奥司他韦干糖浆项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号101096-202103对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.7对照品水分(%)0对照品稀释倍数800
标示量(mg)75供试品稀释倍数5系数0.7612
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
114.072717632711382717892715292717532715940.11
214.062723342714842719090.23
单位质量响应值RSD%判断
19303.0619339.190.14数据可信
供试品溶液-B24060751批-pH4.5
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min1303875-30387589.52095.574.3589.5295.574.35
2313615-31361592.38992.39
3324057-32405795.46595.47
4333230-33323098.16798.17
5343477-343477101.186101.19
6328209-32820996.68896.69
10min1340594-340594100.337100.910.53100.83101.440.53
2344948-344948101.619102.13
3343222-343222101.111101.64
4340189-340189100.217100.76
5343159-343159101.092101.65
6343182-343182101.099101.64
15min1347514-347514102.375101.290.85103.43102.380.83
2346047-346047101.943103.02
3341575-341575100.626101.72
4344937-344937101.616102.72
5343215-343215101.109102.23
6339669-339669100.064101.16
20min1345505-345505101.784101.131.16103.41102.791.13
2349913-349913103.082104.73
3341692-341692100.660102.31
4343437-343437101.174102.84
5339463-339463100.004101.69
6339756-339756100.090101.74
奥司他韦干糖浆项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号101096-202103对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.7对照品水分(%)0对照品稀释倍数800
标示量(mg)75供试品稀释倍数5系数0.7612
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
114.072721402715082708312707902709232712380.22
214.062722652719412721030.09
单位质量响应值RSD%判断
19277.7519352.990.28数据可信
供试品溶液-B24060751批-pH4.5
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min1329195-32919597.00898.021.3097.0198.021.30
2338566-33856699.76999.77
3333667-33366798.32698.33
4336641-33664199.20299.20
5328714-32871496.86696.87
6329030-32903096.95996.96
10min1349925-349925103.117101.801.00103.66102.341.00
2346931-346931102.234102.79
3347749-347749102.475103.02
4342947-342947101.060101.61
5344716-344716101.582102.12
6340417-340417100.315100.85
15min1349175-349175102.896102.100.96104.01103.210.96
2345418-345418101.789102.91
3349948-349948103.123104.24
4343605-343605101.254102.37
5348816-348816102.790103.89
6341916-341916100.757101.85
20min1349429-349429102.970101.121.78104.65102.801.76
2346561-346561102.125103.81
3345534-345534101.823103.51
4339116-33911699.931101.61
5345543-345543101.825103.50
6332784-33278498.06599.72
奥司他韦干糖浆项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号101096-202103对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.7对照品水分(%)0对照品稀释倍数800
标示量(mg)75供试品稀释倍数5系数0.7612
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
114.072724072724112724682720742720122722740.08
214.062725702722872724280.08
单位质量响应值RSD%判断
19351.3919376.100.10数据可信
供试品溶液-B24060951批-pH4.5
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min1336439-33643998.89594.386.4798.8994.386.47
2335588-33558898.64498.64
3334943-33494398.45598.45
4287439-28743984.49184.49
5303077-30307789.08889.09
6329041-32904196.72096.72
10min1343057-343057100.840100.561.97101.39101.091.98
2354111-354111104.089104.64
3342073-342073100.551101.10
4333758-33375898.10698.58
5339174-33917499.698100.19
6340505-340505100.090100.63
15min1340021-34002199.947100.311.05101.06101.391.07
2347766-347766102.224103.35
3342345-342345100.631101.74
4339486-33948699.790100.80
5337357-33735799.164100.21
6340495-340495100.087101.18
20min1340286-340286100.02599.720.95101.69101.360.97
2345055-345055101.427103.12
3338642-33864299.542101.21
4335875-33587598.729100.30
5337330-33733099.156100.76
6338380-33838099.465101.11
奥司他韦干糖浆项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号101096-202103对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.7对照品水分(%)0对照品稀释倍数800
标示量(mg)75供试品稀释倍数5系数0.7612
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
114.072723622726722730782728462726772727270.10
214.062724852718812721830.16
单位质量响应值RSD%判断
19383.5819358.680.10数据可信
供试品溶液-B24060951批-pH4.5
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min1317641-31764193.33395.093.3493.3395.093.34
2324515-32451595.35395.35
3332650-33265097.74497.74
4333120-33312097.88297.88
5304963-30496389.60889.61
6328849-32884996.62796.63
10min1339905-33990599.875100.480.90100.39101.010.89
2347933-347933102.234102.76
3341926-341926100.469101.01
4341133-341133100.236100.78
5341227-341227100.264100.76
6339653-33965399.801100.34
15min1338966-33896699.599100.160.85100.67101.250.83
2341878-341878100.455101.55
3340544-340544100.063101.16
4339461-33946199.745100.85
5346174-346174101.717102.77
6338235-33823599.385100.48
20min1338585-33858599.48799.780.61101.11101.420.59
2340923-340923100.174101.83
3337717-33771799.232100.89
4339506-33950699.758101.41
5342963-342963100.774102.39
6337732-33773299.237100.88
奥司他韦干糖浆项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号101096-202103对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.7对照品水分(%)0对照品稀释倍数800
标示量(mg)75供试品稀释倍数5系数0.7612
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
114.072732072736182732752731082729012732220.10
214.062748822738862743840.26
单位质量响应值RSD%判断
19418.7619515.220.36数据可信
供试品溶液-B24061151批-pH4.5
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min1323690-32369094.64394.405.2694.6494.405.26
2320242-32024293.63593.63
3339151-33915199.16499.16
4344380-344380100.692100.69
5310083-31008390.66490.66
6299671-29967187.62087.62
10min1354791-354791103.737102.721.75104.26103.251.75
2347269-347269101.537102.06
3354189-354189103.560104.11
4351620-351620102.809103.37
5358644-358644104.863105.37
6341466-34146699.840100.33
15min1353195-353195103.270103.832.41104.37104.932.39
2349722-349722102.254103.34
3356885-356885104.349105.48
4353042-353042103.225104.36
5371095-371095108.504109.59
6346796-346796101.399102.44
20min1349358-349358102.148102.912.66103.82104.582.63
2352372-352372103.029104.68
3356528-356528104.244105.95
4343155-343155100.334102.04
5367676-367676107.504109.19
6342780-342780100.225101.83
奥司他韦干糖浆项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号101096-202103对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.7对照品水分(%)0对照品稀释倍数800
标示量(mg)75供试品稀释倍数5系数0.7612
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
114.072746762743942744772741812741112743680.09
214.062737442731882734660.15
单位质量响应值RSD%判断
19500.2119449.930.19数据可信
供试品溶液-B24061151批-pH4.5
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min1333586-33358697.49694.432.8597.5094.432.85
2315707-31570792.27092.27
3317237-31723792.71792.72
4311936-31193691.16891.17
5328789-32878996.09496.09
6331290-33129096.82496.82
10min1351695-351695102.788102.400.90103.33102.920.90
2352367-352367102.985103.50
3346858-346858101.374101.89
4348950-348950101.986102.49
5347406-347406101.535102.07
6354905-354905103.726104.26
15min1352344-352344102.978103.791.72104.09104.891.70
2362465-362465105.936107.02
3353235-353235103.238104.32
4350300-350300102.380103.45
5349376-349376102.110103.21
6363096-363096106.120107.23
20min1344849-344849100.787102.862.00102.47104.531.98
2362184-362184105.854107.53
3348058-348058101.725103.38
4346659-346659101.316102.96
5351044-351044102.598104.26
6358889-358889104.891106.59
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