【新品上市】药物杂质对照品—西地那非
2026-08-17 · 产品方案 · 百灵威授权转载
随着西地那非仿制药持续放量、集采常态化，NMPA、FDA、EP 对于杂质全貌解析、基因毒杂质管控、强制降解研究要求日趋严苛。仅依靠药典指定杂质，极易出现申报发补、未知杂质无法定性、亚硝胺类杂质漏检等问题。
百灵威全新推出西地那非全系列杂质，助您攻克杂质分析难题，补齐杂质研究闭环，规避审评风险，为药品申报与生产保驾护航。
产品优势
- 品质合规：全部附带完整 COA 报告，可用于 CDE 申报资料提交；
- 场景全覆盖：原料药质量研究、制剂稳定性考察、方法学开发、第三方检测机构均可使用；
- 供货稳定：稳定及时的供应保障，助力项目高效推进 。
产品列表
| 品名 | CAS | 货号 |
|---|---|---|
| Sildenafil impurity 1, 99% 西地那非杂质1 | 1467610-65-6 | 9720481 |
| Sildenafil impurity 2, 96% 西地那非杂质2 | / | 2038843 |
| Sildenafil impurity 4, 99% 西地那非杂质4 | 496835-35-9 | 967941 |
| Sildenafil impurity 6, 95% 西地那非杂质6 | 1441-87-8 | 9003952 |
| Sildenafil impurity 7, 95% 西地那非杂质7 | 1467610-62-3 | 9720482 |
| Sildenafil impurity 8, 98% 西地那非杂质8 | 856190-54-0 | 9720483 |
| Sildenafil impurity 9, 99% 西地那非杂质9 | 1797861-66-5 | 9218681 |
| Sildenafil impurity 11, 99% 西地那非杂质11 | 2580950-35-0 | 9720484 |
| Sildenafil impurity 12, 96% 西地那非杂质12 | 1417999-76-8 | 9435782 |
| Sildenafil impurity 13, 98% 西地那非杂质13 | 147676-79-7 | 2337459 |
| Sildenafil impurity 14, 98% 西地那非杂质14 | 1333233-46-7 | 1683919 |
| Sildenafil impurity 15, 96% 西地那非杂质15 | 2135944-70-4 | 9720485 |
| Sildenafil impurity 16, 99% 西地那非杂质16 | 1610830-81-3 | 9270862 |
| Sildenafil impurity 17, 98% 西地那非杂质17 | 1308332-48-0 | 9720486 |
| Sildenafil impurity 18, 97% 西地那非杂质18 | 911715-34-9 | 2375760 |
| Sildenafil impurity 21, 99% 西地那非杂质21 | 139756-03-9 | 996182 |
| Sildenafil impurity 22, 95% 西地那非杂质22 | 2196257-93-7 | 9720487 |
| Sildenafil impurity 23, 99% 西地那非杂质23 | 466684-88-8 | 2358358 |
| Sildenafil impurity 24, 99% 西地那非杂质24 | / | 9720488 |
| Sildenafil impurity 27, 97% 西地那非杂质27 | 769132-77-6 | 498941 |
| Sildenafil impurity 28, 99% 西地那非杂质28 | 139756-08-4 | 1568287 |
| Sildenafil impurity 29, 99% 西地那非杂质29 | 856190-49-3 | 1684241 |
| Sildenafil impurity 30, 99% 西地那非杂质30 | 479073-87-5 | 1684239 |
| Sildenafil impurity 31, 99% 西地那非杂质31 | 479073-90-0 | 1684238 |
| Sildenafil impurity 32, 98% 西地那非杂质32 | 1246820-46-1 | 929560 |
| Sildenafil impurity 33, 99% 西地那非杂质33 | / | 9720489 |
| Sildenafil impurity 34, 98% 西地那非杂质34 | / | 9720490 |
| Sildenafil impurity 35, 99% 西地那非杂质35 | / | 239704 |
| Sildenafil impurity 38, 95% 西地那非杂质38 | 139756-22-2 | 769957 |
| Sildenafil impurity 39, 99% 西地那非杂质39 | 139756-21-1 | 943696 |
| Sildenafil impurity 43, 95% 西地那非杂质43 | 139756-26-6 | 9084118 |
| Sildenafil impurity 44, 98% 西地那非杂质44 | 269394-18-5 | 9084120 |
| Sildenafil impurity 45, 95% 西地那非杂质45 | 6290-24-0 | 602672 |
| Sildenafil impurity 46, 95% 西地那非杂质46 | 3686-55-3 | 950044 |
| Sildefil impurity 47, 99% 西地那非杂质47 | 304435-83-4 | 9720491 |
| Sildefil impurity 48, 96% 西地那非杂质48 | 92945-27-2 | 511528 |
| Sildefil impurity 49, 99% 西地那非杂质49 | 139756-00-6 | 295215 |
| Sildenafil impurity 50, 97% 西地那非杂质50 | 194602-23-8 | 1281169 |
| Sildenafil impurity 52, 99% 西地那非杂质52 | 3920-37-4 | 184099 |
| Sildenafil impurity 53, 95% 西地那非杂质53 | 26308-42-9 | 309740 |
| Sildenafil impurity 54, 98% 西地那非杂质54 | / | 9720492 |
| Sildenafil impurity 56, 99% 西地那非杂质56 | / | 9720493 |
| Sildenafil impurity 57, 95% 西地那非杂质57 | 133261-09-3 | 127630 |
| Sildenafil impurity 58, 98% 西地那非杂质58 | 116833-23-9 | 9720494 |
| Sildenafil impurity 59, 98% 西地那非杂质59 | 1185292-79-8 | 784605 |
| Sildenafil impurity 61, 95% 西地那非杂质61 | 503064-95-7 | 9720495 |
| Sildenafil impurity 62, 95% 西地那非杂质62 | 383427-88-1 | 453788 |
| Sildenafil impurity 64, 99% 西地那非杂质 64 | / | 9720496 |
| Sildenafil impurity 65, 95% 西地那非杂质 65 | 459834-16-3 | 9720497 |
| Sildenafil impurity 66, 95% 西地那非杂质 66 | 360068-47-9 | 9720498 |
| Sildenafil impurity 67, 94% 西地那非杂质67 | 226956-42-9 | 9720499 |
| Sildenafil impurity 68, 99% 西地那非杂质68 | 482573-92-2 | 1875653 |
| Sildenafil impurity 69, 99% 西地那非杂质69 | 944241-52-5 | 900130 |
| Sildenafil impurity 70, 99% 西地那非杂质70 | / | 9720500 |
| Sildenafil impurity 71, 95% 西地那非杂质71 | / | 9720501 |
| Sildenafil impurity 72, 99% 西地那非杂质72 | 1391053-82-9 | 1430766 |
| Sildenafil impurity 74, 95% 西地那非杂质74 | 139756-23-3 | 2321134 |
| Sildenafil impurity 75, 98% 西地那非杂质 75 | 139756-30-2 | 836897 |
| Sildenafil impurity 76, 97% 西地那非杂质76 | 78208-72-7 | 622121 |
| Sildenafil Impurity 77, 95% 西地那非杂质77 | 866256-11-3 | 9720502 |
| Sildenafil impurity 79, 95% 西地那非杂质79 | 479074-16-3 | 9720503 |
| Sildenafil impurity 80, 99% 西地那非杂质80 | / | 9720504 |
| Sildenafil impurity 81, 95% 西地那非杂质81 | 479074-06-1 | 1189027 |
| Sildenafil impurity 82, 99% 西地那非杂质82 | 792969-85-8 | 9720505 |
| Sildenafil impurity 83, 98% 西地那非杂质83 | / | 9720506 |
| Sildenafil impurity 84, 99% 西地那非杂质84 | 479073-86-4 | 988679 |
| Sildenafil impurity 85, 99% 西地那非杂质85 | 479073-80-8 | 913297 |
| Sildenafil impurity 87, 97% 西地那非杂质87 | 1159977-47-5 | 913077 |
| Sildenafil impurity 88, 95% 西地那非杂质88 | / | 9720507 |
| Sildenafil impurity 89, 97% 西地那非杂质89 | 845302-49-0 | 2358413 |
| Sildenafil Iimpurity 90, 97% 西地那非杂质90 | 1058653-74-9 | 1497663 |
| Sildenafil impurity 91, 99% 西地那非杂质91 | / | 9720508 |
| Sildenafil impurity 92, 98% 西地那非杂质92 | 1353018-10-6 | 1683741 |
| Sildenafil impurity 93, 98% 西地那非杂质93 | 147676-55-9 | 813234 |
| Sildenafil impurity 94, 99% 西地那非杂质94 | 147676-78-6 | 931959 |
| Sildenafil impurity 95, 99% 西地那非杂质95 | / | 9539763 |
| Sildenafil impurity 96, 99% 西地那非杂质96 | 139756-24-4 | 2752104 |
| Sildenafil impurity 97, 99% 西地那非杂质97 | 139756-04-0 | 1438985 |
| Sildenafil impurity 98, 98% 西地那非杂质98 | / | 9720509 |
| Sildenafil impurity 99, 99% 西地那非杂质99 | 960009-35-2 | 9084007 |
| Sildenafil impurity 100, 98% 西地那非杂质100 | 76424-56-1 | 9218680 |
| Sildenafil impurity 101, 99% 西地那非杂质101 | 78208-73-8 | 292892 |
| Sildenafil impurity 102, 99% 西地那非杂质102 | 78208-74-9 | 2017301 |
| Sildenafil impurity 103, 95% 西地那非杂质103 | 200575-16-2 | 998473 |
| Sildenafil impurity 104, 97% 西地那非杂质104 | 215299-33-5 | 9720510 |
| Sildenafil impurity 105, 99% 西地那非杂质105 | 2021224-02-0 | 9347220 |
| Sildenafil impurity 106, 95% 西地那非杂质106 | 17243-13-9 | 215548 |
| Sildenafil impurity 107, 98% 西地那非杂质107 | 1428862-09-2 | 9720511 |
| Sildenafil impurity 108, 98% 西地那非杂质108 | 139756-10-8 | 9720512 |
| Sildenafil impurity 109, 95% 西地那非杂质109 | / | 9720513 |
| Sildenafil impurity 110, 99% 西地那非杂质110 | 139755-87-6 | 921583 |
| Sildenafil impurity 111, 98% 西地那非杂质111 | 147676-50-4 | 941525 |
| Sildenafil impurity 112, 98% 西地那非杂质112 | 78208-58-9 | 9720514 |
| Sildenafil impurity 113, 95% 西地那非杂质113 | 73119-79-6 | 2741473 |
| Sildenafil impurity 114, 98% 西地那非杂质114 | 831217-01-7 | 912000 |
| Sildenafil impurity 115, 96% 西地那非杂质115 | 960009-36-3 | 9720515 |
| Sildenafil impurity 116, 97% 西地那非杂质116 | / | 9720516 |
| Sildenafil impurity 117, 97% 西地那非杂质117 | 247583-67-1 | 9720517 |
| Sildenafil impurity 118, 99% 西地那非杂质118 | 1391054-00-4 | 1498373 |
| Sildenafil impurity 119, 99% 西地那非杂质119 | 479073-82-0 | 959924 |
| Sildenafil impurity 120, 95% 西地那非杂质120 | 1004455-71-3 | 721373 |
| Sildenafil impurity 121, 98% 西地那非杂质121 | 479074-08-3 | 2023173 |
| Sildenafil impurity 122, 98% 西地那非杂质122 | / | 9720518 |
| Sildenafil impurity 123, 98% 西地那非杂质123 | 1027192-92-2 | 928503 |
| Sildenafil impurity 124, 98% 西地那非杂质124 | 147676-66-2 | 977305 |
| Sildenafil impurity 126, 99% 西地那非杂质126 | 479073-88-6 | 2358385 |
| Sildenafil impurity 127, 99% 西地那非杂质127 | 1393816-99-3 | 1832004 |
| Sildenafil impurity 128, 99% 西地那非杂质128 | 62871-12-9 | 908515 |
| Sildenafil impurity 129, 95% 西地那非杂质129 | / | 9720519 |
| Sildenafil impurity 130, 99% 西地那非杂质130 | 1446089-82-2 | 2022694 |
| Sildenafil impurity 131, 99% 西地那非杂质131 | 1007310-62-4 | 9720520 |
| Sildenafil impurity 132, 97% 西地那非杂质132 | / | 9720521 |
| Sildenafil impurity 135, 98% 西地那非杂质135 | 1446144-70-2 | 2358373 |
| Sildenafil impurity 139, 95% 西地那非杂质139 | 873221-66-0 | 2662779 |
| Sildenafil impurity 140, 96% 西地那非杂质140 | 374776-34-8 | 1497208 |
| Sildenafil impurity 141, 97% 西地那非杂质141 | / | 9720522 |
| Sildenafil impurity 142, 99% 西地那非杂质142 | / | 9720523 |
| Sildenafil impurity 143, 96% 西地那非杂质143 | 139756-31-3 | 836834 |
| Sildenafil impurity 154, 95% 西地那非杂质154 | 76424-48-1 | 2001687 |
| Sildenafil impurity 144, 95% 西地那非杂质144 | 76424-47-0 | 161653 |
| Sildenafil impurity 145, 99% 西地那非杂质145 | 147676-56-0 | 979185 |
| Sildenafil impurity 146, 98% 西地那非杂质146 | 319491-68-4 | 1832083 |
| Sildenafil impurity 138, 98% 西地那非杂质138 | 1609405-33-5 | 2358374 |
| Sildenafil impurity 159, 98% 西地那非杂质159 | 2711006-62-9 | 9448149 |
| Sildenafil impurity160, 99% 西地那非杂质160 | 2196244-90-1 | 9085635 |
| Sildenafil impurity 161, 95% 西地那非杂质161 | 2725318-34-1 | 9720524 |
| Sildenafil impurity 162, 99% 西地那非杂质162 | 2520113-14-6 | 9291703 |
| Sildenafil impurity 152, 98% 西地那非杂质152 | 2520113-03-3 | 9720525 |
| Sildenafil impurity 153, 98% 西地那非杂质153 | 942125-59-9 | 9334646 |
| Sildenafil impurity 154, 97% 西地那非杂质154 | 2711006-61-8 | 9271753 |
| Sildenafil impurity 156, 99% 西地那非杂质156 | 496835-34-8 | 9720526 |
| Sildenafil impurity 157, 99% 西地那非杂质157 | / | 9720527 |
| Sildenafil impurity 158, 99% 西地那非杂质158 | 1446089-84-4 | 1832177 |
| Sildenafil impurity 159, 99% 西地那非杂质159 | 1621873-33-3 | 9270859 |
| Sildenafil impurity 160, 98% 西地那非杂质160 | 129779-30-2 | 330780 |
| Sildenafil impurity 161, 95% 西地那非杂质161 | 1786437-29-3 | 9539757 |
相关试剂
| 品名 | CAS | 货号 |
|---|---|---|
| Isopropanol, 99.5%, ACS reagent 异丙醇 | 67-63-0 | 923372 危化品 |
| Dichloromethane, 99.5%, ACS reagent 二氯甲烷 | 75-09-2 | 949699 危化品 |
| Ethyl acetate, 99.9%, ACS/HPLC Certified 乙酸乙酯 | 141-78-6 | 243083 危化品 |
| Potassium dihydrogen phosphate, 99%, ACS reagent 磷酸二氢钾 | 7778-77-0 | 900196 |
| Potassium phosphate dibasic, 99%, ACS reagent 磷酸氢二钾 | 7758-11-4 | 127325 |
| Phosphoric acid, 85% solution in H2O, ACS reagent 磷酸 | 7664-38-2 | 933962 危化品 |
相关耗材
| 品名 | CAS | 货号 |
|---|---|---|
| Sample vial, 2mL, 8 mm, clear glass screw thread vials with write-on spot 样品瓶 | / | 2063717 |
| Centrifuge tube, 50 mL, vertical, with scale, conical bottom, sterile, 25 pcs/bag, 2 bags/case 离心管 | / | 958546 |
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