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)4供试品稀释倍数4系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.306674066863666776669566776667500.12
210.376688966623667560.29
单位质量响应值RSD%判断
6480.586437.420.48数据可信
供试品溶液-2025082221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%
5min172444-72444100.84499.251.43100.8499.251.43
270808-7080898.56798.57
371685-7168599.78799.79
470197-7019797.71697.72
570266-7026697.81297.81
672394-72394100.774100.77
10min172952-72952101.551100.540.94102.67101.650.94
271798-7179899.945101.04
372554-72554100.997102.11
471289-7128999.236100.32
571883-71883100.063101.15
672896-72896101.473102.59
15min172763-72763101.28899.251.22103.54101.461.22
270492-7049298.127100.33
371734-7173499.856102.09
470772-7077298.517100.70
570609-7060998.290100.49
671402-7140299.394101.64
20min171594-7159499.66197.861.69103.04101.181.67
269029-6902996.09099.39
369985-6998597.421100.76
469036-6903696.10099.38
570414-7041498.018101.31
671729-7172999.849103.20
30min170556-7055698.21697.511.45102.70101.921.44
269057-6905796.129100.49
370946-7094698.759103.18
469144-6914496.250100.60
569265-6926596.419100.80
671340-7134099.307103.77
极限169841-6984197.22195.841.15102.79101.331.15
267771-6777194.33999.77
368928-6892895.950101.47
468102-6810294.800100.22
568977-6897796.018101.47
669468-6946896.701102.27
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)4供试品稀释倍数4系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.306660466626665626686566566666450.19
210.376659666620666080.03
单位质量响应值RSD%判断
6470.396423.140.52数据可信
供试品溶液-2025082221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%
5min171413-7141399.598101.051.1399.60101.051.12
272616-72616101.275101.28
372398-72398100.971100.97
472986-72986101.791101.79
571698-7169899.995100.00
673611-73611102.663102.66
10min171821-71821100.167102.051.24101.27103.171.24
273037-73037101.863102.99
374083-74083103.321104.44
473417-73417102.393103.52
572516-72516101.136102.25
674140-74140103.401104.54
15min170644-7064498.525100.992.09100.74103.242.07
271935-71935100.326102.58
373718-73718102.812105.08
471930-71930100.319102.59
571509-7150999.732101.97
674722-74722104.213106.50
20min169586-6958697.05099.371.88100.36102.751.87
271576-7157699.825103.20
371960-71960100.361103.77
471899-71899100.275103.66
569642-6964297.128100.47
672851-72851101.603105.05
30min169234-6923496.55997.881.59100.95102.361.58
270226-7022697.942102.42
370897-7089798.878103.41
469454-6945496.866101.36
569241-6924196.568100.99
672021-72021100.446105.02
极限168163-6816395.06597.681.67100.53103.251.65
269964-6996497.577103.15
370493-7049398.315103.94
469780-6978097.320102.89
570072-7007297.727103.22
671771-71771100.097105.79
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)4供试品稀释倍数4系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.306682366515665736672166655666570.19
210.376649666625665600.14
单位质量响应值RSD%判断
6471.556418.510.59数据可信
供试品溶液-2025082321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%
5min167939-6793994.77896.401.5994.7896.401.59
269466-6946696.90996.91
367573-6757394.26894.27
470003-7000397.65897.66
569364-6936496.76696.77
670243-7024397.99397.99
10min169482-6948296.93197.600.8397.9898.670.84
270690-7069098.61699.69
369156-6915696.47697.52
470469-7046998.30899.39
569942-6994297.57398.65
670045-7004597.71698.81
15min168552-6855295.63497.811.7397.7699.961.72
269693-6969397.22599.40
368965-6896596.21098.33
471508-7150899.757101.93
570975-7097599.014101.17
670968-7096899.004101.18
20min168858-6885896.06097.361.1599.25100.601.12
271219-7121999.354102.61
369826-6982697.411100.60
469499-6949996.955100.24
569932-6993297.559100.82
669385-6938596.796100.07
30min167292-6729293.87694.462.7098.1498.782.59
269115-6911596.419100.78
367189-6718993.73298.00
464555-6455590.05894.42
569628-6962897.135101.48
668482-6848295.53699.89
极限166672-6667293.01195.161.6998.31100.541.63
268149-6814995.071100.50
368310-6831095.296100.61
467420-6742094.05499.42
568703-6870395.844101.27
670035-7003597.702103.11
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)4供试品稀释倍数4系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.306641666751664526650266342664930.24
210.376666966459665640.23
单位质量响应值RSD%判断
6455.636418.900.41数据可信
供试品溶液-2025082321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%
5min167195-6719593.85394.681.7593.8594.681.75
266150-6615092.39392.39
368645-6864595.87895.88
467444-6744494.20194.20
569557-6955797.15297.15
667719-6771994.58594.58
10min168242-6824295.31597.072.5596.3698.132.54
268196-6819695.25196.28
368950-6895096.30497.37
468875-6887596.19997.25
572901-72901101.822102.90
669840-6984097.54798.60
15min168218-6821895.28296.821.8797.3898.941.87
267484-6748494.25696.34
369347-6934796.85998.99
470355-7035598.266100.38
570959-7095999.110101.32
669540-6954097.12899.26
20min169094-6909496.50595.811.1799.6799.021.17
267766-6776694.65097.78
368589-6858995.80099.01
468427-6842795.57498.78
569872-6987297.592100.90
667829-6782994.73897.95
30min166694-6669493.15395.172.4097.3999.442.37
266832-6683293.34697.53
368755-6875596.032100.31
467774-6777494.66198.93
571104-7110499.313103.71
667654-6765494.49498.76
极限166347-6634792.66893.781.1997.9499.111.21
266996-6699693.57598.80
367244-6724493.92199.26
466407-6640792.75298.07
568536-6853695.726101.23
667317-6731794.02399.34
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)4供试品稀释倍数4系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.306659666485665246667966588665740.12
210.376652166434664780.10
单位质量响应值RSD%判断
6463.506410.610.59数据可信
供试品溶液-2025082421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%
5min169857-6985797.57598.211.5997.5798.201.59
271718-71718100.174100.17
369605-6960597.22397.22
470543-7054398.53398.53
571354-7135499.66699.67
668779-6877996.06996.07
10min171172-7117299.41298.821.61100.5099.911.61
272295-72295100.980102.09
369785-6978597.47498.55
470648-7064898.68099.77
571430-7143099.772100.88
669165-6916596.60897.68
15min169730-6973097.39897.381.4799.5999.561.46
270867-7086798.986101.22
368877-6887796.20698.37
468516-6851695.70297.89
570971-7097199.131101.35
669323-6932396.82998.97
20min169242-6924296.71696.761.9099.99100.031.88
271010-7101099.185102.52
368390-6839095.52698.76
467722-6772294.59397.85
570681-7068198.726102.04
668604-6860495.82599.04
30min168067-6806795.07595.541.4699.4299.891.45
270345-7034598.257102.69
367840-6784094.75899.05
467667-6766794.51698.82
568510-6851095.693100.11
667979-6797994.95299.23
极限166041-6604192.24594.421.3197.6599.831.28
268341-6834195.457100.99
367354-6735494.07999.43
467711-6771194.57799.93
568523-6852395.712101.19
667640-6764094.47899.81
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)4供试品稀释倍数4系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.306659766432664676665466503665310.14
210.376633266165662480.18
单位质量响应值RSD%判断
6459.326388.430.79数据可信
供试品溶液-2025082421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%
5min169922-6992297.86797.010.8997.8797.010.89
269085-6908596.69696.70
369630-6963097.45997.46
468193-6819395.44795.45
569641-6964197.47497.47
669383-6938397.11397.11
10min170371-7037198.49697.831.4899.5898.901.47
268572-6857295.97897.05
371042-7104299.435100.52
468646-6864696.08197.14
570335-7033598.44599.53
670390-7039098.52299.60
15min170016-7001697.99997.581.44100.1899.741.43
268010-6801095.19197.33
370393-7039398.527100.71
469015-6901596.59898.73
570276-7027698.363100.54
670580-7058098.788100.96
20min168945-6894596.50095.761.1899.7799.011.16
268909-6890996.45099.65
369371-6937197.096100.38
467355-6735594.27497.48
568316-6831695.62098.89
667594-6759494.60997.88
30min167950-6795095.10795.341.2399.4599.661.21
268643-6864396.077100.35
368735-6873596.206100.57
466588-6658893.20197.45
568794-6879496.289100.62
668009-6800995.19099.51
极限168811-6881196.31294.841.71101.71100.211.66
266805-6680593.50598.84
367452-6745294.41099.84
466240-6624092.71498.00
569254-6925496.932102.33
668001-6800195.179100.56
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