阿齐沙坦片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号68522100802对照品来源自制对照品使用方法直接使用
对照品含量(%)99.7对照品水分(%)0对照品稀释倍数5000
标示量(mg)20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%
110.121035011030271026971033111028191030710.33
210.081030541030331030440.02
单位质量响应值RSD%判断
10184.8810222.620.27数据可信
中间条件24月-供试品溶液-2023111721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%
5min13734-37343.2843.5618.113.283.5618.19
24147-41473.6473.65
32835-28352.4932.49
44000-40003.5183.52
54614-46144.0574.06
64931-49314.3364.34
10min19803-98038.6218.536.418.648.566.41
210038-100388.8278.85
38553-85537.5217.54
49506-95068.3598.38
510269-102699.0309.05
610063-100638.8498.87
15min113294-1329411.69111.865.0111.7611.935.03
214078-1407812.38012.45
312504-1250410.99611.05
412945-1294511.38411.45
514023-1402312.33212.40
614078-1407812.38012.45
20min116323-1632314.35414.382.7214.4914.512.76
216359-1635914.38614.52
315752-1575213.85213.97
416029-1602914.09614.22
516601-1660114.59914.74
617027-1702714.97315.12
30min119805-1980517.41617.542.6117.6317.752.62
220282-2028217.83618.05
319715-1971517.33717.53
419083-1908316.78116.99
520272-2027217.82718.05
620507-2050718.03418.26
45min122570-2257019.84820.071.1620.1620.381.20
223135-2313520.34520.66
322573-2257319.85020.14
422621-2262119.89320.19
522978-2297820.20720.53
623071-2307120.28820.61
60min124421-2442121.47521.341.2321.8921.761.23
224577-2457721.61322.04
324046-2404621.14621.55
423972-2397221.08121.49
524590-2459021.62422.06
623982-2398221.08921.53
极限125149-2514922.11621.872.3222.6522.402.26
224323-2432321.38921.94
325269-2526922.22122.74
424082-2408221.17721.71
525576-2557622.49123.04
624787-2478721.79722.35
阿齐沙坦片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号68522100802对照品来源自制对照品使用方法直接使用
对照品含量(%)99.7对照品水分(%)0对照品稀释倍数5000
标示量(mg)20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%
110.121028201032901028291032451030101030390.22
210.081024741019071021900.40
单位质量响应值RSD%判断
10181.7210137.900.31数据可信
中间条件24月-供试品溶液-2023111821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%
5min13511-35113.1012.8819.193.102.8819.15
22218-22181.9591.96
33370-33702.9762.98
44053-40533.5803.58
53504-35043.0953.09
62927-29272.5852.59
10min18500-85007.5078.027.697.528.047.69
28013-80137.0777.09
39271-92718.1888.20
49796-97968.6528.67
59710-97108.5768.59
69202-92028.1278.14
15min112402-1240210.95311.395.0611.0111.455.07
212527-1252711.06411.11
313010-1301011.49011.55
413388-1338811.82411.89
513880-1388012.25912.32
612172-1217210.75010.81
20min115370-1537013.57513.573.8813.6913.693.89
214834-1483413.10113.21
315374-1537413.57813.70
415302-1530213.51513.65
516462-1646214.53914.67
614831-1483113.09913.22
30min118333-1833316.19216.722.4316.3916.922.43
218525-1852516.36116.55
319270-1927017.01917.22
418820-1882016.62216.83
519550-1955017.26617.48
619081-1908116.85217.04
45min122034-2203419.46020.107.4019.7520.407.34
221770-2177019.22719.50
322713-2271320.06020.36
425211-2521122.26622.57
524213-2421321.38521.69
620630-2063018.22018.51
60min122924-2292420.24620.530.9120.6420.930.94
223313-2331320.59020.97
323226-2322620.51320.92
423227-2322720.51420.94
523577-2357720.82321.25
623178-2317820.47120.86
极限124463-2446321.60521.660.5722.1122.180.60
224302-2430221.46321.96
324590-2459021.71822.24
424483-2448321.62322.16
524648-2464821.76922.31
624667-2466721.78622.29
阿齐沙坦片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号68522100802对照品来源自制对照品使用方法直接使用
对照品含量(%)99.7对照品水分(%)0对照品稀释倍数5000
标示量(mg)20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%
110.121021571029001022911027871027291025730.32
210.081018441028971023700.73
单位质量响应值RSD%判断
10135.6710155.750.14数据可信
中间条件24月-供试品溶液-2023111921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%
5min14844-48444.2844.6311.884.284.6311.88
25172-51724.5744.57
34928-49284.3584.36
45129-51294.5364.54
54885-48854.3204.32
66480-64805.7315.73
10min19433-94338.3439.178.488.379.208.46
29886-98868.7438.77
310378-103789.1789.20
410715-107159.4769.50
59884-98848.7428.77
611917-1191710.54010.57
15min112241-1224110.82611.715.7710.9011.785.79
213181-1318111.65711.73
313006-1300611.50311.58
413461-1346111.90511.98
512972-1297211.47311.55
614559-1455912.87612.97
20min114963-1496313.23314.004.2413.3614.144.28
215592-1559213.79013.93
315556-1555613.75813.90
416232-1623214.35614.50
515722-1572213.90514.04
616920-1692014.96415.13
30min118223-1822316.11716.762.7616.3216.982.79
218776-1877616.60616.82
319474-1947417.22317.44
419088-1908816.88217.11
518562-1856216.41616.63
619549-1954917.28917.53
45min121891-2189119.36119.211.1319.6519.521.10
221275-2127518.81619.12
321743-2174319.23019.54
421763-2176319.24719.57
521976-2197619.43619.74
621644-2164419.14219.48
60min123361-2336120.66120.541.5321.0620.961.46
223381-2338120.67821.09
322882-2288220.23720.66
422832-2283220.19320.62
523773-2377321.02521.44
623119-2311920.44720.89
极限124124-2412421.33621.421.6821.8521.961.60
224236-2423621.43521.96
324202-2420221.40521.94
424159-2415921.36721.90
524941-2494122.05822.59
623685-2368520.94721.51
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