褪黑素颗粒项目信息
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520023-202203对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.9对照品水分(%)0对照品稀释倍数10000
标示量(mg)1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 10.066424865141652556513765070649700.63
2 10.006450864574645410.08
单位质量响应值RSD%判断
6458.256454.100.05数据可信
供试品溶液-24120401批-pH1.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min167635-6763594.19096.923.4594.1996.923.45
265892-6589291.76391.76
371446-7144699.49799.50
471410-7141099.44799.45
571697-7169799.84799.85
669502-6950296.79096.79
10min172040-72040100.32499.641.35100.4899.801.35
269926-6992697.38097.53
372314-72314100.706100.87
471891-71891100.117100.28
572296-72296100.681100.85
670836-7083698.64898.81
15min170835-7083598.646100.311.5098.97100.641.50
270818-7081898.62398.94
372860-72860101.466101.80
473362-73362102.165102.50
572608-72608101.115101.45
671682-7168299.826100.15
20min172154-72154100.483100.550.57100.97101.040.57
272406-72406100.834101.31
372068-72068100.363100.87
472537-72537101.017101.52
571471-7147199.532100.03
672568-72568101.060101.55
30min171359-7135999.376100.111.81100.03100.771.80
270140-7014097.67898.33
370867-7086798.69199.36
473350-73350102.149102.82
573142-73142101.859102.53
672455-72455100.902101.56
45min171566-7156699.66499.860.73100.49100.690.72
271574-7157499.675100.49
371552-7155299.645100.48
470954-7095498.81299.65
572342-72342100.745101.58
672267-72267100.640101.47
60min170622-7062298.35099.401.5399.34100.391.52
270846-7084698.66299.64
372024-72024100.302101.30
472638-72638101.157102.16
569862-6986297.29198.30
672256-72256100.625101.62
极限170842-7084298.656100.041.0999.81101.201.09
271211-7121199.170100.31
371996-71996100.263101.43
472744-72744101.305102.48
572682-72682101.218102.39
671530-7153099.614100.78
褪黑素颗粒项目信息
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520023-202203对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.9对照品水分(%)0对照品稀释倍数10000
标示量(mg)1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 10.066371763523635306362163484635750.15
2 10.006297663943634601.08
单位质量响应值RSD%判断
6319.586346.000.30数据可信
供试品溶液-24120401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%
5min172522-72522102.964100.103.82102.96100.103.83
271551-71551101.585101.59
372092-72092102.353102.35
465246-6524692.63492.63
570203-7020399.67199.67
671415-71415101.392101.39
10min172901-72901103.502102.241.74103.67102.401.74
271848-71848102.007102.18
372148-72148102.433102.60
469627-6962798.85499.01
573058-73058103.725103.89
672476-72476102.898103.07
15min172431-72431102.835102.300.77103.18102.630.77
271795-71795101.932102.27
372180-72180102.478102.82
471102-71102100.948101.27
572136-72136102.416102.75
672667-72667103.170103.51
20min172848-72848103.427102.320.62103.94102.820.62
271615-71615101.676102.19
371837-71837101.991102.50
471990-71990102.208102.70
571810-71810101.953102.46
672302-72302102.651103.16
30min173056-73056103.722102.620.86104.41103.300.86
271398-71398101.368102.05
372498-72498102.930103.61
471730-71730101.839102.50
572310-72310102.663103.34
672700-72700103.216103.90
45min172597-72597103.070102.280.79103.93103.130.78
271328-71328101.269102.12
372002-72002102.226103.08
471795-71795101.932102.76
571711-71711101.812102.66
672813-72813103.377104.23
60min172396-72396102.785102.080.68103.82103.100.67
271357-71357101.310102.33
372006-72006102.231103.26
472348-72348102.717103.71
571259-71259101.171102.19
672019-72019102.250103.28
极限172233-72233102.553101.970.70103.76103.160.70
271250-71250101.158102.34
372559-72559103.016104.21
471441-71441101.429102.60
571597-71597101.651102.84
671866-71866102.032103.23
褪黑素颗粒项目信息
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520023-202203对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.9对照品水分(%)0对照品稀释倍数10000
标示量(mg)1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 10.066405564169640346403964045640680.09
2 10.005976259687597240.09
单位质量响应值RSD%判断
6368.595972.404.55数据不可信!(响应值差异过大,请重新称样测定!)
供试品溶液-24120401批-pH6.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min169596-69596101.513101.552.30101.51101.552.30
270298-70298102.537102.54
370683-70683103.098103.10
469271-69271101.039101.04
566686-6668697.26897.27
671199-71199103.851103.85
10min171660-71660104.523105.141.18104.69105.321.18
271545-71545104.355104.53
372074-72074105.127105.30
472912-72912106.349106.52
571069-71069103.661103.82
673257-73257106.853107.03
15min171665-71665104.530105.311.12104.87105.651.12
270985-70985103.539103.88
371947-71947104.942105.29
473025-73025106.514106.86
572603-72603105.899106.23
672958-72958106.416106.77
20min171504-71504104.296105.391.27104.81105.911.27
271148-71148103.776104.29
371858-71858104.812105.33
472842-72842106.247106.77
572599-72599105.893106.40
673577-73577107.319107.85
30min171580-71580104.407105.211.05105.10105.901.05
270968-70968103.514104.20
372143-72143105.228105.92
472661-72661105.983106.68
572352-72352105.533106.22
673064-73064106.571107.28
45min171356-71356104.080105.261.00104.95106.131.00
271445-71445104.210105.07
372180-72180105.282106.15
472526-72526105.786106.66
572193-72193105.301106.16
673298-73298106.912107.80
60min170962-70962103.505104.940.98104.54105.990.98
271261-71261103.941104.98
371982-71982104.993106.04
472355-72355105.537106.59
572332-72332105.503106.54
672791-72791106.173107.24
极限170996-70996103.555104.670.98104.77105.890.97
270874-70874103.377104.59
371716-71716104.605105.83
472205-72205105.318106.55
572176-72176105.276106.49
672586-72586105.874107.11
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