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%
110.146742067176671886721867191672390.16
210.106709667020670580.09
单位质量响应值RSD%判断
6631.076639.410.09数据可信
供试品溶液-2025311521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%
5min166851-6685190.58691.222.1590.5991.222.15
264722-6472287.70187.70
367779-6777991.84391.84
467758-6775891.81591.81
567774-6777491.83691.84
669015-6901593.51893.52
10min167983-6798392.12093.550.9792.2793.700.98
268609-6860992.96893.11
369065-6906593.58693.74
469784-6978494.56094.71
569117-6911793.65693.81
669654-6965494.38494.54
15min168397-6839792.68193.780.8992.9994.090.89
268525-6852592.85493.16
369462-6946294.12494.43
469920-6992094.74495.05
569590-6959094.29794.61
669372-6937294.00294.31
20min167769-6776991.83093.341.1992.2993.801.19
268296-6829692.54493.00
368498-6849892.81793.28
469848-6984894.64795.12
569310-6931093.91894.38
669565-6956594.26394.73
30min167511-6751191.48093.111.7392.0993.731.73
267049-6704990.85491.46
368865-6886593.31593.94
469650-6965094.37895.00
569200-6920093.76994.39
670022-7002294.88395.51
极限166265-6626589.79292.971.7790.5693.741.76
268507-6850792.83093.59
368829-6882993.26694.04
469502-6950294.17894.96
569494-6949494.16794.95
669066-6906693.58794.37
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%
110.146721967103672666727367145672010.12
210.106712467266671950.15
单位质量响应值RSD%判断
6627.326652.970.28数据可信
供试品溶液-2025311521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%
5min169194-6919493.69294.831.6393.6994.831.63
272011-7201197.50697.51
368783-6878393.13593.14
470285-7028595.16995.17
569616-6961694.26394.26
670308-7030895.20095.20
10min170073-7007394.88295.801.3795.0495.961.37
272454-7245498.10698.27
369971-6997194.74494.90
471309-7130996.55596.71
570488-7048895.44495.60
670197-7019795.05095.21
15min170591-7059195.58395.921.4995.9096.241.49
272584-7258498.28298.61
369508-6950894.11794.43
471441-7144196.73497.05
570377-7037795.29395.61
670533-7053395.50595.82
20min170419-7041995.35095.821.5495.8296.301.54
272689-7268998.42498.91
369692-6969294.36694.84
471352-7135296.61497.09
570214-7021495.07395.55
670227-7022795.09095.57
30min170274-7027495.15495.831.4995.7996.471.49
272493-7249398.15998.81
369492-6949294.09594.72
471463-7146396.76497.41
570351-7035195.25895.89
670582-7058295.57196.21
极限170610-7061095.60996.081.5696.4096.881.56
272796-7279698.56999.39
369588-6958894.22595.01
471612-7161296.96697.77
570641-7064195.65196.44
670496-7049695.45596.25
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%
110.146731567055670716726067177671760.17
210.106713867083671100.06
单位质量响应值RSD%判断
6624.856644.550.21数据可信
供试品溶液-2025311521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%
5min169224-6922493.80993.101.3193.8193.101.31
267727-6772791.78091.78
370208-7020895.14295.14
468653-6865393.03593.04
568240-6824092.47592.48
668138-6813892.33792.34
10min170772-7077295.90794.861.3196.0695.021.30
268608-6860892.97493.13
371210-7121096.50096.66
469679-6967994.42694.58
569804-6980494.59594.75
669929-6992994.76494.92
15min170932-7093296.12495.041.1896.4495.351.18
269243-6924393.83594.14
371328-7132896.66096.98
469486-6948694.16494.48
569995-6999594.85495.17
669806-6980694.59894.91
20min170736-7073695.85895.061.1996.3395.531.19
269277-6927793.88194.35
371407-7140796.76797.25
469301-6930193.91394.38
570231-7023195.17495.64
669919-6991994.75195.22
30min170906-7090696.08894.901.2996.7295.531.29
268878-6887893.34093.96
371205-7120596.49397.14
469403-6940394.05194.68
570183-7018395.10995.74
669600-6960094.31894.95
极限170750-7075095.87795.031.2496.6795.811.24
268876-6887693.33794.11
371310-7131096.63697.44
469603-6960394.32395.11
570344-7034495.32796.11
669846-6984694.65295.44
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