Iohexol manufacturers

Iohexol is a non-ionic, water-soluble radiographic contrast medium. When sourcing, you must ensure it complies with international pharmacopoeia standards such as USP (United States Pharmacopeia), EP (European Pharmacopoeia), or BP (British Pharmacopoeia). Key parameters to verify include Assay (98.0% - 102.0%), Specific Optical Rotation, Water Content (max 4.0%), and Heavy Metals (max 10 ppm). For injectable grades, the Bacterial Endotoxins level must be strictly controlled to meet sterile injectable requirements.

As a pharmaceutical raw material, the supplier must possess a GMP (Good Manufacturing Practice) certificate. Additionally, check for a CEP (Certificate of Suitability to the Monographs of the European Pharmacopoeia) or a DMF (Drug Master File) registration number. These documents are essential for regulatory submission in your local market and guarantee that the production process meets stringent quality management systems.

Iohexol is sensitive to light and heat. It should be stored in tight, light-resistant containers at controlled room temperature (typically 25°C, with excursions permitted between 15°C and 30°C). Ensure the supplier provides Stability Testing Data to confirm the product's shelf life and effectiveness under various environmental conditions, especially for long-distance cross-border shipping.

Iohexol is widely used for CT (Computed Tomography) scans, angiography, urography, and myelography. It is preferred over ionic contrast agents due to its lower osmolality and reduced toxicity, which results in fewer adverse reactions for patients. Buyers should specify whether they need the Powder (API) for local formulation or the Finished Dosage Form (Injection).

To ensure transaction security, use secure payment methods and prioritize suppliers on Made-in-China.com who have undergone Audit Reports by third-party agencies like SGS or Intertek. Always request a Pre-shipment Inspection (PSI) to verify that the batch number and COA (Certificate of Analysis) match the physical goods before the final balance is paid.

Iohexol requires an MSDS (Material Safety Data Sheet) and a Non-Hazardous Chemical Appraisal Report for international air or sea freight. Ensure the packaging is UN-certified to prevent leakage. You must also verify the HS Code (typically 2933.79 or 3006.30) with your local customs to determine import duties and whether an Import License for Drugs is required in your country.

Pharmaceutical prices are highly dependent on the purity grade and order volume. For bulk orders exceeding 500kg, you can typically negotiate a 10-20% discount. Discuss Lead Times clearly, as high-quality GMP production cycles can take 4-6 weeks if the product is not currently in stock. Always include a clause for re-testing upon arrival in your contract.