NewHa+® Injection Grade Sodium Hyaluronate is supplied as a raw material for pharmaceutical and medical device development. It is intended for technical evaluation and qualification, not as a finished sterile injectable product.
The current NewHa+® specification and example batch COA support technical review before sampling or purchase. Formulation and quality teams can compare the documented molecular weight, intrinsic viscosity and key quality limits with their own ophthalmic formulation and destination-market requirements.
| 品目 | Details |
| 商品名 | NewHa+® Injection Grade Sodium Hyaluronate |
| CAS番号 | 9067-32-7 |
| 学年 | Injection grade raw material |
| Physical form | 白色またはほぼ白色の粉末または繊維状骨材 |
| Assay specification | 95.0–105.0% |
| Bacterial endotoxins | <0.05 IU/mg |
| Microbial contamination | ≤100 cfu/g |
| pH | 5.0–8.5 in a 0.5% solution |
| 分子量 | Reported by batch; reference batch RN20250208-I: 1.09 × 10⁶ Da |
| 固有粘度 | Reported by batch; reference batch RN20250208-I: 1.85 m³/kg |
| Reference packaging | 10 g/bag |
| Reference shelf life | 24 months from the manufacturing date |
Injection grade sodium hyaluronate requires a different purchasing review from cosmetic or food grades. Buyers need more than a matching CAS number. Molecular weight, intrinsic viscosity, solution clarity, assay, residual impurities, microbial control and bacterial endotoxins all influence raw-material qualification.
NewHa+® is supplied as a white sodium hyaluronate powder under CAS 9067-32-7. Its specification includes identity testing against the Ph. Eur. reference spectrum, reaction of sodium, solution appearance, pH, assay, protein, nucleic acids, chlorides, heavy metals, iron, residual ethanol, microbial contamination and bacterial endotoxins.
Molecular weight and intrinsic viscosity are reported as batch values rather than fixed acceptance ranges in the available specification. This distinction matters during sourcing. A buyer with a defined rheology, filtration or device-performance target should state the required molecular-weight or intrinsic-viscosity window before sample evaluation.
The product is intended for evaluation by pharmaceutical, medical-device and formulation teams. The supplied powder still requires incoming qualification, process development and final-product controls. The raw-material grade name does not replace sterility testing, finished-product endotoxin assessment, biocompatibility work, stability studies or market-specific regulatory review.
| 外観 | 白色またはほぼ白色の粉末または繊維状骨材 |
| 識別 A. 赤外線吸収 B. ナトリウムの反応 | A. The IR spectrum of the sample exhibits maxima at the same wavelength as that of Ph.Eur. reference spectrum of Sodium Hyaluronate B. It gives reaction of sodium |
| 外観 溶液の | 吸光度は600 nmでNMT 0.01。 |
| pH | 5 .0-8.5 (0 .5%溶液) |
| 本質的なもの 粘度 | テスト値の報告 |
| 分子 重量 | テスト値の報告 |
| 核酸 酸類 | 吸光度は260 nmでNMT 0.05である。 |
| タンパク質 | ≤0.05% |
| 塩化物 | ≤0.1% |
| 重金属 | ≤10 ppm |
| 鉄 | ≤20 ppm |
| 乾燥減量 | ≤ 20.0% |
| アッセイ | 95.0%-105.0% |
| 残留 溶媒エタノール | ≤0.5% |
| 微生物 汚染 | ≤ 100 cfu/g |
| バクテリア 内毒素 | <0 .05 IU/mg |
The example batch has a reported molecular weight of 1.09 × 10⁶ Da and an intrinsic viscosity of 1.85 m³/kg. These are lot-specific results, not permanent limits for every supplied batch. They provide a useful starting point for screening, but the intended product concentration and rheological target must also be considered.
For projects with a defined molecular-weight or intrinsic-viscosity requirement, include the target value, acceptable range and preferred test method in the enquiry. This allows the available material and sample documentation to be reviewed against the same technical basis.
The specification requires a clear solution with absorbance not more than 0.01 at 600 nm. The stated pH range is 5.0–8.5 for a 0.5% solution, while the assay range is 95.0–105.0%. Together, these parameters support identity and quality screening before formulation work begins.
Solution clarity in the raw-material test does not guarantee clarity at the buyer’s final use level. Concentration, mixing conditions, other formulation components and the selected processing route can change the appearance and viscosity of the finished system.
The specification limits nucleic acids, protein, chlorides, heavy metals, iron, residual ethanol and microbial contamination. Bacterial endotoxins are specified at <0.05 IU/mg. These controls are especially relevant when a sodium hyaluronate raw material is being assessed for a regulated product.
The raw-material endotoxin result must not be treated as a finished-product release claim. The applicable final limit and test strategy depend on the product, dose, route of administration and regulatory framework. Buyers should include any method-specific or route-specific acceptance criteria in the technical request.
NewHa+® Injection Grade Sodium Hyaluronate can be evaluated as a raw material in pharmaceutical and medical device development. Molecular weight, intrinsic viscosity, solution clarity, impurity profile and bacterial endotoxin specification should be matched to the intended formulation and processing route.
医薬品グレードのヒアルロン酸ナトリウム製品は、眼科用製剤、関節内製剤、術後癒着防止剤、創傷治癒外用剤、軟組織充填剤などの医薬品や医療機器の原料または補助材料として使用することができ、点眼グレードと注射グレードの2つの仕様に分かれています。.
| 注射グレード | 粘弾性、角膜内皮の保護 | 眼科手術用接着剤 |
| 潤滑性、粘弾性、軟骨修復促進、炎症抑制、疼痛緩和など | 関節内注射 | |
| ヒアルロン酸ナトリウムおよびその誘導体は、高い分子不活性、良好な生体適合性および分解性を有する。 | 術後癒着防止剤、医療用プラスチック美容皮膚フィラー、組織工学足場材料 |
NewHa+® Injection Grade
Sodium Hyaluronate can be evaluated as a raw material in pharmaceutical and medical device development. Molecular weight, intrinsic viscosity, solution clarity, impurity profile and bacterial endotoxin specification should be matched to the intended formulation and processing route.
Intra-Articular Formulations
Injection grade sodium hyaluronate is used in the development of sodium hyaluronate-based intra-articular formulations. Define the target concentration, molecular weight, intrinsic viscosity and finished-product rheology before selecting a batch.
Dermal Fillers and Soft-Tissue Products
The material can be assessed as a native sodium hyaluronate starting material or formulation component. Native sodium hyaluronate powder is different from a finished crosslinked gel. Crosslinking, residual reagents, extrusion performance and sterilization require separate process control.
Anti-Adhesion and Other HA-Based Medical Devices
This grade can also be evaluated for hyaluronan-based anti-adhesion products and other medical-device matrices. Raw-material purity, molecular characteristics and microbiological requirements should be matched to the intended device design.
To evaluate product suitability, please provide the intended application, target specifications, estimated quantity, destination market and document requirements.
| Information to Provide | Purpose |
|---|---|
| Intended product and destination market | Define the technical and document requirements |
| Target molecular weight or intrinsic viscosity | Support batch and grade matching |
| Planned concentration | Understand the required viscosity profile |
| Required test items and limits | Check specification compatibility |
| Estimated quantity and packaging | Prepare the sample or quotation |
The published specification provides the initial technical screening criteria. The example COA shows how the defined tests and reported values are presented for one production lot. For an order or qualification sample, use the lot-specific COA for the applicable batch rather than treating an example result as a universal value.
The example document identifies the product, CAS number, batch number, manufacturing date, analysis date, expiry date, packaging, test criteria, results and release conclusion. This gives QA and sourcing teams a traceable starting point for review.
If your project requires a particular document set, list each required document, language and destination market in the enquiry. The current availability and applicable version can then be included in the technical and commercial review.
Sodium hyaluronate is widely distributed in the vitreous body, joints, umbilical cord, skin and other parts of the human body, and is an irreplaceable natural substance in the human body.
The unique human self origin, biocompatibility, strong water locking ability, and viscoelastic lubricity make sodium hyaluronate highly valuable for application.
医薬品グレードのヒアルロン酸ナトリウムは、保水、関節の潤滑、創傷治癒の促進、老化防止など、体内で重要な生理的役割を果たす。.
10g/bottle,100g/bottle, 200g/bottle, 1kg/bag, 5kg/bag, 10kg/bag.
The reference batch is packed at 10 g per bag. State the required quantity, preferred pack size and labelling requirements in the enquiry so these details can be addressed in the quotation.
The example batch carries a 24-month period from manufacturing to expiry. Storage and handling must follow the current product label and applicable safety documentation. Keep the material in its original sealed packaging and protect it from conditions that could compromise powder quality or package integrity.
MOQ, sample quantity and lead time are confirmed with the current quotation. For a useful response, provide the required grade, estimated quantity, project stage, destination country, packaging request and document list.
Renew supports B2B enquiries for NewHa+® Injection Grade Sodium Hyaluronate. The technical review can begin with the example COA and the buyer’s target profile. A sample request should identify the intended product type, required molecular characteristics, test requirements and planned evaluation quantity.
For commercial enquiries, include the estimated annual or project quantity, destination, desired packaging and required delivery window. This helps align the available batch information, document scope and quotation with the intended development program.
No fixed molecular-weight acceptance range appears in the available specification. Molecular weight and intrinsic viscosity are reported by batch. Reference batch RN20250208-I records 1.09 × 10⁶ Da and 1.85 m³/kg. Request the applicable lot result or submit a target range before sample selection.
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