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%
110.231056281055121055031050511044261052240.48
210.191046491047361046920.06
单位质量响应值RSD%判断
10285.8310273.990.09数据可信
长期9月-供试品溶液-2023111821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%
5min156473-5647349.29347.208.9149.2947.208.91
250564-5056444.13644.14
355843-5584348.74448.74
447469-4746941.43441.43
561132-6113253.36053.36
652971-5297146.23746.24
10min194606-9460682.57976.056.5682.8576.316.55
291225-9122579.62779.87
387490-8749076.36776.64
481506-8150671.14471.37
588359-8835977.12677.42
679582-7958269.46569.72
15min198735-9873586.18383.683.9186.9284.373.91
299622-9962286.95787.64
398633-9863386.09486.79
490268-9026878.79279.42
594860-9486082.80083.53
693088-9308881.25481.90
20min1102707-10270789.65088.033.9190.8689.183.91
2106515-10651592.97494.14
3103087-10308789.98191.15
495778-9577883.60284.66
598953-9895386.37387.56
698062-9806285.59586.69
30min1103536-10353690.37392.542.5592.0894.182.52
2108021-10802194.28895.98
3109900-10990095.92897.60
4103799-10379990.60392.13
5103766-10376690.57492.24
6107102-10710293.48695.06
45min1104346-10434691.08093.342.3293.2995.492.26
2107458-10745893.79796.01
3110769-11076996.68798.89
4108184-10818494.43096.46
5104235-10423590.98393.15
6106613-10661393.05995.15
60min1103719-10371990.53393.321.8193.2595.991.77
2108631-10863194.82197.55
3108833-10883394.99797.74
4106804-10680493.22695.78
5105806-10580692.35595.03
6107682-10768293.99296.60
极限1107944-10794494.22195.781.2197.4498.981.14
2109282-10928295.38998.65
3108950-10895095.09998.37
4109694-10969495.74898.82
5111322-11132297.169100.36
6111218-11121897.079100.21
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%
110.231049221049571048741049921048291049150.07
210.191049901050521050210.05
单位质量响应值RSD%判断
10255.6210306.280.35数据可信
长期9月-供试品溶液-2023111821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%
5min154266-5426647.36346.525.2247.3646.525.22
253164-5316446.40146.40
349444-4944443.15443.15
451167-5116744.65844.66
554307-5430747.39847.40
657453-5745350.14450.14
10min191791-9179180.11475.205.2380.3875.465.21
291901-9190180.21080.47
384876-8487674.07874.32
483606-8360672.97073.22
582705-8270572.18472.45
682102-8210271.65771.94
15min199884-9988487.17782.614.1487.8983.294.13
298964-9896486.37487.08
391740-9174080.06980.72
494520-9452082.49683.15
590751-9075179.20679.87
692048-9204880.33881.01
20min1102929-10292989.83586.924.7191.0388.054.69
2107473-10747393.80194.98
397706-9770685.27686.37
497712-9771285.28286.39
596767-9676784.45785.56
694938-9493882.86083.98
30min1104177-10417790.92490.241.6992.6291.861.71
2105602-10560292.16893.87
3102480-10248089.44391.01
4104913-10491391.56693.15
5101510-10151088.59690.17
6101683-10168388.74790.33
45min1105396-10539691.98891.681.7194.1893.801.65
2103113-10311389.99592.21
3104746-10474691.42193.49
4108159-10815994.39996.49
5103546-10354690.37392.44
6105317-10531791.91994.00
60min1104442-10444291.15592.342.0493.8694.971.96
2104383-10438391.10493.82
3106228-10622892.71495.29
4109644-10964495.69698.31
5106306-10630692.78295.35
6103801-10380190.59693.18
极限1109436-10943695.51493.691.5498.7396.831.50
2106512-10651292.96296.18
3108619-10861994.80197.89
4105093-10509391.72494.87
5106271-10627192.75295.83
6108147-10814794.38997.48
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%
110.231051081050751049731049591049801050190.07
210.191034901034801034850.01
单位质量响应值RSD%判断
10265.7910155.540.77数据可信
中间条件9月-供试品溶液-2023111821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%
5min151265-5126545.05242.6611.1245.0542.6611.12
245275-4527539.78839.79
349553-4955343.54843.55
456818-5681849.93249.93
541035-4103536.06236.06
647297-4729741.56541.57
10min185749-8574975.35771.3211.3875.6171.5611.35
293339-9333982.02782.25
377807-7780768.37868.62
478232-7823268.75169.03
566375-6637558.33158.53
685457-8545775.10175.33
15min199002-9900287.00481.478.9587.6782.108.93
2103663-10366391.10091.78
389846-8984678.95879.58
487111-8711176.55477.21
581035-8103571.21571.74
695551-9555183.97184.62
20min1107767-10776794.70788.626.2395.8689.716.25
2108327-10832795.19996.38
397410-9741085.60586.67
497463-9746385.65286.74
592504-9250481.29482.21
6101593-10159389.28190.40
30min1108553-10855395.39894.131.1897.0895.711.26
2108317-10831795.19096.90
3106928-10692893.97095.51
4105323-10532392.55994.12
5106089-10608993.23294.60
6107452-10745294.43096.04
45min1108823-10882395.63595.551.3397.8497.641.36
2108873-10887395.67997.92
3110930-11093097.48799.54
4109188-10918895.95698.03
5106536-10653693.62595.51
6107985-10798594.89997.03
60min1108787-10878795.60396.931.1998.3499.561.13
2110161-11016196.81199.58
3112505-11250598.871101.47
4110989-11098997.539100.15
5109838-10983896.52798.94
6109495-10949596.22698.89
极限1109478-10947896.21196.440.9999.4899.610.92
2108139-10813995.03498.34
3109682-10968296.39099.54
4111509-11150997.996101.15
5109611-10961196.32899.27
6109994-10999496.66499.86
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%
110.231035071034101034301032911033871034050.08
210.191049331050141049740.06
单位质量响应值RSD%判断
10108.0210301.671.35数据可信
中间条件9月-供试品溶液-2023111821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%
5min153102-5310246.69645.5923.9646.7045.5923.97
259984-5998452.74852.75
343269-4326938.04938.05
471080-7108062.50562.51
547266-4726641.56441.56
636378-3637831.99031.99
10min191761-9176180.69272.7111.0580.9572.9611.08
284809-8480974.57874.87
377426-7742668.08668.30
492138-9213881.02381.37
581858-8185871.98372.21
668108-6810859.89260.07
15min1100599-10059988.46483.407.1489.1784.067.15
290178-9017879.30080.01
389411-8941178.62579.21
498300-9830086.44287.24
5103403-10340390.92991.56
687136-8713676.62577.14
20min1103623-10362391.12390.075.5192.3291.195.51
295465-9546583.94985.10
397337-9733785.59586.62
4107606-10760694.62595.90
5109750-10975096.51197.65
6100760-10076088.60589.54
30min1111067-11106797.66995.982.7399.3797.602.79
2105170-10517092.48394.10
3106750-10675093.87295.37
4113225-11322599.566101.37
5110414-11041497.09498.77
6108286-10828695.22396.65
45min1115179-115179101.28599.942.04103.53102.102.08
2112418-11241898.857100.98
3115775-115775101.809103.83
4116003-116003102.009104.37
5112159-11215998.629100.84
6110386-11038697.07099.03
60min1112012-11201298.50096.721.54101.3199.421.60
2109128-10912895.96498.64
3109471-10947196.26598.85
4112128-11212898.602101.52
5108022-10802294.99197.75
6109152-10915295.98598.48
极限1109966-10996696.70197.351.67100.06100.591.71
2109686-10968696.45499.66
3111492-11149298.042101.17
4111766-11176698.283101.75
5113258-11325899.595102.88
6108029-10802994.99798.03
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