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D211-4R701-2402002对照品来源自制工作对照品对照品使用方法直接使用
对照品含量(%)99.5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1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
118.102073872069962070862071912068032070930.11
218.032072872075122074000.08
单位质量响应值RSD%判断
11441.6011503.050.38数据可信
加速6月-供试品溶液-2024123121批-pH7.8
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min13693-36931.8021.726.411.801.726.44
23479-34791.6971.70
33391-33911.6541.65
43875-38751.8901.89
53471-34711.6931.69
63240-32401.5811.58
10min18399-83994.0983.944.094.123.964.10
28064-80643.9343.95
37607-76073.7113.73
48442-84424.1194.14
58132-81323.9673.99
67791-77913.8013.82
15min114010-140106.8356.911.986.906.972.00
214214-142146.9347.00
314168-141686.9126.97
414558-145587.1027.17
514261-142616.9577.02
613718-137186.6926.75
20min116842-168428.2178.524.278.368.664.17
217210-172108.3968.54
317360-173608.4698.61
417192-171928.3878.53
518946-189469.2439.38
617269-172698.4258.56
30min126382-2638212.87113.181.6313.1013.411.62
227162-2716213.25113.48
326744-2674413.04713.28
426929-2692913.13813.38
527668-2766813.49813.74
627210-2721013.27513.50
45min134107-3410716.64017.001.5517.0217.381.51
235366-3536617.25417.63
334773-3477316.96417.34
434297-3429716.73217.12
535263-3526317.20317.60
635227-3522717.18617.56
60min147146-4714623.00123.621.5823.5624.191.57
249435-4943524.11724.69
348856-4885623.83524.40
448206-4820623.51824.09
548549-4854923.68524.27
648272-4827223.55024.12
极限150190-5019024.48625.612.2525.3026.442.21
253098-5309825.90526.74
353057-5305725.88526.71
452326-5232625.52826.36
553364-5336426.03426.88
652912-5291225.81426.64
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D211-4R701-2402002对照品来源自制工作对照品对照品使用方法直接使用
对照品含量(%)99.5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1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
118.102056572060352052902047772045232052560.31
218.032063222058042060630.18
单位质量响应值RSD%判断
11340.1111428.900.56数据可信
长期6月-供试品溶液-2024123121批-pH7.8
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min13862-38621.8992.108.231.902.108.18
24251-42512.0902.09
34472-44722.1992.20
44844-48442.3812.38
53980-39801.9571.96
64262-42622.0952.10
10min18335-83354.0984.393.854.124.413.83
29039-90394.4444.47
39334-93344.5894.61
49118-91184.4834.51
58774-87744.3144.34
68926-89264.3884.41
15min111507-115075.6575.883.245.725.953.28
211883-118835.8425.91
312248-122486.0216.10
412581-125816.1856.26
511744-117445.7745.84
611808-118085.8055.88
20min121560-2156010.60010.952.1510.7311.092.16
222737-2273711.17811.32
322644-2264411.13211.27
422573-2257311.09811.24
521839-2183910.73710.87
622291-2229110.95911.10
30min126600-2660013.07713.713.2213.3213.973.22
227642-2764213.59013.85
328680-2868014.10014.37
429094-2909414.30314.57
527923-2792313.72813.98
627428-2742813.48413.74
45min136530-3653017.95918.782.6218.3519.192.63
238041-3804118.70219.11
338957-3895719.15219.58
439386-3938619.36319.79
538416-3841618.88619.29
637819-3781918.59319.00
60min144317-4431721.78822.431.7322.3823.051.75
246115-4611522.67223.29
346393-4639322.80823.44
446070-4607022.64923.29
545819-4581922.52623.14
645052-4505222.14922.76
极限150529-5052924.84225.782.0125.6826.652.02
252853-5285325.98426.86
353258-5325826.18327.07
453237-5323726.17327.07
552817-5281725.96626.83
651910-5191025.52026.38
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D211-4R701-2402002对照品来源自制工作对照品对照品使用方法直接使用
对照品含量(%)99.5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1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
118.102073532073722069012071932069572071550.11
218.032054262059002056630.17
单位质量响应值RSD%判断
11445.0311406.710.24数据可信
中间条件6月-供试品溶液-2024123121批-pH7.8
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min14063-40631.9901.8220.401.991.8220.50
22599-25991.2731.27
34687-46872.2962.30
44219-42192.0672.07
53367-33671.6491.65
63304-33041.6181.62
10min19112-91124.4634.356.934.494.366.97
28195-81954.0144.03
39877-98774.8384.86
49061-90614.4384.46
58620-86204.2224.24
68361-83614.0964.11
15min112131-121315.9426.075.296.016.135.26
211798-117985.7795.84
312838-128386.2896.37
412170-121705.9616.03
511875-118755.8175.88
613489-134896.6086.67
20min120202-202029.8969.604.0010.039.734.00
218893-188939.2559.38
320874-2087410.22510.37
419374-193749.4909.63
519229-192299.4199.55
618980-189809.2979.43
30min125633-2563312.55612.383.3712.8012.623.39
224940-2494012.21712.44
326796-2679613.12613.39
424935-2493512.21412.46
525008-2500812.25012.48
624338-2433811.92212.16
45min141591-4159120.37320.162.7420.7620.542.75
241192-4119220.17820.54
343056-4305621.09121.50
439880-3988019.53519.91
540939-4093920.05420.42
640233-4023319.70820.08
60min149692-4969224.34124.082.1524.9524.692.17
248974-4897423.99024.58
351027-5102724.99525.64
448489-4848923.75224.35
548715-4871523.86324.46
648112-4811223.56724.16
极限154823-5482326.85526.502.3127.7427.372.32
254146-5414626.52327.38
355958-5595827.41128.33
453685-5368526.29727.16
553702-5370226.30627.16
652230-5223025.58526.44
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