佩玛贝特片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)0
对照品批号DHX240702对照品来源ZZ对照品使用方法直接使用
对照品含量(%)99.74对照品水分(%)0对照品稀释倍数100000
标示量(mg)0.1供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.392169821681215802158121807216690.44
210.352164921607216280.14
单位质量响应值RSD%判断
2085.562089.660.14数据可信
中间条件6月-供试品溶液-2025041221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%
5min111870-1187051.04056.487.9951.0456.487.99
214091-1409160.59060.59
312125-1212552.13752.14
412817-1281755.11255.11
513449-1344957.83057.83
614465-1446562.19962.20
10min118634-1863480.12584.483.4980.2184.573.49
219599-1959984.27584.38
320630-2063088.70888.79
419265-1926582.83882.93
519650-1965084.49484.59
620101-2010186.43386.54
15min120646-2064688.77789.453.1689.0089.693.15
220474-2047488.03788.28
322006-2200694.62494.86
420069-2006986.29586.53
520681-2068188.92789.16
620943-2094390.05490.30
20min121212-2121291.21091.332.0991.5891.712.09
221410-2141092.06292.45
321901-2190194.17394.57
420531-2053188.28288.66
521128-2112890.84991.23
621255-2125591.39591.79
30min121586-2158692.81993.101.7093.3493.641.70
221609-2160992.91793.46
322266-2226695.74296.29
421115-2111590.79391.31
521709-2170993.34793.88
621626-2162692.99193.54
45min122366-2236696.17294.801.0996.8595.501.09
221807-2180793.76994.47
322227-2222795.57596.28
421745-2174593.50294.17
522104-2210495.04695.74
622037-2203794.75895.46
60min122667-2266797.46796.041.6798.3096.891.67
222117-2211795.10295.95
322556-2255696.98997.86
421677-2167793.21094.04
522527-2252796.86597.72
622467-2246796.60797.47
90min122858-2285898.28897.091.5799.2898.101.56
222771-2277197.91498.93
322601-2260197.18398.21
421927-2192794.28595.27
522842-2284298.21999.23
622472-2247296.62897.65
极限123381-23381100.53798.122.03101.7099.292.01
222675-2267597.50198.68
322839-2283998.20699.40
422103-2210395.04296.18
523258-23258100.008101.18
622655-2265597.41598.60
佩玛贝特片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)0
对照品批号DHX240702对照品来源ZZ对照品使用方法直接使用
对照品含量(%)99.74对照品水分(%)0对照品稀释倍数100000
标示量(mg)0.1供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.392163221574218532170421538216600.58
210.352177321581216770.63
单位质量响应值RSD%判断
2084.702094.400.33数据可信
中间条件6月-供试品溶液-2025041321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%
5min114506-1450662.31764.795.0462.3264.795.04
216175-1617569.48769.49
315176-1517665.19665.20
414021-1402160.23460.23
515552-1555266.81166.81
615064-1506464.71564.71
10min119974-1997485.80887.893.4985.9188.003.49
220897-2089789.77389.89
320787-2078789.30189.41
419299-1929982.90883.01
521270-2127091.37591.49
620525-2052588.17588.28
15min121513-2151392.41991.591.7492.6791.841.74
221502-2150292.37292.64
321237-2123791.23491.49
420686-2068688.86789.11
521759-2175993.47693.74
621222-2122291.16991.42
20min121422-2142292.02893.071.6292.4393.481.62
222028-2202894.63295.05
321512-2151292.41592.82
421169-2116990.94291.33
522007-2200794.54294.96
621846-2184693.85094.26
30min121927-2192794.19894.711.0894.7595.271.09
222257-2225795.61696.19
321845-2184593.84694.41
421817-2181793.72594.26
522407-2240796.26096.84
622023-2202394.61095.17
45min122207-2220795.40195.731.1096.1196.451.11
222552-2255296.88397.62
322043-2204394.69695.42
422022-2202294.60695.30
522592-2259297.05597.79
622282-2228295.72396.44
60min122343-2234395.98596.980.7796.8697.860.78
222700-2270097.51998.42
322790-2279097.90598.78
422426-2242696.34297.19
522668-2266897.38198.28
622519-2251996.74197.62
90min122311-2231195.84896.991.4196.8898.031.39
222976-2297698.70499.76
322447-2244796.43297.47
422950-2295098.59399.61
522531-2253196.79397.85
622241-2224195.54796.59
极限122445-2244596.42397.601.1297.6198.801.10
223061-2306199.070100.29
322746-2274697.71698.92
422969-2296998.67499.85
522507-2250796.69097.91
622580-2258097.00398.20
佩玛贝特片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)0
对照品批号DHX240702对照品来源ZZ对照品使用方法直接使用
对照品含量(%)99.74对照品水分(%)0对照品稀释倍数100000
标示量(mg)0.1供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.392168921629215282175821586216380.42
210.352155621465215100.30
单位质量响应值RSD%判断
2082.582078.260.15数据可信
中间条件6月-供试品溶液-2025041421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%
5min112404-1240453.52157.1315.3353.5257.1315.33
211243-1124348.51148.51
313313-1331357.44357.44
416640-1664071.79871.80
511485-1148549.55649.56
614358-1435861.95261.95
10min119478-1947884.04486.135.0484.1386.225.04
218252-1825278.75478.83
320184-2018487.09087.19
421198-2119891.46591.58
520476-2047688.35088.43
620175-2017587.05187.15
15min121715-2171593.69692.632.4993.9392.872.50
220622-2062288.98089.19
320971-2097190.48690.73
421855-2185594.30094.57
521805-2180594.08494.31
621844-2184494.25394.50
20min122232-2223295.92794.302.2496.3194.702.25
221148-2114891.25091.61
321328-2132892.02692.42
422115-2211595.42295.85
522043-2204395.11195.50
622270-2227096.09196.50
30min122958-2295899.05996.232.3799.6096.782.37
221501-2150192.77393.29
321906-2190694.52095.07
422439-2243996.82097.41
522319-2231996.30296.85
622684-2268497.87798.44
45min123277-23277100.43698.011.96101.1598.721.97
222161-2216195.62096.29
322357-2235796.46697.17
422904-2290498.82699.58
522483-2248397.01097.72
623101-2310199.676100.41
60min123126-2312699.78499.000.99100.6699.881.01
222590-2259097.47198.30
322995-2299599.219100.08
422993-2299399.210100.12
522769-2276998.24499.11
623195-23195100.082100.98
90min123172-2317299.98399.870.93101.03100.900.95
222908-2290898.84499.83
323066-2306699.525100.55
423376-23376100.863101.94
522939-2293998.977100.01
623408-23408101.001102.06
极限123392-23392100.932100.670.49102.14101.880.49
223289-23289100.488101.64
323230-23230100.233101.43
423257-23257100.349101.60
523285-23285100.470101.67
623534-23534101.545102.77
佩玛贝特片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)0
对照品批号DHX240702对照品来源ZZ对照品使用方法直接使用
对照品含量(%)99.74对照品水分(%)0对照品稀释倍数100000
标示量(mg)0.1供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.392180021751217242172221689217370.20
210.352171221645216780.22
单位质量响应值RSD%判断
2092.112094.490.09数据可信
中间条件6月-供试品溶液-SI4S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%
5min14831-483120.71744.2241.7820.7244.2241.78
25080-508021.78421.78
310763-1076346.15446.15
413954-1395459.83859.84
513648-1364858.52658.53
613593-1359358.29058.29
10min113366-1336657.31775.8419.8657.3575.9119.88
213010-1301055.79055.83
319288-1928882.71282.79
420117-2011786.26786.37
520589-2058988.29188.39
619737-1973784.63784.73
15min119712-1971284.53089.329.0184.6689.529.04
217486-1748674.98475.11
322133-2213394.91295.13
422165-2216595.04995.29
521653-2165392.85493.10
621825-2182593.59193.83
20min121230-2123091.04092.664.8691.3193.004.90
219701-1970184.48384.74
322619-2261996.99697.37
422348-2234895.83496.24
521825-2182593.59193.99
621917-2191793.98694.38
30min122520-2252096.57196.992.1796.9997.492.22
221833-2183393.62594.02
323250-2325099.702100.24
423006-2300698.65699.22
522640-2264097.08697.64
622456-2245696.29796.85
45min122896-2289698.18497.131.2198.7797.801.20
222455-2245596.29396.84
322950-2295098.41599.12
422840-2284097.94498.67
522415-2241596.12196.84
622350-2235095.84296.55
60min122970-2297098.50197.281.2899.2598.111.25
222623-2262397.01397.72
322925-2292598.30899.17
422891-2289198.16299.05
522422-2242296.15197.03
622284-2228495.55996.43
90min122334-2233495.77496.860.8396.6997.840.82
222794-2279497.74698.62
322739-2273997.51198.54
422706-2270697.36998.42
522430-2243096.18697.22
622514-2251496.54697.58
极限122466-2246696.34096.751.2197.4197.901.16
222931-2293198.33499.37
322768-2276897.63598.83
422615-2261596.97998.19
522417-2241796.13097.33
622166-2216695.05396.24
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