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%
110.246520465215652516514864977651590.17
210.266491665120650180.23
单位质量响应值RSD%判断
6363.186337.040.30数据可信
供试品溶液-2025040921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%
5min168361-6836196.79198.661.0896.7998.661.08
269900-6990098.97098.97
369844-6984498.89198.89
470520-7052099.84899.85
569358-6935898.20398.20
670111-7011199.26999.27
10min170193-7019399.385100.090.7399.92100.640.73
271110-71110100.684101.23
370994-70994100.519101.07
471279-71279100.923101.48
570539-7053999.875100.42
670023-7002399.14599.70
15min169761-6976198.77499.590.7799.86100.690.77
269786-6978698.80999.92
370850-70850100.316101.42
471080-71080100.641101.76
570298-7029899.534100.63
670251-7025199.467100.57
20min170381-7038199.65298.540.93101.29100.200.91
269947-6994799.037100.70
370105-7010599.261100.93
468948-6894897.62399.30
568823-6882397.44699.10
669362-6936298.20999.86
30min168009-6800996.29397.690.9198.4999.900.89
269200-6920097.979100.19
369583-6958398.522100.74
469597-6959798.541100.76
569035-6903597.74699.94
668541-6854197.04699.25
极限167692-6769295.84497.041.2198.5799.791.19
269131-6913197.882100.63
368891-6889197.542100.31
469655-6965598.624101.39
568270-6827096.66399.40
667585-6758595.69398.43
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%
110.246513064842648556514964897649750.24
210.266506665074650700.01
单位质量响应值RSD%判断
6345.216342.110.04数据可信
供试品溶液-2025040921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%
5min171938-71938101.95997.942.35101.9697.942.35
269002-6900297.79897.80
367115-6711595.12395.12
469587-6958798.62798.63
568278-6827896.77296.77
668678-6867897.33997.34
10min172030-72030102.09099.051.73102.6699.601.73
268758-6875897.45298.00
369150-6915098.00898.54
470259-7025999.580100.13
570063-7006399.30299.84
669046-6904697.86098.40
15min172810-72810103.19598.842.31104.3399.942.30
268208-6820896.67397.76
368780-6878097.48398.56
469580-6958098.61799.72
569773-6977398.89199.98
669287-6928798.20299.29
20min172630-72630102.94097.542.77104.6599.182.76
268513-6851397.10598.73
367406-6740695.53697.15
468306-6830696.81298.46
568135-6813596.56998.21
667924-6792496.27097.90
30min171635-71635101.53097.042.34103.8199.222.33
267903-6790396.24098.40
367314-6731495.40697.55
467895-6789596.22998.42
568438-6843896.99999.17
667620-6762095.83998.00
极限170973-70973100.59296.132.40103.4398.862.39
266274-6627493.93296.63
367305-6730595.39398.07
467635-6763595.86098.58
567097-6709795.09897.81
667678-6767895.92198.62
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%
110.246501165114651866503564955650600.14
210.266468364748647160.08
单位质量响应值RSD%判断
6353.526307.600.52数据可信
供试品溶液-2025040921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%
5min167245-6724595.50696.691.1495.5196.691.14
267229-6722995.48395.48
368569-6856997.38797.39
469160-6916098.22698.23
568398-6839897.14497.14
667862-6786296.38396.38
10min167917-6791796.46197.571.6596.9998.101.65
266872-6687294.97695.51
369691-6969198.98099.52
468596-6859697.42597.97
569476-6947698.67599.21
669633-6963398.89899.43
15min167498-6749895.86696.421.9796.9397.501.95
267469-6746995.82496.88
369060-6906098.08499.17
469006-6900698.00799.09
568708-6870897.58498.67
665588-6558893.15394.24
20min167708-6770896.16496.530.8697.7698.140.85
267050-6705095.22996.82
367952-6795296.51098.15
468058-6805896.66198.29
568197-6819796.85898.49
668810-6881097.72999.33
30min168326-6832697.04296.221.3899.1798.371.36
266123-6612393.91396.03
367960-6796096.52298.69
467186-6718695.42297.59
568597-6859797.42699.59
668287-6828796.98699.13
极限166911-6691195.03295.821.8197.7098.501.79
265540-6554093.08595.73
369060-6906098.084100.79
468076-6807696.68699.39
567099-6709995.29998.01
668090-6809096.70699.39
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%
110.246487564831649506501965109649570.18
210.266473464980648570.27
单位质量响应值RSD%判断
6343.466321.350.25数据可信
供试品溶液-2025040921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%
5min169039-6903998.02596.661.1898.0296.661.17
266837-6683794.89894.90
368544-6854497.32297.32
468418-6841897.14397.14
567470-6747095.79795.80
668164-6816496.78296.78
10min168759-6875997.62797.070.7898.1797.600.78
268074-6807496.65597.18
367523-6752395.87296.41
468764-6876497.63498.17
568893-6889397.81798.35
668186-6818696.81497.35
15min169100-6910098.11197.470.7399.2098.540.73
267762-6776296.21297.28
369054-6905498.04699.12
468890-6889097.81398.90
568538-6853897.31398.39
668530-6853097.30298.38
20min169201-6920198.25596.530.9699.8998.140.96
267491-6749195.82797.43
367468-6746895.79497.41
467855-6785596.34497.97
568177-6817796.80198.42
667705-6770596.13197.75
30min167639-6763996.03795.980.6598.2198.130.64
267501-6750195.84197.97
368416-6841697.14099.29
467423-6742395.73097.89
567483-6748395.81597.97
667116-6711695.29497.44
极限167084-6708495.24994.930.6997.9697.620.69
265950-6595093.63996.30
367212-6721295.43198.12
467047-6704795.19697.89
566882-6688294.96297.65
666993-6699395.12097.80
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%
110.246476264788647536476564878647890.08
210.266478764763647750.03
单位质量响应值RSD%判断
6327.056313.350.16数据可信
供试品溶液-2025040921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%
5min167604-6760496.17297.010.6496.1797.010.64
268409-6840997.31797.32
367985-6798596.71496.71
467890-6789096.57996.58
568700-6870097.73197.73
668577-6857797.55697.56
10min168658-6865897.67298.511.3498.2199.061.33
269722-6972299.18599.73
369548-6954898.93899.48
468023-6802396.76897.30
570649-70649100.504101.05
668902-6890298.01998.56
15min168141-6814196.93697.460.4298.0198.540.42
268875-6887597.98099.07
368767-6876797.82798.91
468453-6845397.38098.45
568546-6854697.51298.61
668262-6826297.10898.19
20min167311-6731195.75596.340.8997.3797.970.88
267975-6797596.70098.34
367144-6714495.51897.15
467172-6717295.55897.17
568563-6856397.53799.18
668180-6818096.99298.62
30min167377-6737795.84995.740.5998.0097.900.58
267807-6780796.46198.63
367530-6753096.06798.23
466642-6664294.80496.95
567141-6714195.51497.70
667306-6730695.74897.91
极限166075-6607593.99795.451.5396.6898.151.50
268043-6804396.79799.51
367450-6745095.95398.65
465844-6584493.66996.34
566846-6684695.09497.81
668337-6833797.21599.91
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%
110.246500864864648446484664855648830.11
210.266458264703646420.14
单位质量响应值RSD%判断
6336.236300.390.41数据可信
供试品溶液-2025040921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%
5min166725-6672594.95195.361.2994.9595.361.29
268354-6835497.26997.27
366921-6692195.23095.23
466334-6633494.39594.39
566073-6607394.02394.02
667684-6768496.31696.32
10min167389-6738995.89696.191.2696.4296.721.25
269277-6927798.58299.12
367558-6755896.13696.67
467232-6723295.67296.20
567065-6706595.43595.96
667048-6704895.41195.95
15min167008-6700895.35495.860.8596.4196.920.85
268116-6811696.93098.02
367760-6776096.42497.49
466588-6658894.75695.81
567076-6707695.45096.50
667624-6762496.23097.30
20min167258-6725895.70994.951.3897.3096.541.36
267581-6758196.16997.80
367712-6771296.35597.95
466350-6635094.41796.00
565771-6577193.59395.18
665655-6565593.42895.03
30min166617-6661794.79794.881.1296.9297.001.11
268021-6802196.79598.96
366283-6628394.32296.46
466763-6676395.00597.11
566569-6656994.72996.83
665799-6579993.63395.75
极限166507-6650794.64194.350.9797.2997.000.97
267096-6709695.47998.18
366463-6646394.57897.24
465965-6596593.86996.50
565211-6521192.79695.43
666556-6655694.71097.35
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