奥司他韦干糖浆项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号101096-202103对照品来源中检院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500
标示量(mg)10供试品稀释倍数1系数0.7612
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
19.823077373077893075423065213077843074750.18
29.833084413093103088760.20
单位质量响应值RSD%判断
31311.1031421.770.25数据可信
供试品溶液-24031501批-pH1.0
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min1309168-309168134.647134.452.70134.65134.452.70
2319857-319857139.302139.30
3315326-315326137.329137.33
4297177-297177129.425129.42
5308827-308827134.499134.50
6301989-301989131.521131.52
10min1327011-327011142.418144.311.01143.17145.051.02
2336033-336033146.347147.12
3334556-334556145.704146.47
4329550-329550143.524144.24
5330541-330541143.955144.70
6330395-330395143.892144.62
15min1329204-329204143.373145.011.51144.91146.561.49
2333792-333792145.371146.96
3329946-329946143.696145.27
4333700-333700145.331146.85
5328933-328933143.255144.80
6342144-342144149.009150.54
20min1325727-325727141.859144.071.02144.19146.421.02
2334283-334283145.585147.98
3331431-331431144.343146.71
4330400-330400143.894146.22
5328518-328518143.074145.42
6334404-334404145.638148.00
极限1312387-312387136.049139.781.69139.17142.941.67
2327364-327364142.572145.78
3317137-317137138.118141.29
4321172-321172139.875143.00
5323122-323122140.724143.86
6324562-324562141.351144.52
奥司他韦干糖浆项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号101096-202103对照品来源中检院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500
标示量(mg)10供试品稀释倍数1系数0.7612
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
19.823083033071633075723067113066043072710.23
29.833090053080203085120.23
单位质量响应值RSD%判断
31290.3331384.740.22数据可信
供试品溶液-24031502批-pH1.0
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min1316527-316527137.979135.942.72137.98135.942.72
2306567-306567133.637133.64
3326689-326689142.409142.41
4308096-308096134.304134.30
5309850-309850135.069135.07
6303423-303423132.267132.27
10min1323451-323451140.997141.242.34141.76142.002.34
2318575-318575138.872139.61
3329568-329568143.664144.46
4335808-335808146.384147.13
5321638-321638140.207140.96
6315004-315004137.315138.05
15min1330037-330037143.868142.662.33145.42144.202.33
2318586-318586138.877140.39
3330868-330868144.231145.82
4338320-338320147.479149.04
5326990-326990142.540144.07
6318792-318792138.966140.46
20min1327098-327098142.587138.962.75144.94141.292.73
2317085-317085138.222140.51
3322384-322384140.532142.92
4328134-328134143.039145.42
5311929-311929135.975138.30
6306034-306034133.405135.67
极限1296112-296112129.080138.523.65132.22141.633.57
2325629-325629141.947145.00
3322292-322292140.492143.66
4328652-328652143.265146.44
5317087-317087138.223141.30
6316900-316900138.142141.15
奥司他韦干糖浆项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号101096-202103对照品来源中检院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500
标示量(mg)10供试品稀释倍数1系数0.7612
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
19.823090173089863079013061853088233081820.40
29.833089423097723093570.19
单位质量响应值RSD%判断
31383.1031470.700.20数据可信
供试品溶液-24031503批-pH1.0
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min1309381-309381134.481133.055.95134.48133.055.95
2331049-331049143.899143.90
3308458-308458134.079134.08
4312192-312192135.702135.70
5275402-275402119.711119.71
6300096-300096130.445130.44
10min1319804-319804139.011137.513.69139.76138.253.70
2336688-336688146.350147.15
3313481-313481136.263137.01
4315308-315308137.057137.81
5301504-301504131.057131.72
6311379-311379135.349136.07
15min1313476-313476136.261135.973.82137.78137.483.83
2333635-333635145.023146.64
3303266-303266131.822133.32
4315060-315060136.949138.46
5299354-299354130.122131.52
6312079-312079135.653137.13
20min1313589-313589136.310136.064.36138.59138.324.35
2339506-339506147.575149.99
3302137-302137131.332133.57
4310970-310970135.171137.45
5304304-304304132.274134.39
6307538-307538133.679135.91
极限1313104-313104136.099135.012.95139.13138.022.97
2326553-326553141.945145.18
3306171-306171133.085136.05
4312814-312814135.973139.00
5301766-301766131.170134.02
6303184-303184131.787134.76
奥司他韦干糖浆项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号101096-202103对照品来源中检院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500
标示量(mg)10供试品稀释倍数1系数0.7612
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
19.823090833077593092253071023077613081860.31
29.833079933085173082550.13
单位质量响应值RSD%判断
31383.5031358.600.06数据可信
供试品溶液-24031501批-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%
5min1301780-301780131.410135.812.80131.41135.812.80
2304173-304173132.452132.45
3322946-322946140.627140.63
4307194-307194133.767133.77
5319539-319539139.143139.14
6315701-315701137.472137.47
10min1309345-309345134.704141.222.66135.43141.972.66
2330333-330333143.843144.58
3328971-328971143.250144.03
4321039-321039139.796140.54
5323033-323033140.664141.44
6333082-333082145.040145.80
15min1315497-315497137.383140.801.78138.86142.341.78
2318995-318995138.906140.44
3331955-331955144.550146.13
4323338-323338140.797142.32
5323802-323802140.999142.55
6326458-326458142.156143.73
20min1309539-309539134.788140.372.22137.03142.692.21
2320844-320844139.711142.02
3329990-329990143.694146.07
4325980-325980141.948144.25
5326262-326262142.071144.41
6321513-321513140.003142.36
极限1307403-307403133.858140.382.62136.85143.482.60
2328281-328281142.950146.03
3330107-330107143.745146.92
4317997-317997138.472141.56
5325990-325990141.952145.08
6324463-324463141.287144.42
奥司他韦干糖浆项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号101096-202103对照品来源中检院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500
标示量(mg)10供试品稀释倍数1系数0.7612
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
19.823094513090583083863081563085023087110.18
29.833097363089683093520.18
单位质量响应值RSD%判断
31436.9731470.190.08数据可信
供试品溶液-24031502批-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%
5min1273807-273807118.916125.584.11118.92125.584.11
2291109-291109126.431126.43
3298262-298262129.537129.54
4298904-298904129.816129.82
5274774-274774119.336119.34
6298058-298058129.449129.45
10min1309070-309070134.231138.491.73134.89139.191.73
2315738-315738137.127137.83
3322191-322191139.930140.65
4321303-321303139.544140.27
5323395-323395140.453141.12
6321573-321573139.661140.38
15min1314120-314120136.424138.802.04137.83140.272.02
2317661-317661137.962139.43
3312744-312744135.827137.32
4319828-319828138.903140.40
5330677-330677143.615145.06
6322512-322512140.069141.56
20min1308058-308058133.792138.162.14135.96140.402.13
2316255-316255137.352139.58
3317159-317159137.744140.00
4323549-323549140.519142.79
5327717-327717142.330144.57
6316028-316028137.253139.53
极限1308681-308681134.062136.741.60136.97139.751.60
2311443-311443135.262138.26
3313758-313758136.267139.28
4320121-320121139.031142.08
5321644-321644139.692142.72
6313448-313448136.133139.17
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