褪黑素颗粒项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)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)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%
110.246513365181651616496365181651240.15
210.266527965159652190.14
单位质量响应值RSD%判断
6359.776356.630.04数据可信
供试品溶液-2025041121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%
5min168366-6836696.67595.032.9296.6895.042.92
269584-6958498.39798.40
365908-6590893.19993.20
464498-6449891.20591.21
568681-6868197.12097.12
666191-6619193.59993.60
10min169345-6934598.05997.631.1098.6098.161.11
269141-6914197.77198.32
368815-6881597.31097.83
467694-6769495.72596.23
569956-6995698.92399.46
669281-6928197.96998.49
15min168989-6898997.55697.041.1598.6498.111.15
268146-6814696.36497.45
368565-6856596.95698.01
467489-6748995.43596.47
569816-6981698.72599.81
668749-6874997.21798.28
20min167994-6799496.14996.441.2397.7798.051.23
268044-6804496.22097.84
368380-6838096.69598.29
466797-6679794.45696.03
569280-6928097.96799.61
668696-6869697.14298.75
30min168639-6863997.06195.091.9999.2297.241.97
268453-6845396.79898.96
365846-6584693.11295.25
465430-6543092.52394.62
567352-6735295.24197.42
667754-6775495.81097.95
极限167378-6737895.27895.111.8197.9897.781.80
267882-6788295.99198.69
366956-6695694.68197.33
464995-6499591.90894.52
568418-6841896.74999.46
667913-6791396.03498.71
褪黑素颗粒项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)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)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%
110.246500865111652866523565054651390.19
210.266513165425652780.32
单位质量响应值RSD%判断
6361.236362.380.02数据可信
供试品溶液-2025041121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%
5min168427-6842796.70696.060.8996.7196.060.89
267188-6718894.95594.96
367845-6784595.88495.88
468799-6879997.23297.23
568101-6810196.24696.25
667458-6745895.33795.34
10min169126-6912697.69497.381.2798.2397.911.26
267414-6741495.27595.80
369235-6923597.84898.38
468745-6874597.15697.70
570073-7007399.03399.57
668814-6881497.25397.78
15min168660-6866097.03696.341.3698.1297.411.35
266532-6653294.02895.09
368836-6883697.28498.36
468995-6899597.50998.59
567704-6770495.68596.77
668266-6826696.47997.55
20min167465-6746595.34795.680.7696.9797.290.75
267069-6706994.78796.37
368127-6812796.28297.90
468445-6844596.73298.35
567706-6770695.68797.30
667376-6737695.22196.83
30min167785-6778595.79995.541.0697.9597.691.06
266349-6634993.77095.88
368009-6800996.11698.27
468441-6844196.72698.89
567711-6771195.69497.84
667334-6733495.16297.30
极限166410-6641093.85694.222.0996.5496.902.06
264365-6436590.96693.59
367641-6764195.59698.28
468443-6844396.72999.43
566892-6689294.53797.22
666272-6627293.66196.32
褪黑素颗粒项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)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)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%
110.246512065326651096517365107651670.15
210.266513565067651010.08
单位质量响应值RSD%判断
6363.966345.130.21数据可信
供试品溶液-2025041121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%
5min168204-6820496.50295.440.8896.5095.440.88
267632-6763295.69295.69
367481-6748195.47995.48
466747-6674794.44094.44
566773-6677394.47794.48
667878-6787896.04096.04
10min168493-6849396.91096.810.8197.4597.340.80
268623-6862397.09497.63
368082-6808296.32996.86
467794-6779495.92196.45
568164-6816496.44596.97
669359-6935998.13698.67
15min168695-6869597.19696.300.9998.2797.360.99
267892-6789296.06097.13
368122-6812296.38697.45
467222-6722295.11296.17
567485-6748595.48496.54
668938-6893897.54098.62
20min168937-6893797.53996.191.5599.1597.791.53
269208-6920897.92299.53
368440-6844096.83598.44
466591-6659194.21995.81
567078-6707894.90896.50
667632-6763295.69297.31
30min168738-6873897.25796.551.3199.4198.691.29
267141-6714194.99897.15
367990-6799096.19998.34
468124-6812496.38898.50
567718-6771895.81497.93
669715-6971598.639100.79
极限166803-6680394.51994.641.4197.2297.321.36
265466-6546692.62895.30
366791-6679194.50297.18
466595-6659594.22596.87
568309-6830996.65099.30
667384-6738495.34198.04
褪黑素颗粒项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)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)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%
110.246512165216650906496165315651410.21
210.266495564876649160.09
单位质量响应值RSD%判断
6361.436327.100.39数据可信
供试品溶液-2025041121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%
5min167363-6736395.46796.111.0595.4796.121.05
268848-6884897.57197.57
366897-6689794.80694.81
467984-6798496.34796.35
567498-6749895.65895.66
668331-6833196.83896.84
10min167027-6702794.99096.871.3095.5297.401.30
268866-6886697.59798.14
367440-6744095.57696.10
469155-6915598.00698.54
568786-6878697.48398.01
668827-6882797.54198.08
15min167784-6778496.06396.780.9997.1297.850.99
268891-6889197.63298.72
367804-6780496.09297.15
468079-6807996.48197.56
567822-6782296.11797.19
669356-6935698.29199.37
20min168051-6805196.44297.141.7298.0398.751.71
269885-6988599.041100.67
367292-6729295.36696.96
468117-6811796.53598.15
567775-6777596.05197.66
670146-7014699.411101.04
30min167719-6771995.97196.421.2298.1098.571.21
267923-6792396.26098.44
367017-6701794.97697.10
469014-6901497.80699.96
567495-6749595.65497.79
669046-6904697.852100.03
极限165786-6578693.23294.781.4595.8997.471.44
267538-6753895.71598.43
365818-6581893.27795.93
467818-6781896.11198.81
566501-6650194.24596.92
667818-6781896.11198.83
褪黑素颗粒项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)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)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%
110.246494065010651406507365047650420.12
210.266508265019650500.07
单位质量响应值RSD%判断
6351.766340.160.13数据可信
供试品溶液-2025041121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%
5min165939-6593993.42393.680.5493.4293.680.54
265697-6569793.08093.08
366130-6613093.69493.69
465883-6588393.34493.34
566422-6642294.10794.11
666634-6663494.40894.41
10min167592-6759295.76595.560.7396.2896.080.73
266524-6652494.25294.77
367475-6747595.59996.12
467419-6741995.52096.04
567787-6778796.04196.56
667907-6790796.21196.74
15min167095-6709595.06195.030.8896.1196.080.88
266686-6668694.48195.52
367031-6703194.97096.02
466322-6632293.96695.01
568073-6807396.44697.50
667231-6723195.25396.31
20min166824-6682494.67794.420.9596.2696.000.93
267506-6750695.64397.21
366803-6680394.64796.23
466236-6623693.84495.42
566848-6684894.71196.30
665648-6564893.01194.60
30min166092-6609293.64093.290.4195.7495.400.39
265598-6559892.94095.04
365983-6598393.48595.59
466171-6617193.75295.84
565680-6568093.05695.17
665565-6556592.89395.00
极限167213-6721395.22893.591.0897.8596.211.05
266082-6608293.62696.24
365881-6588193.34195.97
464986-6498692.07394.69
566035-6603593.55996.19
666132-6613293.69696.32
褪黑素颗粒项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)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)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%
110.246486664861650476502664836649270.16
210.266492664903649140.03
单位质量响应值RSD%判断
6340.536326.900.16数据可信
供试品溶液-2025041121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%
5min166316-6631694.13994.370.9694.1494.360.96
265410-6541092.85392.85
366354-6635494.19394.19
466564-6656494.49194.49
567215-6721595.41595.41
666996-6699695.10495.10
10min167718-6771896.12996.401.0296.6596.921.01
267021-6702195.14095.66
367991-6799196.51697.04
467353-6735395.61196.14
568768-6876897.61998.15
668602-6860297.38497.91
15min168134-6813496.71996.261.2497.7897.321.23
266650-6665094.61395.66
367768-6776896.20097.26
467035-6703595.15996.22
568485-6848597.21898.29
668801-6880197.66698.74
20min167543-6754395.88195.220.8997.4796.810.89
266305-6630594.12395.69
366928-6692895.00896.60
466714-6671494.70496.29
566992-6699295.09896.71
667974-6797496.49298.10
30min166642-6664294.60294.660.7796.7396.790.77
265758-6575893.34795.44
367204-6720495.39997.52
466641-6664194.60096.71
567069-6706995.20897.35
666797-6679794.82296.97
极限166921-6692194.99894.701.0297.6597.361.01
265941-6594193.60696.22
366390-6639094.24496.90
466171-6617193.93396.57
567098-6709895.24997.92
667767-6776796.19998.87
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