培哚普利氨氯地平片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号DJ468-220103对照品来源中检院对照品使用方法直接使用
对照品含量(%)94.8对照品水分(%)0对照品稀释倍数4000
标示量(mg)5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%
19.882114421166211702111121235211650.22
29.942115321163211580.04
单位质量响应值RSD%判断
2142.212128.570.46数据可信
供试品溶液-2022082001批-培哚普利-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%
5min123474-2347493.79294.932.3293.7994.932.32
223668-2366894.56794.57
323272-2327292.98592.98
424838-2483899.24299.24
523674-2367494.59194.59
623623-2362394.38794.39
10min124033-2403396.02596.242.9897.0797.302.97
223926-2392695.59896.65
323389-2338993.45294.49
425481-25481101.811102.91
523839-2383995.25096.30
623858-2385895.32696.37
15min123559-2355994.13294.992.5696.2497.112.56
223749-2374994.89197.00
323327-2332793.20595.28
424979-2497999.805102.04
523568-2356894.16796.28
623454-2345493.71295.82
20min123612-2361294.34394.522.4497.5097.702.44
223376-2337693.40096.57
323294-2329493.07396.18
424813-2481399.142102.48
523370-2337093.37696.53
623476-2347693.80096.95
30min123181-2318192.62193.332.2396.8297.562.24
223240-2324092.85797.06
322906-2290691.52295.66
424384-2438497.428101.87
523290-2329093.05797.25
623148-2314892.48996.68
45min122744-2274490.87592.502.2496.1197.762.24
223155-2315592.51797.75
322677-2267790.60795.77
424118-2411896.365101.89
523060-2306092.13897.36
623145-2314592.47797.70
极限123026-2302692.00291.932.8698.2498.222.82
222538-2253890.05296.32
322551-2255190.10496.27
424260-2426096.932103.53
523052-2305292.10698.36
622618-2261890.37296.62
培哚普利氨氯地平片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号100374-202106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4000
标示量(mg)5供试品稀释倍数2系数0.721
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
114.858411183963840698395984086840380.09
214.898410283927840140.15
单位质量响应值RSD%判断
5659.125642.310.22数据可信
供试品溶液-2022082001批-氨氯地平-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%
5min153842-5384261.76862.732.7161.7762.732.71
252476-5247660.20160.20
354331-5433162.32962.33
456380-5638064.67964.68
554823-5482362.89362.89
656212-5621264.48764.49
10min172267-7226782.90581.752.8483.5982.442.82
269934-6993480.22980.90
369543-6954379.78080.47
474887-7488785.91186.63
570154-7015480.48181.18
670761-7076181.17781.89
15min175098-7509886.15385.752.6487.7687.352.64
273841-7384184.71186.27
373239-7323984.02085.60
478565-7856590.13091.80
573632-7363284.47186.06
674094-7409485.00186.62
20min177908-7790889.37688.252.4591.9490.802.44
275197-7519786.26688.77
376132-7613287.33989.85
480234-8023492.04594.72
575533-7553386.65289.18
676541-7654187.80890.37
30min178327-7832789.85790.112.3893.4193.652.38
276870-7687088.18691.65
377024-7702488.36291.85
482017-8201794.09097.79
578821-7882190.42493.92
678231-7823189.74793.29
45min177803-7780389.25690.822.6193.8195.362.59
277687-7768789.12393.56
377995-7799589.47693.94
483102-8310295.335100.08
578817-7881790.41994.92
679620-7962091.34095.88
极限179964-7996491.73591.853.0697.2897.403.01
278043-7804389.53194.96
377858-7785889.31994.78
484577-8457797.027102.83
580445-8044592.28797.79
679480-7948091.18096.73
培哚普利氨氯地平片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号DJ468-220103对照品来源中检院对照品使用方法直接使用
对照品含量(%)94.8对照品水分(%)0对照品稀释倍数4000
标示量(mg)5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%
19.882114521113211842114121248211660.25
29.942105821335211960.93
单位质量响应值RSD%判断
2142.312132.390.33数据可信
供试品溶液-2022082001批-培哚普利
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min124035-2403595.94594.612.2695.9494.612.26
223615-2361594.26894.27
324167-2416796.47296.47
423497-2349793.79793.80
524122-2412296.29296.29
622767-2276790.88390.88
10min124135-2413596.34496.791.2597.4197.841.23
223851-2385195.21096.26
324536-2453697.94599.02
423971-2397195.68996.73
524470-2447097.68198.75
624521-2452197.88598.89
15min123862-2386295.25495.711.6097.3997.841.58
223552-2355294.01796.12
324366-2436697.26699.43
423565-2356594.06996.17
524424-2442497.49899.65
624090-2409096.16498.26
20min123763-2376394.85994.931.5198.0598.121.49
223378-2337893.32296.47
324249-2424996.799100.04
423356-2335693.23496.38
523946-2394695.59098.83
623999-2399995.80198.97
30min123327-2332793.11993.511.0497.3797.751.04
223008-2300891.84596.03
323633-2363394.34098.66
423428-2342893.52297.71
523677-2367794.51698.82
623470-2347093.68997.92
45min123256-2325692.83592.070.6998.1297.360.71
222813-2281391.06796.27
323154-2315492.42897.79
423002-2300291.82197.05
523164-2316492.46897.82
622998-2299891.80597.08
极限123204-2320492.62892.031.2598.9498.341.22
222566-2256690.08196.30
323112-2311292.26098.65
422866-2286691.27897.52
523300-2330093.01199.39
623278-2327892.92399.21
培哚普利氨氯地平片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号100374-202106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4000
标示量(mg)5供试品稀释倍数2系数0.721
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
114.858412784024840848406584122840840.06
214.898404583960840020.08
单位质量响应值RSD%判断
5662.225641.500.26数据可信
供试品溶液-2022082001批-氨氯地平
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min155683-5568363.86763.672.3963.8763.672.39
254458-5445862.46262.46
357849-5784966.35166.35
454715-5471562.75762.76
555998-5599864.22864.23
654381-5438162.37462.37
10min172810-7281083.51183.981.4884.2284.691.47
271337-7133781.82282.52
373798-7379884.64485.38
473855-7385584.71085.41
573149-7314983.90084.61
674383-7438385.31586.01
15min176223-7622387.42687.862.1889.0689.502.15
275142-7514286.18687.79
376967-7696788.27989.96
477345-7734588.71390.35
574672-7467285.64787.29
679280-7928090.93292.57
20min178248-7824889.74890.711.8292.3693.321.80
277370-7737088.74191.30
379500-7950091.18493.84
478611-7861190.16592.79
579178-7917890.81593.41
681587-8158793.57896.23
30min179724-7972491.44192.791.4295.0596.421.40
279709-7970991.42494.97
380294-8029492.09595.77
481491-8149193.46897.09
581804-8180493.82797.43
682391-8239194.50098.19
45min179615-7961591.31692.500.9295.9497.160.89
280410-8041092.22896.79
380121-8012191.89796.59
481045-8104592.95697.62
581640-8164093.63998.29
681048-8104892.96097.70
极限181718-8171893.72894.481.6099.37100.161.56
280964-8096492.86398.45
381455-8145593.42799.14
482453-8245394.571100.27
583057-8305795.264100.95
684584-8458497.016102.79
培哚普利氨氯地平片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号DJ468-220103对照品来源中检院对照品使用方法直接使用
对照品含量(%)94.8对照品水分(%)0对照品稀释倍数4000
标示量(mg)5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%
19.882115721203212762119221208212070.21
29.942124821394213210.49
单位质量响应值RSD%判断
2146.462144.970.05数据可信
供试品溶液-2022082101批-培哚普利
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min124056-2405695.65497.672.1195.6597.672.11
225126-2512699.90999.91
324579-2457997.73397.73
425102-2510299.81399.81
524631-2463197.94097.94
623884-2388494.97094.97
10min124355-2435596.84398.921.7297.91100.001.72
225229-25229100.318101.43
325035-2503599.547100.63
425437-25437101.145102.25
524709-2470998.25099.34
624497-2449797.40798.46
15min124200-2420096.22697.262.3398.3799.442.31
225146-2514699.988102.21
324577-2457797.72699.92
424895-2489598.990101.22
524410-2441097.06199.24
623529-2352993.55895.70
20min124101-2410195.83397.051.7999.04100.321.79
225098-2509899.797103.13
324396-2439697.006100.28
424745-2474598.394101.73
524113-2411395.88199.14
623990-2399095.39198.57
30min123618-2361893.91295.211.7898.1999.561.78
224632-2463297.944102.39
323920-2392095.11399.47
424223-2422396.318100.74
523810-2381094.67699.00
623464-2346493.30097.54
45min122937-2293791.20493.681.8096.5299.081.76
223491-2349193.40798.94
323597-2359793.82999.24
424237-2423796.374101.87
523679-2367994.15599.53
623411-2341193.08998.36
极限123095-2309591.83393.481.6898.1699.931.68
223888-2388894.986101.56
323484-2348493.37999.83
424081-2408195.753102.32
523297-2329792.63699.06
623218-2321892.32298.63
培哚普利氨氯地平片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号100374-202106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4000
标示量(mg)5供试品稀释倍数2系数0.721
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
114.858409483961840898398983954840170.09
214.898471684680846980.04
单位质量响应值RSD%判断
5657.715688.250.39数据可信
供试品溶液-2022082101批-氨氯地平
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min156852-5685264.96565.472.0964.9765.472.09
256615-5661564.69464.69
357485-5748565.68965.69
458248-5824866.56066.56
558942-5894267.35367.35
655616-5561663.55363.55
10min171899-7189982.16082.481.5482.8883.211.55
271513-7151381.71882.44
372708-7270883.08483.81
473500-7350083.98984.73
573004-7300483.42284.17
670468-7046880.52481.23
15min175664-7566486.46286.322.3988.1087.972.36
276457-7645787.36888.99
376213-7621387.08988.74
477491-7749188.55090.22
575202-7520285.93487.61
672231-7223182.53984.14
20min177225-7722588.24688.741.2490.8491.341.25
277816-7781688.92191.52
378188-7818889.34691.97
479118-7911890.40993.07
577285-7728588.31490.94
676309-7630987.19989.72
30min178166-7816689.32190.051.8392.9093.641.82
279745-7974591.12594.71
379095-7909590.38294.00
480230-8023091.67995.34
579375-7937590.70294.31
676228-7622887.10690.59
45min178451-7845189.64791.541.7894.2196.131.75
279110-7911090.40095.00
380412-8041291.88796.51
482473-8247394.24398.92
580683-8068392.19796.82
679512-7951290.85995.31
极限179764-7976491.14792.061.7196.7197.661.68
281370-8137092.98298.58
380185-8018591.62897.27
482944-8294494.781100.51
579934-7993491.34196.98
679177-7917790.47695.94
培哚普利氨氯地平片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号DJ468-220103对照品来源中检院对照品使用方法直接使用
对照品含量(%)94.8对照品水分(%)0对照品稀释倍数4000
标示量(mg)5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%
19.882142021314213082126921349213320.27
29.942121621124211700.31
单位质量响应值RSD%判断
2159.112129.780.97数据可信
供试品溶液-2022082101批-培哚普利
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min125387-25387101.01197.062.59101.0197.062.59
223789-2378994.65394.65
324695-2469598.25798.26
423672-2367294.18794.19
524300-2430096.68696.69
624518-2451897.55397.55
10min124497-2449797.47097.372.7898.5998.452.77
224071-2407195.77596.83
325512-25512101.508102.60
423556-2355693.72694.77
524290-2429096.64697.72
624909-2490999.109100.19
15min124408-2440897.11695.923.0499.3298.083.02
223989-2398995.44897.56
325118-2511899.940102.16
422900-2290091.11593.20
523907-2390795.12297.27
624319-2431996.76198.95
20min124115-2411595.95095.341.7499.2398.571.76
223888-2388895.04798.22
324353-2435396.897100.23
423170-2317092.19095.29
524068-2406895.76398.97
624178-2417896.20099.46
30min123860-2386094.93593.811.9899.2998.101.97
223317-2331792.77597.01
323460-2346093.34497.75
422848-2284890.90995.03
523835-2383594.83699.10
624147-2414796.077100.41
45min123537-2353793.65093.602.5399.0698.932.50
222958-2295891.34696.61
324272-2427296.574102.02
422750-2275090.51995.65
523586-2358693.84599.17
624051-2405195.695101.09
极限123170-2317092.19092.251.5898.6498.621.59
222709-2270990.35596.63
323389-2338993.06199.58
422797-2279790.70696.85
523422-2342293.19299.56
623622-2362293.988100.45
培哚普利氨氯地平片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号100374-202106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4000
标示量(mg)5供试品稀释倍数2系数0.721
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
114.858420284247841538414484593842680.23
214.898399583753838740.21
单位质量响应值RSD%判断
5674.615632.910.53数据可信
供试品溶液-2022082101批-氨氯地平
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min157624-5762466.07265.183.4666.0765.183.46
252871-5287160.62260.62
358111-5811166.63066.63
457504-5750465.93465.93
557372-5737265.78365.78
657598-5759866.04266.04
10min171978-7197882.53082.833.4083.2683.553.39
269126-6912679.26079.93
375721-7572186.82287.56
470071-7007180.34381.08
572429-7242983.04783.78
674088-7408884.94985.68
15min175945-7594587.07986.642.9288.7388.292.91
274010-7401084.86086.41
378802-7880290.35492.06
472398-7239883.01284.64
575610-7561086.69488.35
676621-7662187.85489.53
20min177386-7738688.73188.921.7591.3591.531.77
276163-7616387.32889.83
379037-7903790.62493.33
475791-7579186.90289.45
578150-7815089.60792.22
678779-7877990.32892.98
30min179718-7971891.40590.772.0195.0194.362.00
277913-7791389.33592.80
379087-7908790.68194.40
476864-7686488.13291.65
580097-8009791.83995.45
681303-8130393.22296.88
45min180608-8060892.42593.172.4697.0597.772.44
278672-7867290.20594.67
383055-8305595.23199.95
479317-7931790.94595.44
582680-8268094.80199.43
683204-8320495.402100.09
极限180763-8076392.60393.081.7798.2598.721.78
279254-7925490.87396.33
381523-8152393.47499.26
480043-8004391.77797.28
582641-8264194.756100.44
682852-8285294.998100.75
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