依折麦布辛伐他汀片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
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1000
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%
111.101910701908331903121908031907981907630.15
211.061913611914191913900.03
单位质量响应值RSD%判断
17185.8617304.700.49数据可信
供试品溶液-X024017批-依折麦布-pH1.2(内含0.3%Tween)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min155602-5560228.94528.134.8428.9528.134.84
251015-5101526.55826.56
355469-5546928.87628.88
10min145313-4531323.58928.1515.6323.6428.1915.59
254726-5472628.48928.53
362171-6217132.36532.41
15min195999-9599949.97550.112.1250.0650.202.13
294354-9435449.11949.21
398405-9840551.22851.33
20min190691-9069147.21252.378.5447.3852.558.52
2105323-10532354.82955.00
3105791-10579155.07355.26
30min1119739-11973962.33462.311.7862.5862.581.79
2117545-11754561.19261.46
3121802-12180263.40863.69
45min1120695-12069562.83265.032.9463.1965.402.93
2127140-12714066.18766.55
3126925-12692566.07566.46
60min1133436-13343669.46569.391.6469.9269.871.64
2131054-13105468.22568.70
3135406-13540670.49070.99
极限1136779-13677971.20572.091.1571.7872.691.16
2139911-13991172.83573.43
3138769-13876972.24172.85
依折麦布辛伐他汀片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号100601-201906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(%)99.5对照品水分(%)0对照品稀释倍数500
标示量(mg)20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%
110.994171894174024177204167524180774174280.13
210.994203164203414203280.01
单位质量响应值RSD%判断
37982.5338246.410.49数据可信
供试品溶液-X024017批-辛伐他汀-pH1.2(内含0.3%Tween)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min143135-4313510.13510.237.9110.1310.237.87
240331-403319.4769.48
347178-4717811.08511.08
10min143810-4381010.29312.3516.5110.3112.3716.50
252721-5272112.38712.40
361163-6116314.37014.39
15min188167-8816720.71520.792.7220.7520.832.74
286245-8624520.26420.30
391024-9102421.38621.43
20min190475-9047521.25723.779.2221.3323.859.19
2105637-10563724.82024.89
3107453-10745325.24625.32
30min1116933-11693327.47427.902.6627.5828.012.67
2116879-11687927.46127.57
3122372-12237228.75228.87
45min1125025-12502529.37530.523.2429.5230.673.26
2132152-13215231.05031.21
3132451-13245131.12031.29
60min1136261-13626132.01532.332.3432.2132.542.35
2135284-13528431.78531.99
3141280-14128033.19433.41
极限1144838-14483834.03034.551.3234.2834.811.34
2148445-14844534.87835.14
3147865-14786534.74135.02
依折麦布辛伐他汀片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
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1000
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%
111.101909831909951911141907361912121910080.10
211.061911131911021911080.01
单位质量响应值RSD%判断
17207.9317279.200.30数据可信
供试品溶液-2024030121批-依折麦布-pH4.5(内含0.3%Tween)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min155940-5594029.12429.184.9829.1229.184.98
253311-5331127.75527.76
358886-5888630.65830.66
10min162725-6272532.65729.4610.7132.7129.5110.70
256403-5640329.36529.41
350613-5061326.35126.40
15min197598-9759850.81352.384.1450.9252.474.12
298859-9885951.46951.56
3105350-10535054.84854.94
20min1112212-11221258.42155.578.5358.6155.758.49
2111750-11175058.18158.36
396232-9623250.10150.29
30min1123866-12386664.48965.802.7664.7766.072.74
2124909-12490965.03265.31
3130358-13035867.86868.14
45min1136290-13629070.95769.074.4871.3569.464.46
2135904-13590470.75671.14
3125823-12582365.50765.89
60min1138294-13829472.00073.121.7972.5173.621.77
2139839-13983972.80573.31
3143197-14319774.55375.05
极限1148916-14891677.53076.682.1978.1677.302.18
2149355-14935577.75978.38
3143583-14358374.75475.37
依折麦布辛伐他汀片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号100601-201906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(%)99.5对照品水分(%)0对照品稀释倍数500
标示量(mg)20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%
110.994190714184414194324187144186604188640.10
210.994189224192754190980.06
单位质量响应值RSD%判断
38113.1938134.490.04数据可信
供试品溶液-2024030121批-辛伐他汀-pH4.5(内含0.3%Tween)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1123195-12319528.93829.024.8128.9429.024.82
2117816-11781627.67427.67
3129687-12968730.46230.46
10min1157592-15759237.01733.1811.2537.0733.2311.23
2140310-14031032.95833.00
3125868-12586829.56529.62
15min1221954-22195452.13553.734.2952.2553.834.28
2224271-22427152.68052.78
3239984-23998456.37056.47
20min1273678-27367864.28560.899.1564.4861.089.12
2272132-27213263.92264.11
3231874-23187454.46554.66
30min1284360-28436066.79468.463.0667.1068.763.04
2288560-28856067.78168.08
3301471-30147170.81371.10
45min1322801-32280175.82474.194.0976.2474.604.07
2323794-32379476.05776.47
3300981-30098170.69871.10
60min1320670-32067075.32376.551.9575.8677.081.92
2324047-32404776.11676.65
3332912-33291278.19978.72
极限1348784-34878481.92781.521.7382.5982.181.72
2351986-35198682.67983.34
3340420-34042079.96280.61
依折麦布辛伐他汀片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
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1000
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%
111.101920821920921918951920111915751919310.12
211.061937021938151937580.05
单位质量响应值RSD%判断
17291.0817518.810.93数据可信
供试品溶液-2024030121批-依折麦布-pH7.0(内含0.3%Tween)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min145906-4590623.67926.008.4523.6826.008.46
250937-5093726.27526.27
354371-5437128.04628.05
10min148074-4807424.79824.877.5724.8424.917.56
251930-5193026.78726.83
344642-4464223.02723.07
15min188910-8891045.86250.037.7345.9450.127.72
298390-9839050.75250.84
3103695-10369553.48853.57
20min191941-9194147.42551.478.5147.5851.638.50
2108794-10879456.11956.29
398584-9858450.85251.03
30min1118169-11816960.95464.094.2961.1964.344.30
2126456-12645665.22965.50
3128104-12810466.07966.34
45min1127344-12734465.68767.283.3666.0267.643.37
2135437-13543769.86270.24
3128504-12850466.28566.65
60min1135595-13559569.94371.742.1770.3972.212.19
2140857-14085772.65773.15
3140777-14077772.61673.10
极限1144886-14488674.73675.891.6975.3076.491.70
2149784-14978477.26277.87
3146728-14672875.68676.29
依折麦布辛伐他汀片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号100601-201906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(%)99.5对照品水分(%)0对照品稀释倍数500
标示量(mg)20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%
110.994204504206654203484200104194374201820.12
210.994250684253184251930.05
单位质量响应值RSD%判断
38233.1238689.080.84数据可信
供试品溶液-2024030121批-辛伐他汀-pH7.0(内含0.3%Tween)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1103831-10383124.17626.578.4924.1826.578.48
2115422-11542226.87526.87
3123059-12305928.65328.65
10min1123753-12375328.81528.817.4928.8628.867.47
2132969-13296930.96131.01
3114447-11444726.64826.70
15min1201420-20142046.89951.488.1346.9951.578.11
2225259-22525952.44952.55
3236600-23660055.09055.18
20min1221652-22165251.61056.389.0851.7856.569.06
2265366-26536661.78861.97
3239412-23941255.74555.93
30min1271460-27146063.20766.674.5263.4666.944.52
2292681-29268168.14868.43
3294856-29485668.65568.93
45min1301796-30179670.27072.473.7070.6372.863.71
2324080-32408075.45975.86
3307897-30789771.69172.08
60min1311345-31134572.49474.972.8872.9775.482.90
2328268-32826876.43476.96
3326363-32636375.99176.50
极限1339394-33939479.02580.632.0379.6281.262.05
2353388-35338882.28382.94
3346098-34609880.58681.22
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