NewHa® Eye Drops Grade Sodium Hyaluronate is Renew® branded sodium hyaluronate raw material for ophthalmic formulation applications.
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.
Sodium hyaluronate, the sodium salt form of hyaluronic acid, is a natural substance widely existing in human and animal bodies, and is the main component of soft connective tissues such as human skin, eye vitreous body and joint synovial fluid.
Sodium hyaluronate is a polymer acidic mucopolysaccharide composed of n-acetylglucosamine and D-glucuronic acid disaccharide units. Its irregular crimp state in solution and its fluid dynamics characteristics give it important physical properties, such as moisture retention, lubricity, viscoelasticity and pseudoplasticity. Moreover, due to its good biocompatibility, sodium hyaluronate has been developed. It is widely used in the field of medicine.
| 品目 | Details |
|---|---|
| Product | NewHa+® Eye Drops Grade Sodium Hyaluronate |
| Product type | Sodium hyaluronate raw material for ophthalmic formulation evaluation |
| CAS番号 | 9067-32-7 |
| 外観 | White or almost white powder, granules or fibrous solid |
| ヒアルロン酸ナトリウムの含有量 | 95.0–105.0% |
| 平均分子量 | Measured by batch; example result: 1.05 × 10⁶ Da |
| 固有粘度 | Measured by batch; example result: 1.95 m³/kg |
| Solution appearance | Clear; A600 nm ≤0.01 |
| 細菌性エンドトキシン | ≤0.5 IU/mg |
| Example COA | Batch RN20250329-E |
| Packing shown on example COA | 100 g |
| Storage and expiry | Follow the current product document and applicable batch label |
| Sample, MOQ and lead time | Confirmed with the current quotation |
| 外観 | 白色またはほぼ白色の粉末、または粒状もしくは繊維状の固体で、肉眼で確認できる異物のないもの |
| 赤外線吸収 | 赤外吸収スペクトルが対照スペクトルと一致すること。 |
| ヒアルロン酸ナトリウム含量（%） | 95.0~105(乾燥品で計算) |
| 溶液の外観 | 解決策を明確にすべきである。600nm≦0.01 |
| 核酸 | A260nm≦0.5 |
| pH | 5.0-8.5 |
| 平均分子量 | 測定値 |
| 固有粘度 (m3/kg) | 測定値 |
| タンパク質含有量（%） | ≤0.10 |
| 乾燥減量（%） | ≤15.0 |
| 点火時の残留物 (%) | ≤10 |
| 塩化物 (%) | ≤0.5 |
| 鉄 (ppm) | ≤80 |
| 総コロニー数（CFU/g） | ≤100 |
| 真菌および酵母（CFU/g） | ≤20 |
| 細菌性エンドトキシン(EU/mg) | ≤0.5 |
| 生存可能な溶血性連鎖球菌 | ネガティブ |
| 溶血 | ネガティブ |
| 大腸菌/g | ネガティブ |
| 黄色ブドウ球菌 | ネガティブ |
| シュードモナス・アエルギノーサス | ネガティブ |
医薬品グレードのヒアルロン酸ナトリウム製品は、眼科製剤、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や補助材料として使用することができ、2つの規格に分けられます：点眼グレードと注射グレードに分けられる。.
| 目薬 グレード | 潤滑、保湿、効能改善、ドライアイ緩和、角膜・結膜損傷治癒促進など | 目薬、目の保湿剤、コンタクトレンズケア液、洗眼液、腔内潤滑剤など |
| 創傷治癒を促進する | 外用剤（ゲル、フィルム剤など） | |
| 薬剤または細胞キャリア／マトリックス | 点眼薬、細胞培養、外用剤など | |
| 粘膜損傷、軟骨損傷などの修復 | 経口医薬製剤 |
Eye Drops and Artificial-Tear Formulations
This grade can be evaluated as a sodium hyaluronate raw material for aqueous eye-drop and artificial-tear formulations. Review the batch-specific molecular weight and intrinsic viscosity against the target solution viscosity and processing requirements. Confirm clarity, pH, compatibility and stability in the finished formulation.
Contact Lens Care Solutions
Where permitted for the intended product and market, eye drops grade sodium hyaluronate may also be evaluated in contact lens care solutions. Confirm compatibility with the preservative or disinfecting system, packaging and finished-product microbiological requirements.
The available example COA identifies the product, batch number, manufacturing and analysis dates, expiry date, packing configuration, acceptance criteria and actual batch results. It provides a traceable source for the numerical data shown on this page.
For commercial approval, use the documentation applicable to the proposed product and lot. If the project requires a TDS, SDS, test method, compendial statement, origin statement or destination-market document, include the exact scope in the enquiry so the current version and availability can be confirmed.
| 文書 | 在庫状況 |
|---|---|
| Example COA | Available for batch RN20250329-E |
| ロットごとのCOA | Request for the proposed or supplied batch |
| Current TDS and SDS | Current availability and version confirmed with the document request |
| Test method or compendial statement | State the required method, edition and acceptance criterion |
| 輸出先市場の資料 | Provide the country and required document scope for review |
NewHa+® Eye Drops Grade Sodium Hyaluronate is available in 10 g, 100 g and 200 g bottles, as well as 1 kg, 5 kg and 10 kg bags. Include the required pack size and order quantity in your enquiry.
No. Renew treats eye-drops-grade and injection-grade sodium hyaluronate as separate grades with different specifications and intended applications.
Samples are available for evaluation, subject to current availability. Send the required quantity and destination country for confirmation.
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。.
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