Parecoxib Sodium API
| CAS No. | 198470-85-8 |
| Therapeutic Category | Anesthetic & Analgesics |
| Technology | Synthetic |
| Dosage Form | Injection |
| Innovator Brand | Dynastat(USA) |
| Registration Status | China: A, Written Confirmation Others: DMF |
| Polymorph | Form B; New form with own patent |
| GMP | FDA(USA)/NMPA(China)/MFDS(Korea) approved |
| EHS | ISO 14001 & 45001 certified |
Product Description
- Grade: Active Pharmaceutical Ingredient(API)
- Chemical Name: Propanamide, N-[[4-(5-methyl-3-phenyl-4-isoxazolyl)phenyl]sulfonyl]-, sodium salt (1:1)
- Molecular Formula: C19H17N2NaO4S
- Molecular Weight: 392.404
- Specification: Enterprise Standard established according to ChP/USP/EP
- Appearance: Powder
- Total impurities: not more than 0.5%
- Purity: not less than 99%
- Residual Solvents: fully comply with ICH Q3C
- Mutagenic impurities: fully comply with ICH M8
- Nitrosamine assessment: available
- Particle size: regular grade or milling/sieving according to customer’s requirement.
- Storage: Room temperature
- Production capacity: Commercial
- Standard Package: 1kg/bag, 5kg/bag, or according to the customer’s requirement
Applications of Parecoxib Sodium API
- For the short-term treatment of acute pain and post-operative pain i.e., oral surgery, abdominal hysterectomy, myomectomy, total knee replacement, total hip arthroplasty, laparoscopic cholecystectomy, inguinal hernia repair and other general surgery like diagnostic laparoscopy, gastrectomy, hernioplasty, appendectomy, hemithyroidectomy and splenectomy. Parecoxib Sodium may be used pre-operatively to prevent or reduce post-operative pain and it can reduce opioid requirements when they are used concomitantly.
Why Choose Us as Your Parecoxib Sodium API Manufacturer?
- Qingmu’s Parecoxib Sodium has been approved in China(DMF filed and listed on CDE’s website), DMF in CTD format is available and can be supported for registration in worldwide.
- Qingmu’s factory is established according to ICH/USFDA/EU/JAPAN/China regulations and current GMP, totally complies with environmental law in China, no risk to remove factory. A new API factory is under design and is predicted to be put into use in 2025.
- As a Parecoxib Sodium manufacturer, Qingmu’s team has rich experience in patent challenges on crystalline form & synthesis processes and also synthetic route development and scale-up & quality research.
- Qingmu’s lab is equipped with HPLC, GC, ICP-MS, GC-MS, CAD, microbalance, Malvern particle analyzer, etc. Qingmu passed the site inspection from NMPA(China), FDA(USA) and MFDS(Korea) and also customer audits from Europe, USA and Japan, etc. You can rest assured to choose us.
- Qingmu successfully exported products to more than 40 countries including Japan, USA, Germany, Spain, the Netherlands, Russia, South Korea, and Brazil.
