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%
110.176541465673658616582966021657600.35
210.126620166110661560.10
单位质量响应值RSD%判断
6466.086537.150.78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%
5min167474-6747493.31294.781.7193.3194.781.71
267067-6706792.74992.75
369568-6956896.20896.21
470079-7007996.91496.91
568704-6870495.01395.01
668303-6830394.45894.46
10min168471-6847194.69096.231.7294.8596.391.72
268166-6816694.26994.42
371116-7111698.34898.51
470749-7074997.84198.00
569765-6976596.48096.64
669246-6924695.76295.92
15min168802-6880295.14896.321.5895.4696.641.58
268510-6851094.74495.06
371161-7116198.41198.73
470836-7083697.96198.29
569449-6944996.04396.36
669158-6915895.64195.96
20min168710-6871095.02196.361.3295.4996.841.33
269080-6908095.53396.00
371126-7112698.36298.85
470407-7040797.36897.86
569618-6961896.27796.76
669129-6912995.60096.08
30min168390-6839094.57896.001.5495.2196.641.54
268184-6818494.29494.92
370876-7087698.01698.67
470343-7034397.27997.93
569629-6962996.29296.93
669095-6909595.55396.19
极限168670-6867094.96695.931.5795.7596.731.57
267943-6794393.96094.75
370908-7090898.06198.88
470250-7025097.15197.96
569536-6953696.16396.96
668895-6889595.27796.07
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%
110.176597666278661426616566085661290.17
210.126622465954660890.29
单位质量响应值RSD%判断
6502.366530.530.31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%
5min168287-6828794.21995.291.7994.2295.291.79
267080-6708092.55392.55
369848-6984896.37396.37
470289-7028996.98196.98
570029-7002996.62296.62
668858-6885895.00795.01
10min169522-6952295.92396.721.4896.0896.881.48
268447-6844794.43994.59
370710-7071097.56297.72
471462-7146298.59998.76
570167-7016796.81396.97
670284-7028496.97497.13
15min169503-6950395.89696.991.4596.2197.311.45
268847-6884794.99195.30
370920-7092097.85298.17
471715-7171598.94899.27
570357-7035797.07597.40
670432-7043297.17897.50
20min169215-6921595.49996.781.6295.9897.261.62
268406-6840694.38394.85
370919-7091997.85098.34
471468-7146898.60899.10
570362-7036297.08297.57
670498-7049897.26997.75
30min168863-6886395.01396.451.6195.6597.101.61
268284-6828494.21594.84
370640-7064097.46598.11
471248-7124898.30498.96
570397-7039797.13097.78
670000-7000096.58297.23
极限169318-6931895.64196.461.5896.4497.271.58
268185-6818594.07894.86
370245-7024596.92097.73
471499-7149998.65099.47
570205-7020596.86597.67
670031-7003196.62597.43
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%
110.176593766340662656610566288661870.25
210.126602366165660940.16
单位质量响应值RSD%判断
6508.066531.030.25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%
5min167835-6783593.55092.901.2293.5592.901.22
266661-6666191.93191.93
366480-6648091.68291.68
468208-6820894.06594.06
568247-6824794.11994.12
666766-6676692.07692.08
10min169306-6930695.57994.721.1195.7494.881.11
268212-6821294.07094.22
367765-6776593.45493.61
469366-6936695.66295.82
569429-6942995.74995.91
668033-6803393.82493.98
15min169650-6965096.05395.410.8196.3795.720.80
268797-6879794.87795.19
368231-6823194.09794.41
469484-6948495.82596.14
569387-6938795.69196.01
669548-6954895.91396.22
20min169149-6914995.36394.920.6695.8495.390.67
268699-6869994.74295.21
368130-6813093.95794.42
469361-6936195.65596.13
569073-6907395.25895.73
668556-6855694.54595.01
30min169262-6926295.51894.650.8296.1595.280.82
268271-6827194.15294.78
367776-6777693.46994.09
468905-6890595.02695.66
569092-6909295.28495.92
668504-6850494.47395.10
极限169564-6956495.93594.221.8996.7395.011.88
268467-6846794.42295.20
365894-6589490.87491.65
468917-6891795.04395.84
568966-6896695.11095.90
668117-6811793.93994.72
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%
110.176604166070661316617266168661160.09
210.126620666199662020.01
单位质量响应值RSD%判断
6501.086541.700.45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%
5min169635-6963596.00695.292.6096.0195.292.60
271705-7170598.86098.86
368618-6861894.60494.60
469997-6999796.50596.51
568336-6833694.21594.22
666384-6638491.52491.52
10min170659-7065997.41897.402.2197.5897.562.21
272925-72925100.542100.71
370323-7032396.95597.11
471704-7170498.85999.02
569868-6986896.32896.48
668392-6839294.29394.45
15min170628-7062897.37597.482.1497.7097.802.15
273028-73028100.684101.02
370256-7025696.86297.18
471492-7149298.56798.89
570364-7036497.01197.33
668448-6844894.37094.68
20min170852-7085297.68497.322.2198.1797.812.21
272654-72654100.169100.67
369905-6990596.37996.86
471609-7160998.72899.22
570426-7042697.09797.58
668087-6808793.87294.34
30min170719-7071997.50197.252.2098.1597.902.20
272631-72631100.137100.80
370335-7033596.97197.61
471631-7163198.75899.41
569761-6976196.18096.82
668151-6815193.96094.58
极限170686-7068697.45596.253.4098.2797.063.39
272294-7229499.672100.51
370123-7012396.67997.48
471719-7171998.87999.70
566040-6604091.05091.85
668017-6801793.77694.56
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%
110.176648866475664296653566510664870.06
210.126622766000661140.25
单位质量响应值RSD%判断
6537.566533.000.05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%
5min168861-6886194.73694.971.6794.7494.971.66
268671-6867194.47594.48
370029-7002996.34396.34
469344-6934495.40195.40
567052-6705292.24892.25
670217-7021796.60296.60
10min170313-7031396.73496.701.6896.8996.861.68
269353-6935395.41395.57
370979-7097997.65097.81
470827-7082797.44197.60
568511-6851194.25594.41
671760-7176098.72598.89
15min170606-7060697.13797.041.5797.4697.361.57
269778-6977895.99896.31
371381-7138198.20398.53
470851-7085197.47497.80
568787-6878794.63594.95
671804-7180498.78599.11
20min170025-7002596.33896.251.5596.8296.741.55
269407-6940795.48895.96
370908-7090897.55398.04
470280-7028096.68997.17
568127-6812793.72794.20
671037-7103797.73098.22
30min170082-7008296.41696.261.4897.0696.901.48
269219-6921995.22995.86
370750-7075097.33597.98
470178-7017896.54897.19
568361-6836194.04994.67
671200-7120097.95498.61
极限170449-7044996.92196.671.6697.7297.471.66
269554-6955495.69096.48
371060-7106097.76298.57
470156-7015696.51897.32
568514-6851494.25995.04
671862-7186298.86599.68
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%
110.176611766126659696596565974660300.13
210.126587265982659270.12
单位质量响应值RSD%判断
6492.636514.530.24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%
5min165055-6505589.93793.762.2489.9493.762.24
268492-6849294.68894.69
369085-6908595.50895.51
468060-6806094.09194.09
567226-6722692.93892.94
669013-6901395.40995.41
10min166251-6625191.59096.152.5291.7496.312.52
270008-7000896.78496.94
371290-7129098.55798.72
469899-6989996.63496.79
569306-6930695.81495.97
670544-7054497.52597.68
15min166660-6666092.15696.162.3192.4696.482.31
270442-7044297.38497.70
370732-7073297.78598.11
469682-6968296.33496.65
568895-6889595.24695.56
670933-7093398.06398.38
20min166410-6641091.81095.812.2292.2796.282.22
270290-7029097.17497.66
370342-7034297.24697.73
469386-6938695.92496.40
568960-6896095.33595.81
670413-7041397.34497.83
30min166603-6660392.07795.802.0692.6996.442.06
269893-6989396.62597.27
370409-7040997.33997.99
469698-6969896.35696.99
568907-6890795.26295.89
670278-7027897.15897.80
极限167890-6789093.85696.231.4494.6297.031.45
270270-7027097.14697.95
370377-7037797.29498.11
469631-6963196.26397.06
569041-6904195.44796.24
670434-7043497.37398.18
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