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%
110.086560865761653816551565537655600.22
210.126566265573656180.10
单位质量响应值RSD%判断
6503.976483.990.22数据可信
供试品溶液-2025041121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%
5min171520-7152099.02198.891.5999.0298.901.59
273189-73189101.331101.33
371647-7164799.19699.20
470376-7037697.43797.44
571823-7182399.44099.44
670020-7002096.94496.94
10min172176-7217699.92999.991.29100.09100.151.29
273651-73651101.971102.14
371752-7175299.34299.51
470843-7084398.08398.25
572291-72291100.088100.25
672602-72602100.519100.68
15min172424-72424100.272100.111.45100.60100.441.45
273468-73468101.718102.06
371755-7175599.34699.68
470648-7064897.81398.14
572243-72243100.022100.35
673316-73316101.507101.84
20min171902-7190299.549100.151.21100.05100.651.20
273465-73465101.713102.22
371288-7128898.69999.20
471692-7169299.25999.75
572441-72441100.296100.79
673228-73228101.385101.88
30min172144-7214499.88599.991.42100.55100.661.42
273373-73373101.586102.26
371498-7149898.99099.65
470967-7096798.25598.91
571838-7183899.461100.13
673516-73516101.784102.45
极限172081-7208199.79799.900.97100.63100.730.97
273121-73121101.237102.08
371530-7153099.03499.86
471380-7138098.82799.64
571981-7198199.659100.49
672838-72838100.845101.68
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%
110.086556265309655066565965370654810.22
210.126544365504654740.07
单位质量响应值RSD%判断
6496.136469.760.29数据可信
供试品溶液-2025041121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%
5min171142-7114298.66595.982.3098.6795.982.30
269000-6900095.69495.69
368157-6815794.52594.53
471131-7113198.65098.65
568464-6846494.95194.95
667351-6735193.40793.41
10min172463-72463100.497100.161.31100.66100.321.30
273368-73368101.752101.91
372439-72439100.464100.62
471765-7176599.52999.69
572662-72662100.773100.93
670613-7061397.93198.09
15min172237-72237100.184100.001.27100.52100.321.27
273246-73246101.583101.91
371769-7176999.53599.86
471717-7171799.46399.79
572920-72920101.131101.46
670726-7072698.08898.41
20min172307-72307100.28199.931.28100.78100.421.28
273182-73182101.494101.99
371722-7172299.46999.96
471515-7151599.18299.68
572889-72889101.088101.58
670714-7071498.07198.55
30min172051-7205199.92699.341.41100.59100.001.41
272921-72921101.132101.80
370860-7086098.27498.93
471093-7109398.59799.26
572485-72485100.528101.19
670351-7035197.56898.21
极限171952-7195299.78899.421.36100.62100.241.36
272889-72889101.088101.92
371534-7153499.209100.03
470904-7090498.33599.16
572514-72514100.568101.40
670321-7032197.52698.33
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%
110.086543564943655876541065450653650.38
210.126554165369654550.19
单位质量响应值RSD%判断
6484.626467.890.19数据可信
供试品溶液-AGP01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%
5min171028-7102898.60998.402.4198.6198.402.41
272023-7202399.99099.99
371156-7115698.78698.79
467509-6750993.72393.72
572032-72032100.002100.00
671512-7151299.28099.28
10min172094-72094100.088100.690.68100.25100.860.68
273213-73213101.642101.81
372247-72247100.301100.47
472383-72383100.490100.65
573071-73071101.445101.61
672169-72169100.193100.36
15min172352-72352100.447101.080.43100.78101.410.43
272771-72771101.028101.36
373268-73268101.718102.05
472794-72794101.060101.38
573018-73018101.371101.71
672649-72649100.859101.19
20min171915-7191599.840100.570.94100.34101.070.93
272912-72912101.224101.73
372797-72797101.064101.57
473089-73089101.470101.96
571337-7133799.03899.54
672597-72597100.787101.29
30min172396-72396100.508100.750.44101.17101.420.44
273072-73072101.446102.12
372544-72544100.713101.38
472466-72466100.605101.27
572790-72790101.055101.72
672164-72164100.186100.85
极限172711-72711100.945100.740.33101.78101.580.32
272827-72827101.106101.95
372261-72261100.320101.16
472761-72761101.014101.84
572341-72341100.431101.27
672501-72501100.653101.49
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%
110.086537665702653836528965308654120.26
210.126510365465652840.40
单位质量响应值RSD%判断
6489.296450.990.42数据可信
供试品溶液-AGP01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%
5min172217-72217100.35599.520.84100.3599.520.84
271495-7149599.35199.35
371065-7106598.75498.75
472498-72498100.745100.75
571156-7115698.88098.88
671278-7127899.05099.05
10min172984-72984101.421100.970.56101.59101.140.56
272204-72204100.337100.50
372682-72682101.001101.17
473246-73246101.785101.95
572285-72285100.449100.61
672555-72555100.824100.99
15min172460-72460100.692101.000.60101.03101.330.60
272767-72767101.119101.45
372287-72287100.452100.78
473448-73448102.065102.40
572806-72806101.173101.51
672322-72322100.501100.83
20min172963-72963101.391100.890.53101.90101.390.53
272338-72338100.523101.02
372616-72616100.909101.41
473016-73016101.465101.97
572017-72017100.077100.58
672650-72650100.956101.46
30min172287-72287100.452100.350.90101.13101.020.89
272324-72324100.503101.17
372013-72013100.071100.74
473376-73376101.965102.64
571726-7172699.672100.34
671563-7156399.446100.11
极限172358-72358100.551100.450.50101.39101.280.50
272120-72120100.220101.06
372298-72298100.467101.30
472942-72942101.362102.21
572027-72027100.091100.92
671960-7196099.998100.83
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