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%
1114.45549505551335553155559175556215553870.07
2114.85574835602885588860.36
单位质量响应值RSD%判断
4854.784868.340.20数据可信
供试品溶液-1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%
5min1223111-22311140.64335.2223.8540.6435.2223.84
2196232-19623235.74635.75
3224602-22460240.91440.91
4223673-22367340.74540.75
5105050-10505019.13619.14
6187238-18723834.10834.11
10min1315753-31575357.51955.983.1657.5956.043.17
2307197-30719755.96056.02
3312347-31234756.89856.97
4317300-31730057.80157.87
5296740-29674054.05554.09
6294629-29462953.67153.73
15min1350130-35013063.78164.552.3363.9464.702.32
2351049-35104963.94864.10
3352226-35222664.16364.33
4367197-36719766.89067.05
5361039-36103965.76865.89
6344559-34455962.76662.91
20min1380433-38043369.30170.842.3369.5771.102.32
2389623-38962370.97571.23
3385881-38588170.29470.56
4403819-40381973.56173.84
5393540-39354071.68971.92
6379847-37984769.19469.45
30min1423920-42392077.22379.422.8077.6179.802.78
2430394-43039478.40278.78
3432622-43262278.80879.20
4455715-45571583.01583.41
5445669-44566981.18581.54
6427667-42766777.90678.27
45min1463305-46330584.39787.062.9584.9187.562.93
2469833-46983385.58786.10
3469334-46933485.49686.01
4495530-49553090.26890.80
5495578-49557890.27690.76
6473792-47379286.30886.80
60min1487419-48741988.79092.223.0189.4492.882.99
2495899-49589990.33590.99
3500974-50097491.25991.92
4522677-52267795.21395.90
5526024-52602495.82396.46
6504472-50447291.89792.54
90min1530240-53024096.59197.732.3797.3998.542.36
2521544-52154495.00795.81
3530471-53047196.63397.45
4550712-550712100.320101.17
5553540-553540100.835101.63
6532550-53255097.01197.80
极限1547875-54787599.803100.202.07100.77101.182.07
2533168-53316897.12498.08
3545385-54538599.350100.32
4563654-563654102.677103.69
5562162-562162102.406103.37
6548212-54821299.864100.82
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%
1114.45557135566265560885580965575185568080.18
2114.85674795691445683120.21
单位质量响应值RSD%判断
4867.204950.451.20数据可信
供试品溶液-1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%
5min1233588-23358842.14548.7920.8142.1448.7920.81
2237869-23786942.91742.92
3343816-34381662.03262.03
4218702-21870239.45939.46
5340123-34012361.36661.37
6248355-24835544.80944.81
10min1384075-38407569.29665.733.1669.3765.813.16
2361617-36161765.24465.32
3361720-36172065.26265.37
4353184-35318463.72263.79
5370497-37049766.84666.95
6354635-35463563.98464.06
15min1413711-41371174.64372.542.1874.8372.732.19
2394784-39478471.22871.41
3404427-40442772.96873.18
4405699-40569973.19773.37
5404719-40471973.02073.23
6389040-38904070.19270.37
20min1434818-43481878.45177.831.8678.7678.141.87
2424222-42422276.53976.84
3437657-43765778.96379.30
4434776-43477678.44378.74
5438031-43803179.03179.37
6418720-41872075.54775.84
30min1476469-47646985.96686.020.9086.4186.460.89
2476009-47600985.88386.31
3482587-48258787.07087.53
4480804-48080486.74887.17
5471273-47127385.02885.50
6473581-47358185.44585.87
45min1510247-51024792.06092.821.7792.6493.401.76
2514076-51407692.75193.32
3521046-52104694.00894.62
4527985-52798595.26095.83
5511553-51155392.29692.90
6501881-50188190.55191.12
60min1528434-52843495.34197.011.9496.0897.751.93
2534027-53402796.35197.07
3546355-54635598.57599.34
4553789-55378999.916100.64
5536007-53600796.70897.47
6527440-52744095.16295.88
90min1550337-55033799.293101.211.92100.19102.111.92
2555315-555315100.191101.08
3572273-572273103.251104.18
4576326-576326103.982104.88
5558628-558628100.789101.71
6552875-55287599.751100.63
极限1560877-560877101.195102.301.40102.26103.371.40
2562789-562789101.540102.59
3575933-575933103.911105.01
4578356-578356104.349105.42
5562639-562639101.513102.60
6561447-561447101.298102.34
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%
1114.45606265593805596385585765610845598610.18
2114.85691835693885692860.03
单位质量响应值RSD%判断
4893.894958.940.94数据可信
供试品溶液-2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%
5min1196387-19638735.30540.7011.9535.3140.7011.95
2206675-20667537.15537.15
3234938-23493842.23642.24
4239486-23948643.05343.05
5211007-21100737.93337.93
6269785-26978548.50048.50
10min1331037-33103759.51261.844.3259.5761.914.33
2324480-32448058.33358.39
3353356-35335663.52463.59
4364492-36449265.52665.60
5340703-34070361.24961.31
6349981-34998162.91763.00
15min1388316-38831669.80969.882.6769.9770.052.67
2369717-36971766.46566.62
3389848-38984870.08470.26
4398300-39830071.60471.78
5388496-38849669.84170.01
6397712-39771271.49871.68
20min1418272-41827275.19475.402.1875.4775.692.18
2402379-40237972.33772.61
3429233-42923377.16577.46
4422618-42261875.97676.28
5423429-42342976.12176.40
6420661-42066175.62475.93
30min1466184-46618483.80883.371.8884.2183.791.89
2446280-44628080.22980.62
3465388-46538883.66484.09
4467000-46700083.95484.38
5469979-46997984.49084.90
6467739-46773984.08784.52
45min1511408-51140891.93891.371.6692.4891.921.66
2492901-49290188.61189.13
3514606-51460692.51393.07
4510158-51015891.71392.28
5515455-51545592.66593.21
6504878-50487890.76491.33
60min1539876-53987697.05595.961.7597.7596.661.75
2518760-51876093.25993.93
3539933-53993397.06697.78
4532550-53255095.73896.46
5543685-54368597.74098.44
6527912-52791294.90595.63
90min1566062-566062101.763100.901.46102.62101.761.46
2546379-54637998.22499.05
3564032-564032101.398102.28
4562292-562292101.085101.96
5569885-569885102.450103.32
6558813-558813100.460101.34
极限1574107-574107103.209102.551.37104.23103.581.37
2556947-556947100.124101.12
3572592-572592102.937103.98
4576293-576293103.602104.65
5577152-577152103.757104.79
6565604-565604101.681102.73
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