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.
| Artigo | Detalhes |
|---|---|
| Brand / grade | NewPN-P® Salmão de qualidade farmacêutica PN |
| Product identity | Sodium DNA / salmon-derived polynucleotide raw material |
| Número CAS | 9007-49-2 |
| Aparência | Pó branco ou esbranquiçado ou sólido fibroso |
| Solubilidade | Ligeiramente solúvel em água |
| Peso molecular médio | ≥1 000 kDa |
| Ensaio | ≥95.0% |
| Teor de proteínas | <1,0% |
| Endotoxina bacteriana | <0.5 EU/mg |
| Standard packaging | 50 g/bottle, 100 g/bottle, 1 kg/bag |
| Shelf life | 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.
| Item de teste | Especificação |
|---|---|
| Aparência | Pó branco ou esbranquiçado ou sólido fibroso |
| Solubilidade | Ligeiramente solúvel em água |
| Identificação | UV absorbance ratio at 260/280 nm: 1.5–2.0 |
| pH | 5.0–9.0 |
| Peso molecular médio | ≥1 000 kDa |
| Teor de proteínas | <1,0% |
| Perda por secagem | ≤20.0% |
| Metais pesados | ≤10 μg/g |
| Transmitância | ≥96.0% |
| Ethanol residue | <0,5% |
| Endotoxina bacteriana | <0.5 EU/mg |
| Contagem total de micróbios aeróbios | NMT 100 CFU/g |
| Total molds and yeasts | NMT 100 CFU/g |
| Staphylococcus aureus | Negativo |
| Pseudomonas aeruginosa | Negativo |
| Escherichia coli | Negativo |
| Ensaio | ≥95.0% |
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 | Peso molecular médio | Selection Context |
|---|---|---|
| NewPN-P® Salmão de qualidade farmacêutica PN | ≥1 000 kDa | Projects specifying Renew’s higher-molecular-weight PN grade |
| NewPDRN-P® PDRN de salmão de qualidade farmacêutica | ≤1 000 kDa | 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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