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)1.5
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%
110.002104121164210912124221258211590.45
210.082108921165211270.26
单位质量响应值RSD%判断
2115.902095.930.68数据可信
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%
5min116701-1670171.19142.0047.0171.1942.0047.01
27569-756932.26432.26
36817-681729.05929.06
47493-749331.94031.94
514744-1474462.84962.85
65798-579824.71524.71
10min121019-2101989.59770.7720.2989.7270.8420.32
215211-1521164.83964.89
315314-1531465.27865.33
414440-1444061.55361.61
520615-2061587.87587.98
613020-1302055.50055.54
15min122027-2202793.89484.929.3694.1685.119.41
219215-1921581.90782.07
319227-1922781.95882.12
418694-1869479.68679.84
522457-2245795.72795.98
617915-1791576.36676.50
20min122389-2238995.43790.974.9595.8691.305.01
221222-2122290.46290.76
320825-2082588.77089.06
420432-2043287.09587.38
522863-2286397.45797.87
620316-2031686.60086.86
30min122909-2290997.65395.262.0898.2495.742.14
222026-2202693.88994.34
321775-2177592.81993.26
422350-2235095.27095.70
522883-2288397.54298.12
622148-2214894.40994.81
45min123186-2318698.83497.521.4899.5898.161.53
222688-2268896.71197.32
322398-2239895.47596.07
422917-2291797.68798.28
523316-2331699.388100.12
622762-2276297.02797.59
60min123380-2338099.66198.171.60100.5798.981.63
222653-2265396.56297.33
322505-2250595.93196.69
423163-2316398.73699.49
523352-2335299.542100.44
623133-2313398.60899.33
90min123325-2332599.42797.991.33100.5098.951.36
222551-2255196.12797.05
322683-2268396.69097.61
423070-2307098.34099.26
523082-2308298.39199.46
623212-2321298.94599.83
极限123341-2334199.49598.311.50100.7499.441.53
222460-2246095.73996.83
322907-2290797.64598.72
423051-2305198.25999.34
523370-2337099.618100.85
623250-2325099.107100.16
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)1.5
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%
110.002116921089210312110721268211330.43
210.082113721144211400.03
单位质量响应值RSD%判断
2113.302097.220.55数据可信
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%
5min17714-771432.89239.4825.7032.8939.4825.70
28153-815334.76434.76
310413-1041344.40144.40
46456-645627.52827.53
59642-964241.11341.11
613178-1317856.19056.19
10min114963-1496363.80275.5612.8863.8675.6212.89
218635-1863579.45979.52
319794-1979484.40184.47
414875-1487563.42663.47
518084-1808477.10977.18
619968-1996885.14385.24
15min119118-1911881.51890.206.5381.6890.396.55
222144-2214494.42194.61
321948-2194893.58593.80
419857-1985784.66984.82
521257-2125790.63990.84
622597-2259796.35396.59
20min121027-2102789.65894.703.5689.9695.043.59
222907-2290797.67498.02
322563-2256396.20896.58
421491-2149191.63791.93
522294-2229495.06195.41
622978-2297897.97798.37
30min122350-2235095.29997.651.6495.7598.151.64
223244-2324499.11199.62
322801-2280197.22297.75
423295-2329599.32999.77
522626-2262696.47696.98
623095-2309598.47699.04
45min122845-2284597.41098.160.8898.0298.830.88
223245-2324599.11699.79
322908-2290897.67998.37
423173-2317398.80999.42
522777-2277797.12097.79
623184-2318498.85599.58
60min122799-2279997.21498.240.9997.9899.060.98
223439-2343999.943100.78
322950-2295097.85898.71
423152-2315298.71999.49
522924-2292497.74798.58
622974-2297497.96098.85
90min122862-2286297.48298.070.8398.4199.060.83
223229-2322999.047100.05
322882-2288297.56898.59
423185-2318598.86099.80
522763-2276397.06098.05
623074-2307498.38699.44
极限122910-2291097.68798.001.2398.7899.151.23
223395-2339599.755100.93
322717-2271796.86498.05
423067-2306798.35799.46
522647-2264796.56697.72
623162-2316298.76299.98
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