氢氯噻嗪坎地沙坦酯片项目信息
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100309-202205对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.70对照品水分(%)0对照品稀释倍数1000
标示量(mg)12.5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%
112.034795074793254794624794704791454793820.04
212.054759634766624763120.11
单位质量响应值RSD%判断
39848.8839527.970.58数据可信
中间条件12月-供试品溶液-2024090121批-氢氯噻嗪-含0.35%吐温20的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%
5min1315564-31556457.07763.267.4957.0863.267.48
2371276-37127667.15367.15
3329296-32929659.56059.56
4386426-38642669.89469.89
5344791-34479162.36362.36
6351092-35109263.50363.50
10min1451671-45167181.69581.193.8281.7981.293.83
2461705-46170583.50983.62
3416673-41667375.36475.46
4459948-45994883.19283.31
5459444-45944483.10083.20
6443794-44379480.27080.38
15min1474441-47444185.81385.002.9186.0485.242.91
2480645-48064586.93587.19
3445666-44566680.60880.83
4476579-47657986.20086.45
5480050-48005086.82887.07
6462212-46221283.60183.84
20min1484040-48404087.54986.542.4887.9286.922.48
2486734-48673488.03688.43
3458883-45888382.99983.36
4487041-48704188.09288.49
5485477-48547787.80988.20
6468705-46870584.77685.15
30min1496986-49698689.89188.652.4990.4189.182.49
2502116-50211690.81991.36
3473313-47331385.60986.11
4499909-49990990.41990.97
5491311-49131188.86489.40
6477097-47709786.29386.81
45min1511140-51114092.45190.192.3293.1290.872.32
2497254-49725489.93990.63
3490214-49021488.66689.31
4513573-51357392.89193.59
5495350-49535089.59590.28
6484369-48436987.60988.27
60min1523699-52369994.72291.242.8895.5592.072.87
2497009-49700989.89590.74
3499354-49935490.31991.11
4521342-52134294.29695.15
5496908-49690889.87790.71
6488381-48838188.33489.14
极限1528434-52843495.57996.550.8496.5697.530.84
2530076-53007695.87696.87
3532260-53226096.27197.21
4540615-54061597.78298.79
5536104-53610496.96697.95
6535408-53540896.84097.80
氢氯噻嗪坎地沙坦酯片项目信息
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(%)99.80对照品水分(%)0对照品稀释倍数1000
标示量(mg)16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%
116.233115763116913115043117113115543116070.03
216.313100083108023104050.19
单位质量响应值RSD%判断
19199.4519031.580.63数据可信
中间条件12月-供试品溶液-2024090121批-坎地沙坦酯-含0.35%吐温20的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%
5min1116020-11602034.07337.857.5534.0737.857.55
2137455-13745540.36840.37
3126659-12665937.19737.20
4141687-14168741.61141.61
5120973-12097335.52735.53
6130511-13051138.32938.33
10min1216081-21608163.45964.252.4263.5264.312.42
2225825-22582566.32066.39
3212828-21282862.50362.57
4224240-22424065.85565.92
5214576-21457663.01763.08
6219029-21902964.32564.39
15min1259367-25936776.17175.411.5776.3375.581.57
2261612-26161276.83077.01
3249656-24965673.31973.49
4256659-25665975.37675.55
5256933-25693375.45675.62
6256348-25634875.28475.46
20min1277257-27725781.42580.481.2681.7180.771.25
2276914-27691481.32481.63
3267999-26799978.70678.99
4273219-27321980.23980.54
5275543-27554380.92281.21
6273228-27322880.24280.54
30min1293356-29335686.15384.851.3786.5885.281.37
2293188-29318886.10486.55
3283115-28311583.14583.56
4287038-28703884.29884.74
5289546-28954685.03485.46
6287274-28727484.36784.80
45min1299563-29956387.97686.331.1488.5486.901.13
2293344-29334486.14986.73
3290689-29068985.37085.93
4295446-29544686.76787.35
5294035-29403586.35286.92
6290648-29064885.35885.93
60min1302564-30256488.85787.001.4089.5787.711.39
2296501-29650187.07787.81
3292212-29221285.81786.52
4298881-29888187.77688.50
5295585-29558586.80887.52
6291601-29160185.63886.35
极限1304144-30414489.32190.190.7990.1891.050.78
2305412-30541289.69490.57
3305420-30542089.69690.54
4308311-30831190.54591.41
5309415-30941590.86991.72
6309928-30992891.02091.88
氢氯噻嗪坎地沙坦酯片项目信息
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100309-202205对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.70对照品水分(%)0对照品稀释倍数1000
标示量(mg)12.5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%
112.034794924789054789844790554793474791570.06
212.054773184774144773660.02
单位质量响应值RSD%判断
39830.1739615.440.39数据可信
中间条件12月-供试品溶液-2024090121批-氢氯噻嗪
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1285428-28542851.58156.8217.5551.5856.8217.55
2414806-41480674.96174.96
3273205-27320549.37249.37
4279278-27927850.46950.47
5290959-29095952.58052.58
6342854-34285461.95861.96
10min1469702-46970284.88282.708.3884.9782.798.39
2510430-51043092.24292.37
3429235-42923577.56977.65
4420819-42081976.04876.13
5424205-42420576.66076.75
6491336-49133688.79188.89
15min1488432-48843288.26687.314.8288.4987.544.83
2516648-51664893.36593.64
3466965-46696584.38784.60
4454341-45434182.10682.32
5471364-47136485.18285.40
6501149-50114990.56490.82
20min1492262-49226288.95889.123.8289.3389.503.84
2521525-52152594.24794.68
3479552-47955286.66287.01
4468970-46897084.74985.10
5489832-48983288.51988.88
6506692-50669291.56691.97
30min1498142-49814290.02190.862.8690.5491.382.88
2522117-52211794.35494.95
3495187-49518789.48789.98
4481482-48148287.01087.50
5506753-50675391.57792.08
6513001-51300192.70693.26
45min1500479-50047990.44392.592.5091.1293.272.51
2524416-52441694.76995.52
3512617-51261792.63793.28
4493478-49347889.17889.81
5520443-52044394.05194.71
6522724-52272494.46395.17
60min1500411-50041190.43193.442.5691.2594.282.57
2525455-52545594.95795.86
3525729-52572995.00695.81
4499729-49972990.30891.09
5523679-52367994.63695.45
6527472-52747295.32196.19
极限1534689-53468996.62696.750.6697.6097.740.67
2540723-54072397.71698.78
3535300-53530096.73697.69
4535348-53534896.74597.68
5536425-53642596.93997.91
6529751-52975195.73396.76
氢氯噻嗪坎地沙坦酯片项目信息
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(%)99.80对照品水分(%)0对照品稀释倍数1000
标示量(mg)16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%
116.233115273119263116553122253119403118550.09
216.313105853111493108670.13
单位质量响应值RSD%判断
19214.7319059.900.58数据可信
中间条件12月-供试品溶液-2024090121批-坎地沙坦酯
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1108807-10880731.91834.3214.7631.9234.3214.75
2148095-14809543.44343.44
3105295-10529530.88830.89
4103262-10326230.29130.29
5110301-11030132.35632.36
6126228-12622837.02837.03
10min1226667-22666766.49264.689.1366.5464.749.14
2249377-24937773.15473.23
3208521-20852161.16961.22
4200583-20058358.84058.89
5201476-20147659.10259.16
6236348-23634869.33269.39
15min1271134-27113479.53677.405.3379.7077.565.34
2283782-28378283.24683.44
3255975-25597575.08975.24
4251311-25131173.72173.87
5248312-24831272.84172.99
6272538-27253879.94880.13
20min1290397-29039785.18783.094.0385.4883.394.04
2298598-29859887.59287.93
3277124-27712481.29381.57
4269806-26980679.14679.42
5273471-27347180.22180.50
6290178-29017885.12285.43
30min1302171-30217188.64087.092.9289.0887.532.94
2306582-30658289.93490.41
3296561-29656186.99587.41
4281554-28155482.59383.00
5294221-29422186.30886.72
6300278-30027888.08588.54
45min1305741-30574189.68888.822.4090.2789.402.41
2310424-31042491.06191.69
3304711-30471189.38689.94
4289030-28903084.78685.33
5302326-30232688.68689.24
6304498-30449889.32389.92
60min1305529-30552989.62689.272.1790.3690.002.18
2310187-31018790.99291.77
3307598-30759890.23290.94
4291613-29161385.54386.23
5303818-30381889.12489.82
6307204-30720490.11790.86
极限1311995-31199591.52290.990.8292.4191.870.83
2314206-31420692.17193.10
3309373-30937390.75391.61
4308630-30863090.53591.36
5309781-30978190.87391.72
6307182-30718290.11091.01
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