盐酸达泊西汀片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号DSZJ-4057-240226对照品来源自制工作对照品对照品使用方法直接使用
对照品含量(%)100.0对照品水分(%)0对照品稀释倍数2000
标示量(mg)60供试品稀释倍数10系数0.8934
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
115.992123572122732120712116692120112120760.13
216.002114762116832115800.07
单位质量响应值RSD%判断
13263.0413223.750.21数据可信
供试品溶液-2024042221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%
5min12013-20131.0183.04119.021.023.04119.04
2-0.0000.00
31165-11650.5890.59
42558-25581.2941.29
515823-158238.0068.01
614464-144647.3187.32
10min152615-5261526.62137.2817.1426.6337.3017.16
263820-6382032.29032.29
384104-8410442.55342.56
478379-7837939.65639.66
581730-8173041.35141.40
681449-8144941.20941.25
15min195757-9575748.44855.527.6748.6055.747.69
2106801-10680154.03654.22
3116992-11699259.19259.43
4119426-11942660.42460.65
5108528-10852854.91055.18
6110881-11088156.10056.37
20min1111999-11199956.66661.885.4757.0962.415.51
2119847-11984760.63761.12
3128117-12811764.82165.39
4130523-13052366.03866.60
5119503-11950360.46361.04
6123801-12380162.63763.22
30min1114328-11432857.84463.375.5558.5864.245.58
2123608-12360862.54063.36
3132363-13236366.96967.90
4133007-13300767.29568.23
5122361-12236161.90962.82
6125793-12579363.64564.57
45min1123507-12350762.48966.153.4263.5567.383.47
2132061-13206166.81667.98
3135451-13545168.53269.83
4135011-13501168.30969.61
5128695-12869565.11366.37
6129750-12975065.64766.93
60min1127005-12700564.25867.213.4365.6668.803.49
2130807-13080766.18267.72
3135332-13533268.47170.15
4140044-14004470.85572.54
5130217-13021765.88367.50
6133611-13361167.60169.25
极限1135193-13519368.40171.493.4470.1673.463.47
2142265-14226571.97973.88
3145316-14531673.52375.58
4147462-14746274.60976.69
5136236-13623668.92970.92
6141343-14134371.51373.54
盐酸达泊西汀片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号DSZJ-4057-240226对照品来源自制工作对照品对照品使用方法直接使用
对照品含量(%)100.0对照品水分(%)0对照品稀释倍数2000
标示量(mg)60供试品稀释倍数10系数0.8934
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
115.992125972124312125972123702122362124460.08
216.002130212130612130410.02
单位质量响应值RSD%判断
13286.1813315.060.16数据可信
供试品溶液-2024042221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%
5min144773-4477322.55518.6330.1522.5618.6330.17
222136-2213611.15211.15
346345-4634523.34723.35
423333-2333311.75511.75
541555-4155520.93420.93
643729-4372922.03022.03
10min196994-9699448.86347.845.6948.9947.945.72
296369-9636948.54848.61
396613-9661348.67148.80
484758-8475842.69942.76
5100660-10066050.71050.83
694378-9437847.54547.67
15min1121445-12144561.18161.604.8261.5861.974.82
2123426-12342662.17962.51
3133508-13350867.25867.66
4118371-11837159.63259.93
5119172-11917260.03660.43
6117738-11773859.31359.70
20min1129063-12906365.01965.493.8065.7666.203.78
2132146-13214666.57267.25
3138694-13869469.87070.64
4128729-12872964.85065.48
5126715-12671563.83664.57
6124694-12469462.81863.53
30min1132308-13230866.65368.382.0467.7569.452.01
2137569-13756969.30470.35
3138905-13890569.97771.14
4137454-13745469.24670.24
5135539-13553968.28169.37
6132595-13259566.79867.86
45min1132747-13274766.87467.833.9268.3469.283.86
2139958-13995870.50771.94
3140431-14043170.74572.30
4132884-13288466.94468.32
5126290-12629063.62265.09
6135510-13551068.26669.70
60min1130014-13001465.49866.382.5467.3468.222.55
2135262-13526268.14169.97
3136497-13649768.76470.71
4128255-12825564.61266.36
5129400-12940065.18867.01
6131195-13119566.09367.91
极限1120979-12097960.94662.612.3463.1564.812.32
2126072-12607263.51265.71
3126597-12659763.77666.10
4120453-12045360.68162.79
5124526-12452662.73364.91
6127101-12710164.03066.21
盐酸达泊西汀片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号DSZJ-4057-240226对照品来源自制工作对照品对照品使用方法直接使用
对照品含量(%)100.0对照品水分(%)0对照品稀释倍数2000
标示量(mg)60供试品稀释倍数10系数0.8934
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
115.992128502126472126462123082120832125070.15
216.002119822121752120780.07
单位质量响应值RSD%判断
13289.9913254.880.19数据可信
供试品溶液-2024042321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%
5min142467-4246721.43918.1234.1521.4418.1234.15
225734-2573412.99212.99
323280-2328011.75311.75
426732-2673213.49513.50
553073-5307326.79426.79
644040-4404022.23322.23
10min183319-8331942.06347.6113.9842.1847.7114.00
281771-8177141.28241.35
385944-8594443.38843.45
498581-9858149.76849.84
5115882-11588258.50258.65
6100398-10039850.68550.81
15min1115948-11594858.53662.323.9458.8962.683.97
2125571-12557163.39463.70
3120328-12032860.74761.05
4125866-12586663.54363.89
5129874-12987465.56666.04
6123035-12303562.11462.52
20min1128530-12853064.88867.912.8265.5768.622.83
2137783-13778369.55970.21
3132605-13260566.94567.59
4136329-13632968.82569.53
5138567-13856769.95570.79
6133257-13325767.27468.02
30min1138712-13871270.02870.673.1571.0771.763.12
2140620-14062070.99172.03
3143529-14352972.46073.48
4138301-13830169.82070.91
5145637-14563773.52474.75
6133109-13310967.19968.32
45min1134224-13422467.76267.680.9869.1969.160.90
2134548-13454867.92669.36
3135663-13566368.48969.91
4134636-13463667.97069.44
5133479-13347967.38669.02
6131820-13182066.54968.05
60min1126499-12649963.86262.731.0965.6764.591.03
2123331-12333162.26364.07
3124060-12406062.63164.43
4125202-12520263.20865.06
5123523-12352362.36064.37
6122913-12291362.05263.92
极限1114419-11441957.76458.442.0059.9260.652.04
2114966-11496658.04060.20
3112639-11263956.86559.01
4117782-11778259.46261.67
5118985-11898560.06962.42
6115805-11580558.46360.68
盐酸达泊西汀片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号DSZJ-4057-240226对照品来源自制工作对照品对照品使用方法直接使用
对照品含量(%)100.0对照品水分(%)0对照品稀释倍数2000
标示量(mg)60供试品稀释倍数10系数0.8934
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
115.992112072113092119022116702114932115160.14
216.002124122128172126140.14
单位质量响应值RSD%判断
13228.0213288.380.33数据可信
供试品溶液-2024042321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%
5min123190-2319011.72018.1334.5711.7218.1334.58
242358-4235821.40721.41
326790-2679013.53913.54
425431-2543112.85312.85
544056-4405622.26522.27
653409-5340926.99226.99
10min186813-8681343.87448.1214.2643.9448.2314.27
283631-8363142.26642.39
3100075-10007550.57750.65
482262-8226241.57441.65
5101233-10123351.16251.29
6117317-11731759.29159.44
15min1121324-12132461.31663.143.3461.6263.513.38
2120110-12011060.70261.06
3125451-12545163.40163.76
4127031-12703164.20064.50
5124085-12408562.71163.12
6131638-13163866.52867.01
20min1133650-13365067.54568.393.2368.1969.113.25
2129272-12927265.33366.02
3136425-13642568.94869.66
4138871-13887170.18470.84
5132546-13254666.98767.74
6141184-14118471.35372.20
30min1142444-14244471.99070.802.6173.0171.902.60
2139072-13907270.28571.34
3137445-13744569.46370.55
4141417-14141771.47072.52
5135027-13502768.24169.37
6145128-14512873.34674.59
45min1135251-13525168.35468.231.0869.7869.721.02
2136721-13672169.09770.54
3135360-13536068.40969.89
4135430-13543068.44569.89
5132335-13233566.88168.39
6134930-13493068.19269.84
60min1124635-12463562.98963.170.8964.7965.040.93
2125730-12573063.54265.37
3125805-12580563.58065.44
4124218-12421862.77864.60
5123360-12336062.34564.22
6126215-12621563.78865.82
极限1114055-11405557.64258.601.6259.8060.821.66
2115090-11509058.16560.35
3118108-11810859.69061.90
4115432-11543258.33860.51
5114513-11451357.87460.10
6118452-11845259.86462.25
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