贝派度酸片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号BEMA-231010对照品来源原料对照品使用方法直接使用
对照品含量(%)99.8对照品水分(%)0对照品稀释倍数50
标示量(mg)180供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.343031763032853032283031813032553032250.02
210.433035653035443035540.01
单位质量响应值RSD%判断
29325.4429103.930.54数据可信
供试品溶液-24012201批-水
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min110987-109873.7533.662.573.753.662.47
210681-106813.6493.65
310438-104383.5663.57
10min113767-137674.7034.622.674.724.642.63
213710-137104.6844.70
313117-131174.4814.50
15min114138-141384.8304.781.914.884.821.86
213677-136774.6724.72
314135-141354.8294.87
20min113840-138404.7285.076.084.805.145.97
215053-150535.1425.21
315602-156025.3305.40
30min116526-165265.6465.138.715.755.248.57
214109-141094.8204.92
314455-144554.9385.04
45min114400-144004.9194.941.245.055.071.24
214323-143234.8935.02
314663-146635.0095.14
60min114707-147075.0245.011.185.185.171.19
214488-144884.9495.10
314827-148275.0655.22
极限114496-144964.9524.921.725.145.101.71
214114-141144.8225.00
314579-145794.9805.16
贝派度酸片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号BEMA-231010对照品来源原料对照品使用方法直接使用
对照品含量(%)99.8对照品水分(%)0对照品稀释倍数50
标示量(mg)180供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.343031053035503026683033413033473032020.12
210.433031523031653031580.01
单位质量响应值RSD%判断
29323.2129065.960.63数据可信
供试品溶液-24012201批-pH1.2
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min12872-28720.9820.954.190.980.953.98
22832-28320.9680.97
32654-26540.9070.91
10min13842-38421.3131.273.381.321.273.55
23692-36921.2621.27
33591-35911.2281.23
15min14201-42011.4361.440.271.451.450.40
24221-42211.4431.46
34204-42041.4371.45
20min14395-43951.5021.522.231.521.542.09
24576-45761.5641.58
34415-44151.5091.53
30min14645-46451.5881.611.531.621.641.54
24789-47891.6371.67
34711-47111.6101.64
45min14955-49551.6941.666.211.731.706.14
25083-50831.7381.78
34512-45121.5421.58
60min14932-49321.6861.711.291.731.761.44
25057-50571.7291.78
35018-50181.7151.76
极限15157-51571.7631.734.881.821.784.90
25218-52181.7841.84
34764-47641.6291.68
贝派度酸片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号BEMA-231010对照品来源原料对照品使用方法直接使用
对照品含量(%)99.8对照品水分(%)0对照品稀释倍数50
标示量(mg)180供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.343035463034553034403032933033303034130.04
210.433033623033043033330.02
单位质量响应值RSD%判断
29343.6229082.740.64数据可信
供试品溶液-24012201批-shui(内含0.5%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min147430-4743016.20416.062.2516.2016.062.23
247776-4777616.32216.32
345797-4579715.64615.65
10min162023-6202321.18921.441.0421.2821.531.02
263120-6312021.56421.65
363165-6316521.57921.67
15min170420-7042024.05824.180.5724.2724.380.55
270669-7066924.14324.35
371205-7120524.32624.53
20min174356-7435625.40225.191.3625.7425.531.34
272577-7257724.79525.14
374271-7427125.37325.72
30min186561-8656129.57230.001.4030.0530.481.38
287900-8790030.03030.51
389001-8900130.40630.89
45min197086-9708633.16834.042.4933.8134.692.46
299787-9978734.09134.74
3102033-10203334.85835.51
60min1106682-10668236.44636.782.2937.2837.622.25
2105845-10584536.16037.00
3110466-11046637.73938.58
极限1114081-11408138.97439.000.2840.0140.040.29
2113895-11389538.91039.95
3114505-11450539.11940.17
贝派度酸片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号BEMA-231010对照品来源原料对照品使用方法直接使用
对照品含量(%)99.8对照品水分(%)0对照品稀释倍数50
标示量(mg)180供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.343038603037883037333037563038393037950.02
210.433037993036503037240.04
单位质量响应值RSD%判断
29380.5629120.230.63数据可信
供试品溶液-24012201批-pH1.2(内含0.5%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min139791-3979113.57712.845.0813.5812.845.08
236188-3618812.34712.35
336899-3689912.59012.59
10min149969-4996917.04916.991.1517.1217.061.16
250262-5026217.14917.22
349162-4916216.77416.84
15min156022-5602219.11519.303.1119.2819.463.07
255138-5513818.81318.98
358519-5851919.96720.13
20min161706-6170621.05421.221.0621.3321.501.04
262945-6294521.47721.75
361948-6194821.13721.41
30min170733-7073324.13424.231.9124.5324.621.88
269807-6980723.81824.21
372470-7247024.72725.12
45min179587-7958727.15527.320.5927.6827.840.58
280100-8010027.33027.85
380527-8052727.47628.00
60min190551-9055130.89630.472.4931.5731.142.43
286734-8673429.59430.27
390598-9059830.91231.59
极限194165-9416532.12931.790.9332.9832.640.92
292669-9266931.61932.45
392679-9267931.62232.48
贝派度酸片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号BEMA-231010对照品来源原料对照品使用方法直接使用
对照品含量(%)99.8对照品水分(%)0对照品稀释倍数50
标示量(mg)180供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.343041933039503038243040103039633039880.05
210.433040293041623040960.04
单位质量响应值RSD%判断
29399.2329155.900.59数据可信
供试品溶液-24012201批-pH4.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min14357-43571.4851.396.221.491.396.47
23910-39101.3331.33
33927-39271.3391.34
10min16273-62732.1382.063.332.152.073.39
25891-58912.0082.02
35974-59742.0362.04
15min18015-80152.7322.537.122.752.557.07
26993-69932.3842.40
37270-72702.4782.50
20min17945-79452.7082.8712.332.742.9012.21
27702-77022.6252.66
39606-96063.2753.31
30min18637-86372.9442.971.562.993.021.54
28625-86252.9402.99
38864-88643.0223.07
45min19253-92533.1543.111.203.223.181.26
29035-90353.0803.14
39124-91243.1103.18
60min19188-91883.1323.191.573.223.271.42
29456-94563.2233.30
39425-94253.2133.30
极限19332-93323.1813.282.943.283.382.96
29641-96413.2863.38
39895-98953.3733.48
贝派度酸片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号BEMA-231010对照品来源原料对照品使用方法直接使用
对照品含量(%)99.8对照品水分(%)0对照品稀释倍数50
标示量(mg)180供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.343035743042593029003040353039313037400.18
210.433036643035263035950.04
单位质量响应值RSD%判断
29375.2429107.860.65数据可信
供试品溶液-24012201批-pH4.5(内含0.5%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min140761-4076113.91214.845.6313.9114.845.64
245498-4549815.52915.53
344170-4417015.07515.08
10min153070-5307018.11317.523.2118.1917.603.18
251086-5108617.43617.52
349799-4979916.99717.08
15min161413-6141320.96020.223.4721.1420.403.46
258982-5898220.13120.31
357328-5732819.56619.74
20min166546-6654622.71222.023.1523.0122.323.14
264550-6455022.03122.33
362488-6248821.32721.61
30min173942-7394225.23724.273.5025.6624.693.47
269251-6925123.63624.05
370159-7015923.94524.35
45min188334-8833430.14928.903.9330.7129.453.89
283794-8379428.59929.15
381855-8185527.93728.48
60min1100333-10033334.24432.195.7334.9732.905.66
292719-9271931.64532.35
389887-8988730.67931.37
极限1106681-10668136.41034.544.7337.3335.434.69
298990-9899033.78634.67
397906-9790633.41634.28
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