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%
111.257562557562507559177557147564727561220.04
211.247551527550947551230.01
单位质量响应值RSD%判断
67210.8467181.760.04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%
5min154355-543557.2807.119.427.287.119.42
262126-621268.3218.32
350355-503556.7446.74
451030-510306.8356.83
553056-530567.1067.11
647612-476126.3776.38
10min1122509-12250916.40815.667.4216.4515.707.43
2131849-13184917.65917.71
3115311-11531115.44415.48
4110629-11062914.81714.86
5109776-10977614.70314.74
6111597-11159714.94714.98
15min1162502-16250221.76521.152.8221.9021.282.83
2160337-16033721.47521.62
3155051-15505120.76720.89
4150380-15038020.14120.26
5160388-16038821.48221.60
6158981-15898121.29321.41
20min1185136-18513624.79624.441.2825.0524.691.29
2183238-18323824.54224.81
3183713-18371324.60624.84
4183330-18333024.55424.79
5178664-17866423.93024.17
6180866-18086624.22424.46
30min1190816-19081625.55725.521.1425.9525.901.14
2191003-19100325.58225.98
3193205-19320525.87726.25
4188515-18851525.24925.62
5192152-19215225.73626.11
6187502-18750225.11325.48
45min1194010-19401025.98526.010.6326.5226.530.60
2193765-19376525.95226.49
3193230-19323025.88026.40
4196457-19645726.31326.82
5194576-19457626.06126.58
6193221-19322125.87926.39
60min1192838-19283825.82825.921.0226.5026.591.00
2194083-19408325.99526.68
3192800-19280025.82326.49
4190510-19051025.51626.17
5194806-19480626.09226.75
6196243-19624326.28426.94
极限1191561-19156125.65725.710.8926.4826.520.87
2192725-19272525.81326.64
3194551-19455126.05726.86
4191078-19107825.59226.39
5192205-19220525.74326.55
6189487-18948725.37926.18
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%
111.257476057472077464837490087525427485690.33
211.247551157548857550000.03
单位质量响应值RSD%判断
66539.4767170.820.67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%
5min150779-507796.8366.705.356.846.705.38
248082-480826.4736.47
353925-539257.2607.26
450085-500856.7436.74
546016-460166.1956.19
649803-498036.7056.70
10min1106359-10635914.31814.745.8614.3614.785.85
2110503-11050314.87614.91
3113361-11336115.26115.30
4119282-11928216.05816.10
5100805-10080513.57113.61
6106574-10657414.34714.38
15min1148334-14833419.96920.383.6720.0920.503.66
2149378-14937820.11020.23
3147668-14766819.87920.00
4162312-16231221.85121.98
5148771-14877120.02820.14
6151833-15183320.44020.56
20min1173652-17365223.37723.361.9923.6123.591.99
2173891-17389123.41023.64
3170788-17078822.99223.23
4177540-17754023.90124.15
5168512-16851222.68522.91
6176735-17673523.79224.02
30min1188679-18867925.40025.743.0225.7626.102.99
2182286-18228624.54024.90
3199188-19918826.81527.18
4194276-19427626.15426.53
5193280-19328026.02026.37
6189496-18949625.51025.87
45min1193968-19396826.11225.463.3926.6125.963.34
2192980-19298025.97926.48
3191379-19137925.76426.28
4188663-18866325.39825.92
5176575-17657523.77124.26
6191044-19104425.71926.22
60min1184735-18473524.86925.622.0225.5126.261.96
2187620-18762025.25825.90
3189972-18997225.57426.23
4191859-19185925.82926.50
5195864-19586426.36826.99
6191608-19160825.79526.44
极限1182571-18257124.57825.362.3025.3626.152.24
2184718-18471824.86725.65
3191420-19142025.76926.57
4186775-18677525.14425.95
5191886-19188625.83226.60
6193092-19309225.99526.79
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%
111.257560317555127553537552897548467554060.06
211.247518077513287515680.05
单位质量响应值RSD%判断
67147.2066865.480.30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%
5min1260132-26013234.94035.9511.3734.9435.9511.37
2259350-25935034.83534.83
3309182-30918241.52841.53
4222087-22208729.83029.83
5261805-26180535.16535.16
6293406-29340639.40939.41
10min1481805-48180564.71463.1211.0964.9163.3211.08
2413951-41395155.60055.79
3536135-53613572.01272.24
4400809-40080953.83554.00
5491180-49118065.97366.17
6495822-49582266.59766.82
15min1652024-65202487.57780.6611.0188.1381.2111.00
2531022-53102271.32571.83
3658542-65854288.45389.08
4504006-50400667.69668.16
5634067-63406785.16585.73
6623554-62355483.75384.34
20min1704627-70462794.64389.198.3595.6890.198.36
2600968-60096880.72081.62
3685534-68553492.07893.20
4586565-58656578.78579.63
5712669-71266995.72396.76
6693850-69385093.19594.25
30min1725369-72536997.42993.074.3698.9994.564.41
2653406-65340687.76389.11
3686281-68628192.17993.81
4662542-66254288.99090.27
5717363-71736396.35497.92
6712366-71236695.68297.25
45min1720900-72090096.82994.452.9998.9496.463.07
2673773-67377390.49992.33
3700590-70059094.10196.25
4685263-68526392.04293.81
5709882-70988295.34997.45
6728796-72879697.88999.99
60min1722903-72290397.09893.402.8799.7495.942.91
2673111-67311190.41092.75
3679181-67918191.22593.89
4682143-68214391.62393.91
5707389-70738995.01497.65
6707550-70755095.03597.68
极限1718830-71883096.55193.333.3099.7496.383.30
2675439-67543990.72293.56
3666716-66671689.55192.73
4681878-68187891.58794.38
5717875-71787596.42299.58
6708319-70831995.13998.31
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%
111.257524117522647528717523987530687526020.05
211.247672767681067676910.08
单位质量响应值RSD%判断
66897.9668299.911.47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%
5min1239643-23964331.90934.9910.6231.9134.9910.63
2280600-28060037.36337.36
3294259-29425939.18139.18
4256580-25658034.16434.16
5282925-28292537.67237.67
6222705-22270529.65429.65
10min1415611-41561155.34060.938.6355.5261.138.64
2473620-47362063.06463.27
3497308-49730866.21866.44
4442828-44282858.96459.15
5502771-50277166.94567.15
6413556-41355655.06655.23
15min1544667-54466772.52476.138.4573.0176.668.45
2594955-59495579.22079.78
3636558-63655884.75985.34
4544490-54449072.50073.02
5604333-60433380.46881.05
6505557-50555767.31667.79
20min1618383-61838382.33985.676.8083.2386.626.81
2668464-66846489.00890.01
3713707-71370795.03296.09
4620783-62078382.65983.58
5648610-64861086.36487.39
6590378-59037878.61079.45
30min1649181-64918186.44090.704.5187.7992.144.56
2699305-69930593.11494.61
3730982-73098297.33298.92
4662090-66209088.15989.54
5686430-68643091.40092.91
6659077-65907787.75889.04
45min1667276-66727688.84992.353.9290.6794.293.95
2722301-72230196.17698.19
3730562-73056297.27699.40
4666662-66666288.76890.64
5687178-68717891.49993.52
6687448-68744891.53593.30
60min1657664-65766487.57091.283.5389.8993.723.54
2682905-68290590.93193.47
3726889-72688996.78799.45
4667184-66718488.83791.20
5683879-68387991.06093.58
6694491-69449192.47394.75
极限1640444-64044485.27791.314.0588.0894.264.07
2696192-69619292.70095.75
3724586-72458696.48099.68
4673611-67361189.69392.55
5691234-69123492.04095.07
6688363-68836391.65794.45
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