WHO-GMP Certified Biological / Recombinant Protein API Supplier
| Parameter | Specification |
|---|---|
| Appearance | White to off-white lyophilized powder / sterile solution |
| Identification | SDS-PAGE / Western Blot / Peptide Mapping |
| Purity (SEC-HPLC) | ≥ 98.0% |
| Protein Content | As per validated assay (Lowry / UV280) |
| Potency (Bioassay) | 80% – 125% of label claim |
| Endotoxin | < 1.0 EU/mg |
| Bioburden | NMT 10 CFU/g |
| Moisture Content | NMT 2.0% (lyophilized form) |
Alirocumab (CAS 1245916-14-2) is a biological active ingredient classified as a anti-pcsk9 monoclonal antibody, used in the treatment of hypercholesterolemia and cardiovascular risk reduction. As a trusted Alirocumab sourcing partner in India, Swapnroop Drugs & Pharmaceuticals connects pharmaceutical formulators and research organizations to consistent supply with complete batch documentation for regulated and semi-regulated markets.
Organizations sourcing Alirocumab evaluate SEC-HPLC purity (≥98.0%), confirmed identity by SDS-PAGE / Western blot / peptide mapping, validated potency by bioassay, and tightly controlled endotoxin and bioburden limits. Cold-chain integrity and batch-to-batch consistency in glycosylation and aggregation profile are critical for downstream formulation performance.
Swapnroop Drugs and Pharmaceuticals coordinates Alirocumab supply through our Aurangabad, Maharashtra base with full cold-chain handling and batch-specific quality documentation. We support regulatory dossier compilation, provide validated stability data where available, and serve formulation and research organizations across 25+ countries.
Alirocumab is supplied in validated cold-chain packaging with insulated containers, temperature data loggers, and tamper-evident sealing to preserve product integrity during storage and international transit.
Get Bulk QuoteThe CAS number for Alirocumab API is 1245916-14-2. Please verify the exact salt or hydrate form you require as different forms carry distinct CAS numbers.
Alirocumab is supplied to in-house validated specifications with SEC-HPLC purity ≥98.0%, controlled endotoxin and bioburden limits, and potency confirmed by validated bioassay, with full batch-specific documentation.
Minimum order quantities and lead time for Alirocumab depend on batch size and cold-chain logistics requirements; please contact our team for current availability. Standard lead time is 3–6 weeks from confirmation of order, with expedited supply available on request.
Yes, Swapnroop provides batch-specific Certificate of Analysis, MSDS, and available regulatory support documentation for Alirocumab to assist with import, formulation, and dossier requirements in your target market.
Swapnroop Drugs and Pharmaceuticals is a trusted Alirocumab supplier serving pharmaceutical formulation and research organizations across India and international markets. Our Aurangabad, Maharashtra based team provides consistent Alirocumab sourcing with batch-specific documentation, competitive pricing, and support for domestic and export programs.
As a Alirocumab exporter from Maharashtra, India, Swapnroop supports organizations worldwide with available Certificate of Analysis, MSDS, and regulatory filing assistance documentation. Contact us for Alirocumab pricing, samples, and sourcing support.