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 9.986438464574644406441464529644680.13
2 10.056450064218643590.31
单位质量响应值RSD%判断
6459.726403.880.62数据可信
供试品溶液-25071001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%
5min166643-6664393.16293.523.2793.1693.523.28
267069-6706993.75793.76
368815-6881596.19896.20
468503-6850395.76295.76
567609-6760994.51294.51
662766-6276687.74287.74
10min167533-6753394.40694.722.1594.5694.872.15
267276-6727694.04794.20
369274-6927496.84097.00
469108-6910896.60896.77
568049-6804995.12795.28
665296-6529691.27991.43
15min167531-6753194.40394.881.9994.7295.191.99
267482-6748294.33594.65
369405-6940597.02397.34
469210-6921096.75097.07
567879-6787994.89095.21
665717-6571791.86792.17
20min167140-6714093.85794.521.5294.3394.991.53
267525-6752594.39594.87
368712-6871296.05496.54
468578-6857895.86796.35
567802-6780294.78295.26
665922-6592292.15492.61
30min167192-6719293.92994.292.1394.5694.922.13
267072-6707293.76294.39
368816-6881696.20096.84
468789-6878996.16296.80
567882-6788294.89495.53
664961-6496190.81191.42
45min166948-6694893.58894.042.0994.3794.822.09
266825-6682593.41694.20
368545-6854595.82196.62
468670-6867095.99596.80
567752-6775294.71295.50
664882-6488290.70091.46
60min166679-6667993.21293.742.4194.1594.682.41
266308-6630892.69493.63
368696-6869696.03297.00
468602-6860295.90096.86
567639-6763994.55495.50
664422-6442290.05790.96
极限166511-6651192.97793.881.9194.0794.981.91
266177-6617792.51093.60
368754-6875496.11397.24
468559-6855995.84096.96
567311-6731194.09695.20
665647-6564791.77092.83
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 9.986445664578645296453164592645370.09
2 10.056432764305643160.03
单位质量响应值RSD%判断
6466.636399.600.74数据可信
供试品溶液-25071001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%
5min165886-6588692.08695.752.6192.0995.752.61
267059-6705993.72593.72
370855-7085599.03099.03
468863-6886396.24696.25
568708-6870896.03096.03
669661-6966197.36297.36
10min167492-6749294.33097.082.3094.4897.242.31
268356-6835695.53895.69
372166-72166100.863101.03
469433-6943397.04397.20
569284-6928496.83596.99
670015-7001597.85698.02
15min167822-6782294.79197.312.2695.1097.642.26
268783-6878396.13596.45
371912-71912100.508100.84
469219-6921996.74497.07
568860-6886096.24296.56
671165-7116599.46499.79
20min167872-6787294.86197.312.1695.3397.802.16
268662-6866295.96596.44
371961-71961100.576101.08
468925-6892596.33396.82
569552-6955297.20997.69
670783-7078398.93099.42
30min167931-6793194.94497.112.2095.5797.752.20
268029-6802995.08195.72
371672-71672100.172100.84
469438-6943897.05097.69
568903-6890396.30296.95
670896-7089699.08899.74
45min167321-6732194.09197.002.0994.8897.812.09
268421-6842195.62996.42
371592-71592100.061100.90
469567-6956797.23098.04
569554-6955497.21298.02
669963-6996397.78498.60
60min167462-6746294.28896.902.1595.2397.872.15
267830-6783094.80395.76
371060-7106099.317100.32
469111-6911196.59397.56
569744-6974497.47898.44
670782-7078298.92899.91
极限167192-6719293.91196.982.4695.0198.112.46
268354-6835495.53596.65
371730-71730100.253101.42
468497-6849795.73596.86
569642-6964297.33598.46
670900-7090099.093100.24
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 9.986453464475644356471064733645770.22
2 10.056448664631645580.16
单位质量响应值RSD%判断
6470.646423.680.52数据可信
供试品溶液-25071001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%
5min166849-6684993.22793.642.3293.2393.642.32
265578-6557891.45491.45
367349-6734993.92493.92
469932-6993297.52697.53
565840-6584091.82091.82
667335-6733593.90493.90
10min168885-6888596.06696.312.3696.2296.462.36
267000-6700093.43793.59
369960-6996097.56597.72
471577-7157799.82099.98
567741-6774194.47194.62
669192-6919296.49496.65
15min168815-6881595.96896.552.3996.2896.872.39
267425-6742594.03094.34
370212-7021297.91798.24
471816-71816100.154100.48
567664-6766494.36394.67
669477-6947796.89297.21
20min168355-6835595.32796.772.5295.8097.242.52
267682-6768294.38894.85
370521-7052198.34898.83
472128-72128100.589101.08
567857-6785794.63295.10
669777-6977797.31097.79
30min168580-6858095.64196.792.7596.2897.432.74
267623-6762394.30694.93
370200-7020097.90098.55
472723-72723101.418102.08
567790-6779094.53995.16
669510-6951096.93897.58
45min169011-6901196.24296.722.6897.0497.522.67
267356-6735693.93494.71
370338-7033898.09298.90
472299-72299100.827101.66
567523-6752394.16794.95
669582-6958297.03897.84
60min168865-6886596.03896.963.0796.9997.923.06
267492-6749294.12395.06
370352-7035298.11299.08
473188-73188102.067103.07
567543-6754394.19595.13
669703-6970397.20798.17
极限168735-6873595.85796.922.7496.9798.042.73
267906-6790694.70195.79
370223-7022397.93299.07
472840-72840101.582102.75
567706-6770694.42295.52
669552-6955296.99698.12
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