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DJ333-221017对照品来源自制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%
110.051723541727941723041722751724261724310.13
210.071744201749001746600.20
单位质量响应值RSD%判断
17157.3117344.590.77数据可信
供试品溶液-2024011821批-依折麦布-pH2.0(内含0.2%Tween80)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min157617-5761729.96124.1726.4429.9624.1726.44
249608-4960825.79625.80
323885-2388512.42012.42
445593-4559323.70923.71
545302-4530223.55723.56
656879-5687929.57729.58
10min1133453-13345369.39668.599.4669.5668.729.49
2137550-13755071.52771.67
3107936-10793656.12756.20
4134471-13447169.92570.06
5133440-13344069.38969.52
6144542-14454275.16275.33
15min1170027-17002788.41587.933.5988.9788.443.64
2170381-17038188.59989.14
3157019-15701981.65182.03
4171001-17100188.92189.44
5172649-17264989.77890.29
6173451-17345190.19590.78
20min1186236-18623696.84394.942.2597.8995.952.32
2183203-18320395.26696.30
3175274-17527491.14391.98
4184527-18452795.95596.97
5180594-18059493.91094.92
6185661-18566196.54497.63
30min1186182-18618296.81596.381.8798.4097.921.90
2185669-18566996.54998.11
3181217-18121794.23495.57
4190435-19043599.027100.57
5181688-18168894.47896.02
6186923-18692397.20198.82
45min1191516-19151699.58997.581.95101.7199.641.99
2185348-18534896.38298.48
3182201-18220194.74596.61
4191452-19145299.556101.65
5186567-18656797.01699.08
6188782-18878298.167100.33
60min1185774-18577496.60396.301.1999.2898.911.24
2185241-18524196.32698.96
3182533-18253394.91897.31
4188537-18853798.040100.69
5183004-18300495.16397.76
6186070-18607096.75799.46
极限1187108-18710897.29795.951.76100.5199.091.79
2184056-18405695.71098.88
3181299-18129994.27697.19
4188895-18889598.226101.42
5180562-18056293.89397.02
6185193-18519396.30199.54
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%
110.713091273091523093003091223085513090500.10
210.773118393138283128340.45
单位质量响应值RSD%判断
28856.2129046.800.47数据可信
供试品溶液-2024011821批-阿托伐他汀钙-pH2.0(内含0.2%Tween80)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1192497-19249754.92145.7621.6154.9245.7621.61
2174822-17482249.87849.88
3120228-12022834.30234.30
4112783-11278332.17832.18
5176837-17683750.45350.45
6185119-18511952.81652.82
10min1281597-28159780.34279.544.6380.6579.804.68
2285289-28528981.39581.67
3261377-26137774.57374.76
4264117-26411775.35575.53
5289320-28932082.54582.83
6291084-29108483.04983.34
15min1305445-30544587.14687.402.4287.9088.102.46
2308564-30856488.03688.77
3293694-29369483.79384.40
4305347-30534787.11887.72
5316431-31643190.28091.02
6308583-30858388.04188.80
20min1321463-32146391.71692.141.7492.9593.331.76
2330906-33090694.41095.63
3314001-31400189.58790.66
4324515-32451592.58793.67
5321471-32147191.71892.96
6325435-32543592.84994.09
30min1316303-31630390.24490.861.2791.9992.551.21
2317726-31772690.65092.39
3315479-31547990.00991.58
4326060-32606093.02794.62
5315694-31569490.07091.82
6319532-31953291.16592.92
45min1325132-32513292.76391.441.5795.0193.631.56
2315056-31505689.88892.13
3314054-31405489.60291.67
4326043-32604393.02395.14
5322068-32206891.88994.14
6320524-32052491.44893.71
60min1311690-31169088.92889.240.8091.6991.950.75
2312050-31205089.03091.78
3310844-31084488.68691.25
4317707-31770790.64493.27
5312627-31262789.19591.96
6311875-31187588.98091.75
极限1314141-31414189.62788.621.3492.8891.821.29
2308378-30837887.98391.22
3307154-30715487.63390.69
4316928-31692890.42293.55
5306602-30660287.47690.73
6310364-31036488.54991.82
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DJ333-221017对照品来源自制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%
110.051720271718021717701718131718661718560.06
210.071733841730181732010.15
单位质量响应值RSD%判断
17100.1017199.700.42数据可信
供试品溶液-2024011821批-依折麦布-shui(内含0.2%Tween80)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min157015-5701529.82228.6819.5729.8228.6819.57
234080-3408017.82617.83
355038-5503828.78828.79
464675-6467533.82933.83
560980-6098031.89631.90
657185-5718529.91129.91
10min1144272-14427275.46276.464.4075.6376.624.40
2144614-14461475.64175.74
3140827-14082773.66173.82
4158822-15882283.07383.26
5142798-14279874.69174.87
6145752-14575276.23776.40
15min1172373-17237390.16194.142.8090.7594.732.80
2180611-18061194.47094.99
3184229-18422996.36296.93
4186424-18642497.51098.16
5179236-17923693.75194.34
6177064-17706492.61593.20
20min1185743-18574397.15497.261.2998.2498.371.28
2187923-18792398.29499.34
3187526-18752698.08799.19
4188223-18822398.45199.64
5182317-18231795.36296.48
6183988-18398896.23697.34
30min1182904-18290495.66997.841.6297.2999.491.56
2190749-19074999.773101.36
3187880-18788098.27299.92
4183896-18389696.18897.93
5188287-18828798.485100.13
6188599-18859998.648100.29
45min1180377-18037794.34795.511.6196.5097.701.56
2185456-18545697.00499.15
3180297-18029794.30696.50
4180500-18050094.41296.68
5181869-18186995.12897.32
6187048-18704897.837100.02
60min1175979-17597992.04792.181.7694.7394.901.69
2180975-18097594.66097.34
3174578-17457891.31494.03
4174015-17401591.02093.82
5172977-17297790.47793.20
6178904-17890493.57796.31
极限1166682-16668287.18489.211.9590.3892.441.88
2173413-17341390.70593.91
3171233-17123389.56592.79
4168535-16853588.15391.46
5168208-16820887.98291.20
6175228-17522891.65494.90
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%
110.713072723071823072283072433072923072430.02
210.773084293092703088500.20
单位质量响应值RSD%判断
28687.4928676.880.03数据可信
供试品溶液-2024011821批-阿托伐他汀钙-shui(内含0.2%Tween80)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1223338-22333864.31846.4823.7964.3246.4823.79
2118518-11851834.13134.13
3144075-14407541.49141.49
4189844-18984454.67254.67
5138343-13834339.84139.84
6154220-15422044.41344.41
10min1328351-32835194.56089.184.4994.9289.444.53
2299626-29962686.28786.48
3289738-28973883.44083.67
4314157-31415790.47290.78
5307097-30709788.43988.66
6319158-31915891.91292.16
15min1332626-33262695.79196.420.9496.6797.180.93
2334452-33445296.31796.99
3333451-33345196.02896.72
4339649-33964997.81398.62
5337385-33738597.16197.87
6331360-33136095.42696.18
20min1346110-34611099.67498.561.13101.0999.851.14
2345099-34509999.383100.59
3341288-34128898.28599.51
4344089-34408999.092100.44
5341435-34143598.32899.58
6335431-33543196.59997.89
30min1336697-33669796.96399.772.2598.93101.602.14
2354569-354569102.110103.87
3347310-347310100.020101.79
4340482-34048298.05399.95
5356176-356176102.573104.37
6343353-34335398.880100.70
45min1341369-34136998.309100.171.63100.82102.571.55
2355480-355480102.372104.70
3343994-34399499.065101.39
4344222-34422299.130101.58
5353413-353413101.777104.15
6348607-348607100.393102.77
60min1344876-34487699.319100.081.67102.37103.021.60
2358780-358780103.323106.22
3344538-34453899.221102.10
4344064-34406499.085102.08
5348638-348638100.402103.34
6344160-34416099.112102.04
极限1332908-33290895.87298.681.7699.48102.191.65
2349859-349859100.754104.22
3344761-34476199.286102.72
4338564-33856497.501101.05
5346042-34604299.654103.15
6343817-34381799.014102.50
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DJ333-221017对照品来源自制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%
110.051729301728691728551728221726531728260.07
210.071748611746321747460.10
单位质量响应值RSD%判断
17196.6217353.130.65数据可信
供试品溶液-2024011821批-依折麦布-pH4.5(内含0.2%Tween80)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min156550-5655029.36530.347.8429.3730.337.85
254084-5408428.08528.08
367184-6718434.88734.89
456277-5627729.22329.22
557473-5747329.84529.84
658937-5893730.60530.60
10min1148361-14836177.04176.934.6677.2077.104.65
2142471-14247173.98274.14
3150675-15067578.24278.44
4158327-15832782.21682.38
5138650-13865071.99872.16
6150378-15037878.08878.26
15min1180825-18082593.89993.370.7894.4993.960.80
2178743-17874392.81893.38
3180479-18047993.71994.35
4181036-18103694.00894.63
5177459-17745992.15192.72
6180246-18024693.59894.20
20min1188557-18855797.91497.960.9099.0399.080.92
2186767-18676796.98498.07
3191526-19152699.455100.60
4189506-18950698.40799.55
5187465-18746597.34798.42
6188084-18808497.66898.79
30min1191966-19196699.684100.490.82101.34102.150.83
2191502-19150299.443101.06
3193920-193920100.699102.40
4195097-195097101.310103.00
5193303-193303100.378102.00
6195355-195355101.444103.11
45min1189417-18941798.360100.521.39100.57102.731.36
2193494-193494100.477102.65
3195919-195919101.737104.00
4192637-192637100.032102.28
5197038-197038102.318104.49
6192899-192899100.168102.40
60min1192190-19219099.800100.491.69102.56103.261.67
2190057-19005798.693101.42
3196297-196297101.933104.76
4193667-193667100.567103.37
5190581-19058198.965101.71
6198303-198303102.975105.76
极限1190669-19066999.01099.771.19102.32103.101.19
2191568-19156899.477102.76
3193945-193945100.712104.10
4192380-19238099.899103.26
5188931-18893198.108101.40
6195303-195303101.417104.78
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%
110.713080093084833083143083193081443082540.06
210.773109133115013112070.14
单位质量响应值RSD%判断
28781.8928895.730.28数据可信
供试品溶液-2024011821批-阿托伐他汀钙-pH4.5(内含0.2%Tween80)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1287614-28761482.37979.982.0882.3879.982.08
2280887-28088780.45280.45
3269686-26968677.24477.24
4279827-27982780.14880.15
5279806-27980680.14280.14
6277670-27767079.53079.53
10min1337561-33756196.68498.891.4697.1499.331.45
2343308-34330898.33198.78
3349633-349633100.142100.57
4348004-34800499.676100.12
5342390-34239098.06898.51
6350590-350590100.416100.86
15min1345586-34558698.98399.101.2999.98100.091.27
2348153-34815399.718100.71
3352136-352136100.859101.84
4338969-33896997.08898.09
5347281-34728199.468100.46
6343783-34378398.46799.47
20min1343244-34324498.31298.751.0299.86100.301.01
2343770-34377098.463100.01
3350931-350931100.514102.06
4341986-34198697.95299.49
5346859-34685999.348100.89
6341870-34187097.91999.47
30min1339500-33950097.24098.280.7299.33100.370.70
2341702-34170297.87199.96
3343340-34334098.340100.44
4342572-34257298.120100.20
5346061-34606199.119101.21
6345554-34555498.974101.06
45min1332419-33241995.21297.561.8697.84100.201.81
2344057-34405798.545101.18
3343386-34338698.353101.00
4335959-33595996.22698.85
5349772-349772100.182102.83
6338063-33806396.82899.47
60min1337414-33741496.64297.431.2499.80100.611.20
2336203-33620396.29699.48
3343769-34376998.463101.66
4338209-33820996.870100.03
5338472-33847296.945100.15
6346858-34685899.347102.53
极限1334859-33485995.91196.880.8199.61100.600.79
2338796-33879697.038100.76
3339417-33941797.216100.96
4338994-33899497.095100.80
5335233-33523396.01899.76
6342067-34206797.975101.71
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