替米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)5
对照品批号100629-202204对照品来源中检院对照品使用方法直接使用
对照品含量(%)100对照品水分(%)0对照品稀释倍数1250
标示量(mg)80供试品稀释倍数10系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.257400327413037436287434527422667421360.21
211.247283967273217278580.11
单位质量响应值RSD%判断
65967.6464756.051.32数据可信
供试品溶液-2026031621批-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%
5min158933-589338.1157.4212.298.127.4212.30
245604-456046.2806.28
350045-500456.8926.89
454471-544717.5017.50
550410-504106.9426.94
663772-637728.7828.78
10min191571-9157112.61015.2412.2812.6615.2812.24
2100961-10096113.90313.94
3115173-11517315.86015.90
4122112-12211216.81616.86
5106286-10628614.63614.67
6127776-12777617.59617.64
15min1157798-15779821.73021.394.1821.8521.524.20
2148085-14808520.39220.50
3155338-15533821.39121.52
4163573-16357322.52522.66
5147350-14735020.29120.41
6159785-15978522.00322.15
20min1181951-18195125.05624.653.8225.2924.903.83
2167981-16798123.13223.36
3183289-18328925.24025.49
4186246-18624625.64725.91
5173663-17366323.91524.15
6180979-18097924.92225.19
30min1188771-18877125.99526.221.2926.3726.601.28
2191963-19196326.43526.79
3192836-19283626.55526.94
4192913-19291326.56526.97
5187451-18745125.81326.18
6188442-18844225.95026.36
45min1196345-19634527.03826.383.4427.5626.903.43
2178366-17836624.56225.06
3193848-19384826.69427.23
4194463-19446326.77927.33
5193970-19397026.71127.22
6192298-19229826.48127.03
60min1192196-19219626.46726.341.4127.1427.021.43
2191757-19175726.40627.04
3191966-19196626.43527.12
4192182-19218226.46527.16
5186009-18600925.61526.27
6193723-19372326.67727.38
极限1190789-19078926.27326.252.5927.0927.072.56
2192086-19208626.45227.24
3194095-19409526.72827.56
4194482-19448226.78227.63
5181061-18106124.93325.73
6191260-19126026.33827.18
替米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)5
对照品批号100629-202204对照品来源中检院对照品使用方法直接使用
对照品含量(%)100对照品水分(%)0对照品稀释倍数1250
标示量(mg)80供试品稀释倍数10系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.257548567541087536527539277539407540970.07
211.247541967543227542590.02
单位质量响应值RSD%判断
67030.8467104.890.08数据可信
供试品溶液-2026031721批-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%
5min147462-474626.3697.1410.206.377.1410.18
263373-633738.5048.50
350702-507026.8046.80
451471-514716.9076.91
553830-538307.2247.22
652250-522507.0127.01
10min1111378-11137814.94614.771.9614.9814.811.95
2108756-10875614.59414.64
3109122-10912214.64314.68
4107157-10715714.38014.42
5113232-11323215.19515.24
6110562-11056214.83714.88
15min1162250-16225021.77320.424.3721.8920.544.33
2144661-14466119.41219.54
3150342-15034220.17520.29
4148609-14860919.94220.06
5148891-14889119.98020.10
6158130-15813021.22021.34
20min1179172-17917224.04423.782.5124.2824.012.48
2172453-17245323.14223.38
3184180-18418024.71624.95
4174997-17499723.48323.71
5173355-17335523.26323.50
6179018-17901824.02324.26
30min1187934-18793425.21925.583.2025.5925.953.16
2191078-19107825.64126.01
3187054-18705425.10125.47
4184164-18416424.71325.07
5201691-20169127.06527.43
6191819-19181925.74126.11
45min1189696-18969625.45625.981.5825.9726.491.55
2193625-19362525.98326.49
3197139-19713926.45526.96
4191500-19150025.69826.19
5192561-19256125.84026.36
6197247-19724726.46926.98
60min1200253-20025326.87225.622.7927.5326.282.73
2185107-18510724.84025.49
3189136-18913625.38126.04
4188459-18845925.29025.93
5188986-18898625.36026.02
6193602-19360225.98026.64
极限1185466-18546624.88825.301.4025.6926.101.36
2188203-18820325.25526.04
3192588-19258825.84426.64
4187204-18720425.12125.90
5187126-18712625.11125.91
6190710-19071025.59226.40
替米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)5
对照品批号100629-202204对照品来源中检院对照品使用方法直接使用
对照品含量(%)100对照品水分(%)0对照品稀释倍数1250
标示量(mg)80供试品稀释倍数10系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.257490107495967484457474057480637485040.12
211.247335227343847339530.09
单位质量响应值RSD%判断
66533.6965298.311.33数据可信
供试品溶液-2026031621批-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%
5min1294537-29453740.21938.377.4240.2238.377.42
2296494-29649440.48640.49
3240770-24077032.87732.88
4285746-28574639.01839.02
5290717-29071739.69739.70
6277558-27755837.90037.90
10min1456735-45673562.36763.486.6162.5963.706.61
2494190-49419067.48167.71
3414728-41472856.63156.81
4454523-45452362.06562.28
5498471-49847168.06668.29
6470719-47071964.27664.49
15min1605666-60566682.70380.865.8383.2781.435.83
2602471-60247182.26782.87
3541190-54119073.89974.40
4563249-56324976.91177.47
5638343-63834387.16587.76
6602201-60220182.23082.80
20min1639940-63994087.38389.164.2488.4190.174.24
2632826-63282686.41287.47
3618196-61819684.41485.32
4662389-66238990.44991.44
5693355-69335594.67795.76
6670801-67080191.59792.62
30min1679308-67930892.75993.343.2494.2794.853.26
2679176-67917692.74194.28
3647877-64787788.46789.84
4681671-68167193.08294.57
5711976-71197697.22098.83
6701428-70142895.78097.31
45min1670636-67063691.57595.893.9393.6197.923.92
2709586-70958696.89498.95
3665433-66543390.86492.73
4721152-72115298.473100.48
5731444-73144499.878102.03
6715366-71536697.68399.75
60min1678172-67817292.60493.542.6295.1496.102.66
2687748-68774893.91296.50
3656023-65602389.58091.95
4696820-69682095.15097.71
5708808-70880896.78799.49
6682600-68260093.20995.82
极限1672213-67221391.79093.214.3594.8496.304.33
2675171-67517192.19495.31
3633382-63338286.48889.36
4691026-69102694.35997.44
5709305-70930596.855100.10
6714782-71478297.603100.73
替米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)5
对照品批号100629-202204对照品来源中检院对照品使用方法直接使用
对照品含量(%)100对照品水分(%)0对照品稀释倍数1250
标示量(mg)80供试品稀释倍数10系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.257483667478317458247472767463127471220.15
211.247542577540487541520.02
单位质量响应值RSD%判断
66410.8467095.370.73数据可信
供试品溶液-2026031721批-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%
5min1304690-30469041.08135.4911.1841.0835.4911.17
2218555-21855529.46729.47
3261469-26146935.25435.25
4283555-28355538.23138.23
5261621-26162135.27435.27
6249477-24947733.63733.64
10min1482884-48288465.10761.848.5665.3362.048.55
2412329-41232955.59455.76
3447424-44742460.32660.52
4506139-50613968.24268.45
5486763-48676365.63065.83
6416396-41639656.14256.33
15min1609417-60941782.16776.658.6082.7677.208.60
2515592-51559269.51769.99
3548721-54872173.98374.51
4607475-60747581.90582.50
5617603-61760383.27183.83
6512353-51235369.08069.58
20min1683337-68333792.13386.337.1093.1887.297.11
2592586-59258679.89880.76
3623527-62352784.06985.01
4651487-65148787.83988.89
5698845-69884594.22495.25
6591799-59179979.79280.67
30min1717242-71724296.70592.633.7398.2694.073.78
2667261-66726189.96691.27
3658884-65888488.83690.25
4697689-69768994.06995.60
5713207-71320796.16197.71
6667635-66763590.01691.34
45min1698608-69860894.19293.442.1796.2995.402.19
2699404-69940494.30096.10
3682948-68294892.08193.98
4680083-68008391.69593.75
5717645-71764596.75998.84
6679561-67956191.62493.45
60min1699191-69919194.27193.481.7096.8995.961.73
2699662-69966294.33596.66
3673237-67323790.77293.19
4693938-69393893.56396.13
5706546-70654695.26397.88
6687214-68721492.65694.99
极限1710496-71049695.79593.453.0798.9496.453.05
2701485-70148594.58097.43
3678317-67831791.45794.38
4669574-66957490.27893.36
5722105-72210597.360100.51
6676462-67646291.20794.06
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