Sodium Sulfamethoxazole

Sodium Sulfamethoxazole – High-Purity API for Injectable Formulations

Xi'an Linnas Biotech Co., Ltd. manufactures pharmaceutical-grade Sodium Sulfamethoxazole at 99% purity, engineered specifically for parenteral and ophthalmic applications. Our sodium salt version dissolves in water better than 100 mg/mL, which means it can be made into strong injectable solutions without using harmful solvents.This is much better than regular sulfamethoxazole, which only dissolves about 0.29 mg/mL in water.This high-quality Active Pharmaceutical Ingredient (API) comes in drum sizes of 20 kg, 25 kg, or 50 kg and meets ISO 9001 standards. With samples available and shipment within 3 days of payment confirmation, we support veterinary pharmaceutical manufacturers and human critical care formulation needs across global markets. Our product solves the core industry challenge of formulating stable, bioavailable liquid antibiotics for intravenous and intramuscular administration.

Product Specifications

Key Applications Across Veterinary and Human Medicine

Veterinary Injectable Solutions: Quick therapeutic action is required by your animal treatment protocols. Our product is designed to treat serious respiratory infections and mastitis, and it's the main active part of powerful injectable medications used for cattle, pigs, and chickens.Its better ability to dissolve in water makes it easier to give by injection into the muscle, which helps reduce stress on the animals during treatment.

Human Critical Care Infusions: For intravenous therapy, hospitals need dependable APIs. This component relieves severe urinary tract infections and Pneumocystis jirovecii pneumonia in immunocompromised people when coupled with trimethoprim. Dangerous precipitation during infusion is avoided by its total disintegration.

Ophthalmic Formulations: The fact that this substance dissolves without creating particles is beneficial for makers of eye care products.It effectively treats conditions like conjunctivitis, trachoma, and corneal infections.It does this by delivering a high amount of antibiotic directly to the affected area in eye drops that are based on water.This helps prevent irritation of the mucous membranes.

Critical Quality Control Standards

Professional pharmaceutical manufacturing requires strict API verification. Your procurement team should confirm these essential quality metrics:

Solution Clarity and pH Stability: Our Sodium Sulfamethoxazole maintains alkaline pH between 9.0–10.5, preventing acid-base reactions that cause tissue necrosis or active ingredient precipitation in bloodstream applications. Solution color matches EP/BP reference standards (Y4 or BY4).

Bacterial Endotoxin Compliance: LAL testing is done on materials that are suitable for injection to make sure endotoxin levels are less than 0.35 IU per mg, which helps prevent fever-like reactions in patients receiving intravenous drugs.

HPLC-Verified Purity: Harmful byproducts from the chemical process, such as sulfanilamide and sulfanilic acid, are checked, and the total amount of impurities stays under 0.5%. Batch uniformity and formulation safety are ensured by this thorough study.

Pharmaceutical Properties and Formulation Advantages

The substance has remarkable water solubility properties and appears as an odorless white to yellowish crystalline powder. Because of its lyophilic properties, producers can make concentrated antibiotic solutions that are more than 10% w/v without the need for organic solvents.

There are major benefits to your formulation development. ​​​​​​​The substance works well with trimethoprim to make sulfonamide injections more effective and stays stable in water.It does this by blocking an enzyme bacteria need to make folate, which stops their growth.

Because the substance can absorb moisture and is sensitive to light, it must be stored in sealed containers that block light. If stored correctly, it won't take in too much water or break down from oxidation, which can cause it to change color.

Packaging and Storage

Industrial-grade drums (20 kilogram, 25 kg, or 50 kg variants) intended for pharmaceutical handling are used to deliver your bulk orders. Keep out of direct sunlight and store in climate-controlled areas. To maintain the compound's remarkable water solubility and stop quality deterioration, keep the container intact.

Frequently Asked Questions

Q: Can this sodium salt replace the base form in tablet manufacturing?

A: No. The hygroscopic and alkaline nature suits liquid formulations only. Tablet applications require the base form to prevent moisture-related stability issues and premature disintegration.

Q: What prevents precipitation in IV administration?

A: Compatibility with normal saline or alkaline-buffered diluents maintains solution stability. Avoid mixing with acidic fluids like low-pH dextrose, which converts the salt to insoluble base form, creating dangerous precipitates.

Q: What storage conditions maintain potency?

A: Light-resistant, airtight containers prevent photodegradation and moisture absorption. Exposure to air causes yellowing/browning, indicating oxidative breakdown.

Q: Is Trimethoprim combination possible in liquid forms?

A: Yes. Specialized co-solvent systems (such as propylene glycol) solubilize both compounds simultaneously, enabling standard potentiated sulfonamide formulations.

Q: How do I verify sterile-grade material?

A: Request specific sterility certification with microbial load analysis. Standard pharmaceutical-grade material requires terminal sterilization; aseptic manufacturing demands pre-sterilized API with premium pricing.

Contact Us for Technical Support

Our technical team provides professional consultation for your Sodium Sulfamethoxazole manufacturing requirements. Request COA documentation, regulatory compliance details, or sample testing.

Email: cathy@linnas.com.cn