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%
110.021722991725991728601728361727511726690.14
210.031755841758981757410.13
单位质量响应值RSD%判断
17232.4417521.541.18数据可信
供试品溶液-2024011621批-依折麦布-pH2.0(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%
5min142970-4297022.18322.4913.3522.1822.4913.36
233263-3326317.17217.17
342564-4256421.97421.97
446078-4607823.78823.79
550633-5063326.13926.14
645869-4586923.68023.68
10min1115600-11560059.67963.334.5159.8063.464.50
2129204-12920466.70266.80
3126745-12674565.43265.55
4120228-12022862.06862.20
5126441-12644165.27665.42
6117831-11783160.83160.96
15min1154867-15486779.95183.522.9680.4184.002.96
2166828-16682886.12586.59
3164437-16443784.89185.38
4158594-15859481.87582.35
5166238-16623885.82186.33
6159706-15970682.44982.92
20min1169836-16983687.67891.162.2188.5892.102.22
2176220-17622090.97491.92
3180094-18009492.97493.93
4176073-17607390.89891.83
5180775-18077593.32694.31
6176515-17651591.12692.05
30min1176050-17605090.88692.351.8492.2793.801.84
2176312-17631291.02292.47
3183772-18377294.87396.35
4175853-17585390.78592.22
5180573-18057393.22194.72
6180743-18074393.30994.74
45min1178866-17886692.34092.301.5994.2394.261.54
2179359-17935992.59594.55
3173245-17324589.43891.44
4180713-18071393.29495.23
5179718-17971892.78094.80
6180869-18086993.37495.33
60min1174254-17425489.95993.002.5092.3695.472.47
2177992-17799291.88994.36
3184157-18415795.07297.57
4176283-17628391.00793.47
5184083-18408395.03397.57
6184039-18403995.01197.48
极限1175394-17539490.54892.202.2893.4595.182.26
2176682-17668291.21394.19
3182600-18260094.26897.29
4173430-17343089.53492.50
5183502-18350294.73397.80
6179910-17991092.87995.88
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2500
标示量(mg)20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%
111.173079763081683085163084723082233082710.08
211.113109233137833123530.65
单位质量响应值RSD%判断
27598.1228114.581.32数据可信
供试品溶液-2024011621批-阿托伐他汀钙-pH2.0(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%
5min1116793-11679334.63540.3128.2934.6340.3228.29
274552-7455222.10822.11
3125263-12526337.14637.15
4166809-16680949.46749.47
5152522-15252245.23045.23
6179738-17973853.30153.30
10min1252377-25237774.84276.9012.8275.0377.1212.87
2198372-19837258.82758.95
3257049-25704976.22776.43
4291456-29145686.43086.71
5277586-27758682.31782.57
6279096-27909682.76583.06
15min1294550-29455087.34888.037.0787.9688.687.14
2258097-25809776.53876.99
3293281-29328186.97287.60
4313685-31368593.02293.78
5312989-31298992.81693.52
6308436-30843691.46692.22
20min1312189-31218992.57994.244.8993.6795.384.99
2290485-29048586.14287.02
3316630-31663093.89695.01
4333386-33338698.865100.14
5329847-32984797.81599.04
6324139-32413996.12297.39
30min1316766-31676693.93693.832.2495.5495.492.37
2302732-30273289.77491.13
3317518-31751894.15995.79
4320400-32040095.01496.83
5322891-32289195.75297.52
6318101-31810194.33296.13
45min1318875-31887594.56193.412.8096.6995.592.79
2315067-31506793.43295.28
3299027-29902788.67590.83
4325257-32525796.45498.80
5318165-31816594.35196.65
6313526-31352692.97595.30
60min1305945-30594590.72792.771.6893.3895.481.74
2309600-30960091.81194.18
3313239-31323992.89095.54
4313005-31300592.82195.71
5321677-32167795.39298.22
6313578-31357892.99195.83
极限1305243-30524390.51991.781.8393.6895.001.82
2307572-30757291.20994.09
3311813-31181392.46795.63
4307151-30715191.08594.49
5319938-31993894.87798.23
6305342-30534290.54893.90
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