佩玛贝特片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)0
对照品批号DHX240702对照品来源ZZ对照品使用方法直接使用
对照品含量(%)99.74对照品水分(%)0对照品稀释倍数100000
标示量(mg)0.1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%
1 10.392159421580216442161421689216240.21
2 10.352186321850218560.05
单位质量响应值RSD%判断
2081.232111.691.03数据可信
加速6月-供试品溶液-2025041221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%
5min115275-1527565.40862.6315.9965.4162.6215.99
215841-1584167.83167.83
315222-1522265.18165.18
49924-992442.49542.49
516224-1622469.47169.47
615267-1526765.37365.37
10min120034-2003485.78684.486.4085.8984.596.41
220378-2037887.25987.37
319930-1993085.34185.45
417193-1719373.62173.69
520337-2033787.08387.20
620506-2050687.80787.92
15min121385-2138591.57190.193.0191.8290.433.03
221144-2114490.53990.80
321138-2113890.51390.76
419814-1981484.84485.04
521315-2131591.27191.53
621576-2157692.38992.64
20min121572-2157292.37292.292.0992.7892.692.11
221611-2161192.53992.95
321528-2152892.18392.58
420745-2074588.83089.17
521757-2175793.16493.58
622110-2211094.67595.08
30min122485-2248596.28194.661.2296.8495.211.23
221990-2199094.16194.73
321906-2190693.80294.36
421819-2181993.42993.91
522059-2205994.45795.03
622382-2238295.84096.41
45min122180-2218094.97596.201.4995.6996.901.49
222321-2232195.57996.30
322307-2230795.51996.23
422366-2236695.77196.41
522504-2250496.36297.09
623112-2311298.96699.69
60min122578-2257896.67996.640.4397.5697.510.43
222404-2240495.93496.81
322525-2252596.45297.32
422593-2259396.74497.54
522653-2265397.00097.89
622659-2265997.02697.92
90min122723-2272397.30097.180.5098.3498.210.51
222563-2256396.61597.65
322560-2256096.60297.63
422699-2269997.19798.16
522807-2280797.66098.71
622816-2281697.69898.75
极限122978-2297898.39297.950.4299.5999.150.41
222718-2271897.27998.48
322969-2296998.35499.55
422876-2287697.95599.08
522846-2284697.82799.04
622868-2286897.92199.14
佩玛贝特片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)0
对照品批号DHX240702对照品来源ZZ对照品使用方法直接使用
对照品含量(%)99.74对照品水分(%)0对照品稀释倍数100000
标示量(mg)0.1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%
1 10.392168721638216742169621652216690.12
2 10.352149721507215020.04
单位质量响应值RSD%判断
2085.562077.490.28数据可信
加速6月-供试品溶液-2025041321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%
5min116316-1631670.36360.7322.3370.3660.7322.32
215856-1585668.37968.38
315959-1595968.82468.82
414002-1400260.38460.38
57948-794834.27634.28
614414-1441462.16162.16
10min121038-2103890.72787.125.4590.8487.225.46
219998-1999886.24286.36
321255-2125591.66391.78
419486-1948684.03484.13
518451-1845179.57079.63
620988-2098890.51190.61
15min122245-2224595.93293.633.3196.2093.873.32
221156-2115691.23691.49
322850-2285098.54198.81
420990-2099090.52090.76
521297-2129791.84492.03
621725-2172593.69093.94
20min122960-2296099.01695.823.0099.4496.223.00
221733-2173393.72494.13
323088-2308899.568100.00
421437-2143792.44892.84
522038-2203895.03995.38
622060-2206095.13495.54
30min123219-23219100.13397.432.41100.7397.992.41
222153-2215395.53596.10
323194-23194100.025100.62
421887-2188794.38894.93
522665-2266597.74398.24
622439-2243996.76997.34
45min123583-23583101.70298.542.30102.4699.272.31
222732-2273298.03298.76
323384-23384100.844101.61
422229-2222995.86396.57
522667-2266797.75298.42
622508-2250897.06697.80
60min123611-23611101.82398.462.20102.7599.342.20
222741-2274198.07198.96
323103-2310399.632100.56
422207-2220795.76896.63
522907-2290798.78799.61
622414-2241496.66197.55
90min123533-23533101.48798.811.90102.5999.861.90
222747-2274798.09799.15
323224-23224100.154101.25
422285-2228596.10597.13
522951-2295198.97799.97
622731-2273198.02899.08
极限123524-23524101.44898.731.89102.7299.951.90
222833-2283398.46899.68
323206-23206100.076101.34
422308-2230896.20497.39
522908-2290898.79199.95
622587-2258797.40798.62
佩玛贝特片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)0
对照品批号DHX240702对照品来源ZZ对照品使用方法直接使用
对照品含量(%)99.74对照品水分(%)0对照品稀释倍数100000
标示量(mg)0.1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%
1 10.392156921495215872154221540215470.17
2 10.352161621632216240.06
单位质量响应值RSD%判断
2073.822089.280.53数据可信
加速6月-供试品溶液-2025041421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%
5min18488-848836.60551.5621.7136.6051.5621.71
211166-1116648.15448.15
314881-1488164.17564.17
49608-960841.43541.43
513526-1352658.33158.33
614072-1407260.68660.69
10min115555-1555567.08179.3411.3367.1479.4211.34
218463-1846379.62279.70
320867-2086789.98990.10
416268-1626870.15670.23
519727-1972785.07385.17
619500-1950084.09484.20
15min118818-1881881.15388.895.6581.3389.115.67
220755-2075589.50689.72
322246-2224695.93696.19
419872-1987285.69885.88
520912-2091290.18390.42
621073-2107390.87891.12
20min121139-2113991.16293.533.0191.4793.893.04
221507-2150792.74993.11
322789-2278998.27898.69
420976-2097690.45990.79
521761-2176193.84594.23
621954-2195494.67795.07
30min122264-2226496.01496.771.7496.4797.291.77
222226-2222695.85096.37
323188-2318899.999100.58
422094-2209495.28195.76
522411-2241196.64897.19
622449-2244996.81297.36
45min122837-2283798.48598.251.1599.1198.941.17
222549-2254997.24397.92
323222-23222100.145100.89
422492-2249296.99797.64
522753-2275398.12398.83
622843-2284398.51199.22
60min123037-2303799.34899.401.13100.13100.241.16
222923-2292398.85699.69
323543-23543101.530102.44
422836-2283698.48199.28
523082-2308299.542100.41
622870-2287098.62799.50
90min123225-23225100.158100.081.07101.11101.101.08
223001-2300199.192100.20
323683-23683102.133103.22
423171-2317199.925100.89
523123-2312399.718100.75
623042-2304299.369100.41
极限123307-23307100.512100.030.59101.63101.210.60
223066-2306699.473100.64
323412-23412100.965102.22
423092-2309299.585100.72
523152-2315299.844101.05
623142-2314299.800101.01
佩玛贝特片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)0
对照品批号DHX240702对照品来源ZZ对照品使用方法直接使用
对照品含量(%)99.74对照品水分(%)0对照品稀释倍数100000
标示量(mg)0.1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%
1 10.392166621643216692167721695216700.09
2 10.352165621629216420.09
单位质量响应值RSD%判断
2085.662091.010.19数据可信
加速6月-供试品溶液-SI4S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%
5min15283-528322.70930.5942.9122.7130.5942.91
213090-1309056.26756.27
36569-656928.23728.24
47314-731431.43931.44
55098-509821.91421.91
65342-534222.96222.96
10min113697-1369758.87666.0316.8358.9166.0916.85
220494-2049488.09288.19
314401-1440161.90261.95
415381-1538166.11466.17
513796-1379659.30159.34
614405-1440561.91961.96
15min119353-1935383.18883.677.2483.3283.837.27
222007-2200794.59694.84
317709-1770976.12176.27
419589-1958984.20284.36
518975-1897581.56381.70
619158-1915882.35082.49
20min121128-2112890.81889.175.2291.0989.475.25
222626-2262697.25797.66
319618-1961884.32784.60
420812-2081289.45989.76
519858-1985885.35985.63
620430-2043087.81788.10
30min122119-2211995.07793.933.1395.5094.383.16
222890-2289098.39298.95
321010-2101090.31090.73
422074-2207494.88495.34
521814-2181493.76694.18
621204-2120491.14491.57
45min122441-2244196.46296.152.7397.0596.762.77
223399-23399100.579101.30
321552-2155292.64093.21
422465-2246596.56597.17
522339-2233996.02396.59
622022-2202294.66095.24
60min122804-2280498.02297.762.0298.7798.522.06
223509-23509101.052101.94
322134-2213495.14295.86
422829-2282998.12998.90
522722-2272297.66998.40
622461-2246196.54897.28
90min122903-2290398.44798.581.4899.3699.511.53
223536-23536101.168102.23
322502-2250296.72497.60
422970-2297098.73599.67
522895-2289598.41399.31
622802-2280298.01398.91
极限122693-2269397.54598.811.3298.6299.901.37
223528-23528101.134102.36
322929-2292998.55999.60
423128-2312899.415100.51
522807-2280798.03599.09
622840-2284098.17799.24
佩玛贝特片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)0
对照品批号DHX240702对照品来源ZZ对照品使用方法直接使用
对照品含量(%)99.74对照品水分(%)0对照品稀释倍数100000
标示量(mg)0.1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%
1 10.392160921616216072158621612216060.06
2 10.352166421705216840.14
单位质量响应值RSD%判断
2079.502095.070.53数据可信
长期6月-供试品溶液-2025041421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%
5min113317-1331757.27257.4316.6357.2757.4316.63
210552-1055245.38145.38
315415-1541566.29566.29
415765-1576567.80067.80
510897-1089746.86446.86
614183-1418360.99661.00
10min119653-1965384.52185.297.0384.6285.397.05
218682-1868280.34580.42
320485-2048588.09988.21
421602-2160292.90393.02
517836-1783676.70776.78
620737-2073789.18389.28
15min121742-2174293.50592.073.1093.7492.313.11
220688-2068888.97289.18
321517-2151792.53792.79
422014-2201494.67594.94
520496-2049688.14688.35
621998-2199894.60694.86
20min122517-2251796.83894.743.1097.2395.143.12
221458-2145892.28492.64
322101-2210195.04995.46
422455-2245596.57297.00
520961-2096190.14690.50
622689-2268997.57897.99
30min123190-2319099.73397.382.20100.2997.932.22
222191-2219195.43695.95
322753-2275397.85398.42
422789-2278998.00898.59
521905-2190594.20694.71
623035-2303599.06699.64
45min123264-23264100.05198.831.39100.7799.551.41
222829-2282998.18098.85
323112-2311299.397100.13
423080-2308099.259100.01
522405-2240596.35697.02
623197-2319799.763100.50
60min123470-23470100.93799.850.91101.82100.720.93
223148-2314899.552100.39
323326-23326100.317101.22
423216-2321699.844100.76
522850-2285098.27099.09
623289-23289100.158101.06
90min123975-23975103.109100.381.56104.16101.431.56
223164-2316499.621100.62
323581-23581101.414102.48
423167-2316799.634100.72
523036-2303699.070100.05
623126-2312699.457100.53
极限123705-23705101.947100.371.02103.17101.581.01
223350-23350100.421101.59
323523-23523101.165102.40
423173-2317399.659100.91
523172-2317299.655100.80
623104-2310499.363100.60
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