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%
19.766086460639607436070360594607090.18
29.806091561040609780.15
单位质量响应值RSD%判断
6220.186222.240.03数据可信
供试品溶液-2025041021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%
5min170298-70298101.596100.981.16101.60100.981.16
270590-70590102.018102.02
370141-70141101.369101.37
469596-69596100.581100.58
570233-70233101.502101.50
668358-6835898.79298.79
10min170334-70334101.648101.230.72101.82101.400.72
270438-70438101.798101.97
369325-69325100.190100.36
470595-70595102.025102.19
569611-69611100.603100.77
669983-69983101.141101.31
15min169431-69431100.343101.490.72100.68101.820.72
270870-70870102.422102.76
370605-70605102.039102.38
470241-70241101.513101.85
569940-69940101.078101.42
670247-70247101.522101.86
20min170006-70006101.174100.840.44101.68101.340.44
269796-69796100.870101.38
370168-70168101.408101.91
469282-69282100.127100.63
569707-69707100.742101.25
669687-69687100.713101.22
30min167144-6714497.03898.341.4297.7199.011.41
267700-6770097.84198.52
368216-6821698.58799.26
469144-6914499.928100.60
569139-6913999.921100.59
666915-6691596.70797.38
极限167271-6727197.22198.020.8698.0698.860.86
268207-6820798.57499.42
367793-6779397.97698.81
468457-6845798.93599.78
568229-6822998.60699.45
667005-6700596.83797.67
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%
19.766094260995608686084360930609160.10
29.806086161008609340.18
单位质量响应值RSD%判断
6241.396217.760.27数据可信
供试品溶液-2025041021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%
5min170421-70421101.63799.931.24101.6499.931.24
268013-6801398.16298.16
368667-6866799.10699.11
469766-69766100.692100.69
568983-6898399.56299.56
669565-69565100.402100.40
10min170666-70666101.991100.121.16102.16100.291.16
269378-69378100.132100.30
368923-6892399.47599.64
469199-6919999.874100.04
568297-6829798.57298.74
669764-69764100.689100.86
15min170582-70582101.87099.571.20102.2199.901.20
268523-6852398.89899.23
368483-6848398.84099.17
468470-6847098.82299.16
568695-6869599.14699.48
669169-6916999.830100.17
20min169325-69325100.05698.481.44100.5698.981.44
266608-6660896.13496.63
368305-6830598.58399.08
468517-6851798.88999.39
567661-6766197.65498.15
668992-6899299.575100.08
30min168402-6840298.72397.610.8899.4098.280.88
267605-6760597.57398.23
366745-6674596.33296.99
467945-6794598.06498.73
567196-6719696.98397.64
667908-6790898.01098.68
极限168991-6899199.57397.931.36100.4198.761.35
267399-6739997.27698.09
366748-6674896.33697.16
468964-6896499.534100.36
567412-6741297.29598.11
667609-6760997.57998.41
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%
19.766095560954609476084360957609310.09
29.806076460615606900.18
单位质量响应值RSD%判断
6242.936192.860.57数据可信
供试品溶液-2025041021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%
5min166946-6694696.80596.982.4596.8096.972.45
268765-6876599.43599.43
368331-6833198.80798.81
466316-6631695.89495.89
567768-6776897.99397.99
664257-6425792.91692.92
10min166997-6699796.87897.981.2597.0498.141.24
268018-6801898.35598.52
367970-6797098.28598.45
467698-6769897.89298.05
566762-6676296.53996.70
669116-6911699.943100.10
15min166255-6625595.80597.811.9796.1398.141.97
266476-6647696.12596.45
367748-6774897.96498.29
468141-6814198.53398.86
567306-6730697.32597.65
669925-69925101.112101.43
20min165949-6594995.36397.571.2095.8598.051.20
267474-6747497.56898.06
367971-6797198.28798.78
467854-6785498.11898.60
567377-6737797.42897.91
668208-6820898.63099.12
30min165444-6544494.63396.821.4095.2797.471.39
266860-6686096.68097.33
367505-6750597.61398.27
466584-6658496.28196.93
567141-6714197.08797.74
668210-6821098.63299.29
极限164686-6468693.53795.721.3494.3496.531.33
266519-6651996.18797.00
366229-6622995.76896.59
465729-6572995.04595.86
567097-6709797.02397.83
666910-6691096.75397.57
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%
19.766050060671606576061060763606400.16
29.806033560261602980.09
单位质量响应值RSD%判断
6213.116152.860.69数据可信
供试品溶液-2025041021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%
5min167678-6767898.41697.211.2598.4297.211.25
266998-6699897.42897.43
366494-6649496.69596.69
466612-6661296.86696.87
567767-6776798.54698.55
665534-6553495.29995.30
10min167689-6768998.43296.561.4798.6096.721.47
266062-6606296.06696.23
365240-6524094.87195.03
466304-6630496.41896.58
567431-6743198.05798.22
665675-6567595.50495.66
15min166994-6699497.42296.710.8897.7597.040.88
266666-6666696.94597.27
365821-6582195.71696.04
466530-6653096.74797.07
567210-6721097.73698.06
665817-6581795.71096.03
20min166368-6636896.51195.931.2597.0096.421.25
265787-6578795.66796.15
364534-6453493.84494.32
466083-6608396.09796.58
567015-6701597.45297.94
666035-6603596.02796.50
30min165738-6573895.59595.240.6996.2595.880.69
265631-6563195.44096.08
365054-6505494.60195.24
465080-6508094.63895.28
566206-6620696.27696.93
665255-6525594.89395.53
极限165413-6541395.12394.871.4795.9395.681.47
264745-6474594.15194.95
364972-6497294.48195.27
464748-6474894.15694.96
567091-6709197.56398.38
664485-6448593.77394.57
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%
19.766250362490623716229462372624060.15
29.806228862410623490.14
单位质量响应值RSD%判断
6394.066362.140.36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%
5min170263-7026399.04898.770.8399.0598.770.83
269379-6937997.80297.80
370705-7070599.67199.67
470665-7066599.61599.61
569944-6994498.59898.60
669444-6944497.89497.89
10min170250-7025099.03098.940.8999.1999.110.89
269150-6915097.47997.64
370823-7082399.838100.00
470797-7079799.80199.97
570230-7023099.00299.17
669887-6988798.51898.68
15min169762-6976298.34298.201.3698.6798.521.36
268375-6837596.38796.71
371211-71211100.384100.72
469782-6978298.37098.70
569783-6978398.37198.70
669042-6904297.32797.65
20min169947-6994798.60398.240.9399.1098.730.93
269182-6918297.52498.01
370564-7056499.47299.97
470222-7022298.99099.49
569202-6920297.55298.05
669001-6900197.26997.76
30min168106-6810696.00796.530.9296.6797.190.91
267455-6745595.09095.74
368996-6899697.26297.93
468844-6884497.04897.71
568394-6839496.41397.07
669080-6908097.38098.03
极限168316-6831696.30395.940.5797.1296.760.57
267365-6736594.96395.77
368336-6833696.33297.16
468011-6801195.87396.70
568381-6838196.39597.21
667942-6794295.77696.59
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%
19.766220862255624036225462227622690.13
29.806221462469623420.29
单位质量响应值RSD%判断
6380.026361.430.21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%
5min169648-6964898.29497.940.6198.2997.940.61
269464-6946498.03598.03
369573-6957398.18998.19
469916-6991698.67398.67
568900-6890097.23997.24
668872-6887297.19997.20
10min170064-7006498.88197.720.7799.0597.890.77
268918-6891897.26497.43
369045-6904597.44397.61
468633-6863396.86297.03
569101-6910197.52297.68
669693-6969398.35898.52
15min169761-6976198.45497.060.8198.7897.380.81
268392-6839296.52296.85
368451-6845196.60596.93
468563-6856396.76397.09
569086-6908697.50197.83
668368-6836896.48896.81
20min169618-6961898.25296.900.9398.7497.390.92
268130-6813096.15296.64
367839-6783995.74196.23
468766-6876697.05097.54
568612-6861296.83297.32
668999-6899997.37897.87
30min168321-6832196.42295.961.0597.0896.601.05
268033-6803396.01596.66
368190-6819096.23796.88
466680-6668094.10694.75
567922-6792295.85896.51
668803-6880397.10297.75
极限168198-6819896.24895.681.0197.0796.491.00
268346-6834696.45797.26
366989-6698994.54295.35
468071-6807196.06996.87
568309-6830996.40597.21
666864-6686494.36595.18
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