阿齐沙坦氨氯地平片项目信息
介质体积(ml) 900 取样体积(ml)5补液体积(ml)0
对照品批号68522100802对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.70对照品水分(%)0对照品稀释倍数1000
标示量(mg)20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%
110.632825392833132829022821452823002826400.17
210.692840602844852842720.11
单位质量响应值RSD%判断
26588.9026592.330.01数据可信
供试品溶液-2026050721批-阿齐沙坦-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%
5min1191504-19150464.62370.9510.1764.6270.9510.17
2228092-22809276.97076.97
3204516-20451669.01469.01
4236572-23657279.83179.83
5181782-18178261.34261.34
6219087-21908773.93173.93
10min1291123-29112398.239100.051.6998.60100.441.72
2300705-300705101.473101.90
3294848-29484899.49699.88
4296304-29630499.988100.43
5291996-29199698.53498.87
6303975-303975102.576102.99
15min1296120-29612099.926101.041.15100.83101.991.18
2300464-300464101.392102.38
3296235-29623599.964100.90
4303607-303607102.452103.45
5297057-297057100.242101.13
6303132-303132102.292103.27
20min1294835-29483599.492100.651.41100.95102.161.42
2302884-302884102.208103.76
3293495-29349599.040100.53
4298394-298394100.693102.26
5296370-296370100.010101.46
6303557-303557102.435103.98
30min1293454-29345499.026100.241.64101.04102.311.64
2300656-300656101.456103.58
3292357-29235798.656100.70
4294673-29467399.437101.56
5296192-29619299.950101.95
6304988-304988102.918105.04
45min1289421-28942197.66599.252.11100.23101.882.11
2297239-297239100.303102.99
3290114-29011497.899100.49
4292986-29298698.868101.55
5289755-28975597.778100.33
6305264-305264103.011105.70
60min1287499-28749997.01798.801.30100.12101.971.32
2295115-29511599.587102.83
3290230-29023097.938101.07
4293503-29350399.043102.27
5291962-29196298.523101.62
6298323-298323100.669103.93
极限1290027-29002797.87099.211.30101.51102.941.32
2298331-298331100.672104.47
3291933-29193398.513102.19
4292351-29235198.654102.43
5292125-29212598.578102.22
6299250-299250100.982104.80
阿齐沙坦氨氯地平片项目信息
介质体积(ml)900取样体积(ml) 5补液体积(ml)0
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(%) 99.90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0.7211
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
114.517000570156702166982170014700420.22
214.557080470385705940.42
单位质量响应值RSD%判断
4827.154851.820.37数据可信
供试品溶液-2026050721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%
5min159559-5955979.79175.415.4179.7975.415.41
254194-5419472.60472.60
355686-5568674.60274.60
457972-5797277.66577.66
551590-5159069.11569.12
658738-5873878.69178.69
10min171859-7185996.26990.774.2696.7191.184.26
266689-6668989.34389.75
364199-6419986.00786.42
466775-6677589.45889.89
566377-6637788.92589.31
670607-7060794.59295.03
15min172629-7262997.30194.791.4998.2895.721.51
270054-7005493.85194.75
370425-7042594.34895.24
470375-7037594.28195.21
569780-6978093.48494.36
671287-7128795.50396.47
20min175551-75551101.21696.813.88102.7398.263.86
270287-7028794.16395.58
369166-6916692.66294.08
470919-7091995.01096.46
571817-7181796.21397.61
675846-75846101.611103.10
30min175541-75541101.20296.864.29103.2898.854.26
272975-7297597.76499.71
368031-6803191.14193.07
470871-7087194.94696.93
570446-7044694.37696.31
675950-75950101.750103.81
45min174349-7434999.60596.683.98102.2599.203.96
272141-7214196.64799.13
369763-6976393.46195.90
471443-7144395.71298.22
568798-6879892.16994.62
676496-76496102.482105.10
60min175574-75574101.24697.862.45104.44100.922.47
273436-7343698.382101.41
371733-7173396.10199.06
471303-7130395.52498.56
571599-7159995.92198.89
674625-7462599.975103.17
极限176477-76477102.45698.882.94106.22102.492.94
274161-7416199.353102.92
372650-7265097.329100.82
471290-7129095.50799.08
572114-7211496.611100.11
676177-76177102.054105.80
阿齐沙坦氨氯地平片项目信息
介质体积(ml) 900 取样体积(ml)5补液体积(ml)0
对照品批号68522100802对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.70对照品水分(%)0对照品稀释倍数1000
标示量(mg)20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%
110.632815872804272815412810452812372811670.17
210.692840312822262831280.46
单位质量响应值RSD%判断
26450.3326485.310.10数据可信
供试品溶液-2026050721批-阿齐沙坦-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%
5min1215440-21544073.03874.7310.4373.0474.7310.42
2228795-22879577.56577.57
3182200-18220061.76961.77
4224347-22434776.05776.06
5253040-25304085.78585.78
6218733-21873374.15474.15
10min1298596-298596101.229100.540.88101.63100.960.89
2293103-29310399.36699.80
3294075-29407599.696100.04
4299893-299893101.668102.09
5297179-297179100.748101.22
6296554-296554100.536100.95
15min1298993-298993101.363101.091.35102.33102.061.35
2291116-29111698.69399.68
3295997-295997100.348101.24
4301418-301418102.185103.17
5300185-300185101.767102.80
6301361-301361102.166103.14
20min1297973-297973101.017100.350.95102.55101.890.94
2290811-29081198.589100.12
3295706-295706100.249101.70
4298463-298463101.184102.74
5295775-295775100.272101.87
6297353-297353100.807102.35
30min1298367-298367101.151100.161.25103.24102.251.23
2289538-28953898.158100.24
3293787-29378799.598101.61
4298229-298229101.104103.22
5293929-29392999.647101.81
6298788-298788101.294103.39
45min1295401-295401100.146100.321.13102.80102.971.11
2290695-29069598.550101.17
3295994-295994100.347102.91
4298073-298073101.051103.73
5294784-29478499.936102.65
6300583-300583101.902104.56
60min1296102-296102100.38399.630.87103.59102.840.86
2289694-28969498.211101.38
3293196-29319699.398102.52
4295673-295673100.238103.48
5292660-29266099.216102.48
6296024-296024100.357103.58
极限1294814-29481499.94798.941.50103.72102.701.46
2284235-28423596.360100.08
3291444-29144498.804102.48
4295028-295028100.019103.82
5289910-28991098.284102.10
6295575-295575100.205103.99
阿齐沙坦氨氯地平片项目信息
介质体积(ml)900取样体积(ml) 5补液体积(ml)0
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(%) 99.90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0.7211
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
114.516953169794699376965469781697390.23
214.557053770546705420.01
单位质量响应值RSD%判断
4806.274848.250.62数据可信
供试品溶液-2026050721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%
5min154205-5420572.80375.614.5372.8075.614.53
253380-5338071.69571.70
356522-5652275.91575.92
459594-5959480.04180.04
555098-5509874.00374.00
658979-5897979.21579.22
10min168110-6811091.47990.983.2491.8891.403.23
267860-6786091.14391.54
369317-6931793.10093.52
467983-6798391.30991.75
563531-6353185.32985.74
669636-6963693.52993.97
15min167572-6757290.75794.103.1191.6795.023.11
270391-7039194.54395.45
371060-7106095.44196.38
471107-7110795.50496.46
567343-6734390.44991.33
672877-7287797.88298.84
20min170849-7084995.15893.753.2196.5795.203.19
266996-6699689.98391.41
371233-7123395.67497.14
471634-7163496.21297.69
566876-6687689.82291.21
671238-7123895.68097.18
30min169960-6996093.96495.361.8395.9197.331.84
270166-7016694.24196.17
371929-7192996.60898.61
472835-7283597.82599.84
569566-6956693.43595.32
671547-7154796.09598.13
45min171707-7170796.31097.442.4698.7899.942.46
270413-7041394.57297.03
373334-7333498.496101.03
474979-74979100.705103.27
571019-7101995.38697.79
673859-7385999.201101.77
60min171643-7164396.22496.842.1499.2399.882.14
272144-7214496.89799.88
371389-7138995.88398.97
474515-74515100.082103.20
569960-6996093.96496.90
672965-7296598.000101.12
极限172186-7218696.95496.932.54100.49100.512.53
270651-7065194.89298.41
373869-7386999.214102.83
473804-7380499.127102.80
569348-6934893.14296.60
673151-7315198.250101.91
阿齐沙坦氨氯地平片项目信息
介质体积(ml) 900 取样体积(ml)5补液体积(ml)0
对照品批号68522100802对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.70对照品水分(%)0对照品稀释倍数1000
标示量(mg)20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%
110.632824232815772823722817052816542819460.15
210.692826502822952824720.09
单位质量响应值RSD%判断
26523.6126423.950.27数据可信
供试品溶液-2026050821批-阿齐沙坦-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%
5min1248408-24840884.19586.614.1384.2086.624.13
2258769-25876987.70787.71
3261298-26129888.56488.56
4240399-24039981.48181.48
5270643-27064391.73291.73
6253756-25375686.00886.01
10min1296524-296524100.504100.661.46100.97101.141.45
2289430-28943098.10098.59
3296011-296011100.330100.82
4297979-297979100.997101.45
5300169-300169101.739102.25
6301851-301851102.309102.79
15min1296768-296768100.587100.241.68101.61101.281.67
2285712-28571296.83997.87
3297293-297293100.765101.81
4297803-297803100.937101.95
5298339-298339101.119102.19
6298618-298618101.214102.26
20min1294770-29477099.909100.451.92101.49102.041.90
2286873-28687397.23398.80
3295490-295490100.153101.76
4299461-299461101.499103.07
5297735-297735100.914102.55
6303825-303825102.979104.59
30min1292216-29221699.04499.061.28101.18101.221.28
2284845-28484596.54598.66
3294807-29480799.922102.09
4293811-29381199.584101.72
5294154-29415499.701101.90
6293730-29373099.557101.74
45min1291454-29145498.78698.691.47101.48101.401.47
2282991-28299195.91798.56
3293259-29325999.397102.12
4291217-29121798.705101.40
5292949-29294999.292102.04
6295233-295233100.066102.80
60min1289432-28943298.10099.161.84101.34102.421.82
2285041-28504196.61299.79
3294724-29472499.894103.17
4289812-28981298.229101.47
5297052-297052100.683103.99
6299274-299274101.436104.73
极限1287547-28754797.46198.382.09101.25102.192.05
2280806-28080695.17698.89
3290723-29072398.538102.37
4292885-29288599.271103.06
5290493-29049398.460102.32
6299138-299138101.390105.24
阿齐沙坦氨氯地平片项目信息
介质体积(ml)900取样体积(ml) 5补液体积(ml)0
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(%) 99.90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0.7211
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
114.517038070012699277009370041700910.25
214.556969769781697390.09
单位质量响应值RSD%判断
4830.534793.060.56数据可信
供试品溶液-2026050821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%
5min145539-4553961.36070.507.6261.3670.507.63
255896-5589675.31575.32
353169-5316971.64171.64
455124-5512474.27574.28
554542-5454273.49173.49
649643-4964366.89066.89
10min164069-6406986.32888.003.9086.6788.393.90
269244-6924493.30193.72
363361-6336185.37485.77
466335-6633589.38189.79
566524-6652489.63690.04
662317-6231783.96784.34
15min167442-6744290.87390.915.6991.6991.795.67
272622-7262297.85298.79
364034-6403486.28187.15
470970-7097095.62696.54
567026-6702690.31291.22
662710-6271084.49785.33
20min168083-6808391.73695.244.5993.0696.624.59
275328-75328101.498102.98
367820-6782091.38292.73
473577-7357799.139100.58
571289-7128996.05697.46
667995-6799591.61892.93
30min166876-6687690.11093.585.4391.9595.505.41
275488-75488101.714103.76
367066-6706690.36692.23
470080-7008094.42796.42
571803-7180396.74998.69
665400-6540088.12189.94
45min169575-6957593.74796.114.6396.0898.544.62
276988-76988103.735106.34
368155-6815591.83394.19
473501-7350199.037101.55
570198-7019894.58697.07
669546-6954693.70896.01
60min170822-7082295.42795.574.6698.2898.544.63
276837-76837103.532106.72
368935-6893592.88495.76
472264-7226497.370100.44
567805-6780591.36294.37
668909-6890992.84995.68
极限169807-6980794.05996.633.7197.45100.133.73
274656-74656100.593104.35
368554-6855492.37195.76
474441-74441100.303103.91
573073-7307398.460101.97
669770-6977094.00997.35
阿齐沙坦氨氯地平片项目信息
介质体积(ml) 900 取样体积(ml)5补液体积(ml)0
对照品批号68522100802对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.70对照品水分(%)0对照品稀释倍数1000
标示量(mg)20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%
110.632827842822352797592812702827162817530.46
210.692832712820732826720.30
单位质量响应值RSD%判断
26505.4626442.660.17数据可信
供试品溶液-2026050821批-阿齐沙坦-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%
5min1272119-27211992.23188.935.0892.2388.935.08
2270030-27003091.52391.52
3266520-26652090.33390.33
4274493-27449393.03693.04
5246288-24628883.47683.48
6244789-24478982.96882.97
10min1295745-295745100.239100.162.33100.75100.662.30
2284840-28484096.54397.05
3297335-297335100.778101.28
4293069-29306999.33299.85
5295990-295990100.322100.79
6306113-306113103.753104.21
15min1291615-29161598.83999.911.9799.91100.961.94
2287736-28773697.52498.57
3295340-295340100.101101.16
4292509-29250999.142100.21
5296779-296779100.589101.61
6304688-304688103.270104.31
20min1289003-28900397.95499.231.5699.57100.841.54
2287176-28717697.33498.92
3297809-297809100.938102.56
4290036-29003698.30499.92
5295822-295822100.265101.84
6296771-296771100.586102.20
30min1287189-28718997.33998.771.4699.50100.931.44
2287386-28738697.40599.53
3295297-295297100.087102.27
4288094-28809497.64599.81
5294643-29464399.865102.00
6295864-295864100.279102.45
45min1287018-28701897.28197.851.4599.98100.561.44
2283048-28304895.93598.60
3294474-29447499.808102.54
4286457-28645797.09199.80
5288691-28869197.848100.54
6292502-29250299.139101.87
60min1285052-28505296.61497.531.9399.86100.781.89
2280693-28069395.13798.34
3291683-29168398.862102.15
4282840-28284095.86599.11
5293045-29304599.324102.56
6293133-29313399.353102.63
极限1283308-28330896.02397.411.6699.80101.201.63
2282384-28238495.71099.44
3289923-28992398.265102.10
4285144-28514496.646100.43
5288639-28863997.830101.62
6295040-295040100.000103.83
阿齐沙坦氨氯地平片项目信息
介质体积(ml)900取样体积(ml) 5补液体积(ml)0
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(%) 99.90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0.7211
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
114.517064169822692816963670077698910.73
214.556984170223700320.39
单位质量响应值RSD%判断
4816.754813.200.06数据可信
供试品溶液-2026050821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%
5min149621-4962166.81570.687.1066.8270.687.10
248148-4814864.83264.83
352605-5260570.83370.83
451447-5144769.27469.27
554528-5452873.42373.42
658579-5857978.87778.88
10min160706-6070681.74184.955.5482.1185.345.55
259668-5966880.34480.70
362147-6214783.68284.08
463105-6310584.97285.36
563286-6328685.21585.62
669615-6961593.73794.18
15min164830-6483087.29489.123.9388.1289.983.95
264872-6487287.35188.16
364339-6433986.63387.49
464182-6418286.42287.28
568558-6855892.31493.20
670331-7033194.70195.66
20min166556-6655689.61890.535.0790.9391.885.05
265075-6507587.62488.92
367897-6789791.42492.76
462132-6213283.66185.00
571042-7104295.65997.05
670675-7067595.16596.65
30min165649-6564988.39790.902.7090.2192.762.70
267564-6756490.97692.75
368484-6848492.21494.06
465488-6548888.18089.98
570352-7035294.73096.66
667509-6750990.90292.92
45min169744-6974493.91192.244.4596.2194.614.42
265487-6548788.17990.46
367530-6753090.93093.29
465212-6521287.80990.10
569866-6986694.07596.53
673196-7319698.559101.08
60min169103-6910393.04894.304.7795.8797.184.74
268339-6833992.01994.79
368346-6834692.02994.89
466206-6620689.14791.93
573293-7329398.690101.66
674907-74907100.863103.93
极限167485-6748590.86993.713.8494.2197.113.85
268271-6827191.92895.21
369318-6931893.33796.71
467015-6701590.23693.51
571526-7152696.31199.83
673958-7395899.585103.21
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