苯磺酸左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%
113.972420352419662417892419072415562418510.08
213.942421622422982422300.04
单位质量响应值RSD%判断
17312.1717376.610.27数据可信
长期12月-供试品溶液-2023112221批-苯磺酸左氨氯地平-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%
5min182622-8262230.88030.153.4930.8830.153.49
280525-8052530.09730.10
382174-8217430.71330.71
483807-8380731.32331.32
576264-7626428.50428.50
678648-7864829.39529.39
10min1128224-12822447.92448.051.3247.9848.101.32
2127712-12771247.73347.78
3130760-13076048.87248.92
4130214-13021448.66848.72
5128369-12836947.97848.03
6126163-12616347.15447.20
15min1153495-15349557.36958.131.6057.5058.261.60
2158145-15814559.10759.24
3157354-15735458.81258.94
4157772-15777258.96859.10
5153950-15395057.53957.67
6152518-15251857.00457.13
20min1175558-17555865.61565.171.0265.8465.401.02
2175158-17515865.46665.69
3176737-17673766.05666.29
4172740-17274064.56264.79
5173877-17387764.98765.21
6172123-17212364.33264.55
30min1192074-19207471.78872.522.1072.1272.862.09
2193991-19399172.50572.84
3200845-20084575.06775.41
4195696-19569673.14273.48
5192882-19288272.09072.42
6188750-18875070.54670.88
45min1202081-20208175.52977.101.8175.9877.561.80
2209336-20933678.24078.70
3211926-21192679.20879.67
4206373-20637377.13377.59
5204170-20417076.30976.76
6203857-20385776.19276.64
60min1208274-20827477.84379.541.9378.4380.121.92
2213923-21392379.95580.54
3219887-21988782.18482.78
4209847-20984778.43179.02
5213610-21361079.83880.42
6211295-21129578.97279.55
极限1235391-23539187.97890.191.9288.6990.911.90
2241468-24146890.25090.97
3246845-24684592.25992.99
4236777-23677788.49689.22
5241595-24159590.29791.01
6245825-24582591.87892.58
苯磺酸左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%
116.324820973482092848187914815954480986848173030.10
216.384837013484219948396060.08
单位质量响应值RSD%判断
295177.88295458.240.07数据可信
长期12月-供试品溶液-2023112221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%
5min13434784-343478464.83465.502.0364.8365.502.03
23466286-346628665.42965.43
33542330-354233066.86466.86
43563277-356327767.26067.26
53378186-337818663.76663.77
63436641-343664164.86964.87
10min14092461-409246177.24978.361.9377.3678.471.93
24192705-419270579.14179.25
34264620-426462080.49880.61
44203412-420341279.34379.46
54078620-407862076.98777.09
64075073-407507376.92077.03
15min14377343-437734382.62683.772.2982.8684.012.29
24509369-450936985.11885.36
34585192-458519286.54986.79
44476142-447614284.49184.74
54353256-435325682.17182.41
64326421-432642181.66581.90
20min14576326-457632686.38286.582.4186.7686.962.40
24658857-465885787.94088.32
34744798-474479889.56289.95
44606490-460649086.95187.34
54497052-449705284.88685.26
64438497-443849783.78084.15
30min14592774-459277486.69288.532.6687.2189.062.65
24779770-477977090.22290.75
34876724-487672492.05292.59
44725349-472534989.19589.73
54603640-460364086.89887.41
64562714-456271486.12586.64
45min14658639-465863987.93690.182.4788.6090.852.47
24860584-486058491.74892.43
34952085-495208593.47594.17
44813800-481380090.86591.54
54715790-471579089.01489.67
64664946-466494688.05588.71
60min14714553-471455388.99190.922.2489.8091.742.24
24852332-485233291.59292.42
34998256-499825694.34695.19
44852217-485221791.59092.42
54760778-476077889.86490.67
64721180-472118089.11689.92
极限15064139-506413995.59098.111.6996.5599.081.69
25228080-522808098.68499.67
35292725-529272599.905100.91
45248634-524863499.072100.06
55116534-511653496.57997.53
65235028-523502898.81699.77
苯磺酸左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%
113.972412202411882413722417212415292414060.10
213.942429492425942427720.11
单位质量响应值RSD%判断
17280.3117415.490.56数据可信
长期12月-供试品溶液-2023112221批-苯磺酸左氨氯地平-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%
5min177619-7761929.00528.096.5629.0028.096.56
278108-7810829.18829.19
367252-6725225.13125.13
477228-7722828.85928.86
570962-7096226.51726.52
679880-7988029.85029.85
10min1127224-12722447.54145.643.6447.5945.693.64
2126651-12665147.32747.38
3117634-11763443.95844.00
4118716-11871644.36244.41
5118207-11820744.17244.22
6124379-12437946.47846.53
15min1160907-16090760.12856.804.6460.2656.934.64
2159052-15905259.43559.56
3145617-14561754.41554.53
4149141-14914155.73155.85
5143757-14375753.71953.84
6153613-15361357.40257.53
20min1180889-18088967.59565.363.4367.8265.583.42
2179473-17947367.06667.29
3169182-16918263.22063.43
4166952-16695262.38762.60
5179757-17975767.17267.38
6173246-17324664.73964.96
30min1204340-20434076.35872.133.9176.7072.463.91
2199492-19949274.54774.89
3193575-19357572.33672.65
4187979-18797970.24470.56
5186841-18684169.81970.14
6185907-18590769.47069.80
45min1217706-21770681.35377.563.4281.8278.013.41
2211988-21198879.21679.68
3211334-21133478.97279.40
4201660-20166075.35775.79
5202186-20218675.55375.99
6200463-20046374.91075.36
60min1228521-22852185.39480.623.4886.0081.193.48
2214825-21482580.27680.87
3219901-21990182.17382.74
4207608-20760877.57978.14
5212860-21286079.54280.10
6210681-21068178.72879.30
极限1251187-25118793.86491.622.3594.6192.332.34
2247145-24714592.35493.08
3250800-25080093.72094.42
4241104-24110490.09690.79
5244433-24443391.34092.03
6236447-23644788.35689.06
苯磺酸左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%
116.324823174483041648328554834875483496048312560.11
216.384856284485392548551040.04
单位质量响应值RSD%判断
296032.84296404.400.09数据可信
长期12月-供试品溶液-2023112221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%
5min13377213-337721363.55461.794.4963.5561.794.49
23383853-338385363.67963.68
33094495-309449558.23458.23
43292093-329209361.95261.95
53112148-311214858.56658.57
63440163-344016364.73964.74
10min14274693-427469380.44375.974.3480.5576.074.34
24152224-415222478.13878.24
33841604-384160472.29372.39
43942795-394279574.19774.30
53874576-387457672.91473.01
64136691-413669177.84677.95
15min14646472-464647287.43982.353.9387.6882.583.94
24481836-448183684.34184.58
34255066-425506680.07480.29
44263568-426356880.23480.46
54190693-419069378.86279.08
64419289-441928983.16483.40
20min14817725-481772590.66286.893.6291.0587.263.61
24635999-463599987.24287.62
34466222-446622284.04784.40
44426593-442659383.30283.66
54805611-480561190.43490.78
64551083-455108385.64486.02
30min14972214-497221493.56988.293.3694.1188.803.36
24761750-476175089.60990.13
34641320-464132087.34287.83
44587692-458769286.33386.83
54530366-453036685.25485.76
64657180-465718087.64188.16
45min15089910-508991095.78490.313.2396.4890.973.23
24846772-484677291.20991.88
34752931-475293189.44390.08
44703554-470355488.51489.16
54668439-466843987.85388.50
64732321-473232189.05589.72
60min15154224-515422496.99591.443.2097.8592.253.20
24896984-489698492.15492.98
34830627-483062790.90591.69
44764412-476441289.65990.45
54741063-474106389.21990.01
64766578-476657889.70090.51
极限15399861-5399861101.61798.911.94102.6399.871.94
25279286-527928699.348100.33
35301106-530110699.759100.70
45202266-520226697.89998.84
55256894-525689498.92799.87
65096356-509635695.90696.87
苯磺酸左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%
113.972407752402702401222399222400182402210.14
213.942403782415472409620.35
单位质量响应值RSD%判断
17195.4917285.650.37数据可信
长期12月-供试品溶液-2023112421批-苯磺酸左氨氯地平-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%
5min168712-6871225.83627.879.7325.8427.879.73
270540-7054026.52326.52
382361-8236130.96830.97
478227-7822729.41429.41
580386-8038630.22630.23
664452-6445224.23424.23
10min1110020-11002041.36842.788.9841.4142.838.97
2112531-11253142.31242.36
3126211-12621147.45647.51
4115407-11540743.39443.44
5121671-12167145.74945.80
696876-9687636.42636.47
15min1143404-14340453.92153.678.3154.0353.788.31
2148573-14857355.86455.98
3155562-15556258.49258.62
4145500-14550054.70954.83
5142892-14289253.72853.85
6120468-12046845.29745.40
20min1166500-16650062.60559.937.9462.8160.147.94
2163781-16378161.58361.79
3170827-17082764.23264.46
4163709-16370961.55661.77
5155978-15597858.64958.86
6135524-13552450.95851.13
30min1200468-20046875.37769.867.9275.6870.177.92
2196116-19611673.74174.05
3193353-19335372.70273.04
4183556-18355669.01869.33
5181592-18159268.28068.59
6159713-15971360.05360.31
45min1225958-22595884.96276.827.2885.3977.247.26
2214236-21423680.55480.99
3206920-20692077.80378.26
4196026-19602673.70774.14
5199220-19922074.90875.34
6183448-18344868.97869.34
60min1236261-23626188.83680.246.9589.4180.796.94
2224737-22473784.50285.07
3212615-21261579.94480.53
4208141-20814178.26278.82
5202515-20251576.14776.70
6196070-19607073.72374.20
极限1237119-23711989.15889.191.3289.8889.871.27
2234022-23402287.99488.70
3236163-23616388.79989.52
4238025-23802589.49990.18
5234992-23499288.35889.04
6242860-24286091.31791.92
苯磺酸左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%
116.324825370481547848133794814978481392548166260.11
216.384831987486349448477400.46
单位质量响应值RSD%判断
295136.40295954.820.20数据可信
长期12月-供试品溶液-2023112421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%
5min13043490-304349057.40460.409.4257.4060.409.42
23045889-304588957.45057.45
33534268-353426866.66166.66
43350852-335085263.20263.20
53480398-348039865.64565.64
62760509-276050952.06752.07
10min13746455-374645570.66374.137.9770.7674.247.98
24118989-411898977.69077.79
34225383-422538379.69679.81
43994424-399442475.34075.45
54112060-411206077.55977.67
63385646-338564663.85863.94
15min14331383-433138381.69681.317.2781.9181.537.27
24637433-463743387.46887.69
34477248-447724884.44784.69
44307354-430735481.24281.47
54391472-439147282.82983.07
63720255-372025570.16970.36
20min14737596-473759689.35785.417.1489.7185.777.14
24879341-487934192.03192.40
34601825-460182586.79787.18
44471210-447121084.33384.70
54541084-454108485.65186.03
63939515-393951574.30574.61
30min15080135-508013595.81889.507.1096.3290.017.09
25131371-513137196.78597.31
34700264-470026488.65389.18
44640886-464088687.53388.04
54715031-471503188.93289.45
64204841-420484179.30979.74
45min15162267-516226797.36791.575.9098.0392.225.89
25206098-520609898.19498.88
34756817-475681789.72090.40
44741985-474198589.44090.09
54817620-481762090.86791.53
64445587-444558783.85084.42
60min15177747-517774797.65992.345.1498.4893.145.14
25216522-521652298.39199.24
34763135-476313589.83990.67
44795077-479507790.44291.24
54846708-484670891.41592.23
64574041-457404186.27386.98
极限15170734-517073497.52798.521.2698.5199.471.23
25292077-529207799.816100.83
35133150-513315096.81897.79
45222410-522241098.50299.45
55220932-522093298.47499.45
65299895-529989599.963100.81
苯磺酸左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%
113.972411282407732413642412772411132411310.10
213.942414222413872414040.02
单位质量响应值RSD%判断
17260.6317317.360.24数据可信
长期12月-供试品溶液-2023112421批-苯磺酸左氨氯地平-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%
5min185448-8544832.03929.447.3632.0429.447.37
280569-8056930.20930.21
370288-7028826.35526.35
476430-7643028.65828.66
583768-8376831.40931.41
674638-7463827.98627.99
10min1131024-13102449.12845.595.5349.1845.645.53
2126906-12690647.58447.63
3116907-11690743.83443.88
4121906-12190645.70945.76
5120398-12039845.14345.20
6112358-11235842.12942.18
15min1156004-15600458.49455.983.4558.6356.103.45
2152703-15270357.25657.39
3152302-15230257.10657.22
4147305-14730555.23255.36
5143213-14321353.69853.83
6144212-14421254.07254.19
20min1178544-17854466.94563.873.5067.1864.093.50
2171662-17166264.36564.59
3175888-17588865.94966.16
4166134-16613462.29262.51
5165740-16574062.14462.36
6164120-16412061.53761.74
30min1199459-19945974.78771.733.7675.1372.053.76
2190175-19017571.30671.64
3200442-20044275.15675.48
4182503-18250368.43068.75
5188703-18870370.75471.08
6186499-18649969.92870.24
45min1210848-21084879.05877.363.1279.5377.803.12
2203558-20355876.32476.78
3215685-21568580.87181.32
4197286-19728673.97374.41
5207143-20714377.66978.11
6203354-20335476.24876.67
60min1222153-22215383.29780.543.7483.9081.123.73
2213926-21392680.21280.79
3225558-22555884.57385.16
4203864-20386476.43977.00
5214142-21414280.29380.86
6209230-20923078.45179.00
极限1243552-24355291.32090.002.7692.0690.712.76
2239224-23922489.69790.41
3247976-24797692.97993.70
4228323-22832385.61086.29
5242185-24218590.80891.51
6238927-23892789.58690.27
苯磺酸左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%
116.324845711484141748515414853640485138148487380.11
216.384853136485719948551680.06
单位质量响应值RSD%判断
297104.04296408.300.17数据可信
长期12月-供试品溶液-2023112421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%
5min13594486-359448667.52063.865.1767.5263.865.16
23452821-345282164.85964.86
33074644-307464457.75557.76
43365546-336554663.22063.22
53446571-344657164.74264.74
63464753-346475365.08365.08
10min14349357-434935781.70078.072.5381.8178.172.53
24134769-413476977.66977.78
34182313-418231378.56278.66
44050657-405065776.08976.19
54084446-408444676.72476.83
64133675-413367577.64977.76
15min14603197-460319786.46884.053.2986.7284.293.28
24404047-440404782.72782.96
34699501-469950188.27788.50
44313027-431302781.01881.25
54377691-437769182.23282.47
64449465-444946583.58083.82
20min14733317-473331788.91287.233.7189.3187.613.70
24534896-453489685.18585.56
34932960-493296092.66393.04
44439896-443989683.40183.77
54591856-459185686.25586.63
64628879-462887986.95187.33
30min14858841-485884191.27090.043.8691.8190.563.85
24674603-467460387.81088.33
35112707-511270796.03996.57
44570211-457021185.84986.35
54763901-476390189.48790.00
64780794-478079489.80490.33
45min14953698-495369893.05291.743.8593.7592.413.84
24777906-477790689.75090.41
35178914-517891497.28397.97
44613967-461396786.67187.32
54886551-488655191.79192.46
64891153-489115391.87792.55
60min14996358-499635893.85492.463.6294.7093.283.61
24827104-482710490.67491.49
35191317-519131797.51698.37
44654998-465499887.44188.24
54940638-494063892.80793.63
64921086-492108692.44093.26
极限15212635-521263597.91698.291.4898.9299.271.48
25234760-523476098.33299.30
35306364-530636499.677100.69
45094648-509464895.70096.64
55245157-524515798.52799.50
65301089-530108999.578100.56
苯磺酸左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%
113.972469742469862469622469272469392469580.01
213.942473482475282474380.06
单位质量响应值RSD%判断
17677.7417750.220.29数据可信
长期12月-供试品溶液-2023112521批-苯磺酸左氨氯地平-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%
5min182449-8244930.17331.544.3130.1731.544.30
288111-8811132.24532.24
388490-8849032.38332.38
489691-8969132.82332.82
587724-8772432.10332.10
680611-8061129.50029.50
10min1124791-12479145.66847.013.6745.7247.073.67
2129671-12967147.45447.51
3130194-13019447.64547.70
4135595-13559549.62249.68
5128548-12854847.04347.10
6121971-12197144.63644.69
15min1153979-15397956.35057.643.0556.4857.783.05
2161735-16173559.18859.32
3160552-16055258.75558.89
4161864-16186459.23559.37
5156941-15694157.43457.57
6150014-15001454.89955.02
20min1170592-17059262.42964.113.2962.6564.343.29
2178871-17887165.45965.69
3180296-18029665.98066.21
4180381-18038166.01266.25
5174605-17460563.89864.13
6166380-16638060.88861.10
30min1185635-18563567.93470.193.6568.2670.523.65
2196074-19607471.75472.10
3199505-19950573.01073.35
4198530-19853072.65373.00
5186898-18689868.39668.73
6184084-18408467.36767.68
45min1197688-19768872.34574.993.3772.7875.443.37
2210410-21041077.00177.46
3212473-21247377.75678.22
4209931-20993176.82677.29
5202109-20210973.96374.41
6196811-19681172.02472.45
60min1206228-20622875.47078.723.4076.0379.303.40
2215920-21592079.01779.61
3221730-22173081.14381.74
4224811-22481182.27182.87
5213754-21375478.22578.80
6208251-20825176.21176.76
极限1232749-23274985.17688.222.7685.8688.922.76
2241046-24104688.21288.93
3245472-24547289.83290.56
4248605-24860590.97991.71
5245087-24508789.69190.39
6233392-23339285.41186.09
苯磺酸左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%
116.324769158477288047732284772174477195547718790.04
216.384783119478323347831760.01
单位质量响应值RSD%判断
292394.55292013.190.10数据可信
长期12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%
5min13401431-340143164.88966.463.7164.8966.463.71
23473142-347314266.25766.26
33652411-365241169.67769.68
43596389-359638968.60868.61
53483408-348340866.45366.45
63295468-329546862.86862.87
10min13992336-399233676.16278.843.6476.2778.953.64
24120597-412059778.60978.72
34315968-431596882.33682.45
44276497-427649781.58381.70
54153226-415322679.23179.34
63936820-393682075.10375.21
15min14264708-426470881.35883.933.4981.5984.173.49
24383352-438335283.62183.86
34577498-457749887.32587.58
44556771-455677186.93087.18
54421416-442141684.34784.59
64193472-419347279.99980.23
20min14381745-438174583.59186.313.3283.9686.703.32
24513990-451399086.11386.49
34681470-468147089.30889.71
44688467-468846789.44289.84
54555564-455556486.90787.29
64325319-432531982.51482.88
30min14503505-450350585.91388.903.3386.4289.433.33
24632283-463228388.37088.89
34817036-481703691.89592.44
44847362-484736292.47393.02
54686522-468652289.40589.93
64474963-447496385.36985.87
45min14570972-457097287.20090.323.0287.8591.003.03
24692909-469290989.52790.20
34859821-485982192.71193.41
44925240-492524093.95994.66
54767514-476751490.95091.63
64591549-459154987.59388.24
60min14600525-460052587.76491.122.9188.5691.942.92
24724049-472404990.12190.94
34878577-487857793.06993.92
44969409-496940994.80195.66
54823230-482323092.01392.84
64662354-466235488.94489.73
极限14898297-489829793.44596.842.2594.3997.822.25
25003328-500332895.44996.42
35116725-511672597.61298.62
45233858-523385899.846100.86
55112858-511285897.53898.52
65093439-509343997.16898.10
苯磺酸左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%
113.972473672474282474752473962474132474160.02
213.942481622480962481290.02
单位质量响应值RSD%判断
17710.5217799.780.36数据可信
长期12月-供试品溶液-2023112521批-苯磺酸左氨氯地平-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%
5min182260-8226030.03428.4312.5430.0328.4212.54
266693-6669324.35024.35
364154-6415423.42323.42
483907-8390730.63530.64
583666-8366630.54730.55
686447-8644731.56331.56
10min1132793-13279348.48445.099.9648.5345.139.97
2109616-10961640.02240.06
3106169-10616938.76338.80
4129090-12909047.13247.18
5129028-12902847.10947.16
6134214-13421449.00349.06
15min1159194-15919458.12355.068.4758.2555.188.48
2135968-13596849.64349.75
3132925-13292548.53248.64
4156633-15663357.18857.32
5159674-15967458.29858.43
6160444-16044458.57958.71
20min1184413-18441367.33163.116.8767.5663.336.88
2153682-15368256.11156.30
3162923-16292359.48559.67
4179540-17954065.55265.78
5177841-17784164.93165.16
6178778-17877865.27365.51
30min1210616-21061676.89872.104.3877.2472.424.39
2183804-18380467.10867.39
3200331-20033173.14273.43
4195576-19557671.40671.74
5196134-19613471.61071.94
6198407-19840772.44072.78
45min1224629-22462982.01479.284.3482.4879.724.30
2222509-22250981.24081.64
3228758-22875883.52183.93
4212883-21288377.72578.18
5206710-20671075.47275.93
6207296-20729675.68576.15
60min1238459-23845987.06384.085.4387.6784.655.37
2239367-23936787.39587.93
3246101-24610189.85390.40
4217046-21704679.24579.83
5222283-22228381.15781.74
6218411-21841179.74480.33
极限1252336-25233692.13089.982.5492.8890.692.52
2243786-24378689.00889.68
3255366-25536693.23693.93
4245428-24542889.60890.32
5243178-24317888.78689.50
6238559-23855987.10087.82
苯磺酸左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%
116.324778323477721447779934778905477977447784420.03
216.384804292480591848051050.03
单位质量响应值RSD%判断
292796.69293351.950.14数据可信
长期12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%
5min13389081-338908164.46261.1211.6964.4661.1211.69
22767418-276741852.63752.64
32701964-270196451.39251.39
43402731-340273164.72164.72
53476323-347632366.12166.12
63543927-354392767.40767.41
10min14141272-414127278.76875.028.8478.8875.138.84
23505752-350575266.68166.77
33485759-348575966.30066.39
44170449-417044979.32379.43
54153776-415377679.00679.12
64209739-420973980.07180.18
15min14478721-447872185.18781.526.8785.4381.756.88
23869168-386916873.59373.79
33946344-394634475.06175.26
44487432-448743285.35385.59
54464093-446409384.90985.15
64470029-447002985.02285.27
20min14678572-467857288.98885.784.8589.3786.154.86
24080553-408055377.61477.94
34502008-450200885.63085.95
44629868-462986888.06288.44
54598413-459841387.46387.85
64571220-457122086.94687.33
30min14836128-483612891.98590.004.7492.5190.504.72
24367681-436768183.07583.53
35050703-505070396.06696.53
44759668-475966890.53191.06
54716211-471621189.70490.23
64660349-466034988.64289.17
45min14931230-493123093.79493.504.1694.4894.164.10
24950666-495066694.16394.75
35288415-5288415100.588101.21
44838053-483805392.02292.70
54777029-477702990.86191.54
64708896-470889689.56590.25
60min14959408-495940894.33094.154.1795.1794.964.12
25042818-504281895.91696.66
35306366-5306366100.929101.72
44855176-485517692.34793.18
54801543-480154391.32792.16
64734934-473493490.06090.89
极限15117021-511702197.32897.192.3198.3298.162.29
25052281-505228196.09697.00
35314014-5314014101.074102.03
45159191-515919198.13099.12
55034867-503486795.76596.75
64982242-498224294.76495.74
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