依折麦布片项目信息
介质体积(ml)500取样体积(ml)1.5补液体积(ml)1.5
对照品批号ZT-705-231101-1-D对照品来源中检院对照品使用方法直接使用
对照品含量(%)100对照品水分(%)0对照品稀释倍数500
标示量(mg)10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%
110.393406693400333404273407863402163404260.10
210.413404213408123406160.09
单位质量响应值RSD%判断
32764.7732720.080.10数据可信
影响因素30天-包装高温-供试品溶液-X024017批-pH4.5(内含%SDS)
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min1179527-17952754.83049.879.9654.8349.869.96
2157594-15759448.13148.13
3165094-16509450.42250.42
4172628-17262852.72352.72
5133716-13371640.83940.84
6171090-17109052.25352.25
10min1268675-26867582.05778.195.2182.2278.345.22
2248121-24812175.78075.92
3248869-24886976.00876.16
4274307-27430783.77783.94
5239307-23930773.08873.21
6256825-25682578.43878.59
15min1290394-29039488.69085.143.1889.1085.523.19
2273587-27358783.55783.93
3277569-27756984.77485.15
4286788-28678887.58988.00
5265984-26598481.23581.58
6278281-27828184.99185.38
20min1296271-29627190.48587.632.3891.1688.262.39
2282206-28220686.19086.81
3290326-29032688.67089.30
4290139-29013988.61389.28
5277004-27700484.60185.19
6285505-28550587.19787.84
30min1302805-30280592.48190.321.8493.4391.221.85
2291067-29106788.89689.78
3302052-30205292.25193.15
4292656-29265689.38190.32
5290611-29061188.75789.60
6295120-29512090.13491.04
45min1307642-30764293.95891.811.9395.1892.981.92
2294155-29415589.83990.99
3306797-30679793.70094.88
4294902-29490290.06791.27
5298544-29854491.18092.29
6301632-30163292.12393.30
60min1308127-30812794.10692.222.1295.6193.672.10
2294424-29442489.92191.34
3309132-30913294.41395.87
4294514-29451489.94991.43
5303653-30365392.74094.12
6301915-30191592.20993.66
极限1317979-31797997.11597.570.7698.9199.300.74
2318161-31816197.17198.86
3317723-31772397.03798.78
4318241-31824197.19598.94
5320964-32096498.02799.68
6323787-32378798.889100.62
依折麦布片项目信息
介质体积(ml)500取样体积(ml)1.5补液体积(ml)1.5
对照品批号ZT-705-231101-1-D对照品来源中检院对照品使用方法直接使用
对照品含量(%)100对照品水分(%)0对照品稀释倍数500
标示量(mg)10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%
110.393403673406083404253411333409183406900.10
210.413413473408753411110.10
单位质量响应值RSD%判断
32790.1832767.630.05数据可信
影响因素30天-包装高湿-供试品溶液-X024017批-pH4.5(内含%SDS)
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min1166428-16642850.77342.8720.0150.7742.8720.01
2174975-17497553.38053.38
3153249-15324946.75246.75
4126002-12600238.44038.44
5109032-10903233.26333.26
6113520-11352034.63234.63
10min1285136-28513686.98879.5615.6587.1479.6915.64
2248996-24899675.96276.12
3279874-27987485.38285.52
4280700-28070085.63485.75
5182547-18254755.69055.79
6287444-28744487.69287.80
15min1295412-29541290.12386.1412.6790.5486.5112.67
2262868-26286880.19480.58
3300246-30024691.59791.99
4299319-29931991.31591.69
5219002-21900266.81267.08
6317361-31736196.81997.19
20min1297677-29767790.81488.229.0091.5088.859.01
2269539-26953982.22982.86
3301551-30155191.99592.67
4300774-30077491.75892.40
5247020-24702075.35975.83
6318514-31851497.17097.83
30min1298999-29899991.21790.295.4892.1791.185.51
2275706-27570684.11184.99
3302648-30264892.33093.28
4302136-30213692.17493.10
5278130-27813084.85085.54
6318145-31814597.05898.01
45min1299090-29909091.24591.584.0692.4792.744.05
2278737-27873785.03586.16
3302114-30211492.16793.39
4302602-30260292.31693.51
5302021-30202192.13993.09
6316568-31656896.57797.82
60min1298727-29872791.13491.844.0492.6493.284.01
2279664-27966485.31886.70
3302420-30242092.26193.76
4302790-30279092.37393.85
5305854-30585493.30894.53
6316771-31677196.63998.17
极限1314794-31479496.03697.321.7097.8199.031.71
2319066-31906697.33998.98
3315264-31526496.17997.96
4318480-31848097.16098.91
5316896-31689696.67798.18
6329460-329460100.510102.33
依折麦布片项目信息
介质体积(ml)500取样体积(ml)1.5补液体积(ml)1.5
对照品批号ZT-705-231101-1-D对照品来源中检院对照品使用方法直接使用
对照品含量(%)100对照品水分(%)0对照品稀释倍数500
标示量(mg)10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%
110.393410413418003415503419273415083415650.10
210.413417243422973420100.12
单位质量响应值RSD%判断
32874.4032853.990.05数据可信
影响因素30天-包装光照-供试品溶液-X024017批-pH4.5(内含%SDS)
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min1143630-14363043.70438.3113.3843.7038.3113.38
2124310-12431037.82537.83
3135424-13542441.20741.21
4136484-13648441.53041.53
596767-9676729.44529.44
6118853-11885336.16536.16
10min1303859-30385992.45983.456.7892.5983.576.79
2267347-26734781.34981.46
3278385-27838584.70884.83
4284324-28432486.51586.64
5254347-25434777.39377.48
6257339-25733978.30478.41
15min1316763-31676396.38593.032.2296.7993.402.23
2307734-30773493.63894.00
3303093-30309392.22692.60
4306160-30616093.15993.54
5304706-30470692.71793.04
6296010-29601090.07190.41
20min1316207-31620796.21695.102.5196.9195.742.48
2316628-31662896.34496.98
3304781-30478192.74093.39
4305418-30541892.93393.60
5324464-32446498.72999.33
6307655-30765593.61494.23
30min1316234-31623496.22495.912.9997.2196.842.95
2319358-31935897.17598.10
3306467-30646793.25394.19
4305705-30570593.02193.96
5331022-331022100.724101.62
6312473-31247395.08095.97
45min1315185-31518595.90595.972.9097.1897.192.86
2319462-31946297.20798.43
3307990-30799093.71694.93
4305861-30586193.06894.29
5331146-331146100.762101.96
6312725-31272595.15796.34
60min1314019-31401995.55195.862.8997.1197.372.85
2319662-31966297.26898.78
3307917-30791793.69495.19
4304788-30478892.74294.24
5330316-330316100.509102.01
6313590-31359095.42096.89
极限1319323-31932397.16498.161.8699.0199.961.83
2326268-32626899.278101.08
3316805-31680596.39898.17
4317008-31700896.46098.24
5331915-331915100.996102.80
6324327-32432798.687100.44
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