氢溴酸氟硫西汀口崩片项目信息
介质体积(ml)900取样体积(ml)0补液体积(ml)0
对照品批号D382/2305001对照品来源工作对照品对照品使用方法直接使用
对照品含量(%)99.83对照品水分(%)0对照品稀释倍数1000
标示量(mg)10供试品稀释倍数1系数0.7867
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
113.711762921768371772501769801767421768200.20
213.761772781775901774340.13
单位质量响应值RSD%判断
12897.1612894.910.02数据可信
供试品溶液-24050602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%
2min149494-4949427.12729.6611.1227.1329.6611.12
248822-4882226.75926.76
364918-6491835.58135.58
455558-5555830.45130.45
550701-5070127.78927.79
655252-5525230.28330.28
5min1108099-10809959.24957.695.0159.2557.695.01
2103059-10305956.48656.49
3113817-11381762.38362.38
4105922-10592258.05558.06
599048-9904854.28854.29
6101575-10157555.67355.67
10min1127042-12704269.63169.964.5569.6369.964.54
2125522-12552268.79868.80
3138320-13832075.81375.81
4127250-12725069.74569.75
5120670-12067066.13966.14
6127099-12709969.66269.66
15min1138687-13868776.01474.514.2476.0174.524.24
2134185-13418573.54673.55
3146074-14607480.06380.06
4131322-13132271.97771.98
5130409-13040971.47771.48
6135027-13502774.00874.01
20min1140251-14025176.87176.634.0776.8776.634.08
2138820-13882076.08776.09
3149810-14981082.11082.11
4140902-14090277.22877.23
5136038-13603874.56274.56
6133088-13308872.94572.94
30min1143038-14303878.39978.323.5378.4078.323.53
2143059-14305978.41078.41
3151859-15185983.23383.23
4143039-14303978.39978.40
5137076-13707675.13175.13
6139335-13933576.36976.37
45min1151107-15110782.82181.743.2982.8281.743.29
2145679-14567979.84679.85
3158126-15812686.66886.67
4147710-14771080.95980.96
5144937-14493779.43979.44
6147247-14724780.70580.71
60min1152769-15276983.73281.954.5083.7381.944.50
2149172-14917281.76181.76
3160305-16030587.86387.86
4146110-14611080.08280.08
5140252-14025276.87276.87
6148467-14846781.37481.37
90min1154138-15413884.48282.774.3084.4882.774.29
2148715-14871581.51081.51
3162132-16213288.86488.86
4148784-14878481.54881.55
5143070-14307078.41678.42
6149240-14924081.79881.80
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
120min1154132-15413284.47982.354.7484.4882.354.74
2147821-14782181.02081.02
3161361-16136188.44188.44
4151145-15114582.84282.84
5140599-14059977.06277.06
6146404-14640480.24380.24
极限1154391-15439184.62182.494.2084.6282.494.20
2148822-14882281.56981.57
3160252-16025287.83387.83
4150009-15000982.21982.22
5141598-14159877.60977.61
6147920-14792081.07481.07
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