氢溴酸伏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对照品来源中检院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%
114.19 1805981807911806141806471800711805440.16
214.11 1797261795571796420.07
单位质量响应值RSD%判断
12723.3312731.540.05数据可信
供试品溶液-1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%
2min1125029-12502969.43666.186.1169.4466.186.11
2111891-11189162.13962.14
3119900-11990066.58766.59
4109098-10909860.58860.59
5121515-12151567.48467.48
6127529-12752970.82470.82
5min1171425-17142595.20296.342.4295.2096.342.42
2168490-16849093.57293.57
3174831-17483197.09497.09
4173251-17325196.21696.22
5172020-17202095.53295.53
6180853-180853100.438100.44
10min1177273-17727398.45098.781.7098.4598.781.69
2177458-17745898.55298.55
3178419-17841999.08699.09
4178560-17856099.16499.16
5173075-17307596.11896.12
6182443-182443101.321101.32
15min1178031-17803198.87198.661.6898.8798.661.68
2175676-17567697.56397.56
3174827-17482797.09197.09
4178774-17877499.28399.28
5175733-17573397.59497.59
6182886-182886101.567101.57
20min1179437-17943799.65299.691.4099.6599.691.40
2177274-17727498.45098.45
3178349-17834999.04799.05
4181577-181577100.840100.84
5177059-17705998.33198.33
6183351-183351101.825101.83
30min1179431-17943199.64899.951.5199.6599.951.51
2178265-17826599.00199.00
3179240-17924099.54299.54
4181836-181836100.984100.98
5176726-17672698.14698.15
6184317-184317102.362102.36
45min1179468-17946899.669100.160.9799.67100.160.97
2181424-181424100.755100.76
3181757-181757100.940100.94
4182326-182326101.256101.26
5179267-17926799.55799.56
6177889-17788998.79298.79
60min1179160-17916099.498100.411.1299.50100.411.12
2180709-180709100.358100.36
3179548-17954899.71399.71
4181714-181714100.916100.92
5179279-17927999.56499.56
6184398-184398102.407102.41
90min1180851-180851100.437101.211.32100.44101.211.32
2181361-181361100.720100.72
3181413-181413100.749100.75
4184681-184681102.564102.56
5179455-17945599.66299.66
6185665-185665103.110103.11
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
120min1-0.0000.00-0.000.00-
2-0.0000.00
3-0.0000.00
4-0.0000.00
5-0.0000.00
6-0.0000.00
极限1-0.0000.00-0.000.00-
2-0.0000.00
3-0.0000.00
4-0.0000.00
5-0.0000.00
6-0.0000.00
氢溴酸伏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对照品来源中检院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%
114.19 1816121817611816161813371810001814650.17
214.11 1800471805061802760.19
单位质量响应值RSD%判断
12788.2312776.470.07数据可信
供试品溶液-YD2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%
2min1116052-11605264.17365.046.5464.1765.046.53
2110874-11087461.31061.31
3106674-10667458.98858.99
4125510-12551069.40369.40
5123828-12382868.47368.47
6122759-12275967.88267.88
5min1174726-17472696.61898.452.4696.6298.452.46
2177338-17733898.06398.06
3174023-17402396.23096.23
4175168-17516896.86396.86
5183288-183288101.353101.35
6183705-183705101.583101.58
10min1180280-18028099.690101.662.2799.69101.672.27
2182425-182425100.876100.88
3180634-18063499.88599.89
4181525-181525100.378100.38
5189580-189580104.832104.83
6188670-188670104.329104.33
15min1182815-182815101.091101.861.99101.09101.861.99
2182696-182696101.026101.03
3180521-18052199.82399.82
4181656-181656100.450100.45
5188309-188309104.129104.13
6189283-189283104.668104.67
20min1183554-183554101.500102.402.18101.50102.402.18
2183646-183646101.551101.55
3181294-181294100.250100.25
4182090-182090100.690100.69
5190158-190158105.152105.15
6190334-190334105.249105.25
30min1181908-181908100.590102.252.19100.59102.242.19
2183919-183919101.702101.70
3181621-181621100.431100.43
4181969-181969100.624100.62
5189850-189850104.981104.98
6190151-190151105.148105.15
45min1181929-181929100.601101.732.08100.60101.732.08
2182400-182400100.862100.86
3180553-18055399.84199.84
4181320-181320100.265100.26
5189230-189230104.639104.64
6188431-188431104.197104.20
60min1182698-182698101.027101.822.02101.03101.822.02
2183348-183348101.386101.39
3180611-18061199.87399.87
4180814-18081499.98599.98
5187593-187593103.733103.73
6189697-189697104.897104.90
90min1181798-181798100.529101.361.65100.53101.361.65
2183672-183672101.565101.57
3181171-181171100.182100.18
4180974-180974100.073100.07
5183161-183161101.283101.28
6189037-189037104.532104.53
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
120min1-0.0000.00-0.000.00-
2-0.0000.00
3-0.0000.00
4-0.0000.00
5-0.0000.00
6-0.0000.00
极限1-0.0000.00-0.000.00-
2-0.0000.00
3-0.0000.00
4-0.0000.00
5-0.0000.00
6-0.0000.00
氢溴酸伏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对照品来源中检院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%
114.19 1828041830471828371830121828031829010.07
214.11 1817731818251817990.03
单位质量响应值RSD%判断
12889.4312884.410.03数据可信
供试品溶液-1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%
2min131834-3183417.46015.4620.4217.4615.4620.43
229456-2945616.15616.16
335925-3592519.70419.70
429004-2900415.90815.91
521157-2115711.60411.60
621796-2179611.95511.95
5min1105510-10551057.87161.704.8957.8761.704.89
2118464-11846464.97664.98
3117972-11797264.70664.71
4110231-11023160.46060.46
5107557-10755758.99358.99
6115161-11516163.16463.16
10min1130158-13015871.39074.504.2171.3974.504.21
2145303-14530379.69679.70
3137899-13789975.63575.64
4130745-13074571.71171.71
5133146-13314673.02873.03
6137755-13775575.55675.56
15min1138899-13889976.18479.164.0376.1879.164.03
2154290-15429084.62684.63
3145067-14506779.56779.57
4139858-13985876.71076.71
5140830-14083077.24377.24
6147050-14705080.65580.65
20min1141041-14104177.35981.673.9577.3681.673.95
2157270-15727086.26086.26
3150143-15014382.35182.35
4146251-14625180.21680.22
5145386-14538679.74279.74
6153322-15332284.09584.09
30min1148845-14884581.63984.293.7381.6484.303.73
2161221-16122188.42788.43
3157178-15717886.21086.21
4148467-14846781.43281.43
5148514-14851481.45781.46
6157893-15789386.60286.60
45min1151361-15136183.01986.604.3883.0286.604.38
2168011-16801192.15192.15
3164571-16457190.26490.26
4151957-15195783.34683.35
5154183-15418384.56784.57
6157296-15729686.27486.27
60min1154870-15487084.94487.422.5384.9487.412.53
2161545-16154588.60588.60
3166210-16621091.16391.16
4157254-15725486.25186.25
5157202-15720286.22386.22
6159174-15917487.30487.30
90min1154436-15443684.70689.774.0684.7189.774.06
2172024-17202494.35294.35
3168743-16874392.55392.55
4159746-15974687.61887.62
5160060-16006087.79087.79
6166974-16697491.58391.58
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
120min1155135-15513585.08989.624.3585.0989.624.35
2172188-17218894.44294.44
3169775-16977593.11993.12
4160310-16031087.92787.93
5156512-15651285.84485.84
6166415-16641591.27691.28
极限1158936-15893687.17490.933.4387.1790.933.44
2172464-17246494.59494.59
3171055-17105593.82193.82
4161026-16102688.32088.32
5162475-16247589.11589.11
6168738-16873892.55092.55
氢溴酸伏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对照品来源中检院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%
114.19 1808621809461811251812141813641811020.12
214.11 1816231818681817460.10
单位质量响应值RSD%判断
12762.6512880.650.66数据可信
供试品溶液-YD2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%
2min134893-3489319.23619.5211.3719.2419.5211.38
241132-4113222.67622.68
331152-3115217.17417.17
431183-3118317.19117.19
535184-3518419.39619.40
638849-3884921.41721.42
5min1104552-10455257.63857.973.0457.6457.973.04
2106134-10613458.51058.51
3101725-10172556.08056.08
4102316-10231656.40656.41
5105614-10561458.22458.22
6110598-11059860.97160.97
10min1125545-12554569.21169.071.9669.2169.071.96
2123190-12319067.91367.91
3124271-12427168.50968.51
4122449-12244967.50567.50
5127869-12786970.49370.49
6128408-12840870.79070.79
15min1133393-13339373.53874.401.7473.5474.401.74
2134511-13451174.15474.15
3133907-13390773.82173.82
4132855-13285573.24173.24
5135805-13580574.86874.87
6139251-13925176.76776.77
20min1140090-14009077.23077.752.0877.2377.752.08
2138792-13879276.51476.51
3138829-13882976.53576.53
4139094-13909476.68176.68
5143932-14393279.34879.35
6145482-14548280.20280.20
30min1143512-14351279.11679.992.2879.1279.992.27
2140956-14095677.70777.71
3143574-14357479.15179.15
4145024-14502479.95079.95
5147058-14705881.07181.07
6150438-15043882.93582.93
45min1149735-14973582.54782.242.5782.5582.242.57
2145595-14559580.26580.26
3148333-14833381.77481.77
4146730-14673080.89080.89
5148313-14831381.76381.76
6156416-15641686.23086.23
60min1151367-15136783.44782.941.7483.4582.941.74
2149046-14904682.16782.17
3147134-14713481.11381.11
4151327-15132783.42583.42
5149098-14909882.19682.20
6154675-15467585.27085.27
90min1157500-15750086.82885.081.8786.8385.081.87
2149638-14963882.49482.49
3154599-15459985.22885.23
4152823-15282384.24984.25
5154470-15447085.15785.16
6156956-15695686.52886.53
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
120min1158980-15898087.64486.542.1487.6486.532.14
2152967-15296784.32984.33
3156731-15673186.40486.40
4153972-15397284.88384.88
5157016-15701686.56186.56
6162150-16215089.39189.39
极限1158367-15836787.30686.361.8387.3186.361.83
2153422-15342284.58084.58
3157349-15734986.74586.74
4153342-15334284.53584.54
5156798-15679886.44186.44
6160678-16067888.58088.58
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