KEYNOVO BIOTECH
CEP-Certified Polysaccharide APIs & Excipients
Specialised Polysaccharide API Partner
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Chondroitin Sulfate CEP
Flagship Pharmaceutical API
High-quality chondroitin sulfate manufactured according to the European Pharmacopoeia standards with CEP certification, suitable for pharmaceutical formulations, including injectable applications.
Key Specifications
Assay: ≥95.0%(ondriedbasis)
pH: 5.5–7.5(1%aqueoussolution)
LossonDrying: ≤10.0%
HeavyMetals: ≤10ppm
MicrobialLimits: Complies with EP/USP requirements
Applications
Oral solid dosage forms, injectable formulations, and advanced pharmaceutical
preparations for joint health and osteoarthritis management.
Packaging: Available in 25kg drums or customised packaging to meet specific
pharmaceutical requirements.
Hyaluronic Acid CEP
Injectable-Grade Polysaccharide API
Molecular Weight Options
Available in multiple molecular weight ranges to meet diverse
pharmaceutical applications, from low MW (10–100 kDa) to high
MW (1,000–2,000 kDa).
Injection-Grade Quality
Stringent endotoxin control (≤0.5 EU/mg)
High purity with minimal protein content
Complies with EP and USP monographs
Suitable for parenteral administration
Pharmaceutical Specifications
Appearance: White to off-white powder
Purity: ≥95.0%
pH: 6.0–8.0 (0.1% solution)
Heavy Metals: ≤10 ppm
Microbial Limits: Sterile-grade available
Applications
Injectable formulations for orthopaedics and aesthetics, ophthalmic solutions, and medical device coatings.
Full Regulatory Support: CEP certificate, DMF files, comprehensive analytical documentation, and stability studies available to support your regulatory submissions.
Complementary Joint Health Ingredients
Pharmaceutical-grade active ingredients to support comprehensive joint health formulations.
Glucosamine Sulfate 2KCl
High-purity crystalline form meeting
pharmacopoeial standards. Suitable for oral solid dosage forms with established
bioavailability profiles.
MSM(Methylsulfonylmethane)
Pharmaceutical-grade MSM with high purity. Compliant with relevant pharmacopoeial monographs for joint health formulations.
Glucosamine HCl
Stable hydrochloride salt form with excellent solubility characteristics. Ideal for tablets, capsules, and powder formulations.
Type II Collagen
Bioactive collagen for cartilage support
applications. Manufactured under controlled conditions with consistent quality specifications.
Documentation Available: Certificates of Analysis, Technical Data Sheets, and regulatory support documentation provided for all products.
Pharmaceutical Excipients Portfolio
Comprehensive range of pharmacopoeial-grade excipients for diverse pharmaceutical formulations
Injectable Grade Excipients
Propylene Glycol USP/EP
Benzyl Alcohol USP/EP
Mannitol (Injection Grade)
Sodium Chloride (Injection Grade)
All injectable excipients meet stringent purity and endotoxin
requirements.
Functional Excipients
Trehalose
Tyloxapol
Sorbitol
Glycerin USP/EP
Specialised excipients for stabilisation, solubilisation, and formulation optimisation.
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