Salmon-derived Sodium DNA raw material with an average molecular weight of ≥1,000 kDa. Defined specifications cover assay, protein, residual ethanol, microbiological quality and bacterial endotoxin.
Renew supplies NewPN-P® pharmaceutical grade Salmon PN, identified as Sodium DNA under CAS 9007-49-2. This ≥1,000 kDa raw material is supplied for formulation development, analytical evaluation and material qualification.
The grade combines an average molecular-weight specification of ≥1,000 kDa with defined limits for assay, protein, ethanol residue, heavy metals, bacterial endotoxin and microbiological quality. These parameters give procurement, R&D and QA teams a clearer basis for comparison than the terms PN, PDRN or salmon DNA alone.
NewPN-P® is a raw material for further development and qualification. It is not a finished pharmaceutical or medical-aesthetic product. Finished-product requirements depend on the intended use, route, formulation, manufacturing process and destination market.
| 品目 | Details |
|---|---|
| Brand / grade | NewPN-P®医薬品グレードサーモンPN |
| Product identity | Sodium DNA / salmon-derived polynucleotide raw material |
| CAS番号 | 9007-49-2 |
| 外観 | 白色またはオフホワイトの粉末または繊維状の固体 |
| 溶解度 | 水にわずかに溶ける |
| 平均分子量 | 1,000 kDa以上 |
| アッセイ | ≥95.0%以上 |
| タンパク質含有量 | <1.0% |
| 細菌性エンドトキシン | <0.5 EU/mg |
| 標準梱包 | 50 g/bottle, 100 g/bottle, 1 kg/bag |
| 保存期間 | 2 years |
| Quality documentation | Example COA available; request the current documents required for qualification |
| Sample, MOQ and lead time | Confirmed with the current quotation |
The table presents the acceptance criteria shown in the available product COA. Actual batch results are reported in the applicable lot-specific COA. Buyers with additional test, limit or method requirements can include them in the technical enquiry.
| テスト項目 | 仕様 |
|---|---|
| 外観 | 白色またはオフホワイトの粉末または繊維状の固体 |
| 溶解度 | 水にわずかに溶ける |
| 識別 | UV absorbance ratio at 260/280 nm: 1.5–2.0 |
| pH | 5.0–9.0 |
| 平均分子量 | 1,000 kDa以上 |
| タンパク質含有量 | <1.0% |
| 乾燥減量 | ≤20.0% |
| 重金属 | ≤10 μg/g |
| 透過率 | ≥96.0% |
| Ethanol residue | <0.5% |
| 細菌性エンドトキシン | <0.5 EU/mg |
| 好気性微生物総数 | NMT 100 CFU/g |
| Total molds and yeasts | NMT 100 CFU/g |
| 黄色ブドウ球菌 | ネガティブ |
| 緑膿菌 | ネガティブ |
| 大腸菌 | ネガティブ |
| アッセイ | ≥95.0%以上 |
Renew specifies NewPN-P® at an average molecular weight of ≥1,000 kDa. This identifies it as the higher-molecular-weight PN grade within Renew’s Sodium DNA portfolio.
Because Sodium DNA is polymeric, the reported value represents an average rather than one fixed molecular size. Include any required molecular-weight distribution, reporting basis or analytical method in the technical enquiry.
The assay specification is ≥95.0%. Protein is controlled separately at <1.0%, while ethanol residue, loss on drying and heavy metals each have their own acceptance limits. This separation helps buyers compare the complete quality profile instead of treating assay as the only purchasing criterion.
The specification includes bacterial endotoxin below 0.5 EU/mg, limits for total aerobic microorganisms and molds and yeasts, and absence criteria for three named microorganisms.
The assay specification is ≥95.0%. Protein is controlled separately at <1.0%, while ethanol residue, loss on drying and heavy metals each have their own acceptance limits. This separation helps buyers compare the complete quality profile instead of treating assay as the only purchasing criterion.
Renew supplies NewPN-P® and NewPDRN-P® as separate commercial grades. Within Renew’s current product portfolio, a key stated specification difference is average molecular weight.
| Renew Grade | 平均分子量 | Selection Context |
|---|---|---|
| NewPN-P®医薬品グレードサーモンPN | 1,000 kDa以上 | Projects specifying Renew’s higher-molecular-weight PN grade |
| NewPDRN-P® 医薬品グレードサーモンPDRN | 1,000 kDa以下 | Projects specifying Renew’s lower-molecular-weight PDRN grade |
These limits define Renew’s commercial grades. They are not universal definitions used by every supplier. Compare the current specification, analytical method, sample behavior and applicable batch documentation when assessing alternatives.
For a lower-molecular-weight option, review Renew’s NewPDRN-P® Pharmaceutical Grade Salmon PDRN.
Pharmaceutical Formulation Development
NewPN-P® can be considered during pharmaceutical formulation and analytical development when salmon-derived Sodium DNA with an average molecular weight of ≥1,000 kDa is required. Its defined assay, protein, residual ethanol, endotoxin and microbiological specifications support initial material screening. Confirm compatibility, processing, stability and route-specific requirements before scale-up.
Professional Medical-Aesthetic Product Development
NewPN-P® may be assessed for professional medical-aesthetic product development where higher-molecular-weight salmon PN is specified. Evaluate the product format, use level, processing method, stability and destination-market requirements. Pharmaceutical grade describes the raw-material specification; it does not establish finished-product approval or suitability for injection or implantation.
Medical-Device Development Requirements
For projects following a medical-device pathway, use the NewPN-P® specification and example COA only for initial material screening. Submit the intended purpose, target market, material function, contact type and duration, required tests and document list with the enquiry. Finished-product classification, sterility, biocompatibility, safety and performance must be established separately.
For an order, use the lot-specific COA issued for the applicable batch. Request current supporting documents according to the intended product, destination country and internal qualification requirements.
Include any additional test, standard or analytical-method requirements in the enquiry for technical review.
Yes. Provide the intended application, required sample quantity and document needs. Request the COA applicable to any commercial lot under consideration. Current sample terms are confirmed with the quotation.
MOQ and lead time are confirmed with the current quotation. They may vary with quantity, packaging, documentation and destination.
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