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%
110.156664766480666866663166795666480.18
210.196657466523665480.06
单位质量响应值RSD%判断
6566.316530.720.39数据可信
供试品溶液-2025082821批-水
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min170566-7056696.88796.481.8596.8996.481.85
269880-6988095.94595.94
372171-7217199.09099.09
470171-7017196.34496.34
568181-6818193.61293.61
670654-7065497.00897.01
10min171167-7116797.71296.872.3098.7997.942.28
267741-6774193.00894.07
371253-7125397.83098.93
470974-7097497.44798.52
569773-6977395.79896.84
672429-7242999.445100.52
15min171157-7115797.69895.242.4299.8697.392.40
267016-6701692.01394.11
371082-7108297.59599.78
468933-6893394.64596.80
568027-6802793.40195.51
669999-6999996.10898.29
20min167972-6797293.32593.003.8896.5796.213.79
262557-6255785.89089.01
369848-6984895.90199.17
468260-6826093.72196.93
569182-6918294.98698.13
668592-6859294.17697.43
30min167062-6706292.07692.161.6296.3696.401.64
265171-6517189.47993.56
367488-6748892.66197.00
467853-6785393.16297.41
566876-6687691.82096.02
668290-6829093.76298.06
极限167220-6722092.29391.521.1497.6096.781.17
265581-6558190.04295.11
367754-6775493.02698.39
466349-6634991.09796.38
566380-6638091.13996.36
666667-6666791.53396.87
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%
110.156695166865665026662766562667010.30
210.196663166492665620.15
单位质量响应值RSD%判断
6571.536532.090.43数据可信
供试品溶液-2025082821批-水
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min170834-7083497.20697.720.4397.2197.720.43
271379-7137997.95497.95
370877-7087797.26597.26
471408-7140897.99497.99
571579-7157998.22898.23
671191-7119197.69697.70
10min170536-7053696.79796.810.6797.8897.890.66
271024-7102497.46798.55
370996-7099697.42898.51
470613-7061396.90397.99
570333-7033396.51897.61
669752-6975295.72196.81
15min169061-6906194.77395.920.7396.9398.080.71
269784-6978495.76597.94
369637-6963795.56397.73
470187-7018796.31898.48
570391-7039196.59898.76
670309-7030996.48598.63
20min169503-6950395.37995.300.9198.5998.530.88
269927-6992795.96199.20
369710-6971095.66398.89
470021-7002196.09099.33
568320-6832093.75696.99
669189-6918994.94898.17
30min167167-6716792.17493.151.0496.4497.431.00
267170-6717092.17896.48
367966-6796693.27097.56
468957-6895794.63098.93
567651-6765192.83897.12
668351-6835193.79898.07
极限167151-6715192.15292.750.6697.4498.070.64
267690-6769092.89198.22
368032-6803293.36198.68
468075-6807593.42098.77
567574-6757492.73298.04
666993-6699391.93597.25
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%
110.156661466428664936672366542665600.18
210.196669466558666260.15
单位质量响应值RSD%判断
6557.646538.370.21数据可信
供试品溶液-2025082421批-水
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min166449-6644991.24191.873.6891.2491.873.68
266381-6638191.14791.15
370661-7066197.02497.02
468668-6866894.28894.29
565730-6573090.25390.25
663563-6356387.27887.28
10min169490-6949095.41695.850.8296.4396.870.80
270619-7061996.96697.98
369937-6993796.03097.11
468909-6890994.61895.67
569928-6992896.01897.02
669961-6996196.06397.03
15min167510-6751092.69894.401.1694.7796.481.14
269685-6968595.68497.77
369250-6925095.08797.23
468123-6812393.53995.64
568975-6897594.70996.78
668934-6893494.65396.69
20min166962-6696291.94592.841.3695.0595.971.32
268178-6817893.61596.77
367553-6755392.75795.96
466213-6621390.91794.05
568781-6878194.44397.56
667980-6798093.34396.43
30min167303-6730392.41392.061.0496.5496.220.99
267715-6771592.97997.17
366436-6643691.22395.46
466027-6602790.66194.81
567754-6775493.03397.20
667030-6703092.03896.16
极限165065-6506589.34090.981.3894.4996.171.34
266574-6657491.41296.64
367499-6749992.68297.93
465808-6580890.36195.52
566964-6696491.94897.15
665645-6564590.13795.29
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%
110.156680666420666636636466940666390.37
210.196673366504666180.25
单位质量响应值RSD%判断
6565.426537.590.31数据可信
供试品溶液-2025082421批-水
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min164672-6467288.75392.483.1988.7592.483.19
270186-7018696.32196.32
367199-6719992.22192.22
468556-6855694.08494.08
568569-6856994.10294.10
665135-6513589.38989.39
10min167302-6730292.36394.421.5093.3595.441.52
270253-7025396.41397.48
368311-6831193.74894.77
469193-6919394.95896.00
569400-6940095.24296.29
668342-6834293.79094.78
15min166994-6699491.94093.091.1993.9595.161.19
268848-6884894.48496.63
367662-6766292.85794.92
466870-6687091.77093.87
568066-6806693.41195.52
668535-6853594.05596.09
20min164841-6484188.98591.301.2992.0294.411.29
267088-6708892.06995.26
366497-6649791.25894.36
467097-6709792.08195.20
566740-6674091.59294.73
666900-6690091.81194.89
30min164018-6401887.85690.251.6891.8894.371.67
267148-6714892.15196.37
365388-6538889.73693.85
466252-6625290.92295.07
565273-6527389.57893.74
666479-6647991.23395.33
极限163625-6362587.31789.321.6092.3294.451.59
266238-6623890.90396.14
364078-6407887.93893.05
465873-6587390.40295.56
565645-6564590.08995.24
665041-6504189.26094.37
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%
110.156681766686663566664366342665690.32
210.196629666799665480.54
单位质量响应值RSD%判断
6558.526530.720.31数据可信
供试品溶液-2025082621批-水
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min168695-6869594.37493.481.6594.3793.481.65
268246-6824693.75793.76
368979-6897994.76494.76
469060-6906094.87594.88
566542-6654291.41691.42
666755-6675591.70891.71
10min169855-6985595.96794.750.9497.0295.790.94
269448-6944895.40896.45
368290-6829093.81794.87
469234-6923495.11496.17
568720-6872094.40895.42
668277-6827793.79994.82
15min169999-6999996.16594.411.5298.2896.501.51
268336-6833693.88095.98
369303-6930395.20997.30
469032-6903294.83796.95
568746-6874694.44496.51
666931-6693191.95094.01
20min168251-6825193.76492.770.7596.9595.920.75
267198-6719892.31795.46
367158-6715892.26295.42
467836-6783693.19496.36
567792-6779293.13396.25
666948-6694891.97495.06
30min168016-6801693.44191.541.4397.6795.711.40
266836-6683691.82095.99
367214-6721492.33996.52
465932-6593290.57894.78
566462-6646291.30695.45
665328-6532889.74893.85
极限165932-6593290.57890.630.8095.8495.820.79
265568-6556890.07895.27
366533-6653391.40396.61
466234-6623490.99396.20
566384-6638491.19996.36
665159-6515989.51694.62
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%
110.156707366887669396677766876669100.17
210.196632966263662960.08
单位质量响应值RSD%判断
6592.126505.990.93数据可信
供试品溶液-2025082721批-水
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min168036-6803693.40993.693.6293.4193.703.62
271088-7108897.59997.60
367426-6742692.57192.57
470052-7005296.17696.18
568856-6885694.53494.53
664007-6400787.87787.88
10min170867-7086797.29595.811.5698.3396.851.57
271140-7114097.67098.75
368954-6895494.66995.70
469453-6945395.35496.42
569962-6996296.05397.10
668355-6835593.84794.82
15min170124-7012496.27595.261.3898.3997.371.39
270985-7098597.45799.63
368596-6859694.17796.26
469016-6901694.75496.88
568781-6878194.43196.55
668816-6881694.48096.50
20min169534-6953495.46593.991.1498.6597.151.12
268472-6847294.00797.26
367217-6721792.28495.41
468900-6890094.59597.78
568116-6811693.51896.69
668507-6850794.05597.12
30min168074-6807493.46191.891.8897.7196.101.86
268582-6858294.15898.46
365045-6504589.30293.45
466739-6673991.62895.86
566691-6669191.56295.77
666452-6645291.23495.35
极限167299-6729992.39791.341.6797.6896.571.63
268057-6805793.43798.78
365245-6524589.57794.72
465788-6578890.32295.57
565690-6569090.18895.41
667092-6709292.11397.24
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%
110.156623566713663596653966545664780.28
210.196610266592663470.53
单位质量响应值RSD%判断
6549.566510.990.42数据可信
供试品溶液-2025082221批-水
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min169034-6903495.04893.712.3695.0593.712.36
266007-6600790.88090.88
366162-6616291.09491.09
469055-6905595.07795.08
569786-6978696.08396.08
668321-6832194.06694.07
10min169268-6926895.37094.481.3896.4395.521.38
268423-6842394.20795.22
367577-6757793.04294.05
468826-6882694.76295.82
569999-6999996.37797.44
667648-6764893.14094.18
15min167327-6732792.69892.191.3294.8194.281.32
266589-6658991.68293.74
365694-6569490.44992.50
467586-6758693.05495.16
568110-6811093.77695.91
666438-6643891.47493.55
20min167130-6713092.42791.651.6095.5794.771.60
266030-6603090.91293.99
364942-6494289.41492.47
466858-6685892.05295.20
568080-6808093.73596.92
666366-6636691.37594.47
30min165634-6563490.36790.151.7494.5494.281.72
265869-6586990.69094.78
363365-6336587.24391.29
466306-6630691.29295.46
566500-6650091.55995.78
665177-6517789.73893.85
极限165592-6559290.30989.151.0695.4994.291.07
264116-6411688.27793.37
364294-6429488.52293.54
464752-6475289.15394.33
565577-6557790.28895.53
664191-6419188.38093.49
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%
110.156684766580664016661766519665930.25
210.196634566301663230.05
单位质量响应值RSD%判断
6560.896508.640.57数据可信
供试品溶液-2025082321批-水
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min165843-6584390.59394.743.1690.5994.743.16
268885-6888594.77994.78
372111-7211199.21799.22
469250-6925095.28195.28
567184-6718492.43892.44
669847-6984796.10296.10
10min168179-6817993.80794.521.5694.8195.571.57
268440-6844094.16695.22
370454-7045496.93798.04
469516-6951695.64796.71
567803-6780393.29094.32
667785-6778593.26594.33
15min166622-6662291.66592.751.4393.7194.851.44
266807-6680791.91994.02
368802-6880294.66496.84
468292-6829293.96396.08
566472-6647291.45893.52
667472-6747292.83494.94
20min165894-6589490.66391.631.8093.7394.771.81
265810-6581090.54893.67
368541-6854194.30597.54
467352-6735292.66995.83
565291-6529189.83492.91
666712-6671291.78994.92
30min164125-6412588.22989.822.1092.3093.972.09
264794-6479489.15093.28
367633-6763393.05697.34
466215-6621591.10595.30
564450-6445088.67692.75
664469-6446988.70392.86
极限164727-6472789.05889.391.4894.1194.541.49
265274-6527489.81094.93
366311-6631191.23796.55
465585-6558590.23895.45
563620-6362087.53492.60
664297-6429788.46693.61
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%
110.156701167473676026746667390673880.34
210.196651466038662760.51
单位质量响应值RSD%判断
6639.216504.021.46数据可信
供试品溶液-2025082621批-水
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min169164-6916494.63794.761.9994.6494.761.99
268387-6838793.57493.57
371911-7191198.39698.40
468162-6816293.26693.27
569282-6928294.79994.80
668611-6861193.88193.88
10min169377-6937794.92994.450.9395.9895.510.93
269106-6910694.55895.60
369760-6976095.45396.55
469098-6909894.54795.58
568973-6897394.37695.43
667866-6786692.86193.90
15min168257-6825793.39693.461.1595.5095.561.14
267803-6780392.77594.87
369138-6913894.60296.76
467120-6712091.84093.93
569141-6914194.60696.71
668348-6834893.52195.60
20min168218-6821893.34392.402.0696.4995.542.03
266977-6697791.64594.77
369613-6961395.25298.46
465882-6588290.14693.25
568134-6813493.22896.38
666329-6632990.75893.87
30min167156-6715691.89090.232.0096.0794.401.94
263773-6377387.26191.40
366324-6632490.75195.01
465962-6596290.25694.36
567266-6726692.04096.23
665192-6519289.20293.32
极限166216-6621690.60389.961.1595.8195.131.15
265873-6587390.13495.24
366824-6682491.43596.71
465203-6520389.21794.33
565695-6569589.89195.10
664671-6467188.48993.60
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%
110.156612566185664276658766354663360.29
210.196599665911659540.10
单位质量响应值RSD%判断
6535.576472.420.69数据可信
供试品溶液-2025082721批-水
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min170255-7025597.12194.683.1097.1294.683.10
269640-6964096.27196.27
366753-6675392.28092.28
467203-6720392.90292.90
571126-7112698.32698.33
665947-6594791.16691.17
10min171421-7142198.73396.981.9299.8198.031.93
271764-7176499.208100.28
369265-6926595.75396.78
468366-6836694.51095.54
570688-7068897.72098.81
669401-6940195.94196.95
15min171395-7139598.69795.882.44100.8798.012.43
270625-7062597.63399.80
368656-6865694.91197.00
467519-6751993.33995.42
570441-7044197.37999.56
667505-6750593.32095.40
20min170396-7039697.31694.912.51100.5998.112.49
270429-7042997.362100.62
369084-6908495.50398.65
466500-6650091.93195.05
568815-6881595.13198.39
666717-6671792.23095.35
30min168879-6887995.21993.562.1499.5797.812.13
268701-6870194.97399.31
368444-6844494.61898.82
465063-6506389.94494.08
567980-6798093.97698.29
667011-6701192.63796.78
极限168116-6811694.16492.582.8599.5897.882.81
269063-6906395.474100.87
366915-6691592.50497.76
464195-6419588.74493.88
568306-6830694.42799.79
665246-6524690.19795.37
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%
110.156670466521664456661766637665850.16
210.196609966201661500.11
单位质量响应值RSD%判断
6560.106491.660.75数据可信
供试品溶液-2025082221批-水
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min166475-6647591.58893.241.0791.5993.241.07
268332-6833294.14794.15
368340-6834094.15894.16
468041-6804193.74693.75
567530-6753093.04293.04
667309-6730992.73792.74
10min166770-6677091.99592.210.5893.0193.250.58
266541-6654191.67992.73
366632-6663291.80492.85
467577-6757793.10694.15
567177-6717792.55593.59
666861-6686192.12093.15
15min163893-6389388.03190.871.9290.0792.921.89
266192-6619291.19893.26
365582-6558290.35892.42
467321-6732192.75494.83
565546-6554690.30892.37
667169-6716992.54494.60
20min163562-6356287.57590.001.7990.5993.081.75
266866-6686692.12795.20
365278-6527889.93993.01
465482-6548290.22093.33
566188-6618891.19394.26
664577-6457788.97392.06
30min163390-6339087.33888.831.0091.3392.901.00
265144-6514489.75493.86
364247-6424788.51892.59
465091-6509189.68193.79
564564-6456488.95593.03
664421-6442188.75892.83
极限163090-6309086.92487.881.0591.8992.941.03
263731-6373187.80892.91
362935-6293586.71191.76
464184-6418488.43293.54
564655-6465589.08194.15
664109-6410988.32893.39
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%
110.156635366226666796644566548664500.27
210.196695866139665480.88
单位质量响应值RSD%判断
6546.806530.720.18数据可信
供试品溶液-2025082321批-水
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min168295-6829593.90893.433.1993.9193.433.19
263912-6391287.88187.88
370394-7039496.79496.79
468583-6858394.30494.30
568693-6869394.45594.46
667818-6781893.25293.25
10min168878-6887894.71093.552.6395.7594.582.61
267820-6782093.25594.23
370258-7025896.60797.68
464852-6485289.17490.22
568387-6838794.03495.08
668010-6801093.51694.55
15min167215-6721592.42392.441.5894.5294.521.58
266406-6640691.31193.32
369264-6926495.24097.39
467221-6722192.43194.47
566782-6678291.82893.92
666479-6647991.41193.49
20min166114-6611490.90991.280.9694.0394.380.98
265854-6585490.55193.58
367571-6757192.91296.12
466599-6659991.57694.64
566204-6620491.03394.15
665953-6595390.68893.78
30min164548-6454888.75690.221.4192.8994.341.40
264972-6497289.33993.37
367123-6712392.29696.54
465305-6530589.79793.88
565550-6555090.13394.26
666165-6616590.97995.08
极限164202-6420288.28088.951.7593.4094.071.72
264779-6477989.07394.10
366518-6651891.46596.73
463208-6320886.91391.99
564168-6416888.23393.36
665267-6526789.74494.85
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