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R075K0对照品来源USP对照品使用方法直接使用
对照品含量(%)99.8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%
110.181663271663581664231668321664541664790.13
210.131680571690071685320.40
单位质量响应值RSD%判断
16353.5416636.921.22数据可信
供试品溶液-2023120823批-10mg/10mg规格-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%
5min19295-92955.0625.6312.715.065.6312.69
211602-116026.3186.32
311522-115226.2746.27
49430-94305.1355.14
511438-114386.2296.23
68756-87564.7684.77
10min115864-158648.6398.691.668.678.731.68
216172-161728.8078.84
316206-162068.8258.86
415604-156048.4978.53
516206-162068.8258.86
615747-157478.5758.60
15min115303-153038.3338.552.048.418.632.01
215405-154058.3898.47
315635-156358.5148.60
415794-157948.6018.68
516011-160118.7198.80
616096-160968.7658.84
20min115697-156978.5488.610.918.678.740.96
215870-158708.6428.77
315819-158198.6148.75
415811-158118.6108.73
516039-160398.7348.87
615627-156278.5108.63
30min114774-147748.0458.031.078.228.211.07
214647-146477.9768.15
314756-147568.0368.21
414568-145687.9338.10
514739-147398.0268.21
615033-150338.1868.36
45min114669-146697.9887.971.238.208.191.20
214589-145897.9458.17
314892-148928.1108.33
414364-143647.8228.04
514725-147258.0198.24
614543-145437.9208.14
60min114469-144697.8797.861.538.148.121.50
214570-145707.9348.20
314706-147068.0088.28
414491-144917.8918.15
514088-140887.6727.94
614276-142767.7748.03
极限114133-141337.6967.851.308.008.151.26
214538-145387.9178.23
314509-145097.9018.21
414284-142847.7798.08
514344-143447.8118.12
614637-146377.9718.27
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)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%
111.003025893021083029263035333024863027280.18
211.153064063071233067640.17
单位质量响应值RSD%判断
27520.7327512.470.03数据可信
供试品溶液-2023120823批-10mg/10mg规格-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%
5min144567-4456726.75635.5916.5326.7635.5916.53
269034-6903441.44641.45
363997-6399738.42238.42
459173-5917335.52535.53
567985-6798540.81640.82
650908-5090830.56330.56
10min184871-8487150.95460.608.8251.1060.808.84
2106406-10640663.88264.11
3103175-10317561.94362.16
4102400-10240061.47761.67
5110576-11057666.38666.61
698205-9820558.95959.13
15min1105166-10516663.13869.287.2263.5769.817.21
2105440-10544063.30263.89
3118384-11838471.07471.63
4119628-11962871.82072.36
5125893-12589375.58276.18
6117846-11784670.75171.25
20min1119594-11959471.80077.234.7372.5878.144.77
2130117-13011778.11879.05
3128704-12870477.26978.22
4129699-12969977.86778.80
5138116-13811682.92083.94
6125575-12557575.39176.28
30min1123974-12397474.43076.342.5275.6177.692.56
2123507-12350774.14975.52
3126684-12668476.05777.44
4128250-12825076.99778.37
5132132-13213279.32780.80
6128378-12837877.07478.38
45min1130741-13074178.49279.421.9980.0981.192.04
2133484-13348480.13981.92
3131479-13147978.93580.74
4131019-13101978.65980.46
5137058-13705882.28584.20
6129901-12990177.98879.73
60min1132323-13232379.44279.630.8381.4781.840.86
2134196-13419680.56782.79
3131578-13157878.99581.24
4133117-13311779.91982.15
5133260-13326080.00582.38
6131337-13133778.85081.02
极限1131296-13129678.82680.161.3081.3082.821.36
2134412-13441280.69683.37
3131730-13173079.08681.77
4133436-13343680.11082.79
5135799-13579981.52984.35
6134427-13442780.70583.31
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R075K0对照品来源USP对照品使用方法直接使用
对照品含量(%)99.8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%
110.181661911660241669441667941665761665060.24
210.131688181684491686340.16
单位质量响应值RSD%判断
16356.1916646.991.25数据可信
供试品溶液-2023120823批-10mg/10mg规格-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%
5min19649-96495.2526.1111.605.256.1111.64
210860-108605.9125.91
311539-115396.2816.28
410239-102395.5745.57
511763-117636.4036.40
613348-133487.2667.27
10min116200-162008.8198.830.918.858.870.91
216132-161328.7828.81
316476-164768.9699.00
416086-160868.7568.79
516148-161488.7908.83
616331-163318.8908.93
15min116358-163588.9058.943.638.989.023.58
217559-175599.5589.64
316216-162168.8278.91
416424-164248.9409.02
516072-160728.7498.83
615867-158678.6378.73
20min116293-162938.8698.851.859.008.981.82
216132-161328.7828.92
316683-166839.0819.22
416283-162838.8648.99
516360-163608.9069.04
615768-157688.5838.72
30min115726-157268.5618.103.698.748.293.59
214286-142867.7777.96
315293-152938.3258.51
414533-145337.9118.09
514960-149608.1448.33
614512-145127.9008.09
45min115142-151428.2438.013.798.478.243.69
215016-150168.1748.40
314938-149388.1328.36
414692-146927.9988.22
514885-148858.1038.33
613619-136197.4147.64
60min114907-149078.1157.941.968.388.211.88
214529-145297.9098.18
314834-148348.0758.35
414410-144107.8448.11
514663-146637.9828.25
614138-141387.6967.97
极限115665-156658.5278.441.548.848.751.52
215472-154728.4228.74
315736-157368.5668.89
415064-150648.2008.51
515468-154688.4208.74
615595-155958.4898.80
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)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%
111.003025313021113030923021223031613026030.17
211.153070903058833064860.28
单位质量响应值RSD%判断
27509.3627487.530.06数据可信
供试品溶液-2023120823批-10mg/10mg规格-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%
5min168518-6851841.16340.0111.5841.1640.0111.57
265806-6580639.53439.53
372631-7263143.63443.63
460335-6033536.24736.25
576559-7655945.99445.99
655744-5574433.48933.49
10min1108721-10872165.31564.745.9365.5464.965.95
2105283-10528363.25063.47
3111727-11172767.12167.36
4106521-10652163.99464.20
5116644-11664470.07570.33
697717-9771758.70558.89
15min1124136-12413674.57675.592.8275.1776.172.84
2128190-12819077.01277.58
3124644-12464474.88175.50
4127727-12772776.73377.29
5130013-13001378.10778.75
6120199-12019972.21172.72
20min1134812-13481280.99081.582.9682.0082.582.98
2132061-13206179.33780.34
3137617-13761782.67583.71
4135643-13564381.48982.47
5142694-14269485.72586.80
6131933-13193379.26080.17
30min1135700-13570081.52378.933.6382.9880.393.62
2124680-12468074.90376.34
3130909-13090978.64580.14
4129069-12906977.54078.98
5137922-13792282.85884.41
6130052-13005278.13079.48
45min1135888-13588881.63681.991.7983.5483.881.81
2134416-13441680.75282.61
3134440-13444080.76682.69
4137797-13779782.78384.65
5140768-14076884.56886.58
6135543-13554381.42983.22
60min1136588-13658882.05781.851.9084.4284.201.93
2133605-13360580.26582.57
3134977-13497781.08983.47
4136912-13691282.25184.58
5140869-14086984.62987.11
6134523-13452380.81683.06
极限1144463-14446386.78886.631.4489.6189.431.40
2141589-14158985.06187.81
3142630-14263085.68788.51
4143570-14357086.25189.03
5145651-14565187.50190.46
6147273-14727388.47691.17
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R075K0对照品来源USP对照品使用方法直接使用
对照品含量(%)99.8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%
110.181673821681031686321690611688661684090.41
210.131659231679341669280.86
单位质量响应值RSD%判断
16543.1216478.580.28数据可信
供试品溶液-2023121221批-10mg/20mg规格-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%
5min19386-93865.1065.8410.635.115.8410.61
29335-93355.0785.08
311235-112356.1126.11
412216-122166.6466.65
511146-111466.0646.06
611053-110536.0136.01
10min115120-151208.2258.624.548.258.654.55
215149-151498.2418.27
316618-166189.0409.07
416346-163468.8928.93
515323-153238.3368.37
616515-165158.9849.02
15min117136-171369.3229.034.239.409.114.20
216485-164858.9689.04
317160-171609.3359.42
415940-159408.6718.76
515613-156138.4948.57
617262-172629.3919.47
20min116526-165268.9908.793.549.128.923.47
216652-166529.0599.18
315625-156258.5008.64
416114-161148.7668.90
515318-153188.3338.46
616669-166699.0689.20
30min115274-152748.3098.726.548.488.906.40
215653-156538.5158.69
315859-158598.6278.81
415554-155548.4618.64
518131-181319.86310.04
615716-157168.5508.74
45min115131-151318.2318.6410.958.458.8610.69
215221-152218.2808.50
315126-151268.2298.46
414841-148418.0748.30
519394-1939410.55010.78
615557-155578.4638.70
60min114874-148748.0928.6211.708.368.8911.39
214676-146767.9848.25
315128-151288.2308.51
415268-152688.3068.58
519571-1957110.64710.93
615516-155168.4418.72
极限114734-147348.0158.7013.548.339.0213.18
214855-148558.0818.39
315108-151088.2198.54
415194-151948.2668.59
520358-2035811.07511.42
615709-157098.5468.87
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)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%
111.003061273046763067553066493062333060880.28
211.153030273047383038820.40
单位质量响应值RSD%判断
27826.1827253.991.47数据可信
供试品溶液-2023121221批-10mg/20mg规格-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%
5min175239-7523945.13750.0623.2645.1450.0623.25
275375-7537545.21945.22
385985-8598551.58451.58
495493-9549357.28857.29
556043-5604333.62133.62
6112552-11255267.52267.52
10min1169600-169600101.746102.124.25102.00102.404.30
2169499-169499101.685101.94
3169845-169845101.893102.18
4179178-179178107.492107.81
5157832-15783294.68694.87
6175386-175386105.217105.59
15min1216471-216471129.865128.811.62130.68129.661.64
2217421-217421130.435131.25
3211933-211933127.142128.00
4211489-211489126.876127.79
5211551-211551126.913127.63
6219393-219393131.618132.58
20min1244002-244002146.381143.673.72147.92145.233.66
2250572-250572150.323151.86
3223835-223835134.283135.84
4237873-237873142.704144.32
5241426-241426144.836146.25
6239177-239177143.487145.18
30min1245135-245135147.061148.200.85149.41150.560.84
2250389-250389150.213152.59
3247032-247032148.199150.50
4248478-248478149.066151.48
5246012-246012147.587149.81
6245112-245112147.047149.54
45min1262021-262021157.191156.521.96160.36159.701.94
2264386-264386158.610161.82
3258702-258702155.200158.33
4252415-252415151.428154.67
5260608-260608156.343159.39
6267242-267242160.323163.63
60min1267714-267714160.606161.151.52164.65165.201.45
2266626-266626159.954164.05
3273727-273727164.214168.20
4262345-262345157.385161.47
5272139-272139163.261167.17
6269123-269123161.452165.65
极限1270468-270468162.259166.572.26167.19171.522.18
2274482-274482164.667169.65
3273709-273709164.203169.11
4278612-278612167.144172.10
5288136-288136172.858177.68
6280507-280507168.281173.37
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R075K0对照品来源USP对照品使用方法直接使用
对照品含量(%)99.8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%
110.181696191690971713311695611701621699540.51
210.131700471714271707370.58
单位质量响应值RSD%判断
16694.8916854.590.68数据可信
供试品溶液-2023121221批-10mg/20mg规格-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%
5min111122-111225.9556.127.825.966.127.83
211383-113836.0956.10
311470-114706.1426.14
410536-105365.6425.64
513109-131097.0197.02
610908-109085.8415.84
10min116183-161838.6658.753.038.708.783.05
216014-160148.5758.61
316653-166538.9178.95
416009-160098.5728.60
517198-171989.2099.25
615958-159588.5458.58
15min116173-161738.6608.891.978.748.981.98
216409-164098.7868.87
316905-169059.0529.14
416898-168989.0489.13
516888-168889.0439.13
616380-163808.7718.85
20min116529-165298.8518.961.248.989.091.25
216740-167408.9649.09
316882-168829.0409.17
416596-165968.8869.02
517055-170559.1329.27
616567-165678.8719.00
30min115849-158498.4878.681.608.678.861.57
216194-161948.6718.85
316523-165238.8479.03
416362-163628.7618.94
516366-163668.7638.95
615970-159708.5518.73
45min115891-158918.5098.641.868.738.861.81
216609-166098.8939.12
316298-162988.7278.96
416181-161818.6648.89
515805-158058.4638.70
615975-159758.5548.78
60min115800-158008.4608.581.968.738.861.93
216084-160848.6128.89
316539-165398.8569.14
416208-162088.6798.95
515683-156838.3988.68
615872-158728.4998.77
极限115596-155968.3518.562.968.678.882.91
216343-163438.7519.08
316765-167658.9779.31
415812-158128.4678.79
515802-158028.4618.79
615580-155808.3428.66
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)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%
111.003084753076393109013095153053713083800.68
211.153089443100733095080.26
单位质量响应值RSD%判断
28034.5527758.570.70数据可信
供试品溶液-2023121221批-10mg/20mg规格-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%
5min170658-7065841.84454.1225.8841.8454.1225.88
2100453-10045359.48959.49
391288-9128854.06154.06
494689-9468956.07556.08
5129090-12909076.44776.45
662199-6219936.83436.83
10min1172117-172117101.928109.466.04102.16109.766.09
2187724-187724111.171111.50
3192083-192083113.752114.05
4185600-185600109.913110.22
5199841-199841118.346118.77
6171641-171641101.646101.85
15min1211818-211818125.439131.243.18126.24132.153.23
2222528-222528131.782132.73
3228677-228677135.423136.36
4223021-223021132.074133.00
5228857-228857135.530136.61
6214817-214817127.215127.98
20min1241774-241774143.179148.632.77144.67150.262.80
2256966-256966152.176153.86
3248699-248699147.280148.96
4259728-259728153.812155.47
5253375-253375150.049151.88
6245318-245318145.278146.75
30min1248583-248583147.211151.361.61149.50153.821.65
2256298-256298151.780154.31
3260791-260791154.441156.94
4254599-254599150.774153.28
5258091-258091152.842155.51
6255174-255174151.115153.40
45min1268267-268267158.868160.091.07161.98163.401.04
2269882-269882159.825163.19
3273643-273643162.052165.41
4266610-266610157.887161.24
5269801-269801159.777163.29
6273813-273813162.153165.28
60min1274480-274480162.548164.311.49166.54168.511.46
2280826-280826166.306170.56
3283708-283708168.013172.27
4274056-274056162.297166.52
5273713-273713162.093166.50
6278000-278000164.632168.66
极限1279297-279297165.400169.303.05170.29174.413.01
2293204-293204173.636178.82
3298542-298542176.797181.99
4275466-275466163.132168.26
5286534-286534169.686174.99
6282288-282288167.172172.11
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