坎地沙坦酯左氨氯地平片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号100685-201903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4000
标示量(mg)8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%
116.081747531737781736781744971739281741270.28
216.121753381752761753070.03
单位质量响应值RSD%判断
10828.7910875.120.31数据可信
供试品溶液-2024042711批-pH1.2(内含0.05%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min184834-8483443.88542.1915.4343.8942.1915.43
289566-8956646.33346.33
359664-5966430.86530.86
473587-7358738.06738.07
591397-9139747.28047.28
690307-9030746.71646.72
10min1135836-13583670.26969.504.9870.7669.975.05
2138622-13862271.71072.22
3122575-12257563.40963.75
4131517-13151768.03468.46
5141708-14170873.30673.83
6135887-13588770.29570.81
15min1153788-15378879.55579.282.5580.8280.522.62
2158023-15802381.74683.06
3146574-14657475.82476.87
4153431-15343179.37180.55
5155796-15579680.59481.93
6151944-15194478.60179.90
20min1159503-15950382.51283.101.7484.6685.221.70
2162880-16288084.25986.48
3160500-16050083.02784.92
4162793-16279384.21486.27
5162482-16248284.05386.29
6155698-15569880.54382.72
30min1164386-16438685.03885.521.4588.1188.571.46
2167532-16753286.66589.82
3163413-16341384.53487.35
4168168-16816886.99489.99
5166295-16629586.02589.19
6162140-16214083.87686.94
45min1163510-16351084.58584.670.9688.6088.661.01
2165619-16561985.67689.79
3163118-16311884.38288.13
4162875-16287584.25688.22
5165368-16536885.54689.67
6161527-16152783.55987.56
60min1161085-16108583.33083.581.7888.2888.521.59
2158632-15863282.06187.13
3163744-16374484.70689.39
4166182-16618285.96790.87
5160428-16042882.99088.07
6159351-15935182.43387.36
极限1160272-16027282.91083.231.0888.7989.090.97
2160338-16033882.94488.93
3162679-16267984.15589.79
4162303-16230383.96089.81
5161732-16173283.66589.66
6158003-15800381.73687.58
坎地沙坦酯左氨氯地平片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号100685-201903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4000
标示量(mg)8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%
116.081742941743971741951741071741291742240.07
216.121746231746171746200.01
单位质量响应值RSD%判断
10834.8310832.510.02数据可信
供试品溶液-12235763批-pH1.2(内含0.05%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min133674-3367417.44916.483.5017.4516.483.52
231348-3134816.24416.24
331118-3111816.12516.12
432476-3247616.82816.83
530556-3055615.83315.83
631697-3169716.42516.42
10min166224-6622434.31634.084.4234.5134.264.39
263734-6373433.02533.21
367318-6731834.88335.06
460930-6093031.57231.76
567938-6793835.20435.38
668460-6846035.47435.66
15min1103761-10376153.76753.373.4254.3453.933.41
2100537-10053752.09652.64
3102659-10265953.19553.76
498342-9834250.95951.50
5103982-10398253.88154.45
6108693-10869356.32256.90
20min1128591-12859166.63367.153.1467.8168.303.13
2128725-12872566.70267.83
3131451-13145168.11569.27
4122633-12263363.54664.65
5131459-13145968.11969.28
6134627-13462769.76170.96
30min1154796-15479680.21282.612.2782.1284.512.21
2161219-16121983.54085.41
3164211-16421185.09087.00
4160174-16017482.99884.81
5155476-15547680.56482.49
6160622-16062283.23185.21
45min1173496-17349689.90288.143.2492.7190.963.17
2159629-15962982.71685.51
3171983-17198389.11891.98
4168536-16853687.33190.06
5172829-17282989.55692.37
6174157-17415790.24493.15
60min1176845-17684591.63789.352.3995.4493.152.30
2171809-17180989.02792.74
3165521-16552185.76989.62
4172403-17240389.33593.04
5171608-17160888.92392.74
6176423-17642391.41895.32
极限1172292-17229289.27887.901.2594.1092.691.18
2172317-17231789.29193.99
3168436-16843687.28092.08
4167501-16750186.79591.49
5168883-16888387.51192.31
6168401-16840187.26192.18
坎地沙坦酯左氨氯地平片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号100685-201903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4000
标示量(mg)8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%
116.081730371730451731951733551733441731950.09
216.121724901726181725540.06
单位质量响应值RSD%判断
10770.8310704.340.44数据可信
供试品溶液-12407637批-pH1.2(内含0.05%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min123200-2320012.12911.247.4112.1311.247.41
220859-2085910.90510.91
323296-2329612.18012.18
421914-2191411.45711.46
520330-2033010.62910.63
619352-1935210.11810.12
10min161040-6104031.91331.222.6732.0531.342.67
256935-5693529.76729.89
361078-6107831.93332.07
459448-5944831.08031.21
560655-6065531.71231.83
659108-5910830.90331.02
15min195518-9551849.93949.573.0850.4350.043.07
292403-9240348.31048.76
393606-9360648.93949.43
495791-9579150.08150.55
599799-9979952.17752.65
691807-9180747.99848.45
20min1125133-12513365.42264.822.3266.4765.842.31
2124191-12419164.92965.92
3120239-12023962.86363.90
4124811-12481165.25366.28
5128215-12821567.03368.08
6121274-12127463.40464.39
30min1153342-15334280.17080.801.7581.9482.541.75
2154866-15486680.96782.68
3155097-15509781.08782.82
4156659-15665981.90483.66
5157439-15743982.31284.11
6149883-14988378.36280.06
45min1165410-16541086.47987.081.4089.1489.721.38
2167333-16733387.48590.09
3169234-16923488.47991.11
4168542-16854288.11790.78
5165987-16598786.78189.49
6162881-16288185.15787.72
60min1167468-16746887.55585.892.3891.1889.502.33
2158739-15873982.99286.57
3161060-16106084.20587.82
4166699-16669987.15390.80
5168533-16853388.11291.79
6163219-16321985.33488.84
极限1163084-16308485.26385.202.1889.8689.772.13
2156558-15655881.85186.36
3165858-16585886.71491.27
4165439-16543986.49491.11
5165303-16530386.42391.08
6161557-16155784.46588.92
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