依折麦布瑞舒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RSF-703-230318-D对照品来源工作对照品对照品使用方法直接使用
对照品含量(%)98.9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0.962
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.261697881699881693181699761692761696690.21
211.201696601700691698640.18
单位质量响应值RSD%判断
15068.2915166.430.46数据可信
供试品溶液-CLB05410批-瑞舒伐他汀钙-pH4.5(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%
5min1123218-12321869.79468.308.1469.7968.308.14
2110893-11089362.81362.81
3121624-12162468.89168.89
4122311-12231169.28069.28
5109170-10917061.83761.84
6136263-13626377.18377.18
10min1158299-15829989.66589.952.3290.0590.332.34
2155194-15519487.90688.25
3155465-15546588.05988.44
4159845-15984590.54090.93
5158727-15872789.90790.25
6165288-16528893.62394.05
15min1169855-16985596.21095.721.7397.1096.601.73
2166921-16692194.54895.39
3164097-16409792.94993.82
4170061-17006196.32797.21
5171380-17138097.07497.92
6171589-17158997.19298.14
20min1176909-176909100.20697.902.00101.6399.311.99
2170395-17039596.51697.88
3167241-16724194.72996.12
4173798-17379898.44499.87
5174341-17434198.751100.13
6174303-17430398.730100.22
30min1173634-17363498.35198.221.78100.33100.171.76
2175908-17590899.639101.54
3167699-16769994.98996.90
4175501-17550199.408101.38
5172484-17248497.69999.63
6175181-17518199.227101.26
45min1174364-17436498.76496.081.91101.2998.581.89
2170734-17073496.70899.16
3164634-16463493.25395.70
4170509-17050996.58199.10
5167883-16788395.09397.57
6169596-16959696.06398.65
60min1174027-17402798.57396.861.81101.6599.891.79
2169346-16934695.92298.91
3165651-16565193.82996.79
4171671-17167197.239100.30
5173406-17340698.222101.22
6171893-17189397.364100.49
极限1175009-17500999.12996.902.31102.75100.472.27
2170282-17028296.45299.97
3163770-16377092.76396.25
4172380-17238097.640101.24
5173659-17365998.365101.91
6171312-17131297.035100.70
依折麦布瑞舒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DSMF-387-240606对照品来源工作对照品对照品使用方法直接使用
对照品含量(%)99.75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%
110.951798591809621805641806131811571806310.28
210.931799931814071807000.56
单位质量响应值RSD%判断
16495.9816532.480.16数据可信
供试品溶液-CLB05410批-依折麦布-pH4.5(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%
5min163888-6388834.73134.3621.5034.7334.3621.51
267416-6741636.64936.65
358220-5822031.65031.65
444928-4492824.42424.42
558670-5867031.89431.89
686124-8612446.81946.82
10min1155665-15566584.62382.006.1984.8282.206.22
2150025-15002581.55781.76
3149634-14963481.34481.52
4135400-13540073.60773.74
5150436-15043681.78081.96
6163916-16391689.10889.37
15min1184620-184620100.36498.781.40101.0399.431.42
2180639-18063998.19998.86
3177920-17792096.72197.35
4180223-18022397.97398.52
5183517-18351799.764100.40
6183341-18334199.668100.42
20min1187903-187903102.148101.351.03103.37102.540.99
2184679-184679100.396101.60
3184221-184221100.147101.31
4188938-188938102.711103.80
5187421-187421101.886103.07
6185429-185429100.803102.11
30min1183236-18323699.611101.801.57101.40103.561.52
2191623-191623104.171105.93
3186777-186777101.536103.26
4189479-189479103.005104.66
5186787-186787101.542103.29
6185652-185652100.925102.79
45min1182686-18268699.31298.700.88101.65101.030.81
2182128-18212899.009101.35
3180982-18098298.386100.67
4183803-18380399.919102.15
5180166-18016697.942100.26
6179640-17964097.656100.09
60min1182315-18231599.11199.280.83102.00102.150.81
2180196-18019697.959100.85
3182445-18244599.181102.01
4182732-18273299.337102.12
5184850-184850100.489103.35
6183243-18324399.615102.59
极限1183553-18355399.78499.621.40103.23103.051.36
2181417-18141798.622102.06
3180085-18008597.898101.28
4184191-184191100.130103.47
5187520-187520101.940105.36
6182792-18279299.370102.90
依折麦布瑞舒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RSF-703-230318-D对照品来源工作对照品对照品使用方法直接使用
对照品含量(%)98.9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0.962
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.261706121708521703861711391712281708430.21
211.201708801710321709560.07
单位质量响应值RSD%判断
15172.5615263.930.43数据可信
供试品溶液-CLB05410批-瑞舒伐他汀钙-pH4.5(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%
5min1100731-10073156.67867.229.0456.6867.229.04
2125431-12543170.57670.58
3115999-11599965.26965.27
4129200-12920072.69772.70
5128557-12855772.33572.34
6116867-11686765.75765.76
10min1159108-15910889.52589.851.6389.8490.221.61
2157777-15777788.77689.17
3164652-16465292.64593.01
4160196-16019690.13790.54
5158029-15802988.91889.32
6158324-15832489.08489.45
15min1174582-17458298.23296.681.2399.0497.561.20
2169386-16938695.30896.19
3174273-17427398.05898.94
4170901-17090196.16197.07
5170760-17076096.08196.98
6171067-17106796.25497.11
20min1176593-17659399.36397.670.96100.7299.080.92
2171880-17188096.71298.13
3173184-17318497.44598.87
4172315-17231596.95698.40
5173905-17390597.85199.28
6173614-17361497.68799.08
30min1180960-180960101.82198.082.66103.73100.042.59
2170232-17023295.78497.74
3177815-177815100.051102.01
4171030-17103096.23398.21
5169805-16980595.54497.52
6176075-17607599.072101.01
45min1175519-17551998.75996.861.58101.2399.351.53
2171035-17103596.23698.72
3174922-17492298.423100.94
4170091-17009195.70598.22
5168700-16870094.92297.43
6172551-17255197.08999.58
60min1175850-17585098.94596.651.88101.9799.681.82
2171619-17161996.56599.58
3174908-17490898.415101.48
4167832-16783294.43497.48
5168648-16864894.89397.92
6171750-17175096.63899.67
极限1176355-17635599.23096.261.84102.8099.831.77
2167883-16788394.46398.02
3170470-17047095.91899.53
4169410-16941095.32298.89
5169170-16917095.18798.75
6173125-17312597.412100.98
依折麦布瑞舒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DSMF-387-240606对照品来源工作对照品对照品使用方法直接使用
对照品含量(%)99.75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%
110.951811351818361813541825281823271818360.34
210.931829341824271826800.20
单位质量响应值RSD%判断
16606.0316713.630.46数据可信
供试品溶液-CLB05410批-依折麦布-pH4.5(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%
5min171571-7157138.56834.8523.3338.5734.8523.33
273539-7353939.62839.63
359911-5991132.28532.28
464252-6425234.62434.62
580945-8094543.61943.62
637774-3777420.35620.36
10min1151198-15119881.47782.139.9881.6982.3210.01
2154263-15426383.12983.35
3160042-16004286.24386.42
4162835-16283587.74887.94
5163208-16320887.94988.19
6122944-12294466.25266.36
15min1182113-18211398.13699.132.2698.8099.782.30
2180549-18054997.29497.98
3184360-18436099.347100.01
4188154-188154101.392102.07
5189424-189424102.076102.81
6179154-17915496.54297.02
20min1182947-18294798.586100.882.8499.80102.082.82
2182802-18280298.50899.73
3182433-18243398.30999.52
4190400-190400102.602103.85
5195337-195337105.263106.56
6189275-189275101.996103.01
30min1187962-187962101.288101.002.10103.05102.762.04
2180756-18075697.40599.17
3186247-186247100.364102.12
4187269-187269100.915102.73
5189942-189942102.355104.24
6192406-192406103.683105.27
45min1180076-18007697.03999.022.0399.36101.351.99
2179743-17974396.85999.17
3181671-18167197.898100.21
4185538-18553899.982102.36
5187845-187845101.225103.68
6187680-187680101.136103.30
60min1181470-18147097.79098.701.23100.65101.571.23
2180526-18052697.281100.13
3181896-18189698.020100.88
4183941-18394199.122102.05
5186490-186490100.495103.51
6184577-18457799.464102.19
极限1181494-18149497.80398.462.39101.21101.882.35
2177491-17749195.64699.04
3178544-17854496.21399.62
4183895-18389599.097102.58
5188716-188716101.695105.27
6186099-186099100.284103.56
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