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%
19.911705801702481701411700241703001702590.13
29.991699341701441700390.09
单位质量响应值RSD%判断
17180.5217020.920.66数据可信
供试品溶液-B24120811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%
5min18367-83674.3934.796.074.394.796.06
29528-95285.0025.00
39911-99115.2035.20
49029-90294.7404.74
59201-92014.8304.83
68722-87224.5794.58
10min116430-164308.6268.601.988.658.621.99
216433-164338.6278.65
316748-167488.7938.82
416645-166458.7388.76
516091-160918.4488.47
615902-159028.3488.37
15min117246-172469.0548.812.339.138.882.34
216837-168378.8398.91
317108-171088.9829.06
416822-168228.8318.91
516400-164008.6108.68
616243-162438.5278.60
20min116750-167508.7948.571.728.928.691.74
216276-162768.5458.67
316432-164328.6278.75
416407-164078.6138.74
516131-161318.4698.59
615932-159328.3648.48
30min114675-146757.7048.002.437.888.172.35
215372-153728.0708.24
315320-153208.0438.22
415521-155218.1488.32
514919-149197.8328.00
615636-156368.2098.37
45min115396-153968.0837.991.748.308.201.71
215247-152478.0058.22
315095-150957.9258.14
415519-155198.1478.36
514763-147637.7507.96
615255-152558.0098.22
60min115060-150607.9067.811.558.178.071.54
215152-151527.9558.22
314869-148697.8068.07
414696-146967.7157.98
514530-145307.6287.88
614912-149127.8298.08
极限115711-157118.2487.932.258.558.232.19
215116-151167.9368.24
315003-150037.8768.18
415198-151987.9798.28
514712-147127.7248.02
614913-149137.8298.13
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对照品来源工作对照品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5000
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%
110.963080863071303076803069243078253075290.16
210.973071513068493070000.07
单位质量响应值RSD%判断
28059.2227985.410.19数据可信
供试品溶液-B24120811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%
5min1127802-12780237.67227.1833.2837.6727.1833.28
2105500-10550031.09831.10
3124299-12429936.63936.64
466448-6644819.58719.59
569519-6951920.49220.49
659720-5972017.60317.60
10min1253866-25386674.83168.538.1575.0468.688.20
2240656-24065670.93771.11
3251863-25186374.24174.44
4214716-21471663.29163.40
5223535-22353565.89066.00
6210203-21020361.96162.06
15min1296344-29634487.35284.532.5787.9885.062.64
2283396-28339683.53584.10
3295450-29545087.08987.70
4281505-28150582.97883.44
5285129-28512984.04684.53
6278859-27885982.19882.64
20min1314498-31449892.70390.121.7993.8191.121.85
2302749-30274989.24090.27
3307136-30713690.53391.63
4301627-30162788.90989.83
5308741-30874191.00691.95
6299749-29974988.35689.25
30min1296553-29655387.41491.262.8389.0492.762.70
2303062-30306289.33290.86
3310739-31073991.59593.20
4309718-30971891.29492.71
5318579-31857993.90695.36
6318900-31890094.00195.39
45min1324162-32416295.55293.731.7397.6695.741.67
2309488-30948891.22693.25
3313250-31325092.33594.45
4320603-32060394.50396.43
5320500-32050094.47296.45
6319942-31994294.30896.22
60min1322181-32218194.96893.521.2997.6196.051.29
2312948-31294892.24694.78
3315467-31546792.98995.61
4313943-31394392.54094.99
5322364-32236495.02297.52
6316768-31676893.37295.81
极限1323208-32320895.27194.270.9398.4497.320.93
2315468-31546892.98996.03
3318489-31848993.88097.02
4319494-31949494.17697.14
5323092-32309295.23698.26
6319122-31912294.06697.02
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%
19.911705341706411708471706681706701706720.07
29.991700311705431702870.22
单位质量响应值RSD%判断
17222.2017045.750.73数据可信
供试品溶液-B24120811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%
5min18552-85524.4814.692.604.484.692.62
28918-89184.6734.67
38983-89834.7074.71
49272-92724.8584.86
59021-90214.7274.73
68976-89764.7034.70
10min116110-161108.4418.470.808.478.500.79
216261-162618.5208.55
316223-162238.5008.53
416327-163278.5558.58
516100-161008.4368.46
615974-159748.3708.40
15min116817-168178.8128.760.988.888.840.95
216832-168328.8208.89
316934-169348.8738.95
416670-166708.7358.81
516553-165538.6738.75
616533-165338.6638.74
20min116728-167288.7658.582.068.898.702.04
216019-160198.3948.52
316742-167428.7728.90
416523-165238.6588.78
516218-162188.4988.62
616004-160048.3868.51
30min115456-154568.0997.981.318.278.151.30
215401-154018.0708.24
315315-153158.0258.20
415138-151387.9328.10
514924-149247.8207.99
615144-151447.9358.10
45min115531-155318.1388.081.538.358.291.50
215153-151537.9408.15
315677-156778.2148.43
415514-155148.1298.34
515090-150907.9078.12
615516-155168.1308.34
60min115185-151857.9577.901.658.228.161.62
215328-153288.0318.29
315303-153038.0188.28
414753-147537.7307.99
514803-148037.7568.01
615137-151377.9318.19
极限115320-153208.0277.981.038.338.281.04
215357-153578.0478.35
315407-154078.0738.38
415155-151557.9418.24
515180-151807.9548.25
614989-149897.8548.15
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对照品来源工作对照品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5000
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%
110.963072273082523075933074753066303074350.20
210.973070243066293068260.10
单位质量响应值RSD%判断
28050.6427969.550.21数据可信
供试品溶液-B24120811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%
5min185693-8569325.27027.1026.6125.2727.1026.63
296521-9652128.46328.46
3117587-11758734.67634.68
4121094-12109435.71035.71
565871-6587119.42519.42
664683-6468319.07519.07
10min1234272-23427269.08568.165.8769.2368.315.92
2230274-23027467.90668.06
3242873-24287371.62271.81
4248130-24813073.17273.37
5217031-21703164.00164.11
6214285-21428563.19163.30
15min1288131-28813184.96884.571.0785.4985.101.13
2287395-28739584.75185.29
3290860-29086085.77386.36
4287894-28789484.89885.50
5284044-28404483.76384.23
6282395-28239583.27783.73
20min1312424-31242492.13290.851.3793.1391.851.41
2307139-30713990.57491.58
3313081-31308192.32693.39
4308606-30860691.00692.08
5304959-30495989.93190.86
6302238-30223889.12890.05
30min1316701-31670193.39391.671.2894.9093.181.24
2313913-31391392.57194.08
3307577-30757790.70392.28
4307686-30768690.73592.32
5307301-30730190.62192.05
6312013-31201392.01193.43
45min1323398-32339895.36895.320.9897.4097.330.96
2319807-31980794.30996.33
3324429-32442995.67297.76
4323799-32379995.48697.57
5319755-31975594.29496.23
6328181-32818196.77998.70
60min1325415-32541595.96394.611.6898.5297.161.61
2324197-32419795.60498.15
3318545-31854593.93796.55
4312951-31295192.28794.90
5317391-31739193.59796.05
6326552-32655296.29898.76
极限1323387-32338795.36595.100.3298.4598.160.27
2322604-32260495.13498.21
3321989-32198994.95398.09
4320706-32070694.57497.70
5323302-32330295.34098.32
6322902-32290295.22298.22
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%
19.911706761703511701671704211706711704570.13
29.991712461715701714080.14
单位质量响应值RSD%判断
17200.5017157.960.18数据可信
供试品溶液-B24120812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%
5min111619-116196.0725.8110.306.075.8210.30
29045-90454.7274.73
311145-111455.8245.82
411994-119946.2686.27
512182-121826.3666.37
610777-107775.6325.63
10min119015-190159.9379.355.609.979.385.56
219018-190189.9389.96
316415-164158.5788.61
417431-174319.1099.14
517835-178359.3209.36
617608-176089.2029.23
15min117773-177739.2889.273.559.389.363.53
218666-186669.7549.84
317277-172779.0299.11
416960-169608.8638.95
518259-182599.5429.63
617554-175549.1739.26
20min118029-180299.4229.084.269.569.224.22
218356-183569.5929.73
316486-164868.6158.75
416699-166998.7278.86
517555-175559.1749.31
617125-171258.9499.08
30min116385-163858.5628.533.068.768.713.03
216697-166978.7268.91
315677-156778.1928.37
415764-157648.2388.42
516920-169208.8429.03
616441-164418.5928.77
45min115976-159768.3498.362.418.598.602.42
216223-162238.4788.72
315562-155628.1328.36
415566-155668.1348.36
516524-165248.6358.88
616192-161928.4628.69
60min115660-156608.1848.144.778.478.424.69
216118-161188.4238.71
314969-149697.8228.09
414452-144527.5527.83
516453-164538.5988.89
615784-157848.2488.53
极限116083-160838.4058.173.728.748.503.68
216146-161468.4388.77
314896-148967.7848.10
414967-149677.8218.14
516119-161198.4238.76
615633-156338.1698.49
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对照品来源工作对照品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5000
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%
110.963079763073553068963069723073673073130.14
210.973089023085543087280.08
单位质量响应值RSD%判断
28039.5128142.940.27数据可信
供试品溶液-B24120812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%
5min1115249-11524933.88826.6632.7933.8926.6632.79
261162-6116217.98417.98
359023-5902317.35517.36
4123447-12344736.29936.30
5113297-11329733.31433.31
671823-7182321.11921.12
10min1232659-23265968.41266.167.4968.6066.317.54
2205263-20526360.35660.46
3207124-20712460.90361.00
4250273-25027373.59173.79
5226565-22656566.62066.80
6228169-22816967.09267.21
15min1264045-26404577.64180.383.8678.2180.893.87
2258668-25866876.06076.49
3278151-27815181.78882.22
4287784-28778484.62185.23
5273528-27352880.42980.98
6277912-27791281.71882.21
20min1289158-28915885.02586.252.6686.0287.212.67
2283429-28342983.34084.20
3300317-30031788.30689.20
4303350-30335089.19890.28
5287735-28773584.60685.61
6295902-29590287.00887.95
30min1282024-28202482.92788.194.3784.4089.634.34
2285446-28544683.93385.25
3309726-30972691.07392.45
4313539-31353992.19493.77
5303110-30311089.12790.60
6305714-30571489.89391.32
45min1300715-30071588.42392.033.6890.3693.963.68
2297351-29735187.43489.22
3323923-32392395.24797.13
4324505-32450595.41897.51
5315086-31508692.64994.62
6316321-31632193.01294.94
60min1298147-29814787.66891.202.9590.0993.642.94
2300387-30038788.32790.60
3321591-32159194.56296.98
4316301-31630193.00695.62
5311985-31198591.73794.22
6312526-31252691.89694.34
极限1307778-30777890.50093.552.0793.4196.492.07
2313500-31350092.18394.95
3325356-32535695.66998.61
4323183-32318395.03098.16
5317852-31785293.46296.45
6321146-32114694.43197.38
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%
19.911704281710761706141708661706691707310.15
29.991702701704431703560.08
单位质量响应值RSD%判断
17228.1517052.650.73数据可信
供试品溶液-B24120812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%
5min111093-110935.8105.716.245.815.716.26
210749-107495.6305.63
39983-99835.2295.23
410395-103955.4455.44
511887-118876.2266.23
611327-113275.9335.93
10min117938-179389.3959.263.029.439.293.03
218317-183179.5949.63
318170-181709.5179.55
417267-172679.0449.07
517098-170988.9568.99
617229-172299.0249.06
15min117555-175559.1959.253.979.289.343.92
218344-183449.6089.69
318481-184819.6809.76
417728-177289.2869.37
516579-165798.6848.77
617298-172989.0609.14
20min117425-174259.1279.072.529.269.212.49
217863-178639.3569.49
317710-177109.2769.41
417222-172229.0209.15
517051-170518.9319.06
616679-166798.7368.87
30min116318-163188.5478.541.038.738.721.06
216492-164928.6388.83
316477-164778.6308.82
416277-162778.5268.71
516125-161258.4468.63
616096-160968.4318.61
45min116130-161308.4498.481.488.688.711.46
216405-164058.5938.83
316532-165328.6598.89
416171-161718.4708.70
516002-160028.3818.61
615905-159058.3318.56
60min115776-157768.2638.132.808.548.412.75
216218-162188.4958.78
315547-155478.1438.43
414962-149627.8378.11
515355-153558.0438.32
615296-152968.0128.29
极限115721-157218.2348.112.868.568.442.80
215404-154048.0688.40
316263-162638.5188.85
415192-151927.9578.28
515086-150867.9028.22
615234-152347.9798.30
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对照品来源工作对照品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5000
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%
110.963071883064063065933077723078383071590.22
210.973067623061093064360.16
单位质量响应值RSD%判断
28025.4627934.000.24数据可信
供试品溶液-B24120812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%
5min183740-8374024.72126.9215.6924.7226.9215.69
289037-8903726.28526.29
386846-8684625.63825.64
475112-7511222.17422.17
5117033-11703334.55034.55
695292-9529228.13228.13
10min1229310-22931067.69665.864.9867.8366.015.00
2217919-21791964.33364.48
3213642-21364263.07063.21
4210050-21005062.01062.13
5239382-23938270.66970.86
6228209-22820967.37167.53
15min1274073-27407380.91079.611.4081.4280.121.39
2267774-26777479.05179.55
3266383-26638378.64079.13
4269284-26928479.49779.96
5265933-26593378.50779.09
6274466-27446681.02681.56
20min1292927-29292786.47685.391.6587.4486.341.67
2285522-28552284.29085.23
3281800-28180083.19184.12
4289278-28927885.39986.31
5294228-29422886.86087.88
6291655-29165586.10187.08
30min1293574-29357486.66787.102.5588.1188.532.55
2289135-28913585.35786.77
3284272-28427283.92185.31
4297709-29770987.88889.27
5303872-30387289.70791.21
6301685-30168589.06290.52
45min1308775-30877591.15591.951.3393.0893.861.35
2308502-30850291.07492.96
3306525-30652590.49192.35
4313570-31357092.57094.44
5317228-31722893.65095.65
6314166-31416692.74694.70
60min1307402-30740290.75090.341.7093.1892.761.72
2304885-30488590.00692.40
3297584-29758487.85190.21
4303912-30391289.71992.11
5312557-31255792.27194.79
6309669-30966991.41993.89
极限1315763-31576393.21893.260.5796.1596.190.57
2318273-31827393.95996.85
3314713-31471392.90895.76
4314188-31418892.75395.64
5314556-31455692.86295.90
6318002-31800293.87996.86
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%
19.911706931705451703731706491704641705450.08
29.991704391707141705760.12
单位质量响应值RSD%判断
17209.3817074.670.56数据可信
供试品溶液-B24120911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%
5min18900-89004.6614.619.504.664.619.50
29343-93434.8934.89
39899-98995.1845.18
48969-89694.6974.70
58213-82134.3014.30
67528-75283.9433.94
10min117447-174479.1379.212.309.169.242.31
218337-183379.6039.63
317736-177369.2899.32
417383-173839.1049.13
517453-174539.1419.16
617200-172009.0089.03
15min117750-177509.2969.282.369.379.362.37
218406-184069.6409.72
317901-179019.3759.46
417233-172339.0259.10
517368-173689.0969.17
617674-176749.2569.33
20min117118-171188.9658.992.289.099.122.30
217748-177489.2959.43
317350-173509.0879.22
417311-173119.0669.19
516855-168558.8278.95
616647-166478.7188.84
30min116247-162478.5098.531.188.698.711.17
216551-165518.6688.85
316347-163478.5618.74
416190-161908.4798.66
516403-164038.5918.76
615997-159978.3788.55
45min116153-161538.4608.381.278.698.611.30
216276-162768.5248.76
315936-159368.3468.58
416033-160338.3978.62
515693-156938.2198.44
615917-159178.3368.55
60min115911-159118.3338.322.038.618.591.99
216298-162988.5368.82
315512-155128.1248.40
415966-159668.3628.63
515504-155048.1208.39
616121-161218.4438.71
极限116173-161738.4708.312.728.798.622.66
216489-164898.6368.96
315563-155638.1518.47
415748-157488.2488.56
515287-152878.0068.32
615930-159308.3438.65
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对照品来源工作对照品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5000
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%
110.963065343065043066363065903067443066020.04
210.973071573065963068760.13
单位质量响应值RSD%判断
27974.6427974.110.01数据可信
供试品溶液-B24120911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%
5min1106016-10601631.30326.3512.2931.3026.3612.28
275102-7510222.17522.18
380695-8069523.82723.83
495530-9553028.20728.21
590964-9096426.85926.86
687221-8722125.75425.75
10min1232005-23200568.50467.693.0668.6867.843.07
2221975-22197565.54365.67
3219473-21947364.80464.94
4237108-23710870.01170.17
5234288-23428869.17869.33
6230675-23067568.11168.25
15min1277329-27732981.88781.562.1682.4482.082.17
2274513-27451381.05681.54
3265017-26501778.25278.74
4279379-27937982.49283.04
5281060-28106082.98983.52
6279982-27998282.67083.19
20min1293554-29355486.67886.942.3087.6987.922.30
2295060-29506087.12288.06
3282659-28265983.46184.39
4302629-30262989.35790.36
5299003-29900388.28789.28
6293778-29377886.74487.72
30min1297674-29767487.89488.922.7789.3990.382.77
2297817-29781787.93789.36
3288175-28817585.09086.48
4306949-30694990.63392.13
5311698-31169892.03593.52
6304478-30447889.90391.37
45min1312477-31247792.26591.502.7894.2493.452.78
2307648-30764890.83992.75
3294071-29407186.83088.69
4317712-31771293.81195.81
5310531-31053191.69193.69
6316773-31677393.53495.50
60min1309938-30993891.51591.963.0194.0194.422.99
2312871-31287192.38294.80
3293624-29362486.69889.04
4319051-31905194.20696.73
5315385-31538593.12495.63
6317882-31788293.86196.34
极限1313289-31328992.50593.533.0995.5196.503.06
2314146-31414692.75895.69
3302659-30265989.36692.19
4325864-32586496.21899.27
5314718-31471892.92795.95
6329842-32984297.393100.40
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%
19.911707651708781709561709601710001709120.06
29.991707291706301706800.05
单位质量响应值RSD%判断
17246.4217085.090.67数据可信
供试品溶液-B24120911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%
5min18155-81554.2654.507.594.274.507.55
28852-88524.6304.63
38974-89744.6934.69
49587-95875.0145.01
58149-81494.2624.26
67860-78604.1114.11
10min117481-174819.1439.161.719.179.181.73
217729-177299.2729.30
317541-175419.1749.20
417928-179289.3769.40
517324-173249.0609.08
617078-170788.9328.95
15min117681-176819.2479.241.049.329.321.06
217860-178609.3419.42
317645-176459.2289.31
417878-178789.3509.43
517460-174609.1329.21
617458-174589.1319.20
20min117138-171388.9639.030.889.099.150.87
217324-173249.0609.19
317258-172589.0269.15
417424-174249.1139.24
517376-173769.0889.21
617025-170258.9049.03
30min116237-162378.4928.551.058.678.721.04
216681-166818.7248.90
316261-162618.5058.68
416352-163528.5528.73
516266-162668.5078.68
616254-162548.5018.67
45min116201-162018.4738.411.138.708.631.13
215953-159538.3438.57
316292-162928.5218.75
416205-162058.4758.71
515894-158948.3138.54
615882-158828.3068.53
60min116058-160588.3988.321.078.678.591.07
215914-159148.3238.60
316126-161268.4348.71
415857-158578.2938.57
515697-156978.2108.48
615744-157448.2348.50
极限116089-160898.4158.352.148.738.672.09
215895-158958.3138.63
316340-163408.5468.87
416307-163078.5298.85
515532-155328.1238.44
615630-156308.1748.49
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对照品来源工作对照品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5000
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%
110.963064643067103067343066803066913066560.04
210.973066513062203064360.10
单位质量响应值RSD%判断
27979.5627934.000.12数据可信
供试品溶液-B24120911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%
5min195141-9514128.11026.234.7828.1126.234.78
282487-8248724.37124.37
389801-8980126.53226.53
486362-8636225.51625.52
590482-9048226.73326.73
688388-8838826.11526.11
10min1231892-23189268.51467.661.9068.6767.801.90
2227934-22793467.34567.48
3222462-22246265.72865.88
4226091-22609166.80066.94
5234290-23429069.22269.37
6231313-23131368.34368.49
15min1279448-27944882.56581.471.9183.1081.991.90
2278962-27896282.42182.93
3269239-26923979.54880.06
4268740-26874079.40179.91
5278859-27885982.39182.92
6279222-27922282.49883.02
20min1295614-29561487.34187.111.8888.3488.091.87
2298443-29844388.17789.14
3290551-29055185.84586.80
4286404-28640484.62085.57
5301680-30168089.13390.12
6296367-29636787.56388.55
30min1305541-30554190.27489.991.9891.7591.451.97
2306852-30685290.66192.12
3299923-29992388.61490.05
4295154-29515487.20588.63
5308300-30830091.08992.58
6311641-31164192.07693.55
45min1316510-31651093.51592.381.1095.5094.341.10
2308462-30846291.13793.10
3312950-31295092.46394.39
4308544-30854491.16193.07
5314984-31498493.06495.06
6314553-31455392.93794.92
60min1319015-31901594.25593.501.5796.7695.971.56
2320616-32061694.72897.20
3316480-31648093.50695.94
4306769-30676990.63793.05
5317631-31763193.84696.36
6318266-31826694.03496.53
极限1325091-32509196.05094.601.4299.0897.601.42
2318081-31808193.97996.97
3315503-31550393.21796.17
4315811-31581193.30896.23
5320780-32078094.77697.81
6325905-32590596.29199.31
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