替米沙坦氢氯噻嗪片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号100309-202205对照品来源中检所对照品使用方法直接使用
对照品含量(%)99.7对照品水分(%)0对照品稀释倍数10000
标示量(mg)12.5供试品稀释倍数10系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
114.205192652291522715213952178521610.28
214.185225452411523320.22
单位质量响应值RSD%判断
3673.313690.550.34数据可信
供试品溶液-24121101批-氢氯噻嗪-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%
5min140943-4094379.82482.962.1979.8282.962.19
243504-4350484.81784.82
342754-4275483.35583.35
442526-4252682.91082.91
542212-4221282.29882.30
643373-4337384.56284.56
10min147281-4728192.18192.042.7992.6292.502.78
248829-4882995.19995.67
345365-4536588.44588.91
447862-4786293.31493.77
545943-4594389.57290.03
647981-4798193.54694.02
15min146017-4601789.71795.294.4790.6796.264.44
250590-5059098.63299.63
350893-5089399.223100.18
450520-5052098.49699.47
546432-4643290.52691.48
648802-4880295.14696.14
20min150332-5033298.12996.981.2199.5898.481.19
249798-4979897.08898.64
349492-4949296.49298.00
450472-5047298.40299.93
549499-4949996.50597.96
648850-4885095.24096.76
30min150759-5075998.96298.611.52100.96100.661.49
250583-5058398.619100.71
350176-5017697.82599.87
451699-51699100.794102.87
550870-5087099.178101.17
649397-4939796.30698.35
45min147569-4756992.74297.203.3495.2999.783.28
248955-4895595.44598.08
351836-51836101.062103.65
451706-51706100.808103.44
549167-4916795.85898.40
649892-4989297.27199.85
60min150487-5048798.43197.392.91101.50100.522.84
249310-4931096.13799.30
350878-5087899.194102.34
451840-51840101.069104.26
547669-4766992.93796.01
649546-4954696.59799.72
极限150139-5013997.75398.731.48101.36102.401.42
251153-5115399.730103.43
350321-5032198.108101.81
450801-5080199.044102.80
551736-51736100.867104.46
649677-4967796.852100.51
替米沙坦氢氯噻嗪片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号100629-202204对照品来源中检所对照品使用方法直接使用
对照品含量(%)100对照品水分(%)0对照品稀释倍数1250
标示量(mg)80供试品稀释倍数10系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.101766631771811769021763561765821767370.18
211.161776501779371777940.12
单位质量响应值RSD%判断
15922.2515931.360.05数据可信
供试品溶液-24121101批-替米沙坦-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%
5min150892-5089228.75832.077.1728.7632.077.17
258098-5809832.83032.83
352778-5277829.82429.82
457478-5747832.48032.48
560406-6040634.13534.13
660852-6085234.38734.39
10min196989-9698954.80760.528.4554.9760.708.43
2117451-11745166.37066.55
399119-9911956.01156.18
4110648-11064862.52662.71
5101642-10164257.43657.63
6116757-11675765.97866.17
15min1115691-11569165.37578.2310.5165.8478.7510.48
2152234-15223486.02586.58
3139806-13980679.00279.48
4144865-14486581.86182.39
5126680-12668071.58572.09
6151406-15140685.55786.11
20min1143057-14305780.83987.054.6181.6788.004.64
2158362-15836289.48890.52
3151835-15183585.80086.72
4157319-15731988.89989.88
5150542-15054285.06985.98
6163208-16320892.22693.26
30min1158880-15888089.78193.202.0491.0694.632.09
2166231-16623193.93595.46
3163815-16381592.56993.96
4168732-16873295.34896.82
5165655-16565593.60994.99
6166224-16622493.93195.48
45min1155217-15521787.71193.513.8989.4995.463.87
2162265-16226591.69493.74
3172966-17296697.74199.65
4169668-16966895.87797.88
5163640-16364092.47194.37
6169162-16916295.59197.66
60min1163982-16398292.66493.662.1194.9396.132.11
2163346-16334692.30494.86
3169669-16966995.87798.33
4168019-16801994.94597.48
5160896-16089690.92093.33
6168520-16852095.22897.83
极限1162452-16245291.79994.231.7194.5897.221.71
2169126-16912695.57198.64
3166513-16651394.09497.08
4166180-16618093.90696.97
5170589-17058996.39799.32
6165620-16562093.58996.72
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