美阿沙坦钾片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号D209-20230901R1 对照品来源自制对照品使用方法直接使用
对照品含量(%)99.4对照品水分(%)0对照品稀释倍数1000
标示量(mg)80供试品稀释倍数5系数0.9372
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
119.591909701909661901841908881907921907600.18
219.071885661885471885560.01
单位质量响应值RSD%判断
9737.629887.571.09数据可信
供试品溶液-69223050103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%
5min178667-7866742.01243.405.3842.0143.405.38
277240-7724041.25041.25
383701-8370144.70144.70
488719-8871947.38047.38
577974-7797441.64241.64
681287-8128743.41143.41
10min193247-9324749.79949.605.1450.2750.085.14
287684-8768446.82847.29
396847-9684751.72152.22
499934-9993453.37053.90
588866-8886647.45947.92
690649-9064948.41148.89
15min191392-9139248.80848.544.9549.8349.574.94
285234-8523445.51946.50
392148-9214849.21250.28
498454-9845452.57953.70
587822-8782246.90147.89
690288-9028848.21849.24
20min192591-9259149.44849.554.9151.0151.134.91
288457-8845747.24148.72
393357-9335749.85751.48
4101032-10103253.95655.66
588735-8873547.38948.90
692563-9256349.43350.99
30min193330-9333049.84349.804.6251.9551.924.61
291694-9169448.96950.98
392619-9261949.46351.64
4100438-10043853.63955.94
587149-8714946.54248.58
694249-9424950.33452.44
45min15714-57143.0523.155.215.725.824.87
25792-57923.0935.65
35955-59553.1805.90
46488-64883.4656.36
55664-56643.0255.58
65757-57573.0755.74
60min17574-75744.0453.894.066.746.603.98
27214-72143.8536.44
37059-70593.7706.53
47682-76824.1037.04
56923-69233.6976.29
67198-71983.8446.54
极限17671-76714.0974.114.326.846.874.40
27657-76574.0896.72
37694-76944.1096.91
48322-83224.4447.43
57322-73223.9106.54
67558-75584.0366.78
美阿沙坦钾片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号D209-20230901R1 对照品来源自制对照品使用方法直接使用
对照品含量(%)99.4对照品水分(%)0对照品稀释倍数1000
标示量(mg)80供试品稀释倍数5系数0.9372
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
119.591895571894591883571885051886111888980.30
219.071860581866041863310.21
单位质量响应值RSD%判断
9642.579770.900.94数据可信
供试品溶液-12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%
5min134659-3465918.71118.158.6918.7118.158.69
234795-3479518.78518.78
334749-3474918.76018.76
435559-3555919.19719.20
534258-3425818.49518.49
627723-2772314.96714.97
10min156512-5651230.50931.734.6830.7231.934.69
260539-6053932.68332.89
360885-6088532.87033.08
459900-5990032.33832.55
560532-6053232.67932.88
654222-5422229.27329.44
15min169704-6970437.63139.233.3538.1839.793.37
275227-7522740.61341.18
374740-7474040.35040.92
473580-7358039.72340.30
573092-7309239.46040.03
669677-6967737.61638.11
20min179883-7988343.12644.022.1644.0945.022.20
282253-8225344.40645.43
383833-8383345.25946.28
482222-8222244.38945.40
582038-8203844.29045.30
679054-7905442.67943.59
30min192541-9254149.96050.571.9651.4052.041.95
296615-9661552.15953.68
394271-9427150.89452.42
491193-9119349.23250.74
594123-9412350.81452.31
693239-9323950.33751.72
45min15297-52972.8602.992.414.865.032.30
25552-55522.9975.09
35607-56073.0275.12
45623-56233.0365.09
55665-56653.0585.12
65487-54872.9624.91
60min17152-71523.8613.821.525.895.901.77
27150-71503.8605.99
37041-70413.8015.93
47014-70143.7875.87
57203-72033.8895.99
66917-69173.7345.71
极限17764-77644.1924.386.626.276.504.84
28067-80674.3556.53
38042-80424.3426.51
49187-91874.9607.09
57903-79034.2676.41
67768-77684.1946.21
美阿沙坦钾片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号D209-20230901R1 对照品来源自制对照品使用方法直接使用
对照品含量(%)99.4对照品水分(%)0对照品稀释倍数1000
标示量(mg)80供试品稀释倍数5系数0.9372
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
119.591908191912011908951910071904461908740.15
219.071860611850881855740.38
单位质量响应值RSD%判断
9743.449731.200.09数据可信
供试品溶液-69223050103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%
5min148000-4800025.83126.053.5525.8326.053.55
250197-5019727.01327.01
350470-5047027.16027.16
448220-4822025.95025.95
545832-4583224.66424.66
647745-4774525.69425.69
10min150932-5093227.40927.022.8827.7027.312.85
251566-5156627.75028.05
350190-5019027.01027.31
450472-5047227.16127.45
550680-5068027.27327.55
647425-4742525.52225.81
15min148285-4828525.98426.602.3226.5827.192.30
249898-4989826.85327.46
350632-5063227.24827.85
450441-5044127.14527.73
549500-4950026.63827.22
647838-4783825.74426.31
20min150036-5003626.92727.252.2827.8128.132.27
250922-5092227.40428.31
351629-5162927.78428.69
451638-5163827.78928.68
550942-5094227.41428.29
648608-4860826.15827.01
30min150300-5030027.06927.541.4528.2528.731.37
251841-5184127.89829.11
350895-5089527.38928.60
450373-5037327.10828.31
551817-5181727.88529.06
651810-5181027.88129.03
45min149461-4946126.61727.121.8628.1028.611.80
250184-5018427.00628.53
350987-5098727.43928.96
451960-5196027.96229.46
550077-5007726.94928.44
649669-4966926.72928.18
60min15562-55622.9933.124.844.774.923.50
25903-59033.1775.00
36256-62563.3675.19
45634-56343.0324.84
55927-59273.1904.98
65531-55312.9764.73
极限15965-59653.2103.353.725.025.182.95
26260-62603.3695.23
36534-65343.5165.38
46399-63993.4445.29
56221-62213.3485.17
65955-59553.2054.99
美阿沙坦钾片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号D209-20230901R1 对照品来源自制对照品使用方法直接使用
对照品含量(%)99.4对照品水分(%)0对照品稀释倍数1000
标示量(mg)80供试品稀释倍数5系数0.9372
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
119.591938401918731906601907991909861916320.69
219.071832641823251827940.37
单位质量响应值RSD%判断
9782.139585.421.44数据可信
供试品溶液-06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%
5min132201-3220117.42717.392.6517.4317.392.65
232708-3270817.70117.70
330586-3058616.55316.55
432898-3289817.80417.80
532591-3259117.63817.64
631841-3184117.23217.23
10min147703-4770325.81625.481.8126.0125.671.80
248093-4809326.02726.22
346069-4606924.93225.12
446826-4682625.34125.54
547589-4758925.75425.95
646164-4616424.98325.17
15min153446-5344628.92428.771.9129.4029.241.91
254080-5408029.26729.75
352093-5209328.19228.65
454466-5446629.47629.96
552841-5284128.59629.08
652029-5202928.15728.63
20min158572-5857231.69830.971.9932.5031.771.94
255979-5597930.29531.11
357363-5736331.04431.82
456648-5664830.65731.46
558568-5856831.69632.50
656271-5627130.45331.23
30min161158-6115833.09732.881.8934.2534.021.84
260854-6085432.93334.08
362044-6204433.57734.70
460505-6050532.74433.89
561269-6126933.15834.31
658663-5866331.74732.87
45min160011-6001132.47732.981.3034.0034.491.21
262098-6209833.60635.12
360783-6078332.89534.39
460926-6092632.97234.48
560268-6026832.61634.14
661591-6159133.33234.80
60min15324-53242.8812.912.674.764.781.43
25417-54172.9324.82
35567-55673.0134.87
45180-51802.8034.68
55303-53032.8704.75
65510-55102.9824.83
极限16175-61753.3423.241.835.265.141.37
26044-60443.2715.19
35972-59723.2325.12
45948-59483.2195.13
55899-58993.1925.11
65882-58823.1835.06
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