依折麦布阿托伐他汀片项目信息
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%
110.221680031675741678541675061676021677080.13
210.161684031692781688400.37
单位质量响应值RSD%判断
16409.7816618.110.90数据可信
供试品溶液-X007293批-依折麦布-水
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min116998-169989.2348.0214.479.238.0214.45
215467-154678.4028.40
311170-111706.0686.07
415513-155138.4278.43
513341-133417.2477.25
616122-161228.7588.76
10min124616-2461613.37212.846.3513.4212.896.37
224519-2451913.31913.37
321182-2118211.50611.54
425050-2505013.60813.65
522477-2247712.21012.25
624008-2400813.04213.09
15min126134-2613414.19613.663.9014.3213.773.90
225929-2592914.08514.21
325537-2553713.87213.97
425162-2516213.66813.79
523490-2349012.76012.87
624579-2457913.35213.47
20min124809-2480913.47713.064.5813.6813.254.58
225222-2522213.70113.90
324260-2426013.17813.35
423994-2399413.03413.23
522046-2204611.97612.15
623890-2389012.97713.17
30min122585-2258512.26912.230.7412.5512.500.83
222574-2257412.26312.54
322564-2256412.25712.51
422706-2270612.33412.61
522216-2221612.06812.31
622474-2247412.20812.48
45min123431-2343112.72812.603.5313.0812.943.46
223980-2398013.02613.37
323740-2374012.89613.21
423541-2354112.78813.13
522737-2273712.35112.66
621764-2176411.82312.16
60min121992-2199211.94611.893.2212.3612.293.21
222879-2287912.42812.84
321536-2153611.69912.09
422350-2235012.14112.55
520823-2082311.31111.69
621776-2177611.82912.23
极限121224-2122411.52911.222.3112.0111.692.23
220315-2031511.03511.52
321271-2127111.55512.01
420559-2055911.16811.65
520338-2033811.04811.49
620206-2020610.97611.44
依折麦布阿托伐他汀片项目信息
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%
111.141551831550081550941550031550471550670.05
211.071560891567811564350.32
单位质量响应值RSD%判断
13919.8414131.441.07数据可信
供试品溶液-X007293批-阿托伐他汀-水
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min171609-7160942.17442.4816.5842.1742.4816.58
272707-7270742.82142.82
354881-5488132.32232.32
491174-9117453.69753.70
576302-7630244.93844.94
666107-6610738.93438.93
10min1148866-14886687.67580.2714.4187.9180.5114.40
2135152-13515279.59879.84
3108939-10893964.16064.34
4157941-15794193.02093.32
5117077-11707768.95369.20
6149817-14981788.23588.45
15min1159727-15972794.07292.032.0494.7992.722.11
2155473-15547391.56792.25
3152129-15212989.59790.13
4158453-15845393.32294.14
5153107-15310790.17390.81
6158690-15869093.46194.17
20min1161488-16148895.10995.601.3196.3596.791.37
2165111-16511197.24398.43
3159674-15967494.04195.07
4164558-16455896.91798.25
5160969-16096994.80495.94
6162100-16210095.47096.70
30min1161115-16111594.89095.051.3796.6696.781.39
2159737-15973794.07895.81
3158735-15873593.48895.04
4163362-16336296.21398.08
5164570-16457096.92498.58
6160847-16084794.73296.49
45min1159762-15976294.09394.621.2296.3996.871.22
2161488-16148895.10997.36
3159700-15970094.05696.13
4162777-16277795.86898.27
5162484-16248495.69697.89
6157703-15770392.88095.16
60min1158435-15843593.31193.221.4596.1396.001.52
2159741-15974194.08096.86
3155001-15500191.28993.89
4161569-16156995.15798.10
5156759-15675992.32495.05
6158203-15820393.17495.97
极限1159470-15947093.92192.091.9897.2695.391.90
2150875-15087588.85992.16
3157934-15793493.01696.12
4157461-15746192.73796.21
5157628-15762892.83696.08
6154803-15480391.17294.49
依折麦布阿托伐他汀片项目信息
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%
110.221672651678421683961690361693291683740.51
210.161684051687741685900.16
单位质量响应值RSD%判断
16474.9516593.500.51数据可信
供试品溶液-X007293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%
5min112208-122086.6235.8314.286.625.8214.29
29241-92415.0145.01
311985-119856.5026.50
411426-114266.1996.20
511118-111186.0326.03
68461-84614.5904.59
10min116662-166629.0408.801.879.088.841.90
216289-162898.8378.87
316146-161468.7608.80
416452-164528.9268.96
515872-158728.6118.64
615945-159458.6518.68
15min116895-168959.1669.242.649.259.322.61
217650-176509.5769.65
317530-175309.5119.60
416880-168809.1589.24
516615-166159.0149.10
616631-166319.0239.10
20min116937-169379.1899.130.649.339.260.68
216906-169069.1729.30
316867-168679.1519.29
416793-167939.1119.25
516801-168019.1159.25
616641-166419.0289.15
30min116820-168209.1259.031.389.319.221.38
216863-168639.1499.33
316539-165398.9739.16
416860-168609.1479.33
516495-164958.9499.13
616323-163238.8569.03
45min116655-166559.0368.931.019.289.161.00
216636-166369.0269.26
316487-164878.9459.18
416237-162378.8099.05
516376-163768.8859.12
616354-163548.8739.10
60min116152-161528.7638.682.349.058.962.24
216046-160468.7068.99
315802-158028.5738.86
416012-160128.6878.97
515403-154038.3578.64
616525-165258.9659.24
极限116370-163708.8818.722.049.229.052.01
216298-162988.8429.17
315833-158338.5908.93
416428-164288.9139.25
515694-156948.5158.84
615807-158078.5768.90
依折麦布阿托伐他汀片项目信息
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%
111.141550081555281559121563981566731559040.43
211.071541061543141542100.10
单位质量响应值RSD%判断
13994.9713930.440.33数据可信
供试品溶液-X007293批-阿托伐他汀-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%
5min147803-4780328.27934.0237.4128.2834.0237.41
236272-3627221.45821.46
342533-4253325.16225.16
449924-4992429.53429.53
578918-7891846.68646.69
689575-8957552.99152.99
10min1122735-12273572.60773.4613.1372.7673.6513.18
296362-9636257.00657.12
3118381-11838170.03270.17
4127572-12757275.46975.63
5141858-14185883.92084.18
6138146-13814681.72482.02
15min1148725-14872587.98386.573.9588.5487.174.00
2136558-13655880.78581.22
3151408-15140889.57090.10
4143062-14306284.63285.22
5151730-15173089.76090.49
6146573-14657386.71087.46
20min1154164-15416491.20089.613.1592.2590.683.20
2143892-14389285.12386.01
3154301-15430191.28192.31
4150259-15025988.89089.94
5157239-15723993.01994.24
6148966-14896688.12589.36
30min1155995-15599592.28391.321.8993.8492.891.88
2151827-15182789.81891.18
3156715-15671592.70994.24
4154207-15420791.22692.77
5157374-15737493.09994.84
6150056-15005688.77090.49
45min1156178-15617892.39291.171.8794.4693.261.89
2152308-15230890.10291.96
3155463-15546391.96994.02
4151592-15159289.67991.73
5158134-15813493.54995.81
6151030-15103089.34691.56
60min1153229-15322990.64789.041.4093.2391.631.43
2147532-14753287.27789.63
3151476-15147689.61092.17
4149708-14970888.56491.12
5149087-14908788.19790.97
6152018-15201889.93192.64
极限1155093-15509391.75089.482.1294.8492.562.03
2150158-15015888.83091.67
3152382-15238290.14693.20
4152232-15223290.05793.10
5152089-15208989.97393.24
6145559-14555986.11089.32
依折麦布阿托伐他汀片项目信息
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%
110.221676731680241682881685561687401682560.26
210.161676491683131679810.28
单位质量响应值RSD%判断
16463.4116533.560.31数据可信
供试品溶液-X007293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%
5min110322-103225.6126.478.495.616.478.51
211870-118706.4546.45
312925-129257.0277.03
411569-115696.2906.29
511640-116406.3296.33
613075-130757.1097.11
10min115961-159618.6789.042.228.719.072.22
216963-169639.2239.26
316663-166639.0609.10
416519-165198.9819.02
516950-169509.2169.25
616659-166599.0589.10
15min117103-171039.2999.191.499.389.281.45
216847-168479.1609.25
316651-166519.0539.14
416945-169459.2139.30
517264-172649.3879.47
616630-166309.0429.13
20min117012-170129.2509.131.179.389.271.12
216853-168539.1639.30
316662-166629.0599.20
416479-164798.9609.10
516940-169409.2109.35
616823-168239.1479.29
30min117032-170329.2609.051.999.449.231.95
216395-163958.9149.10
316749-167499.1079.30
416312-163128.8699.05
516355-163558.8929.08
617001-170019.2449.43
45min116780-167809.1239.034.689.369.274.54
218052-180529.81510.05
316503-165038.9739.21
415966-159668.6818.92
515970-159708.6838.92
616356-163568.8939.14
60min116639-166399.0478.841.279.339.131.21
216315-163158.8719.16
316109-161098.7599.05
416142-161428.7779.06
516241-162418.8309.12
616093-160938.7509.04
极限116453-164538.9468.791.369.289.131.30
216099-160998.7539.10
316389-163898.9119.25
415939-159398.6669.00
515944-159448.6699.01
616218-162188.8189.16
依折麦布阿托伐他汀片项目信息
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%
111.141550581553701555731557111558681555160.21
211.071552151556661554400.21
单位质量响应值RSD%判断
13960.1414041.550.42数据可信
供试品溶液-X007293批-阿托伐他汀-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%
5min140346-4034623.80326.7226.1523.8026.7226.15
236754-3675421.68421.68
356539-5653933.35633.36
437218-3721821.95721.96
537074-3707421.87321.87
663858-6385837.67437.67
10min180780-8078047.65853.136.1847.7953.286.20
293353-9335355.07555.20
394777-9477755.91656.10
489537-8953752.82452.95
586843-8684351.23551.36
695018-9501856.05856.27
15min1110390-11039065.12766.651.6965.5267.091.65
2113981-11398167.24567.67
3112286-11228666.24566.74
4114469-11446967.53367.95
5115268-11526868.00568.41
6111438-11143865.74566.27
20min1126786-12678674.80073.281.3275.5674.091.24
2125235-12523573.88574.68
3123120-12312072.63773.50
4124162-12416273.25274.04
5123790-12379073.03273.82
6122164-12216472.07372.96
30min1137853-13785381.32977.882.6982.5079.102.62
2129808-12980876.58377.79
3127220-12722075.05676.32
4131994-13199477.87279.07
5132999-13299978.46579.66
6132149-13214977.96479.25
45min1141373-14137383.40679.182.7785.0380.832.69
2133083-13308378.51580.15
3132613-13261378.23879.92
4133668-13366878.86080.49
5133952-13395279.02880.65
6130524-13052477.00578.72
60min1139149-13914982.09479.042.6584.1881.132.56
2133008-13300878.47180.54
3131237-13123777.42679.54
4135329-13532979.84081.91
5135834-13583480.13882.20
6129231-12923176.24278.39
极限1138855-13885581.92078.572.2384.4781.102.17
2131602-13160277.64180.15
3132405-13240578.11580.66
4133089-13308978.51881.03
5132828-13282878.36480.87
6130249-13024976.84379.41
依折麦布阿托伐他汀片项目信息
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%
110.221685311685411685761685431686391685660.03
210.161699531711561705540.50
单位质量响应值RSD%判断
16493.7416786.811.25数据可信
供试品溶液-X007293批-依折麦布-pH6.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min16920-69203.7314.9619.713.734.9619.68
212121-121216.5356.53
38829-88294.7604.76
49163-91634.9404.94
57973-79734.2984.30
610245-102455.5235.52
10min114413-144137.7708.172.847.798.202.91
215730-157308.4808.52
315210-152108.2008.23
415024-150248.1008.13
515287-152878.2418.27
615225-152258.2088.24
15min115782-157828.5088.431.398.578.501.33
215265-152658.2308.31
315797-157978.5168.59
415560-155608.3898.46
515576-155768.3978.47
615837-158378.5388.61
20min115467-154678.3388.442.808.458.562.78
215513-155138.3638.49
316341-163418.8108.93
415035-150358.1068.22
515872-158728.5578.67
615701-157018.4658.59
30min115026-150268.1018.222.668.268.392.67
215420-154208.3138.49
315669-156698.4478.62
414935-149358.0528.22
514718-147187.9358.10
615682-156828.4548.63
45min115175-151758.1818.123.268.388.333.15
214631-146317.8888.11
315729-157298.4808.69
415036-150368.1068.31
514392-143927.7597.97
615388-153888.2968.51
60min115025-150258.1008.182.178.358.442.04
214730-147307.9418.21
315543-155438.3798.64
415545-155458.3818.63
515254-152548.2248.47
614979-149798.0758.34
极限115155-151558.1707.854.798.468.164.61
214464-144647.7988.11
314688-146887.9188.23
414259-142597.6877.99
513430-134307.2407.54
615387-153878.2958.60
依折麦布阿托伐他汀片项目信息
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%
111.141553551554561554261554641554211554240.03
211.071574611583681579140.41
单位质量响应值RSD%判断
13951.8914265.041.57数据可信
供试品溶液-X007293批-阿托伐他汀-pH6.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min185302-8530249.94773.5021.3749.9573.5021.37
2145773-14577385.35585.36
3139410-13941081.63081.63
4103983-10398360.88660.89
5123042-12304272.04672.05
6155620-15562091.12191.12
10min1145221-14522185.03292.294.6485.3192.704.71
2159355-15935593.30893.78
3162727-16272795.28395.74
4152421-15242189.24889.59
5162936-16293695.40595.81
6163002-16300295.44495.95
15min1156878-15687891.85892.822.6592.6193.742.68
2154673-15467390.56791.56
3158489-15848992.80193.78
4154834-15483490.66191.50
5160467-16046793.95994.89
6165805-16580597.08598.12
20min1156856-15685691.84593.962.6293.1195.402.68
2157252-15725292.07793.57
3164385-16438596.25397.75
4157163-15716392.02593.36
5160490-16049093.97395.43
6166680-16668097.59799.17
30min1153891-15389190.10992.402.8191.8894.362.87
2158835-15883593.00495.01
3159412-15941293.34295.37
4154997-15499790.75692.61
5154224-15422490.30492.28
6165433-16543396.86798.99
45min1156735-15673591.77492.862.2394.0595.332.27
2154976-15497690.74493.27
3160026-16002693.70196.25
4156563-15656391.67394.03
5158352-15835292.72195.20
6164868-16486896.53699.19
60min1154274-15427490.33391.991.9493.1194.981.93
2152663-15266389.39092.42
3159147-15914793.18696.26
4160138-16013893.76796.63
5157010-15701091.93594.93
6159350-15935093.30596.50
极限1155806-15580691.23090.823.7094.5194.323.64
2149395-14939587.47691.00
3156233-15623391.48095.07
4154270-15427090.33193.71
5149776-14977687.69991.20
6165128-16512896.688100.40
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