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)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%
110.306492165143649406484565045649790.18
210.376565865598656280.07
单位质量响应值RSD%判断
6308.646328.640.23数据可信
供试品溶液-2025082221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%
5min171652-71652101.956101.552.05101.96101.552.05
270103-7010399.75299.75
371473-71473101.702101.70
470362-70362100.121100.12
570535-70535100.367100.37
674065-74065105.390105.39
10min172237-72237102.789102.831.93103.92103.951.94
271394-71394101.589102.70
372618-72618103.331104.46
470901-70901100.888102.00
571603-71603101.887103.00
674822-74822106.467107.64
15min170933-70933100.933100.771.53103.21103.041.54
270095-7009599.741101.98
370648-70648100.528102.81
470090-7009099.734101.97
570214-7021499.910102.16
672909-72909103.745106.10
20min169167-6916798.42099.582.37101.82102.972.34
268773-6877397.860101.20
369044-6904498.245101.64
469002-6900298.185101.53
570937-70937100.939104.30
672957-72957103.813107.32
30min169995-6999599.59899.682.27104.09104.182.25
269457-6945798.833103.27
368832-6883297.944102.43
469193-6919398.457102.89
569665-6966599.129103.61
673187-73187104.140108.80
极限167810-6781096.48997.882.35102.09103.482.32
267895-6789596.610102.14
368122-6812296.933102.51
468145-6814596.966102.49
568741-6874197.814103.39
672018-72018102.477108.29
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)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%
110.306591965894658486608266087659660.17
210.376603666032660340.01
单位质量响应值RSD%判断
6404.476367.790.41数据可信
供试品溶液-2025082221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%
5min172924-72924102.67099.072.09102.6799.072.09
270794-7079499.67199.67
368455-6845596.37896.38
470079-7007998.66598.66
569997-6999798.54998.55
669960-6996098.49798.50
10min172811-72811102.51199.391.89103.65100.491.89
271215-71215100.264101.37
369155-6915597.36498.43
470617-7061799.422100.52
569399-6939997.70798.80
670354-7035499.052100.15
15min172135-72135101.55998.551.92103.84100.761.92
270376-7037699.083101.30
368030-6803095.78097.93
469349-6934997.63799.84
570019-7001998.580100.76
670082-7008298.669100.86
20min171411-71411100.54097.471.65103.95100.781.66
269056-6905697.224100.55
368068-6806895.83399.05
469223-6922397.460100.75
568782-6878296.839100.11
668861-6886196.950100.24
30min170618-7061899.42495.971.91103.95100.361.91
268344-6834496.222100.62
366791-6679194.03698.32
467808-6780895.46799.84
567699-6769995.31499.67
667746-6774695.38099.75
极限170600-7060099.39895.282.21105.03100.722.18
267491-6749195.021100.49
366441-6644193.54398.87
467295-6729594.745100.17
566798-6679894.04599.46
667404-6740494.899100.33
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)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%
110.306592966202659956615066333661220.25
210.376585965821658400.05
单位质量响应值RSD%判断
6419.616349.080.79数据可信
供试品溶液-2025082321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%
5min171746-71746101.04299.391.25101.0499.391.25
269158-6915897.39797.40
370362-7036299.09399.09
470646-7064699.49399.49
570330-7033099.04899.05
671200-71200100.273100.27
10min172570-72570102.203102.080.96103.33103.190.96
271202-71202100.276101.36
372450-72450102.034103.13
473204-73204103.095104.20
572534-72534102.152103.25
672950-72950102.738103.85
15min172414-72414101.983101.170.90104.24103.410.90
271052-71052100.065102.26
372191-72191101.669103.90
471507-71507100.706102.96
571273-71273100.376102.61
672601-72601102.246104.50
20min170549-7054999.35699.281.22102.75102.641.21
268903-6890397.038100.35
370418-7041899.172102.54
471217-71217100.297103.67
570591-7059199.415102.77
671273-71273100.376103.77
30min170293-7029398.99698.720.95103.49103.180.94
268856-6885696.972101.36
369856-6985698.380102.85
470572-7057299.389103.87
570580-7058099.400103.86
670415-7041599.168103.67
极限169795-6979598.29496.701.07103.89102.261.04
267941-6794195.683101.15
368557-6855796.551102.11
469259-6925997.540103.13
568012-6801295.783101.34
668410-6841096.344101.95
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)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%
110.306604066014658476596665850659430.14
210.376589266022659570.14
单位质量响应值RSD%判断
6402.236360.370.47数据可信
供试品溶液-2025082321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%
5min171710-71710101.03899.401.01101.0499.401.01
270878-7087899.86599.87
369801-6980198.34898.35
469991-6999198.61698.62
570167-7016798.86498.86
670725-7072599.65099.65
10min172200-72200101.728101.420.66102.85102.520.66
272695-72695102.425103.54
371323-71323100.492101.59
471631-71631100.926102.02
572034-72034101.494102.59
671994-71994101.438102.55
15min171620-71620100.911100.690.44103.16102.920.43
271865-71865101.256103.50
371580-71580100.854103.06
471460-71460100.685102.90
571285-71285100.439102.67
670967-7096799.991102.23
20min170143-7014398.83099.001.14102.20102.341.10
270418-7041899.217102.59
370009-7000998.641101.97
469941-6994198.545101.88
569339-6933997.697101.04
671713-71713101.042104.39
30min170555-7055599.41099.951.11103.88104.401.08
272297-72297101.865106.34
370431-7043199.236103.66
470134-7013498.817103.25
570825-7082599.791104.22
671367-71367100.554105.02
极限167972-6797295.77195.520.90101.35101.080.87
267985-6798595.789101.40
366683-6668393.95599.48
468423-6842396.406101.94
567566-6756695.199100.74
668124-6812495.985101.57
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)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%
110.306571265855660556586065956658880.20
210.376584565854658500.01
单位质量响应值RSD%判断
6396.896350.050.52数据可信
供试品溶液-2025082421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%
5min171608-71608101.01899.840.86101.0299.840.86
270835-7083599.92899.93
370671-7067199.69699.70
470712-7071299.75499.75
571051-71051100.232100.23
669756-6975698.40698.41
10min172115-72115101.733100.980.94102.86102.100.94
271753-71753101.223102.33
371416-71416100.747101.86
471260-71260100.527101.64
572425-72425102.171103.28
670537-7053799.507100.60
15min172001-72001101.573100.231.12103.83102.461.12
270923-70923100.052102.29
371173-71173100.404102.63
470750-7075099.808102.03
571708-71708101.159103.41
669745-6974598.390100.59
20min169982-6998298.72498.620.60102.11101.960.60
270024-7002498.784102.13
370254-7025499.108102.45
469383-6938397.879101.21
570366-7036699.266102.64
669421-6942197.933101.23
30min170197-7019799.02898.931.15103.51103.371.12
269846-6984698.532102.98
369336-6933697.813102.26
470510-7051099.469103.89
571475-71475100.831105.31
669390-6939097.889102.27
极限169375-6937597.86897.890.20103.45103.430.19
269508-6950898.056103.59
369444-6944497.965103.50
469128-6912897.520103.05
569427-6942797.941103.54
669460-6946097.988103.46
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)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%
110.306575265860658046568965820657850.11
210.376559565471655330.14
单位质量响应值RSD%判断
6386.896319.480.76数据可信
供试品溶液-2025082421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%
5min170137-7013799.26099.491.1499.2699.491.14
271783-71783101.590101.59
369587-6958798.48298.48
470423-7042399.66599.67
569629-6962998.54198.54
670230-7023099.39299.39
10min171361-71361100.993100.940.78102.10102.040.78
272309-72309102.334103.46
370806-70806100.207101.30
471471-71471101.148102.26
570861-70861100.285101.38
671129-71129100.664101.77
15min169384-6938498.19599.231.27100.42101.461.27
271855-71855101.692103.96
369961-6996199.011101.22
470086-7008699.188101.42
569568-6956898.455100.66
669852-6985298.857101.08
20min168579-6857997.05598.331.12100.37101.661.09
269753-6975398.717102.11
369128-6912897.832101.14
470136-7013699.259102.59
570511-7051199.790103.09
668781-6878197.341100.66
30min169214-6921497.95498.200.62102.35102.620.63
269923-6992398.957103.45
369395-6939598.210102.61
469836-6983698.834103.27
569148-6914897.861102.27
668799-6879997.367101.77
极限169019-6901997.67897.670.87103.16103.180.85
269519-6951998.386103.98
369119-6911997.820103.31
469602-6960298.503104.04
568865-6886597.460102.96
667944-6794496.157101.64
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