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%
1111.95848725839305831175836395814985834110.22
2112.95837775846515842140.11
单位质量响应值RSD%判断
5213.685174.610.54数据可信
供试品溶液-2409136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%
5min1107534-10753418.33521.9719.0718.3321.9719.08
2177185-17718530.21030.21
3117420-11742020.02020.02
4124130-12413021.16421.16
5120530-12053020.55120.55
6126362-12636221.54521.54
10min1235353-23535340.12838.768.7240.1638.808.71
2236394-23639440.30640.36
3228483-22848338.95738.99
4242283-24228341.31041.35
5233446-23344639.80339.84
6187934-18793432.04332.08
15min1268560-26856045.79044.757.7745.8944.867.77
2268673-26867345.80945.93
3263157-26315744.86944.97
4277453-27745347.30647.41
5274807-27480746.85546.96
6222148-22214837.87737.97
20min1292592-29259249.88849.146.6050.0649.316.60
2291867-29186749.76449.96
3288129-28812949.12749.30
4301790-30179051.45651.64
5303349-30334951.72251.90
6251341-25134142.85443.01
30min1332556-33255656.70156.205.0856.9656.465.09
2335725-33572557.24257.52
3328692-32869256.04356.30
4342228-34222858.35158.62
5341298-34129858.19258.46
6297082-29708250.65350.88
45min1372948-37294863.58863.264.4763.9463.614.48
2381355-38135565.02265.39
3369383-36938362.98163.33
4386879-38687965.96466.33
5375733-37573364.06364.43
6339654-33965457.91258.22
60min1399276-39927668.07768.013.9568.5368.463.96
2409657-40965769.84770.33
3399309-39930968.08368.54
4415141-41514170.78271.26
5400201-40020168.23568.70
6369644-36964463.02563.43
90min1428644-42864473.08573.172.7873.6673.742.80
2437925-43792574.66775.26
3427513-42751372.89273.46
4445759-44575976.00376.60
5423748-42374872.25072.83
6411159-41115970.10370.61
极限1483365-48336582.41584.141.2583.1184.831.24
2499241-49924185.12285.84
3499654-49965485.19285.88
4490799-49079983.68284.40
5491838-49183883.85984.56
6495929-49592984.55785.18
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%
1111.95779845766965776305778975788775778170.14
2112.95861985849215855600.16
单位质量响应值RSD%判断
5163.695186.540.32数据可信
供试品溶液-2409136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%
5min1232719-23271939.82532.0020.3439.8232.0020.34
2120059-12005920.54520.55
3172053-17205329.44329.44
4198820-19882034.02434.02
5198670-19867033.99834.00
6199802-19980234.19234.19
10min1251771-25177143.08539.056.3043.1539.106.31
2211763-21176336.23836.27
3234260-23426040.08840.14
4229951-22995139.35139.41
5225718-22571838.62738.68
6215522-21552236.88236.94
15min1266755-26675545.64942.155.3645.7942.285.38
2227812-22781238.98539.08
3253088-25308843.31043.43
4243253-24325341.62741.75
5248034-24803442.44542.57
6239047-23904740.90841.03
20min1283142-28314248.45345.054.8948.6745.244.91
2246102-24610242.11542.27
3269999-26999946.20446.39
4259695-25969544.44144.63
5265996-26599645.51945.71
6254688-25468843.58443.77
30min1314536-31453653.82650.084.6954.1250.344.71
2274768-27476847.02047.25
3295299-29529950.53450.80
4287567-28756749.21149.48
5299223-29922351.20551.47
6284504-28450448.68648.95
45min1355995-35599560.92156.304.9361.3156.654.95
2308302-30830252.75953.07
3325996-32599655.78756.14
4322118-32211855.12355.47
5337715-33771557.79258.15
6323939-32393955.43555.78
60min1384181-38418165.74461.354.3966.2361.804.40
2337778-33777857.80358.20
3357311-35731161.14661.59
4350756-35075660.02460.46
5366749-36674962.76163.21
6354415-35441560.65061.08
90min1431557-43155773.85168.654.6674.4569.204.67
2379088-37908864.87265.36
3385330-38533065.94166.48
4397539-39753968.03068.57
5408821-40882169.96170.51
6404768-40476869.26769.80
极限1527735-52773590.31090.302.4191.0390.962.41
2519755-51975588.94489.54
3527258-52725890.22890.88
4509611-50961187.20887.86
5535168-53516891.58292.25
6546712-54671293.55794.21
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%
1111.96029136041186038996038806000546029730.29
2112.95943475944905944180.02
单位质量响应值RSD%判断
5388.505265.001.64数据可信
供试品溶液-2409136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%
5min1116453-11645319.36425.9425.8619.3625.9425.88
2188115-18811531.27931.28
399380-9938016.52516.52
4175606-17560629.19929.20
5200183-20018333.28633.29
6156322-15632225.99325.99
10min1177718-17771829.55137.7417.7129.5837.7817.72
2264813-26481344.03244.08
3176115-17611529.28429.31
4254083-25408342.24842.30
5256283-25628342.61442.67
6232661-23266138.68638.73
15min1219905-21990536.56542.6813.4536.6542.7913.46
2285787-28578747.52047.65
3205744-20574434.21134.29
4273947-27394745.55145.67
5277729-27772946.18046.31
6277089-27708946.07446.18
20min1236577-23657739.33746.2013.0839.4846.3813.10
2308034-30803451.21951.42
3226427-22642737.65037.78
4295267-29526749.09649.29
5297158-29715849.41149.61
6303689-30368950.49750.68
30min1270192-27019244.92752.1011.5545.1352.3611.57
2341235-34123556.74057.03
3264129-26412943.91944.11
4329134-32913454.72855.00
5333125-33312555.39155.68
6342339-34233956.92357.19
45min1306767-30676751.00859.0410.1851.2959.3810.21
2379808-37980863.15463.54
3311662-31166251.82252.09
4370487-37048761.60461.97
5372826-37282661.99362.37
6388884-38888464.66365.03
60min1339259-33925956.41164.519.0356.7864.959.05
2410099-41009968.19068.68
3348778-34877857.99458.35
4400644-40064466.61867.09
5405827-40582767.48067.96
6423272-42327270.38170.85
90min1387876-38787664.49572.417.4364.9672.967.46
2451713-45171375.11075.71
3403638-40363867.11667.57
4444350-44435073.88574.47
5454581-45458175.58776.18
6470699-47069978.26778.86
极限1533117-53311788.64589.911.6389.2190.581.67
2555006-55500692.28593.01
3535619-53561989.06189.63
4546271-54627190.83391.54
5532582-53258288.55689.28
6541710-54171090.07490.79
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