沙库巴曲缬沙坦钠氨氯地平片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号100374-202106对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.9对照品水分(%)0对照品稀释倍数2000
标示量(mg)5供试品稀释倍数1系数0.7210
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
122.651022051023181024671024191020691022960.16
222.691031761033751032760.14
单位质量响应值RSD%判断
4516.384551.610.55数据可信
供试品溶液-25100901-1批-沙库巴曲-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%
5min154276-5427677.60391.7316.1377.6091.7316.14
264159-6415991.73391.73
369057-6905798.73698.74
477478-77478110.776110.78
549948-4994871.41571.41
670012-70012100.102100.10
10min178100-78100111.666120.974.65111.80121.124.66
282844-82844118.449118.60
386164-86164123.195123.36
488223-88223126.139126.32
583757-83757119.754119.87
688556-88556126.615126.78
15min182207-82207117.538122.512.53117.85122.862.54
284588-84588120.942121.29
387036-87036124.442124.81
488523-88523126.568126.96
586188-86188123.230123.55
685551-85551122.319122.70
20min182781-82781118.359123.202.32118.87123.762.33
284888-84888121.371121.92
386791-86791124.092124.67
488273-88273126.211126.82
586926-86926124.285124.81
687341-87341124.878125.46
30min185112-85112121.691123.801.53122.40124.561.55
285246-85246121.883122.64
386027-86027123.000123.78
488196-88196126.101126.92
587067-87067124.487125.22
687869-87869125.633126.42
45min185882-85882122.792124.672.04123.70125.642.05
284853-84853121.321122.28
387920-87920125.706126.70
489521-89521127.995129.02
586397-86397123.529124.47
688595-88595126.671127.67
60min186153-86153123.180126.771.95124.30127.951.96
287423-87423124.996126.16
388801-88801126.966128.16
490820-90820129.853131.09
588621-88621126.708127.85
690183-90183128.942130.15
极限189733-89733128.298130.541.55129.62131.931.57
290171-90171128.925130.29
391013-91013130.128131.54
493083-93083133.088134.54
590863-90863129.914131.27
692953-92953132.902134.33
沙库巴曲缬沙坦钠氨氯地平片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号57323100856对照品来源ZZ对照品使用方法直接使用
对照品含量(%)100对照品水分(%)5.8对照品稀释倍数100
标示量(mg)200供试品稀释倍数1系数0.477
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
122.651551135155148915523561550612154807315507330.11
222.691573276157361615734460.02
单位质量响应值RSD%判断
68465.0369345.350.91数据可信
供试品溶液-25100901-1批-缬沙坦钠-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%
5min1234674-2346746.8876.5016.816.896.5016.84
2238996-2389967.0147.01
3256184-2561847.5187.52
4208555-2085556.1206.12
5152138-1521384.4654.46
6237602-2376026.9736.97
10min1777591-77759122.81922.9911.7122.8323.0011.72
2837474-83747424.57624.59
3870672-87067225.55125.56
4700412-70041220.55420.56
5649326-64932619.05519.06
6864704-86470425.37625.39
15min11257492-125749236.90236.558.7736.9536.608.78
21321624-132162438.78438.84
31335472-133547239.19139.25
41111784-111178432.62632.67
51108125-110812532.51932.56
61339453-133945339.30739.36
20min11569343-156934346.05445.885.7446.1645.995.75
21630213-163021347.84047.96
31626840-162684047.74147.86
41434587-143458742.09942.20
51472983-147298343.22643.32
61646280-164628048.31248.43
30min11690381-169038149.60649.750.7749.7949.930.79
21691074-169107449.62649.82
31718704-171870450.43750.64
41679280-167928049.28049.45
51697084-169708449.80249.97
61694261-169426149.72049.92
45min11690762-169076249.61749.790.6549.8950.060.66
21687893-168789349.53349.81
31717519-171751950.40250.69
41689559-168955949.58249.83
51697485-169748549.81450.06
61695813-169581349.76550.05
60min11699448-169944849.87249.820.6150.2250.170.62
21689820-168982049.58949.95
31716071-171607150.36050.73
41686737-168673749.49949.83
51696724-169672449.79250.12
61696710-169671049.79150.16
极限11689534-168953449.58149.750.4650.0250.180.46
21690056-169005649.59650.04
31709130-170913050.15650.61
41691242-169124249.63150.05
51699035-169903549.86050.27
61692347-169234749.66350.11
沙库巴曲缬沙坦钠氨氯地平片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号57323100856对照品来源中检院对照品使用方法直接使用
对照品含量(%)100对照品水分(%)5.8对照品稀释倍数100
标示量(mg)200供试品稀释倍数1系数0.451
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
115.671067792106876110691711067860106737110681910.07
215.721081437108273010820840.09
单位质量响应值RSD%判断
68167.9068834.860.69数据可信
供试品溶液-25100901-1批-氨氯地平-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%
5min1152889-1528894.2674.0018.064.274.0018.05
2156340-1563404.3634.36
3167669-1676694.6804.68
4133299-1332993.7203.72
595679-956792.6702.67
6154555-1545554.3144.31
10min1519318-51931814.49414.6412.0014.5014.6412.00
2559369-55936915.61215.62
3588146-58814616.41516.42
4463127-46312712.92612.93
5437037-43703712.19712.20
6579844-57984416.18316.19
15min1844470-84447023.56923.448.8423.6023.478.85
2890183-89018324.84424.88
3905863-90586325.28225.32
4745605-74560520.80920.84
5750850-75085020.95620.98
6901806-90180625.16925.20
20min11058529-105852929.54329.515.7329.6129.585.74
21100940-110094030.72730.80
31106650-110665030.88630.96
4965753-96575326.95427.02
51003044-100304427.99428.05
61108975-110897530.95131.03
30min11148152-114815232.04432.240.9432.1632.360.95
21156075-115607532.26532.39
31173797-117379732.76032.89
41143304-114330431.90932.02
51159921-115992132.37332.48
61150185-115018532.10132.23
45min11155267-115526732.24332.370.6432.4232.540.65
21153536-115353632.19532.37
31174144-117414432.77032.95
41157442-115744232.30432.46
51159377-115937732.35832.52
61159915-115991532.37332.55
60min11157616-115761632.30832.410.6032.5432.640.61
21156532-115653232.27832.51
31174276-117427632.77333.01
41155735-115573532.25632.47
51160975-116097532.40232.62
61162561-116256132.44632.68
极限11155767-115576732.25732.390.4932.5432.670.50
21156483-115648332.27732.56
31171158-117115832.68632.98
41158792-115879232.34132.61
51161514-116151432.41732.69
61159594-115959432.36432.65
沙库巴曲缬沙坦钠氨氯地平片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号100374-202106对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.9对照品水分(%)0对照品稀释倍数2000
标示量(mg)5供试品稀释倍数1系数0.7210
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
122.651025311024191025461024321024271024710.07
222.691037481035751036620.12
单位质量响应值RSD%判断
4524.114568.620.70数据可信
供试品溶液-25100901-2批-沙库巴曲-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%
5min182089-82089117.051118.422.54117.05118.422.54
285200-85200121.487121.49
383445-83445118.984118.98
479346-79346113.140113.14
583639-83639119.261119.26
684588-84588120.614120.61
10min191334-91334130.233130.420.86130.43130.620.86
292303-92303131.615131.82
391256-91256130.122130.32
490195-90195128.609128.80
592272-92272131.571131.77
691424-91424130.362130.56
15min191577-91577130.580129.740.84130.99130.150.84
290629-90629129.228129.65
391928-91928131.080131.50
490134-90134128.522128.93
591434-91434130.376130.79
690210-90210128.631129.05
20min190935-90935129.664129.140.93130.29129.780.93
290119-90119128.501129.14
391230-91230130.085130.72
489311-89311127.349127.97
591591-91591130.600131.24
690235-90235128.666129.30
30min192311-92311131.626129.810.88132.47130.650.87
290516-90516129.067129.92
391151-91151129.972130.82
490998-90998129.754130.58
591283-91283130.161131.01
689953-89953128.264129.11
45min191877-91877131.008129.141.49132.07130.201.49
288406-88406126.058127.12
391799-91799130.896131.96
489690-89690127.889128.93
591204-91204130.048131.12
690424-90424128.936130.00
60min188949-88949126.833129.961.46128.12131.241.45
292570-92570131.996133.27
391361-91361130.272131.56
492087-92087131.307132.57
591630-91630130.655131.94
690242-90242128.676129.95
极限192729-92729132.222132.220.97133.72133.720.96
294057-94057134.116135.61
391680-91680130.727132.23
492414-92414131.773133.25
593475-93475133.286134.79
692015-92015131.204132.69
沙库巴曲缬沙坦钠氨氯地平片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号57323100856对照品来源ZZ对照品使用方法直接使用
对照品含量(%)100对照品水分(%)5.8对照品稀释倍数100
标示量(mg)200供试品稀释倍数1系数0.477
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
122.651560302156260915627421560506156048115613280.08
222.691585843158575215857980.01
单位质量响应值RSD%判断
68932.8069889.730.98数据可信
供试品溶液-25100901-2批-缬沙坦钠-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%
5min1240272-2402727.0009.5316.597.009.5316.60
2324842-3248429.4639.46
3370295-37029510.78710.79
4397778-39777811.58811.59
5311535-3115359.0769.08
6318251-3182519.2719.27
10min1871097-87109725.37726.283.9925.3926.293.99
2912379-91237926.58026.60
3888564-88856425.88625.90
4961674-96167428.01628.03
5863347-86334725.15125.17
6915007-91500726.65626.67
15min11435813-143581341.82840.365.1141.8840.425.11
21349675-134967539.31939.38
31332444-133244438.81738.88
41496402-149640243.59343.66
51307385-130738538.08738.14
61391495-139149540.53740.60
20min11702778-170277849.60648.053.1149.7348.173.11
21645192-164519247.92848.05
31594969-159496946.46546.59
41710431-171043149.82949.97
51589779-158977946.31446.43
61652485-165248548.14048.27
30min11713381-171338149.91449.741.1250.1249.951.11
21690986-169098649.26249.47
31733948-173394850.51450.72
41710183-171018349.82150.04
51716000-171600049.99150.19
61680549-168054948.95849.17
45min11702765-170276549.60549.651.3149.8949.941.30
21679692-167969248.93349.22
31737979-173797950.63150.92
41706170-170617049.70450.01
51717846-171784650.04550.33
61681323-168132348.98149.27
60min11699214-169921449.50249.631.1649.8750.001.15
21690307-169030749.24249.61
31734749-173474950.53750.91
41707315-170731549.73850.13
51711874-171187449.87150.24
61677486-167748648.86949.24
极限11692241-169224149.29949.501.0249.7549.951.01
21688808-168880849.19949.65
31725336-172533650.26350.72
41700463-170046349.53850.01
51710762-171076249.83850.29
61676838-167683848.85049.30
沙库巴曲缬沙坦钠氨氯地平片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号57323100856对照品来源中检院对照品使用方法直接使用
对照品含量(%)100对照品水分(%)5.8对照品稀释倍数100
标示量(mg)200供试品稀释倍数1系数0.451
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
115.671074002107288110740651073292107315010734780.05
215.721087208108737110872900.02
单位质量响应值RSD%判断
68505.3069166.030.68数据可信
供试品溶液-25100901-2批-氨氯地平-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%
5min1155698-1556984.3245.9717.334.325.9617.38
2209716-2097165.8255.82
3245085-2450856.8076.81
4263401-2634017.3167.32
5204841-2048415.6895.69
6209982-2099825.8325.83
10min1587226-58722616.31016.853.9416.3216.863.95
2607843-60784316.88216.89
3601128-60112816.69616.71
4648367-64836718.00818.02
5581268-58126816.14416.15
6614241-61424117.06017.07
15min1976287-97628727.11526.075.3727.1526.115.37
2908894-90889425.24425.28
3904860-90486025.13125.17
41017965-101796528.27328.32
5884255-88425524.55924.60
6940196-94019626.11326.15
20min11162254-116225432.28031.143.3032.3631.223.31
21114523-111452330.95531.03
31084199-108419930.11230.19
41164356-116435632.33932.43
51078079-107807929.94230.02
61124490-112449031.23131.31
30min11173822-117382232.60232.371.1132.7332.501.10
21151264-115126431.97532.11
31180669-118066932.79232.92
41169891-116989132.49232.64
51168773-116877332.46132.59
61148307-114830731.89332.03
45min11165497-116549732.37032.321.7432.5632.511.73
21131769-113176931.43431.62
31189320-118932033.03233.22
41168387-116838732.45132.65
51176248-117624832.66932.85
61150363-115036331.95032.14
60min11152878-115287832.02032.331.2532.2632.571.24
21155749-115574932.10032.34
31187123-118712332.97133.21
41169364-116936432.47832.73
51170814-117081432.51832.75
61148025-114802531.88532.13
极限11158727-115872732.18232.300.9632.4832.600.95
21155205-115520532.08532.38
31180055-118005532.77533.07
41164577-116457732.34532.65
51170532-117053232.51032.80
61149339-114933931.92232.21
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