阿齐沙坦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68522100802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)20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%
110.562865482862832862942862172858952862470.09
210.622865492866782866140.04
单位质量响应值RSD%判断
27106.7226988.140.32数据可信
中间条件3月-供试品溶液-2023101221批-阿齐沙坦-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%
5min1104111-10411134.53926.7933.3334.5426.7933.33
265622-6562221.77021.77
345112-4511214.96614.97
4116368-11636838.60538.61
564929-6492921.54021.54
688366-8836629.31629.32
10min1252476-25247683.75976.2213.1883.9576.3613.22
2228474-22847475.79775.92
3183397-18339760.84260.93
4270724-27072489.81390.03
5214448-21444871.14471.26
6228903-22890375.93976.10
15min1273238-27323890.64788.467.1991.3089.047.26
2260575-26057586.44686.99
3237056-23705678.64479.06
4288625-28862595.75296.47
5256570-25657085.11885.63
6283862-28386294.17294.76
20min1274594-27459491.09790.585.8092.2691.645.87
2272300-27230090.33691.36
3248727-24872782.51683.37
4291685-29168596.76798.01
5263258-26325887.33688.32
6287623-28762395.42096.53
30min1279025-27902592.56792.563.3294.2394.123.43
2275957-27595791.54993.07
3266779-26677988.50589.82
4291510-29151096.70998.49
5272945-27294590.55092.02
6287760-28776095.46597.10
45min1284714-28471494.45494.163.0596.6496.253.15
2279899-27989992.85794.89
3275597-27559791.43093.24
4293983-29398397.52999.85
5274772-27477291.15693.13
6294073-29407397.55999.73
60min1274993-27499391.23093.862.5493.9496.462.55
2282353-28235393.67196.22
3284421-28442194.35796.67
4290222-29022296.28299.14
5274411-27441191.03693.52
6291069-29106996.56399.27
极限1293015-29301597.20898.621.13100.42101.741.06
2302592-302592100.386103.45
3296182-29618298.259101.10
4297619-29761998.736102.13
5299087-29908799.223102.21
6295105-29510597.902101.15
阿齐沙坦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68522100802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)20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%
110.562863782863512863052863952865822864020.04
210.622862222862062862140.01
单位质量响应值RSD%判断
27121.4026950.470.45数据可信
中间条件3月-供试品溶液-2024010621批-阿齐沙坦-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%
5min1125399-12539941.61944.1721.8041.6244.1721.79
2140185-14018546.52746.53
385051-8505128.22828.23
4157841-15784152.38752.39
5123881-12388141.11541.12
6166102-16610255.12855.13
10min1284344-28434494.37282.218.9694.6082.468.95
2231802-23180276.93477.19
3220203-22020373.08473.24
4257546-25754685.47885.77
5248026-24802682.31982.55
6244360-24436081.10281.41
15min1296655-29665598.45888.367.0199.2189.067.02
2246511-24651181.81682.50
3248456-24845682.46183.02
4274684-27468491.16691.93
5269859-26985989.56590.25
6261128-26112886.66787.42
20min1304487-304487101.05890.856.34102.3692.046.34
2255071-25507184.65785.80
3261313-26131386.72887.75
4279031-27903192.60993.88
5273975-27397590.93192.11
6268437-26843789.09390.33
30min1297071-29707198.59691.514.89100.4693.214.92
2260166-26016686.34887.96
3265973-26597388.27589.78
4282616-28261693.79995.59
5279850-27985092.88194.57
6268590-26859089.14490.88
45min1293454-29345497.39692.223.8199.8194.423.85
2264539-26453987.79989.89
3270791-27079189.87491.87
4282656-28265693.81296.12
5283526-28352694.10196.31
6272149-27214990.32592.55
60min1298623-29862399.11193.363.72102.0696.083.76
2268443-26844389.09591.67
3277874-27787492.22594.72
4286229-28622994.99897.83
5282034-28203493.60696.33
6274610-27461091.14293.87
极限1302167-302167100.28899.641.65103.79102.881.71
2290971-29097196.57299.64
3300449-30044999.717102.72
4305455-305455101.379104.74
5300007-30000799.571102.82
6302324-302324100.340103.58
阿齐沙坦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68522100802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)20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%
110.562864782865262864702863762863582864420.03
210.622861082862922862000.05
单位质量响应值RSD%判断
27125.1926949.150.47数据可信
中间条件3月-供试品溶液-2024010721批-阿齐沙坦-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%
5min1147734-14773449.03040.8830.6249.0340.8830.62
2115221-11522138.24038.24
382855-8285527.49827.50
4181129-18112960.11360.11
5127038-12703842.16142.16
685164-8516428.26428.26
10min1266129-26612988.32380.3710.7088.6080.6010.75
2244994-24499481.30981.52
3212065-21206570.38070.53
4276372-27637291.72292.06
5237200-23720078.72278.96
6216302-21630271.78671.94
15min1278514-27851492.43387.575.8493.2088.245.92
2263877-26387787.57588.24
3243635-24363580.85881.40
4282845-28284593.87194.71
5264594-26459487.81388.49
6249726-24972682.87983.43
20min1279110-27911092.63189.444.8093.9190.604.89
2266185-26618588.34189.49
3251819-25181983.57484.57
4284739-28473994.49995.86
5276994-27699491.92993.09
6258073-25807385.64986.67
30min1279258-27925892.68091.413.3794.4793.073.47
2270530-27053089.78391.42
3264072-26407287.64089.10
4287520-28752095.42297.31
5283221-28322193.99595.67
6268001-26800188.94490.44
45min1284380-28438094.38092.083.0296.6994.253.12
2272254-27225490.35692.50
3266648-26664888.49590.44
4284604-28460494.45496.87
5285676-28567694.81097.00
6271209-27120990.00992.00
60min1280997-28099793.25791.021.7296.0993.691.85
2274496-27449691.10093.74
3270586-27058689.80292.24
4278053-27805392.28095.23
5273007-27300790.60693.32
6268322-26832289.05191.54
极限1286060-28606094.93895.353.8498.2998.543.74
2271520-27152090.11293.26
3278391-27839192.39295.33
4291828-29182896.852100.31
5294465-29446597.727100.95
6301589-301589100.091103.07
阿齐沙坦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68522100802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)20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%
110.562869382870652869442868662868492869320.03
210.622870562869962870260.02
单位质量响应值RSD%判断
27171.5927026.930.38数据可信
中间条件3月-供试品溶液-2024010921批-阿齐沙坦-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%
5min1104581-10458134.62941.2024.2634.6341.2024.26
2131105-13110543.41143.41
386012-8601228.48028.48
4127847-12784742.33242.33
5175602-17560258.14558.15
6121409-12140940.20140.20
10min1238182-23818278.86685.358.6179.0685.588.63
2232685-23268577.04677.29
3246386-24638681.58381.74
4275230-27523091.13491.37
5288687-28868795.59095.91
6265323-26532387.85388.08
15min1256825-25682585.03992.147.2085.6792.847.22
2255400-25540084.56885.24
3270858-27085889.68690.30
4296556-29655698.19598.94
5301033-30103399.678100.53
6288953-28895395.67896.39
20min1265104-26510487.78194.105.9788.8895.316.01
2266341-26634188.19089.33
3277814-27781491.98993.10
4298043-29804398.68899.97
5305504-305504101.158102.57
6292251-29225196.77098.01
30min1265890-26589088.04195.005.1489.6396.745.19
2273797-27379790.65992.29
3284279-28427994.13095.75
4300742-30074299.581101.42
5300817-30081799.606101.58
6295861-29586197.96599.75
45min1269953-26995389.38695.575.0391.4797.835.08
2274977-27497791.05093.18
3286076-28607694.72596.87
4303350-303350100.445102.83
5305373-305373101.115103.64
6291964-29196496.67599.00
60min1273091-27309190.42595.994.6093.0098.794.65
2274556-27455690.91193.55
3291257-29125796.44199.11
4304984-304984100.986103.93
5300748-30074899.583102.67
6294793-29479397.611100.47
极限1305981-305981101.316101.711.19104.39105.041.32
2304974-304974100.983104.13
3304553-304553100.843104.05
4306254-306254101.406104.91
5314384-314384104.098107.74
6306860-306860101.607105.01
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