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DJ832-220225对照品来源自制对照品使用方法直接使用
对照品含量(%)99.86对照品水分(%)0对照品稀释倍数2000
标示量(mg)30供试品稀释倍数5系数0.8934
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
116.182100092099822093242097792094802097150.15
216.222100902102932101920.07
单位质量响应值RSD%判断
12961.3712958.820.02数据可信
供试品溶液-2022060201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%
5min1-0.0001.60122.370.001.60122.41
27804-78044.0294.03
3-0.0000.00
4-0.0000.00
53122-31221.6121.61
67723-77233.9873.99
10min161225-6122531.61034.4820.2131.6134.4920.22
265085-6508533.60233.62
346954-4695424.24224.24
478607-7860740.58440.58
563785-6378532.93132.94
685091-8509143.93143.95
15min1103304-10330453.33452.873.5353.5153.073.59
2103183-10318353.27253.48
395257-9525749.18049.31
4103110-10311053.23453.46
5104209-10420953.80253.99
6105411-10541154.42254.69
20min1113537-11353758.61858.672.0759.0959.162.13
2115055-11505559.40159.91
3108987-10898756.26856.68
4115056-11505659.40259.92
5114730-11473059.23459.72
6114475-11447559.10259.67
30min1114046-11404658.88059.292.4159.6860.112.38
2117168-11716860.49261.33
3112785-11278558.22958.95
4113806-11380658.75659.61
5119185-11918561.53462.35
6112017-11201757.83358.73
45min1119568-11956861.73160.401.4162.8661.551.40
2118307-11830761.08062.25
3115564-11556459.66460.71
4115865-11586559.82061.00
5115669-11566959.71860.88
6116955-11695560.38261.60
60min1120654-12065462.29262.222.3663.7663.702.29
2124064-12406464.05365.56
3120039-12003961.97463.35
4117230-11723060.52462.03
5123424-12342463.72265.22
6117683-11768360.75862.31
极限1127119-12711965.63066.031.9767.4467.861.96
2130081-13008167.15969.03
3126680-12668065.40367.12
4123825-12382563.92965.78
5130392-13039267.32069.17
6129308-12930866.76068.65
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DJ832-220225对照品来源自制对照品使用方法直接使用
对照品含量(%)99.86对照品水分(%)0对照品稀释倍数2000
标示量(mg)30供试品稀释倍数5系数0.8934
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
116.182101762099732099232097002097602099060.09
216.222104142107512105820.12
单位质量响应值RSD%判断
12973.1812982.860.06数据可信
供试品溶液-2022060201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%
5min111007-110075.6755.0089.205.675.0089.18
2-0.0000.00
321497-2149711.08311.08
418032-180329.2979.30
54415-44152.2762.28
63236-32361.6681.67
10min165122-6512233.57536.7814.7833.6136.8114.79
281765-8176542.15642.16
372884-7288437.57737.64
485610-8561044.13844.19
562133-6213332.03432.05
660500-6050031.19231.20
15min1104138-10413853.69154.443.9953.9154.674.04
2109970-10997056.69856.93
3105771-10577154.53354.80
4111048-11104857.25357.55
5101806-10180652.48852.68
6100775-10077551.95752.14
20min1119896-11989661.81560.002.8762.3360.542.90
2117454-11745460.55661.11
3115218-11521859.40359.98
4119977-11997761.85762.47
5114128-11412858.84159.32
6111621-11162157.54958.02
30min1117199-11719960.42560.693.8461.2861.563.88
2119444-11944461.58262.47
3117890-11789060.78161.68
4123712-12371263.78364.74
5118287-11828760.98661.79
6109804-10980456.61257.40
45min1125725-12572564.82062.023.3566.0263.223.37
2119790-11979061.76162.99
3120475-12047562.11463.35
4123104-12310463.46964.78
5118793-11879361.24762.39
6113883-11388358.71559.82
60min1128059-12805966.02464.322.1767.5865.872.19
2125799-12579964.85966.43
3123587-12358763.71865.30
4126962-12696265.45867.12
5120715-12071562.23763.73
6123367-12336763.60565.04
极限1133386-13338668.77067.432.3870.6969.342.41
2133328-13332868.74070.67
3127485-12748565.72867.67
4133941-13394169.05671.09
5129282-12928266.65468.49
6127311-12731165.63867.42
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DJ832-220225对照品来源自制对照品使用方法直接使用
对照品含量(%)99.86对照品水分(%)0对照品稀释倍数2000
标示量(mg)30供试品稀释倍数5系数0.8934
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
116.182103492103162102642103562103772103320.03
216.222097542103822100680.22
单位质量响应值RSD%判断
12999.5112951.170.27数据可信
供试品溶液-2022060401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%
5min110974-109745.6594.5693.095.664.5693.06
23075-30751.5861.59
311003-110035.6745.67
43107-31071.6021.60
523336-2333612.03412.03
61549-15490.7990.80
10min155958-5595828.85732.9121.0028.8932.9321.03
258026-5802629.92329.93
381599-8159942.07942.11
457588-5758829.69729.71
579772-7977241.13741.20
649947-4994725.75725.76
15min197253-9725350.15253.015.3450.3453.225.41
299911-9991151.52251.70
3112054-11205457.78458.05
4101516-10151652.35052.52
5106469-10646954.90455.20
699556-9955651.33951.49
20min1110294-11029456.87759.663.3657.3560.163.41
2115847-11584759.74060.20
3121597-12159762.70563.29
4112809-11280958.17458.64
5117332-11733260.50661.11
6116259-11625959.95360.39
30min1115204-11520459.40961.322.0860.1962.152.15
2119714-11971461.73462.53
3120519-12051962.14963.08
4119232-11923261.48662.27
5121929-12192962.87763.81
6116840-11684060.25261.02
45min1119512-11951261.63062.881.9762.7564.051.98
2123325-12332563.59664.73
3125715-12571564.82966.11
4122632-12263263.23964.37
5120070-12007061.91863.20
6120320-12032062.04763.15
60min1120714-12071462.25062.443.0563.7163.973.05
2122949-12294963.40364.89
3127123-12712365.55567.20
4120492-12049262.13563.62
5118951-11895161.34162.97
6116294-11629459.97161.42
极限1130107-13010767.09463.733.8468.9065.603.77
2125472-12547264.70466.55
3125555-12555564.74666.75
4117967-11796760.83362.66
5124332-12433264.11666.09
6118099-11809960.90162.68
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DJ832-220225对照品来源自制对照品使用方法直接使用
对照品含量(%)99.86对照品水分(%)0对照品稀释倍数2000
标示量(mg)30供试品稀释倍数5系数0.8934
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
116.182106132109362112322110122103672108320.17
216.222137482133492135480.14
单位质量响应值RSD%判断
13030.4113165.720.74数据可信
供试品溶液-2022060401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%
5min19278-92784.7404.0995.774.744.0995.77
21633-16330.8340.83
31364-13640.6970.70
42014-20141.0291.03
519559-195599.9929.99
614193-141937.2517.25
10min186197-8619744.03537.8912.7644.0637.9212.77
258269-5826929.76729.77
370612-7061236.07336.08
477287-7728739.48339.49
573349-7334937.47137.53
679346-7934640.53540.58
15min1111403-11140356.91254.493.5457.1854.723.58
2103374-10337452.81052.98
3101231-10123151.71551.92
4108845-10884555.60555.83
5108495-10849555.42655.69
6106574-10657454.44554.71
20min1117795-11779560.17759.401.9660.7659.932.01
2114581-11458158.53559.00
3113148-11314857.80358.29
4117345-11734559.94760.48
5115446-11544658.97759.55
6119297-11929760.94461.51
30min1121239-12123961.93661.652.3162.8662.522.35
2117225-11722559.88660.67
3117437-11743759.99460.81
4124180-12418063.43964.31
5121679-12167962.16163.06
6122310-12231062.48363.39
45min1125428-12542864.07662.881.7065.3464.091.74
2121900-12190062.27463.40
3119867-11986761.23562.38
4125040-12504063.87865.10
5123784-12378463.23664.48
6122517-12251762.58963.84
60min1126108-12610864.42463.651.6066.0565.211.56
2123523-12352363.10364.57
3126117-12611764.42865.91
4126187-12618764.46466.04
5124416-12441663.55965.16
6121210-12121061.92263.52
极限1130798-13079866.82064.384.0568.8066.303.97
2121538-12153862.08963.91
3127450-12745065.10966.95
4130805-13080566.82368.76
5127338-12733865.05267.00
6118248-11824860.40862.35
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