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%
1 111.75435885429985428975423215426705428950.09
2 111.65433625429585431600.06
单位质量响应值RSD%判断
4860.304867.030.10数据可信
供试品溶液-25061801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%
5min1218527-21852739.79151.4819.7239.7951.4819.72
2277732-27773250.57150.57
3269474-26947449.06749.07
4375122-37512268.30468.30
5313969-31396957.16957.17
6241432-24143243.96143.96
10min1364593-36459366.38769.166.5866.4569.246.59
2370976-37097667.54967.63
3370885-37088567.53367.61
4430146-43014678.32378.44
5375652-37565268.40168.50
6366566-36656666.74666.82
15min1416346-41634675.81075.485.4475.9975.685.45
2404767-40476773.70273.90
3401840-40184073.16973.36
4458813-45881383.54383.79
5407150-40715074.13674.35
6398309-39830972.52672.71
20min1434596-43459679.13380.534.4279.4480.864.43
2433891-43389179.00579.32
3434582-43458279.13179.45
4482107-48210787.78588.17
5434921-43492179.19379.53
6433639-43363978.95979.26
30min1482479-48247987.85288.233.2988.2988.693.31
2479494-47949487.30987.76
3475170-47517086.52186.97
4515834-51583493.92694.46
5471729-47172985.89586.36
6482659-48265987.88588.32
45min1525580-52558095.70095.162.6496.2895.772.66
2515816-51581693.92294.52
3511562-51156293.14893.74
4546551-54655199.519100.21
5509155-50915592.71093.32
6526971-52697195.95496.54
60min1548412-54841299.85899.112.49100.6099.882.49
2537025-53702597.78498.54
3531236-53123696.73097.48
4563305-563305102.569103.42
5530540-53054096.60397.37
6555350-555350101.121101.86
90min1566251-566251103.106102.931.97104.01103.861.98
2560210-560210102.006102.92
3556548-556548101.339102.25
4580147-580147105.636106.66
5552191-552191100.546101.47
6576327-576327104.941105.85
极限1578815-578815105.394104.871.64106.47105.971.64
2573795-573795104.480105.57
3568587-568587103.531104.61
4586674-586674106.825108.02
5562687-562687102.457103.55
6585052-585052106.529107.62
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%
1 111.75453915461765459735449715452495455520.10
2 111.65521065522505521780.02
单位质量响应值RSD%判断
4884.084947.830.92数据可信
供试品溶液-25061801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%
5min1227299-22729940.94944.429.3440.9544.429.35
2282635-28263550.91850.92
3221865-22186539.97039.97
4264316-26431647.61847.62
5239859-23985943.21243.21
6243562-24356243.87943.88
10min1304475-30447554.85359.895.7354.9259.965.72
2313559-31355956.48956.57
3337238-33723860.75560.82
4347870-34787062.67162.75
5340561-34056161.35461.43
6350982-35098263.23163.30
15min1363528-36352865.49267.914.7765.6568.084.76
2348686-34868662.81863.00
3379265-37926568.32768.49
4381288-38128868.69168.87
5393548-39354870.90071.07
6395250-39525071.20771.39
20min1386251-38625169.58573.093.2769.8573.373.27
2393432-39343270.87971.16
3406924-40692473.31073.59
4414598-41459874.69274.99
5412209-41220974.26274.55
6420697-42069775.79176.09
30min1428757-42875777.24380.233.0577.6380.643.05
2431757-43175777.78378.19
3442719-44271979.75880.16
4451721-45172181.38081.80
5452993-45299381.60982.03
6464104-46410483.61184.03
45min1475084-47508485.58987.862.0986.1088.402.10
2479741-47974186.42886.96
3484634-48463487.31087.85
4490451-49045188.35888.92
5492373-49237388.70489.26
6503724-50372490.74991.31
60min1499853-49985390.05192.502.1390.7193.192.14
2505816-50581691.12691.80
3509675-50967591.82192.50
4513947-51394792.59093.30
5521385-52138593.93094.63
6530101-53010195.50196.21
90min1526693-52669394.88797.881.9795.6998.721.97
2542044-54204497.65298.48
3541062-54106297.47598.31
4542802-54280297.78998.65
5547440-54744098.62499.48
6559667-559667100.827101.70
极限1565783-565783101.929102.560.77102.89103.570.77
2569972-569972102.684103.67
3575272-575272103.638104.64
4566286-566286102.020103.04
5564870-564870101.765102.79
6573583-573583103.334104.38
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%
1 111.75496375490375494815492855486125492100.08
2 111.65539535536715538120.04
单位质量响应值RSD%判断
4916.834962.470.66数据可信
供试品溶液-25061801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%
5min1233208-23320841.81141.6612.8541.8141.6612.84
2258024-25802446.26146.26
3276391-27639149.55449.55
4220305-22030539.49839.50
5202444-20244436.29636.30
6203799-20379936.53936.54
10min1333422-33342259.77862.607.5459.8562.677.54
2370872-37087266.49366.57
3383936-38393668.83568.92
4351221-35122162.97063.04
5345168-34516861.88461.94
6310258-31025855.62555.69
15min1398253-39825371.40271.515.6771.5771.685.67
2412102-41210273.88574.07
3430218-43021877.13377.33
4395732-39573270.95071.12
5394883-39488370.79870.96
6361917-36191764.88765.04
20min1429891-42989177.07477.964.6977.3678.254.70
2447582-44758280.24680.56
3462330-46233082.89083.22
4428762-42876276.87277.16
5438359-43835978.59278.87
6401950-40195072.06572.33
30min1478329-47832985.75986.493.6886.1886.913.69
2496105-49610588.94689.39
3503686-50368690.30590.77
4476316-47631685.39885.81
5486776-48677687.27387.69
6453167-45316781.24781.63
45min1515563-51556392.43492.872.2492.9993.432.26
2525155-52515594.15494.75
3531655-53165595.31995.93
4510414-51041491.51192.07
5524937-52493794.11594.67
6500086-50008689.65990.18
60min1532605-53260595.49095.552.1696.2096.272.18
2538687-53868796.58097.33
3544033-54403397.53898.31
4526948-52694894.47595.19
5542084-54208497.18997.90
6513280-51328092.02592.69
90min1537257-53725796.32496.301.5897.2097.181.60
2541019-54101996.99897.91
3543833-54383397.50398.44
4530399-53039995.09495.96
5546114-54611497.91298.79
6523960-52396093.94094.76
极限1535929-53592996.08596.071.3197.1297.111.34
2539005-53900596.63797.71
3541963-54196397.16798.27
4530530-53053095.11896.15
5542830-54283097.32398.36
6524809-52480994.09295.07
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