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)40供试品稀释倍数2.5系数0.9372
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
118.352040292038252038032037982034172037740.11
218.392025912019532022720.23
单位质量响应值RSD%判断
11104.8510999.020.68数据可信
长期24月-供试品溶液-2023082221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%
5min18735-87354.1423.936.494.143.936.50
28845-88454.1944.19
38059-80593.8213.82
48723-87234.1364.14
57768-77683.6833.68
67640-76403.6223.62
10min112334-123345.8485.793.945.895.833.93
213108-131086.2156.26
311812-118125.6015.64
412062-120625.7195.77
512029-120295.7045.74
611865-118655.6265.67
15min116611-166117.8767.832.167.997.942.16
217145-171458.1298.24
316272-162727.7157.82
416390-163907.7717.88
516552-165527.8487.95
616127-161277.6477.75
20min119669-196699.3269.253.169.529.453.13
220666-206669.79910.00
319148-191489.0799.27
419132-191329.0719.27
519459-194599.2269.42
619007-190079.0129.20
30min126231-2623112.43712.681.9512.7412.981.95
227593-2759313.08313.40
326200-2620012.42312.71
426661-2666112.64112.94
526865-2686512.73813.03
626961-2696112.78313.07
45min139209-3920918.59118.711.7519.0319.151.76
240807-4080719.34919.81
338800-3880018.39718.83
439348-3934818.65719.09
539296-3929618.63219.07
639331-3933118.64919.08
60min149766-4976623.59623.851.7224.2424.501.72
251983-5198324.64825.32
350346-5034623.87124.51
449638-4963823.53624.18
550138-5013823.77324.42
649941-4994123.67924.32
极限156446-5644626.76426.831.5027.6727.741.50
257858-5785827.43328.38
356836-5683626.94927.85
455628-5562826.37627.28
557019-5701927.03527.94
655701-5570126.41027.31
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)40供试品稀释倍数2.5系数0.9372
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
118.352023672028442026962024772027222026210.10
218.391992951994751993850.07
单位质量响应值RSD%判断
11042.0210842.031.30数据可信
长期24月-供试品溶液-2023082221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%
5min18487-84874.0653.942.214.063.942.17
27951-79513.8083.81
38225-82253.9393.94
48326-83263.9883.99
58169-81693.9123.91
68144-81443.9003.90
10min111756-117565.6305.570.985.685.611.02
211665-116655.5875.63
311464-114645.4915.53
411498-114985.5075.55
511650-116505.5805.62
611688-116885.5985.64
15min116865-168658.0778.051.558.198.161.56
216983-169838.1348.24
316495-164957.9008.00
416993-169938.1398.24
517040-170408.1618.27
616466-164667.8867.99
20min119921-199219.5419.500.779.749.700.74
219802-198029.4849.68
319847-198479.5059.70
419545-195459.3619.56
519931-199319.5469.74
619955-199559.5579.75
30min126726-2672612.80013.001.2313.1013.301.19
227357-2735713.10213.40
327373-2737313.11013.41
427570-2757013.20413.50
526843-2684312.85613.16
627032-2703212.94713.25
45min138705-3870518.53718.701.5418.9819.151.51
240218-4021819.26219.71
339037-3903718.69619.14
438732-3873218.55019.00
539036-3903618.69619.14
638598-3859818.48618.93
60min149275-4927523.60024.051.3624.2524.701.34
251050-5105024.45025.11
350114-5011424.00224.65
450002-5000223.94824.60
550974-5097424.41325.07
649915-4991523.90624.55
极限155329-5532926.49926.962.1127.4127.882.07
257366-5736627.47528.41
357219-5721927.40428.32
456153-5615326.89427.81
557171-5717127.38128.31
654470-5447026.08827.00
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)40供试品稀释倍数2.5系数0.9372
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
118.352032202024532026542022912023662025970.19
218.392005931996162001040.35
单位质量响应值RSD%判断
11040.7110881.131.03数据可信
长期24月-供试品溶液-12355772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%
5min14952-49522.3682.478.032.372.478.12
24902-49022.3442.34
35452-54522.6072.61
45357-53572.5612.56
54589-45892.1942.19
65706-57062.7282.73
10min18029-80293.8393.923.893.863.953.95
28127-81273.8863.91
38252-82523.9453.97
48445-84454.0384.07
57734-77343.6983.72
68642-86424.1324.16
15min112971-129716.2016.351.836.276.421.86
213356-133566.3856.45
313369-133696.3926.46
413499-134996.4546.53
512997-129976.2146.28
613521-135216.4646.54
20min116678-166787.9747.882.268.118.022.26
216399-163997.8407.98
316355-163557.8197.96
416304-163047.7957.94
516028-160287.6637.80
617109-171098.1808.33
30min125673-2567312.27412.411.3112.5012.641.31
226369-2636912.60712.83
326287-2628712.56812.80
425827-2582712.34812.58
525520-2552012.20112.42
626034-2603412.44712.69
45min137010-3701017.69417.901.1518.0618.271.15
237868-3786818.10518.47
338022-3802218.17818.55
437033-3703317.70518.07
537235-3723517.80218.16
637519-3751917.93818.32
60min150383-5038324.08824.041.3124.6524.611.30
250071-5007123.93924.51
349669-4966923.74724.32
450600-5060024.19224.76
549611-4961123.71924.27
651365-5136524.55825.13
极限155294-5529426.43626.622.3827.2627.452.31
257792-5779227.63028.46
356288-5628826.91127.75
455953-5595326.75127.59
554091-5409125.86126.68
654603-5460326.10626.96
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)40供试品稀释倍数2.5系数0.9372
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
118.352029432029592028892027142029402028890.05
218.391997251993861995560.13
单位质量响应值RSD%判断
11056.6210851.331.33数据可信
长期24月-供试品溶液-12343797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%
5min15329-53292.5492.397.332.552.397.28
25307-53072.5392.54
34402-44022.1062.11
44701-47012.2492.25
55059-50592.4202.42
65124-51242.4512.45
10min18879-88794.2484.254.124.284.284.17
29026-90264.3184.35
38644-86444.1354.16
48316-83163.9794.00
59087-90874.3474.37
69363-93634.4794.51
15min113322-133226.3736.373.826.456.443.84
214152-141526.7716.85
313007-130076.2236.29
412695-126956.0746.14
513566-135666.4906.57
613106-131066.2706.35
20min117003-170038.1357.893.798.288.033.80
217176-171768.2178.37
316250-162507.7747.91
415418-154187.3767.51
516525-165257.9068.05
616571-165717.9288.07
30min126685-2668512.76712.562.6013.0012.792.61
227320-2732013.07013.31
325810-2581012.34812.57
425380-2538012.14212.36
526075-2607512.47512.71
626295-2629512.58012.81
45min137482-3748217.93217.851.5818.3118.231.61
238212-3821218.28118.67
337015-3701517.70918.07
436425-3642517.42617.78
537384-3738417.88518.26
637403-3740317.89418.27
60min149991-4999123.91724.181.0924.4924.751.08
250610-5061024.21324.80
351172-5117224.48225.04
449846-4984623.84724.39
551105-5110524.45025.02
650551-5055124.18524.76
极限156210-5621026.89226.841.7927.7427.681.77
256807-5680727.17728.04
355306-5530626.45927.29
455279-5527926.44627.26
555294-5529426.45427.30
657700-5770027.60528.45
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