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DSMF-387-240606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(%)99.75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%
110.181751081749851750341750171749101750110.05
210.191756881755301756090.07
单位质量响应值RSD%判断
17191.6517233.460.18数据可信
供试品溶液-2022091801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%
5min18974-89744.6815.7710.074.685.7710.07
212049-120496.2846.28
311430-114305.9625.96
411850-118506.1816.18
511294-112945.8915.89
610803-108035.6345.63
10min118440-184409.6189.624.199.649.654.19
219619-1961910.23310.27
318271-182719.5309.56
418249-182499.5189.55
517266-172669.0059.04
618820-188209.8169.85
15min119499-1949910.1709.823.7010.259.903.68
219386-1938610.11110.20
318093-180939.4379.52
419214-1921410.02110.11
517847-178479.3089.39
618890-188909.8529.94
20min119109-191099.9679.544.2610.109.684.20
218676-186769.7419.89
317778-177789.2729.41
418499-184999.6489.79
516970-169708.8518.99
618684-186849.7459.89
30min117732-177329.2489.192.569.449.382.59
218322-183229.5569.76
317456-174569.1049.29
417574-175749.1669.36
516931-169318.8319.01
617697-176979.2309.42
45min117927-179279.3508.983.359.599.233.30
217692-176929.2289.48
316770-167708.7478.99
417163-171638.9529.20
516385-163858.5468.78
617417-174179.0849.33
60min116857-168578.7928.752.749.099.052.74
217373-173739.0619.37
316233-162338.4678.76
416614-166148.6658.96
516379-163798.5438.82
617240-172408.9929.29
极限117241-172418.9928.862.769.349.202.71
217166-171668.9539.31
316340-163408.5228.86
416671-166718.6959.04
516831-168318.7799.11
617661-176619.2119.56
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%
111.103146993145943146513146653145753146370.02
211.163159333153273156300.14
单位质量响应值RSD%判断
28345.6828282.260.16数据可信
供试品溶液-2022091801批-阿托伐他汀钙-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%
5min163179-6317918.43129.7230.4418.4329.7230.44
2106464-10646431.05931.06
3121607-12160735.47635.48
478045-7804522.76822.77
5149296-14929643.55443.55
692712-9271227.04727.05
10min1219793-21979364.12067.713.6064.2267.873.65
2240779-24077970.24270.41
3238665-23866569.62669.82
4224481-22448165.48865.61
5236581-23658169.01869.26
6232290-23229067.76667.92
15min1273332-27333279.73979.292.3780.2079.832.32
2280095-28009581.71282.27
3268610-26861078.36178.95
4272753-27275379.57080.06
5261050-26105076.15676.78
6274876-27487680.18980.72
20min1290544-29054484.76082.324.0785.6683.303.98
2291039-29103984.90585.92
3275648-27564880.41581.43
4282785-28278582.49783.43
5262351-26235176.53577.58
6290679-29067984.80085.77
30min1298911-29891187.20185.814.3788.5787.254.30
2314641-31464191.79093.28
3286059-28605983.45284.92
4290317-29031784.69486.08
5277205-27720580.86982.34
6297749-29774986.86288.31
45min1324621-32462194.70188.536.3696.5690.456.23
2325477-32547794.95196.95
3287875-28787583.98285.91
4298473-29847387.07388.93
5277981-27798181.09583.02
6306455-30645589.40291.33
60min1323218-32321894.29289.475.6296.6891.885.51
2327728-32772895.60898.13
3293919-29391985.74588.14
4302104-30210488.13390.48
5282842-28284282.51384.89
6310353-31035390.53992.96
极限1325767-32576795.03693.163.2997.9496.063.25
2329201-32920196.03899.09
3311810-31181090.96493.84
4320308-32030893.44396.28
5302074-30207488.12490.96
6326810-32681095.34098.27
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DSMF-387-240606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(%)99.75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%
110.181743431748021750771752401753291749580.23
210.191756341766201761270.40
单位质量响应值RSD%判断
17186.4417284.300.41数据可信
供试品溶液-2022091801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%
5min111137-111375.8016.167.545.806.167.53
212936-129366.7386.74
311688-116886.0886.09
412909-129096.7246.72
510901-109015.6785.68
611359-113595.9175.92
10min119231-1923110.0179.981.8210.0510.021.81
219338-1933810.07310.11
318473-184739.6229.66
419445-1944510.12910.17
519226-1922610.01410.05
619241-1924110.02210.06
15min119637-1963710.22910.001.4510.3210.091.46
219213-1921310.00810.10
318877-188779.8339.92
419172-191729.98610.08
518942-189429.8679.95
619352-1935210.08010.17
20min119199-1919910.0009.861.1610.1510.011.14
218773-187739.7789.93
318612-186129.6959.84
418911-189119.85010.00
519125-191259.96210.10
618995-189959.89410.04
30min118639-186399.7099.471.589.919.661.57
218250-182509.5069.71
318023-180239.3889.58
418307-183079.5369.74
517924-179249.3369.53
617886-178869.3169.52
45min117810-178109.2779.301.229.539.551.21
218088-180889.4229.68
317452-174529.0909.34
417929-179299.3399.60
517840-178409.2939.54
617948-179489.3499.60
60min117552-175529.1428.991.389.459.291.39
217201-172018.9609.27
317000-170008.8559.15
417531-175319.1329.44
517031-170318.8719.17
617223-172238.9719.27
极限117607-176079.1719.234.689.539.584.52
219073-190739.93510.29
316942-169428.8259.17
417425-174259.0769.44
516963-169638.8369.19
618283-182839.5239.88
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%
111.103136063142633146213148273152293145090.20
211.163153563167783160670.32
单位质量响应值RSD%判断
28334.1428321.420.04数据可信
供试品溶液-2022091801批-阿托伐他汀钙-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%
5min193405-9340527.23631.0018.1027.2431.0018.10
2124872-12487236.41136.41
3102307-10230729.83129.83
4135383-13538339.47639.48
589381-8938126.06226.06
692505-9250526.97326.97
10min1224416-22441665.43768.183.0065.5968.363.03
2234527-23452768.38568.59
3231736-23173667.57167.74
4246109-24610971.76271.98
5233050-23305067.95468.10
6233173-23317367.99068.14
15min1268890-26889078.40579.712.2578.9280.262.25
2267070-26707077.87478.46
3274346-27434679.99680.54
4279274-27927481.43382.05
5268773-26877378.37178.89
6281841-28184182.18182.71
20min1284900-28490083.07384.242.4784.0285.242.46
2282894-28289482.48883.50
3286303-28630383.48284.47
4294515-29451585.87786.95
5284136-28413682.85083.81
6300764-30076487.69988.68
30min1299384-29938487.29686.983.1088.7188.443.08
2292688-29268885.34486.82
3294833-29483385.96987.42
4307147-30714789.56091.11
5285572-28557283.26984.69
6310205-31020590.45291.92
45min1300659-30065987.66890.384.1689.5792.334.13
2310809-31080990.62892.57
3302950-30295088.33690.26
4323952-32395294.46096.51
5294971-29497186.01087.89
6326503-32650395.20497.18
60min1302496-30249688.20490.234.2390.5992.684.20
2307268-30726889.59592.05
3304621-30462188.82391.24
4326238-32623895.12797.70
5292327-29232785.23987.60
6323677-32367794.38096.88
极限1321716-32171693.80893.721.8396.6896.661.87
2318172-31817292.77595.72
3318414-31841492.84595.76
4329285-32928596.01599.11
5313760-31376091.48894.32
6327093-32709395.37698.40
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DSMF-387-240606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(%)99.75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%
110.181757901760201761281761271761201760370.09
210.191753961756801755380.12
单位质量响应值RSD%判断
17292.4417226.500.28数据可信
供试品溶液-2022092201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%
5min19687-96875.0394.978.015.044.968.03
28806-88064.5804.58
38728-87284.5404.54
49848-98485.1225.12
510799-107995.6175.62
69409-94094.8944.89
10min118646-186469.6999.363.069.739.383.06
217959-179599.3419.37
317589-175899.1499.17
418654-186549.7039.73
517698-176989.2069.24
617368-173689.0349.06
15min118960-189609.8629.443.869.949.523.82
218745-187459.7509.83
318412-184129.5779.65
418047-180479.3879.47
517547-175479.1279.21
617151-171518.9219.00
20min118490-184909.6189.233.349.759.363.29
218207-182079.4709.60
317959-179599.3419.47
417621-176219.1669.30
516872-168728.7768.91
617340-173409.0199.15
30min117273-172738.9859.101.909.179.281.89
217979-179799.3529.54
317413-174139.0579.24
417795-177959.2569.44
517392-173929.0469.23
617099-170998.8949.07
45min117210-172108.9528.851.069.199.081.07
217127-171278.9099.14
316965-169658.8249.06
417076-170768.8829.12
516989-169898.8379.07
616693-166938.6838.91
60min116388-163888.5248.501.288.818.791.28
216504-165048.5858.87
316260-162608.4588.74
416599-165998.6348.92
516334-163348.4968.78
615999-159998.3228.60
极限116533-165338.6008.521.308.948.851.29
216391-163918.5268.86
316141-161418.3968.72
416374-163748.5178.85
516676-166768.6749.00
616143-161438.3978.72
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%
111.103145193147393149753150633152183149030.09
211.163145443143153144300.06
单位质量响应值RSD%判断
28369.6428174.730.49数据可信
供试品溶液-2022092201批-阿托伐他汀钙-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%
5min198399-9839928.74929.4718.5528.7529.4718.55
285051-8505124.84924.85
378307-7830722.87822.88
4101718-10171829.71829.72
5130461-13046138.11638.12
6111188-11118832.48532.49
10min1227339-22733966.42068.272.7366.5868.442.75
2235328-23532868.75468.89
3224287-22428765.52865.66
4239563-23956369.99270.16
5239061-23906169.84570.06
6236483-23648369.09269.27
15min1266389-26638977.82980.932.5778.3681.472.53
2285574-28557483.43483.95
3283704-28370482.88883.38
4278196-27819681.27981.83
5272846-27284679.71680.32
6275280-27528080.42780.99
20min1283029-28302982.69185.722.8483.6586.712.79
2299643-29964387.54588.53
3302949-30294988.51189.46
4290934-29093485.00086.01
5284899-28489983.23784.28
6298836-29883687.30988.32
30min1285226-28522683.33390.033.8884.7591.503.84
2316729-31672992.53794.01
3318535-31853593.06494.51
4310219-31021990.63592.11
5308569-30856990.15391.66
6309715-30971590.48791.98
45min1296448-29644886.61192.113.3288.4994.083.29
2320781-32078193.72095.70
3322028-32202894.08596.05
4312520-31252091.30793.29
5314209-31420991.80093.81
6325540-32554095.11197.11
60min1289080-28908084.45991.564.1886.8294.044.13
2320234-32023493.56196.07
3317416-31741692.73795.22
4314763-31476391.96294.45
5311468-31146891.00093.52
6327378-32737895.64898.18
极限1311634-31163491.04893.931.6893.8896.921.71
2326130-32613095.28398.31
3320471-32047193.63096.63
4320949-32094993.77096.77
5324008-32400894.66397.68
6325879-32587995.21098.27
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DSMF-387-240606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(%)99.75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%
110.181762691766191767971768821770741767280.18
210.191776481784111780300.31
单位质量响应值RSD%判断
17360.3117471.050.45数据可信
供试品溶液-2022092201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%
5min17071-70713.6454.8117.153.654.8017.13
211949-119496.1606.16
39203-92034.7444.74
48618-86184.4424.44
59852-98525.0795.08
69237-92374.7624.76
10min117508-175089.0259.182.049.059.212.09
218354-183549.4619.50
317987-179879.2729.30
417420-174208.9809.00
517996-179969.2779.30
617581-175819.0639.09
15min117865-178659.2099.381.229.289.451.21
218054-180549.3079.39
318305-183059.4369.51
418462-184629.5179.59
518095-180959.3289.41
618350-183509.4599.54
20min118001-180019.2799.161.969.409.281.94
218107-181079.3349.47
317593-175939.0699.20
418101-181019.3319.46
517348-173488.9439.07
617422-174228.9819.11
30min117283-172838.9098.981.779.089.161.76
217690-176909.1199.31
317756-177569.1539.33
417591-175919.0689.25
516968-169688.7478.93
617235-172358.8849.06
45min117382-173828.9608.742.229.188.972.14
216546-165468.5298.77
317373-173738.9569.19
417071-170718.8009.03
516610-166108.5628.79
616734-167348.6268.85
60min116763-167638.6418.592.128.918.872.08
216914-169148.7199.01
317063-170638.7969.08
416685-166858.6018.88
516436-164368.4738.75
616085-160858.2928.57
极限116474-164748.4928.865.058.819.194.92
217839-178399.1969.53
318121-181219.3419.67
417950-179509.2539.58
516541-165418.5278.85
616207-162078.3558.68
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%
111.103152833158823160663165113165763160640.17
211.163184023193583188800.22
单位质量响应值RSD%判断
28474.2328573.480.25数据可信
供试品溶液-2022092201批-阿托伐他汀钙-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%
5min182966-8296624.02628.1234.7924.0328.1234.78
2149198-14919843.20543.21
375099-7509921.74721.75
457658-5765816.69716.70
5124261-12426135.98435.98
693486-9348627.07227.07
10min1223511-22351164.72565.788.7064.8665.948.75
2243650-24365070.55770.80
3213865-21386561.93262.05
4195817-19581756.70556.80
5242051-24205170.09470.29
6244088-24408870.68470.83
15min1269879-26987978.15279.615.8078.6580.135.84
2280209-28020981.14481.78
3253653-25365373.45473.92
4261970-26197075.86276.27
5288400-28840083.51684.11
6295268-29526885.50586.05
20min1299333-29933386.68284.764.9087.6185.724.95
2301616-30161687.34388.43
3267978-26797877.60278.47
4282446-28244681.79282.62
5301993-30199387.45288.51
6302763-30276387.67588.69
30min1311900-31190090.32190.822.2391.7392.262.31
2316242-31624291.57893.15
3304084-30408488.05889.36
4308185-30818589.24590.53
5317929-31792992.06793.61
6323371-32337193.64395.15
45min1322020-32202093.25293.391.0895.1695.331.14
2320702-32070292.87094.95
3321490-32149093.09894.89
4317972-31797292.07993.86
5324969-32496994.10696.16
6327832-32783294.93596.96
60min1319960-31996092.65593.311.2695.0895.771.32
2320290-32029092.75195.34
3321841-32184193.20095.51
4317228-31722891.86494.15
5328000-32800094.98397.56
6326019-32601994.41096.96
极限1317923-31792392.06594.752.3695.0197.722.35
2323230-32323093.60296.71
3322109-32210993.27796.11
4327174-32717494.74497.55
5335617-33561797.189100.29
6337054-33705497.605100.68
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