替米沙坦氨氯地平片项目信息
介质体积(ml)500取样体积(ml)5补液体积(ml)5
对照品批号100374-202106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)5供试品稀释倍数10系数0.7211
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
113.792695326818269642692126795268900.30
213.862688027067269740.50
单位质量响应值RSD%判断
1949.961946.180.14数据可信
供试品溶液-2024100821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%
5min115413-1541356.99662.606.5657.0062.606.56
217765-1776565.69365.69
315922-1592258.87858.88
418385-1838567.98667.99
517037-1703763.00163.00
617046-1704663.03563.03
10min120509-2050975.84177.403.7676.4178.033.76
221224-2122478.48579.14
320715-2071576.60277.19
422146-2214681.89482.57
521177-2117778.31178.94
619816-1981673.27873.91
15min121103-2110378.03780.812.1879.3782.212.20
222364-2236482.70084.14
321817-2181780.67782.03
422326-2232682.56084.06
521574-2157479.77981.19
621930-2193081.09582.46
20min121390-2139079.09881.102.0281.2183.312.05
222049-2204981.53583.80
321549-2154979.68681.85
422623-2262383.65885.98
522122-2212281.80584.02
621860-2186080.83683.01
30min121634-2163480.00177.024.2082.9080.044.02
221851-2185180.80383.89
320114-2011474.38077.34
420404-2040475.45278.61
519713-1971372.89775.93
621257-2125778.60781.59
45min122006-2200681.37677.874.8485.0881.664.68
221681-2168180.17484.07
319618-1961872.54676.25
422110-2211081.76185.68
520544-2054475.97079.73
620386-2038675.38679.15
60min121400-2140079.13574.604.8183.6579.174.61
220905-2090577.30582.00
319672-1967272.74577.17
420740-2074076.69581.43
519015-1901570.31674.83
619315-1931571.42575.95
极限119587-1958772.43171.476.1177.7476.785.83
219706-1970672.87178.34
318919-1891969.96175.12
421226-2122678.49283.99
517669-1766965.33870.56
618851-1885169.70974.95
替米沙坦氨氯地平片项目信息
介质体积(ml)500取样体积(ml)5补液体积(ml)5
对照品批号100374-202106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)5供试品稀释倍数10系数0.7211
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
113.792683826959267702706726655268580.60
213.862654526551265480.02
单位质量响应值RSD%判断
1947.641915.441.18数据可信
供试品溶液-2024100821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%
5min113511-1351150.39456.1213.8350.3956.1213.83
215529-1552957.92057.92
312065-1206545.00045.00
414986-1498655.89555.89
518032-1803267.25667.26
616157-1615760.26360.26
10min119312-1931272.03073.885.6872.5374.455.73
219802-1980273.85874.44
318038-1803867.27867.73
420539-2053976.60777.17
521360-2136079.66980.34
619804-1980473.86574.47
15min120695-2069577.18880.183.4178.4181.483.47
221496-2149680.17681.49
320688-2068877.16278.29
422526-2252684.01885.34
522070-2207082.31783.79
621513-2151380.23981.58
20min121534-2153480.31880.421.7982.3182.521.80
221222-2122279.15481.27
321259-2125979.29281.19
422266-2226683.04885.21
521413-2141379.86682.16
621671-2167180.82982.97
30min121307-2130779.47180.153.6682.2783.053.57
220098-2009874.96277.87
321715-2171580.99383.68
422493-2249383.89586.89
521598-2159880.55783.65
621715-2171580.99383.94
45min121036-2103678.46078.294.9282.0582.004.75
219291-1929171.95275.61
321210-2121079.10982.61
422518-2251883.98887.82
520778-2077877.49881.39
621111-2111178.74082.50
60min119341-1934172.13874.085.6576.5278.575.42
217915-1791566.82071.20
320738-2073877.34981.64
420988-2098878.28182.96
520302-2030275.72380.39
619881-1988174.15278.70
极限120294-2029475.69376.390.7380.7981.620.83
220575-2057576.74181.79
320297-2029775.70480.77
420551-2055176.65182.11
520537-2053776.59982.03
620634-2063476.96182.25
替米沙坦氨氯地平片项目信息
介质体积(ml)500取样体积(ml)5补液体积(ml)5
对照品批号100374-202106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)5供试品稀释倍数10系数0.7211
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
113.792686226704266922672726769267510.26
213.862635126455264030.28
单位质量响应值RSD%判断
1939.881904.981.29数据可信
供试品溶液-2026031721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%
5min111400-1140042.72250.6221.6342.7250.6121.63
210845-1084540.64240.64
316206-1620660.73360.73
414050-1405052.65352.65
517614-1761466.00966.01
610922-1092240.93140.93
10min118290-1829068.54268.5310.5368.9769.0410.60
215825-1582559.30559.71
320074-2007475.22875.84
417426-1742665.30565.83
520972-2097278.59379.25
617135-1713564.21464.62
15min119133-1913371.70274.955.1872.8176.145.29
219095-1909571.55972.56
321209-2120979.48280.84
419146-1914671.75072.93
521253-2125379.64681.09
620165-2016575.56976.62
20min121724-2172481.41279.173.7283.2481.113.75
219913-1991374.62576.34
321522-2152280.65582.81
420372-2037276.34578.24
521442-2144280.35582.60
621784-2178481.63683.44
30min121476-2147680.48280.874.7383.1383.614.62
221167-2116779.32481.79
323006-2300686.21689.18
420487-2048776.77679.44
520733-2073377.69880.74
622614-2261484.74787.37
45min122115-2211582.87781.643.1986.3385.182.99
221801-2180181.70084.95
322455-2245584.15187.97
421891-2189182.03785.47
520444-2044476.61580.44
622002-2200282.45385.92
60min121799-2179981.69379.144.2385.9783.503.83
221648-2164881.12785.20
320979-2097978.62083.28
421823-2182381.78386.03
519475-1947572.98377.57
620982-2098278.63182.93
极限120752-2075277.76975.903.3382.8681.053.14
219729-1972973.93578.82
320794-2079477.92683.38
420643-2064377.36082.43
519134-1913471.70577.02
620467-2046776.70181.78
替米沙坦氨氯地平片项目信息
介质体积(ml)500取样体积(ml)5补液体积(ml)5
对照品批号100374-202106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)5供试品稀释倍数10系数0.7211
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
113.792690826966269692694127103269770.28
213.862683126742267860.24
单位质量响应值RSD%判断
1956.271932.610.87数据可信
供试品溶液-2026031721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%
5min116521-1652161.20948.3920.4761.2148.3920.48
210365-1036538.40238.40
315252-1525256.50856.51
410463-1046338.76538.76
511320-1132041.94041.94
614447-1444753.52553.53
10min120435-2043575.71167.699.3976.3268.189.43
216336-1633660.52460.91
318157-1815767.27167.84
416222-1622260.10260.49
519546-1954672.41772.84
618926-1892670.12070.66
15min121403-2140379.29774.646.8480.6775.806.89
218074-1807466.96367.95
319606-1960672.63973.88
419271-1927171.39872.39
521446-2144679.45680.60
621073-2107378.07479.31
20min121503-2150379.66777.147.1081.8379.057.12
219079-1907970.68772.35
320517-2051776.01477.98
419226-1922671.23172.93
522746-2274684.27386.21
621858-2185880.98383.00
30min119448-1944872.05476.867.8175.0179.547.69
219217-1921771.19873.56
320947-2094777.60880.33
419581-1958172.54774.96
523147-2314785.75888.54
622130-2213081.99084.82
45min119329-1932971.61378.528.3575.2981.978.14
219071-1907170.65773.73
320948-2094877.61181.11
421571-2157179.91983.06
523148-2314885.76289.40
623099-2309985.58189.23
60min118201-1820167.43476.4510.7171.8380.6810.38
218190-1819067.39371.18
320538-2053876.09280.37
420640-2064076.47080.41
522877-2287784.75889.25
623366-2336686.57091.07
极限118085-1808567.00472.185.3372.0777.175.17
219386-1938671.82476.28
319199-1919971.13176.17
419264-1926471.37276.08
521285-2128578.86084.20
619670-1967072.87678.24
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