替米沙坦左氨氯地平片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号100629-202204对照品来源中检院对照品使用方法直接使用
对照品含量(%)100.0对照品水分(%)0对照品稀释倍数1250
标示量(mg)80供试品稀释倍数10系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.087511707513957513667515547512867513540.02
211.057492177495647493900.04
单位质量响应值RSD%判断
67811.7367818.100.01数据可信
供试品溶液-2024070321批-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%
5min1245522-24552232.58435.584.9032.5835.584.90
2260434-26043434.56334.56
3272741-27274136.19736.20
4282373-28237337.47537.47
5275086-27508636.50836.51
6272374-27237436.14836.15
10min1448282-44828259.49366.056.3459.6766.256.34
2505121-50512167.03767.23
3469455-46945562.30362.50
4519328-51932868.92269.13
5525902-52590269.79570.00
6518148-51814868.76668.97
15min1566992-56699275.24883.536.9275.7684.106.91
2650735-65073586.36286.93
3586531-58653177.84178.39
4672819-67281989.29389.88
5666630-66663088.47189.06
6632675-63267583.96584.55
20min1644773-64477385.57193.006.1086.5094.036.09
2728949-72894996.74297.79
3646595-64659585.81286.79
4731600-73160097.09498.18
5725577-72557796.29497.38
6726965-72696596.47997.53
30min1731795-73179597.12097.951.1098.5299.501.14
2737833-73783397.92199.50
3730253-73025396.91598.37
4739790-73979098.18199.81
5735979-73597997.67599.29
6752771-75277199.903101.49
45min1705970-70597093.69295.554.2495.6497.644.21
2690092-69009291.58593.71
3686753-68675391.14293.14
4736105-73610597.69299.86
5737346-73734697.856100.02
6763556-763556101.335103.48
60min1723088-72308895.96497.431.0398.43100.051.05
2733282-73328297.31799.95
3738890-73889098.061100.56
4732796-73279697.25299.97
5731346-73134697.06099.76
6745386-74538698.923101.63
极限1675506-67550689.64994.682.7792.6597.842.74
2710915-71091594.34897.52
3728996-72899696.74899.79
4720710-72071095.64898.90
5717216-71721695.18598.43
6727020-72702096.48699.74
替米沙坦左氨氯地平片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号100629-202204对照品来源中检院对照品使用方法直接使用
对照品含量(%)100.0对照品水分(%)0对照品稀释倍数1250
标示量(mg)80供试品稀释倍数10系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.087482187496177490107486657483267487670.08
211.057447737450637449180.03
单位质量响应值RSD%判断
67578.2567413.390.18数据可信
供试品溶液-2024070421批-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%
5min1250462-25046233.39738.268.0433.4038.268.03
2271779-27177936.23936.24
3311625-31162541.55341.55
4283158-28315837.75737.76
5300963-30096340.13140.13
6303493-30349340.46840.47
10min1458754-45875461.17168.938.7861.3669.148.78
2465662-46566262.09262.29
3557219-55721974.30174.53
4515160-51516068.69268.90
5544385-54438572.58972.81
6560493-56049374.73774.96
15min1595364-59536479.38787.057.4279.9187.647.43
2595838-59583879.45080.00
3686682-68668291.56392.21
4645576-64557686.08286.67
5688517-68851791.80892.43
6704875-70487593.98994.63
20min1669716-66971689.30193.714.4390.2794.794.46
2660063-66006388.01489.00
3732540-73254097.67898.83
4722419-72241996.32997.40
5728313-72831397.11598.25
6703569-70356993.81594.98
30min1739385-73938598.59198.951.01100.05100.551.07
2734544-73454497.94599.42
3743953-74395399.200100.89
4733823-73382397.84999.45
5751466-751466100.202101.88
6749390-74939099.925101.61
45min1709870-70987094.65595.861.8996.6798.011.86
2725012-72501296.67498.70
3719266-71926695.90898.15
4722804-72280496.38098.53
5737996-73799698.406100.64
6698380-69838093.12395.36
60min1729189-72918997.23196.851.7699.7799.531.67
2737389-73738998.325100.88
3705968-70596894.13596.91
4727493-72749397.00599.69
5740217-74021798.702101.48
6717636-71763695.69198.45
极限1697940-69794093.06596.091.6996.1499.321.70
2724601-72460196.62099.72
3721216-72121696.16899.47
4725006-72500696.67499.90
5720867-72086796.12299.45
6734356-73435697.920101.21
替米沙坦左氨氯地平片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号100629-202204对照品来源中检院对照品使用方法直接使用
对照品含量(%)100.0对照品水分(%)0对照品稀释倍数1250
标示量(mg)80供试品稀释倍数10系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.087444377446777446487442137442417444430.03
211.057446157444787445460.02
单位质量响应值RSD%判断
67188.0067379.730.21数据可信
供试品溶液-2024070521批-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%
5min1269884-26988436.10037.686.9136.1037.686.90
2280181-28018137.47837.48
3311929-31192941.72441.72
4268889-26888935.96735.97
5297907-29790739.84939.85
6261474-26147434.97534.98
10min1507071-50707167.82765.726.1268.0365.936.12
2493517-49351766.01466.22
3521458-52145869.75169.98
4459666-45966661.48661.69
5516429-51642969.07969.30
6449850-44985060.17360.37
15min1657412-65741287.93785.083.8488.5185.653.85
2629613-62961384.21884.79
3663304-66330488.72589.34
4627515-62751583.93884.48
5642557-64255785.95086.55
6595862-59586279.70480.23
20min1716068-71606895.78395.001.5096.8596.041.53
2710119-71011994.98796.03
3723625-72362596.79397.91
4698046-69804693.37294.38
5715969-71596995.76996.85
6697367-69736793.28194.25
30min1701974-70197493.89796.771.8695.5098.351.80
2717884-71788496.02697.60
3724797-72479796.95098.60
4722769-72276996.67998.21
5731377-73137797.83099.45
6741938-74193899.243100.73
45min1692197-69219792.59096.232.0094.7198.341.97
2731980-73198097.911100.02
3728329-72832997.42399.61
4719228-71922896.20598.27
5726346-72634697.15799.32
6718199-71819996.06898.11
60min1646013-64601386.41293.654.2589.0596.304.13
2699795-69979593.60696.25
3692588-69258892.64295.37
4719785-71978596.28098.88
5729863-72986397.628100.33
6712741-71274195.33897.91
极限1565779-56577975.68090.128.3278.7993.298.07
2662060-66206088.55891.73
3694675-69467592.92196.17
4704224-70422494.19897.33
5718163-71816396.06399.30
6697517-69751793.30196.41
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