依折麦布阿托伐他汀钙片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号DJ333-221017对照品来源自制对照品使用方法直接使用
对照品含量(%)99.67对照品水分(%)0对照品稀释倍数5000
标示量(mg)10供试品稀释倍数5系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.021682651680591679711678421678701680010.11
210.031698081706591702340.36
单位质量响应值RSD%判断
16766.5716972.480.87数据可信
供试品溶液-2024011222批-依折麦布-shui(内含0.2%Tween80)
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min154214-5421428.82935.1619.5428.8335.1619.54
285255-8525545.33645.34
354395-5439528.92528.93
458510-5851031.11431.11
566834-6683435.54035.54
677543-7754341.23541.23
10min1150351-15035179.95281.596.1280.1181.786.14
2160876-16087685.54885.80
3137990-13799073.37873.54
4151285-15128580.44880.62
5155285-15528582.57582.77
6164775-16477587.62287.85
15min1175822-17582293.49694.480.8694.1095.120.90
2177872-17787294.58695.31
3175758-17575893.46294.03
4178508-17850894.92495.54
5178871-17887195.11795.77
6179172-17917295.27895.99
20min1180226-18022695.83897.921.4896.9699.091.49
2186641-18664199.249100.50
3182128-18212896.84997.94
4186420-18642099.132100.28
5186330-18633099.084100.27
6183072-18307297.35198.60
30min1187156-18715699.52399.281.12101.18100.991.10
2188485-188485100.230102.03
3185224-18522498.496100.12
4189135-189135100.576102.27
5186647-18664799.252100.99
6183497-18349797.57799.36
45min1186527-18652799.18999.751.23101.40102.021.22
2189525-189525100.783103.14
3186663-18666399.261101.43
4188132-188132100.042102.30
5190530-190530101.317103.60
6184157-18415797.928100.26
60min1187331-18733199.61699.760.90102.38102.580.91
2187741-18774199.834102.75
3185436-18543698.608101.33
4187664-18766499.793102.61
5190579-190579101.343104.19
6186880-18688099.376102.25
极限1183486-18348697.57299.030.88100.89102.410.88
2185780-18578098.791102.27
3186317-18631799.077102.35
4186689-18668999.275102.64
5188477-188477100.226103.64
6186669-18666999.264102.69
依折麦布阿托伐他汀钙片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号100590-202005对照品来源中检院对照品使用方法直接使用
对照品含量(%)94.9对照品水分(%)0对照品稀释倍数5000
标示量(mg)10供试品稀释倍数5系数0.9671
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.171588761587791590071588361587151588430.07
211.111604781609371607080.21
单位质量响应值RSD%判断
14220.5014465.171.21数据可信
供试品溶液-2024011222批-阿托伐他汀钙-shui(内含0.2%Tween80)
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min164133-6413336.93755.8521.3936.9455.8421.38
2100552-10055257.91257.91
3112828-11282864.98264.98
4112600-11260064.85164.85
579104-7910445.55945.56
6112570-11257064.83364.83
10min1110101-11010163.41180.4910.5163.6280.8010.54
2144359-14435983.14283.46
3146174-14617484.18784.55
4148312-14831285.41985.78
5142268-14226881.93882.19
6147307-14730784.84085.20
15min1132093-13209376.07887.856.8276.6488.616.86
2153937-15393788.65889.44
3160178-16017892.25393.08
4158530-15853091.30492.14
5157587-15758790.76191.47
6152889-15288988.05588.89
20min1140744-14074481.06090.225.2982.0491.475.35
2158612-15861291.35192.63
3160929-16092992.68594.03
4162722-16272293.71895.06
5161950-16195093.27394.49
6154956-15495689.24590.57
30min1152612-15261287.89591.062.5389.3392.802.60
2158694-15869491.39893.18
3161032-16103292.74594.60
4161875-16187593.23095.09
5160694-16069492.55094.28
6153694-15369488.51890.33
45min1156768-15676890.28991.122.1292.2193.382.11
2158076-15807691.04293.33
3159834-15983492.05594.43
4159493-15949391.85894.24
5162503-16250393.59295.84
6152629-15262987.90590.21
60min1157482-15748290.70090.581.4493.1293.341.40
2155677-15567789.66192.46
3157329-15732990.61293.49
4158313-15831391.17994.07
5160739-16073992.57695.34
6154141-15414188.77691.57
极限1153033-15303388.13889.261.4991.0692.521.54
2152948-15294888.08991.38
3157009-15700990.42893.81
4156166-15616689.94293.34
5157877-15787790.92894.21
6152810-15281088.00991.30
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