贝派度酸片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号BEMA-231010D对照品来源自制对照品使用方法直接使用
对照品含量(%)99.72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2系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.073020643021373021473022463024613022110.06
210.023021943021673021800.01
单位质量响应值RSD%判断
30011.0230157.680.35数据可信
供试品溶液-24122501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%
5min1-0.0000.00-0.000.00-
2-0.0000.00
3-0.0000.00
4-0.0000.00
5-0.0000.00
6-0.0000.00
10min13281-32812.1752.203.202.182.203.27
23376-33762.2382.24
33205-32052.1252.12
43467-34672.2982.30
53364-33642.2302.23
63197-31972.1192.12
15min14480-44802.9702.933.892.992.963.89
24571-45713.0303.06
34366-43662.8942.92
44640-46403.0763.10
54325-43252.8672.89
64173-41732.7662.79
20min14997-49973.3133.382.213.373.432.13
25243-52433.4763.53
35107-51073.3863.44
45163-51633.4233.48
55123-51233.3963.45
64934-49343.2713.33
30min15022-50223.3293.473.593.423.573.59
25297-52973.5123.61
35213-52133.4563.55
45463-54633.6223.72
55404-54043.5833.68
65023-50233.3303.42
45min15821-58213.8593.682.713.993.822.53
25505-55053.6493.79
35441-54413.6073.74
45397-53973.5783.72
55595-55953.7093.84
65566-55663.6903.82
60min15631-56313.7333.762.803.913.932.61
25414-54143.5893.77
35759-57593.8183.99
45606-56063.7163.89
55875-58753.8954.07
65737-57373.8033.97
极限15898-58983.9103.821.904.134.031.78
25565-55653.6893.91
35778-57783.8304.04
45739-57393.8054.02
55798-57983.8444.06
65756-57563.8164.03
贝派度酸片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号BEMA-231010D对照品来源自制对照品使用方法直接使用
对照品含量(%)99.72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2系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.073023843025203023553024303023433024060.03
210.023021343023283022310.05
单位质量响应值RSD%判断
30030.3930162.770.32数据可信
供试品溶液-24122501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%
5min12608-26081.7282.1111.891.732.1111.85
23408-34082.2582.26
33346-33462.2172.22
43117-31172.0662.07
53673-36732.4342.43
62934-29341.9441.94
10min16121-61214.0564.285.054.084.315.05
26657-66574.4114.44
36550-65504.3404.37
46521-65214.3214.34
56899-68994.5724.60
66042-60424.0044.03
15min17988-79885.2935.432.515.365.502.51
28479-84795.6195.69
38233-82335.4565.53
48093-80935.3635.43
58385-83855.5565.63
67997-79975.2995.37
20min19146-91466.0616.021.646.186.151.67
29316-93166.1736.31
39072-90726.0126.15
49069-90696.0106.14
59058-90586.0026.14
68856-88565.8695.99
30min19384-93846.2186.352.386.416.552.35
29676-96766.4126.62
39799-97996.4946.69
49248-92486.1286.33
59809-98096.5006.71
69605-96056.3656.56
45min19942-99426.5886.582.106.856.852.05
210097-100976.6916.97
310213-102136.7687.04
49761-97616.4686.73
59649-96496.3946.67
69915-99156.5706.83
60min111181-111817.4096.903.897.747.243.65
210345-103456.8557.21
310415-104156.9027.25
410132-101326.7147.05
510042-100426.6557.00
610335-103356.8497.18
极限110405-104056.8956.861.627.317.281.63
210481-104816.9457.37
310537-105376.9837.41
410150-101506.7267.14
510401-104016.8927.32
610145-101456.7237.13
贝派度酸片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号BEMA-231010D对照品来源自制对照品使用方法直接使用
对照品含量(%)99.72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2系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.073019933020023021993018913018663019900.05
210.023035963015633025800.48
单位质量响应值RSD%判断
29989.0830197.600.49数据可信
供试品溶液-24122501批-pH4.5(内含%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min122713-2271315.05316.309.4615.0516.309.47
226704-2670417.69817.70
327576-2757618.27618.28
421699-2169914.38114.38
523514-2351415.58415.58
625353-2535316.80316.80
10min170142-7014246.48646.466.8646.6546.646.86
276671-7667150.81351.01
371264-7126447.23047.43
463871-6387142.33042.49
565419-6541943.35643.53
673272-7327248.56148.75
15min189724-8972459.46459.423.7160.1560.123.75
293501-9350161.96762.73
393071-9307161.68262.41
484806-8480656.20556.83
587379-8737957.91058.56
689478-8947859.30160.03
20min1103012-10301268.27166.842.5369.6268.202.57
2103316-10331668.47269.92
3103114-10311468.33869.75
498049-9804964.98266.24
598361-9836165.18866.49
699236-9923665.76867.15
30min1116007-11600776.88378.074.0378.9980.173.87
2116531-11653177.23079.44
3119297-11929779.06481.24
4126598-12659883.90285.88
5115039-11503976.24278.26
6113312-11331275.09777.21
45min1125431-12543183.12984.951.9986.0987.921.93
2128543-12854385.19188.26
3130340-13034086.38289.43
4130551-13055186.52289.43
5129568-12956885.87188.74
6124628-12462882.59785.55
60min1132078-13207887.53489.782.1591.4293.702.06
2133693-13369388.60492.62
3137028-13702890.81594.83
4140302-14030292.98596.85
5135628-13562889.88793.71
6134110-13411088.88192.75
极限1140303-14030392.98592.823.0597.8497.732.88
2134720-13472089.28594.28
3140403-14040393.05298.07
4147657-14765797.859102.76
5138348-13834891.69096.51
6138901-13890192.05696.91
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