Pharmaceutical-Grade Enzymes
Pharmaceutical-Grade Enzymes (EC Various) — USP/EP Enzyme-Grade Biocatalysts
USP/EP grade enzymes for reliable performance in pharmaceutical and bioprocess workflows. Available from bovine (trypsin), porcine (pepsin), and bacterial (lysozyme) sources, plus additional pharmaceutical-grade enzyme families (e.g., lipase, esterase, protease) for API processing and downstream manufacturing. Optimal pH 2.0–8.5 (enzyme-dependent) and optimal temperature 25°C–40°C. White to off-white lyophilized powder. Activity: USP/EP grade available. MOQ 100 g. Ships worldwide.
Product Specifications
Pharmaceutical-Grade Enzymes Powder — USP/EP grade available
Activity
USP/EP grade available
Optimal pH
2.0 – 8.5 (enzyme-dependent)
Optimal Temperature
25°C – 40°C
Appearance
White to off-white lyophilized powder
Source organism
Bovine (Trypsin), Porcine (Pepsin), Bacterial (Lysozyme)
Shelf Life
24 months (sealed, -20°C)
Packaging
100 g – 25 kg / cGMP packaging
MOQ
100 g
Certifications
ISO 9001, cGMP, USP/EP, DMF available, >95% purity (HPLC)
Applications
Pharmaceutical-Grade Enzymes for USP/EP-compliant bioprocessing, consistent activity across recommended pH/temperature windows, and documented quality for cGMP and QC laboratory use.
Pharmaceutical Manufacturing
USP/EP-grade trypsin, pepsin, and lipase for API processing, drug formulation, and pharmaceutical intermediate production.
Cell Culture
Ultra-pure trypsin and collagenase for cell dissociation, tissue engineering, and biopharmaceutical production — low endotoxin guaranteed.
Protein Analysis
Sequencing-grade trypsin and chymotrypsin for mass spectrometry, peptide mapping, and proteomic research workflows.
Vaccine Production
GMP-documented enzymes for viral inactivation, cell harvesting, and downstream processing in vaccine manufacturing facilities.
API Processing
Pharmaceutical-grade lipase, esterase, and protease for chiral resolution, peptide synthesis, and active ingredient manufacturing.
Quality Control
Reference-standard enzymes with full CoA, HPLC purity data, and lot traceability for QC laboratories and cGMP compliance.
Why Source From Us
Pharmaceutical-Grade Quality Systems
ISO 9001 and cGMP packaging support consistent manufacturing controls for USP/EP-grade enzyme supply.
Documented Purity & Traceability
HPLC purity data (>95%) and lot traceability available, with CoA support for QC laboratories and cGMP compliance.
Optimized for Bioprocess Conditions
Designed for reliable performance within optimal pH 2.0–8.5 (enzyme-dependent) and optimal temperature 25°C–40°C.
Flexible Bulk Packaging & Fast Procurement
Available in 100 g – 25 kg formats with cGMP packaging. MOQ 100 g for smoother qualification and production planning.
Frequently Asked Questions
What does “USP/EP grade available” mean for Pharmaceutical-Grade Enzymes?
It means we can supply enzyme grades suitable for USP/EP-aligned specifications, with documentation such as CoA and supporting quality data to support your regulatory and manufacturing needs.
What are the optimal pH and temperature ranges?
Optimal pH is 2.0–8.5 depending on the specific enzyme, and optimal temperature is 25°C–40°C for best activity and process consistency.
What is the shelf life and recommended storage?
Shelf life is 24 months when sealed and stored at -20°C. Follow the storage guidance on your CoA/TDS for best results.
Which source organisms are available?
We offer enzymes from bovine (trypsin), porcine (pepsin), and bacterial (lysozyme) sources, with additional pharmaceutical-grade enzyme families available depending on your application.
Do you provide purity data and documentation for QC and cGMP use?
Yes. We provide >95% purity (HPLC) information, full CoA, and lot traceability. DMF availability is also supported upon request.
Get a Free Sample & Quote
Tell us about your application and volume needs. We'll send you a free sample, COA, and competitive pricing within 24 hours.
Response
Response within 24 hours
Shipping
Ships from China to 80+ countries