非奈利酮片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)0
对照品批号D231201对照品来源自制对照品使用方法直接使用
对照品含量(%)99.92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1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
1 11.341919831924291916201920941913771919010.22
2 11.361907101912121909610.19
单位质量响应值RSD%判断
16922.4916809.950.48数据可信
供试品溶液-2025060821批-pH4.5(内含0.1%Tween)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min165959-6595935.16945.5625.6435.1745.5625.65
263358-6335833.78233.78
399471-9947153.03753.04
4108351-10835157.77257.77
5107766-10776657.46057.46
667770-6777036.13436.13
10min1176655-17665594.19191.603.6294.2591.683.63
2161728-16172886.23286.29
3175593-17559393.62493.71
4173959-17395992.75392.85
5176351-17635194.02994.12
6166484-16648488.76888.83
15min1187062-18706299.74097.361.7999.9697.591.80
2178655-17865595.25795.46
3183184-18318497.67297.92
4184779-18477998.52298.77
5182874-18287497.50797.76
6179065-17906595.47695.68
20min1189253-189253100.90899.171.20101.2999.561.21
2183644-18364497.91798.28
3187237-18723799.833100.24
4187125-18712599.773100.19
5184848-18484898.55998.97
6183906-18390698.05798.42
30min1191912-191912102.326100.161.25102.88100.711.24
2187594-187594100.023100.55
3185531-18553198.92399.50
4189107-189107100.830101.41
5186438-18643899.40799.99
6186469-18646999.42399.95
45min1194048-194048103.464101.241.27104.19101.961.27
2189304-189304100.935101.62
3189533-189533101.057101.80
4190975-190975101.826102.58
5187419-18741999.930100.67
6187931-187931100.203100.90
60min1193823-193823103.345101.490.98104.24102.380.97
2190217-190217101.422102.28
3189800-189800101.199102.11
4190552-190552101.600102.52
5188561-188561100.539101.45
6189092-189092100.822101.69
极限1194767-194767103.848101.641.25104.91102.701.24
2190320-190320101.477102.50
3190297-190297101.464102.54
4191362-191362102.032103.12
5187778-187778100.121101.20
6189182-189182100.870101.90
非奈利酮片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)0
对照品批号D231201对照品来源自制对照品使用方法直接使用
对照品含量(%)99.92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1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
1 11.341910671911151905801909441908411909090.12
2 11.361898731893771896250.19
单位质量响应值RSD%判断
16835.0116692.340.61数据可信
供试品溶液-2025060921批-pH4.5(内含0.1%Tween)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min191413-9141349.03941.8820.6649.0441.8820.66
281979-8197943.97843.98
371912-7191238.57838.58
467201-6720136.05036.05
556153-5615330.12430.12
699765-9976553.51953.52
10min1173714-17371493.19090.332.1193.2790.402.12
2166852-16685289.50989.58
3166329-16632989.22889.29
4164890-16489088.45688.52
5166550-16655089.34789.40
6171927-17192792.23192.32
15min1181951-18195197.60996.590.5897.8596.810.59
2179982-17998296.55296.77
3179690-17969096.39696.61
4178827-17882795.93396.14
5179831-17983196.47196.67
6179997-17999796.56096.80
20min1184838-18483899.15798.310.8599.5698.700.85
2185079-18507999.28799.67
3182259-18225997.77498.15
4182856-18285698.09498.46
5183535-18353598.45898.82
6181012-18101297.10597.51
30min1187723-187723100.70599.850.70101.27100.390.71
2187759-187759100.724101.27
3185511-18551199.518100.05
4184818-18481899.14799.68
5185875-18587599.714100.24
6185072-18507299.28399.85
45min1188555-188555101.151100.450.70101.88101.160.69
2188194-188194100.958101.67
3186004-18600499.783100.49
4186283-18628399.933100.63
5188496-188496101.120101.81
6185909-18590999.732100.46
60min1189117-189117101.453100.830.55102.35101.710.54
2188555-188555101.151102.04
3187455-187455100.561101.43
4187050-187050100.344101.21
5188881-188881101.326102.18
6186703-186703100.158101.06
极限1188850-188850101.310100.930.65102.38101.980.64
2189166-189166101.479102.53
3187339-187339100.499101.54
4186852-186852100.238101.27
5189637-189637101.732102.76
6187056-187056100.347101.41
非奈利酮片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)0
对照品批号D231201对照品来源自制对照品使用方法直接使用
对照品含量(%)99.92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1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
1 11.341902891908821905371902691905701905090.14
2 11.361908481907641908060.04
单位质量响应值RSD%判断
16799.7416796.300.02数据可信
供试品溶液-2025061021批-pH4.5(内含0.1%Tween)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min174680-7468039.98047.609.7339.9847.609.73
284580-8458045.28045.28
398708-9870852.84352.84
494705-9470550.70050.70
587331-8733146.75346.75
693457-9345750.03250.03
10min1171914-17191492.03490.682.4592.1090.762.45
2170527-17052791.29191.37
3162144-16214486.80486.89
4173111-17311192.67592.76
5166826-16682689.31089.39
6171734-17173491.93892.02
15min1182030-18203097.45096.691.0597.6796.921.05
2182645-18264597.77998.01
3178439-17843995.52795.76
4181924-18192497.39397.63
5178351-17835195.48095.71
6180315-18031596.53196.77
20min1184909-18490998.99198.630.9199.3799.020.91
2186729-18672999.965100.36
3184267-18426798.64799.04
4184414-18441498.72699.13
5181663-18166397.25397.64
6183462-18346298.21698.61
30min1188114-188114100.70799.980.97101.25100.540.97
2189487-189487101.442102.00
3186566-18656699.878100.43
4185755-18575599.444100.01
5184358-18435898.69699.24
6186309-18630999.740100.30
45min1189214-189214101.295100.890.73102.01101.620.73
2190138-190138101.790102.52
3189206-189206101.291102.01
4187903-187903100.594101.33
5186241-18624199.704100.42
6188071-188071100.684101.41
60min1189174-189174101.274101.171.12102.16102.061.11
2192477-192477103.042103.94
3189791-189791101.604102.50
4188737-188737101.040101.94
5186641-18664199.918100.80
6187070-187070100.148101.04
极限1189351-189351101.369100.672.09102.42101.722.08
2191988-191988102.781103.85
3189788-189788101.603102.66
4187887-187887100.585101.65
5180544-18054496.65497.70
6188662-188662101.000102.06
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