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%
19.956572765573655676553765633656070.12
29.956586366006659340.16
单位质量响应值RSD%判断
6593.676626.530.36数据可信
供试品溶液-2025082621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%
5min166508-6650890.46491.451.5790.4691.441.57
268436-6843693.08793.09
367710-6771092.09992.10
465515-6551589.11389.11
567812-6781292.23892.24
667395-6739591.67191.67
10min167626-6762691.98592.951.2392.9993.971.22
269227-6922794.16395.20
368050-6805092.56293.58
469553-6955394.60695.60
567944-6794492.41793.44
667622-6762291.97993.00
15min167993-6799392.48492.031.6994.5194.081.66
268240-6824092.82094.90
366810-6681090.87592.93
469222-6922294.15696.20
567716-6771692.10794.16
665954-6595489.71191.75
20min165925-6592589.67190.591.0592.7393.661.02
266172-6617290.00793.12
367285-6728591.52194.58
467659-6765992.03095.12
566339-6633990.23493.31
666228-6622890.08393.12
30min165645-6564589.29089.451.5993.3493.531.55
266124-6612489.94294.05
365104-6510488.55492.63
467502-6750291.81695.93
565808-6580889.51293.59
664400-6440087.59791.64
极限164067-6406787.14488.381.6892.1993.451.62
264762-6476288.08993.20
364930-6493088.31893.38
467112-6711291.28696.42
564454-6445487.67092.74
664523-6452387.76492.78
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%
19.956597865750659226586465612658250.23
29.956610465779659420.35
单位质量响应值RSD%判断
6615.586627.340.13数据可信
供试品溶液-2025082621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%
5min168802-6880293.42393.990.3893.4293.990.39
269290-6929094.08694.09
369199-6919993.96393.96
469199-6919993.96393.96
569623-6962394.53894.54
669202-6920293.96793.97
10min168313-6831392.75994.000.7693.8095.050.76
269315-6931594.12095.17
369900-6990094.91495.96
469058-6905893.77194.82
569411-6941194.25095.30
669376-6937694.20395.25
15min168079-6807992.44293.711.1594.5195.801.13
269229-6922994.00396.09
370111-7011195.20197.30
468376-6837692.84594.93
569660-6966094.58896.69
668629-6862993.18995.28
20min167484-6748491.63492.591.7794.7395.721.72
266871-6687190.80193.94
370354-7035495.53198.69
467709-6770991.93995.06
568422-6842292.90796.06
668275-6827592.70895.83
30min166624-6662490.46690.931.2394.5895.091.21
266277-6627789.99594.14
368461-6846192.96097.18
466405-6640590.16994.31
566669-6666990.52794.71
667371-6737191.48095.64
极限165190-6519088.51989.451.5093.6494.621.46
265311-6531188.68393.83
367259-6725991.32896.58
464745-6474587.91593.06
566800-6680090.70595.89
665945-6594589.54494.72
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%
19.956568465628660346600565235657170.50
29.956557165477655240.11
单位质量响应值RSD%判断
6604.726585.330.21数据可信
供试品溶液-2025082721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%
5min166182-6618290.22686.5212.8790.2386.5212.87
264012-6401287.26887.27
366501-6650190.66190.66
468656-6865693.59993.60
547143-4714364.27064.27
668280-6828093.08693.09
10min167956-6795692.64589.848.1293.6590.808.17
267048-6704891.40792.38
368327-6832793.15094.16
468581-6858193.49794.54
555040-5504075.03675.75
668440-6844093.30494.34
15min167969-6796992.66290.174.5794.6992.134.58
268414-6841493.26995.25
367446-6744691.94993.99
468435-6843593.29895.38
562774-6277485.58087.13
661814-6181484.27186.34
20min166703-6670390.93690.513.3394.0093.473.46
266363-6636390.47393.49
367205-6720591.62194.68
468256-6825693.05496.17
562101-6210184.66287.16
667704-6770492.30195.31
30min167085-6708591.45790.880.6995.5394.840.82
267023-6702391.37395.40
366041-6604190.03494.12
467060-6706091.42395.57
566274-6627490.35293.79
666471-6647190.62094.65
极限166608-6660890.80790.101.2595.8995.080.97
266021-6602190.00795.05
365399-6539989.15994.24
465514-6551489.31594.48
567493-6749392.01396.46
665499-6549989.29594.33
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%
19.956561365755660526559165835657690.29
29.956582665503656640.35
单位质量响应值RSD%判断
6609.956599.400.12数据可信
供试品溶液-2025082721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%
5min166866-6686691.02590.696.4691.0390.696.46
267827-6782792.33492.33
368112-6811292.72292.72
458074-5807479.05779.06
569332-6933294.38294.38
669522-6952294.64194.64
10min166504-6650490.53391.803.6491.5492.813.67
268876-6887693.76294.79
368821-6882193.68794.72
462816-6281685.51286.39
569080-6908094.03995.09
668535-6853593.29794.35
15min165540-6554089.22091.691.8991.2493.711.93
268604-6860493.39195.46
367568-6756891.98194.05
466027-6602789.88391.71
568035-6803592.61794.71
668331-6833193.02095.11
20min164011-6401187.13990.331.9290.1593.381.92
267082-6708291.31994.42
366428-6642890.42993.52
466107-6610789.99292.82
566804-6680490.94194.06
667701-6770192.16295.28
30min163402-6340286.31090.042.4190.2994.092.30
266116-6611690.00494.12
365527-6552789.20393.30
467678-6767892.13195.96
566486-6648690.50894.64
667639-6763992.07896.22
极限163287-6328786.15388.362.0391.0993.401.91
265140-6514088.67693.80
363398-6339886.30491.39
466651-6665190.73395.58
565419-6541989.05694.19
665536-6553689.21594.38
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%
19.956553365379656076569865832656100.26
29.956573865705657220.04
单位质量响应值RSD%判断
6593.976605.230.13数据可信
供试品溶液-2025082821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%
5min168323-6832393.08093.550.5693.0893.540.56
268897-6889793.86293.86
368839-6883993.78393.78
468576-6857693.42593.42
569183-6918394.25294.25
668175-6817592.87992.88
10min168115-6811592.79793.651.4993.8394.691.48
269949-6994995.29596.34
369478-6947894.65495.70
468341-6834193.10594.14
569352-6935294.48295.53
667221-6722191.57992.61
15min167781-6778192.34292.340.4094.4194.420.41
267807-6780792.37794.48
367814-6781492.38794.48
467398-6739891.82093.89
568229-6822992.95295.05
667667-6766792.18794.24
20min167018-6701891.30291.421.3294.3994.521.29
267637-6763792.14695.27
367445-6744591.88495.00
465606-6560689.37992.47
568150-6815092.84595.97
666754-6675490.94394.02
30min165975-6597589.88190.150.8593.9994.270.85
266275-6627590.29094.44
366705-6670590.87695.02
465495-6549589.22893.31
566896-6689691.13695.30
665670-6567089.46693.55
极限165496-6549689.22989.441.1494.3394.561.11
265283-6528388.93994.09
365908-6590889.79094.94
465199-6519988.82493.90
567032-6703291.32196.50
664997-6499788.54993.63
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%
19.956574965539656226540965307655250.27
29.956544165980657100.59
单位质量响应值RSD%判断
6585.436604.020.20数据可信
供试品溶液-2025082821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%
5min167422-6742291.92190.984.0891.9290.984.08
268940-6894093.99093.99
368160-6816092.92792.93
465737-6573789.62489.62
561668-6166884.07684.08
668462-6846293.33993.34
10min169144-6914494.26993.402.3195.2994.412.32
268912-6891293.95295.00
368029-6802992.74893.78
470070-7007095.53196.53
565576-6557689.40490.34
669311-6931194.49695.53
15min167518-6751892.05292.451.1394.1294.501.15
268206-6820692.99095.08
367248-6724891.68493.75
468355-6835593.19395.25
566747-6674791.00192.93
668767-6876793.75595.84
20min166855-6685591.14890.691.3894.2493.761.36
266500-6650090.66493.79
364963-6496388.56891.65
467469-6746991.98595.08
566070-6607090.07893.02
667246-6724691.68194.81
30min165980-6598089.95589.872.3594.0693.952.31
265847-6584789.77493.90
364394-6439487.79391.86
467698-6769892.29796.41
563999-6399987.25491.19
667584-6758492.14296.29
极限165034-6503488.66588.441.5793.7793.521.58
265061-6506188.70293.83
364910-6491088.49693.54
465416-6541689.18694.33
562921-6292185.78490.69
665856-6585689.78694.96
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