.30数据可信
供试品溶液-25061802批-pH1.2(内含5%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1299721-29972154.12942.1314.6554.1342.1314.65
2213381-21338138.53638.54
3236830-23683042.77142.77
4209418-20941837.82137.82
5227272-22727241.04541.05
6213073-21307338.48138.48
10min1377080-37708068.10062.915.5268.1962.985.53
2318480-31848057.51757.58
3351324-35132463.44963.52
4349800-34980063.17363.24
5354202-35420263.96864.04
6339154-33915461.25161.31
15min1433222-43322278.23973.575.0378.4473.755.03
2374516-37451667.63767.80
3410494-41049474.13574.31
4415816-41581675.09675.26
5416406-41640675.20275.38
6393870-39387071.13271.30
20min1466561-46656184.26080.294.6184.5980.594.61
2411926-41192674.39374.67
3449494-44949481.17881.48
4455190-45519082.20782.50
5456285-45628582.40482.70
6428031-42803177.30277.59
30min1496131-49613189.60187.803.3390.0888.233.34
2459154-45915482.92383.32
3494785-49478589.35789.79
4497357-49735789.82290.25
5496494-49649489.66690.10
6473060-47306085.43485.85
45min1522935-52293594.44193.082.6195.0793.662.62
2494294-49429489.26989.80
3525257-52525794.86195.45
4522583-52258394.37894.96
5524713-52471394.76295.35
6502627-50262790.77491.33
60min1529039-52903995.54495.081.9896.3395.821.99
2511568-51156892.38893.07
3536488-53648896.88997.63
4526355-52635595.05995.80
5537884-53788497.14197.89
6517506-51750693.46194.17
90min1527940-52794095.34595.291.6296.2996.181.63
2523474-52347494.53995.38
3539516-53951697.43698.34
4523680-52368094.57695.47
5535121-53512196.64297.55
6516022-51602293.19394.06
极限1524796-52479694.77794.861.6695.8895.911.66
2522959-52295994.44695.44
3535927-53592796.78897.85
4520103-52010393.93094.98
5534499-53449996.53097.60
6513218-51321892.68693.70
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