阿齐沙坦片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号68522100802对照品来源自制对照品使用方法直接使用
对照品含量(%)99.7对照品水分(%)0对照品稀释倍数5000
标示量(mg)20供试品稀释倍数10系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.231054631053171054851053181055951054360.12
210.191053981056311055140.16
单位质量响应值RSD%判断
10306.5510354.660.33数据可信
长期9月-供试品溶液-2023111921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%
5min142742-4274237.12538.5916.5437.1338.5916.53
244949-4494939.04239.04
357098-5709849.59549.59
446985-4698540.81140.81
537823-3782332.85332.85
636954-3695432.09832.10
10min177276-7727667.12171.3713.6067.3371.5813.58
286235-8623574.90375.12
384868-8486873.71573.99
498201-9820185.29685.52
564303-6430355.85356.04
682120-8212071.32971.51
15min192227-9222780.10782.968.6280.6983.578.65
297840-9784084.98385.62
397212-9721284.43785.12
4106998-10699892.93793.64
581881-8188171.12171.61
696920-9692084.18484.76
20min1106677-10667792.65890.376.0793.6891.446.09
2102198-10219888.76889.87
3103920-10392090.26491.42
4109925-10992595.48096.70
592633-9263380.46081.35
6108908-10890894.59695.64
30min1113871-11387198.90795.552.95100.4597.133.01
2108749-10874994.45896.06
3110157-11015795.68197.34
4112196-11219697.45299.20
5104454-10445490.72892.06
6110643-11064396.10397.67
45min1114121-11412199.12497.121.30101.2199.231.34
2112580-11258097.78699.91
3111111-11111196.51098.70
4111745-11174597.06099.35
5109795-10979595.36797.21
6111541-11154196.88398.98
60min1113144-11314498.27696.822.36100.9199.462.44
2112739-11273997.924100.59
3112180-11218097.438100.16
4113411-11341198.508101.34
5106427-10642792.44194.81
6110874-11087496.30498.94
极限1112207-11220797.46296.982.06100.65100.162.15
2113630-11363098.698101.91
3112352-11235297.588100.85
4113797-11379798.843102.22
5107824-10782493.65596.54
6110088-11008895.62198.80
阿齐沙坦片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号68522100802对照品来源自制对照品使用方法直接使用
对照品含量(%)99.7对照品水分(%)0对照品稀释倍数5000
标示量(mg)20供试品稀释倍数10系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.231054031051861052201054951050321052670.18
210.191055111050811052960.29
单位质量响应值RSD%判断
10290.0310333.270.30数据可信
长期9月-供试品溶液-2023111921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%
5min150040-5004043.54444.3314.9543.5444.3314.95
241671-4167136.26136.26
348646-4864642.33142.33
447644-4764441.45941.46
564425-6442556.06256.06
653224-5322446.31546.31
10min189577-8957777.94974.635.4178.1974.885.44
280554-8055470.09770.30
381826-8182671.20471.44
483009-8300972.23372.46
592043-9204380.09480.41
687598-8759876.22676.48
15min1101985-10198588.74685.884.7689.4286.544.78
292907-9290780.84681.44
394696-9469682.40383.03
496670-9667084.12184.75
5105105-10510591.46192.22
6100805-10080587.71988.40
20min1108109-10810994.07591.103.0495.2492.243.08
2100132-10013287.13388.17
3105641-10564191.92793.02
4102284-10228489.00690.10
5108004-10800493.98395.25
6103988-10398890.48991.66
30min1108183-10818394.13995.122.0895.8396.762.06
2106243-10624392.45193.98
3111312-11131296.86298.46
4112178-11217897.61699.21
5110074-11007495.78597.57
6107844-10784493.84495.52
45min1109150-10915094.98196.671.8297.1998.841.81
2109494-10949495.28097.32
3114262-11426299.429101.57
4111484-11148497.01299.15
5112480-11248097.878100.20
6109688-10968895.44997.64
60min1110238-11023895.92796.931.4498.6799.641.43
2109425-10942595.22097.79
3112263-11226397.690100.38
4113818-11381899.043101.72
5111981-11198197.444100.31
6110611-11061196.25298.97
极限1110922-11092296.52397.292.2299.80100.542.16
2110670-11067096.30399.40
3113001-11300198.332101.56
4115151-115151100.203103.43
5113046-11304698.371101.77
6108014-10801493.99297.25
阿齐沙坦片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号68522100802对照品来源自制对照品使用方法直接使用
对照品含量(%)99.7对照品水分(%)0对照品稀释倍数5000
标示量(mg)20供试品稀释倍数10系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.231060131058611060241057031061111059420.16
210.191054131054931054530.06
单位质量响应值RSD%判断
10356.0110348.680.06数据可信
中间条件9月-供试品溶液-2023111921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%
5min151844-5184444.93644.8611.0444.9444.8611.04
253298-5329846.19746.20
352314-5231445.34445.34
447620-4762041.27541.28
561119-6111952.97652.98
644308-4430838.40438.40
10min188131-8813176.38872.388.0676.6472.638.05
291347-9134779.17679.43
384446-8444673.19473.45
474785-7478564.82165.05
586412-8641274.89875.19
675908-7590865.79466.01
15min198147-9814785.07082.155.1685.7482.805.17
2102287-10228788.65889.35
391361-9136179.18879.85
489984-8998477.99578.58
596000-9600083.20983.92
690857-9085778.75179.33
20min1100566-10056687.16788.333.0788.3189.433.09
2106967-10696792.71593.90
398509-9850985.38486.48
4100637-10063787.22888.25
5104332-10433290.43191.60
6100414-10041487.03588.05
30min1106423-10642392.24393.621.2493.8795.221.25
2109856-10985695.21996.92
3108916-10891694.40495.98
4108543-10854394.08195.59
5107672-10767293.32695.00
6106675-10667592.46293.96
45min1107712-10771293.36094.781.9295.5096.901.95
2110876-11087696.10398.34
3110517-11051795.79297.89
4107761-10776193.40395.43
5112161-11216197.21799.41
6107076-10707692.80994.82
60min1109295-10929594.73395.321.2697.3997.961.30
2111040-11104096.24599.01
3110281-11028195.58798.22
4109923-10992395.27797.83
5111595-11159596.72699.46
6107699-10769993.34995.88
极限1110182-11018295.50195.860.7998.6999.030.70
2109515-10951594.92398.23
3110744-11074495.98999.15
4110343-11034395.64198.72
5110637-11063795.89699.17
6112134-11213497.193100.24
阿齐沙坦片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号68522100802对照品来源自制对照品使用方法直接使用
对照品含量(%)99.7对照品水分(%)0对照品稀释倍数5000
标示量(mg)20供试品稀释倍数10系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.231059351054801054321056681052281055490.26
210.191057061058011057540.07
单位质量响应值RSD%判断
10317.6010378.210.42数据可信
中间条件9月-供试品溶液-2023111921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%
5min157113-5711349.52548.0912.7949.5248.0912.79
245022-4502239.04039.04
361898-6189853.67453.67
462627-6262754.30654.31
557233-5723349.62949.63
648846-4884642.35642.36
10min180087-8008769.44770.458.7769.7270.718.78
269948-6994860.65560.87
383200-8320072.14672.44
489002-8900277.17777.48
587939-8793976.25576.53
677255-7725566.99167.23
15min189531-8953177.63679.196.7478.3079.856.76
280390-8039069.70970.26
393594-9359481.15981.86
496716-9671683.86684.60
596945-9694584.06584.76
690764-9076478.70579.31
20min186738-8673875.21485.926.5976.3187.026.52
2101646-10164688.14189.08
3104013-10401390.19491.34
4103130-10313089.42890.62
5102010-10201088.45789.62
696985-9698584.10085.14
30min1102286-10228688.69692.212.5990.2193.792.64
2103702-10370289.92491.35
3108800-10880094.34596.00
4107822-10782293.49795.19
5108810-10881094.35396.01
6106607-10660792.44393.96
45min1109048-10904894.56094.310.7196.5696.400.68
2109036-10903694.54996.48
3109591-10959195.03197.21
4107379-10737993.11395.33
5109081-10908194.58896.77
6108431-10843194.02596.05
60min1107185-10718592.94494.501.6695.4797.111.65
2108509-10850994.09296.55
3109938-10993895.33298.03
4107028-10702892.80895.54
5111775-11177596.92599.63
6109458-10945894.91597.46
极限1108404-10840494.00195.581.4097.0598.711.33
2110601-11060195.90698.88
3109843-10984395.24998.48
4109075-10907594.58397.83
5110583-11058395.89199.14
6112811-11281197.823100.90
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