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%
111.051844581843731830841831631830511836260.40
211.121869391871881870640.10
单位质量响应值RSD%判断
16617.7416822.300.87数据可信
供试品溶液-2024011221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%
5min114119-141197.5757.8712.017.587.8712.03
211448-114486.1426.14
315983-159838.5758.58
416013-160138.5918.59
514596-145967.8317.83
615802-158028.4788.48
10min119421-1942110.42010.544.5610.4610.584.58
217975-179759.6449.68
320282-2028210.88210.93
420451-2045110.97211.02
519747-1974710.59510.64
619952-1995210.70510.75
15min119964-1996410.71110.912.1210.8111.012.14
219850-1985010.65010.74
320070-2007010.76810.88
420445-2044510.96911.08
520828-2082811.17511.28
620813-2081311.16711.27
20min119596-1959610.51410.862.0810.6711.022.05
220564-2056411.03311.18
319974-1997410.71610.88
420278-2027810.88011.05
520782-2078211.15011.31
620272-2027210.87611.04
30min118846-1884610.11110.542.7910.3310.762.75
219815-1981510.63110.84
319151-1915110.27510.50
419895-1989510.67410.90
520358-2035810.92211.15
619776-1977610.61010.84
45min118424-184249.88510.463.3110.1610.743.23
220171-2017110.82211.09
319162-1916210.28110.57
419542-1954210.48510.77
520091-2009110.77911.07
619561-1956110.49510.78
60min118733-1873310.05110.282.3110.3810.622.26
219425-1942510.42210.75
318565-185659.96110.30
419283-1928310.34610.69
519753-1975310.59810.94
619247-1924710.32610.67
极限118732-1873210.05010.535.7210.4310.925.55
220254-2025410.86711.25
318538-185389.94610.34
419392-1939210.40410.81
521551-2155111.56311.97
619241-1924110.32310.73
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%
111.041577471575221572771572471573071574200.14
211.021596901596651596780.02
单位质量响应值RSD%判断
14259.0614489.841.14数据可信
供试品溶液-2024011221批-阿托伐他汀钙-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%
5min149883-4988328.66629.0022.8328.6729.0022.83
242476-4247624.41024.41
346811-4681126.90126.90
454920-5492031.56131.56
537997-3799721.83621.84
670734-7073440.64940.65
10min186648-8664849.79448.5812.0949.9548.7412.11
272321-7232141.56141.70
378732-7873245.24545.39
488587-8858750.90851.08
579366-7936645.60945.73
6101596-10159658.38458.61
15min1106259-10625961.06460.289.2761.5060.719.31
293122-9312253.51453.88
397459-9745956.00756.41
4109624-10962462.99763.46
5102264-10226458.76859.14
6120629-12062969.32269.87
20min1116755-11675567.09567.197.3267.8767.967.37
2107043-10704361.51462.18
3109374-10937462.85463.57
4123363-12336370.89371.70
5115157-11515766.17766.88
6129820-12982074.60375.54
30min1122732-12273270.53072.126.4171.6873.266.46
2116751-11675167.09368.10
3118360-11836068.01869.08
4133723-13372376.84678.05
5125015-12501571.84272.91
6136453-13645378.41579.76
45min1127956-12795673.53276.464.3975.0778.004.46
2130770-13077075.14976.53
3128282-12828273.72075.16
4140126-14012680.52682.15
5130437-13043774.95876.43
6140784-14078480.90482.69
60min1130220-13022074.83375.814.2576.7877.784.34
2129241-12924174.27176.07
3125825-12582572.30874.16
4138521-13852179.60481.68
5128424-12842473.80175.69
6139267-13926780.03282.27
极限1137028-13702878.74682.322.4881.1184.702.46
2143683-14368382.57084.78
3142014-14201481.61183.86
4147307-14730784.65387.17
5145562-14556283.65085.94
6143858-14385882.67185.35
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%
111.051831161831931830781832041831481831480.03
211.121856341863451859900.28
单位质量响应值RSD%判断
16574.4816725.720.65数据可信
供试品溶液-2024011221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%
5min110897-108975.8717.0512.205.877.0512.19
215078-150788.1238.12
311988-119886.4596.46
413915-139157.4977.50
514288-142887.6987.70
612297-122976.6256.63
10min116978-169789.14710.135.099.1810.165.11
219770-1977010.65110.70
318954-1895410.21210.25
418731-1873110.09210.13
519135-1913510.30910.35
619207-1920710.34810.38
15min119404-1940410.45410.832.1110.5410.922.13
220659-2065911.13011.23
320238-2023810.90411.00
420293-2029310.93311.03
520069-2006910.81210.91
619904-1990410.72410.82
20min119563-1956310.54010.822.2310.6810.972.25
220257-2025710.91411.08
320452-2045211.01911.17
420543-2054311.06811.23
520154-2015410.85811.02
619496-1949610.50410.66
30min119552-1955210.53410.671.8310.7310.891.84
219532-1953210.52310.75
320235-2023510.90211.12
420298-2029810.93611.16
519701-1970110.61410.83
619524-1952410.51910.73
45min119031-1903110.25310.562.6510.5110.832.62
219107-1910710.29410.58
320093-2009310.82511.10
420207-2020710.88711.17
519850-1985010.69410.97
619279-1927910.38710.66
60min120303-2030310.93910.633.0511.2510.962.92
219257-1925710.37510.72
320121-2012110.84011.18
420348-2034810.96311.30
519326-1932610.41210.75
618986-1898610.22910.56
极限118955-1895510.21210.583.7410.5910.973.67
219215-1921510.35210.75
320377-2037710.97811.37
420600-2060011.09911.50
519754-1975410.64311.04
618894-1889410.17910.56
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%
111.041561451562231561681561741561851561790.02
211.021584571586511585540.09
单位质量响应值RSD%判断
14146.6514387.841.20数据可信
供试品溶液-2024011221批-阿托伐他汀钙-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%
5min134228-3422819.81823.5323.9219.8223.5323.92
255958-5595832.39932.40
336571-3657121.17421.17
449515-4951528.66928.67
531900-3190018.47018.47
635666-3566620.65020.65
10min178668-7866845.54846.1113.3545.6646.2413.37
291161-9116152.78152.96
377226-7722644.71344.83
491548-9154853.00553.16
563188-6318836.58536.69
676050-7605044.03244.15
15min1107945-10794562.49961.1910.5762.8661.5810.61
2117679-11767968.13568.61
3103451-10345159.89760.26
4116791-11679167.62168.07
587820-8782050.84751.15
6100455-10045558.16258.52
20min1120726-12072669.89969.638.2170.6170.358.25
2130470-13047075.54176.39
3121507-12150770.35171.05
4130112-13011275.33476.16
5104582-10458260.55261.14
6114144-11414466.08866.77
30min1132711-13271176.83876.305.9077.9477.425.97
2139283-13928380.64381.91
3133612-13361277.36078.45
4137694-13769479.72380.97
5117564-11756468.06868.99
6129843-12984375.17876.23
45min1137699-13769979.72680.763.2881.2582.293.39
2144534-14453483.68485.40
3141183-14118381.74483.26
4142244-14224482.35884.05
5131422-13142276.09277.39
6139791-13979180.93882.40
60min1144410-14441083.61281.683.2185.5883.663.29
2144868-14486883.87786.06
3142245-14224582.35884.33
4141646-14164682.01284.16
5132436-13243676.67978.40
6140788-14078881.51583.43
极限1140850-14085081.55183.331.5583.9885.771.64
2145805-14580584.42087.07
3146343-14634384.73187.16
4144755-14475583.81286.42
5141682-14168282.03284.18
6144125-14412583.44785.82
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%
111.051816351824071822461820251819071820440.17
211.121831801831831831820.01
单位质量响应值RSD%判断
16474.5716473.200.01数据可信
供试品溶液-2024011222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%
5min111468-114686.2456.578.246.246.578.21
212971-129717.0637.06
310627-106275.7875.79
413359-133597.2747.27
511910-119106.4856.49
612061-120616.5676.57
10min117826-178269.7079.474.709.749.504.70
218239-182399.9319.97
315902-159028.6598.69
417334-173349.4399.48
517811-178119.6989.73
617216-172169.3749.41
15min118366-1836610.0019.841.3710.099.931.38
218336-183369.98410.08
317973-179739.7879.87
417933-179339.7659.86
518081-180819.8459.94
617727-177279.6539.74
20min117850-178509.7209.681.089.869.821.05
218039-180399.8239.97
317864-178649.7279.86
417797-177979.6919.84
517561-175619.5629.71
617544-175449.5539.70
30min118057-180579.8329.642.1210.039.842.08
217993-179939.79710.00
318031-180319.81810.01
417547-175479.5559.76
517325-173259.4349.63
617240-172409.3879.58
45min117807-178079.6969.441.789.959.691.71
216951-169519.2309.49
317569-175699.5679.81
417274-172749.4069.66
517208-172089.3709.62
617175-171759.3529.60
60min117710-177109.6439.421.539.959.721.47
217211-172119.3729.68
317454-174549.5049.80
417240-172409.3879.69
516921-169219.2149.52
617262-172629.3999.70
极限117590-175909.5789.412.269.949.772.17
216816-168169.1579.52
317216-172169.3749.72
417212-172129.3729.73
517881-178819.73610.09
617003-170039.2589.61
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%
111.041561301563811564171564531563271563420.09
211.021563381561311562340.10
单位质量响应值RSD%判断
14161.4114177.310.08数据可信
供试品溶液-2024011222批-阿托伐他汀钙-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%
5min135561-3556120.73023.1924.3820.7323.1924.37
252992-5299230.89230.89
326365-2636515.36915.37
439089-3908922.78722.79
548822-4882228.46128.46
635846-3584620.89620.90
10min173236-7323642.69342.4813.8942.8142.6113.91
283344-8334448.58548.76
355374-5537432.28032.37
468108-6810839.70339.83
580586-8058646.97747.14
676573-7657344.63844.75
15min196280-9628056.12653.8211.7756.4854.1811.78
299706-9970658.12358.56
373937-7393743.10143.37
484216-8421649.09449.44
599245-9924557.85558.27
6100553-10055358.61758.98
20min1107623-10762362.73959.9710.8263.4060.6310.84
2108290-10829063.12763.89
383562-8356248.71249.22
495586-9558655.72256.34
5109217-10921763.66864.41
6112919-11291965.82666.52
30min1122675-12267571.51366.969.3372.5367.969.36
2117712-11771268.62069.74
397006-9700656.54957.32
4107009-10700962.38163.31
5120212-12021270.07771.17
6124626-12462672.65073.71
45min1129765-12976575.64671.418.7377.0672.788.75
2120898-12089870.47771.97
3105253-10525361.35762.45
4115951-11595167.59368.87
5129294-12929475.37276.86
6133864-13386478.03679.49
60min1133257-13325777.68273.577.9779.5175.348.02
2126188-12618873.56175.45
3110076-11007664.16965.60
4119277-11927769.53271.18
5131138-13113876.44778.35
6137310-13731080.04581.94
极限1143507-14350783.65782.631.5085.9284.801.68
2141925-14192582.73585.03
3137895-13789580.38682.17
4142206-14220682.89984.94
5141189-14118982.30684.63
6143734-14373483.78986.13
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%
111.051821021827631825521828231828551826190.18
211.121846911855751851330.34
单位质量响应值RSD%判断
16526.6116648.650.53数据可信
供试品溶液-2024011222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%
5min19584-95845.1835.8611.815.185.8611.81
212283-122836.6436.64
312059-120596.5216.52
410866-108665.8765.88
511112-111126.0096.01
69119-91194.9314.93
10min116566-165668.9598.984.358.999.014.38
217953-179539.7099.75
316531-165318.9408.98
416570-165708.9618.99
515902-159028.6008.63
616072-160728.6928.72
15min117514-175149.4719.756.899.559.846.80
218085-180859.7809.87
317219-172199.3129.40
417683-176839.5639.65
517213-172139.3099.39
620479-2047911.07511.15
20min117816-178169.6359.561.219.779.701.21
217912-179129.6879.83
317293-172939.3529.49
417649-176499.5449.68
517691-176919.5679.70
617748-177489.5989.74
30min117646-176469.5439.511.089.739.701.10
217899-178999.6809.88
317390-173909.4049.59
417610-176109.5239.71
517531-175319.4819.67
617399-173999.4099.60
45min117443-174439.4339.441.739.679.681.70
217489-174899.4589.71
317032-170329.2119.45
417970-179709.7189.96
517364-173649.3909.63
617410-174109.4159.66
60min120762-2076211.2289.707.9611.529.997.72
217521-175219.4759.78
316788-167889.0799.37
417388-173889.4039.70
517840-178409.6489.94
617303-173039.3579.65
极限117355-173559.3859.271.049.749.621.05
217097-170979.2469.60
316937-169379.1599.50
417307-173079.3599.71
516955-169559.1699.51
617221-172219.3139.66
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%
111.041562871566911567441569561570261567410.19
211.021578181584301581240.28
单位质量响应值RSD%判断
14197.5514348.820.75数据可信
供试品溶液-2024011222批-阿托伐他汀钙-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%
5min113585-135857.86217.4140.047.8617.4140.03
247257-4725727.34927.35
338877-3887722.49922.50
430301-3030117.53617.54
529373-2937316.99917.00
621126-2112612.22612.23
10min141335-4133523.92236.8621.4023.9736.9521.43
275131-7513143.48043.63
375501-7550143.69443.82
463559-6355936.78336.88
572164-7216441.76341.86
654417-5441731.49231.56
15min169243-6924340.07349.3612.3940.2549.6612.47
290919-9091952.61753.01
395896-9589655.49755.87
483689-8368948.43348.73
594740-9474054.82855.15
677248-7724844.70544.95
20min190733-9073352.50957.498.1652.9158.068.24
299796-9979657.75458.44
3108502-10850262.79363.47
496046-9604655.58456.15
5109323-10932363.26863.90
691637-9163753.03353.52
30min1112592-11259265.16065.846.4065.8566.736.42
2108766-10876662.94563.95
3122472-12247270.87771.90
4111805-11180564.70465.58
5122367-12236770.81771.80
6104578-10457860.52261.31
45min1125652-12565272.71871.125.4273.7772.385.38
2113522-11352265.69867.05
3128576-12857674.41075.83
4122280-12228070.76672.01
5130440-13044075.48976.86
6116869-11686967.63568.76
60min1132560-13256076.71674.525.8378.1776.185.76
2117916-11791668.24169.96
3132187-13218776.50078.33
4128815-12881574.54876.18
5138647-13864780.23882.03
6122475-12247570.87972.38
极限1137865-13786579.78679.462.4681.6781.532.38
2130785-13078575.68877.79
3138148-13814879.95082.21
4140733-14073381.44683.49
5137744-13774479.71681.96
6138492-13849280.14982.04
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%
111.051829181831851832591831741831841831440.08
211.121828551830991829770.10
单位质量响应值RSD%判断
16574.1216454.770.52数据可信
供试品溶液-2024011223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%
5min112136-121366.5927.055.406.597.055.42
213872-138727.5357.54
312353-123536.7106.71
413393-133937.2757.27
513472-134727.3187.32
612615-126156.8526.85
10min117472-174729.4919.373.049.539.413.02
217471-174719.4909.53
317711-177119.6209.66
416762-167629.1059.15
517624-176249.5739.61
616424-164248.9218.96
15min118959-1895910.2989.793.5410.399.883.54
218243-182439.90910.00
318190-181909.8819.97
417201-172019.3439.43
518177-181779.8739.97
617405-174059.4549.54
20min118421-1842110.0069.721.6410.159.861.63
217847-178479.6949.84
317972-179729.7629.91
417792-177929.6649.81
517739-177399.6369.78
617569-175699.5439.68
30min118041-180419.8009.611.3910.009.811.37
217325-173259.4119.61
317647-176479.5869.79
417812-178129.6759.87
517757-177579.6459.85
617542-175429.5299.72
45min117687-176879.6079.441.209.869.691.16
217339-173399.4189.67
317385-173859.4439.70
417348-173489.4239.67
517042-170429.2579.51
617448-174489.4789.72
60min117770-177709.6529.361.599.969.661.54
217082-170829.2799.59
317120-171209.2999.60
417184-171849.3349.64
517034-170349.2539.56
617154-171549.3189.62
极限117236-172369.3629.300.909.739.660.89
217056-170569.2659.62
316904-169049.1829.54
417344-173449.4219.78
517065-170659.2699.63
617164-171649.3239.67
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%
111.041555411556531557191556321555941556280.05
211.021551741553171552460.07
单位质量响应值RSD%判断
14096.7414087.660.05数据可信
供试品溶液-2024011223批-阿托伐他汀钙-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%
5min116975-169759.95021.1732.559.9521.1732.55
239987-3998723.43823.44
328712-2871216.82916.83
443269-4326925.36225.36
550322-5032229.49629.50
637426-3742621.93721.94
10min137814-3781422.16441.3224.5522.2241.4424.56
269551-6955140.76740.90
370988-7098841.60941.70
484537-8453749.55149.69
584956-8495649.79649.96
675152-7515244.05044.17
15min157418-5741833.65554.5219.5433.8354.8719.59
295240-9524055.82456.18
394092-9409255.15155.48
4106615-10661562.49162.91
5105380-10538061.76762.21
699391-9939158.25758.62
20min171494-7149441.90562.4516.5942.2763.1016.66
2111400-11140065.29665.96
3107478-10747862.99763.63
4119967-11996770.31771.08
5115624-11562467.77268.56
6113354-11335466.44167.13
30min188090-8809051.63370.3813.4252.2371.3813.52
2125270-12527073.42674.46
3120523-12052370.64371.62
4131400-13140077.01978.17
5129292-12929275.78376.94
6125903-12590373.79774.86
45min1104019-10401960.97075.809.8061.8577.199.95
2134964-13496479.10880.55
3129687-12968776.01577.39
4137680-13768080.70082.28
5134809-13480979.01780.60
6134768-13476878.99380.46
60min1115207-11520767.52778.376.9468.7580.187.15
2138401-13840181.12283.00
3134058-13405878.57780.37
4139851-13985181.97284.00
5138036-13803680.90882.93
6136684-13668480.11682.02
极限1131492-13149277.07381.813.2578.6784.053.54
2141336-14133682.84385.17
3138357-13835781.09783.33
4144725-14472584.82987.31
5142061-14206183.26885.74
6139438-13943881.73084.08
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%
111.051837381842211843981844681844331842520.17
211.121844061860611852340.64
单位质量响应值RSD%判断
16674.3916657.730.08数据可信
供试品溶液-2024011223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%
5min112489-124896.7226.814.686.726.814.70
213491-134917.2617.26
312988-129886.9916.99
412512-125126.7346.73
512727-127276.8506.85
611713-117136.3046.30
10min117317-173179.3219.151.909.369.191.90
217209-172099.2639.30
316649-166498.9619.00
416810-168109.0489.09
517338-173389.3329.37
616681-166818.9789.01
15min117839-178399.6029.482.189.699.562.17
218208-182089.8009.89
317302-173029.3139.40
417315-173159.3209.41
517716-177169.5359.63
617249-172499.2849.37
20min118184-181849.7879.521.859.939.661.87
218005-180059.6919.84
317545-175459.4439.58
417463-174639.3999.54
517505-175059.4229.56
617397-173979.3649.50
30min117636-176369.4929.420.829.699.610.82
217674-176749.5139.71
317514-175149.4279.62
417382-173829.3569.55
517441-174419.3879.58
617314-173149.3199.51
45min117414-174149.3739.340.979.629.580.99
217422-174229.3779.63
317488-174889.4139.66
417085-170859.1969.44
517481-174819.4099.66
617194-171949.2549.49
60min117191-171919.2539.190.449.559.490.41
217067-170679.1869.49
317024-170249.1639.46
417023-170239.1629.46
516997-169979.1489.45
617121-171219.2159.51
极限117177-171779.2459.201.229.609.551.21
217400-174009.3659.72
317141-171419.2269.57
416799-167999.0429.39
517136-171369.2239.57
616940-169409.1189.46
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%
111.041561331563461565091566101565581564310.13
211.021569431580931575180.52
单位质量响应值RSD%判断
14169.4714293.830.62数据可信
供试品溶液-2024011223批-阿托伐他汀钙-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%
5min124450-2445014.19118.6926.3014.1918.6926.30
245794-4579426.57926.58
327340-2734015.86815.87
433593-3359319.49819.50
537520-3752021.77721.78
624475-2447514.20514.21
10min167539-6753939.20040.4512.6239.2840.5612.64
282041-8204147.61747.76
368278-6827839.62939.72
470151-7015140.71640.82
574712-7471243.36343.48
655481-5548132.20232.28
15min192501-9250153.68853.5710.3053.9853.9010.33
2105882-10588261.45561.87
391941-9194153.36353.67
489897-8989752.17752.51
596790-9679056.17856.54
676770-7677044.55844.82
20min1109519-10951963.56661.468.4064.1662.088.43
2117499-11749968.19768.95
3106336-10633661.71862.32
4102092-10209259.25559.88
5108926-10892663.22163.90
690957-9095752.79253.30
30min1122439-12243971.06569.515.1772.0170.485.24
2129064-12906474.91076.04
3119905-11990569.59470.54
4115748-11574867.18168.13
5120640-12064070.02071.05
6110762-11076264.28765.09
45min1130404-13040475.68775.163.3077.0376.513.39
2135631-13563178.72180.27
3129282-12928275.03676.37
4124798-12479872.43473.76
5132154-13215476.70378.12
6124661-12466172.35473.51
60min1135002-13500278.35677.051.2480.1278.821.27
2132406-13240676.84978.84
3130938-13093875.99777.75
4131565-13156576.36178.09
5134525-13452578.07979.92
6132054-13205476.64578.20
极限1138254-13825480.24480.092.2082.4482.292.30
2141399-14139982.06984.48
3135973-13597378.92081.09
4136133-13613379.01381.17
5141771-14177182.28584.56
6134443-13444378.03280.02
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