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%
19.871617641618501620231620201619671619250.08
29.821616741630461623600.60
单位质量响应值RSD%判断
16405.7816533.600.55数据可信
供试品溶液-2023121221批-依折麦布-pH4.5(内含0.2%Tween)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min143753-4375323.83123.4718.0123.8323.4718.01
247914-4791426.09726.10
343898-4389823.91023.91
433425-3342518.20518.21
554177-5417729.50829.51
635324-3532419.24019.24
10min1130250-13025070.94270.847.3171.0770.977.33
2138694-13869475.54275.69
3129697-12969770.64170.77
4116896-11689663.66963.77
5142238-14223877.47277.64
6122634-12263466.79466.90
15min1175173-17517395.41092.833.3295.9493.363.35
2175398-17539895.53396.10
3165993-16599390.41090.94
4162436-16243688.47388.93
5175359-17535995.51296.11
6168279-16827991.65592.13
20min1183172-18317299.76797.671.39100.8298.721.37
2180850-18085098.50299.60
3178289-17828997.10798.14
4179733-17973397.89498.84
5176164-17616495.95097.08
6177759-17775996.81997.81
30min1189688-189688103.316102.430.86104.93104.010.89
2187394-187394102.067103.71
3186434-186434101.544103.11
4186771-186771101.727103.22
5190360-190360103.682105.34
6187678-187678102.221103.75
45min1182459-18245999.379100.841.22101.56103.001.16
2184859-184859100.686102.90
3184001-184001100.219102.35
4189203-189203103.052105.11
5184742-184742100.622102.86
6185637-185637101.110103.20
60min1188063-188063102.431101.480.92105.17104.200.90
2185335-185335100.945103.71
3186000-186000101.307104.00
4188412-188412102.621105.25
5186297-186297101.469104.26
6183831-183831100.126102.78
极限1180191-18019198.14399.751.55101.45103.021.45
2180608-18060898.371101.70
3186177-186177101.404104.65
4186866-186866101.779104.98
5181764-18176499.000102.36
6183186-18318699.775102.99
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%
110.852976542976392979862980222979282978460.07
210.842979003003792991400.59
单位质量响应值RSD%判断
27451.2427595.940.38数据可信
供试品溶液-2023121221批-阿托伐他汀-pH4.5(内含0.2%Tween)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1156893-15689347.08556.7722.4847.0856.7722.48
2221905-22190566.59666.60
3177553-17755353.28553.29
4189644-18964456.91456.91
5252501-25250175.77875.78
6136494-13649440.96340.96
10min1302144-30214490.67691.965.1190.9492.285.16
2309835-30983592.98493.35
3313342-31334294.03794.33
4309496-30949692.88293.20
5325305-32530597.62798.05
6278470-27847083.57183.80
15min1329716-32971698.95199.431.3799.72100.261.43
2331461-33146199.474100.36
3334952-334952100.522101.34
4333122-33312299.973100.80
5335481-335481100.681101.64
6323218-32321897.00097.69
20min1331629-33162999.52599.291.38100.84100.671.32
2326919-32691998.11199.55
3336923-336923101.113102.49
4334652-334652100.432101.82
5324954-32495497.52199.04
6330008-33000899.038100.27
30min1339185-339185101.792100.601.19103.66102.531.16
2329591-32959198.913100.90
3339763-339763101.966103.90
4336138-336138100.878102.82
5334275-334275100.319102.38
6332264-33226499.715101.50
45min1324524-32452497.39299.061.6699.83101.551.60
2323679-32367997.13999.67
3331588-33158899.512102.02
4337074-337074101.159103.66
5328566-32856698.605101.23
6335017-335017100.541102.88
60min1337152-337152101.18299.711.26104.16102.741.19
2325164-32516497.584100.66
3334466-334466100.376103.43
4334197-334197100.295103.36
5330384-33038499.151102.32
6332046-33204699.650102.54
极限1323194-32319496.99398.132.37100.53101.722.25
2316059-31605994.85298.47
3335152-335152100.582104.20
4331223-33122399.403103.03
5321918-32191896.610100.33
6334322-334322100.333103.78
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%
19.871634411635801639261642531645101639420.28
29.821634871645681640280.47
单位质量响应值RSD%判断
16610.1316703.460.40数据可信
供试品溶液-2023121421批-依折麦布-pH4.5(内含0.2%Tween)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min149961-4996126.90626.3718.0526.9126.3718.05
253461-5346128.79128.79
355354-5535429.81029.81
455894-5589430.10130.10
546782-4678225.19425.19
632363-3236317.42917.43
10min1134106-13410672.22275.2111.4772.3775.3511.48
2152560-15256082.16082.32
3153372-15337282.59782.76
4146828-14682879.07379.24
5140423-14042375.62475.76
6110614-11061459.57059.67
15min1172598-17259892.95191.553.2893.5092.113.33
2172608-17260892.95793.57
3175635-17563594.58795.21
4170517-17051791.83092.44
5168984-16898491.00591.56
6159584-15958485.94386.37
20min1177749-17774995.72595.071.5496.7996.141.59
2174459-17445993.95395.09
3178502-17850296.13197.28
4178148-17814895.94097.06
5178383-17838396.06797.13
6171927-17192792.59093.49
30min1178427-17842796.09096.081.2097.6997.681.26
2177126-17712695.39097.04
3180433-18043397.17198.85
4180778-18077897.35699.01
5178607-17860796.18797.79
6175064-17506494.27995.70
45min1179722-17972296.78895.721.0898.9297.861.05
2176158-17615894.86897.05
3179823-17982396.84299.07
4175023-17502394.25796.45
5177793-17779395.74997.88
6177966-17796695.84297.79
60min1179350-17935096.58795.171.7399.2697.841.64
2174791-17479194.13296.84
3172042-17204292.65295.41
4179748-17974896.80299.52
5175712-17571294.62897.29
6178675-17867596.22498.70
极限1178868-17886896.32894.801.8899.5397.991.76
2173482-17348293.42796.66
3171426-17142692.32095.60
4178120-17812095.92599.18
5174663-17466394.06397.25
6179604-17960496.72499.73
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%
110.853012073010763012973018463021353015120.16
210.843011463028293019880.40
单位质量响应值RSD%判断
27789.1227858.670.18数据可信
供试品溶液-2023121421批-阿托伐他汀-pH4.5(内含0.2%Tween)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1178492-17849252.98851.4227.9752.9951.4227.97
2134990-13499040.07440.07
3250044-25004474.23074.23
4207820-20782061.69561.70
5128493-12849338.14538.15
6139424-13942441.39041.39
10min1300013-30001389.06488.456.3089.3688.746.36
2297825-29782588.41588.64
3317247-31724794.18094.59
4319008-31900894.70395.05
5271925-27192580.72680.94
6281703-28170383.62883.86
15min1321775-32177595.52593.782.6696.3194.562.74
2313840-31384093.16993.88
3322946-32294695.87296.81
4323677-32367796.08996.96
5302739-30273989.87390.53
6310405-31040592.14992.84
20min1320285-32028595.08294.201.5996.4095.501.67
2310083-31008392.05493.29
3320911-32091195.26896.74
4323410-32341096.01097.41
5314213-31421393.28094.44
6314928-31492893.49294.70
30min1318459-31845994.54094.111.7796.3995.941.85
2312185-31218592.67894.42
3321873-32187395.55497.55
4324697-32469796.39298.33
5314184-31418493.27194.95
6310716-31071692.24293.97
45min1321102-32110295.32593.501.4797.7095.851.51
2309939-30993992.01194.27
3320284-32028495.08297.61
4312216-31221692.68795.16
5312687-31268792.82795.02
6313566-31356693.08895.33
60min1320377-32037795.11093.022.1498.0195.882.10
2307591-30759191.31494.08
3306015-30601590.84693.90
4321575-32157595.46598.45
5309394-30939491.84994.56
6315130-31513093.55296.31
极限1319731-31973194.91892.662.2398.3596.042.18
2305176-30517690.59793.87
3305130-30513090.58394.14
4318585-31858594.57898.09
5307353-30735391.24394.47
6316677-31667794.01197.29
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%
19.871624391625091629081629991632661628240.22
29.821635001643671639340.38
单位质量响应值RSD%判断
16496.8616693.890.84数据可信
供试品溶液-2023121621批-依折麦布-pH4.5(内含0.2%Tween)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min146027-4602724.88025.5210.2924.8825.5210.29
243204-4320423.35423.35
342884-4288423.18123.18
449343-4934326.67226.67
555906-5590630.22030.22
645927-4592724.82624.83
10min1131158-13115870.89769.873.8571.0470.013.83
2126232-12623268.23568.36
3135739-13573973.37473.50
4127806-12780669.08569.23
5121856-12185665.86966.04
6132708-13270871.73571.87
15min1165344-16534489.37788.523.1789.9189.053.16
2162340-16234087.75388.26
3168731-16873191.20791.74
4160844-16084486.94487.48
5155780-15578084.20784.74
6169531-16953191.64092.18
20min1173384-17338493.72393.001.3194.7594.031.31
2170658-17065892.24993.25
3174450-17445094.29995.34
4170273-17027392.04193.06
5169281-16928191.50592.51
6174270-17427094.20295.25
30min1173511-17351193.79196.021.3495.3497.561.32
2178669-17866996.57998.09
3179118-17911896.82298.39
4176324-17632495.31296.84
5178186-17818696.31897.83
6180030-18003097.31598.88
45min1176358-17635895.33094.671.0997.4096.741.07
2171881-17188192.91094.96
3175210-17521094.71096.81
4174505-17450594.32996.38
5177439-17743995.91597.96
6175443-17544394.83696.95
60min1174485-17448594.31894.891.0596.9297.491.02
2175669-17566994.95897.52
3175715-17571594.98397.61
4178892-17889296.70099.28
5173510-17351093.79196.37
6174999-17499994.59697.23
极限1175800-17580095.02993.841.4398.1596.971.41
2170171-17017191.98695.07
3174043-17404394.07997.24
4171488-17148892.69895.81
5173469-17346993.76996.87
6176685-17668595.50798.67
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%
110.852986502987402993182995422996412991780.16
210.843006953018633012790.28
单位质量响应值RSD%判断
27574.0127793.270.57数据可信
供试品溶液-2023121621批-阿托伐他汀-pH4.5(内含0.2%Tween)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1144310-14431043.05950.7316.3943.0650.7416.39
2132877-13287739.64739.65
3199029-19902959.38559.39
4200160-20016059.72359.72
5165483-16548349.37649.38
6178340-17834053.21253.21
10min1284446-28444684.87287.514.1285.1187.794.16
2274434-27443481.88482.10
3305522-30552291.16091.49
4304036-30403690.71791.05
5292674-29267487.32787.60
6298651-29865189.11089.41
15min1311619-31161992.98095.022.4493.6995.792.49
2307891-30789191.86792.54
3327396-32739697.68798.52
4325384-32538497.08797.92
5316707-31670794.49895.26
6321765-32176596.00796.80
20min1314886-31488693.95494.911.2595.1896.201.30
2312775-31277593.32594.51
3322236-32223696.14797.53
4322093-32209396.10597.48
5319990-31999095.47796.76
6316482-31648294.43195.75
30min1307633-30763391.79094.642.5593.5496.462.59
2306539-30653991.46493.17
3324501-32450196.82398.74
4324343-32434396.77698.69
5319799-31979995.42097.24
6320278-32027895.56397.41
45min1309449-30944992.33293.301.6594.5995.651.69
2305505-30550591.15593.37
3316497-31649794.43596.89
4318555-31855595.04997.50
5316254-31625494.36396.71
6309889-30988992.46394.84
60min1308455-30845592.03693.482.0194.8196.352.02
2311759-31175993.02195.74
3317236-31723694.65697.63
4324256-32425696.75099.72
5309022-30902292.20595.07
6309066-30906692.21895.11
极限1311305-31130592.88692.621.4596.1796.001.50
2302364-30236490.21893.45
3314726-31472693.90797.41
4313193-31319393.44996.96
5308284-30828491.98595.37
6312578-31257893.26696.67
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