依折麦布贝派度酸片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号DSMF-387-240606对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.75对照品水分(%)0对照品稀释倍数2000
标示量(mg)10供试品稀释倍数2系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.889495709492779493129497759489749493820.04
210.849482239470019476120.10
单位质量响应值RSD%判断
87259.3887418.080.13数据可信
长期12月-供试品溶液-2024092721批-依折麦布-pH4.5SDS
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1400805-40080541.19930.1042.5541.2030.1042.56
2160847-16084716.53316.53
3170780-17078017.55417.55
4457848-45784847.06247.06
5339239-33923934.87034.87
6227595-22759523.39423.39
10min1805153-80515382.76169.7323.1083.2270.0723.18
2470727-47072748.38648.57
3550625-55062556.59856.79
4856798-85679888.07088.59
5779842-77984280.16080.55
6607311-60731162.42562.69
15min1890605-89060591.54588.309.0092.9289.409.19
2714327-71432773.42574.15
3844528-84452886.80987.63
4929209-92920995.51397.01
5911711-91171193.71494.99
6863696-86369688.77989.73
20min1874402-87440289.87993.164.3192.2795.254.37
2842496-84249686.60088.14
3941394-94139496.76598.55
4930019-93001995.59698.16
5920855-92085594.65496.97
6928795-92879595.47097.41
30min1889132-88913291.39393.392.6394.7996.522.53
2883503-88350390.81593.31
3948725-94872597.519100.38
4903110-90311092.83096.46
5905031-90503193.02896.40
6921852-92185294.75797.76
45min1893463-89346391.83993.081.2796.2597.241.15
2899892-89989292.49996.01
3924993-92499395.08099.03
4902107-90210792.72797.38
5899932-89993292.50496.91
6912781-91278193.82497.88
60min1880647-88064790.52191.921.1095.9597.120.95
2898095-89809592.31596.85
3893242-89324291.81696.82
4893709-89370991.86497.55
5889346-88934691.41596.85
6910317-91031793.57198.67
极限1863515-86351588.76091.671.8195.2097.891.47
2909936-90993693.53299.09
3894949-89494991.99198.02
4892502-89250291.74098.45
5886605-88660591.13497.58
6903320-90332092.85298.99
依折麦布贝派度酸片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号BEMA-231010D对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.72对照品水分(%)0对照品稀释倍数100
标示量(mg)180供试品稀释倍数2系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
19.642395642399252396382391082391892394850.15
29.722389812383032386420.21
单位质量响应值RSD%判断
24842.8424551.650.84数据可信
长期12月-供试品溶液-2024092721批-贝派度酸-pH4.5SDS
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min158754-5875423.72417.7040.4323.7217.7040.44
224196-241969.7709.77
327638-2763811.16011.16
467883-6788327.41027.41
549883-4988320.14220.14
634633-3463313.98413.98
10min1125474-12547450.66443.1123.5750.9343.3023.64
273615-7361529.72529.83
384161-8416133.98334.11
4136062-13606254.94055.24
5123193-12319349.74349.97
698053-9805339.59239.75
15min1154222-15422262.27258.6411.8163.1059.3211.98
2117309-11730947.36747.81
3136825-13682555.24855.75
4164237-16423766.31667.23
5157837-15783763.73264.51
6140977-14097756.92457.52
20min1168973-16897368.22969.498.0869.7570.828.17
2151503-15150361.17462.14
3183080-18308073.92575.04
4191341-19134177.26078.91
5172010-17201069.45570.94
6165664-16566466.89268.12
30min1187091-18709175.54475.183.2177.8277.283.44
2174952-17495270.64372.29
3190320-19032076.84878.78
4191305-19130577.24679.76
5188604-18860476.15578.41
6184855-18485574.64176.61
45min1207890-20789083.94382.791.8287.0685.722.10
2198027-19802779.96082.39
3203848-20384882.31185.10
4207545-20754583.80387.17
5206065-20606583.20686.31
6206809-20680983.50686.31
60min1217369-21736987.77091.154.3291.8295.014.32
2209976-20997684.78588.10
3232923-23292394.05197.76
4229477-22947792.65996.96
5230989-23098993.27097.30
6233724-23372494.37498.10
极限1220390-22039088.99090.851.6894.0195.721.78
2221242-22124289.33493.59
3229534-22953492.68297.43
4228852-22885292.40797.74
5224971-22497190.84095.90
6224992-22499290.84895.62
依折麦布贝派度酸片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号DSMF-387-240606对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.75对照品水分(%)0对照品稀释倍数2000
标示量(mg)10供试品稀释倍数2系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.889441279435899443109442629440299440630.04
210.849490539502149496340.09
单位质量响应值RSD%判断
86770.5087604.610.68数据可信
长期12月-供试品溶液-2024092721批-依折麦布-pH4.5SDS
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1184959-18495919.04524.5636.1719.0524.5636.17
2404457-40445741.64741.65
3198587-19858720.44920.45
4177917-17791718.32018.32
5205563-20556321.16721.17
6259496-25949626.72026.72
10min1480631-48063149.49159.9023.8249.7060.1723.88
2832156-83215685.68786.15
3540253-54025355.63055.86
4455728-45572846.92647.13
5539338-53933855.53655.77
6642133-64213366.12066.42
15min1701324-70132472.21581.7512.8372.9882.6912.96
2926401-92640195.39296.81
3783997-78399780.72881.57
4670031-67003168.99369.72
5786810-78681081.01881.87
6895038-89503892.16293.19
20min1832665-83266585.74090.097.6987.3091.937.84
2928514-92851495.60998.08
3897735-89773592.44094.18
4757053-75705377.95479.45
5910830-91083093.78895.54
6922498-92249894.99097.05
30min1890061-89006191.65092.735.0294.1795.585.15
2918868-91886894.61698.15
3942589-94258997.05899.83
4815206-81520683.94286.30
5924714-92471495.21898.01
6911827-91182793.89197.00
45min1895091-89509192.16892.622.3895.7096.492.67
2915650-91565094.28598.87
3909890-90989093.69197.54
4858183-85818388.36791.66
5910514-91051493.75697.61
6907291-90729193.42497.58
60min1896076-89607692.26992.571.6296.8397.481.94
2911507-91150793.85899.49
3910138-91013893.71798.61
4872281-87228189.81994.09
5906082-90608293.29998.19
6898005-89800592.46897.66
极限1931658-93165895.93394.920.78101.52100.860.99
2929945-92994595.756102.44
3916465-91646594.368100.30
4915851-91585194.30599.58
5920446-92044694.778100.71
6916777-91677794.401100.62
依折麦布贝派度酸片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号BEMA-231010D对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.72对照品水分(%)0对照品稀释倍数100
标示量(mg)180供试品稀释倍数2系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
19.642385442380862377932382192376942380670.15
29.722401232400332400780.03
单位质量响应值RSD%判断
24695.7524699.380.02数据可信
长期12月-供试品溶液-2024092721批-贝派度酸-pH4.5SDS
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min132068-3206812.94814.4731.9312.9514.4731.92
257020-5702023.02323.02
327580-2758011.13611.14
426925-2692510.87110.87
531024-3102412.52612.53
640389-4038916.30816.31
10min172375-7237529.22237.2523.2629.3737.4123.28
2127919-12791951.64951.90
380561-8056132.52832.65
472838-7283829.40929.53
598754-9875439.87340.01
6101157-10115740.84441.02
15min1113980-11398046.02153.3114.3846.4953.8814.49
2159750-15975064.50165.33
3124646-12464650.32850.81
4113104-11310445.66746.11
5131484-13148453.08953.67
6149179-14917960.23360.87
20min1168884-16888468.18964.778.1569.1765.948.23
2171861-17186169.39170.94
3154202-15420262.26163.31
4137105-13710555.35856.31
5161978-16197865.40166.57
6168537-16853768.04969.35
30min1174566-17456670.48473.505.6072.2275.385.72
2188987-18898776.30678.62
3184231-18423174.38676.12
4165185-16518566.69668.27
5191857-19185777.46579.36
6187370-18737075.65377.71
45min1193762-19376278.23483.985.2580.7586.685.22
2209136-20913684.44287.61
3214639-21463986.66489.23
4200112-20011280.79883.11
5224707-22470790.72993.49
6205575-20557583.00485.90
60min1206531-20653183.39085.603.0286.7889.243.20
2214983-21498386.80390.91
3210865-21086585.14088.67
4203228-20322882.05685.27
5215999-21599987.21390.98
6220423-22042388.99992.82
极限1225095-22509590.88591.591.8095.2096.181.97
2228287-22828792.17497.24
3221324-22132489.36393.83
4224217-22421790.53194.65
5232597-23259793.91498.65
6229578-22957892.69597.51
依折麦布贝派度酸片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号DSMF-387-240606对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.75对照品水分(%)0对照品稀释倍数2000
标示量(mg)10供试品稀释倍数2系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.889495799481799493089500609491219492490.08
210.849469369462109465730.06
单位质量响应值RSD%判断
87247.1587322.230.07数据可信
中间条件12月-供试品溶液-2024092721批-依折麦布-pH4.5SDS
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1364359-36435937.47523.8136.6037.4823.8136.60
2169006-16900617.38317.38
3196399-19639920.20020.20
4311535-31153532.04232.04
5170505-17050517.53717.54
6177028-17702818.20818.21
10min1774268-77426879.63660.2024.8580.0560.4724.88
2426259-42625943.84244.04
3628387-62838764.63264.86
4721419-72141974.20074.56
5445408-44540845.81246.01
6516286-51628653.10253.30
15min1888741-88874191.41078.9716.5192.7179.9016.60
2586718-58671860.34661.03
3868021-86802189.27990.22
4856482-85648288.09289.27
5645650-64565066.40767.11
6761301-76130178.30279.09
20min1887650-88765091.29886.5411.8093.6188.3511.93
2686051-68605170.56271.91
3905360-90536093.11995.05
4929558-92955895.60897.77
5748598-74859876.99678.44
6891223-89122391.66593.33
30min1892838-89283891.83189.927.3795.1692.697.58
2758169-75816977.98080.11
3903190-90319092.89695.87
4933740-93374096.03899.26
5843650-84365086.77289.07
6914061-91406194.01496.69
45min1905947-90594793.17991.475.5097.5395.245.78
2801325-80132582.41985.42
3901253-90125392.69796.70
4936024-93602496.273100.56
5867967-86796789.27392.53
6923315-92331594.96698.69
60min1874104-87410489.90491.071.2895.2995.861.51
2882640-88264090.78294.70
3880735-88073590.58695.62
4905437-90543793.12798.49
5878764-87876490.38494.64
6891012-89101291.64396.42
极限1873261-87326189.81892.532.0996.2098.332.08
2889666-88966691.50596.43
3896795-89679592.23898.28
4927918-92791895.439101.83
5911733-91173393.77599.03
6898320-89832092.39598.19
依折麦布贝派度酸片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号BEMA-231010D对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.72对照品水分(%)0对照品稀释倍数100
标示量(mg)180供试品稀释倍数2系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
19.642394422388542393672392502391322392090.10
29.722392982386862389920.19
单位质量响应值RSD%判断
24814.2124587.650.65数据可信
中间条件12月-供试品溶液-2024092721批-贝派度酸-pH4.5SDS
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min157091-5709123.04915.2831.2823.0515.2831.28
234454-3445413.91013.91
331677-3167712.78912.79
447430-4743019.14819.15
527119-2711910.94810.95
629278-2927811.82011.82
10min1125314-12531450.59238.9424.1950.8539.1124.20
272574-7257429.29929.45
3106821-10682143.12643.27
4117775-11777547.54847.76
571645-7164528.92429.05
684612-8461234.15934.29
15min1158961-15896164.17556.3815.2364.9956.9815.29
2103326-10332641.71542.19
3150747-15074760.85961.48
4158444-15844463.96764.71
5131238-13123852.98353.43
6135197-13519754.58155.09
20min1167623-16762367.67264.2413.7769.2065.4713.76
2128045-12804551.69452.64
3171055-17105569.05870.36
4172539-17253969.65771.11
5134989-13498954.49755.53
6180464-18046472.85773.97
30min1186042-18604275.10872.957.8577.3974.908.01
2157703-15770363.66865.19
3190894-19089477.06779.13
4189835-18983576.64078.87
5168472-16847268.01569.65
6191261-19126177.21579.14
45min1206295-20629583.28581.536.1186.4084.286.30
2181349-18134973.21475.44
3207796-20779683.89186.81
4210182-21018284.85487.93
5192730-19273077.80980.20
6213377-21337786.14488.93
60min1209594-20959484.61788.443.5088.6692.103.07
2226580-22658091.47494.51
3220127-22012788.86992.72
4210501-21050184.98389.00
5220149-22014988.87892.14
6227492-22749291.84395.58
极限1216071-21607187.23290.702.3892.2295.341.99
2232501-23250193.86597.92
3224040-22404090.44995.29
4223979-22397990.42495.39
5224357-22435790.57794.82
6227036-22703691.65996.42
依折麦布贝派度酸片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号DSMF-387-240606对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.75对照品水分(%)0对照品稀释倍数2000
标示量(mg)10供试品稀释倍数2系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.889534739533789522509519969520259526240.08
210.849454149453859454000.01
单位质量响应值RSD%判断
87557.3587214.020.28数据可信
中间条件12月-供试品溶液-2024092721批-依折麦布-pH4.5SDS
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1352298-35229836.19328.9516.9636.1928.9516.95
2220827-22082722.68722.69
3315026-31502632.36432.36
4264168-26416827.13927.14
5291647-29164729.96229.96
6246902-24690225.36525.37
10min1796059-79605981.78370.3714.9382.1870.6914.93
2518655-51865553.28453.54
3785033-78503380.65081.01
4646744-64674466.44366.74
5701397-70139772.05872.39
6662010-66201068.01168.29
15min1916061-91606194.11189.317.7895.4290.417.85
2735104-73510475.52176.36
3906794-90679493.15994.41
4868858-86885889.26290.30
5892766-89276691.71892.85
6896103-89610392.06193.10
20min1923592-92359294.88593.174.9897.2495.265.07
2817178-81717883.95285.64
3915723-91572394.07696.37
4936535-93653596.21598.25
5936589-93658996.22098.37
6911500-91150093.64395.70
30min1918274-91827494.33993.902.2497.7597.042.38
2875082-87508289.90192.52
3912450-91245093.74097.08
4930782-93078295.62498.72
5918070-91807094.31897.54
6929648-92964895.50798.61
45min1894284-89428491.87492.632.1696.3396.802.20
2875276-87527689.92193.54
3901028-90102892.56796.94
4931490-93149095.69699.86
5893048-89304891.74796.02
6914733-91473393.97598.14
60min1896682-89668292.12091.651.2597.6096.861.41
2874707-87470789.86394.48
3888835-88883591.31496.72
4908748-90874893.36098.59
5891251-89125191.56296.85
6892467-89246791.68796.89
极限1909716-90971693.45993.010.6499.9699.240.82
2899509-89950992.41198.02
3903253-90325392.79599.22
4912274-91227493.72299.99
5909032-90903293.38999.70
6898535-89853592.31198.54
依折麦布贝派度酸片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号BEMA-231010D对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.72对照品水分(%)0对照品稀释倍数100
标示量(mg)180供试品稀释倍数2系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
19.642406972402322398112401352408592403470.18
29.722392082388802390440.10
单位质量响应值RSD%判断
24932.2624593.000.97数据可信
中间条件12月-供试品溶液-2024092721批-贝派度酸-pH4.5SDS
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min159765-5976524.06919.5817.8824.0719.5817.90
240432-4043216.28316.28
350713-5071320.42320.42
456658-5665822.81722.82
546165-4616518.59218.59
638050-3805015.32415.32
10min1133760-13376053.86845.5116.6854.1445.7316.66
281669-8166932.89033.07
3129244-12924452.04952.28
4105375-10537542.43742.69
5118434-11843447.69647.90
6109522-10952244.10744.28
15min1159496-15949664.23361.339.2165.1062.059.26
2125991-12599150.73951.29
3166471-16647167.04267.85
4150219-15021960.49761.22
5158007-15800763.63364.37
6153494-15349461.81562.48
20min1174182-17418270.14768.926.9571.7370.326.99
2149090-14909060.04261.15
3172464-17246469.45571.01
4181996-18199673.29474.69
5180330-18033072.62374.07
6168704-16870467.94169.29
30min1188722-18872276.00377.375.9878.3679.545.91
2176311-17631171.00472.78
3188738-18873876.00978.33
4192837-19283777.66079.87
5194523-19452378.33980.59
6211605-21160585.21887.32
45min1219610-21961088.44286.863.1391.6589.903.17
2208470-20847083.95686.52
3209833-20983384.50487.67
4222074-22207489.43492.51
5223428-22342889.97993.10
6210754-21075484.87587.92
60min1214662-21466286.44985.811.7890.6489.811.93
2207436-20743683.53987.04
3211802-21180285.29789.40
4215875-21587586.93891.01
5217866-21786687.74091.86
6210868-21086884.92188.91
极限1223797-22379790.12890.751.4395.2795.701.49
2221683-22168389.27793.70
3222475-22247589.59694.65
4226538-22653891.23296.27
5227698-22769891.69996.79
6229865-22986592.57297.51
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