厄贝沙坦非奈利酮片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号80324110503对照品来源自制对照品使用方法直接使用
对照品含量(%)100.1对照品水分(%) 0.33对照品稀释倍数2500
标示量(mg)150供试品稀释倍数2系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
114.588019968004577987167990628009968002450.18
214.528021388031798026580.10
单位质量响应值RSD%判断
54886.4955279.480.51数据可信
供试品溶液-25110301批-厄贝沙坦-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%
5min1404358-4043583.5163.5649.023.523.5649.03
2698956-6989566.0776.08
3220998-2209981.9211.92
4572713-5727134.9794.98
5175744-1757441.5281.53
6383447-3834473.3343.33
10min11699422-169942214.77514.0421.1414.8114.0821.21
21950971-195097116.96217.03
31299280-129928011.29611.32
41898177-189817716.50316.56
51099156-10991569.5569.57
61743243-174324315.15615.19
15min12301883-230188320.01319.642.3920.2219.842.58
22322695-232269520.19420.45
32187038-218703819.01419.16
42246986-224698619.53619.77
52209394-220939419.20919.33
62286915-228691519.88320.09
20min12335996-233599620.31020.341.9820.7420.762.13
22405114-240511420.91021.39
32262877-226287719.67420.03
42335607-233560720.30620.76
52339783-233978320.34220.68
62360456-236045620.52220.95
30min12354458-235445820.47020.492.1221.1221.132.12
22398925-239892520.85721.57
32281646-228164619.83720.41
42317422-231742220.14820.83
52412481-241248120.97521.54
62374370-237437020.64321.30
45min12361854-236185420.53420.641.3321.4121.501.26
22405648-240564820.91521.86
32369489-236948920.60121.40
42322062-232206220.18821.09
52406143-240614320.91921.72
62377390-237739020.66921.55
60min12323123-232312320.19820.301.4721.3021.391.39
22366690-236669020.57621.75
32323783-232378320.20321.23
42279702-227970219.82020.95
52373694-237369420.63721.67
62340658-234065820.35021.46
极限12334951-233495120.30020.721.6821.6322.051.52
22383925-238392520.72622.13
32365645-236564520.56721.82
42362774-236277420.54221.89
52449670-244967021.29822.56
62404917-240491720.90922.25
厄贝沙坦非奈利酮片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号240901对照品来源自制对照品使用方法直接使用
对照品含量(%)100.2对照品水分(%)0.06对照品稀释倍数500
标示量(mg)20供试品稀释倍数2系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
1 10.116061260679605386055960654606080.10
2 10.316062260907607640.34
单位质量响应值RSD%判断
5994.865893.701.21数据可信
供试品溶液-25110301批-非奈利酮-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%
5min16444-644419.54260.5379.1819.5460.5379.19
250033-50033151.729151.73
322055-2205566.88466.88
415882-1588248.16348.16
58504-850425.78925.79
616849-1684951.09651.10
10min1133755-133755405.623406.514.85405.84407.184.86
2132751-132751402.578404.26
3138689-138689420.585421.33
4138417-138417419.760420.30
5121941-121941369.796370.08
6138725-138725420.694421.26
15min1140617-140617426.432428.902.88431.16434.092.76
2134412-134412407.615413.77
3145894-145894442.435447.85
4140133-140133424.964430.16
5143852-143852436.242440.64
6143677-143677435.712440.95
20min1136761-136761414.738423.352.10424.20433.312.05
2135350-135350410.459421.15
3142415-142415431.885442.22
4140695-140695426.669436.59
5140065-140065424.758434.00
6142320-142320431.597441.68
30min1134867-134867408.995416.692.30423.07431.342.21
2132652-132652402.278417.53
3139839-139839424.073439.20
4136956-136956415.330429.99
5139506-139506423.063437.02
6140598-140598426.374441.25
45min1134864-134864408.986415.282.53427.60434.572.46
2132140-132140400.725420.44
3141872-141872430.238450.08
4135894-135894412.109431.39
5137289-137289416.340435.00
6139584-139584423.299442.92
60min1131062-131062397.456404.742.42420.61428.642.34
2129010-129010391.233415.40
3137290-137290416.343440.97
4132359-132359401.389425.24
5134586-134586408.143431.43
6136475-136475413.871438.19
极限1128571-128571389.902403.012.75417.48431.412.64
2128194-128194388.758417.28
3135176-135176409.932439.18
4133516-133516404.898433.21
5135147-135147409.844437.67
6136752-136752414.711443.63
厄贝沙坦非奈利酮片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号80324110503对照品来源自制对照品使用方法直接使用
对照品含量(%)100.1对照品水分(%) 0.33对照品稀释倍数2500
标示量(mg)150供试品稀释倍数2系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
114.588051888079698115398095778082728085090.29
214.528088638131328109980.38
单位质量响应值RSD%判断
55453.2955853.860.51数据可信
供试品溶液-25110301批-厄贝沙坦-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%
5min122527-225270.1940.1819.790.190.1819.42
226095-260950.2250.22
317981-179810.1550.15
422906-229060.1970.20
514736-147360.1270.13
624340-243400.2090.21
10min170576-705760.6070.603.790.610.613.86
273975-739750.6370.64
369395-693950.5970.60
469323-693230.5970.60
566043-660430.5680.57
671520-715200.6150.62
15min1100684-1006840.8660.842.400.880.862.54
296282-962820.8290.84
399131-991310.8530.86
496407-964070.8300.84
595547-955470.8220.83
6100926-1009260.8680.88
20min1113004-1130040.9720.961.840.990.981.69
2110933-1109330.9550.97
3110650-1106500.9520.97
4108979-1089790.9380.96
5109058-1090580.9380.96
6113961-1139610.9811.00
30min1127219-1272191.0951.083.621.121.113.47
2120628-1206281.0381.07
3125469-1254691.0801.11
4123860-1238601.0661.09
5123362-1233621.0621.09
6133921-1339211.1521.18
45min1139281-1392811.1991.171.981.241.211.96
2132792-1327921.1431.18
3138480-1384801.1921.23
4133281-1332811.1471.19
5135336-1353361.1651.20
6136941-1369411.1781.22
60min1140568-1405681.2101.201.751.261.261.78
2139364-1393641.1991.25
3139867-1398671.2041.26
4138189-1381891.1891.24
5137650-1376501.1841.24
6144461-1444611.2431.30
极限1149446-1494461.2861.262.001.351.331.95
2143513-1435131.2351.30
3149111-1491111.2831.35
4143121-1431211.2321.30
5145030-1450301.2481.31
6148778-1487781.2801.35
厄贝沙坦非奈利酮片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号240901对照品来源自制对照品使用方法直接使用
对照品含量(%)100.2对照品水分(%)0.06对照品稀释倍数500
标示量(mg)20供试品稀释倍数2系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
1 10.116169462028625206201062170620840.49
2 10.316226662525623960.30
单位质量响应值RSD%判断
6140.856051.991.04数据可信
供试品溶液-25110301批-非奈利酮-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%
5min113985-1398541.35139.1133.2741.3539.1133.27
216819-1681949.73149.73
313052-1305238.59338.59
417314-1731451.19551.19
513122-1312238.80038.80
65067-506714.98214.98
10min170388-70388208.126206.7615.79208.59207.1915.82
282509-82509243.966244.52
367846-67846200.610201.04
479494-79494235.051235.62
568130-68130201.449201.88
651180-51180151.331151.50
15min1101884-101884301.255297.783.31304.03300.513.44
2103197-103197305.137308.40
398625-98625291.618294.28
4104749-104749309.726312.91
5100279-100279296.509299.18
695514-95514282.420284.27
20min1112161-112161331.642330.492.38337.76336.542.49
2115203-115203340.637347.29
3108260-108260320.107326.01
4114170-114170337.582344.20
5111333-111333329.194335.16
6109511-109511323.806328.79
30min1120582-120582356.542355.491.59366.35365.211.66
2120785-120785357.142367.58
3116844-116844345.489354.94
4122370-122370361.828372.20
5121303-121303358.674368.30
6119481-119481353.286361.87
45min1125796-125796371.959373.761.50385.72387.421.57
2127654-127654377.452391.86
3123641-123641365.587378.88
4127704-127704377.600391.99
5128575-128575380.176393.78
6125055-125055369.768382.28
60min1126128-126128372.940373.492.25390.84391.312.27
2129506-129506382.928401.53
3121148-121148358.215375.57
4127798-127798377.878396.47
5127266-127266376.305394.14
6126045-126045372.695389.31
极限1131690-131690389.386385.701.36411.43407.661.42
2131396-131396388.517411.37
3127027-127027375.598396.93
4131566-131566389.020411.81
5130825-130825386.829408.84
6130150-130150384.833405.59
厄贝沙坦非奈利酮片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号80324110503对照品来源自制对照品使用方法直接使用
对照品含量(%)100.1对照品水分(%) 0.33对照品稀释倍数2500
标示量(mg)150供试品稀释倍数2系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
114.588026788022838045748015738009628024140.18
214.528073128112238092680.35
单位质量响应值RSD%判断
55035.2555734.710.90数据可信
供试品溶液-25110301批-厄贝沙坦-pH6.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1119134-1191341.0301.3124.391.031.3124.39
2121989-1219891.0551.05
3200245-2002451.7321.73
4196567-1965671.7001.70
5140514-1405141.2151.22
6131735-1317351.1391.14
10min1643555-6435555.5656.2916.865.586.3016.86
2742224-7422246.4186.43
3868130-8681307.5077.53
4818149-8181497.0757.09
5758843-7588436.5626.58
6530609-5306094.5884.60
15min11283612-128361211.09911.383.4611.1711.463.55
21342594-134259411.60911.69
31370545-137054511.85111.95
41329410-132941011.49511.59
51327177-132717711.47611.56
61243083-124308310.74910.81
20min11570803-157080313.58313.621.1213.7813.841.15
21590627-159062713.75413.97
31579502-157950213.65813.89
41558203-155820313.47413.70
51598922-159892213.82614.04
61555122-155512213.44713.63
30min11834983-183498315.86715.961.2316.2116.321.22
21850552-185055216.00216.37
31840910-184091015.91816.30
41824046-182404615.77316.15
51888066-188806616.32616.69
61834539-183453915.86316.20
45min12064818-206481817.85417.782.4418.3818.322.34
22088174-208817418.05618.60
32012454-201245417.40217.96
41982355-198235517.14117.69
52117618-211761818.31118.86
62072461-207246117.92118.43
60min12146259-214625918.55918.582.5019.2819.322.37
22158479-215847918.66419.41
32107144-210714418.22018.98
42071869-207186917.91518.66
52215747-221574719.16019.91
62194837-219483718.97919.69
极限12132878-213287818.44318.751.8519.3719.691.80
22184420-218442018.88919.84
32141582-214158218.51819.48
42132910-213291018.44319.38
52234259-223425919.32020.28
62182234-218223418.87019.79
厄贝沙坦非奈利酮片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号240901对照品来源自制对照品使用方法直接使用
对照品含量(%)100.2对照品水分(%)0.06对照品稀释倍数500
标示量(mg)20供试品稀释倍数2系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
1 10.116164061878617986162361611617100.20
2 10.316208562476622800.45
单位质量响应值RSD%判断
6103.866040.740.74数据可信
供试品溶液-25110301批-非奈利酮-pH6.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min16093-609318.08728.2027.4418.0928.2027.44
212301-1230136.51636.52
312910-1291038.32338.32
48797-879726.11426.11
58760-876026.00426.00
68139-813924.16124.16
10min147798-47798141.889170.5713.57142.09170.8813.58
261273-61273181.889182.30
366627-66627197.783198.21
463834-63834189.492189.78
556087-56087166.495166.78
649141-49141145.875146.14
15min180434-80434238.769252.514.01240.55254.724.11
287160-87160258.735261.16
389040-89040264.316266.94
487501-87501259.747262.14
584352-84352250.400252.54
681898-81898243.115245.00
20min193861-93861278.627287.521.73283.06292.541.84
297976-97976290.843296.14
398062-98062291.098296.66
497934-97934290.718296.00
597397-97397289.124294.04
695912-95912284.716289.31
30min1105407-105407312.902323.411.80320.43331.621.87
2108576-108576322.309330.84
3110226-110226327.207336.00
4110703-110703328.623337.13
5110179-110179327.067335.20
6108597-108597322.371330.13
45min1116375-116375345.460353.101.33356.46364.911.37
2120104-120104356.530368.64
3118628-118628352.148364.58
4118923-118923353.024365.19
5121003-121003359.198370.97
6118668-118668352.267363.60
60min1120457-120457357.578367.661.60372.42383.391.60
2123473-123473366.531382.61
3123844-123844367.632383.98
4124017-124017368.145384.23
5126426-126426375.297391.06
6124900-124900370.767386.02
极限1119427-119427354.520369.542.26373.33389.352.27
2124533-124533369.677389.83
3125181-125181371.601392.03
4126812-126812376.442396.62
5127195-127195377.579397.51
6123776-123776367.430386.80
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