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%
110.221686651691931690331690761691351690200.13
210.161697461708341702900.46
单位质量响应值RSD%判断
16538.1616760.830.95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%
5min116033-160338.6396.8825.718.646.8825.70
212695-126956.8406.84
310875-108755.8595.86
411758-117586.3356.34
517024-170249.1729.17
68243-82434.4414.44
10min125971-2597113.99312.888.6014.0412.928.63
223557-2355712.69212.73
323391-2339112.60312.64
425467-2546713.72213.76
524812-2481213.36913.42
620271-2027110.92210.95
15min126490-2649014.27313.602.6114.4013.712.63
225086-2508613.51613.62
324665-2466513.28913.39
424861-2486113.39513.51
524953-2495313.44513.57
625392-2539213.68113.77
20min123989-2398912.92513.143.3013.1313.323.22
223830-2383012.84013.02
325908-2590813.95914.14
424283-2428313.08413.27
523745-2374512.79412.99
624554-2455413.23013.39
30min122766-2276612.26612.241.3412.5412.501.29
222315-2231512.02312.28
323053-2305312.42112.67
422359-2235912.04712.31
522880-2288012.32812.60
622888-2288812.33212.57
45min123555-2355512.69112.621.8413.0412.951.86
223554-2355412.69113.01
323900-2390012.87713.20
423322-2332212.56612.89
523578-2357812.70413.04
622631-2263112.19412.50
60min121595-2159511.63512.001.9012.0512.401.80
222383-2238312.06012.45
322798-2279812.28312.68
421980-2198011.84312.24
522492-2249212.11912.53
622388-2238812.06312.43
极限120269-2026910.92111.172.5411.4011.642.43
220723-2072311.16511.62
321021-2102111.32611.79
420004-2000410.77811.24
521427-2142711.54512.02
620989-2098911.30911.75
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%
111.141565391566141567811567941568141567080.08
211.071576561585251580900.39
单位质量响应值RSD%判断
14067.1514280.941.07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%
5min1150732-15073287.84559.5637.0387.8459.5637.03
257317-5731733.40433.40
373679-7367942.93942.94
4144582-14458284.26184.26
597157-9715756.62256.62
689730-8973052.29452.29
10min1165812-16581296.63386.6910.4097.1287.0210.49
2134588-13458878.43678.62
3129691-12969175.58275.82
4165729-16572996.58597.05
5153431-15343189.41889.73
6143297-14329783.51283.80
15min1166478-16647897.02191.814.3998.0592.624.49
2152802-15280289.05189.67
3146707-14670785.49986.16
4158059-15805992.11593.12
5160954-16095493.80294.61
6160221-16022193.37594.13
20min1163156-16315695.08595.703.0496.6597.033.00
2157752-15775291.93693.05
3172794-172794100.702101.84
4166014-16601496.75198.27
5163152-16315295.08396.42
6162427-16242794.66195.93
30min1163087-16308795.04594.751.7497.1496.611.83
2157498-15749891.78893.41
3163304-16330495.17296.86
4164080-16408095.62497.68
5165800-16580096.62698.49
6161737-16173794.25896.06
45min1166421-16642196.98894.762.5199.6197.142.56
2161598-16159894.17796.31
3163166-16316695.09197.31
4164760-16476096.02098.61
5164681-16468195.97498.37
6154968-15496890.31492.64
60min1158062-15806292.11793.100.8995.2896.010.90
2158585-15858592.42295.08
3160893-16089393.76796.52
4161152-16115293.91897.04
5161014-16101493.83796.77
6158757-15875792.52295.35
极限1158136-15813692.16092.541.3795.8395.971.39
2155881-15588190.84694.02
3158590-15859092.42495.70
4158395-15839592.31195.95
5162585-16258594.75398.20
6159180-15918092.76896.11
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%
110.221717371715511716231711861711531714500.16
210.161694791695301695040.03
单位质量响应值RSD%判断
16775.9316683.460.40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%
5min111696-116966.2715.6412.706.275.6412.73
28679-86794.6544.65
310360-103605.5555.55
410800-108005.7915.79
59385-93855.0325.03
612179-121796.5306.53
10min116634-166348.9198.762.878.958.792.89
216140-161408.6548.68
316170-161708.6708.70
416401-164018.7948.83
515633-156338.3828.41
617002-170029.1169.15
15min117695-176959.4889.063.039.579.143.02
216285-162858.7328.81
316852-168529.0369.11
417264-172649.2579.34
516565-165658.8828.96
616686-166868.9479.03
20min117216-172169.2319.121.539.379.251.52
217142-171429.1919.31
316842-168429.0319.16
417355-173559.3069.44
516716-167168.9639.09
616802-168029.0099.15
30min117147-171479.1948.941.699.389.121.71
216705-167058.9579.13
316654-166548.9309.11
416650-166508.9289.11
516263-162638.7208.89
616670-166708.9389.13
45min116382-163828.7848.653.229.028.883.14
215739-157398.4398.66
316157-161578.6638.89
416796-167969.0069.24
516355-163558.7698.99
615334-153348.2228.46
60min116573-165738.8868.641.669.178.921.62
216070-160708.6178.89
316090-160908.6278.90
416064-160648.6138.90
516156-161568.6638.93
615742-157428.4418.72
极限116620-166208.9128.662.099.258.992.05
215832-158328.4898.81
316108-161088.6378.96
416410-164108.7999.13
516208-162088.6919.01
615736-157368.4388.77
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%
111.141590401589651589681586781584441588190.16
211.071568551569831569190.06
单位质量响应值RSD%判断
14256.6414175.160.41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%
5min177032-7703244.75942.9414.5344.7642.9414.54
255748-5574832.39232.39
367531-6753139.23939.24
480037-8003746.50546.51
576899-7689944.68244.68
686135-8613550.04850.05
10min1131765-13176576.56177.325.8276.8177.565.83
2126651-12665173.59073.77
3126686-12668673.61073.83
4142263-14226382.66182.92
5127856-12785674.29074.54
6143249-14324983.23483.51
15min1152017-15201788.32986.542.6789.0087.212.70
2143644-14364483.46484.05
3147638-14763885.78486.41
4154055-15405589.51390.23
5145693-14569384.65485.32
6150586-15058687.49788.24
20min1157423-15742391.47090.221.4692.6391.361.48
2154933-15493390.02391.08
3151132-15113287.81488.92
4156335-15633590.83892.05
5154964-15496490.04191.17
6156795-15679591.10592.33
30min1158533-15853392.11590.131.1893.7991.781.15
2155779-15577990.51592.07
3154280-15428089.64491.23
4153775-15377589.35091.07
5154166-15416689.57791.21
6154136-15413689.56091.29
45min1155097-15509790.11888.331.8292.3090.481.78
2150004-15000487.15989.21
3151528-15152888.04490.13
4154477-15447789.75891.97
5153130-15313088.97591.10
6147918-14791885.94788.18
60min1159710-15971092.79989.332.2595.4891.972.17
2154007-15400789.48592.02
3154795-15479589.94392.52
4151727-15172788.16090.87
5152661-15266188.70391.33
6149571-14957186.90789.62
极限1157404-15740491.45989.081.5094.6692.221.50
2150869-15086987.66290.70
3153108-15310888.96392.04
4153760-15376089.34192.55
5153302-15330289.07592.19
6151446-15144687.99791.19
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%
110.221699361704911708771717961722071710610.55
210.161715171719291717230.17
单位质量响应值RSD%判断
16737.8716901.870.69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%
5min110492-104925.5965.7312.165.605.7312.18
212396-123966.6116.61
311111-111115.9265.93
48444-84444.5034.50
511298-112986.0266.03
610710-107105.7125.71
10min116015-160158.5418.832.668.578.862.67
216788-167888.9548.99
316518-165188.8108.84
416267-162678.6768.70
517283-172839.2189.25
616504-165048.8028.83
15min117062-170629.1009.011.179.189.101.18
217060-170609.0999.19
317091-170919.1159.20
416770-167708.9449.02
516617-166178.8628.95
616805-168058.9639.04
20min117669-176699.4239.022.579.559.152.54
217006-170069.0709.21
316930-169309.0299.16
416357-163578.7248.85
516839-168398.9819.11
616691-166918.9029.03
30min115923-159238.4928.681.568.678.861.55
216099-160998.5868.77
316423-164238.7598.94
416143-161438.6108.78
516511-165118.8068.99
616536-165368.8199.00
45min116634-166348.8718.661.749.108.891.67
216109-161098.5918.83
316286-162868.6868.92
416458-164588.7789.00
515900-159008.4808.71
616000-160008.5338.76
60min116088-160888.5808.631.658.868.901.57
215674-156748.3598.64
316377-163778.7349.01
416359-163598.7258.99
516286-162868.6868.97
616271-162718.6788.95
极限116083-160838.5788.511.288.908.841.21
215603-156038.3228.65
315870-158708.4648.79
416145-161458.6118.93
516107-161078.5908.92
615932-159328.4978.82
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%
111.141580761583781589231593951596851588910.43
211.071588401592081590240.17
单位质量响应值RSD%判断
14263.1114365.310.51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%
5min128640-2864016.52720.3927.8016.5320.3927.80
246995-4699527.11927.12
343075-4307524.85724.86
425799-2579914.88714.89
542277-4227724.39624.40
625217-2521714.55214.55
10min178216-7821645.13551.329.5845.2351.439.61
298109-9810956.61456.77
394120-9412054.31354.45
478663-7866345.39345.48
594391-9439154.46954.60
690055-9005551.96752.05
15min1108748-10874862.75464.944.6463.1065.344.68
2119570-11957068.99969.46
3113585-11358565.54565.98
4104678-10467860.40560.74
5113122-11312265.27865.72
6115566-11556666.68867.06
20min1123085-12308571.02772.342.4771.7273.092.53
2127459-12745973.55174.40
3126505-12650573.00173.80
4120095-12009569.30269.97
5127794-12779473.74474.55
6127171-12717173.38574.12
30min1129418-12941874.68176.171.8275.7777.331.80
2129876-12987674.94676.20
3131306-13130675.77176.98
4131628-13162875.95777.01
5134507-13450777.61878.83
6135234-13523478.03879.19
45min1140246-14024680.93078.472.1082.4380.051.96
2132327-13232776.36078.03
3134259-13425977.47579.11
4138253-13825379.78081.26
5135173-13517378.00279.64
6135616-13561678.25879.84
60min1136240-13624078.61878.282.6180.5780.302.49
2128878-12887874.37076.47
3135230-13523078.03580.10
4138539-13853979.94581.87
5136914-13691479.00781.08
6138133-13813379.71181.73
极限1136072-13607278.52176.972.6780.9179.422.54
2127170-12717073.38475.90
3131160-13116075.68778.18
4135628-13562878.26580.63
5135926-13592678.43780.95
6134324-13432477.51379.97
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%
110.221695831704581712401715941718901709530.55
210.161690231691071690650.04
单位质量响应值RSD%判断
16727.3016640.260.37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%
5min19700-97005.2154.6910.285.224.6910.29
29749-97495.2425.24
39066-90664.8754.87
48050-80504.3284.33
57812-78124.2004.20
67945-79454.2724.27
10min114858-148587.9898.172.108.028.202.12
215768-157688.4788.51
315061-150618.0988.12
415027-150278.0808.10
515144-151448.1428.17
615328-153288.2418.27
15min116104-161048.6598.642.158.738.712.10
215621-156218.3998.48
316218-162188.7208.79
416188-161888.7048.77
515698-156988.4408.51
616533-165338.8898.96
20min116010-160108.6088.581.248.738.701.25
215989-159898.5978.72
316259-162598.7428.86
415951-159518.5768.69
515881-158818.5398.65
615652-156528.4168.53
30min115132-151328.1368.381.888.318.551.83
215826-158268.5098.68
315929-159298.5658.73
415691-156918.4378.60
515398-153988.2798.44
615572-155728.3738.54
45min115547-155478.3598.462.368.578.672.30
215965-159658.5848.80
315628-156288.4038.62
415176-151768.1608.37
515782-157828.4868.69
616258-162588.7418.95
60min115425-154258.2948.232.458.558.492.37
215294-152948.2238.49
315428-154288.2958.56
415261-152618.2058.46
514636-146367.8698.13
615772-157728.4808.74
极限115045-150458.0898.242.258.408.552.19
215390-153908.2758.59
315994-159948.5998.91
415146-151468.1448.45
515160-151608.1518.45
615273-152738.2128.52
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%
111.141575661579521586731592121591731585150.47
211.071560681561511561100.04
单位质量响应值RSD%判断
14229.3514102.080.64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%
5min168401-6840139.88557.3835.0839.8957.3835.07
2135031-13503178.73878.74
379140-7914046.14746.15
463353-6335336.94236.94
5144335-14433584.16384.16
6100116-10011658.37958.38
10min1141876-14187682.72987.836.4082.9588.156.49
2159961-15996193.27593.71
3140632-14063282.00482.26
4143086-14308683.43583.64
5158398-15839892.36392.83
6159779-15977993.16993.49
15min1157024-15702491.56292.042.4592.2492.852.50
2158480-15848092.41193.37
3155504-15550490.67691.39
4153400-15340089.44990.12
5157914-15791492.08193.06
6164765-16476596.07696.92
20min1160312-16031293.48092.761.5794.6794.081.61
2161353-16135394.08795.56
3160110-16011093.36294.58
4154532-15453290.10991.27
5157990-15799092.12693.62
6160180-16018093.40394.78
30min1153995-15399589.79691.491.8191.5193.331.86
2160093-16009393.35295.34
3159526-15952693.02194.76
4153438-15343889.47191.14
5156085-15608591.01593.02
6158302-15830292.30794.20
45min1158213-15821392.25693.152.5994.4695.502.64
2162812-16281294.93797.45
3159859-15985993.21595.47
4153154-15315489.30691.47
5159287-15928792.88295.39
6165199-16519996.32998.74
60min1158997-15899792.71392.102.1995.4394.962.15
2158066-15806692.17095.21
3159196-15919692.82995.60
4154206-15420689.91992.58
5154016-15401689.80892.83
6163176-16317695.15098.09
极限1159013-15901392.72291.532.3995.9694.902.29
2158203-15820392.25095.80
3161997-16199794.46297.75
4153203-15320389.33492.49
5151999-15199988.63292.16
6157402-15740291.78395.25
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