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%
110.251736351744541749231748411748211745350.31
210.281737541752081744810.59
单位质量响应值RSD%判断
17027.8016972.860.23数据可信
供试品溶液-2023121421批-依折麦布-pH2.0
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min17170-71703.7835.6720.583.785.6720.60
211604-116046.1236.12
312497-124976.5946.59
49368-93684.9434.94
513195-131956.9626.96
610692-106925.6425.64
10min114500-145007.6518.766.607.678.796.64
216803-168038.8668.90
317727-177279.3549.39
416974-169748.9568.98
516960-169608.9498.99
616638-166388.7798.81
15min116723-167238.8249.363.068.899.443.10
217683-176839.3319.41
317992-179929.4949.58
418184-181849.5959.67
518145-181459.5749.66
617686-176869.3329.41
20min117680-176809.3299.403.339.449.543.32
218117-181179.5609.69
318071-180719.5359.68
418342-183429.6789.81
518041-180419.5199.66
616694-166948.8098.94
30min117152-171529.0509.102.839.219.282.82
217435-174359.2009.39
317431-174319.1989.39
417465-174659.2169.40
517674-176749.3269.52
616310-163108.6068.79
45min117615-176159.2959.282.439.519.512.30
217883-178839.4369.68
316999-169998.9709.22
417291-172919.1249.36
517504-175049.2369.48
618203-182039.6059.83
60min116878-168788.9069.031.009.179.311.07
217207-172079.0799.37
317091-170919.0189.31
416992-169928.9669.25
517367-173679.1649.46
617117-171179.0329.31
极限117095-170959.0209.041.489.349.381.44
217406-174069.1849.53
316868-168688.9009.25
416792-167928.8609.20
517320-173209.1399.49
617283-172839.1199.45
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%
110.523046863055163052813048983045863049930.13
210.523036163056123046140.47
单位质量响应值RSD%判断
28991.7328955.700.09数据可信
供试品溶液-2023121421批-瑞舒伐他汀钙-pH2.0
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min131963-319639.11218.8939.439.1118.8939.44
2103872-10387229.61229.61
353332-5333215.20415.20
459081-5908116.84316.84
559523-5952316.96916.97
689897-8989725.62825.63
10min1120321-12032134.30239.3413.2234.3539.4513.28
2161796-16179646.12646.29
3125903-12590335.89335.98
4143142-14314240.80840.90
5120968-12096834.48634.58
6155922-15592244.45144.59
15min1171622-17162248.92751.136.7549.1751.456.82
2192508-19250854.88155.30
3169745-16974548.39248.68
4183899-18389952.42752.75
5165242-16524247.10847.39
6192990-19299055.01955.41
20min1210033-21003359.87759.673.5460.3960.283.62
2220396-22039662.83263.56
3202490-20249057.72758.28
4210872-21087260.11760.73
5199698-19969856.93157.48
6212418-21241860.55761.25
30min1233694-23369466.62365.791.9867.4766.731.99
2237614-23761467.74068.82
3231634-23163466.03666.91
4229671-22967165.47666.42
5226753-22675364.64465.51
6225214-22521464.20565.24
45min1266003-26600375.83474.562.0577.0575.872.06
2264558-26455875.42276.87
3257769-25776973.48674.73
4253751-25375172.34173.65
5259667-25966774.02775.25
6267552-26755276.27577.66
60min1265120-26512075.58275.551.2377.2277.271.13
2265005-26500575.54977.42
3267405-26740576.23377.88
4264484-26448475.40177.11
5268754-26875476.61878.25
6259281-25928173.91775.73
极限1276406-27640678.80078.271.3280.8680.411.23
2275238-27523878.46780.76
3275587-27558778.56680.64
4271611-27161177.43379.56
5279278-27927879.61881.68
6269118-26911876.72278.94
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%
110.251750931760401768561766721768891763100.44
210.281729711741411735560.48
单位质量响应值RSD%判断
17200.9816882.881.32数据可信
供试品溶液-2023121621批-依折麦布-pH2.0
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min18909-89094.6905.1411.944.695.1411.91
210533-105335.5455.54
311626-116266.1206.12
49896-98965.2095.21
59138-91384.8104.81
68503-85034.4764.48
10min116221-162218.5398.464.768.568.494.74
216486-164868.6788.71
317098-170989.0019.03
415236-152368.0208.05
515104-151047.9517.98
616274-162748.5678.59
15min116787-167878.8379.032.448.919.102.45
217099-170999.0019.08
317622-176229.2769.36
416896-168968.8948.97
516790-167908.8388.91
617717-177179.3269.40
20min117248-172489.0809.131.729.209.261.70
217330-173309.1239.25
317256-172569.0849.22
417524-175249.2259.35
516898-168988.8959.02
617785-177859.3629.49
30min116953-169538.9249.051.289.109.231.25
217206-172069.0579.24
317224-172249.0679.25
417582-175829.2559.43
517181-171819.0449.21
617023-170238.9619.14
45min116289-162898.5758.842.458.809.072.37
216447-164478.6588.89
316854-168548.8729.11
417446-174469.1849.41
516989-169898.9439.16
616756-167568.8219.05
60min116959-169598.9278.902.209.209.182.12
216977-169778.9379.22
316404-164048.6358.92
417384-173849.1519.43
517174-171749.0419.31
616545-165458.7098.98
极限116542-165428.7088.812.389.039.142.30
216572-165728.7249.05
316347-163478.6058.94
417494-174949.2099.54
516755-167558.8209.14
616711-167118.7979.12
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%
110.523047543061573069893065673068683062670.30
210.523017263025483021370.20
单位质量响应值RSD%判断
29112.8328720.250.96数据可信
供试品溶液-2023121621批-瑞舒伐他汀钙-pH2.0
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min172172-7217220.61717.5619.6220.6217.5619.61
274710-7471021.34221.34
366683-6668319.04919.05
452107-5210714.88514.89
543614-4361412.45912.46
659616-5961617.03017.03
10min1156701-15670144.76440.8212.9644.8840.9112.98
2165884-16588447.38747.51
3151709-15170943.33843.44
4125979-12597935.98836.07
5118094-11809433.73533.80
6138938-13893839.68939.78
15min1192269-19226954.92452.676.3855.2953.006.43
2200189-20018957.18757.57
3188453-18845353.83454.18
4172211-17221149.19449.48
5169768-16976848.49648.75
6183429-18342952.39952.71
20min1221876-22187663.38261.243.7264.0561.863.78
2225904-22590464.53265.23
3211362-21136260.37861.02
4209132-20913259.74160.30
5204893-20489358.53059.06
6213113-21311360.87861.48
30min1248500-24850070.98769.732.2272.0170.692.25
2251463-25146371.83472.89
3242092-24209269.15770.14
4241978-24197869.12470.01
5244422-24442269.82270.67
6236125-23612567.45268.40
45min1253662-25366272.46272.991.7873.8874.341.72
2258423-25842373.82275.28
3252545-25254572.14373.51
4260317-26031774.36375.63
5259329-25932974.08175.32
6248859-24885971.09072.41
60min1272324-27232477.79376.603.2079.6178.343.14
2273335-27333578.08279.95
3258524-25852473.85175.62
4272799-27279977.92979.61
5275886-27588678.81080.46
6255921-25592173.10774.82
极限1288310-28831082.35980.722.3584.6182.902.33
2285449-28544981.54283.84
3274822-27482278.50680.68
4291034-29103483.13885.26
5276577-27657779.00881.10
6279329-27932979.79481.91
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%
110.251739201751591764411771831755091756420.72
210.281767071775241771160.33
单位质量响应值RSD%判断
17135.8017229.180.39数据可信
供试品溶液-2023121621批-依折麦布-pH2.0
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min110923-109235.7035.499.595.705.499.57
211579-115796.0456.04
310762-107625.6185.62
411039-110395.7635.76
510138-101385.2935.29
68697-86974.5404.54
10min116246-162468.4818.374.368.518.404.34
216338-163388.5298.56
315163-151637.9167.95
416829-168298.7868.82
515187-151877.9297.96
616475-164758.6018.63
15min116877-168778.8118.802.498.898.872.49
216992-169928.8718.95
316235-162358.4768.55
417451-174519.1119.19
516545-165458.6388.71
617000-170008.8758.95
20min117187-171878.9739.000.719.109.120.70
217439-174399.1049.23
317305-173059.0349.16
417196-171968.9779.11
517096-170968.9259.05
617177-171778.9679.09
30min116859-168598.8018.891.658.989.061.63
217372-173729.0699.25
317264-172649.0139.19
416612-166128.6738.85
517117-171178.9369.11
616928-169288.8389.01
45min115936-159368.3208.702.558.558.922.45
216731-167318.7358.97
317147-171478.9529.17
416765-167658.7528.98
516937-169378.8429.06
616453-164538.5908.81
60min116563-165638.6478.660.678.928.930.68
216610-166108.6718.95
316657-166578.6968.97
416606-166068.6698.95
516698-166988.7178.99
616382-163828.5528.82
极限116190-161908.4528.572.018.778.891.93
216801-168018.7719.10
316710-167108.7249.04
415958-159588.3318.66
516552-165528.6418.96
616244-162448.4808.80
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%
110.523032503054383069763077963080463063010.65
210.523085723088383087050.07
单位质量响应值RSD%判断
29116.0629344.580.56数据可信
供试品溶液-2023121621批-瑞舒伐他汀钙-pH2.0
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min154102-5410215.28916.7630.1215.2916.7630.11
254151-5415115.30215.30
349314-4931413.93613.94
466749-6674918.86218.86
540219-4021911.36511.37
691276-9127625.79325.79
10min1130922-13092236.99738.0818.1537.0838.1718.18
2124517-12451735.18735.27
3136270-13627038.50838.59
4150670-15067042.57742.68
596952-9695227.39727.46
6169195-16919547.81247.96
15min1178026-17802650.30849.5611.4050.6049.8611.46
2162250-16225045.85046.13
3177145-17714550.05950.35
4187831-18783153.07953.42
5144762-14476240.90841.12
6202264-20226457.15757.57
20min1207722-20772258.70058.218.1359.2758.798.21
2192033-19203354.26654.80
3210276-21027659.42159.99
4213412-21341260.30860.94
5182449-18244951.55852.00
6230001-23000164.99565.72
30min1243653-24365368.85367.185.2169.7568.085.31
2225868-22586863.82764.66
3240085-24008567.84568.74
4238156-23815667.30068.27
5222305-22230562.82163.55
6256362-25636272.44573.53
45min1251787-25178771.15272.153.7172.4373.433.82
2246766-24676669.73370.92
3259671-25967173.38074.66
4259487-25948773.32874.67
5244483-24448369.08870.17
6269711-26971176.21777.71
60min1274680-27468077.62176.062.7179.3077.742.83
2261782-26178273.97675.56
3266780-26678075.38977.07
4272344-27234476.96178.71
5260581-26058173.63775.10
6278710-27871078.76080.67
极限1278830-27883078.79479.351.4080.9081.451.53
2281090-28109079.43381.42
3278138-27813878.59880.70
4283994-28399480.25382.43
5276188-27618878.04779.92
6286600-28660080.99083.34
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