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%
113.692690726835268282671726830268230.26
213.792691926780268500.37
单位质量响应值RSD%判断
1959.311947.060.45数据可信
长期24月-供试品溶液-20220104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%
5min115067-1506755.57164.147.2655.5764.147.26
217908-1790866.04966.05
317078-1707862.98862.99
417553-1755364.74064.74
518725-1872569.06369.06
618011-1801166.42966.43
10min118612-1861268.64676.445.5369.2077.085.55
221030-2103077.56478.22
320555-2055575.81276.44
420940-2094077.23277.88
522034-2203481.26781.96
621183-2118378.12878.79
15min118776-1877669.25178.035.7370.4979.445.72
222109-2210981.54482.98
321361-2136178.78580.17
421581-2158179.59681.02
521225-2122578.28379.79
621884-2188480.71482.16
20min118673-1867368.87181.117.6770.8183.307.62
222727-2272783.82386.07
321939-2193980.91783.09
422407-2240782.64384.86
523182-2318285.50187.79
623025-2302584.92287.17
30min118355-1835567.69882.368.8570.3285.358.76
223340-2334086.08489.17
322517-2251783.04886.03
423270-2327085.82688.87
523442-2344286.46089.60
623052-2305285.02288.12
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%
113.692687326990269812691426901269320.20
213.792687726738268080.37
单位质量响应值RSD%判断
1967.281944.020.85数据可信
长期24月-供试品溶液-20220104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%
5min116576-1657661.06164.384.6961.0664.384.69
217282-1728263.66263.66
318718-1871868.95268.95
418113-1811366.72366.72
516728-1672861.62161.62
617445-1744564.26264.26
10min118927-1892769.72275.254.8370.3375.894.83
219986-1998673.62374.26
321625-2162579.66080.35
421193-2119378.06978.74
519976-1997673.58674.20
620858-2085876.83577.48
15min120493-2049375.49080.443.5876.8081.843.55
221663-2166379.80081.17
321973-2197380.94282.43
422194-2219481.75683.20
522867-2286784.23685.59
621831-2183180.41981.83
20min120808-2080876.65180.203.6578.7182.403.64
221155-2115577.92980.10
322827-2282784.08886.38
422396-2239682.50084.77
521316-2131678.52280.72
622124-2212481.49983.71
30min121443-2144378.99083.214.1181.8286.214.09
221876-2187680.58583.54
323860-2386087.89391.03
423476-2347686.47989.57
522298-2229882.13985.12
622571-2257183.14586.18
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%
113.692678126812268332688626936268500.23
213.792690627057269820.40
单位质量响应值RSD%判断
1961.291956.640.17数据可信
中间24月-供试品溶液-20220104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%
5min117840-1784065.60462.115.4665.6062.105.46
216806-1680661.80261.80
316974-1697462.41962.42
416782-1678261.71361.71
517682-1768265.02365.02
615250-1525056.08056.08
10min121203-2120377.97174.063.3978.6374.683.40
219671-1967172.33772.96
319838-1983872.95173.58
420439-2043975.16275.78
520395-2039575.00075.65
619289-1928970.93371.49
15min122204-2220481.65279.881.9983.0981.242.02
221281-2128178.25879.60
321660-2166079.65281.01
422008-2200880.93182.30
522027-2202781.00182.40
621154-2115477.79179.06
20min122834-2283483.96981.012.0986.2283.172.08
221842-2184280.32182.44
321429-2142978.80280.95
421937-2193780.67082.85
522095-2209581.25183.46
622038-2203881.04283.09
30min122899-2289984.20884.322.9587.3087.292.89
222457-2245782.58285.51
322679-2267983.39986.34
422484-2248482.68285.67
524265-2426589.23192.25
622796-2279683.82986.69
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%
113.692703226827269502677626774268720.43
213.792682526801268130.07
单位质量响应值RSD%判断
1962.891944.380.67数据可信
中间24月-供试品溶液-20220104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%
5min117500-1750064.53164.107.1664.5364.107.16
218266-1826667.35567.36
317705-1770565.28665.29
415099-1509955.67755.68
517100-1710063.05663.06
618628-1862868.69068.69
10min119194-1919470.77775.364.3571.4276.004.35
221088-2108877.76178.43
320660-2066076.18376.84
420154-2015474.31774.87
519857-1985773.22273.85
621667-2166779.89680.58
15min122076-2207681.40479.811.7782.7681.211.79
221658-2165879.86381.31
321502-2150279.28880.70
421165-2116578.04579.34
521364-2136478.77980.14
622104-2210481.50882.99
20min122081-2208181.42382.172.0383.5984.372.03
222288-2228882.18684.44
322030-2203081.23583.44
422522-2252283.04985.13
521746-2174680.18782.34
623039-2303984.95587.26
30min122804-2280484.08984.752.6287.0787.772.54
222833-2283384.19687.27
321983-2198381.06184.08
423623-2362387.10990.02
523100-2310085.18088.13
623561-2356186.88090.03
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