非布司他片项目信息
介质体积(ml)900取样体积(ml)2补液体积(ml)2
对照品批号430038-202402对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.9对照品水分(%)0对照品稀释倍数500
标示量(mg)20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%
110.602090117208857320894052091701208948620898560.06
210.382093152209765120954020.16
单位质量响应值RSD%判断
197156.23201869.171.68数据可信
供试品溶液-250601批-pH4.5(内含0.5%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1271137-27113712.22016.0135.4412.2216.0135.45
2459091-45909120.69220.69
3348849-34884915.72315.72
4322826-32282614.55014.55
5191526-1915268.6328.63
6538223-53822324.25824.26
10min1813436-81343636.66242.8819.3936.6942.9119.40
21087809-108780949.02949.07
3969757-96975743.70843.74
4940998-94099842.41242.44
5691394-69139431.16231.18
61204991-120499154.31054.36
15min11278248-127824857.61262.298.9857.7262.429.01
21455399-145539965.59665.75
31407495-140749563.43763.57
41422391-142239164.10964.24
51194371-119437153.83253.92
61534366-153436669.15669.33
20min11544651-154465169.61971.853.3869.8672.123.42
21614371-161437172.76173.06
31612984-161298472.69972.97
41611160-161116072.61772.89
51516932-151693268.37068.58
61665025-166502575.04475.37
30min11741889-174188978.50979.441.3978.9079.871.42
21760423-176042379.34479.81
31792877-179287780.80781.24
41777195-177719580.10080.53
51727449-172744977.85878.22
61775683-177568380.03280.53
45min11883823-188382384.90685.341.9685.4785.941.96
21874560-187456084.48885.13
31963242-196324288.48589.10
41904888-190488885.85586.46
51864413-186441384.03184.56
61869356-186935684.25484.93
60min11940673-194067387.46887.671.5088.2288.471.50
21928186-192818686.90587.73
31994027-199402789.87390.68
41964537-196453788.54489.34
51915538-191553886.33587.06
61928574-192857486.92387.78
极限12008875-200887590.54291.081.1091.4992.071.13
22007361-200736190.47491.49
32041132-204113291.99693.01
42011630-201163090.66691.66
52000045-200004590.14491.06
62055551-205555192.64693.70
非布司他片项目信息
介质体积(ml)900取样体积(ml)2补液体积(ml)2
对照品批号430038-202402对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.9对照品水分(%)0对照品稀释倍数500
标示量(mg)20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%
110.602107830210587221067542109003210612221071160.07
210.382160747216062621606860.01
单位质量响应值RSD%判断
198784.53208158.573.26数据不可信!(响应值差异过大,请重新称样测定!)
供试品溶液-250601批-pH4.5(内含0.5%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1561503-56150324.82523.6912.5624.8223.6912.57
2536800-53680023.73323.73
3609272-60927226.93726.94
4525358-52535823.22723.23
5412221-41222118.22518.22
6570246-57024625.21125.21
10min11231525-123152554.44853.664.8954.5053.714.89
21164156-116415651.46951.52
31268496-126849656.08256.14
41227020-122702054.24854.30
51121690-112169049.59249.63
61269681-126968156.13456.19
15min11518123-151812367.11867.591.1067.2967.761.11
21510010-151001066.76066.93
31539237-153923768.05268.24
41543999-154399968.26268.43
51513320-151332066.90667.06
61547528-154752868.41868.60
20min11685754-168575474.53075.251.0274.8575.571.02
21693987-169398774.89475.21
31686190-168619074.54974.88
41724944-172494476.26276.59
51699769-169976975.14975.45
61721479-172147976.10976.44
30min11840909-184090981.38981.761.1081.8882.261.09
21833265-183326581.05181.53
31829961-182996180.90581.41
41883814-188381483.28683.78
51861593-186159382.30482.77
61846907-184690781.65482.16
45min11963112-196311286.79287.721.5487.4688.391.51
21976368-197636887.37888.04
31959327-195932786.62587.31
41993724-199372488.14588.82
52041175-204117590.24390.89
61971140-197114087.14787.83
60min12038123-203812390.10890.640.9790.9791.510.96
22035112-203511289.97590.83
32029867-202986789.74390.62
42074370-207437091.71192.59
52074378-207437891.71192.56
62049267-204926790.60191.48
极限12076810-207681091.81992.581.0192.8893.651.00
22081961-208196192.04793.10
32080038-208003891.96293.03
42120061-212006193.73194.81
52122025-212202593.81894.87
62083404-208340492.11093.19
非布司他片项目信息
介质体积(ml)900取样体积(ml)2补液体积(ml)2
对照品批号430038-202402对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.9对照品水分(%)0对照品稀释倍数500
标示量(mg)20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%
110.602148901214672121507302148700214811021486320.07
210.382222083221472622184040.24
单位质量响应值RSD%判断
202701.13213719.083.75数据不可信!(响应值差异过大,请重新称样测定!)
供试品溶液-250602批-pH4.5(内含0.5%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1531877-53187722.98422.649.9122.9822.649.91
2606039-60603926.18926.19
3522189-52218922.56522.57
4545425-54542523.56923.57
5459778-45977819.86819.87
6478430-47843020.67420.67
10min11169974-116997450.55850.512.1850.6150.562.18
21174346-117434650.74750.80
31204569-120456952.05352.10
41182983-118298351.12051.17
51131790-113179048.90848.95
61150159-115015949.70149.75
15min11497322-149732264.70364.501.3364.8764.661.33
21459454-145945463.06763.24
31514873-151487365.46265.63
41509270-150927065.21965.39
51488518-148851864.32364.48
61485712-148571264.20164.36
20min11636261-163626170.70770.631.0171.0170.941.01
21612806-161280669.69470.00
31646028-164602871.12971.44
41658970-165897071.68872.00
51623219-162321970.14470.44
61629609-162960970.42070.72
30min11792526-179252677.46077.270.9877.9277.730.98
21765107-176510776.27576.74
31795930-179593077.60778.08
41815801-181580178.46578.94
51780450-178045076.93877.39
61778630-177863076.85977.31
45min11913313-191331382.67982.521.1683.3283.151.16
21882310-188231081.33981.97
31911150-191115082.58683.23
41948746-194874684.21084.85
51901762-190176282.18082.80
61899964-189996482.10282.73
60min11985839-198583985.81385.581.0586.6386.401.05
21960861-196086184.73485.55
31970980-197098085.17186.00
42018702-201870287.23388.07
51977973-197797385.47386.28
61967679-196767985.02985.84
极限12030429-203042987.74087.750.7688.7588.760.77
22016952-201695287.15888.16
32025531-202553187.52888.54
42060881-206088189.05690.08
52025550-202555087.52988.52
62024703-202470387.49388.49
非布司他片项目信息
介质体积(ml)900取样体积(ml)2补液体积(ml)2
对照品批号430038-202402对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.9对照品水分(%)0对照品稀释倍数500
标示量(mg)20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%
110.602185914218815121856222186294218835021868660.06
210.382167975216227121651230.19
单位质量响应值RSD%判断
206308.11208586.030.78数据可信
供试品溶液-250602批-pH4.5(内含0.5%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1308555-30855513.37414.4032.5413.3714.4032.53
2436571-43657118.92218.92
3436039-43603918.89918.90
4183123-1831237.9377.94
5233044-23304410.10110.10
6396582-39658217.18917.19
10min1779232-77923233.77438.4514.4333.8038.4814.43
2974349-97434942.23142.27
3854244-85424437.02537.07
4722416-72241631.31131.33
5923760-92376040.03840.06
61068945-106894546.33146.37
15min11250994-125099454.22157.577.2954.3357.687.31
21390984-139098460.28960.42
31294535-129453556.10856.23
41198768-119876851.95852.04
51375999-137599959.63959.75
61457608-145760863.17663.32
20min11516857-151685765.74467.503.5365.9767.753.56
21587472-158747268.80569.07
31542323-154232366.84867.10
41478404-147840464.07864.28
51593507-159350769.06769.31
61626234-162623470.48570.77
30min11738133-173813375.33576.421.4275.7176.821.45
21771976-177197676.80277.22
31761032-176103276.32776.73
41730250-173025074.99375.34
51785070-178507077.36977.77
61792372-179237277.68678.12
45min11958819-195881984.90083.021.2885.4483.591.27
21911262-191126282.83983.43
31912856-191285682.90883.48
41883006-188300681.61482.13
51916089-191608983.04883.62
61910782-191078282.81883.43
60min11959756-195975684.94185.730.8285.6786.480.85
21982619-198261985.93286.71
31967070-196707085.25886.01
41965459-196545985.18885.88
51997497-199749786.57687.33
61995450-199545086.48887.28
极限12085079-208507990.37288.441.2891.2989.381.27
22036585-203658588.27189.24
32018008-201800887.46588.41
42012183-201218387.21388.10
52049628-204962888.83689.78
62040895-204089588.45789.44
非布司他片项目信息
介质体积(ml)900取样体积(ml)2补液体积(ml)2
对照品批号430038-202402对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.9对照品水分(%)0对照品稀释倍数500
标示量(mg)20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%
110.602180467217280221673402165518216181521695880.34
210.382096324209936320978440.11
单位质量响应值RSD%判断
204678.11202104.430.90数据可信
供试品溶液-250603批-pH4.5(内含0.5%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1233193-23319310.30910.4117.3310.3110.4117.32
2291101-29110112.86912.87
3174346-1743467.7077.71
4260108-26010811.49911.50
5207891-2078919.1909.19
6246175-24617510.88310.88
10min1791118-79111834.97335.159.3235.0035.179.33
2919623-91962340.65440.68
3690054-69005430.50530.52
4777675-77767534.37934.40
5779147-77914734.44434.46
6813143-81314335.94735.97
15min11251154-125115455.31056.155.0555.4156.255.07
21375932-137593260.82660.95
31180775-118077552.19952.28
41261642-126164255.77455.88
51254516-125451655.45955.56
61296732-129673257.32557.43
20min11511031-151103166.79867.383.4267.0267.613.43
21603917-160391770.90571.16
31456244-145624464.37664.58
41511964-151196466.84067.07
51498441-149844166.24266.46
61563540-156354069.12069.35
30min11756777-175677777.66278.261.6878.0378.641.70
21808859-180885979.96580.38
31728407-172840776.40876.75
41762869-176286977.93278.31
51764713-176471378.01378.38
61799994-179999479.57379.96
45min11900968-190096884.03684.721.3484.5885.261.36
21949760-194976086.19386.78
31883949-188394983.28483.80
41907740-190774084.33684.88
51911388-191138884.49785.04
61944310-194431085.95386.51
60min11980758-198075887.56488.070.9788.3088.810.99
22018946-201894689.25290.03
31969715-196971587.07687.77
41982142-198214287.62588.36
51990236-199023687.98388.71
62011961-201196188.94389.70
极限12044077-204407790.36391.030.8891.2991.960.89
22073557-207355791.66692.65
32039759-203975990.17291.06
42051784-205178490.70491.63
52059085-205908591.02691.95
62086371-208637192.23393.18
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