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)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%
110.156580765871657426583965817658150.08
210.196629165984661380.33
单位质量响应值RSD%判断
6484.246490.480.07数据可信
供试品溶液-2025040921批-水
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min169858-6985896.81896.081.1696.8296.081.15
270575-7057597.81297.81
368493-6849394.92694.93
468612-6861295.09195.09
569440-6944096.23996.24
668978-6897895.59895.60
10min169456-6945696.26196.311.0596.8096.841.04
269363-6936396.13296.68
368566-6856695.02795.55
469873-6987396.83997.37
569020-6902095.65796.19
670663-7066397.93498.46
15min168712-6871295.23096.151.0896.3097.221.07
269800-6980096.73897.82
368397-6839794.79395.85
470147-7014797.21998.28
570095-7009597.14798.21
669113-6911395.78696.86
20min168216-6821694.54294.920.4296.1496.520.42
268766-6876695.30596.92
368095-6809594.37595.96
468485-6848594.91596.52
568777-6877795.32096.93
668587-6858795.05796.66
30min168482-6848294.91194.851.1897.0496.981.16
269121-6912195.79797.94
367851-6785194.03696.14
467134-6713493.04395.18
568958-6895895.57197.71
669097-6909795.76397.90
极限167786-6778693.94694.650.9696.6097.310.95
269456-6945696.26198.94
367627-6762793.72696.35
468457-6845794.87697.53
568081-6808194.35597.02
668365-6836594.74997.42
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)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%
110.156652166503663876628565816663020.44
210.196634466037661900.33
单位质量响应值RSD%判断
6532.226495.580.40数据可信
供试品溶液-2025040921批-水
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min169842-6984296.40293.901.5296.4093.901.52
266886-6688692.32292.32
368422-6842294.44294.44
467341-6734192.95092.95
567932-6793293.76693.77
667739-6773993.49993.50
10min168714-6871494.84594.771.3895.3895.291.37
269514-6951495.94996.46
369121-6912195.40795.93
468405-6840594.41994.94
566915-6691592.36292.88
669271-6927195.61496.13
15min169805-6980596.35195.871.0297.4196.921.00
269139-6913995.43296.48
370507-7050797.32098.37
469247-6924795.58196.62
569630-6963096.11097.14
668424-6842494.44595.50
20min168536-6853694.60094.530.8496.2096.100.82
269045-6904595.30296.88
368818-6881894.98996.58
468734-6873494.87396.44
568324-6832494.30795.87
667435-6743593.08094.66
30min168302-6830294.27794.240.8196.4096.340.79
268103-6810394.00296.11
368452-6845294.48496.61
468003-6800393.86495.96
569212-6921295.53397.62
667580-6758093.28095.37
极限167522-6752293.20093.271.4195.8595.901.37
269191-6919195.50498.13
366515-6651591.81094.46
467795-6779593.57796.20
567678-6767893.41596.04
666722-6672292.09694.71
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)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%
110.156609566171660896609865747660400.26
210.196625966138661980.13
单位质量响应值RSD%判断
6506.406496.370.11数据可信
供试品溶液-2025041021批-水
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min167294-6729493.06393.752.6093.0693.742.60
269989-6998996.79096.79
366253-6625391.62491.62
467730-6773093.66693.67
569739-6973996.44596.44
665720-6572090.88790.89
10min168990-6899095.40996.461.6895.9396.991.68
270977-7097798.15798.69
369836-6983696.57997.09
469277-6927795.80696.33
571221-7122198.49499.03
668220-6822094.34494.85
15min168816-6881695.16896.040.8196.2297.100.81
269929-6992996.70797.79
370099-7009996.94297.99
469584-6958496.23097.28
569487-6948796.09697.18
668754-6875495.08296.11
20min168169-6816994.27395.611.7595.8597.201.74
269316-6931695.86097.48
369588-6958896.23697.82
470670-7067097.73299.32
569789-6978996.51498.13
667302-6730293.07494.63
30min167658-6765893.56794.631.1395.6796.761.11
269868-6986896.62398.78
368427-6842794.63096.75
468107-6810794.18896.32
568016-6801694.06296.21
668503-6850394.73596.81
极限168067-6806794.13294.521.4896.7597.171.46
268365-6836594.54497.23
369473-6947396.07798.72
468700-6870095.00897.66
568942-6894295.34298.02
666548-6654892.03294.63
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)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%
110.156603866278663116612266273662040.18
210.196620166320662600.13
单位质量响应值RSD%判断
6522.566502.450.22数据可信
供试品溶液-2025041021批-水
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min170611-7061197.48494.671.6997.4894.661.69
267353-6735392.98692.99
367752-6775293.53793.54
468734-6873494.89394.89
568073-6807393.98093.98
668893-6889395.11295.11
10min169793-6979396.35594.941.2396.9095.471.23
267575-6757593.29393.81
368724-6872494.87995.40
468699-6869994.84495.37
569633-6963396.13496.66
668203-6820394.16094.69
15min169682-6968296.20195.081.2097.2896.131.20
267467-6746793.14394.18
368902-6890295.12596.17
468738-6873894.89895.95
569705-6970596.23397.29
668722-6872294.87695.93
20min168724-6872494.87994.311.2696.4995.891.25
266926-6692692.39793.95
368610-6861094.72196.30
468643-6864394.76796.35
569286-6928695.65597.25
667670-6767093.42495.00
30min168580-6858094.68094.020.6196.8296.120.59
268265-6826594.24596.31
367483-6748393.16695.27
468317-6831794.31796.42
567728-6772893.50495.63
668218-6821894.18096.28
极限167741-6774193.52293.911.3996.1996.541.36
266428-6642891.70994.30
367941-6794193.79896.42
469121-6912195.42798.06
568784-6878494.96297.60
668137-6813794.06896.69
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)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%
110.156639066048665536643966267663390.30
210.196621666401663080.20
单位质量响应值RSD%判断
6535.866507.160.32数据可信
供试品溶液-2025041121批-水
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min168963-6896395.07893.313.3195.0893.313.31
269328-6932895.58195.58
369466-6946695.77195.77
463831-6383188.00288.00
568320-6832094.19194.19
666170-6617091.22791.23
10min168456-6845694.37993.961.0194.9194.481.01
268519-6851994.46595.00
367668-6766893.29293.82
467002-6700292.37492.86
568846-6884694.91695.44
668406-6840694.31094.82
15min168266-6826694.11794.130.5595.1795.170.56
268349-6834994.23195.29
368645-6864594.63995.69
467709-6770993.34994.35
568662-6866294.66395.71
668013-6801393.76894.80
20min167152-6715292.58194.001.1294.1695.561.09
268449-6844994.36995.95
368529-6852994.47996.06
468675-6867594.68096.20
568968-6896895.08496.66
667315-6731592.80594.36
30min167277-6727792.75393.180.6094.8495.260.58
266903-6690392.23794.34
367788-6778893.45895.56
467831-6783193.51795.56
567849-6784993.54295.65
667870-6787093.57195.64
极限167680-6768093.30992.540.7995.9195.140.77
266415-6641591.56594.18
366679-6667991.92994.55
466927-6692792.27194.84
567659-6765993.28095.90
667377-6737792.89195.48
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)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%
110.156650666251664096635566241663520.17
210.196636666243663040.14
单位质量响应值RSD%判断
6537.146506.770.33数据可信
供试品溶液-2025041121批-水
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min166665-6666591.90394.771.7191.9094.771.71
269427-6942795.71195.71
369631-6963195.99295.99
469776-6977696.19296.19
568283-6828394.13494.13
668693-6869394.69994.70
10min168875-6887594.95095.300.3495.4695.820.35
268833-6883394.89295.42
369435-6943595.72296.26
469286-6928695.51696.05
569150-6915095.32995.85
669175-6917595.36395.89
15min170389-7038997.03795.521.3198.0896.581.30
268946-6894695.04896.11
368998-6899895.11996.18
470422-7042297.08298.15
568263-6826394.10695.16
668702-6870294.71195.77
20min168076-6807693.84894.340.8495.4395.920.83
268750-6875094.77796.36
368551-6855194.50396.10
468964-6896495.07296.68
568787-6878794.82896.40
667450-6745092.98594.57
30min166892-6689292.21693.660.9994.3195.780.97
267513-6751393.07295.19
367902-6790293.60895.73
468748-6874894.77596.91
568187-6818794.00196.10
668412-6841294.31296.41
极限167634-6763493.23992.820.8295.8595.450.80
267192-6719292.63095.26
366367-6636791.49294.13
467629-6762993.23295.89
567934-6793493.65396.28
667225-6722592.67595.30
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