缬沙坦氨氯地平片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
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2000
标示量(mg)5供试品稀释倍数1系数0.7210
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
114.232473292477472473252472572473882474090.08
214.202468772469032468900.01
单位质量响应值RSD%判断
17386.4417386.620.01数据可信
稳定性考察-长期3月-供试品溶液-2023112521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%
5min198676-9867636.79133.445.5336.7933.445.53
286373-8637332.20432.20
384844-8484431.63431.63
491622-9162234.16134.16
588310-8831032.92632.93
688373-8837332.95032.95
10min1144883-14488354.01949.944.7054.0850.004.70
2130498-13049848.65648.71
3126433-12643347.14047.19
4134105-13410550.00150.06
5136127-13612750.75550.81
6131639-13163949.08149.14
15min1171300-17130063.86959.145.7364.0259.285.73
2148745-14874555.45955.59
3147481-14748154.98855.12
4163611-16361161.00261.14
5160046-16004659.67359.81
6160488-16048859.83759.97
20min1195137-19513772.75666.975.8273.0167.205.81
2168898-16889862.97363.20
3167081-16708162.29662.52
4182461-18246168.03068.27
5184542-18454268.80669.04
6179587-17958766.95867.19
30min1214786-21478680.08275.553.8180.4675.903.81
2202396-20239675.46375.79
3193462-19346272.13272.46
4202978-20297875.68076.04
5206541-20654177.00877.36
6195543-19554372.90873.26
45min1231307-23130786.24281.693.5686.7582.173.56
2217985-21798581.27581.73
3209332-20933278.04978.50
4219976-21997682.01782.50
5223196-22319683.21883.70
6212811-21281179.34679.82
60min1231430-23143086.28884.991.9986.9485.602.00
2224028-22402883.52884.12
3221092-22109282.43383.01
4231243-23124386.21886.84
5232090-23209086.53487.15
6227753-22775384.91785.52
极限1256920-25692095.79294.441.6296.5995.191.62
2252451-25245194.12694.86
3250334-25033493.33694.05
4257861-25786196.14396.90
5247187-24718792.16392.93
6254985-25498595.07095.81
缬沙坦氨氯地平片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号DZP67822106602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200
标示量(mg)80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%
115.934586392459186245873514594495458923745898670.08
216.074583017458550945842630.04
单位质量响应值RSD%判断
288127.24285268.390.71数据可信
稳定性考察-长期3月-供试品溶液-2023112521批-缬沙坦-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%
5min13699082-369908272.28766.824.1172.2966.824.11
23389618-338961866.24066.24
33319113-331911364.86264.86
43393361-339336166.31366.31
53381135-338113566.07466.07
63333833-333383365.15065.15
10min14426750-442675086.50781.003.6486.6381.113.64
24135221-413522180.81080.92
33980551-398055177.78877.90
44119455-411945580.50280.61
54138561-413856180.87680.99
64067499-406749979.48779.60
15min14702985-470298591.90687.013.0792.1787.263.08
24429770-442977086.56686.81
34284936-428493683.73683.97
44452970-445297087.02087.26
54434752-443475286.66486.91
64410644-441064486.19386.43
20min14840026-484002694.58490.272.6395.0090.662.63
24606482-460648290.02090.41
34468650-446865087.32687.70
44625199-462519990.38590.78
54587647-458764789.65290.04
64588909-458890989.67690.06
30min14969647-496964797.11793.252.3297.6993.802.32
24778537-477853793.38293.92
34633312-463331290.54491.07
44777742-477774293.36693.91
54729883-472988392.43192.97
64742495-474249592.67893.21
45min15039711-503971198.48695.042.0399.2295.742.04
24868131-486813195.13395.83
34744983-474498392.72693.40
44869340-486934095.15695.85
54805977-480597793.91894.61
64851826-485182694.81495.50
60min15062068-506206898.92395.891.8799.8296.751.88
24924435-492443596.23397.09
34798599-479859993.77494.60
44909950-490995095.95096.80
54831062-483106294.40895.26
64916073-491607396.07096.92
极限15187554-5187554101.375100.291.68102.44101.301.68
25234014-5234014102.283103.30
35127680-5127680100.205101.19
45121845-5121845100.091101.11
54979030-497903097.30098.31
65140675-5140675100.459101.47
缬沙坦氨氯地平片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
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2000
标示量(mg)5供试品稀释倍数1系数0.7210
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
114.232491982493382490472488152488202490440.10
214.202488062487532487800.02
单位质量响应值RSD%判断
17501.3417519.720.08数据可信
稳定性考察-长期3月-供试品溶液-2023112521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%
5min187882-8788232.53432.374.5032.5332.374.50
284383-8438331.23931.24
389200-8920033.02233.02
491163-9116333.74933.75
590840-9084033.63033.63
681167-8116730.04930.05
10min1129586-12958647.97448.024.1748.0348.074.17
2125988-12598846.64246.69
3130287-13028748.23348.29
4137029-13702950.72950.79
5133556-13355649.44349.50
6121759-12175945.07645.13
15min1153920-15392056.98257.356.1957.1257.486.18
2154617-15461757.24057.37
3157810-15781058.42258.56
4166515-16651561.64561.79
5158941-15894158.84158.98
6137644-13764450.95751.08
20min1172016-17201663.68164.813.4963.9165.043.50
2168438-16843862.35762.58
3177923-17792365.86866.10
4184063-18406368.14168.38
5178523-17852366.09066.33
6169383-16938362.70762.92
30min1192277-19227771.18272.192.4571.5272.532.46
2192612-19261271.30671.64
3195428-19542872.34972.69
4203577-20357775.36675.72
5196144-19614472.61472.96
6189945-18994570.31970.63
45min1204038-20403875.53677.332.2875.9977.792.29
2208691-20869177.25977.71
3210247-21024777.83578.30
4216773-21677380.25180.73
5209636-20963677.60978.08
6203883-20388375.47975.91
60min1212404-21240478.63380.412.6579.2181.002.65
2215003-21500379.59680.17
3219092-21909281.10981.70
4226362-22636283.80184.42
5219689-21968981.33081.93
6210636-21063677.97978.54
极限1242755-24275589.87092.011.9490.5892.731.92
2249287-24928792.28893.00
3244750-24475090.60891.34
4253033-25303393.67494.43
5246300-24630091.18291.91
6255022-25502294.41195.10
缬沙坦氨氯地平片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号DZP67822106602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200
标示量(mg)80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%
115.934636691463307546323784628117462757846315680.09
216.074623492462389746236940.01
单位质量响应值RSD%判断
290745.01287722.090.74数据可信
稳定性考察-长期3月-供试品溶液-2023112521批-缬沙坦-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%
5min13344534-334453464.78664.493.3364.7964.493.33
23202866-320286662.04262.04
33418975-341897566.22866.23
43434886-343488666.53666.54
53393307-339330765.73165.73
63181806-318180661.63461.63
10min13978488-397848877.06677.413.0477.1777.523.04
23904210-390421075.62775.73
34071426-407142678.86678.98
44160956-416095680.60180.71
54038428-403842878.22778.34
63823148-382314874.05774.16
15min14237603-423760382.08583.053.0082.3283.293.00
24191986-419198681.20281.43
34362004-436200484.49584.74
44488630-448863086.94887.19
54313503-431350383.55683.80
64131423-413142380.02980.25
20min14360868-436086884.47386.052.8484.8586.432.84
24358368-435836884.42584.79
34508680-450868087.33687.72
44656393-465639390.19890.59
54452244-445224486.24386.62
64318231-431823183.64784.01
30min14484257-448425786.86388.972.6487.3889.492.65
24518161-451816187.52088.03
34651282-465128290.09990.63
44810634-481063493.18593.73
54571274-457127488.54989.07
64523605-452360587.62588.12
45min14575502-457550288.63190.812.4189.2991.472.40
24621853-462185389.52890.18
34743455-474345591.88492.56
44887588-488758894.67695.37
54635197-463519789.78790.46
64663309-466330990.33290.98
60min14619121-461912189.47691.682.2690.2892.502.26
24673061-467306190.52091.32
34785568-478556892.70093.53
44916596-491659695.23896.09
54671238-467123890.48591.31
64732012-473201291.66292.46
极限14987107-498710796.60498.802.1597.5699.772.14
25050103-505010397.82498.78
35136735-513673599.502100.49
45201325-5201325100.753101.77
54985867-498586796.58097.55
65242189-5242189101.545102.49
缬沙坦氨氯地平片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
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2000
标示量(mg)5供试品稀释倍数1系数0.7210
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
114.232470892472812463912461332464462466680.20
214.202487892485372486630.08
单位质量响应值RSD%判断
17334.3617511.480.72数据可信
稳定性考察-长期3月-供试品溶液-BDJL7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%
5min163378-6337823.58227.619.6323.5827.619.64
279586-7958629.61229.61
371388-7138826.56226.56
482016-8201630.51630.52
578938-7893829.37129.37
669997-6999726.04426.04
10min1133006-13300649.48956.897.5049.5356.947.50
2152745-15274556.83356.88
3153197-15319757.00157.05
4168428-16842862.66862.72
5157360-15736058.55058.60
6152695-15269556.81456.86
15min1164495-16449561.20566.485.4661.3366.625.46
2175291-17529165.22265.37
3174462-17446264.91365.05
4188808-18880870.25170.41
5178450-17845066.39766.54
6190591-19059170.91571.05
20min1184311-18431168.57872.733.9068.8072.983.90
2187439-18743969.74269.99
3200591-20059174.63574.88
4200663-20066374.66274.93
5197908-19790873.63773.89
6201897-20189775.12175.38
30min1188084-18808469.98277.015.5870.3277.385.58
2210800-21080078.43478.80
3197791-19779173.59473.97
4212853-21285379.19879.59
5214039-21403979.63980.02
6218217-21821781.19481.58
45min1211890-21189078.84081.611.9979.2982.112.01
2218895-21889581.44681.95
3221119-22111982.27382.77
4218299-21829981.22481.75
5220635-22063582.09382.61
6225112-22511283.75984.28
60min1202792-20279275.45481.844.2876.0482.484.28
2227424-22742484.61985.25
3215432-21543280.15780.79
4223388-22338883.11883.78
5224625-22462583.57884.23
6226107-22610784.12984.79
极限1238663-23866388.80191.272.1189.5192.042.12
2245081-24508191.18991.97
3242920-24292090.38591.15
4246648-24664891.77292.57
5244226-24422690.87191.66
6254289-25428994.61595.41
缬沙坦氨氯地平片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号DZP67822106602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200
标示量(mg)80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%
115.934605123460320645921294588359459340145964440.16
216.074682192468150746818500.02
单位质量响应值RSD%判断
288540.11291341.010.69数据可信
稳定性考察-长期3月-供试品溶液-BDJL7批-缬沙坦-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%
5min14323671-432367183.54882.142.6283.5582.142.62
24110565-411056579.43079.43
34235936-423593681.85381.85
44275680-427568082.62182.62
54410421-441042185.22485.22
64148888-414888880.17180.17
10min14818981-481898193.11992.421.3193.2692.561.31
24724558-472455891.29491.43
34701173-470117390.84390.98
44787438-478743892.50992.65
54871669-487166994.13794.28
64793287-479328792.62292.76
15min14883904-488390494.37493.711.1694.6794.001.16
24820434-482043493.14793.43
34757785-475778591.93692.22
44844132-484413293.60593.90
54918645-491864595.04595.34
64872533-487253394.15494.44
20min14881510-488151094.32794.041.1094.7894.491.10
24847278-484727893.66694.11
34777007-477700792.30892.75
44861078-486107893.93294.38
54931471-493147195.29395.75
64902205-490220594.72795.17
30min14899123-489912394.66894.661.1295.2895.271.12
24898288-489828894.65195.25
34800718-480071892.76693.36
44895127-489512794.59095.19
54952758-495275895.70496.32
64947143-494714395.59696.20
45min14919274-491927495.05795.221.1795.8295.981.17
24937794-493779495.41596.17
34820894-482089493.15693.91
44932928-493292895.32196.08
54973331-497333196.10296.88
64980474-498047496.24097.00
60min14932657-493265795.31695.641.2296.2496.561.22
24966111-496611195.96296.87
34841085-484108593.54694.45
44953831-495383195.72596.65
54993590-499359096.49397.43
65010710-501071096.82497.75
极限15053603-505360397.65398.581.9898.7499.661.97
25163465-516346599.776100.85
34932723-493272395.31796.38
45122070-512207098.976100.06
55111364-511136498.76999.87
65226382-5226382100.991102.08
缬沙坦氨氯地平片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
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2000
标示量(mg)5供试品稀释倍数1系数0.7210
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
114.232476542469932472002473712468712472180.13
214.202514682514332514500.01
单位质量响应值RSD%判断
17373.0117707.751.35数据可信
稳定性考察-长期3月-供试品溶液-BDJL7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%
5min169258-6925825.59828.508.3525.6028.508.34
282690-8269030.56330.56
374666-7466627.59727.60
485362-8536231.55131.55
571249-7124926.33426.33
679494-7949429.38229.38
10min1151245-15124555.90258.773.8655.9458.813.86
2166364-16636461.49061.54
3165765-16576561.26861.31
4154924-15492457.26157.31
5155737-15573757.56257.61
6159961-15996159.12359.17
15min1187675-18767569.36769.252.4269.5069.402.42
2195299-19529972.18472.34
3182838-18283867.57967.73
4188993-18899369.85470.00
5183694-18369467.89568.03
6185731-18573168.64868.80
20min1199942-19994273.90174.072.3574.1574.332.36
2208503-20850377.06577.34
3200978-20097874.28374.54
4199569-19956973.76374.03
5193821-19382171.63871.89
6199599-19959973.77474.04
30min1214945-21494579.44679.121.8679.8279.511.86
2221208-22120881.76182.16
3210548-21054877.82178.21
4214607-21460779.32179.71
5210535-21053577.81678.19
6212583-21258378.57378.96
45min1221915-22191582.02281.593.0482.5382.113.04
2233320-23332086.23786.78
3219375-21937581.08381.60
4215358-21535879.59880.12
5214999-21499979.46679.97
6219501-21950181.13081.65
60min1222782-22278282.34282.102.6282.9982.752.62
2230900-23090085.34386.03
3219125-21912580.99181.64
4221808-22180881.98282.63
5213427-21342778.88579.52
6224647-22464783.03283.68
极限1251194-25119492.84490.993.5893.6291.783.56
2259754-25975496.00896.83
3245481-24548190.73291.52
4236329-23632987.35088.14
5237260-23726087.69488.46
6247033-24703391.30692.10
缬沙坦氨氯地平片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号DZP67822106602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200
标示量(mg)80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%
115.934609890459754246041644604038460432846039920.10
216.074693862469291546933880.02
单位质量响应值RSD%判断
289013.94292058.990.75数据可信
稳定性考察-长期3月-供试品溶液-BDJL7批-缬沙坦-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%
5min14142334-414233479.88079.293.7179.8879.293.71
24214843-421484381.27881.28
34126939-412693979.58379.58
44139402-413940279.82379.82
53813857-381385773.54673.55
64233119-423311981.63181.63
10min14798722-479872292.53891.281.7992.6791.421.79
24847809-484780993.48493.62
34660050-466005089.86490.00
44680139-468013990.25190.38
54641434-464143489.50589.63
64774164-477416492.06492.20
15min14857941-485794193.68092.891.6293.9793.171.62
24935214-493521495.17095.46
34784618-478461892.26692.55
44731939-473193991.25091.53
54744299-474429991.48891.76
64847287-484728793.47493.76
20min14894581-489458194.38693.191.8694.8393.631.86
24953219-495321995.51795.97
34752179-475217991.64092.08
44762180-476218091.83392.27
54746108-474610891.52391.95
64887301-488730194.24694.69
30min14927290-492729095.01793.961.8395.6294.561.83
24998776-499877696.39697.00
34791203-479120392.39392.98
44810830-481083092.77193.36
54784654-478465492.26692.84
64922689-492268994.92895.53
45min14979571-497957196.02594.742.0296.7895.492.02
25049307-504930797.37098.14
34821007-482100792.96793.71
44839884-483988493.33194.07
54818383-481838392.91793.65
64969757-496975795.83696.60
60min15013680-501368096.68395.031.9297.6095.941.91
25048356-504835697.35298.28
34845498-484549893.44094.34
44855317-485531793.62994.53
54835174-483517493.24194.13
64970939-497093995.85996.78
极限15220079-5220079100.66398.702.07101.7499.772.07
25264761-5264761101.525102.62
35058828-505882897.55498.61
45028372-502837296.96698.02
55007941-500794196.57297.61
65129702-512970298.920100.00
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