褪黑素颗粒项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
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%
19.986641066600665846648166588665330.13
29.966678766649667180.15
单位质量响应值RSD%判断
6666.636698.590.34数据可信
供试品溶液-2025082621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%
5min171120-7112095.68895.081.6295.6995.081.62
268943-6894392.75992.76
370040-7004094.23594.23
470271-7027194.54594.55
572070-7207096.96696.97
671567-7156796.28996.29
10min171084-7108495.63995.212.0496.7096.272.04
268296-6829691.88892.92
370351-7035194.65395.70
470659-7065995.06796.12
572558-7255897.62298.70
671656-7165696.40997.48
15min171145-7114595.72193.762.1797.8595.872.16
267297-6729790.54492.60
368712-6871292.44894.55
469499-6949993.50795.61
571193-7119395.78697.95
670259-7025994.52996.67
20min169856-6985693.98793.422.0297.1896.582.01
266999-6699990.14393.20
370141-7014194.37097.50
468856-6885692.64295.79
571094-7109495.65398.88
669663-6966393.72796.92
30min168834-6883492.61291.981.9196.8596.181.90
266341-6634189.25893.32
367357-6735790.62594.80
468636-6863692.34696.52
569972-6997294.14398.43
669059-6905992.91597.15
极限166998-6699890.14290.651.7195.4095.861.71
265539-6553988.17993.23
367241-6724190.46995.65
467271-6727190.50995.71
568728-6872892.46997.80
668477-6847792.13297.40
褪黑素颗粒项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
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%
19.986653966816667716654266683666700.20
29.966664666556666010.10
单位质量响应值RSD%判断
6680.366686.850.07数据可信
供试品溶液-2025082621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%
5min173691-7369199.13295.882.2599.1395.882.25
272020-7202096.88496.88
371233-7123395.82595.82
470020-7002094.19394.19
571582-7158296.29496.29
669106-6910692.96492.96
10min174272-7427299.91395.802.48101.0196.872.48
271579-7157996.29097.37
371125-7112595.68096.74
470361-7036194.65295.70
571068-7106895.60396.67
668900-6890092.68793.72
15min172864-7286498.01994.811.90100.2396.941.90
270547-7054794.90297.05
370209-7020994.44796.58
469715-6971593.78395.88
570638-7063895.02597.16
668897-6889792.68294.75
20min171396-7139696.04493.801.8099.3496.991.81
270203-7020394.43997.64
370692-7069295.09798.27
468830-6883092.59295.73
569237-6923793.14096.33
668029-6802991.51594.61
30min170968-7096895.46893.092.0299.8497.322.01
268711-6871192.43296.68
369840-6984093.95198.18
467906-6790691.34995.52
570313-7031394.58798.81
667460-6746090.74994.86
极限169622-6962293.65892.521.3399.0997.781.35
268119-6811991.63696.91
369656-6965693.70498.98
468566-6856692.23797.42
569310-6931093.23898.51
667386-6738690.65095.77
褪黑素颗粒项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
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%
19.986659566729665846667466636666440.09
29.966680166813668070.02
单位质量响应值RSD%判断
6677.766707.530.32数据可信
供试品溶液-2025082721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%
5min169770-6977093.73194.691.4793.7394.691.47
270858-7085895.19295.19
370613-7061394.86394.86
472308-7230897.14097.14
569609-6960993.51493.51
669743-6974393.69493.69
10min168739-6873992.34593.921.6493.3994.971.63
270624-7062494.87895.94
369732-6973293.68094.73
471723-7172396.35497.43
568771-6877192.38893.43
669875-6987593.87294.91
15min168432-6843291.93392.691.9094.0094.791.88
269265-6926593.05295.16
368756-6875692.36894.46
471177-7117795.62197.77
567187-6718790.26192.33
669160-6916092.91195.00
20min167183-6718390.25591.871.9493.3494.991.93
269043-6904392.75495.90
367625-6762590.84993.97
470710-7071094.99398.21
567460-6746090.62793.70
668271-6827191.71794.83
30min166495-6649589.33190.782.4093.4294.922.36
266844-6684489.80093.98
367438-6743890.59894.73
470812-7081295.13099.40
566925-6692589.90993.98
666910-6691089.88894.02
极限165143-6514387.51590.052.2292.6095.202.19
267420-6742090.57495.75
367211-6721190.29395.43
469261-6926193.04798.37
565593-6559388.11993.19
667552-6755290.75195.89
褪黑素颗粒项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
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%
19.986646266637667126680766789666810.21
29.966656566633665990.08
单位质量响应值RSD%判断
6681.466686.650.06数据可信
供试品溶液-2025082721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%
5min172062-7206296.93494.982.4596.9394.982.45
269272-6927293.18193.18
371364-7136495.99595.99
470211-7021194.44494.44
568112-6811291.62091.62
672624-7262497.69097.69
10min171419-7141996.06995.601.9297.1596.651.92
270550-7055094.90095.94
372487-7248797.50598.57
470461-7046194.78095.83
568975-6897592.78193.80
672513-7251397.54098.63
15min170449-7044994.76493.712.2496.9195.832.23
269080-6908092.92295.01
370601-7060194.96897.12
468788-6878892.53094.63
567375-6737590.62992.68
671720-7172096.47498.64
20min170346-7034694.62593.452.0997.8296.602.09
268877-6887792.64995.77
370575-7057594.93398.14
469088-6908892.93396.06
567037-6703790.17493.23
670897-7089795.36798.61
30min169442-6944293.40991.991.6697.6696.191.66
267506-6750690.80594.96
368645-6864592.33796.60
469217-6921793.10797.27
566544-6654489.51193.57
668982-6898292.79197.09
极限167896-6789691.33091.141.4096.6296.361.42
267479-6747990.76995.93
368056-6805691.54596.83
468252-6825291.80997.01
566043-6604388.83793.89
668795-6879592.53997.87
褪黑素颗粒项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
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%
19.986666366918668836678566679667860.18
29.966664366639666410.01
单位质量响应值RSD%判断
6691.986690.860.02数据可信
供试品溶液-2025082821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%
5min170925-7092595.29995.791.2695.3095.791.26
272172-7217296.97596.97
371061-7106195.48295.48
470739-7073995.04995.05
572586-7258697.53197.53
670252-7025294.39594.39
10min170030-7003094.09795.181.1295.1696.241.13
271083-7108395.51196.59
371132-7113295.57796.64
470902-7090295.26896.32
572007-7200796.75397.84
669850-6985093.85594.90
15min168239-6823991.69093.351.2093.7995.481.20
269787-6978793.77095.91
369411-6941193.26595.39
470035-7003594.10396.22
570537-7053794.77896.94
668847-6884792.50794.60
20min167728-6772891.00392.831.8594.1395.991.83
269592-6959293.50896.69
368414-6841491.92595.08
469650-6965093.58696.75
571124-7112495.56698.78
668030-6803091.40994.53
30min168233-6823391.68291.751.4895.8295.941.46
268487-6848792.02396.24
367345-6734590.48994.67
467682-6768290.94295.14
570162-7016294.27498.55
667784-6778491.07995.21
极限167202-6720290.29790.630.7895.4595.840.80
267799-6779991.09996.34
367503-6750390.70195.89
467660-6766090.91296.12
568013-6801391.38696.71
666539-6653989.40694.55
褪黑素颗粒项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
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%
19.986660766794667326640266768666610.25
29.966680366637667200.18
单位质量响应值RSD%判断
6679.466698.800.21数据可信
供试品溶液-2025082821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%
5min170141-7014194.27895.791.4494.2895.791.44
271403-7140395.97595.97
372205-7220597.05397.05
470819-7081995.19095.19
570327-7032794.52894.53
672686-7268697.69997.70
10min171757-7175796.45096.011.1697.5097.081.16
271702-7170296.37697.44
371799-7179996.50797.59
470970-7097095.39396.45
570011-7001194.10395.15
672346-7234697.24298.33
15min169729-6972993.72493.570.5995.8495.700.60
269250-6925093.08195.22
369938-6993894.00596.16
469393-6939393.27395.39
569164-6916492.96595.06
670190-7019094.34496.51
20min169796-6979693.81593.161.4496.9896.331.42
268956-6895692.68595.86
369790-6979093.80697.00
468906-6890692.61895.77
567762-6776291.08194.21
670648-7064894.96098.17
30min168353-6835391.87591.770.8696.0895.980.84
268267-6826791.75995.96
368492-6849292.06296.30
467140-6714090.24594.43
568596-6859692.20296.34
668796-6879692.47096.74
极限166422-6642289.27990.301.7194.5095.521.66
266634-6663489.56494.79
367775-6777591.09896.36
467312-6731290.47695.66
565863-6586388.52893.69
669081-6908192.85398.15
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