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%
113.872467362465742463802461472459882463650.13
213.942431372431002431180.02
单位质量响应值RSD%判断
17762.4417440.321.30数据可信
长期3月-供试品溶液-2023112221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%
5min184780-8478031.22731.6012.1531.2331.6012.15
289189-8918932.85132.85
365400-6540024.08924.09
492894-9289434.21534.22
589865-8986533.10033.10
692678-9267834.13634.14
10min1138737-13873751.10150.425.0651.1550.475.07
2136522-13652250.28550.34
3123501-12350145.48945.53
4139343-13934351.32451.38
5143387-14338752.81352.87
6139773-13977351.48251.54
15min1164322-16432260.52460.693.0960.6660.833.10
2163643-16364360.27460.41
3156616-15661657.68657.80
4164789-16478960.69660.84
5172268-17226863.45163.59
6167069-16706961.53661.68
20min1188531-18853169.44168.592.4669.6868.832.47
2184090-18409067.80568.04
3179046-17904665.94766.16
4185942-18594268.48768.73
5192727-19272770.98671.24
6186987-18698768.87269.12
30min1214600-21460079.04376.692.3279.4077.042.32
2203924-20392475.11175.46
3204466-20446675.31075.63
4205905-20590575.84076.20
5214062-21406278.84579.21
6206271-20627175.97576.34
45min1230577-23057784.92881.463.1685.4181.943.14
2217554-21755480.13180.61
3218622-21862280.52480.97
4211236-21123677.80478.29
5227135-22713583.66084.16
6221928-22192881.74282.23
60min1236774-23677487.21083.862.5187.8484.472.50
2220840-22084081.34181.95
3225859-22585983.19083.77
4224247-22424782.59683.21
5231748-23174885.35986.00
6226534-22653483.43884.06
极限1252018-25201892.82591.821.5893.6092.581.57
2247870-24787091.29792.04
3253132-25313293.23593.96
4242583-24258389.35090.10
5251938-25193892.79593.58
6248170-24817091.40892.17
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%
116.014890233488569148815044879119487649748826090.12
216.004785061478449347847770.01
单位质量响应值RSD%判断
304972.45299048.561.39数据可信
长期3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%
5min13610213-361021366.64265.527.0166.6465.527.01
23596043-359604366.38166.38
33048795-304879556.27956.28
43695471-369547168.21668.22
53690922-369092268.13268.13
63654886-365488667.46767.47
10min14449553-444955382.13680.642.0682.2580.752.06
24336367-433636780.04680.16
34221867-422186777.93378.03
44369230-436923080.65380.77
54473853-447385382.58482.70
64358994-435899480.46480.58
15min14780746-478074688.24985.981.8488.5086.221.85
24608845-460884585.07685.32
34562522-456252284.22184.44
44619453-461945385.27285.52
54745763-474576387.60487.85
64628342-462834285.43685.68
20min14906083-490608390.56388.701.6190.9689.081.60
24728679-472867987.28887.67
34825452-482545289.07589.44
44734871-473487187.40387.79
54880080-488008090.08390.48
64754455-475445587.76488.15
30min15021043-502104392.68590.741.5893.2391.281.58
24848575-484857589.50190.03
34900039-490003990.45190.96
44842425-484242589.38889.92
55002848-500284892.34992.90
64879552-487955290.07390.61
45min15060411-506041193.41291.891.4294.1192.571.42
24912421-491242190.68091.36
34986086-498608692.04092.70
44894443-489444390.34891.03
55057021-505702193.34994.05
64957154-495715491.50692.19
60min15069387-506938793.57792.381.3494.4393.221.34
24943143-494314391.24792.08
35028139-502813992.81693.63
44918171-491817190.78691.62
55082720-508272093.82494.68
64986537-498653792.04892.89
极限15221786-522178696.39196.481.5597.4097.481.53
25155556-515555695.16896.15
35362400-536240098.98699.96
45156824-515682495.19296.18
55277120-527712097.41298.43
65187407-518740795.75696.75
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%
113.872509002509232507082508592510352508850.05
213.942493982492712493340.04
单位质量响应值RSD%判断
18088.3217886.230.80数据可信
长期3月-供试品溶液-2023112221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%
5min192038-9203833.17133.434.3133.1733.434.31
288464-8846431.88331.88
388242-8824231.80331.80
497035-9703534.97234.97
593413-9341333.66733.67
697426-9742635.11335.11
10min1137255-13725549.46750.131.7549.5250.181.75
2137471-13747149.54549.60
3136370-13637049.14949.20
4141919-14191951.14851.21
5141874-14187451.13251.19
6139599-13959950.31250.37
15min1164646-16464659.33960.592.1259.4860.732.12
2167025-16702560.19760.33
3163537-16353758.94059.07
4171752-17175261.90062.04
5170564-17056461.47261.61
6171228-17122861.71261.85
20min1185791-18579166.96067.472.2767.2067.712.27
2179945-17994564.85365.09
3186561-18656167.23867.47
4189314-18931468.23068.48
5192289-19228969.30269.55
6189367-18936768.24968.49
30min1203301-20330173.27173.681.3673.6274.031.36
2199379-19937971.85772.20
3205334-20533474.00474.35
4205441-20544174.04274.40
5206971-20697174.59474.95
6206204-20620474.31774.68
45min1213240-21324076.85377.961.5977.3278.441.58
2214448-21444877.28877.75
3216917-21691778.17878.65
4213043-21304376.78277.27
5221776-22177679.92980.41
6218522-21852278.75779.24
60min1220938-22093879.62779.941.9580.2380.541.94
2215207-21520777.56278.15
3226456-22645681.61682.21
4222482-22248280.18480.80
5226346-22634681.57682.19
6219414-21941479.07879.69
极限1248892-24889289.70290.601.6090.4391.341.60
2245780-24578088.58189.30
3250759-25075990.37591.11
4251468-25146890.63091.38
5257230-25723092.70793.46
6254254-25425491.63592.38
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%
116.014833232483519748310014831982483205748326940.04
216.004789855479185547908550.03
单位质量响应值RSD%判断
301854.72299428.440.58数据可信
长期3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%
5min13512518-351251865.12965.893.2565.1365.903.26
23570031-357003166.19566.20
33378770-337877062.64962.65
43544323-354432365.71865.72
53736171-373617169.27669.28
63581006-358100666.39966.40
10min14155109-415510977.04478.182.2277.1578.292.22
24238805-423880578.59578.71
34111886-411188676.24276.35
44178011-417801177.46877.58
54379213-437921381.19981.31
64236467-423646778.55278.66
15min14438205-443820582.29383.191.7982.5383.431.80
24488631-448863183.22883.47
34404104-440410481.66081.89
44443841-444384182.39782.64
54629305-462930585.83686.09
64514618-451461883.71083.95
20min14574930-457493084.82885.471.5785.2085.851.58
24589796-458979685.10485.48
34546985-454698584.31084.68
44572181-457218184.77785.15
54746712-474671288.01388.41
64628144-462814485.81586.20
30min14701456-470145687.17487.691.4887.6988.211.48
24683973-468397386.85087.37
34693224-469322487.02187.53
44692733-469273387.01287.53
54866153-486615390.22890.77
64737364-473736487.84088.36
45min14760581-476058188.27088.761.3888.9389.431.38
24725557-472555787.62188.29
34775364-477536488.54489.20
44756267-475626788.19088.85
54914411-491441191.12391.81
64791266-479126688.83989.51
60min14796921-479692188.94489.401.4389.7590.221.43
24754186-475418688.15288.96
34820345-482034589.37890.18
44788445-478844588.78789.60
54952776-495277691.83492.68
64816006-481600689.29890.12
极限15119578-511957894.92795.351.2295.8896.321.22
25093990-509399094.45295.41
35152584-515258495.53996.49
45073902-507390294.08095.04
55247521-524752197.29998.29
65168291-516829195.83096.80
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