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对照品来源自制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%
111.872046202049902047722047492048952048050.07
211.842045962044782045370.05
单位质量响应值RSD%判断
17254.0017275.080.09数据可信
供试品溶液-2024011621批-依折麦布-pH1.2
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min16560-65603.4113.9116.773.413.9116.77
28456-84564.3974.40
35933-59333.0853.09
47954-79544.1364.14
59283-92834.8274.83
66941-69413.6093.61
10min115771-157718.2018.582.888.228.602.90
217010-170108.8458.87
316411-164118.5348.55
416224-162248.4368.46
516591-165918.6278.65
616992-169928.8368.86
15min117984-179849.3529.173.299.429.243.23
217694-176949.2019.27
318028-180289.3749.44
417557-175579.1309.20
516526-165268.5938.67
618036-180369.3799.45
20min117677-176779.1929.132.679.319.252.63
217715-177159.2129.34
317990-179909.3559.47
417065-170658.8748.99
516911-169118.7948.92
618012-180129.3669.49
30min116186-161868.4178.742.358.588.912.33
216748-167488.7098.88
317356-173569.0259.19
416886-168868.7818.95
516615-166158.6408.81
617023-170238.8529.03
45min116805-168058.7398.731.508.958.951.44
216869-168698.7729.00
317146-171468.9169.13
416629-166298.6478.87
516403-164038.5308.75
616857-168578.7668.99
60min116674-166748.6708.732.148.938.992.08
216518-165188.5898.86
317271-172718.9819.25
416560-165608.6118.88
516465-164658.5628.83
617197-171978.9429.21
极限116679-166798.6738.692.168.989.002.13
216326-163268.4898.81
317168-171688.9279.25
416532-165328.5978.91
516420-164208.5388.85
617126-171268.9059.23
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%
110.923126043129523128473128813129623128490.05
211.013119643117843118740.05
单位质量响应值RSD%判断
28649.1828326.430.81数据可信
供试品溶液-2024011621批-阿托伐他汀钙-pH1.2
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min159219-5921917.17115.716.5317.1715.716.52
255293-5529316.03316.03
352104-5210415.10815.11
452030-5203015.08715.09
556818-5681816.47516.47
649702-4970214.41114.41
10min1108672-10867231.51029.016.1631.6129.106.17
2106503-10650330.88130.97
396903-9690328.09828.18
495761-9576127.76727.85
599088-9908828.73128.82
693366-9336627.07227.15
15min1130315-13031537.78635.324.7338.0635.574.73
2126306-12630636.62336.88
3119251-11925134.57834.82
4122760-12276035.59535.83
5116873-11687333.88834.14
6115378-11537833.45533.69
20min1138405-13840540.13238.783.0040.6139.233.02
2137614-13761439.90240.37
3130806-13080637.92838.36
4132277-13227738.35538.79
5135171-13517139.19439.63
6128226-12822637.18037.60
30min1118882-11888234.47135.633.5035.1736.283.43
2122693-12269335.57636.26
3123410-12341035.78436.43
4124671-12467136.14936.80
5129723-12972337.61438.27
6117813-11781334.16134.78
45min1130108-13010837.72638.432.9838.6239.292.93
2132938-13293838.54639.43
3133726-13372638.77539.62
4130316-13031637.78638.64
5139555-13955540.46541.33
6128559-12855937.27738.09
60min1131468-13146838.12040.103.7239.2241.173.62
2138523-13852340.16641.26
3140670-14067040.78841.85
4134326-13432638.94940.01
5146289-14628942.41843.51
6138514-13851440.16341.18
极限1149517-14951743.35444.342.1444.6745.632.09
2151477-15147743.92245.24
3152250-15225044.14645.43
4151288-15128843.86745.14
5158874-15887446.06747.39
6154020-15402044.65945.90
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DSMF-387-240606对照品来源自制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%
111.872056092058142062352064282063772060930.18
211.842074532085842080180.39
单位质量响应值RSD%判断
17362.5117569.090.84数据可信
供试品溶液-2024011621批-依折麦布-pH1.2
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min17304-73043.7543.807.133.753.797.11
27689-76893.9523.95
37302-73023.7533.75
47060-70603.6293.63
56714-67143.4513.45
68235-82354.2334.23
10min115438-154387.9358.403.377.968.423.36
216498-164988.4808.50
316444-164448.4538.47
416959-169598.7178.74
515963-159638.2058.22
616710-167108.5898.61
15min117689-176899.0939.161.239.169.231.26
218150-181509.3309.40
317697-176979.0979.16
417693-176939.0959.16
517675-176759.0859.15
618070-180709.2889.36
20min117572-175729.0329.131.499.159.251.47
217855-178559.1789.30
317765-177659.1329.25
417352-173528.9199.04
517932-179329.2179.33
618088-180889.2989.42
30min117096-170968.7888.850.998.959.021.02
217353-173538.9209.09
317395-173958.9419.11
416955-169558.7158.88
517191-171918.8379.00
617317-173178.9019.08
45min116968-169688.7228.721.448.948.941.43
216751-167518.6108.83
316797-167978.6348.85
416742-167428.6068.82
517206-172068.8449.06
617305-173058.8959.12
60min116707-167078.5888.641.418.858.901.37
216852-168528.6628.93
316924-169248.6998.97
416386-163868.4238.69
517074-170748.7769.04
616876-168768.6758.95
极限116780-167808.6258.681.968.948.991.91
216767-167678.6198.94
317045-170458.7629.08
416344-163448.4018.71
517315-173158.9009.21
617022-170228.7509.07
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%
110.923138813142523145493149013148903144950.14
211.013180513183263181880.07
单位质量响应值RSD%判断
28799.9128899.910.25数据可信
供试品溶液-2024011621批-阿托伐他汀钙-pH1.2
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min153739-5373915.38614.568.9915.3914.569.00
251252-5125214.67414.67
351064-5106414.62014.62
450763-5076314.53414.53
542407-4240712.14212.14
655797-5579715.97515.98
10min198704-9870428.26027.3410.4228.3527.4210.42
299953-9995328.61828.70
386645-8664524.80724.89
494339-9433927.01027.09
582854-8285423.72223.79
6110503-11050331.63831.73
15min1126345-12634536.17434.1410.3336.4234.3710.32
2122098-12209834.95835.20
3106624-10662430.52830.75
4116510-11651033.35833.59
5105823-10582330.29830.50
6138023-13802339.51739.78
20min1143153-14315340.98637.748.7441.4338.168.75
2133527-13352738.23038.66
3118967-11896734.06134.45
4127399-12739936.47636.89
5120923-12092334.62134.99
6146939-14693942.07042.55
30min1138992-13899239.79535.777.5440.4736.407.54
2117679-11767933.69334.34
3118449-11844933.91334.49
4122596-12259635.10035.72
5117479-11747933.63534.20
6134398-13439838.48039.20
45min1150096-15009642.97438.597.0943.8739.427.10
2133791-13379138.30639.14
3124255-12425535.57536.34
4130642-13064237.40438.22
5128190-12819036.70237.45
6141781-14178140.59341.52
60min1153353-15335343.90740.195.7045.0441.245.74
2141874-14187440.62041.67
3131929-13192937.77338.74
4137270-13727039.30240.32
5133280-13328038.15939.11
6144524-14452441.37942.54
极限1164462-16446247.08744.304.5348.4645.574.61
2155839-15583944.61845.89
3147650-14765042.27443.45
4152109-15210943.55044.79
5147384-14738442.19843.36
6160892-16089246.06547.45
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对照品来源自制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%
111.872060602058132057462059002057772058590.07
211.842079272085142082200.20
单位质量响应值RSD%判断
17342.8017586.150.99数据可信
供试品溶液-2024011621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%
5min110837-108375.5715.515.975.575.515.98
211553-115535.9395.94
310069-100695.1765.18
410927-109275.6175.62
59846-98465.0625.06
611048-110485.6795.68
10min118203-182039.3589.282.499.399.312.50
217569-175699.0329.06
318034-180349.2719.30
418517-185179.5199.55
517477-174778.9849.01
618502-185029.5119.54
15min118575-185759.5499.482.149.639.562.14
218727-187279.6279.71
318689-186899.6079.69
418549-185499.5359.62
517663-176639.0809.16
618417-184179.4689.55
20min119274-192749.9089.413.5310.049.543.48
218768-187689.6489.78
317975-179759.2409.37
418409-184099.4639.60
517598-175989.0479.18
617753-177539.1269.26
30min116589-165898.5288.923.318.729.113.27
218168-181689.3409.53
317296-172968.8919.08
417485-174858.9889.18
516857-168578.6668.84
617720-177209.1099.30
45min117783-177839.1428.824.899.389.054.82
217996-179969.2519.49
317026-170268.7538.99
417638-176389.0679.31
515769-157698.1068.33
616676-166768.5738.81
60min117006-170068.7428.601.939.038.881.92
216895-168958.6858.98
316230-162308.3438.63
416980-169808.7299.02
516414-164148.4388.71
616798-167988.6358.92
极限116018-160188.2348.492.318.578.822.27
216865-168658.6709.01
316436-164368.4498.78
416991-169918.7359.07
516174-161748.3158.63
616588-165888.5278.86
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%
110.923130303129303132033130413130693130550.04
211.013173823176793175300.07
单位质量响应值RSD%判断
28668.0428840.150.43数据可信
供试品溶液-2024011621批-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%
5min137525-3752510.78013.0324.7510.7813.0324.75
238378-3837811.02511.02
366854-6685419.20519.20
444912-4491212.90212.90
537884-3788410.88310.88
646587-4658713.38313.38
10min1135875-13587539.03237.7412.5939.0937.8112.59
2133542-13354238.36238.42
3153572-15357244.11644.22
4138972-13897239.92239.99
5121004-12100434.76034.82
6105223-10522330.22730.30
15min1183742-18374252.78349.0811.4553.0649.3611.44
2176777-17677750.78251.06
3186464-18646453.56553.92
4178430-17843051.25751.55
5166137-16613747.72647.98
6133596-13359638.37838.62
20min1204920-20492058.86754.3411.0059.4454.8910.99
2195169-19516956.06556.62
3201279-20127957.82158.47
4196047-19604756.31856.90
5189356-18935654.39654.91
6148114-14811442.54843.00
30min1218231-21823162.69059.218.9363.5960.078.95
2210618-21061860.50361.37
3220187-22018763.25264.22
4209778-20977860.26261.15
5208077-20807759.77360.59
6169897-16989748.80649.50
45min1230199-23019966.12862.968.9767.3764.158.99
2223471-22347164.19665.40
3242195-24219569.57470.90
4217437-21743762.46263.69
5218020-21802062.63063.78
6183722-18372252.77753.74
60min1231360-23136066.46263.507.8968.0765.037.91
2221045-22104563.49965.06
3242418-24241869.63871.35
4211002-21100260.61462.19
5227800-22780065.43966.94
6192570-19257055.31956.58
极限1236072-23607267.81569.484.4769.8071.374.55
2245242-24524270.45072.36
3260059-26005974.70676.80
4238032-23803268.37970.29
5243776-24377670.02971.89
6228102-22810265.52667.09
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对照品来源自制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%
111.872053682055622059292062312064132059010.22
211.842072162079302075730.25
单位质量响应值RSD%判断
17346.3417531.500.76数据可信
供试品溶液-2024011621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%
5min111302-113025.8186.114.615.826.114.59
212900-129006.6416.64
311788-117886.0696.07
411813-118136.0816.08
511890-118906.1216.12
611551-115515.9475.95
10min118363-183639.4539.471.199.499.501.19
218591-185919.5719.61
318300-183009.4219.45
418709-187099.6329.67
518186-181869.3629.40
618186-181869.3629.40
15min117939-179399.2359.421.279.329.511.28
218487-184879.5179.61
318248-182489.3949.48
418610-186109.5819.67
518313-183139.4289.51
618248-182489.3949.48
20min117620-176209.0719.152.059.219.292.04
218150-181509.3449.49
317216-172168.8639.00
418121-181219.3299.47
517592-175929.0579.19
617941-179419.2369.37
30min117630-176309.0768.982.049.269.161.98
217305-173058.9099.10
317852-178529.1909.38
417737-177379.1319.32
517012-170128.7588.95
617074-170748.7908.98
45min116810-168108.6548.871.828.899.111.78
217541-175419.0309.27
317364-173648.9399.18
417442-174428.9799.22
516858-168588.6798.92
617344-173448.9299.17
60min116651-166518.5728.602.758.868.892.69
217171-171718.8409.13
316887-168878.6948.98
417146-171468.8279.12
516389-163898.4378.72
615994-159948.2348.52
极限116625-166258.5598.661.238.899.001.22
217185-171858.8479.19
316768-167688.6328.97
416726-167268.6118.95
516707-167078.6018.93
616950-169508.7269.06
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%
110.923123003128543129863136263138753131280.21
211.013160683166283163480.13
单位质量响应值RSD%判断
28674.7328732.790.15数据可信
供试品溶液-2024011621批-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%
5min162519-6251917.99116.4716.8817.9916.4716.88
267018-6701819.28619.29
364594-6459418.58818.59
457828-5782816.64116.64
549257-4925714.17514.17
642244-4224412.15612.16
10min1150306-15030643.25340.234.9743.3540.324.98
2140522-14052240.43840.54
3143786-14378641.37741.48
4139725-13972540.20840.30
5132703-13270338.18838.27
6131803-13180337.92938.00
15min1181894-18189452.34350.963.3252.6851.283.32
2171580-17158049.37549.71
3176487-17648750.78751.12
4185870-18587053.48753.80
5170700-17070049.12249.41
6176077-17607750.66950.95
20min1196922-19692256.66855.315.1857.3055.905.13
2186035-18603553.53554.14
3180579-18057951.96552.58
4207017-20701759.57360.19
5185076-18507653.25953.82
6197528-19752856.84257.40
30min1209345-20934560.24360.475.0461.1961.385.00
2201058-20105857.85858.76
3209546-20954660.30161.20
4230083-23008366.21067.15
5201259-20125957.91658.78
6209529-20952960.29661.17
45min1211987-21198761.00364.025.7562.2865.265.68
2219294-21929463.10664.33
3218485-21848562.87364.11
4246247-24624770.86272.17
5212474-21247461.14362.32
6226356-22635665.13866.35
60min1220493-22049363.45164.085.1165.0765.685.07
2221527-22152763.74865.32
3220405-22040563.42565.01
4244706-24470670.41872.12
5211669-21166960.91162.43
6217383-21738362.55664.13
极限1240690-24069069.26371.082.9171.2373.042.90
2247828-24782871.31773.25
3241056-24105669.36871.31
4256301-25630173.75575.85
5241285-24128569.43471.29
6254929-25492973.36075.28
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