精氨酸培哚普利片项目信息
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DJ468-220103对照品来源中检院对照品使用方法直接使用
对照品含量(%)94.8对照品水分(%)0对照品稀释倍数1000
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%
19.943269763267363271123265023265813267810.08
29.863242643244523243580.05
单位质量响应值RSD%判断
32875.3532896.350.05数据可信
供试品溶液-2023091921批-pH1.2盐酸溶液
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min1147696-14769676.63778.403.6376.6478.403.63
2160382-16038283.22083.22
3146716-14671676.12976.13
4148286-14828676.94476.94
5148243-14824376.92176.92
6155235-15523580.54980.55
10min1192569-19256999.92197.273.46100.0597.403.46
2194896-194896101.129101.27
3180015-18001593.40793.53
4179215-17921592.99293.12
5188937-18893798.03798.16
6189092-18909298.11798.25
15min1193805-193805100.56398.902.01100.8699.192.01
2194507-194507100.927101.23
3184631-18463195.80296.08
4187860-18786097.47897.76
5190113-19011398.64798.94
6192632-19263299.954100.25
20min1193975-193975100.65199.351.53101.1199.811.53
2194278-194278100.808101.28
3186561-18656196.80497.25
4191100-19110099.15999.60
5190001-19000198.58999.04
6192908-192908100.097100.56
30min1193699-193699100.50899.931.15101.14100.561.15
2193924-193924100.624101.27
3189305-18930598.22898.83
4195159-195159101.265101.88
5190638-19063898.91999.54
6192825-192825100.054100.69
极限1194170-194170100.752100.511.62101.55101.301.61
2193214-193214100.256101.07
3191266-19126699.245100.01
4199354-199354103.442104.22
5190408-19040898.80099.59
6193798-193798100.559101.36
精氨酸培哚普利片项目信息
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DJ468-220103对照品来源中检院对照品使用方法直接使用
对照品含量(%)94.8对照品水分(%)0对照品稀释倍数1000
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%
19.943260123258643262403264963261573261540.08
29.863258413256773257590.04
单位质量响应值RSD%判断
32812.2733038.440.49数据可信
供试品溶液-2023091921批
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min1132708-13270868.77878.848.4168.7878.848.40
2158764-15876482.28382.28
3158653-15865382.22582.22
4168524-16852487.34187.34
5143030-14303074.12874.13
6151084-15108478.30278.30
10min1191765-19176599.38697.832.1999.5097.962.19
2190752-19075298.86199.00
3182044-18204494.34894.48
4193298-193298100.180100.33
5188483-18848397.68597.81
6186189-18618996.49696.63
15min1193443-193443100.25698.851.57100.5499.141.57
2191381-19138199.18799.49
3185945-18594596.37096.66
4194046-194046100.568100.88
5190522-19052298.74299.03
6188990-18899097.94898.24
20min1193394-193394100.23099.091.34100.6899.551.33
2191490-19149099.24399.71
3186836-18683696.83197.29
4193930-193930100.508100.99
5191310-19131099.15099.60
6190232-19023298.59199.05
30min1193321-193321100.19299.210.84100.8199.840.84
2191655-19165599.32999.96
3189225-18922598.07098.69
4193073-193073100.064100.71
5191005-19100598.99299.61
6190272-19027298.61299.23
极限1193045-193045100.04999.410.41100.83100.200.41
2191115-19111599.04999.85
3191664-19166499.334100.11
4192488-19248899.761100.58
5191472-19147299.234100.02
6191138-19113899.06199.84
精氨酸培哚普利片项目信息
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DJ468-220103对照品来源中检院对照品使用方法直接使用
对照品含量(%)94.8对照品水分(%)0对照品稀释倍数1000
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%
19.943243003237353237093238343236653238490.09
29.863240683239103239890.04
单位质量响应值RSD%判断
32580.3832858.920.61数据可信
供试品溶液-2023092021批
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min1181249-18124994.52792.365.8894.5392.365.88
2188351-18835198.23198.23
3183513-18351395.70895.71
4180784-18078494.28494.28
5161589-16158984.27484.27
6167025-16702587.10987.11
10min1194091-194091101.224100.822.24101.38100.982.24
2199202-199202103.890104.05
3187279-18727997.67297.83
4195228-195228101.817101.97
5189304-18930498.72898.87
6194819-194819101.604101.75
15min1194616-194616101.498101.162.02101.82101.492.02
2199074-199074103.823104.16
3187309-18730997.68798.01
4195268-195268101.838102.17
5192401-192401100.343100.65
6195178-195178101.791102.11
20min1193945-193945101.148101.302.28101.64101.792.28
2198768-198768103.664104.17
3186940-18694097.49597.98
4198805-198805103.683104.18
5192553-192553100.422100.89
6194374-194374101.372101.86
30min1194659-194659101.521101.112.16102.18101.772.15
2198932-198932103.749104.43
3186183-18618397.10097.75
4195077-195077101.739102.41
5194147-194147101.254101.89
6194238-194238101.301101.95
极限1194596-194596101.488101.012.10102.32101.842.09
2198084-198084103.307104.16
3186029-18602997.02097.83
4194681-194681101.532102.37
5195148-195148101.776102.58
6193577-193577100.956101.78
精氨酸培哚普利片项目信息
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DJ468-220103对照品来源中检院对照品使用方法直接使用
对照品含量(%)94.8对照品水分(%)0对照品稀释倍数1000
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%
19.943254973254493257263255643253753255220.05
29.863244533250403247460.13
单位质量响应值RSD%判断
32748.6932935.700.41数据可信
供试品溶液-2023092021批
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min1164237-16423785.33486.6312.3985.3386.6312.40
2130920-13092068.02368.02
3169187-16918787.90687.91
4162364-16236484.36184.36
5189156-18915698.28298.28
6184531-18453195.87995.88
10min1182859-18285995.01097.803.1595.1597.953.15
2189086-18908698.24598.36
3179829-17982993.43593.58
4189089-18908998.24798.39
5195095-195095101.367101.53
6193461-193461100.518100.68
15min1188065-18806597.71599.012.4298.0299.322.42
2192059-19205999.790100.07
3182665-18266594.90995.21
4191094-19109499.28999.59
5194608-194608101.114101.45
6194808-194808101.218101.55
20min1189465-18946598.44299.872.4298.91100.342.43
2193129-193129100.346100.79
3184913-18491396.07796.54
4192157-19215799.841100.31
5198308-198308103.037103.54
6195267-195267101.457101.95
30min1191839-19183999.67699.881.52100.30100.521.52
2193434-193434100.504101.12
3186712-18671297.01297.63
4192500-192500100.019100.66
5194500-194500101.058101.73
6194467-194467101.041101.71
极限1196192-196192101.937100.800.93102.73101.600.94
2194339-194339100.975101.75
3190693-19069399.08099.86
4193932-193932100.763101.57
5194371-194371100.991101.83
6194500-194500101.058101.89
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