| 1 | Intended-use and grade fit | Confirm that the offered grade is specified for the intended application, such as cosmetic, food, or pharmaceutical use. Requirements differ by market and application. | Product specification, intended-use statement, applicable regulatory documentation, and a sample certificate of analysis (CoA). |
| 2 | Identity and specification | Check that the product is sodium hyaluronate and that each specification clearly defines its tests, units, acceptance criteria, and test methods. | Current specification and batch CoA; where applicable, confirm alignment with the relevant edition of the Chinese Pharmacopoeia, USP–NF, or European Pharmacopoeia. |
| 3 | Molecular-weight control | Verify the declared molecular-weight range and whether the supplier controls and reports molecular-weight distribution consistently for the grade being purchased. | Specification, validated or qualified test method, representative batch results, and change-control information for the method or process. |
| 4 | Manufacturing process and source | Ask how the material is produced and how the process controls contamination and batch consistency. Fermentation is a commonly used production route for sodium hyaluronate. | Process overview, raw-material controls, microbial-control measures, and a statement describing relevant animal-origin or allergen considerations. |
| 5 | Purity and process-related impurities | Review controls for relevant impurities, which may include residual proteins, nucleic acids, fermentation residues, and other process-related substances, according to grade and intended use. | Impurity limits, test methods, batch data, and an explanation of how out-of-specification results are investigated. |
| 6 | Microbiological and endotoxin controls | Check microbial limits appropriate to the grade. For applications where endotoxin control is required, confirm the limit and method are suitable for the specific product and use; limits are not universal. | Microbiological and, where applicable, bacterial endotoxin test results, methods, acceptance criteria, and monitoring records. |
| 7 | Quality-management system | Assess documented controls for production, testing, deviations, complaints, corrective actions, and change management. Certification relevance depends on the product and intended market. | Quality-system certificates and their scope, audit information, relevant procedures, and evidence that the certified site matches the manufacturing site. |
| 8 | Batch consistency and traceability | Determine whether batches are identifiable and traceable from incoming materials through manufacture, testing, packaging, and shipment. | Anonymized batch records, traceability procedure, batch-release process, and documented deviation and recall procedures. |
| 9 | Stability, packaging, and transport | Confirm the shelf life, storage conditions, packaging configuration, and shipping protections are supported by product-specific data. | Stability summary, retest or expiry information, packaging specifications, and recommended storage and transport conditions. |
| 10 | Supply, commercial terms, and change notification | Evaluate lead times, minimum order quantities, sample availability, export documentation, and the supplier’s commitment to notify customers of material or process changes. | Written quotation and delivery terms, sample plan, export-document list, and a documented change-notification agreement. |