XXYYYY片项目信息
介质体积(ml)1000取样体积(ml)10补液体积(ml)10
对照品批号S2561对照品来源中检院对照品使用方法直接使用
对照品含量(%)100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%
110.332579282579052578342579642579362579130.02
210.342564232568992566610.14
单位质量响应值RSD%判断
24967.3824822.150.42数据可信
供试品溶液-20211122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%
5min123435-234359.41410.7412.259.4110.7412.27
231844-3184412.79212.79
322940-229409.2159.21
426667-2666710.71210.71
527964-2796411.23311.23
627580-2758011.07911.08
10min150840-5084020.42224.8413.0520.5224.9513.04
270081-7008128.15128.28
352693-5269321.16621.26
464279-6427925.82125.93
567632-6763227.16727.28
665499-6549926.31126.42
15min173521-7352129.53337.3615.6829.8337.7115.63
293505-9350537.56037.97
376823-7682330.85931.16
4102267-10226741.08041.45
5105593-10559342.41642.80
6106290-10629042.69643.07
20min189154-8915435.81346.6922.6936.4147.4222.50
296582-9658238.79639.58
391497-9149736.75437.37
4135628-13562854.48155.26
5140046-14004656.25657.06
6144560-14456058.06958.87
30min197440-9744039.14159.2937.3240.0960.4936.88
297380-9738039.11740.29
397538-9753839.18040.16
4192337-19233777.26178.58
5196274-19627478.84280.21
6204651-20465182.20783.59
45min197886-9788639.32068.1546.7640.6669.9446.14
296708-9670838.84740.41
397376-9737639.11540.49
4242785-24278597.52599.62
5235698-23569894.67996.84
6247494-24749499.417101.62
60min198046-9804639.38569.1647.4741.1271.6346.83
296864-9686438.91040.86
397818-9781839.29341.06
4247434-24743499.393102.46
5244612-24461298.259101.37
6248205-24820599.703102.90
极限198125-9812539.41669.3047.6041.5572.4646.97
296883-9688338.91741.26
397656-9765639.22841.38
4247136-24713699.273103.34
5247113-24711399.264103.35
6248143-24814399.678103.87
XXYYYY片项目信息
介质体积(ml)1000取样体积(ml)10补液体积(ml)10
对照品批号S2561对照品来源中检院对照品使用方法直接使用
对照品含量(%)100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%
110.332569702565262568722566522569982568040.09
210.342563732572312568020.24
单位质量响应值RSD%判断
24860.0224835.780.07数据可信
供试品溶液-20211122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%
5min124848-2484810.00010.9312.7510.0010.9312.75
226214-2621410.55010.55
321897-218978.8128.81
429863-2986312.01812.02
529088-2908811.70611.71
631019-3101912.48412.48
10min156552-5655222.75926.2018.0622.8626.3118.04
258518-5851823.55023.66
349723-4972320.01120.10
475875-7587530.53630.66
571188-7118828.65028.77
678685-7868531.66731.79
15min178847-7884731.73240.4325.5832.0640.8025.50
283135-8313533.45833.80
372387-7238729.13229.42
4122162-12216249.16449.59
5111994-11199445.07245.48
6134262-13426254.03454.48
20min190747-9074736.52151.3832.3637.1752.1632.20
296046-9604638.65439.33
387647-8764735.27335.85
4161109-16110964.83865.76
5147457-14745759.34460.20
6182968-18296873.63574.62
30min196837-9683738.97263.2641.9739.9864.5441.63
297585-9758539.27340.34
398393-9839339.59840.53
4216680-21668087.20388.77
5201607-20160781.13682.58
6231949-23194993.34895.07
45min196956-9695639.02068.7246.7740.4270.6446.32
298033-9803339.45340.91
398684-9868439.71541.04
4248202-24820299.889102.33
5241655-24165597.25499.51
6240952-24095296.97199.62
60min196989-9698939.03369.0146.9740.8271.6146.51
298130-9813039.49241.34
398797-9879739.76141.49
4247770-24777099.715103.15
5243489-24348997.992101.22
6243612-24361298.041101.66
极限196604-9660438.87868.9046.9541.0672.2046.50
298261-9826139.54541.79
398686-9868639.71641.84
4246963-24696399.390103.82
5242305-24230597.515101.73
6244386-24438698.353102.95
XXYYYY片项目信息
介质体积(ml)1000取样体积(ml)10补液体积(ml)10
对照品批号S2561对照品来源中检院对照品使用方法直接使用
对照品含量(%)100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%
110.332570592571512569092576342570712571650.11
210.342574402573612574000.03
单位质量响应值RSD%判断
24894.9724893.620.01数据可信
供试品溶液-20211122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%
5min131625-3162512.70421.1746.1312.7021.1746.13
231986-3198612.84912.85
330518-3051812.25912.26
477140-7714030.98730.99
582721-8272133.22933.23
662242-6224225.00325.00
10min168013-6801327.32146.3147.5227.4546.5247.52
266673-6667326.78226.91
365693-6569326.38926.51
4172573-17257369.32269.63
5179108-17910871.94772.28
6139635-13963556.09156.34
15min193058-9305837.38161.5045.0937.7862.1745.11
290233-9023336.24636.64
389147-8914735.81036.20
4226600-22660091.02592.03
5222973-22297389.56890.62
6196569-19656978.96179.77
20min1100063-10006340.19567.4345.2040.9768.7245.21
297462-9746239.15039.91
398477-9847739.55840.30
4240895-24089596.76798.68
5239301-23930196.12798.07
6230908-23090892.75594.36
30min1101137-10113740.62768.8545.7341.8070.8245.72
298877-9887739.71940.87
399617-9961740.01641.16
4245440-24544098.593101.47
5242970-24297097.601100.51
6240401-24040196.56999.10
45min1101682-10168240.84669.0945.7342.4371.7445.71
299051-9905139.78941.34
399892-9989240.12641.67
4245849-24584998.757102.62
5243128-24312897.664101.55
6242335-24233597.346100.84
60min1101110-10111040.61668.8845.7042.6172.2245.69
298919-9891939.73641.68
399823-9982340.09942.04
4245297-24529798.535103.39
5242022-24202297.220102.08
6241676-24167697.081101.55
极限1101483-10148340.76669.0645.8743.1673.0945.85
298922-9892239.73742.08
399432-9943239.94242.28
4246124-24612498.868104.71
5242436-24243697.386103.22
6243130-24313097.665103.10
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