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对照品来源工作对照品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%
19.851655671654331654601652431652341653870.09
29.911651311664811658060.58
单位质量响应值RSD%判断
16790.5616731.180.26数据可信
供试品溶液-2022091801批-依折麦布-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%
5min19035-90354.8355.128.704.845.128.71
29589-95895.1325.13
38526-85264.5634.56
410759-107595.7585.76
59198-91984.9234.92
610297-102975.5115.51
10min117219-172199.2169.231.869.249.261.87
217309-173099.2649.29
316804-168048.9939.02
417412-174129.3199.35
517032-170329.1159.14
617731-177319.4909.52
15min117153-171539.1809.251.849.269.331.82
217455-174559.3429.42
316783-167838.9829.06
417294-172949.2569.34
517276-172769.2469.32
617734-177349.4919.57
20min117105-171059.1559.081.879.289.221.85
217207-172079.2099.34
316663-166638.9189.04
416519-165198.8418.98
517021-170219.1109.24
617328-173289.2749.41
30min115891-158918.5058.731.818.688.911.81
216411-164118.7838.97
316071-160718.6018.78
416296-162968.7228.91
516428-164288.7928.97
616731-167318.9549.14
45min115639-156398.3708.551.738.608.781.74
216071-160718.6018.83
315788-157888.4508.67
415945-159458.5348.77
515931-159318.5268.75
616444-164448.8019.04
60min115441-154418.2648.491.668.548.771.63
216083-160838.6088.89
315707-157078.4068.68
415981-159818.5538.83
515824-158248.4698.75
616140-161408.6388.92
极限115673-156738.3888.501.718.718.821.70
215819-158198.4668.79
315741-157418.4248.74
415951-159518.5378.86
515728-157288.4188.74
616401-164018.7789.11
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%
111.003096533092103094413090713089183092590.10
211.053097733122053109890.56
单位质量响应值RSD%判断
28114.4528143.800.08数据可信
供试品溶液-2022091801批-阿托伐他汀钙-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%
5min196861-9686128.44323.1216.3628.4423.1216.36
280983-8098323.78023.78
366853-6685319.63119.63
490312-9031226.52026.52
565593-6559319.26119.26
671847-7184721.09821.10
10min1201615-20161559.20357.722.0359.3657.852.05
2200583-20058358.90059.03
3191141-19114156.12856.24
4195199-19519957.31957.47
5194097-19409756.99657.10
6196695-19669557.75957.88
15min1237400-23740069.71269.712.0170.2070.152.00
2244202-24420271.70972.17
3233447-23344768.55168.97
4230853-23085367.78968.25
5238180-23818069.94170.36
6240183-24018370.52970.97
20min1256796-25679675.40775.012.5176.2875.852.49
2261122-26112276.67777.54
3255389-25538974.99475.80
4242988-24298871.35272.19
5257584-25758475.63876.45
6258827-25882776.00376.83
30min1263042-26304277.24178.722.8178.5379.972.77
2273659-27365980.35981.64
3268100-26810078.72679.94
4255699-25569975.08576.32
5272935-27293580.14681.38
6275091-27509180.77982.03
45min1273713-27371380.37581.991.9482.1083.681.92
2286385-28638584.09685.83
3275798-27579880.98782.64
4274430-27443080.58582.24
5280482-28048282.36284.04
6284486-28448683.53885.24
60min1279521-27952182.08084.331.7984.2586.481.75
2293678-29367886.23788.43
3284726-28472683.60985.71
4292104-29210485.77587.88
5286688-28668884.18586.32
6286392-28639284.09886.26
极限1300066-30006688.11389.991.5190.7492.601.49
2309550-30955090.89893.57
3303765-30376589.19991.77
4308223-30822390.50893.09
5304229-30422989.33691.94
6312876-31287691.87594.51
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对照品来源工作对照品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%
19.851641801651501660111663831666031656650.61
29.911654681665141659910.45
单位质量响应值RSD%判断
16818.7816749.850.30数据可信
供试品溶液-2022091801批-依折麦布-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%
5min110493-104935.6085.316.615.615.316.61
29252-92524.9454.94
310653-106535.6935.69
410221-102215.4635.46
59051-90514.8374.84
69990-99905.3395.34
10min116980-169809.0759.281.479.119.311.46
217285-172859.2389.27
317426-174269.3139.34
417550-175509.3809.41
517213-172139.1999.23
617693-176939.4569.49
15min117262-172629.2269.391.269.319.471.24
217839-178399.5349.61
317563-175639.3879.47
417624-176249.4199.50
517368-173689.2829.36
617745-177459.4849.57
20min116861-168619.0119.251.369.149.381.35
217496-174969.3519.48
317446-174469.3249.46
417268-172689.2299.36
517405-174059.3029.43
617396-173969.2979.43
30min116355-163558.7418.841.868.929.021.85
216826-168268.9939.18
316773-167738.9649.15
416794-167948.9769.16
516069-160698.5888.77
616420-164208.7768.96
45min116041-160418.5738.742.258.808.982.24
216228-162288.6738.91
316706-167068.9289.17
416729-167298.9419.18
515863-158638.4788.71
616586-165868.8649.10
60min115480-154808.2738.572.058.558.852.03
216117-161178.6148.90
316143-161438.6288.91
416193-161938.6548.94
515832-158328.4618.74
616412-164128.7719.06
极限115376-153768.2188.421.998.548.751.97
216104-161048.6078.94
315917-159178.5078.84
415754-157548.4208.75
515391-153918.2268.55
616014-160148.5598.89
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%
111.003088263102753116893124353127953112040.53
211.053112413132133122270.45
单位质量响应值RSD%判断
28291.2728255.840.09数据可信
供试品溶液-2022091801批-阿托伐他汀钙-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%
5min186873-8687325.38019.9731.1325.3819.9731.12
278768-7876823.01223.01
384618-8461824.72124.72
445804-4580413.38113.38
537260-3726010.88510.89
676873-7687322.45822.46
10min1188938-18893855.19753.867.0055.3453.977.05
2193903-19390356.64856.78
3193378-19337856.49556.63
4167812-16781249.02649.10
5167973-16797349.07349.13
6194119-19411956.71156.84
15min1227814-22781466.55566.444.4367.0066.864.47
2240953-24095370.39370.84
3231579-23157967.65568.11
4213465-21346562.36362.71
5218242-21824263.75964.09
6232561-23256167.94268.38
20min1243137-24313771.03171.944.2171.8572.724.25
2262044-26204476.55577.39
3247935-24793572.43373.26
4231499-23149967.63168.32
5241066-24106670.42671.11
6251764-25176473.55274.37
30min1258478-25847875.51375.214.4576.7376.394.47
2277468-27746881.06182.32
3257565-25756575.24776.48
4246648-24664872.05773.13
5245829-24582971.81872.90
6258560-25856075.53776.76
45min1268653-26865378.48678.344.0780.1279.934.11
2283795-28379582.91084.62
3271294-27129479.25780.90
4257342-25734275.18176.65
5254229-25422974.27275.75
6273529-27352979.91081.56
60min1270127-27012778.91780.143.9680.9882.173.99
2291324-29132485.10987.28
3277144-27714480.96683.05
4259848-25984875.91477.80
5268107-26810778.32680.22
6279267-27926781.58783.68
极限1295527-29552786.33787.982.2088.8490.462.26
2310486-31048690.70793.35
3302627-30262788.41190.95
4296286-29628686.55988.87
5294940-29494086.16688.49
6307074-30707489.71092.25
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