氟伐他汀钠缓释片项目信息
介质体积(ml)1000取样体积(ml)1.5补液体积(ml)1.5
对照品批号100800-202103对照品来源中检院对照品使用方法直接使用
对照品含量(%)93.4对照品水分(%)0对照品稀释倍数125
标示量(mg)80供试品稀释倍数1系数0.9493
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.011452140145283714513021451580145118414518090.05
210.721429475143004114297580.03
单位质量响应值RSD%判断
131862.76133372.950.81数据可信
供试品溶液-2024041521批-水
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
30min196769-967696.4706.376.216.476.366.20
295119-951196.3606.36
393958-939586.2826.28
490305-903056.0386.04
589365-893655.9755.97
6105815-1058157.0757.07
120min1341934-34193422.86223.324.0522.8723.334.04
2362322-36232224.22524.23
3339991-33999122.73222.74
4338033-33803322.60122.61
5339826-33982622.72122.73
6370951-37095124.80224.81
240min1826556-82655655.26352.127.0755.3152.177.07
2805956-80595653.88653.93
3790200-79020052.83252.88
4692846-69284646.32346.37
5732809-73280948.99549.04
6829191-82919155.43955.49
360min11238246-123824682.78880.966.4082.9281.086.40
21259649-125964984.21984.35
31210573-121057380.93881.06
41085354-108535472.56672.68
51165485-116548577.92478.04
61305976-130597687.31787.45
480min11508845-1508845100.880101.220.66101.13101.470.66
21509954-1509954100.955101.21
31505523-1505523100.658100.90
41508047-1508047100.827101.05
51520222-1520222101.641101.87
61531314-1531314102.383102.64
极限11511779-1511779101.077101.510.68101.48101.910.68
21516276-1516276101.377101.78
31503890-1503890100.549100.94
41518648-1518648101.536101.91
51527883-1527883102.153102.54
61531477-1531477102.394102.81
氟伐他汀钠缓释片项目信息
介质体积(ml)1000取样体积(ml)1.5补液体积(ml)1.5
对照品批号100800-202103对照品来源中检院对照品使用方法直接使用
对照品含量(%)93.4对照品水分(%)0对照品稀释倍数125
标示量(mg)80供试品稀释倍数1系数0.9493
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.011450455144999914501221450206145093814503440.03
210.721417737141685614172960.05
单位质量响应值RSD%判断
131729.70132210.450.26数据可信
供试品溶液-2024041521批-水
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
30min195488-954886.4156.324.606.426.324.60
298938-989386.6476.65
399131-991316.6606.66
489407-894076.0076.01
590975-909756.1126.11
690752-907526.0976.10
120min1359816-35981624.17424.053.6624.1824.063.66
2378808-37880825.45025.46
3340898-34089822.90322.91
4347295-34729523.33323.34
5361193-36119324.26724.28
6359634-35963424.16224.17
240min1798762-79876253.66554.633.5253.7154.683.52
2853871-85387157.36857.42
3818814-81881455.01355.06
4825269-82526955.44655.49
5768020-76802051.60051.65
6814091-81409154.69554.74
360min11253194-125319484.19784.020.8784.3284.150.88
21268054-126805485.19585.33
31254814-125481484.30584.43
41238577-123857783.21583.34
51239938-123993883.30683.43
61248848-124884883.90584.03
480min11517833-1517833101.977101.960.45102.23102.220.44
21509334-1509334101.406101.67
31519115-1519115102.063102.32
41521470-1521470102.221102.47
51527280-1527280102.611102.86
61510757-1510757101.501101.75
极限11517449-1517449101.951101.970.46102.36102.380.45
21510349-1510349101.474101.89
31517712-1517712101.968102.37
41527029-1527029102.594103.00
51523931-1523931102.386102.79
61510351-1510351101.474101.88
氟伐他汀钠缓释片项目信息
介质体积(ml)1000取样体积(ml)1.5补液体积(ml)1.5
对照品批号100800-202103对照品来源中检院对照品使用方法直接使用
对照品含量(%)93.4对照品水分(%)0对照品稀释倍数125
标示量(mg)80供试品稀释倍数1系数0.9493
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.011444566144469314443181444221144428314444160.02
210.721407926140734014076330.03
单位质量响应值RSD%判断
131191.28131309.050.07数据可信
供试品溶液-2024041721批-水
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
30min189357-893576.0365.823.546.045.823.55
288562-885625.9835.98
381324-813245.4945.49
485519-855195.7775.78
587998-879985.9455.94
684364-843645.6995.70
120min1349162-34916223.58722.615.0923.6022.625.09
2343258-34325823.18823.20
3303439-30343920.49820.51
4346772-34677223.42623.43
5328404-32840422.18522.19
6336875-33687522.75722.77
240min1808133-80813354.59352.835.5854.6452.885.58
2807528-80752854.55254.60
3748389-74838950.55750.60
4843741-84374156.99857.04
5749259-74925950.61550.66
6735389-73538949.67849.72
360min11253084-125308484.65182.662.7284.7882.792.72
21237934-123793483.62783.75
31196684-119668480.84180.96
41266820-126682085.57985.71
51199281-119928181.01681.13
61188270-118827080.27280.39
480min11515138-1515138102.354102.531.16102.61102.781.16
21550510-1550510104.743104.99
31513040-1513040102.212102.45
41521016-1521016102.751103.01
51504734-1504734101.651101.89
61502018-1502018101.467101.70
极限11517245-1517245102.496102.581.26102.90102.981.26
21554851-1554851105.036105.44
31513248-1513248102.226102.62
41519032-1519032102.617103.03
51503486-1503486101.566101.96
61503429-1503429101.563101.95
氟伐他汀钠缓释片项目信息
介质体积(ml)1000取样体积(ml)1.5补液体积(ml)1.5
对照品批号100800-202103对照品来源中检院对照品使用方法直接使用
对照品含量(%)93.4对照品水分(%)0对照品稀释倍数125
标示量(mg)80供试品稀释倍数1系数0.9493
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.011450127145065614511061451611145222014511440.06
210.721431063143003314305480.06
单位质量响应值RSD%判断
131802.36133446.640.88数据可信
供试品溶液-2024041721批-水
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
30min196580-965806.4575.896.916.465.906.87
284596-845965.6565.66
383701-837015.5965.60
480852-808525.4055.41
593106-931066.2256.22
690082-900826.0236.02
120min1352257-35225723.55122.795.2023.5622.805.20
2361252-36125224.15224.16
3323833-32383321.65021.66
4334635-33463522.37322.38
5354799-35479923.72123.73
6318531-31853121.29621.30
240min1836025-83602555.89452.357.5155.9452.397.51
2779137-77913752.09052.14
3793555-79355553.05453.10
4750980-75098050.20850.25
5849347-84934756.78456.83
6688651-68865146.04146.08
360min11253022-125302283.77381.145.4583.9081.265.45
21237469-123746982.73382.86
31232844-123284482.42482.54
41195866-119586679.95180.07
51273620-127362085.15085.28
61089367-108936772.83172.94
480min11502681-1502681100.464100.760.59100.72101.000.60
21506683-1506683100.731100.98
31502152-1502152100.429100.67
41514475-1514475101.252101.49
51520107-1520107101.629101.89
61496183-1496183100.029100.25
极限11514051-1514051101.224101.110.55101.63101.510.55
21510946-1510946101.016101.41
31499539-1499539100.254100.65
41514583-1514583101.260101.65
51525019-1525019101.957102.37
61510265-1510265100.971101.34
氟伐他汀钠缓释片项目信息
介质体积(ml)1000取样体积(ml)1.5补液体积(ml)1.5
对照品批号100800-202103对照品来源中检院对照品使用方法直接使用
对照品含量(%)93.4对照品水分(%)0对照品稀释倍数125
标示量(mg)80供试品稀释倍数1系数0.9493
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.011458052145704214577721457646145817914577380.04
210.721432508143204314322760.03
单位质量响应值RSD%判断
132401.27133607.840.65数据可信
供试品溶液-2024041821批-水
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
30min186348-863485.7565.824.365.765.824.39
285752-857525.7175.72
385061-850615.6715.67
484951-849515.6635.66
594880-948806.3256.33
686392-863925.7595.76
120min1317174-31717421.14422.686.2521.1522.696.25
2321487-32148721.43221.44
3343852-34385222.92322.93
4364533-36453324.30124.31
5365551-36555124.36924.38
6328800-32880021.91921.93
240min1763402-76340250.89252.016.4750.9352.066.46
2688347-68834745.88845.93
3827587-82758755.17055.21
4817052-81705254.46854.51
5786031-78603152.40052.45
6798856-79885653.25553.30
360min11234784-123478482.31681.934.3282.4382.044.32
21127312-112731275.15175.26
31227143-122714381.80781.93
41272596-127259684.83784.96
51268396-126839684.55784.68
61243320-124332082.88583.01
480min11522268-1522268101.481100.920.79101.72101.170.78
21520212-1520212101.344101.57
31517471-1517471101.161101.41
41512687-1512687100.842101.10
51520330-1520330101.352101.60
61490609-149060999.37099.62
极限11524265-1524265101.614100.980.67102.01101.370.67
21521915-1521915101.457101.83
31514372-1514372100.954101.35
41513479-1513479100.895101.30
51518337-1518337101.219101.62
61495885-149588599.722100.12
氟伐他汀钠缓释片项目信息
介质体积(ml)1000取样体积(ml)1.5补液体积(ml)1.5
对照品批号100800-202103对照品来源中检院对照品使用方法直接使用
对照品含量(%)93.4对照品水分(%)0对照品稀释倍数125
标示量(mg)80供试品稀释倍数1系数0.9493
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.011460665145942614598341459535145917714597270.04
210.721427252142728814272700.01
单位质量响应值RSD%判断
132581.93133140.860.30数据可信
供试品溶液-2024041821批-水
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
30min187177-871775.8185.605.865.825.605.87
290761-907616.0576.06
384212-842125.6205.62
484040-840405.6085.61
580280-802805.3575.36
676878-768785.1305.13
120min1338688-33868822.60221.817.0422.6121.827.04
2332986-33298622.22222.23
3336961-33696122.48722.50
4334524-33452422.32422.33
5337702-33770222.53722.54
6280086-28008618.69218.70
240min1737074-73707449.18950.4012.4949.2350.4412.48
2852974-85297456.92356.97
3713619-71361947.62347.67
4840390-84039056.08356.13
5788411-78841152.61552.66
6598852-59885239.96440.00
360min11157173-115717377.22477.099.8677.3477.209.85
21224631-122463181.72681.85
31106419-110641973.83773.95
41248310-124831083.30683.43
51242422-124242282.91383.03
6952081-95208163.53763.63
480min11510653-1510653100.81398.066.92101.0598.296.92
21507205-1507205100.583100.83
31519966-1519966101.435101.66
41497478-149747899.934100.19
51518125-1518125101.312101.56
61262678-126267884.26584.46
极限11514129-1514129101.04599.174.49101.4399.554.50
21510390-1510390100.796101.20
31523771-1523771101.689102.07
41504200-1504200100.383100.78
51513017-1513017100.971101.37
61350717-135071790.14090.46
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