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105℃烘干2小时
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%
111.237661197646717657877664927663717658880.10
211.297685937679997682960.06
单位质量响应值RSD%判断
68200.1868051.020.16数据可信
长期36月-供试品溶液-20220104批-80mg-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%
5min162979-629798.3208.169.548.328.169.53
269079-690799.1269.13
368049-680498.9908.99
458563-585637.7377.74
554771-547717.2367.24
657297-572977.5697.57
10min1151519-15151920.01718.895.2120.0618.935.20
2147180-14718019.44419.49
3148984-14898419.68219.73
4134953-13495317.82917.87
5133868-13386817.68517.73
6141420-14142018.68318.72
15min1181019-18101923.91423.053.4424.0723.203.45
2177922-17792223.50523.66
3178041-17804123.52123.68
4167555-16755522.13622.28
5166561-16656122.00422.14
6175679-17567923.20923.35
20min1190890-19089025.21824.891.3125.5125.171.32
2189591-18959125.04725.34
3186104-18610424.58624.88
4186416-18641624.62724.89
5186218-18621824.60124.86
6191313-19131325.27425.55
30min1186299-18629924.61224.931.7025.0425.341.62
2187998-18799824.83625.26
3188137-18813724.85525.28
4193265-19326525.53225.93
5191704-19170425.32625.72
6184870-18487024.42324.84
45min1195837-19583725.87225.491.3026.4426.041.31
2194935-19493525.75326.32
3193628-19362825.58026.14
4193303-19330325.53726.08
5190676-19067625.19025.73
6189320-18932025.01125.56
60min1190476-19047625.16425.061.3625.8725.761.28
2189783-18978325.07225.78
3184614-18461424.38925.10
4191365-19136525.28125.97
5191390-19139025.28425.96
6190558-19055825.17425.86
极限1194850-19485025.74125.630.7326.5926.470.73
2194437-19443725.68726.54
3193878-19387825.61326.46
4195606-19560625.84126.67
5193772-19377225.59926.42
6191461-19146125.29426.12
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105℃烘干2小时
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%
111.237705177680767685947716977668907691550.26
211.297706267698407702330.08
单位质量响应值RSD%判断
68491.1068222.590.28数据可信
长期36月-供试品溶液-20220104批-80mg-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%
5min168674-686749.0428.0915.299.048.0915.31
267508-675088.8888.89
370248-702489.2499.25
461953-619538.1578.16
546962-469626.1836.18
653414-534147.0337.03
10min1142648-14264818.78118.124.6318.8318.174.65
2145131-14513119.10819.16
3135761-13576117.87517.93
4140528-14052818.50218.55
5127773-12777316.82316.86
6134094-13409417.65517.69
15min1176401-17640123.22522.862.1423.3823.002.13
2170447-17044722.44122.60
3168338-16833822.16422.31
4178130-17813023.45323.60
5173160-17316022.79922.93
6175241-17524123.07323.21
20min1190975-19097525.14424.651.4725.4324.921.49
2186925-18692524.61124.89
3184335-18433524.27024.54
4189905-18990525.00325.28
5186979-18697924.61824.87
6184386-18438624.27724.54
30min1185883-18588324.47424.961.5724.9025.371.52
2192955-19295525.40525.82
3187019-18701924.62325.03
4190692-19069225.10725.52
5192635-19263525.36325.75
6188207-18820724.78025.18
45min1190799-19079925.12125.161.0625.6825.711.05
2190433-19043325.07325.63
3189166-18916624.90625.45
4194155-19415525.56326.12
5189255-18925524.91825.45
6192965-19296525.40625.94
60min1192533-19253325.34925.180.6826.0525.870.64
2191325-19132525.19025.89
3190390-19039025.06725.75
4189175-18917524.90725.61
5192414-19241425.33426.00
6191763-19176325.24825.93
极限1194815-19481525.65025.600.6826.4926.430.69
2194789-19478925.64626.48
3194529-19452925.61226.44
4195365-19536525.72226.56
5191818-19181825.25526.07
6195249-19524925.70726.53
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105℃烘干2小时
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%
111.237655037670527662617686017667507668330.15
211.297677687655617666640.21
单位质量响应值RSD%判断
68284.3367906.470.40数据可信
长期36月-供试品溶液-20220105批-80mg-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%
5min1145746-14574619.26320.423.6919.2620.423.70
2157913-15791320.87120.87
3155055-15505520.49320.49
4156589-15658920.69620.70
5161669-16166921.36821.37
6150253-15025319.85919.86
10min1175556-17555623.20323.841.7423.3123.961.75
2180633-18063323.87423.99
3180859-18085923.90424.02
4182532-18253224.12524.24
5184442-18444224.37724.50
6178309-17830923.56723.68
15min1178913-17891323.64724.541.9823.8824.781.99
2184973-18497324.44824.70
3187616-18761624.79725.04
4186996-18699624.71524.96
5189654-18965425.06625.32
6185890-18589024.56924.81
20min1192100-19210025.39024.651.8625.7625.041.80
2187552-18755224.78825.17
3187439-18743924.77425.16
4184509-18450924.38624.77
5181838-18183824.03324.43
6185694-18569424.54324.92
30min1185738-18573824.54924.291.4525.0624.811.42
2187136-18713624.73325.26
3185504-18550424.51825.04
4181286-18128623.96024.48
5182207-18220724.08224.61
6180904-18090423.91024.42
45min1178952-17895223.65223.820.8724.3024.470.85
2182359-18235924.10224.76
3178486-17848623.59024.25
4180130-18013023.80824.46
5179503-17950323.72524.39
6181810-18181024.03024.68
60min1179422-17942223.71423.600.7724.4924.380.73
2179262-17926223.69324.49
3175987-17598723.26024.05
4179308-17930823.69924.49
5177914-17791423.51524.31
6179237-17923723.68924.47
极限1176253-17625323.29523.400.9224.2024.320.89
2178275-17827523.56224.49
3178980-17898023.65624.57
4178194-17819423.55224.47
5175590-17559023.20724.13
6175114-17511423.14524.06
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