盐酸奥洛他定口崩片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号101098-202303对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.8对照品水分(%)0对照品稀释倍数2000
标示量(mg)5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%
111.012290532293372288772291302289912290780.08
211.092287812291582289700.12
单位质量响应值RSD%判断
20806.3620646.530.55数据可信
供试品溶液-2025032121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%
5min1194474-19447484.27883.650.6784.2883.650.67
2192951-19295183.61883.62
3192547-19254783.44383.44
4192507-19250783.42683.43
5194519-19451984.29884.30
6191188-19118882.85482.85
10min1206538-20653889.50789.560.6989.6589.700.69
2207344-20734489.85690.00
3206647-20664789.55489.69
4206392-20639289.44389.58
5208696-20869690.44290.58
6204360-20436088.56388.70
15min1210834-21083491.36891.610.7791.6691.900.78
2210756-21075691.33491.62
3211813-21181391.79392.08
4211483-21148391.65091.94
5214195-21419592.82593.12
6209276-20927690.69390.98
20min1214060-21406092.76693.010.8293.2193.450.82
2213647-21364792.58793.03
3214830-21483093.10093.54
4215287-21528793.29893.74
5217520-21752094.26694.71
6212334-21233492.01892.46
30min1217779-21777994.37895.141.1194.9795.731.11
2222699-22269996.51097.11
3218809-21880994.82495.42
4219604-21960495.16995.77
5221931-22193196.17796.78
6216364-21636493.76594.35
极限1222603-22260396.46996.640.7797.2297.390.77
2221392-22139295.94496.70
3223064-22306496.66897.42
4223558-22355896.88297.64
5225975-22597597.93098.69
6221352-22135295.92696.67
盐酸奥洛他定口崩片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号101098-202303对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.8对照品水分(%)0对照品稀释倍数2000
标示量(mg)5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%
111.012291722287392289712291742290502290210.08
211.092282922289722286320.22
单位质量响应值RSD%判断
20801.1820616.050.64数据可信
供试品溶液-2025032121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%
5min1211164-21116491.59191.793.1991.5991.783.19
2201900-20190087.57287.57
3220992-22099295.85395.85
4210439-21043991.27691.28
5208049-20804990.23990.24
6217142-21714294.18394.18
10min1228488-22848899.10598.732.9799.2698.882.97
2218141-21814194.61794.76
3237921-237921103.196103.36
4225601-22560197.85298.00
5224145-22414597.22197.37
6231490-231490100.407100.56
15min1230248-23024899.86899.212.88100.1999.522.88
2219184-21918495.06995.37
3238576-238576103.480103.81
4227655-22765598.74399.06
5224869-22486997.53597.85
6231821-231821100.550100.87
20min1230190-23019099.84399.232.93100.3399.712.93
2218931-21893194.95995.42
3239101-239101103.708104.21
4227601-22760198.72099.20
5225466-22546697.79498.27
6231361-231361100.351100.84
30min1230000-23000099.76099.212.83100.4199.852.83
2219881-21988195.37195.99
3239002-239002103.665104.34
4227820-22782098.81599.46
5224573-22457397.40798.04
6231066-231066100.223100.88
极限1229584-22958499.58099.192.93100.40100.002.92
2219095-21909595.03195.81
3239025-239025103.675104.52
4228431-22843199.08099.89
5224656-22465697.44398.24
6231340-231340100.342101.17
盐酸奥洛他定口崩片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号101098-202303对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.8对照品水分(%)0对照品稀释倍数2000
标示量(mg)5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%
111.012287442288182285212292132284622287520.14
211.092295442288282291860.23
单位质量响应值RSD%判断
20776.7520666.010.38数据可信
供试品溶液-2025032121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%
5min1191073-19107382.82480.402.1682.8280.402.16
2185926-18592680.59380.59
3181558-18155878.70078.70
4182335-18233579.03679.04
5182643-18264379.17079.17
6189359-18935982.08182.08
10min1209629-20962990.86888.221.9491.0188.361.94
2203713-20371388.30388.44
3198654-19865486.11086.24
4201003-20100387.12887.26
5201891-20189187.51387.65
6206303-20630389.42689.56
15min1216508-21650893.84992.052.6094.1492.332.60
2220052-22005295.38695.67
3204962-20496288.84589.12
4209031-20903190.60890.89
5209622-20962290.86591.14
6213985-21398592.75693.04
20min1220341-22034195.51193.221.8995.9693.661.89
2216700-21670093.93394.37
3208738-20873890.48190.90
4213027-21302792.34092.77
5214014-21401492.76893.20
6217516-21751694.28694.73
30min1224125-22412597.15194.982.0397.7695.572.03
2220841-22084195.72896.32
3212162-21216291.96692.54
4216464-21646493.83094.41
5218222-21822294.59295.18
6222873-22287396.60897.21
极限1228075-22807598.86396.201.9299.6396.951.92
2224743-22474397.41998.18
3215678-21567893.49094.22
4220025-22002595.37496.11
5220744-22074495.68696.43
6222279-22227996.35197.11
盐酸奥洛他定口崩片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号101098-202303对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.8对照品水分(%)0对照品稀释倍数2000
标示量(mg)5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%
111.012310992320532314352313572307122313310.22
211.092294402294092294240.01
单位质量响应值RSD%判断
21010.9920687.471.10数据可信
供试品溶液-2025032121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%
5min1228076-22807698.26397.702.4598.2697.702.45
2219195-21919594.43694.44
3232782-232782100.290100.29
4220766-22076695.11395.11
5231235-23123599.62499.62
6228521-22852198.45498.45
10min1233028-233028100.39698.732.10100.5698.892.10
2228225-22822598.32798.48
3234136-234136100.874101.04
4222141-22214195.70695.86
5232232-232232100.053100.22
6225149-22514997.00297.17
15min1232602-232602100.21398.632.03100.5498.962.03
2229205-22920598.74999.07
3233714-233714100.692101.03
4221863-22186395.58695.90
5231190-23119099.60499.94
6224985-22498596.93197.26
20min1231213-23121399.61498.312.07100.1198.802.06
2228898-22889898.61799.10
3233179-233179100.461100.96
4221085-22108595.25195.73
5230879-23087999.47099.97
6223892-22389296.46096.95
30min1231474-23147499.72798.251.90100.3998.911.90
2228401-22840198.40399.05
3232261-232261100.066100.74
4221400-22140095.38696.02
5230427-23042799.27699.94
6224379-22437996.67097.32
极限1231484-23148499.73198.031.95100.5698.841.94
2228016-22801698.23799.05
3231727-23172799.836100.67
4220973-22097395.20396.00
5229541-22954198.89499.72
6223409-22340996.25297.06
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