Pharmaceutical Grade L-Lysine HCl: High-Purity API for Pharma & Nutraceuticals

(Intro):

Pharmaceutical Grade L-Lysine Supplier

Blue Eyes Bio is your trusted global supplier of premium L-Lysine Monohydrochloride (L-Lysine HCl, CAS 657-27-2) manufactured to the highest pharmaceutical grade standards (USP-NF, Ph.Eur., JP). Our GMP-compliant production ensures this essential amino acid delivers consistent quality, purity, and safety for critical applications in pharmaceutical formulations (including parenteral nutrition and injectables) and high-quality nutraceutical products. We offer reliable bulk supply backed by comprehensive regulatory documentation.

Specification:

Button: Request Certificate of Analysis (COA)

Key Applications):

1. Pharmaceutical Formulations:

Essential component in Amino Acid Injections and Parenteral Nutrition (PN) solutions for patients unable to obtain adequate nutrition orally.

Raw material in Oral Solid Dosage Forms (tablets, capsules) requiring amino acid supplementation.

Ingredient in specialized Enteral Nutrition products.

Potential use in developing therapeutic agents where lysine plays a role.

2. Nutraceuticals & Dietary Supplements:

Key ingredient in Protein Powders, Amino Acid Blends, and Sports Nutrition products to support muscle protein synthesis.

Formulation component in supplements targeting Immune System Support, Skin Health (collagen synthesis), and Calcium Absorption.

Used in Clinical Nutrition products for specific dietary needs.

3.Research & Development:

High-purity material for biochemical research and pharmaceutical development.

Quality & Compliance - Core:

At Blue Eyes Bio, quality and regulatory compliance are paramount:

1. Manufactured under strict GMP (Good Manufacturing Practice) guidelines.

2. Conforms to current pharmacopeial standards: United States Pharmacopeia (USP-NF), European Pharmacopoeia (Ph.Eur.), Japanese Pharmacopoeia (JP).

3. Rigorous Quality Control: Every batch undergoes extensive testing against pharmacopeia specifications in our state-of-the-art QC laboratories. Full traceability guaranteed.

4. Comprehensive Documentation: Available upon request: Certificate of Analysis (COA), Material Safety Data Sheet (MSDS), and relevant regulatory support documents (e.g., DMF CEP references if applicable). We provide transparency and support for your regulatory filings.

5. Stability Studies: Data available to support shelf-life and storage conditions.

Blue Eyes Bio ？(Why Choose Us?):

1. Uncompromising Purity & Quality: Consistent API-grade material meeting the strictest global pharmacopeia requirements.

2. GMP Assurance: Production adhering to international Good Manufacturing Practices.

3. Regulatory Expertise: Dedicated support for navigating global pharmaceutical regulations.

4. Reliable Global Supply Chain: Proven track record of secure, on-time delivery to customers in Europe, North America, and worldwide.

5. Technical & Customer Support: Experienced team ready to assist with technical inquiries and customized solutions.

6. Commitment to Excellence: Partnering with us means partnering with a supplier dedicated to the highest standards of the pharmaceutical and nutraceutical industries.

[mail]: Contact Our Pharma Sales Team]

[mail]: Request a Sample]

Packaging & Shipping:

1. Standard Packaging: 25 kg net weight in clean, durable paperboard drums / fiber drums with double polyethylene liners. (Custom packaging options available upon request).

2. Storage: Store in a cool, dry, well-ventilated place. Keep container tightly closed. Protect from moisture.

3. Shelf Life: Typically 36 months from the date of manufacture when stored under recommended conditions.

4. Global Shipping: We expertly handle international logistics for pharmaceutical raw materials, ensuring compliance with regulations and maintaining product integrity throughout transit. Specific cold chain options available if required.

FAQ - :

Q: What is the difference between Feed Grade, Food Grade, and Pharmaceutical Grade L-Lysine?

A: Pharmaceutical Grade (like ours) has the highest purity standards, strictest limits on impurities (heavy metals, residual solvents, microbes), and adheres to pharmacopeia monographs (USP/EP/JP). It's produced under GMP and undergoes rigorous QC testing for use in drugs and high-end supplements. Food Grade has lower purity requirements, Feed Grade lower still.

Q: Can I get L-Lysine HCl suitable for injection applications?

A: Yes, we supply low-endotoxin L-Lysine HCl specifically controlled for parenteral use. Please specify your requirement when inquiring.

Q: Do you offer custom specifications or packaging?

A: Yes, we can discuss tailored solutions based on your specific project needs. Contact our sales team.

Q: What documentation do you provide with each shipment?

A: We provide a detailed Certificate of Analysis (COA) for each batch and a Material Safety Data Sheet (MSDS). Additional regulatory documents are available upon request.

Q: What is your minimum order quantity (MOQ)?

A: Our standard MOQ is [25] kg. We offer you flexible MOQ, please contact us. Please contact us for specific quantities and pricing.

Final :

Ready to source premium Pharmaceutical Grade L-Lysine HCl for your critical applications? Contact Blue Eyes Bio today for a competitive quote, request a sample to evaluate our quality, or speak with our technical experts.