氨氯地平缬沙坦片项目信息
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%
114.392514802511702515412514632513492514010.06
214.362503732503432503580.01
单位质量响应值RSD%判断
17470.5417434.400.15数据可信
长期12月-供试品溶液-BDJL7批-氨氯地平-pH4.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min116354-163546.0756.578.966.076.578.96
216554-165546.1496.15
317720-177206.5826.58
416602-166026.1676.17
520491-204917.6117.61
618353-183536.8176.82
10min136240-3624013.46114.105.3513.4714.115.36
236577-3657713.58613.60
338565-3856514.32514.34
436166-3616613.43313.44
541341-4134115.35615.37
638793-3879314.40914.42
15min157428-5742821.33122.505.0221.3622.535.02
263657-6365723.64523.68
360593-6059322.50722.54
456453-5645320.96921.00
563384-6338423.54323.58
661914-6191422.99723.03
20min177775-7777528.88929.303.6128.9629.373.60
277086-7708628.63328.71
381960-8196030.44330.52
475847-7584728.17228.24
577686-7768628.85628.93
682866-8286630.78030.85
30min1114026-11402642.35442.182.6342.4742.302.64
2111655-11165541.47341.59
3115850-11585043.03143.15
4108430-10843040.27540.39
5115497-11549742.90043.03
6115888-11588843.04543.17
45min1151397-15139756.23556.702.4556.4256.902.46
2151348-15134856.21656.41
3155760-15576057.85558.05
4146372-14637254.36854.55
5154971-15497157.56257.76
6156125-15612557.99158.19
60min1180362-18036266.99367.532.9167.2767.822.90
2179941-17994166.83767.12
3187755-18775569.73970.03
4172936-17293664.23564.51
5185128-18512868.76469.06
6184714-18471468.61068.90
极限1208923-20892377.60280.312.9077.9980.702.90
2220663-22066381.96382.36
3216986-21698680.59781.00
4208568-20856877.47077.85
5218075-21807581.00181.41
6224023-22402383.21183.62
氨氯地平缬沙坦片项目信息
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100651-202307对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.1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%
116.294576420457724145797084580203457999745787140.04
216.294583523458087145821970.05
单位质量响应值RSD%判断
281075.14281288.950.06数据可信
长期12月-供试品溶液-BDJL7批-缬沙坦-pH4.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1892033-89203317.68418.454.9817.6818.454.99
2911908-91190818.07818.08
3949436-94943618.82218.82
4876744-87674417.38117.38
51002605-100260519.87619.88
6951936-95193618.87218.87
10min11479873-147987329.33829.923.1229.3729.953.13
21489224-148922429.52429.55
31540399-154039930.53830.57
41441140-144114028.57028.60
51567353-156735331.07231.11
61537754-153775430.48630.52
15min11972980-197298039.11439.462.5939.1939.542.59
21959508-195950838.84738.93
32031322-203132240.27140.35
41910479-191047937.87537.95
52032731-203273140.29840.38
62036379-203637940.37140.45
20min12373792-237379247.06047.232.1847.2047.372.18
22359217-235921746.77146.92
32433349-243334948.24148.39
42294605-229460545.49045.63
52407082-240708247.72047.87
62425301-242530148.08148.23
30min12979257-297925759.06359.051.9859.2959.281.98
22960024-296002458.68258.90
33047159-304715960.40960.64
42876814-287681457.03257.25
52987853-298785359.23459.47
63021294-302129459.89760.13
45min13622658-362265871.81871.652.1172.1471.972.11
23600721-360072171.38471.70
33708707-370870773.52473.85
43480640-348064069.00369.31
53613145-361314571.63071.96
63659141-365914172.54272.87
60min14015967-401596779.61680.041.9180.0680.491.91
24038617-403861780.06580.50
34137266-413726682.02082.47
43906211-390621177.44077.87
54046585-404658580.22380.67
64080850-408085080.90281.35
极限14466104-446610488.54089.901.7589.1190.471.75
24558913-455891390.38090.95
34636727-463672791.92292.51
44417352-441735287.57388.13
54556675-455667590.33590.92
64572022-457202290.63991.22
氨氯地平缬沙坦片项目信息
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%
114.392496072496642493182497312492092495060.10
214.362493152490862492000.07
单位质量响应值RSD%判断
17338.8517353.760.07数据可信
长期12月-供试品溶液-BDJL7批-氨氯地平-pH4.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min115601-156015.8306.5711.775.836.5811.77
215387-153875.7505.75
317658-176586.5996.60
417811-178116.6566.66
521113-211137.8907.89
617973-179736.7176.72
10min138428-3842814.36114.743.7414.3714.753.75
238043-3804314.21714.23
340678-4067815.20215.21
441331-4133115.44615.46
540239-4023915.03815.05
637977-3797714.19214.20
15min162742-6274223.44723.762.8523.4823.802.86
263483-6348323.72423.76
363178-6317823.61023.65
466981-6698125.03225.07
563504-6350423.73223.77
661596-6159623.01923.05
20min183141-8314131.07131.882.6331.1431.952.63
285921-8592132.11032.18
385673-8567332.01732.09
487569-8756932.72632.80
587396-8739632.66132.74
682092-8209230.67930.75
30min1118864-11886444.42144.812.8644.5544.942.85
2120130-12013044.89445.02
3121592-12159245.44045.57
4124908-12490846.68046.81
5119400-11940044.62144.75
6114506-11450642.79242.92
45min1163886-16388661.24660.332.5961.4460.532.58
2163183-16318360.98361.18
3163264-16326461.01461.22
4164851-16485161.60761.82
5159672-15967259.67159.88
6153712-15371257.44457.64
60min1191531-19153171.57771.252.0971.8871.562.09
2192023-19202371.76172.06
3193008-19300872.12972.44
4195235-19523572.96273.28
5188051-18805170.27770.58
6184110-18411068.80469.10
极限1227755-22775585.11584.082.3385.5384.502.33
2227224-22722484.91685.34
3225108-22510884.12584.55
4231576-23157686.54386.98
5221442-22144282.75583.18
6216741-21674180.99981.40
氨氯地平缬沙坦片项目信息
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100651-202307对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.1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%
116.294577713458015745784714576168457419345773400.05
216.294581832458061845812250.02
单位质量响应值RSD%判断
280990.79281229.280.06数据可信
长期12月-供试品溶液-BDJL7批-缬沙坦-pH4.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1904774-90477417.94218.461.8117.9418.461.81
2924409-92440918.33118.33
3928226-92822618.40718.41
4955028-95502818.93818.94
5932849-93284918.49818.50
6940553-94055318.65118.65
10min11533578-153357830.41130.861.8230.4430.881.81
21559955-155995530.93430.96
31556208-155620830.85930.89
41603801-160380131.80331.83
51560813-156081330.95130.98
61522011-152201130.18130.21
15min12058917-205891740.82841.142.0840.9141.232.08
22087525-208752541.39541.48
32065491-206549140.95841.04
42148500-214850042.60442.69
52071948-207194841.08641.17
62017024-201702439.99740.08
20min12477848-247784849.13549.322.0949.2849.472.09
22516257-251625749.89750.05
32483562-248356249.24949.40
42562846-256284650.82150.98
52476525-247652549.10949.26
62405365-240536547.69847.85
30min13098856-309885661.45061.572.3061.6861.802.30
23144046-314404662.34662.58
33107461-310746161.62161.85
43206680-320668063.58863.83
53082185-308218561.11961.35
62991006-299100659.31159.54
45min13732610-373261074.01773.942.3074.3574.282.30
23773340-377334074.82575.16
33738067-373806774.12574.46
43850436-385043676.35476.70
53682367-368236773.02173.36
63596264-359626471.31371.64
60min14149131-414913182.27782.262.1982.7382.722.19
24190439-419043983.09683.56
34153404-415340482.36182.82
44286892-428689285.00985.48
54089122-408912281.08781.54
64020086-402008679.71880.16
极限14609986-460998691.41591.582.3292.0192.172.32
24657927-465792792.36692.97
34621534-462153491.64492.24
44795257-479525795.08995.70
54540223-454022390.03290.62
64483722-448372288.91289.49
氨氯地平缬沙坦片项目信息
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%
114.392494632493692492972494182496292494350.05
214.362492362494222493290.06
单位质量响应值RSD%判断
17333.9117362.740.12数据可信
长期12月-供试品溶液-BDJL7批-氨氯地平-pH2.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min199909-9990937.33339.8411.4937.3339.8411.49
2120152-12015244.89744.90
391320-9132034.12334.12
4116373-11637343.48543.48
5115744-11574443.25043.25
696193-9619335.94435.94
10min1138048-13804851.58455.136.7051.6555.206.70
2157531-15753158.86458.94
3137311-13731151.30951.37
4157218-15721858.74758.82
5154607-15460757.77257.84
6140492-14049252.49752.56
15min1147000-14700054.92960.556.6755.0860.706.67
2173652-17365264.88865.06
3154287-15428757.65257.79
4172249-17224964.36464.53
5167860-16786062.72462.89
6157149-15714958.72258.87
20min1160646-16064660.02864.425.4560.2764.685.46
2182033-18203368.02068.30
3163868-16386861.23261.47
4182058-18205868.02968.31
5177550-17755066.34566.62
6168206-16820662.85363.10
30min1172815-17281564.57569.365.1364.9269.735.14
2195583-19558373.08373.48
3178750-17875066.79367.13
4195143-19514372.91973.31
5190753-19075371.27871.66
6180660-18066067.50767.86
45min1181458-18145867.80573.535.3568.2574.025.36
2207342-20734277.47777.99
3190161-19016171.05771.51
4207707-20770777.61378.13
5201677-20167775.36075.86
6192394-19239471.89172.35
60min1189943-18994370.97676.564.7871.5477.164.79
2215040-21504080.35481.00
3199220-19922074.44275.01
4214951-21495180.32080.96
5208167-20816777.78578.41
6201975-20197575.47276.05
极限1202668-20266875.73180.404.1376.4181.144.15
2224042-22404283.71784.50
3209618-20961878.32879.02
4225121-22512184.12184.90
5218639-21863981.69882.46
6210944-21094478.82379.53
氨氯地平缬沙坦片项目信息
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100651-202307对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.1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%
116.294574361457595845762314576388457570745757290.02
216.294583668458574645847070.04
单位质量响应值RSD%判断
280891.90281443.030.14数据可信
长期12月-供试品溶液-BDJL7批-缬沙坦-pH2.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1179140-1791403.5523.7210.183.553.7210.18
2205347-2053474.0714.07
3164860-1648603.2683.27
4206229-2062294.0894.09
5201472-2014723.9943.99
6168212-1682123.3353.33
10min1372991-3729917.3958.228.007.408.228.01
2449058-4490588.9038.91
3386018-3860187.6537.66
4441257-4412578.7488.76
5440970-4409708.7438.75
6396145-3961457.8547.86
15min1525928-52592810.42712.379.1110.4512.399.10
2673975-67397513.36213.38
3603009-60300911.95511.97
4664477-66447713.17413.20
5666028-66602813.20513.23
6610422-61042212.10212.12
20min1665509-66550913.19416.129.5813.2316.169.58
2868775-86877517.22417.27
3791028-79102815.68315.72
4864736-86473617.14417.19
5857731-85773117.00517.05
6829676-82967616.44916.49
30min1887587-88758717.59722.1110.5817.6522.1710.59
21200708-120070823.80523.88
31115768-111576822.12122.19
41197849-119784923.74823.82
51174983-117498323.29523.37
61112942-111294222.06522.13
45min11177515-117751523.34529.1710.3023.4329.2810.30
21574724-157472431.22031.33
31475018-147501829.24329.34
41584759-158475931.41931.53
51541618-154161830.56430.67
61475346-147534629.25029.35
60min11412297-141229728.00034.709.8528.1334.859.84
21864773-186477336.97137.13
31769614-176961435.08435.23
41874411-187441137.16237.33
51822397-182239736.13136.29
61758169-175816934.85735.01
极限11794693-179469335.58142.928.7635.7543.138.76
22284699-228469945.29645.52
32197034-219703443.55843.77
42308717-230871745.77246.00
52244247-224424744.49444.72
62159647-215964742.81743.03
氨氯地平缬沙坦片项目信息
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%
114.392501852496592495402496232496672497350.11
214.362505752500542503140.15
单位质量响应值RSD%判断
17354.7617431.340.32数据可信
长期12月-供试品溶液-BDJL7批-氨氯地平-pH2.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1108557-10855740.46039.163.6340.4639.163.63
2101523-10152337.83937.84
3110577-11057741.21341.21
4101505-10150537.83237.83
5105316-10531639.25239.25
6102866-10286638.33938.34
10min1150292-15029256.01554.042.7856.0854.112.78
2140360-14036052.31352.38
3149054-14905455.55455.62
4141583-14158352.76952.83
5145520-14552054.23754.30
6143206-14320653.37453.44
15min1165473-16547361.67360.253.2161.8360.403.21
2155745-15574558.04858.20
3169804-16980463.28763.45
4157994-15799458.88659.04
5161456-16145660.17660.33
6159405-15940559.41259.56
20min1175038-17503865.23863.812.8865.5064.062.88
2165590-16559061.71761.96
3178671-17867166.59266.86
4167420-16742062.39962.65
5171550-17155063.93864.19
6168985-16898562.98263.23
30min1187750-18775069.97668.583.0370.3568.943.03
2177070-17707065.99666.35
3192598-19259871.78372.16
4180387-18038767.23267.58
5184581-18458168.79569.16
6181576-18157667.67568.03
45min1200307-20030774.65673.072.6875.1573.542.69
2189014-18901470.44770.91
3203414-20341475.81476.31
4192702-19270271.82272.29
5196842-19684273.36573.84
6193995-19399572.30472.77
60min1207511-20751177.34175.922.5377.9576.522.53
2197093-19709373.45874.04
3211530-21153078.83979.46
4201043-20104374.93075.52
5203732-20373275.93376.53
6201257-20125775.01075.60
极限1216871-21687180.83079.392.6781.5780.112.67
2205909-20590976.74477.44
3221188-22118882.43983.19
4208102-20810277.56178.27
5214492-21449279.94380.67
6211478-21147878.82079.53
氨氯地平缬沙坦片项目信息
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100651-202307对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.1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%
116.294591338459274545932234588749458865545909420.05
216.294610746460918246099640.03
单位质量响应值RSD%判断
281825.78282993.490.30数据可信
长期12月-供试品溶液-BDJL7批-缬沙坦-pH2.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1190969-1909693.7693.596.743.773.596.72
2175019-1750193.4553.45
3174754-1747543.4493.45
4176810-1768103.4903.49
5202385-2023853.9953.99
6170779-1707793.3713.37
10min1419271-4192718.2768.279.338.288.289.31
2392169-3921697.7417.75
3483771-4837719.5499.55
4391524-3915247.7287.73
5444458-4444588.7738.78
6382694-3826947.5547.56
15min1624349-62434912.32412.174.8912.3412.194.87
2598137-59813711.80611.83
3624532-62453212.32712.35
4597240-59724011.78911.81
5668854-66885413.20213.22
6585586-58558611.55911.58
20min1804821-80482115.88615.854.4515.9315.904.46
2784200-78420015.47915.52
3822891-82289116.24316.29
4778363-77836315.36415.40
5863239-86323917.03917.08
6765817-76581715.11615.15
30min11106292-110629221.83721.944.1421.9022.004.14
21084670-108467021.41021.47
31148030-114803022.66122.73
41076661-107666121.25221.32
51185030-118503023.39123.46
61068275-106827521.08621.15
45min11450961-145096128.64029.003.4928.7429.103.49
21430277-143027728.23228.33
31514476-151447629.89430.00
41440484-144048428.43328.53
51551054-155105430.61630.73
61428583-142858328.19828.30
60min11707798-170779833.71034.453.1633.8634.603.17
21711182-171118233.77733.92
31804215-180421535.61335.77
41715905-171590533.87034.02
51827126-182712636.06536.23
61705630-170563033.66733.81
极限12098551-209855141.42342.482.9141.6342.682.92
22104905-210490541.54841.75
32222611-222261143.87144.09
42126419-212641941.97342.18
52240163-224016344.21844.44
62118827-211882741.82342.02
氨氯地平缬沙坦片项目信息
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%
114.392495582494612495822497152497792496190.06
214.362503212507282505240.12
单位质量响应值RSD%判断
17346.7017445.960.41数据可信
长期12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%
5min188366-8836632.92933.062.3032.9333.062.30
287273-8727332.52132.52
388405-8840532.94332.94
492054-9205434.30334.30
589894-8989433.49833.50
686287-8628732.15432.15
10min1162267-16226760.46759.621.6260.5259.681.61
2158806-15880659.17759.23
3156060-15606058.15458.21
4159543-15954359.45259.51
5163300-16330060.85260.91
6160026-16002659.63259.69
15min1196612-19661273.26573.811.9773.4273.961.97
2197936-19793673.75973.91
3192323-19232371.66771.82
4196614-19661473.26673.42
5202436-20243675.43675.59
6202480-20248075.45275.61
20min1205632-20563276.62779.612.8476.9079.882.83
2214642-21464279.98480.26
3221821-22182182.65982.93
4217666-21766681.11181.39
5214258-21425879.84180.12
6207744-20774477.41477.69
30min1222790-22279083.02085.332.5583.4385.742.54
2227007-22700784.59285.00
3234857-23485787.51787.93
4237474-23747488.49288.91
5226893-22689384.54984.97
6224890-22489083.80384.21
45min1232934-23293486.80087.452.8187.3488.012.80
2232893-23289386.78587.34
3242479-24247990.35790.91
4242372-24237290.31790.88
5231896-23189686.41486.97
6225567-22556784.05584.60
60min1239061-23906189.08488.941.6189.7789.641.61
2235952-23595287.92588.62
3237003-23700388.31789.02
4245850-24585091.61392.33
5238906-23890689.02689.73
6235220-23522087.65288.34
极限1246428-24642891.82991.342.6192.6792.182.59
2240188-24018889.50490.34
3249679-24967993.04093.89
4254983-25498395.01795.88
5239947-23994789.41490.26
6239407-23940789.21390.05
氨氯地平缬沙坦片项目信息
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100651-202307对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.1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%
116.294603857460155346024564600653460177646020590.03
216.294621777462692946243530.08
单位质量响应值RSD%判断
282508.23283876.800.35数据可信
长期12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%
5min13984992-398499278.44179.472.1178.4479.472.11
23932125-393212577.40177.40
34048932-404893279.70079.70
44171424-417142482.11182.11
54087621-408762180.46180.46
63997692-399769278.69178.69
10min15053518-505351899.47498.371.2799.6198.501.27
24989427-498942798.21398.34
34884445-488444596.14696.28
44988606-498860698.19798.33
55057983-505798399.56299.70
65011123-501112398.64098.77
15min15180544-5180544101.975101.271.12102.27101.561.12
25146110-5146110101.297101.59
35035473-503547399.11999.41
45136059-5136059101.099101.40
55189490-5189490102.151102.45
65179803-5179803101.960102.26
20min15087162-5087162100.137101.561.67100.60102.021.66
25189676-5189676102.154102.62
35198442-5198442102.327102.79
45282918-5282918103.990104.46
55156429-5156429101.500101.97
65041165-504116599.23199.70
30min15064070-506407099.682101.561.91100.32102.201.91
25193988-5193988102.239102.87
35200703-5200703102.371103.00
45311083-5311083104.544105.19
55143570-5143570101.247101.89
65044317-504431799.29399.92
45min15065289-506528999.706101.361.75100.51102.161.74
25174759-5174759101.861102.66
35187963-5187963102.121102.92
45285506-5285506104.041104.86
55143508-5143508101.246102.05
65037665-503766599.16299.96
60min15087985-5087985100.153101.231.74101.12102.201.74
25153396-5153396101.440102.41
35179528-5179528101.955102.92
45285351-5285351104.038105.03
55130036-5130036100.980101.96
65020356-502035698.82299.78
极限15092557-5092557100.243101.101.69101.38102.241.68
25136231-5136231101.102102.24
35161350-5161350101.597102.74
45285548-5285548104.042105.20
55114338-5114338100.671101.82
65026384-502638498.940100.07
氨氯地平缬沙坦片项目信息
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%
114.392496942500332500012502912503842500810.11
214.362506812507652507230.03
单位质量响应值RSD%判断
17378.8017459.820.33数据可信
长期12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%
5min190354-9035433.62533.172.4133.6233.162.41
288436-8843632.91132.91
387496-8749632.56132.56
489244-8924433.21233.21
592591-9259134.45734.46
686613-8661332.23332.23
10min1161948-16194860.26859.691.7160.3259.741.71
2158976-15897659.16259.22
3156304-15630458.16858.22
4160129-16012959.59259.65
5164429-16442961.19261.25
6160563-16056359.75359.81
15min1197559-19755973.52173.911.8573.6874.061.85
2197520-19752073.50673.66
3193284-19328471.93072.08
4197755-19775573.59473.75
5203655-20365575.79075.95
6201845-20184575.11675.27
20min1214428-21442879.79980.252.2980.0880.532.29
2213630-21363079.50279.78
3208412-20841277.56077.83
4215067-21506780.03780.31
5220073-22007381.90082.19
6222268-22226882.71682.99
30min1227597-22759784.70085.371.9685.1185.791.96
2225541-22554183.93484.34
3226673-22667384.35684.76
4228124-22812484.89685.31
5230630-23063085.82886.25
6237900-23790088.53488.95
45min1233816-23381687.01486.644.4487.5787.204.42
2231111-23111186.00786.56
3214198-21419879.71380.25
4233214-23321486.79087.34
5241186-24118689.75790.32
6243414-24341490.58691.15
60min1236247-23624787.91989.502.0188.6290.202.00
2244535-24453591.00391.69
3238070-23807088.59789.27
4239318-23931889.06189.76
5248216-24821692.37393.09
6236627-23662788.06088.77
极限1243163-24316390.49291.732.0791.3492.582.06
2250500-25050093.22394.07
3241117-24111789.73190.55
4241590-24159089.90790.75
5252525-25252593.97694.85
6250063-25006393.06093.92
氨氯地平缬沙坦片项目信息
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100651-202307对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.1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%
116.294569644457354745790244580527458203045769540.12
216.294597730460125145994900.06
单位质量响应值RSD%判断
280967.10282350.520.35数据可信
长期12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%
5min14089750-408975080.94279.922.1180.9479.922.11
23979217-397921778.75478.75
33929792-392979277.77677.78
44065096-406509680.45480.45
54164765-416476582.42682.43
63998975-399897579.14579.15
10min15033689-503368999.62498.731.2999.7698.871.29
24973766-497376698.43898.57
34878156-487815696.54596.67
44973972-497397298.44298.58
55060990-5060990100.164100.30
65011999-501199999.19499.33
15min15176871-5176871102.457101.561.16102.76101.861.16
25109852-5109852101.131101.43
35030723-503072399.56599.86
45131278-5131278101.555101.85
55200088-5200088102.917103.22
65139712-5139712101.722102.02
20min15164627-5164627102.215101.901.27102.69102.371.27
25118698-5118698101.306101.77
35035833-503583399.666100.12
45159523-5159523102.114102.58
55222947-5222947103.369103.85
65190840-5190840102.734103.20
30min15184173-5184173102.602101.981.18103.24102.621.17
25134961-5134961101.628102.26
35043533-504353399.818100.44
45152060-5152060101.966102.60
55211161-5211161103.136103.78
65191935-5191935102.755103.39
45min15176705-5176705102.454101.881.16103.27102.691.16
25133464-5133464101.598102.40
35040580-504058099.760100.55
45138540-5138540101.699102.51
55203815-5203815102.991103.81
65192960-5192960102.776103.58
60min15140043-5140043101.728101.470.99102.71102.450.99
25121220-5121220101.356102.33
35035397-503539799.657100.61
45129259-5129259101.515102.49
55187042-5187042102.659103.65
65148955-5148955101.905102.89
极限15150732-5150732101.940101.430.91103.09102.580.91
25109251-5109251101.119102.26
35048503-504850399.917101.04
45114682-5114682101.226102.37
55183665-5183665102.592103.75
65143379-5143379101.794102.94
点击查看处理图标(人工保存)
 
原始图谱下载图谱(谢鑫慧 于 2024-12-26 15:09:47 完成)
生成报告数据部分下载报告(谢鑫慧 于 2024-12-26 15:11:04 完成)
Current page cost:109 ms