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%
19.911715741718441718371717451714981717000.10
29.991717051718381717720.06
单位质量响应值RSD%判断
17325.9317194.390.54数据可信
供试品溶液-B25010111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%
5min16412-64123.3354.5219.983.344.5219.93
27461-74613.8813.88
38406-84064.3724.37
48430-84304.3854.38
510424-104245.4225.42
610968-109685.7055.70
10min115978-159788.3118.311.658.338.341.66
216140-161408.3958.42
315943-159438.2938.32
415503-155038.0648.09
516015-160158.3308.36
616282-162828.4698.50
15min117345-173459.0228.642.429.098.712.38
216645-166458.6588.73
316410-164108.5358.61
416190-161908.4218.49
516409-164098.5358.61
616674-166748.6738.75
20min115840-158408.2398.271.308.358.391.26
216230-162308.4428.56
315769-157698.2028.32
416097-160978.3738.49
515752-157528.1938.32
615755-157558.1958.32
30min116367-163678.5138.302.358.678.462.28
216433-164338.5478.71
315472-154728.0488.21
415810-158108.2238.39
515945-159458.2948.46
615728-157288.1818.35
45min114929-149297.7657.841.017.978.051.06
215132-151327.8718.08
314911-149117.7567.96
414987-149877.7958.00
515288-152887.9528.17
615174-151747.8938.11
60min115867-158678.2537.991.798.508.251.67
215371-153717.9958.25
315397-153978.0098.26
415244-152447.9298.18
515293-152937.9548.21
615043-150437.8248.09
极限115455-154558.0397.971.238.348.271.16
215404-154048.0128.31
315449-154498.0368.33
415477-154778.0508.35
515164-151647.8878.19
615027-150277.8168.12
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%
110.961526171526771525581527641526651526560.06
210.971523721522501523110.06
单位质量响应值RSD%判断
13928.4713884.320.23数据可信
供试品溶液-B25010111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%
5min156202-5620233.38237.9624.8933.3837.9624.89
255115-5511532.73732.74
356271-5627133.42333.42
451419-5141930.54130.54
571245-7124542.31842.32
693229-9322955.37655.38
10min1128381-12838176.25578.044.4476.4478.254.49
2125373-12537374.46874.65
3128431-12843176.28576.47
4128761-12876176.48176.65
5137577-13757781.71781.95
6139779-13977983.02583.33
15min1152103-15210390.34590.152.2390.9590.802.28
2148242-14824288.05288.65
3147680-14768087.71888.33
4151693-15169390.10290.70
5156052-15605292.69193.38
6154870-15487091.98992.76
20min1146638-14663887.09991.553.5488.2192.693.55
2150837-15083789.59390.68
3150783-15078389.56190.66
4158804-15880494.32595.42
5160289-16028995.20796.41
6157413-15741393.49994.78
30min1160074-16007495.08097.772.9596.6799.432.97
2160773-16077395.49597.08
3161353-16135395.83997.43
4165738-16573898.444100.06
5172613-172613102.527104.26
6167105-16710599.256101.06
45min1154251-15425191.62196.354.2993.7498.554.28
2154988-15498892.05994.17
3161528-16152895.94398.07
4164258-16425897.56599.73
5172708-172708102.584104.89
6165576-16557698.348100.70
60min1161620-16162095.99898.943.2998.63101.683.30
2160465-16046595.31297.94
3165702-16570298.423101.08
4168363-168363100.003102.71
5175687-175687104.353107.23
6167623-16762399.564102.46
极限1162468-16246896.50299.772.8699.67103.052.89
2163809-16380997.298100.45
3165159-16515998.100101.31
4171054-171054101.601104.87
5174380-174380103.577107.03
6170919-170919101.521104.97
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%
19.911716841717341716711715451716601716590.05
29.991717561717481717520.01
单位质量响应值RSD%判断
17321.8017192.390.54数据可信
供试品溶液-B25010111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%
5min19209-92094.7914.3913.964.794.3913.97
29132-91324.7514.75
36593-65933.4303.43
47416-74163.8583.86
58666-86664.5084.51
69602-96024.9955.00
10min116125-161258.3898.192.298.428.222.29
216276-162768.4678.49
315468-154688.0478.07
415485-154858.0568.08
515621-156218.1268.15
615503-155038.0658.09
15min117038-170388.8648.522.748.948.592.72
216530-165308.5998.67
316473-164738.5708.63
416395-163958.5298.60
516102-161028.3778.45
615700-157008.1688.24
20min115876-158768.2598.211.398.388.331.37
216002-160028.3258.45
316012-160128.3308.44
415575-155758.1038.22
515496-154968.0618.18
615732-157328.1848.30
30min116118-161188.3858.221.928.558.381.90
216039-160398.3448.51
315963-159638.3048.46
415818-158188.2298.39
515324-153247.9728.13
615588-155888.1098.27
45min115075-150757.8427.822.128.068.022.12
215308-153087.9648.18
314741-147417.6697.87
414742-147427.6697.87
514795-147957.6977.90
615481-154818.0548.26
60min115461-154618.0437.871.618.308.121.57
215209-152097.9128.17
315345-153457.9838.23
415000-150007.8038.05
514942-149427.7738.02
614848-148487.7247.98
极限115324-153247.9727.891.688.288.191.66
215395-153958.0098.31
315333-153337.9778.27
415263-152637.9408.23
514930-149307.7678.06
614774-147747.6867.98
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%
110.961523391521941521641518531521511521400.12
210.971521861522871522360.05
单位质量响应值RSD%判断
13881.3913877.480.02数据可信
供试品溶液-B25010111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%
5min177378-7737846.05037.4116.4446.0537.4016.44
264062-6406238.12538.12
353421-5342131.79231.79
454677-5467732.54032.54
554755-5475532.58632.59
672827-7282743.34143.34
10min1135085-13508580.39276.913.6880.6577.123.71
2129980-12998077.35477.57
3122696-12269673.01973.20
4124377-12437774.02074.20
5131061-13106177.99878.18
6132166-13216678.65578.90
15min1153200-15320091.17388.472.5891.8889.112.60
2152718-15271890.88691.53
3144153-14415385.78986.37
4145085-14508586.34486.94
5149585-14958589.02289.64
6147219-14721987.61488.29
20min1151147-15114789.95190.722.7391.1691.842.73
2154867-15486792.16593.31
3149085-14908588.72489.78
4146977-14697787.47088.54
5154252-15425291.79992.91
6158274-15827494.19395.36
30min1163949-16394997.57096.812.6299.2898.442.63
2167088-16708899.438101.10
3156784-15678493.30694.86
4157937-15793793.99295.55
5165457-16545798.468100.09
6164800-16480098.07799.76
45min1159775-15977595.08696.334.7597.3498.504.70
2166692-16669299.203101.41
3151153-15115389.95592.03
4155981-15598192.82894.91
5165556-16555698.527100.69
6172057-172057102.395104.63
60min1165548-16554898.52297.973.21101.30100.683.21
2169573-169573100.917103.68
3157868-15786893.95196.52
4158202-15820294.15096.75
5168286-168286100.151102.86
6168293-168293100.155102.96
极限1168610-168610100.34498.971.89103.67102.221.94
2168483-168483100.268103.59
3161405-16140596.05699.15
4163289-16328997.177100.30
5168167-168167100.080103.35
6167903-16790399.923103.28
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%
19.911717751716651716941718241717881717490.04
29.991725351723441724400.08
单位质量响应值RSD%判断
17330.8817261.260.29数据可信
供试品溶液-B25010511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%
5min111332-113325.8826.093.575.886.103.57
212121-121216.2916.29
311841-118416.1466.15
412309-123096.3896.39
511546-115465.9935.99
611300-113005.8655.87
10min116606-166068.6198.632.198.658.662.17
216460-164608.5448.58
316906-169068.7758.81
416176-161768.3968.43
516420-164208.5238.56
617181-171818.9188.95
15min117097-170978.8748.712.168.958.802.11
217169-171698.9128.99
316695-166958.6668.75
416234-162348.4268.51
516539-165398.5858.67
616982-169828.8158.90
20min116597-165978.6158.601.388.748.731.36
216400-164008.5128.64
316673-166738.6548.79
416313-163138.4678.60
516954-169548.8008.93
616507-165078.5688.70
30min115815-158158.2098.220.768.398.400.76
215892-158928.2498.43
316050-160508.3318.51
415755-157558.1788.35
515777-157778.1898.37
615722-157228.1618.34
45min116157-161578.3868.152.188.618.372.10
215932-159328.2708.49
315830-158308.2178.44
415309-153097.9468.17
515637-156378.1168.34
615320-153207.9528.18
60min115233-152337.9077.742.158.188.012.07
215208-152087.8948.16
314837-148377.7017.97
414393-143937.4717.74
514773-147737.6687.94
615078-150787.8268.09
极限115552-155528.0728.010.868.398.320.86
215415-154158.0018.32
315624-156248.1108.42
415368-153687.9778.28
515285-152857.9348.24
615331-153317.9588.27
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%
110.961524131520691521331524071523821522810.11
210.971529271529411529340.01
单位质量响应值RSD%判断
13894.2513941.110.24数据可信
供试品溶液-B25010511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%
5min169900-6990041.48542.847.5641.4942.847.55
277994-7799446.28946.29
376892-7689245.63545.63
475523-7552344.82244.82
568507-6850740.65840.66
664260-6426038.13838.14
10min1124457-12445773.86474.802.4474.0975.042.45
2126678-12667875.18275.44
3131383-13138377.97578.23
4125989-12598974.77375.02
5122104-12210472.46872.69
6125572-12557274.52674.74
15min1143897-14389785.40285.291.9586.0485.941.95
2148539-14853988.15788.83
3144878-14487885.98486.67
4142513-14251384.58085.24
5140798-14079883.56284.19
6141643-14164384.06484.69
20min1149432-14943288.68789.481.7489.8090.611.75
2152372-15237290.43191.60
3154792-15479291.86893.03
4150566-15056689.36090.49
5150349-15034989.23190.32
6147106-14710687.30688.40
30min1152554-15255490.53991.251.9892.1592.871.99
2155254-15525492.14293.81
3157694-15769493.59095.26
4155953-15595392.55794.19
5151293-15129389.79191.38
6149752-14975288.87790.45
45min1158759-15875994.22294.111.7996.3396.241.77
2163731-16373197.17399.35
3158300-15830093.95096.14
4155481-15548192.27794.42
5158446-15844694.03696.12
6156668-15666892.98195.05
60min1157618-15761893.54593.501.7396.1896.151.67
2160976-16097695.53898.26
3154381-15438191.62494.34
4154929-15492991.94994.61
5156944-15694493.14595.75
6160361-16036195.17397.76
极限1163017-16301796.74997.120.4399.90100.290.42
2164215-16421597.460100.71
3162837-16283796.64299.87
4164636-16463697.710100.88
5163484-16348497.026100.15
6163623-16362397.109100.23
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%
19.911717221719791716611717061716401717420.08
29.991726561729831728200.14
单位质量响应值RSD%判断
17330.1717299.300.13数据可信
供试品溶液-B25010511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%
5min111367-113675.8946.226.415.896.226.44
211999-119996.2216.22
313302-133026.8976.90
411918-119186.1796.18
512246-122466.3496.35
611111-111115.7615.76
10min116985-169858.8078.592.748.848.632.73
217125-171258.8798.91
316736-167368.6778.72
416165-161658.3818.42
515988-159888.2908.32
616444-164448.5268.56
15min117391-173919.0178.752.099.108.832.05
217259-172598.9499.03
316649-166498.6328.72
416659-166598.6388.72
516614-166148.6148.70
616684-166848.6508.73
20min116931-169318.7798.542.968.918.682.95
216931-169318.7798.91
316685-166858.6518.79
416557-165578.5858.71
515768-157688.1768.30
616008-160088.3008.43
30min115375-153757.9728.181.938.158.361.86
215857-158578.2228.40
315480-154808.0268.21
416073-160738.3348.51
515766-157668.1758.35
616118-161188.3578.53
45min116380-163808.4938.321.768.728.551.74
216390-163908.4988.73
315704-157048.1428.37
416037-160378.3158.54
515918-159188.2538.47
615869-158698.2288.45
60min114973-149737.7637.912.508.048.182.40
215267-152677.9168.19
315033-150337.7948.07
415661-156618.1208.39
514848-148487.6997.96
615768-157688.1768.44
极限115811-158118.1987.982.518.518.302.45
215846-158468.2168.54
315085-150857.8218.14
415360-153607.9648.28
514875-148757.7138.02
615380-153807.9748.29
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%
110.961518821522881521741519201520671520660.12
210.971528071530911529490.14
单位质量响应值RSD%判断
13874.6413942.480.35数据可信
供试品溶液-B25010511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%
5min176987-7698745.72142.5810.2745.7242.5810.27
276749-7674945.58045.58
373873-7387343.87243.87
464572-6457238.34838.35
577625-7762546.10046.10
660430-6043035.88835.89
10min1130866-13086677.71974.414.6877.9774.644.69
2132599-13259978.74879.00
3127237-12723775.56475.81
4118909-11890970.61870.83
5122979-12297973.03573.29
6119168-11916870.77270.97
15min1149048-14904888.51786.163.5089.2086.813.52
2152123-15212390.34391.03
3144937-14493786.07686.74
4138911-13891182.49783.10
5145359-14535986.32686.99
6140091-14009183.19883.79
20min1153824-15382491.35389.183.4292.5390.313.44
2156939-15693993.20394.40
3152473-15247390.55191.69
4146911-14691187.24888.31
5147805-14780587.77988.92
6143055-14305584.95886.01
30min1149224-14922488.62290.991.8990.3192.621.87
2156082-15608292.69494.40
3155486-15548692.34093.99
4150132-15013289.16190.71
5153471-15347191.14492.77
6154910-15491091.99893.53
45min1160374-16037495.24396.071.4697.4298.201.48
2163588-16358897.15299.38
3163924-16392497.35299.51
4159699-15969994.84296.89
5164078-16407897.44399.58
6158928-15892894.38596.42
60min1154441-15444191.72094.501.7394.4397.161.67
2158049-15804993.86396.63
3162332-16233296.40699.10
4159271-15927194.58897.16
5161173-16117395.71898.39
6159472-15947294.70897.27
极限1164515-16451597.70397.351.97100.92100.531.98
2167991-16799199.767103.05
3167388-16738899.409102.64
4161089-16108995.66898.76
5161924-16192496.16499.37
6160582-16058295.36798.46
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%
19.911717881717241717611718101718121717790.03
29.991722891720811721850.09
单位质量响应值RSD%判断
17333.9117235.740.41数据可信
供试品溶液-B25010311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%
5min18468-84684.3984.8610.974.404.8611.01
27903-79034.1054.10
39286-92864.8234.82
410194-101945.2955.29
59697-96975.0375.04
610599-105995.5055.51
10min116887-168878.7718.842.078.808.862.07
217019-170198.8408.86
316581-165818.6128.64
416937-169378.7978.83
517011-170118.8358.86
617651-176519.1689.20
15min117307-173078.9898.912.249.068.982.20
217122-171228.8938.96
317103-171038.8838.96
416828-168288.7408.82
516747-167478.6988.78
617815-178159.2539.33
20min115960-159608.2898.412.468.418.532.46
216435-164358.5368.66
315850-158508.2328.36
416212-162128.4208.55
515812-158128.2138.34
616836-168368.7448.88
30min116817-168178.7358.413.888.908.583.80
216628-166288.6368.81
315075-150757.8308.00
416133-161338.3798.55
516004-160048.3128.48
616506-165068.5738.75
45min115496-154968.0488.041.918.278.261.89
215723-157238.1668.38
315349-153497.9728.19
415110-151107.8488.07
515315-153157.9548.17
615920-159208.2698.50
60min115669-156698.1388.092.138.408.362.08
215925-159258.2718.53
315487-154878.0448.30
415233-152337.9128.18
515205-152057.8978.16
615966-159668.2938.57
极限115502-155028.0528.042.828.368.352.73
216108-161088.3668.67
315106-151067.8468.15
415051-150517.8178.13
515251-152517.9218.23
615904-159048.2608.58
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%
110.961528291528971527361526931526501527610.07
210.971532571532801532680.02
单位质量响应值RSD%判断
13938.0513971.560.17数据可信
供试品溶液-B25010311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%
5min179055-7905546.79444.2318.9946.7944.2318.99
257393-5739333.97233.97
357043-5704333.76433.76
491245-9124554.00954.01
582460-8246048.80948.81
681159-8115948.03948.04
10min1133128-13312878.80076.834.4379.0677.074.47
2123179-12317972.91173.10
3122114-12211472.28172.47
4134300-13430079.49479.79
5135225-13522580.04180.31
6130809-13080977.42777.69
15min1147210-14721087.13586.451.6987.8387.121.74
2141584-14158483.80584.40
3144979-14497985.81586.40
4146523-14652386.72987.47
5147688-14768887.41888.13
6148311-14831187.78788.48
20min1148188-14818887.71488.562.4088.9089.712.44
2144905-14490585.77186.83
3146568-14656886.75587.82
4153108-15310890.62691.85
5151360-15136089.59290.79
6153528-15352890.87592.06
30min1161076-16107695.34395.271.3197.0196.911.37
2158261-15826193.67795.21
3158586-15858693.86995.42
4161813-16181395.77997.51
5163415-16341596.72798.43
6162548-16254896.21497.90
45min1157433-15743393.18693.922.4995.3996.092.49
2154506-15450691.45493.51
3156297-15629792.51494.58
4156545-15654592.66194.92
5163651-16365196.86799.10
6163576-16357696.82399.05
60min1162129-16212995.96695.861.4298.6898.561.44
2160487-16048794.99497.56
3159832-15983294.60697.19
4159926-15992694.66297.44
5164144-16414497.15999.93
6165215-16521597.793100.55
极限1163988-16398897.06696.031.93100.3299.261.95
2159179-15917994.22097.31
3158577-15857793.86496.97
4160761-16076195.15698.46
5165332-16533297.862101.18
6165549-16554997.990101.30
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%
19.911715801717951717661717391718861717530.07
29.991721741722731722240.05
单位质量响应值RSD%判断
17331.2817239.640.38数据可信
供试品溶液-B25010311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%
5min19704-97045.0404.838.065.044.838.05
28875-88754.6094.61
38310-83104.3164.32
48743-87434.5414.54
59946-99465.1665.17
610167-101675.2805.28
10min117295-172958.9838.722.349.018.742.35
216769-167698.7098.73
316716-167168.6828.71
416259-162598.4448.47
516512-165128.5768.60
617168-171688.9178.95
15min117313-173138.9928.831.299.078.901.29
216876-168768.7658.84
317153-171538.9098.98
416767-167678.7088.78
516795-167958.7238.80
617074-170748.8688.95
20min116358-163588.4968.411.558.628.531.57
216217-162178.4238.55
315961-159618.2908.41
416065-160658.3448.46
515933-159338.2758.40
616575-165758.6098.74
30min116669-166698.6578.441.428.838.611.39
216330-163308.4818.65
316192-161928.4108.58
416192-161928.4108.58
515999-159998.3098.48
616139-161398.3828.56
45min115887-158878.2517.903.168.478.123.08
215493-154938.0478.26
315143-151437.8658.08
414451-144517.5057.72
515043-150437.8138.03
615238-152387.9148.14
60min115650-156508.1288.111.998.408.371.96
216128-161288.3768.64
315491-154918.0468.30
415574-155748.0898.34
515169-151697.8788.14
615664-156648.1358.40
极限115731-157318.1708.061.788.488.371.66
215619-156198.1128.42
315469-154698.0348.34
415874-158748.2448.54
515312-153127.9538.26
615127-151277.8578.17
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%
110.961528381525371529291529161528611528160.11
210.971530791531451531120.04
单位质量响应值RSD%判断
13943.0713957.340.08数据可信
供试品溶液-B25010311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%
5min180504-8050447.66744.8911.5747.6744.8911.57
270607-7060741.80741.81
370320-7032041.63741.64
463941-6394137.86037.86
586174-8617451.02451.02
683342-8334249.34749.35
10min1132416-13241678.40476.533.3578.6776.783.37
2129595-12959576.73476.97
3126632-12663274.98075.21
4121924-12192472.19272.40
5133421-13342178.99979.28
6131560-13156077.89878.17
15min1147484-14748487.32686.871.3788.0387.541.40
2148486-14848687.92088.58
3144629-14462985.63686.28
4143744-14374485.11285.72
5148238-14823887.77388.50
6147651-14765187.42588.13
20min1151585-15158589.75488.311.5990.9489.471.62
2149229-14922988.35989.51
3145986-14598686.43987.56
4146561-14656186.78087.86
5150527-15052789.12890.34
6151011-15101189.41590.61
30min1162011-16201195.92895.061.3797.6196.711.39
2162368-16236896.13997.78
3157038-15703892.98394.59
4158612-15861293.91595.48
5161898-16189895.86197.57
6161386-16138695.55897.25
45min1161188-16118895.44093.262.7497.6695.442.73
2159880-15988094.66696.84
3153596-15359690.94593.07
4150674-15067489.21591.30
5160337-16033794.93797.17
6159350-15935094.35296.57
60min1163801-16380196.98896.141.2999.7398.831.31
2163175-16317596.61799.31
3158987-15898794.13796.76
4161115-16111595.39797.98
5162337-16233796.12198.89
6164809-16480997.584100.33
极限1166347-16634798.49596.641.22101.7899.871.21
2163238-16323896.65499.89
3160855-16085595.24398.39
4163589-16358996.86299.98
5163923-16392397.060100.36
6161346-16134695.53498.82
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