奥美沙坦酯左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100546-202105对照品来源中检院对照品使用方法直接使用
对照品含量(%)97.3对照品水分(%)0对照品稀释倍数4000
标示量(mg)2.5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%
115.951833118088181941811118324182100.63
215.861820418233182180.12
单位质量响应值RSD%判断
1141.691148.680.44数据可信
供试品溶液-2024080121批-左氨氯地平-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%
5min113818-1381876.18475.922.7476.1875.922.74
213389-1338973.81973.82
313483-1348374.33774.34
413783-1378375.99175.99
514456-1445679.70279.70
613687-1368775.46275.46
10min115604-1560486.03186.101.0486.1686.221.05
215486-1548685.38085.50
315482-1548285.35885.48
415892-1589287.61987.75
515715-1571586.64386.78
615516-1551685.54685.67
15min116037-1603788.41888.191.5888.6988.461.58
215742-1574286.79287.06
315633-1563386.19186.46
416166-1616689.13089.40
516132-1613288.94289.22
616267-1626789.68689.95
20min115938-1593887.87387.921.7988.2988.341.79
215825-1582587.25087.66
315475-1547585.32085.73
416320-1632089.97990.40
516098-1609888.75589.18
616021-1602188.33088.75
30min116002-1600288.22587.802.4588.7988.362.45
215641-1564186.23586.79
315343-1534384.59285.14
416335-1633590.06190.63
516330-1633090.03490.61
615901-1590187.66988.23
45min116112-1611288.83288.231.7589.5488.941.75
215774-1577486.96887.67
315597-1559785.99286.69
416266-1626689.68190.40
516306-1630689.90190.62
615965-1596588.02188.73
60min115661-1566186.34587.192.0887.2088.052.07
215552-1555285.74486.59
315528-1552885.61286.45
416315-1631589.95190.82
515696-1569686.53887.41
616133-1613388.94889.81
极限116062-1606288.55690.161.6389.5691.161.62
216237-1623789.52190.51
316384-1638490.33191.31
416785-1678592.54293.56
516506-1650691.00492.02
616140-1614088.98689.99
奥美沙坦酯左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100864-202205对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.8对照品水分(%)0对照品稀释倍数500
标示量(mg)20供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.972250162250932249962242482251952249100.17
211.122245102248552246820.11
单位质量响应值RSD%判断
20502.2820205.221.04数据可信
供试品溶液-2024080121批-奥美沙坦酯-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%
5min1108698-10869847.97048.043.7747.9748.043.78
2110421-11042148.73148.73
3105128-10512846.39546.39
4103530-10353045.69045.69
5114949-11494950.72950.73
6110349-11034948.69948.70
10min1158274-15827469.84969.901.2569.9369.981.25
2159763-15976370.50670.59
3154989-15498968.39968.48
4159421-15942170.35570.43
5160409-16040970.79170.88
6157435-15743569.47969.56
15min1176655-17665577.96178.031.0578.1678.231.05
2176436-17643677.86478.06
3173695-17369576.65576.85
4179193-17919379.08179.27
5176830-17683078.03878.24
6178086-17808678.59378.79
20min1184131-18413181.26081.641.4181.5981.961.40
2183680-18368081.06181.39
3181305-18130580.01380.33
4188448-18844883.16683.49
5184969-18496981.63081.96
6187377-18737782.69383.02
30min1187837-18783782.89683.801.6283.3684.261.61
2188326-18832683.11283.58
3186253-18625382.19782.65
4194711-19471185.93086.39
5190379-19037984.01884.49
6191736-19173684.61785.08
45min1190003-19000383.85284.191.5284.4584.791.52
2189212-18921283.50384.10
3186715-18671582.40182.99
4195177-19517786.13586.74
5191014-19101484.29884.91
6192526-19252684.96585.57
60min1187350-18735082.68183.241.4983.4283.981.48
2187321-18732182.66883.41
3185408-18540881.82482.55
4193107-19310785.22285.97
5187728-18772882.84883.60
6190752-19075284.18284.93
极限1199413-19941388.00588.620.5688.8889.500.57
2200967-20096788.69089.57
3199965-19996588.24889.11
4202629-20262989.42490.32
5201301-20130188.83889.73
6200527-20052788.49689.38
奥美沙坦酯左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100546-202105对照品来源中检院对照品使用方法直接使用
对照品含量(%)97.3对照品水分(%)0对照品稀释倍数4000
标示量(mg)2.5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%
115.951812018329182471820718299182400.45
215.861843518310183720.49
单位质量响应值RSD%判断
1143.571158.390.92数据可信
供试品溶液-2024080421批-左氨氯地平-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%
5min113731-1373175.32675.432.3075.3375.432.30
214034-1403476.98876.99
314180-1418077.78977.79
413304-1330472.98372.98
513634-1363474.79474.79
613617-1361774.70074.70
10min115318-1531884.03284.562.3684.1684.682.36
215821-1582186.79186.92
315850-1585086.95087.08
415375-1537584.34484.47
515204-1520483.40683.53
614916-1491681.82681.95
15min115999-1599987.76886.501.9088.0386.761.89
215345-1534584.18084.45
316035-1603587.96588.24
416045-1604588.02088.28
515627-1562785.72785.99
615556-1555685.33785.60
20min115678-1567886.00786.712.0086.4287.122.00
216230-1623089.03589.45
316180-1618088.76089.18
415514-1551485.10785.52
515578-1557885.45885.86
615652-1565285.86486.27
30min115940-1594087.44486.991.5488.0087.541.54
216130-1613088.48689.05
316089-1608988.26188.83
415831-1583186.84687.40
515585-1558585.49686.05
615564-1556485.38185.93
45min115953-1595387.51587.242.1388.2287.942.12
216110-1611088.37689.09
316208-1620888.91489.63
416183-1618388.77789.47
515474-1547484.88785.58
615491-1549184.98185.67
60min116092-1609288.27887.493.6589.1288.333.63
216222-1622288.99189.85
316539-1653990.73091.59
416139-1613988.53689.38
514853-1485381.48182.31
615845-1584586.92387.75
极限116213-1621388.94191.541.9989.9492.531.97
217114-1711493.88494.89
316779-1677992.04693.06
416863-1686392.50793.50
516766-1676691.97592.94
616380-1638089.85890.83
奥美沙坦酯左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100864-202205对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.8对照品水分(%)0对照品稀释倍数500
标示量(mg)20供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.972245132243092248632250572249662247420.15
211.122252432255242253840.09
单位质量响应值RSD%判断
20486.9620268.350.76数据可信
供试品溶液-2024080421批-奥美沙坦酯-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%
5min1108238-10823847.71049.303.1847.7149.303.18
2115790-11579051.03951.04
3114948-11494850.66850.67
4108512-10851247.83147.83
5114403-11440350.42850.43
6109151-10915148.11348.11
10min1159022-15902270.09570.461.5470.1770.541.55
2163235-16323571.95272.04
3161239-16123971.07271.16
4160036-16003670.54270.62
5159734-15973470.40970.49
6155841-15584168.69368.77
15min1178421-17842178.64678.551.2278.8478.751.22
2180599-18059979.60679.81
3179192-17919278.98679.19
4178803-17880378.81579.01
5178092-17809278.50178.70
6174143-17414376.76076.96
20min1186607-18660782.25481.891.3782.5882.221.37
2189349-18934983.46383.80
3186312-18631282.12482.46
4186325-18632582.13082.46
5184285-18428581.23181.56
6181787-18178780.13080.45
30min1192978-19297885.06384.261.5185.5384.731.51
2194263-19426385.62986.11
3191918-19191884.59585.07
4192524-19252484.86385.33
5188215-18821582.96383.43
6187003-18700382.42982.89
45min1191089-19108984.23083.861.2984.8484.471.29
2193374-19337485.23785.86
3190652-19065284.03784.65
4191695-19169584.49785.10
5187808-18780882.78483.39
6186890-18689082.37982.97
60min1189605-18960583.57682.921.7584.3283.671.74
2191445-19144584.38785.15
3189436-18943683.50184.25
4190211-19021183.84384.59
5183245-18324580.77281.52
6184821-18482181.46782.20
极限1205972-20597290.79089.641.2091.6890.521.20
2203814-20381489.83990.74
3205460-20546090.56591.46
4204071-20407189.95290.84
5199976-19997688.14789.03
6200860-20086088.53789.40
奥美沙坦酯左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100546-202105对照品来源中检院对照品使用方法直接使用
对照品含量(%)97.3对照品水分(%)0对照品稀释倍数4000
标示量(mg)2.5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%
115.951827618390183761836718319183460.26
215.861826518216182400.19
单位质量响应值RSD%判断
1150.221150.060.01数据可信
供试品溶液-2024080421批-左氨氯地平-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%
5min113459-1345973.88477.283.6173.8877.283.61
213466-1346673.92373.92
314459-1445979.37479.37
414077-1407777.27777.28
514385-1438578.96878.97
614616-1461680.23680.24
10min114918-1491881.89486.014.2482.0286.144.23
215924-1592487.41687.54
316025-1602587.97188.10
414915-1491581.87782.01
515626-1562685.78085.91
616602-1660291.13891.27
15min115879-1587987.16988.181.9187.4388.461.91
216119-1611988.48788.76
316056-1605688.14188.42
415988-1598887.76788.03
515721-1572186.30286.58
616617-1661791.22091.51
20min115841-1584186.96187.581.8087.3788.001.80
215772-1577286.58287.00
315896-1589687.26287.69
415714-1571486.26386.67
516000-1600087.83388.25
616502-1650290.58991.03
30min115596-1559685.61688.212.2886.1788.782.27
216181-1618188.82789.39
316098-1609888.37188.94
416095-1609588.35588.91
515783-1578386.64287.21
616657-1665791.44092.03
45min115789-1578986.67587.852.4187.3788.562.39
216233-1623389.11289.82
315315-1531584.07384.79
416156-1615688.69089.39
516191-1619188.88289.59
616334-1633489.66790.41
60min115903-1590387.30188.381.7188.1489.241.70
216339-1633989.69490.55
316113-1611388.45489.31
416100-1610088.38289.23
515698-1569886.17587.03
616444-1644490.27191.16
极限116641-1664191.35292.561.3992.3393.571.39
217090-1709093.81794.82
317030-1703093.48894.49
416569-1656990.95791.95
516760-1676092.00593.01
617080-1708093.76294.80
奥美沙坦酯左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100864-202205对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.8对照品水分(%)0对照品稀释倍数500
标示量(mg)20供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.972248952255712246032248502250902250020.17
211.122246492236362241420.32
单位质量响应值RSD%判断
20510.6720156.651.24数据可信
供试品溶液-2024080421批-奥美沙坦酯-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%
5min1104064-10406445.97248.634.0545.9748.634.05
2114045-11404550.38150.38
3113670-11367050.21550.22
4105172-10517246.46146.46
5113277-11327750.04250.04
6110261-11026148.70948.71
10min1156666-15666669.20970.561.6269.2970.651.62
2163083-16308372.04472.13
3159374-15937470.40670.49
4158167-15816769.87269.95
5158452-15845269.99870.08
6162658-16265871.85671.94
15min1176123-17612377.80578.651.5978.0078.851.59
2178928-17892879.04479.25
3176096-17609677.79377.99
4179246-17924679.18479.38
5175151-17515177.37577.58
6182713-18271380.71680.92
20min1183984-18398481.27882.171.8281.6082.501.82
2186247-18624782.27782.61
3183352-18335280.99881.33
4188239-18823983.15783.48
5182727-18272780.72281.05
6191499-19149984.59784.93
30min1189583-18958383.75184.692.1584.2185.152.15
2192471-19247185.02785.50
3188190-18819083.13683.60
4194007-19400785.70586.17
5187558-18755882.85683.32
6198387-19838787.64088.12
45min1189615-18961583.76584.481.8584.3685.081.85
2191757-19175784.71185.33
3188028-18802883.06483.67
4194406-19440685.88286.49
5187389-18738982.78283.38
6196166-19616686.65987.28
60min1188272-18827283.17283.831.8783.9184.581.87
2189541-18954183.73284.49
3186820-18682082.53083.27
4192279-19227984.94285.69
5186201-18620182.25783.00
6195494-19549486.36287.13
极限1203081-20308189.71489.871.1090.5990.761.10
2205292-20529290.69191.59
3202553-20255389.48190.36
4203664-20366489.97190.86
5199818-19981888.27289.15
6206154-20615491.07191.98
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