依折麦布阿托伐他汀片项目信息
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%
19.721613511611821611981610451613601612270.09
29.851614701618751616720.18
单位质量响应值RSD%判断
16587.1416413.400.75数据可信
供试品溶液-B25010511批-依折麦布-pH6.8(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%
5min138762-3876221.09031.4129.6121.0931.4129.61
255725-5572530.32030.32
375308-7530840.97540.97
480985-8098544.06444.06
552759-5275928.70628.71
642828-4282823.30323.30
10min1119697-11969765.12775.6312.3965.2475.8012.43
2140880-14088076.65276.82
3153706-15370683.63183.86
4163595-16359589.01289.26
5132736-13273672.22172.38
6123352-12335267.11567.24
15min1161966-16196688.12591.415.3288.6092.015.39
2167215-16721590.98191.58
3176023-17602395.77496.47
4180948-18094898.45399.19
5164822-16482289.67990.24
6157096-15709685.47585.98
20min1176011-17601195.76796.502.2096.7497.602.30
2175897-17589795.70596.80
3180347-18034798.12699.35
4183489-18348999.836101.12
5175793-17579395.64896.71
6172587-17258793.90494.88
30min1180550-18055098.23799.171.3499.74100.811.44
2181919-18191998.982100.61
3183706-18370699.954101.72
4186446-186446101.445103.29
5179960-17996097.91699.51
6181026-18102698.49699.99
45min1184384-184384100.323100.020.55102.37102.210.61
2184578-184578100.428102.61
3183170-18317099.662101.99
4184919-184919100.614103.02
5183637-18363799.916102.05
6182243-18224399.158101.20
60min1186881-186881101.681100.031.76104.29102.781.71
2188432-188432102.525105.26
3180959-18095998.459101.34
4184326-184326100.291103.25
5181232-18123298.608101.30
6181271-18127198.629101.23
极限1185480-185480100.919100.571.74104.09103.881.66
2190925-190925103.882107.19
3182467-18246799.280102.71
4183414-18341499.795103.32
5182369-18236999.226102.46
6184412-184412100.338103.48
依折麦布阿托伐他汀片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号100590-202406对照品来源中检院对照品使用方法直接使用
对照品含量(%)95.1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%
110.531441981439041438431437711441211439670.13
210.541443071445381444220.12
单位质量响应值RSD%判断
13672.0813702.280.16数据可信
供试品溶液-B25010511批-阿托伐他汀-pH6.8(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%
5min1122752-12275274.23573.4416.8574.2473.4416.84
281945-8194549.55749.56
3121364-12136473.39673.40
4138973-13897384.04584.04
5133817-13381780.92780.93
6129724-12972478.45278.45
10min1145504-14550487.99590.004.0188.4190.414.06
2139596-13959684.42284.70
3146507-14650788.60189.01
4154612-15461293.50393.97
5154176-15417693.23993.69
6152571-15257192.26892.70
15min1150661-15066191.11393.292.6492.0194.202.69
2149256-14925690.26491.01
3152014-15201491.93292.83
4157888-15788895.48496.47
5157922-15792295.50496.47
6157859-15785995.46696.41
20min1153095-15309592.58594.262.6993.9995.692.74
2151471-15147191.60392.85
3152047-15204791.95293.36
4157717-15771795.38096.90
5159753-15975396.61298.11
6161119-16111997.43898.92
30min1152109-15210991.98994.622.2193.9196.572.25
2153556-15355692.86494.62
3154844-15484493.64395.56
4158559-15855995.89097.94
5158748-15874896.00498.04
6160900-16090097.30599.33
45min1153592-15359292.88694.791.7595.3297.261.79
2155428-15542893.99696.27
3154402-15440293.37695.82
4157465-15746595.22897.81
5160636-16063697.14699.71
6158894-15889496.09298.65
60min1155910-15591094.28894.521.2997.2497.521.35
2155080-15508093.78696.58
3153105-15310592.59195.55
4157199-15719995.06798.18
5158395-15839595.79198.90
6158085-15808595.60398.70
极限1156764-15676494.80496.111.1698.2899.641.12
2161200-16120097.487100.80
3156864-15686494.86598.34
4158590-15859095.90899.55
5159818-15981896.651100.29
6160331-16033196.961100.59
依折麦布阿托伐他汀片项目信息
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%
19.721620061627701628411629181625171626100.23
29.851619681632551626120.56
单位质量响应值RSD%判断
16729.4216508.830.94数据可信
供试品溶液-B25010511批-依折麦布-pH6.8(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%
5min166867-6686736.12333.1625.5436.1233.1625.54
277606-7760641.92441.92
373429-7342939.66739.67
442081-4208122.73322.73
566614-6661435.98635.99
641648-4164822.49922.50
10min1151214-15121481.68880.4310.0681.8980.6110.09
2166819-16681990.11890.35
3161891-16189187.45687.68
4130960-13096070.74770.87
5150817-15081781.47481.67
6131602-13160271.09371.22
15min1172460-17246093.16593.803.9293.8294.433.99
2182545-18254598.61399.35
3180698-18069897.61698.32
4166275-16627589.82490.34
5172957-17295793.43494.09
6166856-16685690.13890.66
20min1178273-17827396.30698.102.2397.4899.262.27
2188017-188017101.570102.85
3185089-18508999.988101.24
4179785-17978597.12298.14
5178124-17812496.22597.40
6180308-18030897.40598.43
30min1179107-17910796.756100.262.7798.46101.962.74
2190294-190294102.800104.65
3188993-188993102.097103.90
4187434-187434101.255102.81
5179038-17903896.71998.43
6188706-188706101.942103.50
45min1177791-17779196.04599.732.9998.29101.992.95
2190953-190953103.156105.57
3186885-186885100.958103.33
4187052-187052101.048103.17
5177765-17776596.03198.27
6187253-187253101.157103.29
60min1179808-17980897.13599.872.1599.91102.682.12
2188461-188461101.809104.80
3186344-186344100.666103.60
4187387-187387101.229103.91
5179859-17985997.16299.94
6187372-187372101.221103.91
极限1178904-17890496.64799.462.1999.96102.822.15
2187410-187410101.242104.80
3185206-185206100.051103.54
4187040-187040101.042104.29
5179111-17911196.758100.08
6186979-186979101.009104.26
依折麦布阿托伐他汀片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号100590-202406对照品来源中检院对照品使用方法直接使用
对照品含量(%)95.1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%
110.531448221451131453511453371451841451610.15
210.541451541460041455790.42
单位质量响应值RSD%判断
13785.4713812.050.14数据可信
供试品溶液-B25010511批-阿托伐他汀-pH6.8(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%
5min1126452-12645275.85475.912.6575.8575.912.65
2125943-12594375.54975.55
3120920-12092072.53672.54
4130043-13004378.00878.01
5126015-12601575.59275.59
6129907-12990777.92777.93
10min1149945-14994589.94790.411.5590.3790.831.56
2153120-15312091.85292.27
3147017-14701788.19188.59
4151654-15165490.97291.41
5149571-14957189.72390.14
6152950-15295091.75092.18
15min1154464-15446492.65892.961.4693.5893.881.47
2156670-15667093.98194.91
3150958-15095890.55591.45
4156370-15637093.80194.74
5154379-15437992.60793.53
6156960-15696094.15595.10
20min1155116-15511693.04994.001.8894.4895.441.88
2159493-15949395.67597.13
3152335-15233591.38192.78
4158730-15873095.21796.68
5155114-15511493.04894.48
6159389-15938995.61297.08
30min1153909-15390992.32594.111.8894.2896.081.87
2160305-16030596.16298.15
3154853-15485392.89194.79
4158559-15855995.11497.10
5154060-15406092.41594.37
6159639-15963995.76297.76
45min1152415-15241591.42993.392.1693.8995.882.14
2161266-16126696.73899.26
3154066-15406692.41994.84
4156717-15671794.00996.53
5152680-15268091.58894.05
6156980-15698094.16796.70
60min1154275-15427592.54493.551.4095.5296.561.40
2159195-15919595.49698.55
3153944-15394492.34695.28
4157170-15717094.28197.32
5154094-15409492.43695.41
6157058-15705894.21497.27
极限1153689-15368992.19393.581.3895.6897.101.38
2159281-15928195.54799.13
3155389-15538993.21396.66
4157084-15708494.22997.79
5153812-15381292.26795.75
6156756-15675694.03397.61
依折麦布阿托伐他汀片项目信息
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%
19.721606621616181620061622181624641617940.44
29.851618451624121621280.25
单位质量响应值RSD%判断
16645.4716459.700.80数据可信
供试品溶液-B24120811批-依折麦布-pH6.8(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%
5min163961-6396134.69128.0121.5134.6928.0121.52
255340-5534030.01530.02
351939-5193928.17128.17
455724-5572430.22430.22
552126-5212628.27228.27
630796-3079616.70316.70
10min1127302-12730269.04672.406.2469.2472.566.21
2141023-14102376.48876.65
3123344-12334466.89967.06
4140745-14074576.33776.51
5127351-12735169.07369.23
6141130-14113076.54676.64
15min1152068-15206882.47987.835.9083.0588.385.87
2171804-17180493.18393.77
3155549-15554984.36784.89
4169892-16989292.14692.74
5152323-15232382.61783.16
6169931-16993192.16792.69
20min1161581-16158187.63892.955.0688.6794.005.04
2179893-17989397.57098.68
3168759-16875991.53192.53
4178260-17826096.68597.79
5161281-16128187.47688.48
6178525-17852596.82897.86
30min1173902-17390294.32196.932.4895.8498.492.50
2183522-18352299.539101.19
3176160-17616095.54697.05
4181963-18196398.693100.33
5174245-17424594.50795.99
6182516-18251698.993100.56
45min1176886-17688695.93997.681.5397.9899.781.57
2183359-18335999.450101.65
3179776-17977697.50799.54
4182116-18211698.776100.97
5176891-17689195.94297.95
6181587-18158798.489100.61
60min1176699-17669995.83897.561.4498.42100.201.48
2181675-18167598.537101.29
3178634-17863496.88799.47
4182607-18260799.042101.78
5177460-17746096.25198.79
6182120-18212098.778101.44
极限1180261-18026197.77098.230.98100.88101.411.04
2182510-18251098.990102.29
3178467-17846796.79799.91
4182801-18280199.148102.44
5180051-18005197.656100.73
6182527-18252798.999102.21
依折麦布阿托伐他汀片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号100590-202406对照品来源中检院对照品使用方法直接使用
对照品含量(%)95.1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%
110.532853332861002869022873132870362865370.29
210.542862892871972867430.23
单位质量响应值RSD%判断
27211.4927205.220.02数据可信
供试品溶液-B24120811批-阿托伐他汀-pH6.8(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%
5min1266939-26693981.20959.4331.1181.2159.4331.11
2243099-24309973.95673.96
3199445-19944560.67660.68
4170146-17014651.76251.76
5199091-19909160.56860.57
693408-9340828.41728.42
10min1301070-30107091.59285.925.5792.0486.255.63
2285441-28544186.83887.25
3270041-27004182.15382.49
4268244-26824481.60681.89
5300909-30090991.54391.88
6268876-26887681.79881.96
15min1312494-31249495.06891.493.0396.0392.303.09
2296345-29634590.15591.05
3294178-29417889.49690.29
4294460-29446089.58290.32
5312371-31237195.03095.88
6294581-29458189.61890.23
20min1313490-31349095.37192.892.0396.8694.202.09
2299707-29970791.17892.57
3301163-30116391.62192.91
4302345-30234591.98093.22
5312957-31295795.20996.58
6302269-30226991.95793.07
30min1317221-31722196.50694.271.9498.5296.101.98
2304291-30429192.57294.47
3304165-30416592.53494.33
4307966-30796693.69095.44
5317315-31731596.53598.44
6308345-30834593.80695.43
45min1315134-31513495.87194.301.3298.4396.661.39
2306320-30632093.19095.60
3306969-30696993.38795.70
4308535-30853593.86396.13
5315184-31518495.88698.32
6307778-30777893.63395.78
60min1310859-31085994.57094.110.9597.6697.000.96
2307618-30761893.58496.52
3304268-30426892.56595.40
4311354-31135494.72197.51
5312055-31205594.93497.91
6309990-30999094.30696.97
极限1313483-31348395.36994.941.4898.9898.341.47
2316801-31680196.37899.83
3303163-30316392.22995.58
4313249-31324995.29898.62
5312818-31281895.16698.66
6312926-31292695.19998.39
依折麦布阿托伐他汀片项目信息
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%
19.721608911616151622751627621629101620910.52
29.851621541623621622580.10
单位质量响应值RSD%判断
16676.0316472.890.87数据可信
供试品溶液-B24120811批-依折麦布-pH6.8(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%
5min149229-4922926.66625.4242.4626.6725.4242.46
258326-5832631.59331.59
357608-5760831.20431.20
422370-2237012.11712.12
523231-2323112.58312.58
670833-7083338.36838.37
10min1136330-13633073.84567.5021.0873.9967.6421.11
2145709-14570978.92679.10
3145211-14521178.65678.83
482715-8271544.80444.87
5101274-10127454.85754.93
6136472-13647273.92274.14
15min1168962-16896291.52185.5810.6892.0886.1010.76
2170947-17094792.59693.21
3168759-16875991.41192.02
4128041-12804169.35669.67
5148267-14826780.31180.69
6163037-16303788.31288.94
20min1176653-17665395.68792.665.5296.7593.665.64
2177334-17733496.05697.18
3176470-17647095.58896.71
4152869-15286982.80483.51
5168998-16899891.54192.36
6174103-17410394.30695.42
30min1182088-18208898.63196.941.84100.2398.451.98
2182657-18265798.939100.60
3178467-17846796.67098.32
4173498-17349893.97895.14
5178935-17893596.92398.25
6178183-17818396.51698.15
45min1179788-17978897.38597.650.5399.5399.690.52
2179720-17972097.34899.56
3180976-18097698.029100.21
4179599-17959997.28398.97
5181875-18187598.516100.38
6179694-17969497.33499.51
60min1179577-17957797.27197.380.8499.9699.970.68
2178878-17887896.89299.64
3177330-17733096.05498.78
4181252-18125298.178100.40
5181016-18101698.050100.47
6180611-18061197.831100.55
极限1179034-17903496.97797.320.62100.20100.440.65
2178928-17892896.919100.21
3181062-18106298.075101.34
4178690-17869096.79099.56
5181074-18107498.082101.04
6179174-17917497.053100.31
依折麦布阿托伐他汀片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号100590-202406对照品来源中检院对照品使用方法直接使用
对照品含量(%)95.1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%
110.532853172864712873012878902883532870660.42
210.542872672878702875680.15
单位质量响应值RSD%判断
27261.7327283.490.06数据可信
供试品溶液-B24120811批-阿托伐他汀-pH6.8(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%
5min1246398-24639874.78373.917.9574.7873.917.95
2261921-26192179.49579.49
3212116-21211664.37964.38
4237904-23790472.20572.21
5237547-23754772.09772.10
6265253-26525380.50680.51
10min1301979-30197991.65389.653.2992.0790.063.31
2302695-30269591.87092.31
3277688-27768884.28084.64
4296340-29634089.94190.34
5291507-29150788.47488.87
6302168-30216891.71092.16
15min1312451-31245194.83193.122.3795.7694.032.40
2313385-31338595.11496.07
3294315-29431589.32690.15
4303381-30338192.07892.98
5306166-30616692.92393.82
6311207-31120794.45395.41
20min1313413-31341395.12394.211.2996.5795.641.33
2312930-31293094.97696.46
3302719-30271991.87793.20
4310036-31003694.09895.51
5310631-31063194.27895.69
6312695-31269594.90596.39
30min1318140-31814096.55894.931.3798.5496.881.39
2316060-31606095.92697.93
3306294-30629492.96294.79
4313752-31375295.22697.16
5312601-31260194.87696.81
6309900-30990094.05796.07
45min1313138-31313895.03994.700.5497.5697.170.48
2311236-31123694.46297.00
3314030-31403095.31097.66
4312347-31234794.79997.26
5312090-31209094.72197.18
6309201-30920193.84496.38
60min1311635-31163594.58394.310.6197.6397.320.59
2307826-30782693.42796.49
3310341-31034194.19097.07
4313536-31353695.16098.15
5310065-31006594.10797.09
6311056-31105694.40797.46
极限1311030-31103094.40094.391.1097.9797.921.01
2309824-30982494.03497.62
3317737-31773796.43599.84
4308383-30838393.59697.12
5309900-30990094.05797.56
6309154-30915493.83097.41
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