替米沙坦片项目信息
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对照品来源原料药对照品使用方法直接使用
对照品含量(%)100.00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%
111.014837704839124834654833194830604835050.08
211.024850914848984849940.03
单位质量响应值RSD%判断
43915.0844010.340.16数据可信
供试品溶液-E43216批-pH1.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min153607-5360710.97411.9228.5910.9711.9228.59
257395-5739511.75011.75
353832-5383211.02011.02
448644-486449.9589.96
544869-448699.1869.19
690983-9098318.62618.63
10min1105068-10506821.50922.7617.0221.5722.8217.04
2126358-12635825.86825.93
3102123-10212320.90720.97
487043-8704317.81917.87
5106346-10634621.77121.82
6140035-14003528.66828.77
15min1152730-15273031.26733.8814.9731.4534.0714.99
2184486-18448637.76837.98
3169853-16985334.77234.95
4139286-13928628.51528.67
5144001-14400129.48029.65
6202557-20255741.46741.73
20min1198855-19885540.70946.4817.1041.0646.8617.09
2258227-25822752.86453.28
3225199-22519946.10346.47
4207289-20728942.43642.75
5185409-18540937.95738.29
6287354-28735458.82759.32
30min1310895-31089563.64667.048.3564.2367.688.42
2356563-35656372.99573.71
3322521-32252166.02666.65
4313968-31396864.27564.82
5295940-29594060.58561.13
6365026-36502674.72875.55
45min1395864-39586481.04183.146.1681.9784.156.23
2442860-44286090.66291.78
3394348-39434880.73181.72
4385091-38509178.83679.74
5386138-38613879.05079.93
6432309-43230988.50289.74
60min1453753-45375392.89291.344.0694.2892.824.13
2470789-47078996.38098.00
3428310-42831087.68389.13
4427995-42799587.61988.96
5435520-43552089.15990.48
6460745-46074594.32396.05
90min1484575-48457599.20295.972.43101.1097.952.43
2476734-47673497.59799.75
3465556-46555695.30897.24
4450972-45097292.32394.15
5468729-46872995.95897.78
6466232-46623295.44797.70
120min1477209-47720997.69496.211.10100.1598.721.11
2469379-46937996.09198.79
3472421-47242196.71499.17
4461443-46144394.46696.81
5469778-46977896.17398.52
6469435-46943596.10298.88
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
极限1478569-47856997.97296.671.72100.9799.721.54
2471866-47186696.60099.83
3478184-47818497.893100.89
4470848-47084896.39299.26
5476719-47671997.594100.48
6457116-45711693.58096.90
替米沙坦片项目信息
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对照品来源原料药对照品使用方法直接使用
对照品含量(%)100.00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%
111.014865884864014861204860114861064862450.05
211.024851434854944853180.06
单位质量响应值RSD%判断
44163.9444039.750.20数据可信
供试品溶液-F73104批-pH1.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1109156-10915622.27616.4923.9522.2816.4923.96
283792-8379217.10017.10
374698-7469815.24415.24
460682-6068212.38412.38
595635-9563519.51719.52
660892-6089212.42612.43
10min1148829-14882930.37225.7911.1230.5025.8811.17
2129970-12997026.52326.62
3129364-12936426.40026.48
4108790-10879022.20122.27
5127221-12722125.96226.07
6114071-11407123.27923.35
15min1196945-19694540.19135.319.9840.4835.5510.00
2176046-17604635.92636.17
3183072-18307237.36037.59
4150079-15007930.62730.82
5175646-17564635.84536.10
6156497-15649731.93732.14
20min1233664-23366447.68542.8710.2348.2043.3010.25
2223210-22321045.55145.99
3222608-22260845.42845.87
4180497-18049736.83537.20
5213560-21356043.58244.03
6186962-18696238.15438.53
30min1285617-28561758.28755.554.8159.0756.224.87
2288670-28867058.91059.60
3272097-27209755.52856.22
4254023-25402351.83952.41
5268132-26813254.71955.41
6264676-26467654.01354.60
45min1362527-36252773.98271.183.5975.0972.153.66
2360261-36026173.52074.54
3352202-35220271.87572.87
4331132-33113267.57568.43
5349457-34945771.31572.31
6337082-33708268.79069.68
60min1393539-39353980.31180.761.9381.8382.131.92
2403385-40338582.32083.75
3405257-40525782.70284.10
4394433-39443380.49381.72
5384374-38437478.44179.83
6393334-39333480.26981.54
90min1410630-41063083.79985.922.2485.7687.742.20
2422390-42239086.19988.09
3438423-43842389.47191.33
4416541-41654185.00586.68
5418453-41845385.39587.23
6419642-41964285.63887.35
120min1413620-41362084.40987.722.3486.8490.022.25
2436188-43618889.01491.38
3441810-44181090.16292.52
4435133-43513388.79990.95
5426996-42699687.13989.44
6425398-42539886.81289.00
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
极限1434387-43438788.64789.031.6591.5491.811.61
2431838-43183888.12790.99
3448295-44829591.48594.34
4441590-44159090.11792.76
5430138-43013887.78090.57
6431266-43126688.01090.68
替米沙坦片项目信息
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对照品来源原料药对照品使用方法直接使用
对照品含量(%)100.00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%
111.014842714836444836704838324834734837780.07
211.024837234833834835530.05
单位质量响应值RSD%判断
43939.8743879.580.10数据可信
供试品溶液-F66942批-pH1.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min144704-447049.16312.1219.429.1612.1219.43
267292-6729213.79313.79
351092-5109210.47210.47
471949-7194914.74714.75
551133-5113310.48110.48
668702-6870214.08214.08
10min190938-9093818.63923.0314.0818.6923.1014.10
2125107-12510725.64325.72
3103289-10328921.17121.23
4126867-12686726.00326.09
5101159-10115920.73420.79
6126918-12691826.01426.09
15min1130829-13082926.81631.4411.0726.9731.6411.10
2170907-17090735.03035.25
3146682-14668230.06530.24
4169501-16950134.74234.97
5138773-13877328.44428.62
6163717-16371733.55633.78
20min1163799-16379933.57338.7210.7333.8839.0910.76
2209978-20997843.03843.45
3176030-17603036.08036.42
4205042-20504242.02742.45
5172675-17267535.39335.72
6205907-20590742.20442.61
30min1246097-24609750.44253.274.9150.9353.854.97
2269890-26989055.31855.97
3260505-26050553.39553.94
4277268-27726856.83157.48
5245070-24507050.23150.76
6260447-26044753.38354.03
45min1322446-32244666.09067.804.5666.8668.684.59
2355909-35590972.94973.91
3325548-32554866.72667.57
4341803-34180370.05871.03
5315658-31565864.69965.51
6323350-32335066.27667.22
60min1359931-35993173.77475.216.7674.9176.476.72
2414359-41435984.93086.29
3365926-36592675.00276.21
4366856-36685675.19376.55
5347568-34756871.24072.41
6347051-34705171.13472.44
90min1425639-42563987.24289.044.7588.7990.724.76
2475848-47584897.53399.37
3427778-42777887.68089.31
4431086-43108688.35890.13
5420217-42021786.13087.69
6425905-42590587.29689.00
120min1439374-43937490.05793.973.1392.0996.143.18
2481560-48156098.703101.08
3456061-45606193.47795.59
4456985-45698593.66695.93
5450659-45065992.37094.41
6466152-46615295.54597.73
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
极限1472525-47252596.85296.482.1899.3899.172.22
2487596-48759699.941102.87
3473004-47300496.95099.58
4471026-47102696.54499.33
5459472-45947294.17696.73
6460588-46058894.40597.12
替米沙坦片项目信息
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对照品来源原料药对照品使用方法直接使用
对照品含量(%)100.00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%
111.014843804849494851734847264854194849290.09
211.024879184872064875620.11
单位质量响应值RSD%判断
44044.4144243.380.32数据可信
供试品溶液-F90166批-pH1.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min153534-5353410.91412.147.3310.9112.147.35
258612-5861211.95011.95
358364-5836411.89911.90
458961-5896112.02112.02
566936-6693613.64713.65
660880-6088012.41212.41
10min1100707-10070720.53221.375.4020.5921.445.41
2105060-10506021.42021.49
3103086-10308621.01721.08
4105288-10528821.46621.53
5115319-11531923.51123.59
699396-9939620.26520.33
15min1142624-14262429.07830.145.3329.2530.335.34
2145603-14560329.68629.87
3145260-14526029.61629.80
4146516-14651629.87230.06
5163637-16363733.36233.57
6143352-14335229.22729.41
20min1184940-18494037.70637.745.3738.0438.105.37
2181118-18111836.92637.28
3184035-18403537.52137.87
4180084-18008436.71537.07
5204385-20438541.67042.06
6176182-17618235.92036.26
30min1253553-25355351.69450.716.1452.2451.276.13
2240161-24016148.96449.52
3244094-24409449.76650.32
4241053-24105349.14649.70
5277437-27743756.56457.19
6235945-23594548.10448.65
45min1320648-32064865.37466.351.8266.2167.201.81
2321489-32148965.54566.37
3335677-33567768.43869.27
4327786-32778666.82967.66
5326477-32647766.56267.50
6320537-32053765.35166.16
60min1365781-36578174.57575.203.1875.7776.413.12
2357797-35779772.94874.14
3378664-37866477.20278.41
4387582-38758279.02080.22
5361371-36137173.67674.98
6361814-36181473.76774.94
90min1427396-42739687.13787.732.3588.7589.362.33
2418567-41856785.33786.93
3444213-44421390.56692.21
4440300-44030089.76891.41
5429255-42925587.51689.23
6422097-42209786.05787.64
120min1428484-42848487.35992.003.8789.4594.113.81
2447879-44787991.31393.38
3468132-46813295.44397.59
4475214-47521496.88799.02
5447278-44727891.19193.39
6440393-44039389.78791.85
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
极限1454375-45437592.63894.672.6495.2297.302.62
2459117-45911793.60596.18
3475276-47527696.89999.57
4482423-48242398.356101.03
5463732-46373294.54697.25
6451071-45107191.96494.52
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