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%
110.066429164252642916397463947641510.28
210.026449364468644800.03
单位质量响应值RSD%判断
6376.846435.130.65数据可信
供试品溶液-2025041021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%
5min166637-6663793.52993.041.5893.5393.041.58
266690-6669093.60393.60
365895-6589592.48892.49
466685-6668593.59693.60
567419-6741994.62794.63
664393-6439390.37990.38
10min167777-6777795.12995.961.2395.2896.111.23
268126-6812695.61995.77
367524-6752494.77494.93
468995-6899596.83996.99
569740-6974097.88498.04
668040-6804095.49895.65
15min168167-6816795.67796.131.0495.9996.451.04
267937-6793795.35495.67
368336-6833695.91496.23
468611-6861196.30096.62
569854-6985498.04498.37
668054-6805495.51895.83
20min168459-6845996.08695.820.6696.5696.300.66
268224-6822495.75796.23
368274-6827495.82796.30
468848-6884896.63297.11
568330-6833095.90596.39
667476-6747694.70795.18
30min167752-6775295.09495.640.9795.7396.280.97
267912-6791295.31995.95
367491-6749194.72895.36
468356-6835695.94296.58
569346-6934697.33197.98
667996-6799695.43696.06
45min168102-6810295.58595.870.7496.3896.660.74
268132-6813295.62796.42
367765-6776595.11295.90
468453-6845396.07896.88
569226-6922697.16397.97
668153-6815395.65796.44
60min168051-6805195.51495.580.8696.4796.530.86
268458-6845896.08597.04
367195-6719594.31295.26
468609-6860996.29797.26
568623-6862396.31797.28
667646-6764694.94595.89
极限168628-6862896.32495.590.7797.4396.710.76
267682-6768294.99696.11
367504-6750494.74695.85
468004-6800495.44896.57
568817-6881796.58997.72
668011-6801195.45896.56
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%
110.066472364446643516480664526645700.30
210.026434364332643380.02
单位质量响应值RSD%判断
6418.496420.960.03数据可信
供试品溶液-AGP01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%
5min168487-6848795.91892.774.0095.9292.774.00
267994-6799495.22795.23
365054-6505491.11091.11
461994-6199486.82486.82
565157-6515791.25491.25
668749-6874996.28596.28
10min170890-7089099.28397.751.2999.4497.901.29
270543-7054398.79798.96
369862-6986297.84498.00
468723-6872396.24896.39
568772-6877296.31796.47
669983-6998398.01398.17
15min170750-7075099.08797.811.1099.4198.121.10
269309-6930997.06997.39
370341-7034198.51598.83
469709-6970997.62997.93
568662-6866296.16396.48
670249-7024998.38698.71
20min170726-7072699.05497.961.0699.5498.441.06
269846-6984697.82198.31
369405-6940597.20497.68
470724-7072499.05199.52
568859-6885996.43996.91
670092-7009298.16698.65
30min170886-7088699.27898.161.0199.9398.801.01
270497-7049798.73399.38
370363-7036398.54599.19
469809-6980997.76998.40
568849-6884996.42597.06
670129-7012998.21898.87
45min170303-7030398.46197.631.0499.2898.441.04
270482-7048298.71299.52
369891-6989197.88498.69
469685-6968597.59698.39
568459-6845995.87996.67
669432-6943297.24198.06
60min170396-7039698.59297.910.6699.5898.880.66
270097-7009798.17399.15
370232-7023298.36299.33
470058-7005898.11899.08
569299-6929997.05598.01
669372-6937297.15798.13
极限170394-7039498.58998.050.3499.7499.180.35
269987-6998798.01999.16
370152-7015298.25099.38
469794-6979497.74898.87
569779-6977997.72798.84
669945-6994597.96099.10
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%
110.066456264426647026448964621645600.17
210.026451264323644180.21
单位质量响应值RSD%判断
6417.506428.940.13数据可信
供试品溶液-2025041021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%
5min164523-6452390.31790.330.7290.3290.330.72
265361-6536191.49091.49
364294-6429489.99790.00
464074-6407489.68989.69
564246-6424689.92989.93
664700-6470090.56590.56
10min167552-6755294.55793.840.8394.7194.000.83
267286-6728694.18594.34
367016-6701693.80793.96
466042-6604292.44392.59
566878-6687893.61493.76
667485-6748594.46394.61
15min167681-6768194.73894.400.7595.0594.710.76
268297-6829795.60095.91
367321-6732194.23494.54
466964-6696493.73494.04
566946-6694693.70994.01
667434-6743494.39294.70
20min167678-6767894.73393.900.5195.2094.360.51
267277-6727794.17294.64
366906-6690693.65394.12
466788-6678893.48893.95
566855-6685593.58194.04
666978-6697893.75494.22
30min167608-6760894.63594.030.5595.2694.650.54
267361-6736194.29094.92
366985-6698593.76394.38
466743-6674393.42594.04
567497-6749794.48095.10
666843-6684393.56594.19
45min167774-6777494.86893.970.7295.6594.750.72
267732-6773294.80995.59
366952-6695293.71794.49
466761-6676193.45094.22
566824-6682493.53894.31
666771-6677193.46494.24
60min167659-6765994.70793.840.8395.6594.780.83
267779-6777994.87595.82
366944-6694493.70694.64
466678-6667893.33494.26
566422-6642292.97593.91
666769-6676993.46194.39
极限167651-6765194.69693.860.7695.7994.950.75
267295-6729594.19795.30
367114-6711493.94495.03
466130-6613092.56793.65
567045-6704593.84794.93
667093-6709393.91595.00
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%
110.066427564185642696442964180642680.16
210.026427764163642200.13
单位质量响应值RSD%判断
6388.476409.180.23数据可信
供试品溶液-AGP01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%
5min166757-6675793.80192.221.3293.8092.221.32
264514-6451490.64990.65
365903-6590392.60192.60
464676-6467690.87790.88
566018-6601892.76292.76
665939-6593992.65192.65
10min172250-72250101.51996.052.96101.6896.202.96
266818-6681893.88694.04
367642-6764295.04495.20
466831-6683193.90594.06
568304-6830495.97496.13
668282-6828295.94396.10
15min170658-7065899.28296.913.0799.6197.233.07
267197-6719794.41994.73
372366-72366101.682101.99
467083-6708394.25994.57
568673-6867396.49396.81
667857-6785795.34695.66
20min171256-71256100.12297.283.30100.6197.753.29
267706-6770695.13495.60
372859-72859102.375102.86
467232-6723294.46894.93
567968-6796895.50295.98
668359-6835996.05296.52
30min168401-6840196.11195.350.9596.7795.990.95
267289-6728994.54895.17
368100-6810095.68896.34
466936-6693694.05294.67
568573-6857396.35296.99
667855-6785595.34395.98
45min173910-73910103.85196.813.65104.6797.603.63
267397-6739794.70095.48
368799-6879996.67097.48
467399-6739994.70395.48
568092-6809295.67696.47
667783-6778395.24296.03
60min169460-6946097.59996.893.2798.5997.853.25
267950-6795095.47796.42
373218-73218102.879103.85
467008-6700894.15395.09
568541-6854196.30797.26
667564-6756494.93595.89
极限167089-6708994.26795.100.6995.4296.220.69
267784-6778495.24496.34
368361-6836196.05497.20
467219-6721994.45095.54
567875-6787595.37296.49
667773-6777395.22896.34
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