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%
110.176524865371654496517665317653120.17
210.126583165997659140.18
单位质量响应值RSD%判断
6422.036513.241.00数据可信
供试品溶液-2025082621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%
5min166612-6661292.60592.491.0592.6192.491.05
267139-6713993.33893.34
366247-6624792.09892.10
466359-6635992.25492.25
567393-6739393.69193.69
665438-6543890.97390.97
10min168519-6851995.25795.200.3595.4195.360.35
268548-6854895.29795.45
368650-6865095.43995.59
468476-6847695.19795.35
568666-6866695.46195.62
668029-6802994.57594.73
15min168286-6828694.93395.651.0195.2595.961.01
269033-6903395.97196.29
369628-6962896.79897.11
468567-6856795.32395.64
569446-6944696.54596.86
667843-6784394.31794.63
20min168069-6806994.63195.340.7995.1095.810.79
268792-6879295.63696.11
369238-6923896.25696.73
468213-6821394.83195.30
569123-6912396.09696.57
668051-6805194.60695.07
30min168859-6885995.72995.370.7796.3696.000.77
268725-6872595.54396.18
368986-6898695.90696.54
468747-6874795.57496.20
568736-6873695.55896.19
667543-6754393.90094.52
极限168563-6856395.31895.120.5796.1195.910.57
268047-6804794.60095.39
368736-6873695.55896.35
468433-6843395.13795.93
568859-6885995.72996.52
667877-6787794.36495.14
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%
110.176626266040659506622765983660920.22
210.126632065989661540.36
单位质量响应值RSD%判断
6498.726536.960.42数据可信
供试品溶液-2025082621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%
5min169772-6977296.24792.592.0396.2592.592.03
266762-6676292.09592.10
365949-6594990.97490.97
466878-6687892.25592.26
566318-6631891.48391.48
667024-6702492.45792.46
10min172253-7225399.67096.002.0399.8396.152.03
270069-7006996.65796.81
368450-6845094.42494.58
468933-6893395.09095.24
569001-6900195.18495.34
668837-6883794.95895.11
15min172255-7225599.67395.772.15100.0096.092.15
269795-6979596.27996.59
368291-6829194.20494.51
469089-6908995.30595.62
568338-6833894.26994.58
668801-6880194.90895.22
20min172344-7234499.79596.102.14100.2996.582.14
270303-7030396.98097.46
368247-6824794.14494.61
469245-6924595.52095.99
568652-6865294.70295.17
669199-6919995.45795.93
30min172688-72688100.27096.042.36100.9396.672.36
270082-7008296.67597.31
368312-6831294.23394.86
469217-6921795.48296.11
568351-6835194.28794.91
669079-6907995.29195.92
极限172282-7228299.71095.892.12100.5496.682.12
269892-6989296.41397.21
368457-6845794.43395.21
469132-6913295.36596.15
568274-6827494.18194.96
669052-6905295.25496.04
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%
110.176628766299658756589765888660490.34
210.126631666094662050.24
单位质量响应值RSD%判断
6494.496542.000.52数据可信
供试品溶液-2025082721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%
5min168083-6808393.91290.901.8793.9190.901.87
264541-6454189.02689.03
365634-6563490.53490.53
465031-6503189.70289.70
565869-6586990.85890.86
666222-6622291.34591.35
10min170195-7019596.82594.661.2696.9894.821.26
267620-6762093.27393.42
368377-6837794.31894.47
468234-6823494.12094.27
568603-6860394.62994.78
668738-6873894.81694.97
15min170242-7024296.89094.871.2597.2195.181.25
268240-6824094.12994.43
368226-6822694.10994.42
468016-6801693.82094.13
568615-6861594.64694.96
669320-6932095.61895.93
20min170218-7021896.85794.961.2297.3495.431.22
267845-6784593.58494.04
368860-6886094.98495.45
468117-6811793.95994.42
568898-6889895.03695.50
669129-6912995.35595.82
30min170137-7013796.74594.861.0497.3995.491.04
268295-6829594.20594.82
368619-6861994.65195.27
468226-6822694.10994.73
568888-6888895.02395.65
668476-6847694.45495.08
极限170119-7011996.72194.751.0697.5295.531.06
268222-6822294.10494.88
368390-6839094.33695.12
468299-6829994.21094.99
568360-6836094.29495.08
668737-6873794.81495.60
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%
110.176639966195660876607766190661900.20
210.126639366261663270.15
单位质量响应值RSD%判断
6508.366554.050.50数据可信
供试品溶液-2025082721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%
5min166483-6648391.52391.872.7491.5291.872.74
264481-6448188.76788.77
368748-6874894.64194.64
469110-6911095.14095.14
565932-6593290.76590.76
665666-6566690.39890.40
10min168849-6884994.78095.332.2594.9395.482.25
267733-6773393.24493.39
370793-7079397.45697.61
471555-7155598.50598.66
568174-6817493.85194.00
668368-6836894.11894.27
15min169052-6905295.06095.492.1395.3795.812.13
268099-6809993.74894.05
370716-7071697.35097.67
471645-7164598.62998.95
568558-6855894.38094.69
668136-6813693.79994.11
20min168820-6882094.74095.452.2895.2195.922.28
267660-6766093.14393.60
370816-7081697.48897.97
471725-7172598.73999.23
568404-6840494.16894.63
668574-6857494.40294.87
30min168366-6836694.11595.212.0794.7495.842.07
268269-6826993.98294.60
370523-7052397.08597.73
471412-7141298.30998.96
568106-6810693.75794.38
668301-6830194.02694.65
极限168936-6893694.90095.141.9995.6895.931.99
268006-6800693.62094.39
370116-7011696.52497.33
471374-7137498.25699.07
567972-6797293.57394.35
668262-6826293.97294.75
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%
110.176645566006660906612166121661590.27
210.126610066231661660.14
单位质量响应值RSD%判断
6505.316538.140.36数据可信
供试品溶液-2025082821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%
5min167842-6784293.52991.980.9993.5391.980.99
266306-6630691.41291.41
367018-6701892.39392.39
466410-6641091.55591.55
566739-6673992.00892.01
665986-6598690.97090.97
10min169436-6943695.72795.440.9595.8895.600.95
269543-6954395.87496.03
369922-6992296.39796.55
468803-6880394.85495.01
569557-6955795.89396.05
668114-6811493.90494.06
15min169213-6921395.41995.541.1595.7395.861.15
269573-6957395.91696.23
370136-7013696.69297.01
469322-6932295.56995.88
569741-6974196.14796.46
667832-6783293.51593.82
20min169301-6930195.54195.390.9196.0295.870.91
269130-6913095.30595.78
369666-6966696.04496.52
469598-6959895.95096.42
569487-6948795.79796.27
667983-6798393.72494.19
30min169446-6944695.74095.490.8396.3796.120.83
268957-6895795.06695.70
370051-7005196.57597.21
469062-6906295.21195.84
569640-6964096.00896.64
668426-6842694.33494.95
极限169052-6905295.19795.321.0495.9996.111.04
269391-6939195.66596.45
370136-7013696.69297.49
469146-6914695.32796.12
569215-6921595.42296.22
667909-6790993.62194.40
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%
110.176642366449665216639666260664100.15
210.126629466280662870.02
单位质量响应值RSD%判断
6529.996550.100.22数据可信
供试品溶液-2025082821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%
5min166479-6647991.39391.601.3491.3991.591.34
266545-6654591.48491.48
368015-6801593.50593.50
466805-6680591.84191.84
566696-6669691.69191.69
665216-6521689.65789.66
10min168863-6886394.67094.781.1094.8294.931.10
268906-6890694.73094.88
370148-7014896.43796.59
468590-6859094.29594.45
569267-6926795.22695.38
667862-6786293.29493.44
15min169114-6911495.01595.390.7795.3395.700.77
269129-6912995.03695.35
370369-7036996.74197.06
469123-6912395.02895.34
568952-6895294.79395.10
669611-6961195.69996.00
20min169228-6922895.17295.301.3095.6495.771.30
269308-6930895.28295.75
370481-7048196.89597.37
469089-6908994.98195.45
567837-6783793.26093.73
669985-6998596.21396.68
30min169195-6919595.12795.480.7295.7596.110.72
269716-6971695.84396.47
370263-7026396.59597.23
468923-6892394.75395.38
569058-6905894.93895.56
669554-6955495.62096.25
极限169094-6909494.98895.430.7095.7796.220.70
269713-6971395.83996.63
370123-7012396.40397.20
469099-6909994.99595.78
568854-6885494.65895.44
669622-6962295.71496.50
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