XXYYYY片项目信息
介质体积(ml)1000取样体积(ml)2补液体积(ml)2
对照品批号x2561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对照品水分(%)0对照品稀释倍数1000
标示量(mg)25供试品稀释倍数2.5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%
5min123435-234359.32010.6312.259.3210.6312.25
231844-3184412.66412.66
322940-229409.1239.12
426667-2666710.60510.60
527964-2796411.12111.12
627580-2758010.96810.97
10min150840-5084020.21824.5913.0520.2424.6113.05
270081-7008127.87027.89
352693-5269320.95520.97
464279-6427925.56225.58
567632-6763226.89626.92
665499-6549926.04726.07
15min173521-7352129.23836.9815.6829.3037.0615.67
293505-9350537.18537.27
376823-7682330.55130.61
4102267-10226740.66940.74
5105593-10559341.99242.07
6106290-10629042.26942.34
20min189154-8915435.45546.2322.6935.5746.3722.65
296582-9658238.40838.56
391497-9149736.38636.51
4135628-13562853.93654.09
5140046-14004655.69355.85
6144560-14456057.48857.65
30min197440-9744038.75058.7037.3238.9458.9437.23
297380-9738038.72638.96
397538-9753838.78938.98
4192337-19233776.48876.75
5196274-19627478.05478.33
6204651-20465181.38581.66
45min197886-9788638.92767.4746.7639.1967.8246.63
296708-9670838.45938.77
397376-9737638.72439.00
4242785-24278596.55096.96
5235698-23569893.73294.16
6247494-24749498.42398.86
60min198046-9804638.99168.4747.4739.3368.9647.34
296864-9686438.52138.91
397818-9781838.90039.25
4247434-24743498.39999.01
5244612-24461297.27797.89
6248205-24820598.70699.34
极限198125-9812539.02268.6047.6039.4469.2347.47
296883-9688338.52838.99
397656-9765638.83639.26
4247136-24713698.28099.08
5247113-24711398.27199.08
6248143-24814398.68199.51
XXYYYY片项目信息
介质体积(ml)1000取样体积(ml)2补液体积(ml)2
对照品批号x2561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对照品水分(%)0对照品稀释倍数1000
标示量(mg)25供试品稀释倍数2.5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%
5min124848-248489.90010.8212.759.9010.8212.77
226214-2621410.44410.44
321897-218978.7248.72
429863-2986311.89811.90
529088-2908811.58911.59
631019-3101912.35912.36
10min156552-5655222.53225.9318.0622.5525.9618.05
258518-5851823.31523.34
349723-4972319.81119.83
475875-7587530.23030.25
571188-7118828.36328.39
678685-7868531.35031.37
15min178847-7884731.41540.0325.5831.4840.1025.57
283135-8313533.12333.19
372387-7238728.84128.90
4122162-12216248.67248.76
5111994-11199444.62144.70
6134262-13426253.49353.58
20min190747-9074736.15650.8632.3636.2851.0232.33
296046-9604638.26738.40
387647-8764734.92135.04
4161109-16110964.19064.37
5147457-14745758.75058.92
6182968-18296872.89973.09
30min196837-9683738.58262.6241.9738.7862.8841.90
297585-9758538.88039.09
398393-9839339.20239.39
4216680-21668086.33186.64
5201607-20160780.32580.61
6231949-23194992.41492.75
45min196956-9695638.63068.0346.7738.9168.4146.68
298033-9803339.05939.35
398684-9868439.31839.58
4248202-24820298.89099.37
5241655-24165596.28196.73
6240952-24095296.00196.53
60min196989-9698938.64368.3246.9739.0068.8346.88
298130-9813039.09739.46
398797-9879739.36339.70
4247770-24777098.71899.40
5243489-24348997.01297.65
6243612-24361297.06197.78
极限196604-9660438.48968.2146.9538.9268.8646.86
298261-9826139.15039.59
398686-9868639.31939.74
4246963-24696398.39699.27
5242305-24230596.54097.37
6244386-24438697.36998.28
XXYYYY片项目信息
介质体积(ml)1000取样体积(ml)2补液体积(ml)2
对照品批号x2561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对照品水分(%)0对照品稀释倍数1000
标示量(mg)25供试品稀释倍数2.5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%
5min131625-3162512.57720.9646.1312.5820.9646.13
231986-3198612.72012.72
330518-3051812.13612.14
477140-7714030.67730.68
582721-8272132.89732.90
662242-6224224.75224.75
10min168013-6801327.04845.8547.5227.0745.8947.52
266673-6667326.51526.54
365693-6569326.12526.15
4172573-17257368.62968.69
5179108-17910871.22871.29
6139635-13963555.53055.58
15min193058-9305837.00760.8845.0937.0961.0245.09
290233-9023335.88435.96
389147-8914735.45235.53
4226600-22660090.11590.31
5222973-22297388.67288.88
6196569-19656978.17278.33
20min1100063-10006339.79366.7545.2039.9567.0145.20
297462-9746238.75938.91
398477-9847739.16239.31
4240895-24089595.79996.18
5239301-23930195.16695.55
6230908-23090891.82892.14
30min1101137-10113740.22068.1745.7340.4568.5545.73
298877-9887739.32239.55
399617-9961739.61639.84
4245440-24544097.60798.18
5242970-24297096.62597.20
6240401-24040195.60396.10
45min1101682-10168240.43768.4045.7340.7568.9245.73
299051-9905139.39139.70
399892-9989239.72540.03
4245849-24584997.77098.54
5243128-24312896.68897.46
6242335-24233596.37297.06
60min1101110-10111040.21068.1945.7040.6068.8545.70
298919-9891939.33839.72
399823-9982339.69840.08
4245297-24529797.55098.51
5242022-24202296.24897.21
6241676-24167696.11096.99
极限1101483-10148340.35868.3745.8740.8369.1745.87
298922-9892239.33939.80
399432-9943239.54240.01
4246124-24612497.87999.04
5242436-24243696.41297.57
6243130-24313096.68897.77
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