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)1.5
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%
111.171928241926761928401927081926821927460.05
211.121913601910581912090.12
单位质量响应值RSD%判断
17255.6817195.050.25数据可信
供试品溶液-2025042521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%
5min124576-2457612.83017.3335.7312.8317.3335.74
228726-2872614.99715.00
341431-4143121.63021.63
444074-4407423.01023.01
515965-159658.3358.33
644425-4442523.19323.19
10min189487-8948746.71850.1410.8946.7450.1610.91
291609-9160947.82647.85
395906-9590650.07050.11
4101388-10138852.93252.97
584082-8408243.89743.91
6113720-11372059.37059.41
15min1127618-12761866.62568.855.7566.7268.965.75
2123130-12313064.28264.39
3128919-12891967.30567.42
4132457-13245769.15269.28
5133859-13385969.88469.97
6145251-14525175.83175.97
20min1139400-13940072.77675.784.6772.9976.014.68
2137000-13700071.52371.74
3143572-14357274.95475.19
4147926-14792677.22877.47
5147138-14713876.81677.02
6155902-15590281.39281.66
30min1150719-15071978.68681.933.4779.0282.293.49
2150671-15067178.66178.99
3157288-15728882.11582.47
4160225-16022583.64884.02
5158208-15820882.59582.93
6164521-16452185.89186.29
45min1158233-15823382.60985.672.8883.0786.162.90
2158783-15878382.89683.36
3164939-16493986.11086.60
4166554-16655486.95387.46
5165643-16564386.47786.95
6170394-17039488.95789.50
60min1162391-16239184.77987.332.5085.3887.962.52
2162547-16254784.86185.46
3167642-16764287.52188.16
4169525-16952588.50489.16
5168365-16836587.89888.51
6173154-17315490.39891.09
极限1173436-17343690.54692.131.0191.2992.901.01
2178058-17805892.95993.70
3177452-17745292.64293.42
4175387-17538791.56492.37
5176615-17661592.20592.97
6177825-17782592.83793.68
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)1.5
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%
111.171910391909861912001910421909731910480.05
211.121897941898431898180.02
单位质量响应值RSD%判断
17103.6717069.960.14数据可信
供试品溶液-2025042521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%
5min137840-3784019.91518.7436.4819.9218.7436.47
237539-3753919.75719.76
347542-4754225.02125.02
450121-5012126.37926.38
517703-177039.3179.32
622917-2291712.06112.06
10min1109556-10955657.65954.6316.9557.6954.6616.95
2102025-10202553.69653.73
3122442-12244264.44164.48
4116890-11689061.51961.56
572643-7264338.23238.25
699276-9927652.24952.27
15min1140963-14096374.18972.727.1974.3272.847.21
2140437-14043773.91274.03
3149104-14910478.47478.62
4141906-14190674.68574.83
5119583-11958362.93763.02
6137008-13700872.10772.21
20min1153447-15344780.75979.214.9181.0179.454.93
2154463-15446381.29481.54
3157051-15705182.65682.94
4152931-15293180.48880.76
5136530-13653071.85672.04
6148548-14854878.18178.41
30min1164011-16401186.31984.843.1986.7185.223.22
2164608-16460886.63387.01
3165291-16529186.99387.41
4162707-16270785.63386.04
5151876-15187679.93280.24
6158694-15869483.52183.88
45min1170131-17013189.54088.212.2890.0788.722.31
2170769-17076989.87690.40
3170170-17017089.56190.12
4168566-16856688.71689.26
5161276-16127684.88085.32
6164657-16465786.65987.16
60min1173255-17325591.18489.891.9291.8690.551.95
2173605-17360591.36892.04
3172992-17299291.04691.76
4171189-17118990.09790.79
5165561-16556187.13587.71
6168144-16814488.49489.14
极限1178460-17846093.92493.480.4994.7694.290.47
2178396-17839693.89094.72
3176386-17638692.83293.70
4177611-17761193.47794.32
5178012-17801293.68894.41
6176779-17677993.03993.83
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)1.5
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%
111.171896711898881898961897331897341897840.06
211.121895811895991895900.01
单位质量响应值RSD%判断
16990.5117049.460.25数据可信
供试品溶液-2025042521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%
5min139492-3949220.86621.5746.8620.8721.5746.87
258730-5873031.03131.03
329190-2919015.42315.42
431426-3142616.60516.60
568307-6830736.09136.09
617836-178369.4249.42
10min192685-9268548.97246.8323.8749.0146.8623.88
2103239-10323954.54854.60
356546-5654629.87729.90
478311-7831141.37741.40
5117641-11764162.15862.22
683312-8331244.01944.04
15min1116875-11687561.75358.2218.5061.8758.3318.51
2122610-12261064.78364.93
374974-7497439.61439.69
4101336-10133653.54353.64
5133791-13379170.69170.85
6111520-11152058.92459.01
20min1131109-13110969.27464.9815.1869.4965.1915.20
2133016-13301670.28170.53
389297-8929747.18247.32
4115563-11556361.06061.25
5142265-14226575.16875.45
6126628-12662866.90667.09
30min1145795-14579577.03473.0911.2777.3773.4111.30
2144936-14493676.58076.95
3109237-10923757.71757.94
4133129-13312970.34170.63
5152683-15268380.67381.08
6144212-14421276.19776.50
45min1158168-15816883.57179.998.1984.0380.438.23
2156038-15603882.44682.94
3127646-12764667.44467.76
4148631-14863178.53278.94
5161629-16162985.40085.94
6156188-15618882.52582.95
60min1165052-16505287.20883.856.1887.8184.426.23
2160900-16090085.01585.65
3139783-13978373.85774.29
4157111-15711183.01383.55
5165941-16594187.67888.36
6163340-16334086.30486.87
极限1171826-17182690.78787.155.2191.5487.875.26
2167492-16749288.49889.27
3147967-14796778.18178.73
4165347-16534787.36488.04
5169076-16907689.33490.16
6167978-16797888.75489.46
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)1.5
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%
111.171893931893521892491892721892521893040.04
211.121898151895981897060.09
单位质量响应值RSD%判断
16947.5417059.890.47数据可信
供试品溶液-2025042521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%
5min138817-3881720.52922.4410.1420.5322.4410.14
245277-4527723.94623.95
348833-4883325.82725.83
439814-3981421.05721.06
543945-4394523.24223.24
637835-3783520.01020.01
10min180497-8049742.57347.307.0742.6147.347.06
293860-9386049.64149.68
383980-8398044.41544.46
488580-8858046.84846.88
597196-9719651.40551.44
692517-9251748.93048.96
15min1102907-10290754.42559.666.6654.5359.786.66
2116504-11650461.61661.74
3103898-10389854.94955.07
4115102-11510260.87560.99
5120509-12050963.73563.86
6117961-11796162.38762.50
20min1119640-11964063.27567.115.4463.4767.325.44
2130239-13023968.88169.11
3116815-11681561.78161.99
4129466-12946668.47268.69
5133447-13344770.57770.81
6131695-13169569.65169.87
30min1140305-14030574.20476.113.9774.5176.443.97
2146303-14630377.37777.72
3133955-13395570.84671.16
4149129-14912978.87179.20
5146916-14691677.70178.05
6146875-14687577.67978.01
45min1153539-15353981.20382.502.7181.6382.962.72
2158456-15845683.80484.27
3148577-14857778.57979.01
4160064-16006484.65485.11
5157848-15784883.48283.96
6157479-15747983.28783.75
60min1161742-16174285.54286.402.2186.1086.992.22
2165630-16563087.59888.21
3156994-15699483.03183.59
4167038-16703888.34388.94
5163746-16374686.60287.22
6165019-16501987.27587.88
极限1166910-16691088.27589.041.9488.9889.781.95
2170666-17066690.26291.02
3162803-16280386.10386.80
4171758-17175890.83991.59
5167931-16793188.81589.58
6170125-17012589.97590.72
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