塞来昔布片项目信息
介质体积(ml)1000取样体积(ml)1.5补液体积(ml)1.5
对照品批号510141-202102 对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.6对照品水分(%)0对照品稀释倍数50
标示量(mg)200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%
19.682927587292487829243032919726292264429238280.10
29.652974712297630329755080.04
单位质量响应值RSD%判断
302048.35308342.801.46数据可信
中间条件36月-供试品溶液-2023010811批-pH12.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1422875-42287513.80213.692.6113.8013.692.63
2405486-40548613.23413.23
3411310-41131013.42413.42
4422619-42261913.79413.79
5437064-43706414.26514.27
6417637-41763713.63113.63
10min1871826-87182628.45528.272.1228.4828.292.13
2841191-84119127.45527.47
3851351-85135127.78727.81
4875930-87593028.58928.61
5892699-89269929.13629.16
6864191-86419128.20628.23
15min11177601-117760138.43538.421.3638.5038.491.36
21158161-115816137.80037.86
31167531-116753138.10638.17
41189731-118973138.83138.89
51201384-120138439.21139.28
61169121-116912138.15838.22
20min11351820-135182044.12144.170.9044.2444.290.91
21338926-133892643.70043.82
31341983-134198343.80043.92
41363952-136395244.51744.64
51370225-137022544.72244.85
61353105-135310544.16344.28
30min11498698-149869848.91549.391.9949.1049.581.99
21496912-149691248.85749.04
31487543-148754348.55148.74
41521840-152184049.67049.86
51570064-157006451.24451.44
61505178-150517849.12649.31
45min11575460-157546051.42051.550.4751.6851.810.47
21573378-157337851.35251.61
31570703-157070351.26551.52
41588329-158832951.84052.10
51580782-158078251.59451.86
61587425-158742551.81152.07
60min11596426-159642652.10552.240.4152.4452.580.42
21597648-159764852.14452.48
31591087-159108751.93052.26
41607097-160709752.45352.79
51607305-160730552.46052.80
61603901-160390152.34952.69
极限11601901-160190152.28352.550.7952.7052.970.78
21602946-160294652.31752.73
31595327-159532752.06952.48
41610681-161068152.57052.99
51624700-162470053.02753.45
61625607-162560753.05753.47
塞来昔布片项目信息
介质体积(ml)1000取样体积(ml)1.5补液体积(ml)1.5
对照品批号510141-202102 对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.6对照品水分(%)0对照品稀释倍数50
标示量(mg)200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%
19.682995127298643129812642984068298141229856600.20
29.653053862301546530346640.90
单位质量响应值RSD%判断
308435.95314472.951.38数据可信
中间条件36月-供试品溶液-2023010811批-pH12.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1460004-46000414.71215.264.6014.7115.264.59
2459506-45950614.69614.70
3470598-47059815.05115.05
4518552-51855216.58416.58
5472838-47283815.12215.12
6482083-48208315.41815.42
10min1940416-94041630.07630.872.6530.1030.902.64
2949299-94929930.36030.38
3968775-96877530.98331.01
41011476-101147632.34932.37
5970875-97087531.05131.07
6951123-95112330.41930.44
15min11258383-125838340.24640.882.3640.3140.952.36
21241618-124161839.70939.78
31285272-128527241.10641.17
41324866-132486642.37242.45
51296285-129628541.45841.53
61263117-126311740.39740.47
20min11457278-145727846.60747.001.9446.7347.131.94
21446231-144623146.25346.38
31441359-144135946.09846.23
41493600-149360047.76847.91
51513961-151396148.41948.55
61465127-146512746.85846.99
30min11607129-160712951.39953.362.5651.6053.562.55
21622231-162223151.88252.08
31683159-168315953.83154.03
41704254-170425454.50554.71
51691135-169113554.08654.29
61702480-170248054.44954.65
45min11732628-173262855.41355.780.4555.6956.060.45
21745252-174525255.81756.09
31755919-175591956.15856.44
41743027-174302755.74556.04
51747462-174746255.88756.17
61739634-173963455.63755.92
60min11753695-175369556.08755.970.6956.4456.330.68
21763235-176323556.39256.75
31761349-176134956.33156.70
41746539-174653955.85856.23
51743767-174376755.76956.14
61731402-173140255.37455.74
极限11705853-170585354.55755.711.8355.0056.161.82
21769116-176911656.58057.02
31724097-172409755.14055.59
41771627-177162756.66057.12
51770257-177025756.61657.07
61710383-171038354.70155.15
塞来昔布片项目信息
介质体积(ml)1000取样体积(ml)1.5补液体积(ml)1.5
对照品批号510141-202102 对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.6对照品水分(%)0对照品稀释倍数50
标示量(mg)200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%
19.682830432285994728713762876567287853528633710.70
29.652885682289042528880540.12
单位质量响应值RSD%判断
295802.79299280.210.83数据可信
中间条件36月-供试品溶液-2023011011批-pH12.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1576213-57621319.28920.425.3519.2920.425.34
2585209-58520919.59019.59
3581787-58178719.47619.48
4643576-64357621.54421.54
5626836-62683620.98420.98
6646678-64667821.64821.65
10min1891614-89161429.84732.695.7829.8832.725.78
2963180-96318032.24332.27
3935058-93505831.30231.33
41034749-103474934.63934.67
51011613-101161333.86433.90
61022941-102294134.24334.28
15min11172357-117235739.24542.114.4339.3242.194.43
21269902-126990242.51142.59
31206671-120667140.39440.47
41308435-130843543.80043.88
51289711-128971143.17443.26
61300656-130065643.54043.62
20min11389117-138911746.50147.891.8946.6348.041.89
21448193-144819348.47948.62
31404701-140470147.02347.16
41450708-145070848.56348.71
51451101-145110148.57648.72
61440395-144039548.21848.37
30min11573238-157323852.66552.961.9652.8753.171.95
21610054-161005453.89754.11
31579425-157942552.87253.08
41623480-162348054.34754.57
51568613-156861352.51052.73
61537139-153713951.45651.68
45min11671959-167195955.97055.211.4856.2555.511.47
21672484-167248455.98756.28
31639928-163992854.89755.18
41660514-166051455.58655.89
51642734-164273454.99155.29
61608750-160875053.85454.15
60min11687768-168776856.49955.631.5956.8656.001.57
21677762-167776256.16456.54
31671766-167176655.96356.33
41666170-166617055.77656.16
51654068-165406855.37155.75
61613200-161320054.00354.38
极限11686738-168673856.46456.031.3656.9156.491.35
21684630-168463056.39456.86
31683126-168312656.34356.80
41691673-169167356.63057.10
51664282-166428255.71356.18
61631401-163140154.61255.07
塞来昔布片项目信息
介质体积(ml)1000取样体积(ml)1.5补液体积(ml)1.5
对照品批号510141-202102 对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.6对照品水分(%)0对照品稀释倍数50
标示量(mg)200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%
19.682820857286210128660562861761286400328549560.68
29.652837145287493828560420.94
单位质量响应值RSD%判断
294933.47295962.900.25数据可信
中间条件36月-供试品溶液-2023011011批-pH12.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1605816-60581620.42321.165.2420.4221.165.24
2616414-61641420.78020.78
3624986-62498621.06921.07
4675960-67596022.78822.79
5586610-58661019.77619.78
6655452-65545222.09622.10
10min11010031-101003134.05034.533.2734.0834.563.27
2999650-99965033.70033.73
31025203-102520334.56134.59
41088541-108854136.69636.73
5998878-99887833.67433.70
61023431-102343134.50134.53
15min11257666-125766642.39843.563.2942.4843.643.29
21278166-127816643.08943.17
31275924-127592443.01343.10
41375192-137519246.36046.45
51294489-129448943.63943.72
61270508-127050842.83142.92
20min11432460-143246048.29148.831.7348.4448.981.73
21431649-143164948.26348.41
31447805-144780548.80848.96
41487893-148789350.15950.32
51467412-146741249.46949.61
61422709-142270947.96248.11
30min11531117-153111751.61653.552.3251.8353.782.32
21571810-157181052.98853.21
31590753-159075353.62753.85
41636947-163694755.18455.42
51617153-161715354.51754.74
61583262-158326253.37453.60
45min11643228-164322855.39655.652.2955.6955.952.28
21638156-163815655.22555.52
31669359-166935956.27756.58
41685255-168525556.81357.13
51683413-168341356.75157.05
61585261-158526153.44253.74
60min11658914-165891455.92556.371.6756.3056.761.67
21624964-162496454.78055.16
31684122-168412256.77457.16
41699115-169911557.28057.68
51696929-169692957.20657.59
61669380-166938056.27756.66
极限11638105-163810555.22356.401.4655.6956.871.46
21653339-165333955.73756.20
31697066-169706657.21157.68
41700780-170078057.33657.82
51676354-167635456.51356.99
61672960-167296056.39856.86
塞来昔布片项目信息
介质体积(ml)1000取样体积(ml)1.5补液体积(ml)1.5
对照品批号510141-202102 对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.6对照品水分(%)0对照品稀释倍数50
标示量(mg)200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%
19.682849219288203928808902877084288182528742110.50
29.652874847286491728698820.25
单位质量响应值RSD%判断
296922.62297397.100.12数据可信
中间条件36月-供试品溶液-2023011111批-pH12.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1637676-63767621.37320.813.7021.3720.813.70
2585748-58574819.63319.63
3615317-61531720.62420.62
4652964-65296421.88621.89
5613941-61394120.57820.58
6619749-61974920.77220.77
10min11000678-100067833.54032.611.9833.5732.641.98
2953530-95353031.96031.99
3951833-95183331.90331.93
4983148-98314832.95232.99
5965638-96563832.36632.40
6982988-98298832.94732.98
15min11255195-125519542.07141.400.9542.1541.480.95
21228756-122875641.18541.26
31234619-123461941.38141.46
41240173-124017341.56741.65
51221231-122123140.93241.01
61231520-123152041.27741.36
20min11391200-139120046.62945.910.9446.7746.050.94
21366916-136691645.81545.95
31351362-135136245.29445.43
41371766-137176645.97846.12
51370550-137055045.93746.08
61367365-136736545.83045.97
30min11511560-151156050.66350.081.0050.8850.301.00
21494169-149416950.08150.29
31482562-148256249.69249.90
41513264-151326450.72150.93
51484707-148470749.76349.97
61479495-147949549.58949.80
45min11558274-155827452.22951.960.6652.5252.240.66
21554309-155430952.09652.38
31546813-154681351.84552.13
41549761-154976151.94452.23
51559769-155976952.27952.56
61531861-153186151.34451.63
60min11571966-157196652.68852.371.0953.0652.741.08
21555826-155582652.14752.51
31551012-155101251.98652.35
41586913-158691353.18953.56
51569145-156914552.59452.96
61539591-153959151.60351.97
极限11573648-157364852.74452.640.7653.1953.080.76
21575403-157540352.80353.24
31556840-155684052.18152.62
41583990-158399053.09153.54
51578144-157814452.89553.34
61554797-155479752.11352.55
塞来昔布片项目信息
介质体积(ml)1000取样体积(ml)1.5补液体积(ml)1.5
对照品批号510141-202102 对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.6对照品水分(%)0对照品稀释倍数50
标示量(mg)200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%
19.682799661280201828370642835874283310728215450.68
29.652792449281822328053360.65
单位质量响应值RSD%判断
291481.92290708.390.19数据可信
中间条件36月-供试品溶液-2023011111批-pH12.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1618572-61857221.16520.844.9421.1620.844.93
2593311-59331120.30120.30
3577442-57744219.75819.76
4655335-65533522.42322.42
5582291-58229119.92319.92
6626774-62677421.44521.45
10min1946841-94684132.39733.032.9932.4333.063.00
2945216-94521632.34132.37
3940239-94023932.17132.20
41013912-101391234.69234.73
5960511-96051132.86532.89
6985023-98502333.70333.74
15min11182232-118223240.45141.392.4640.5341.472.46
21175311-117531140.21440.29
31197401-119740140.97041.05
41250845-125084542.79942.88
51218670-121867041.69841.78
61233126-123312642.19242.27
20min11352267-135226746.26946.051.4346.4146.201.44
21321922-132192245.23045.37
31349315-134931546.16846.31
41366926-136692646.77046.92
51323134-132313445.27245.41
61362064-136206446.60446.75
30min11476967-147696750.53550.661.1650.7550.871.17
21466429-146642950.17550.38
31497058-149705851.22351.43
41502398-150239851.40651.63
51458231-145823149.89450.10
61482912-148291250.73950.95
45min11514493-151449351.81952.871.2552.1153.161.25
21544069-154406952.83153.11
31556604-155660453.26053.55
41567025-156702553.61753.91
51557008-155700853.27453.56
61532152-153215252.42452.72
60min11507000-150700051.56352.871.4051.9353.241.39
21542316-154231652.77153.13
31573189-157318953.82854.19
41547593-154759352.95253.33
51549559-154955953.01953.38
61552332-155233253.11453.48
极限11564718-156471853.53853.810.6853.9854.260.68
21562530-156253053.46353.90
31581380-158138054.10854.55
41586722-158672254.29154.75
51578107-157810753.99654.44
61563354-156335453.49153.94
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