Valacyclovir Hydrochloride is a synthetic nucleoside analogue antiviral agent functioning as a prodrug of acyclovir. Upon oral administration, it is rapidly and almost completely converted to acyclovir, which inhibits replication of human herpes viruses. As a high-purity small molecule active pharmaceutical ingredient produced via validated chemical synthesis, it serves as the core raw material for solid oral dosage forms designed for the management of herpes simplex virus infections, herpes zoster, and recurrent herpes labialis.
Product Information
|
Parameter |
Specification Details |
|
Chemical Name |
2-[(2-amino-6-oxo-6,9-dihydro-3H-purin-9-yl)methoxy]ethyl L-valinate hydrochloride |
|
CAS Number |
124832-27-5 |
|
Molecular Formula |
C13H20N6O4·HCl |
|
Molecular Weight |
360.80 g/mol |
|
Physical Description |
White to off-white crystalline powder |
|
Solubility |
Freely soluble in water, slightly soluble in methanol, practically insoluble in acetone |
|
Storage Conditions |
Store in a tightly closed container, protected from light and moisture at controlled room temperature |
Quality & Specification
|
Test Item |
Specification (Compliant with USP/EP) |
|
Assay (Dried Basis) |
98.0% - 102.0% |
|
Appearance of Solution |
Clear and colorless |
|
Loss on Drying |
≤ 1.0% |
|
Residue on Ignition |
≤ 0.1% |
|
Heavy Metals |
≤ 10 ppm |
|
Related Substances |
Any individual impurity ≤ 0.10%; Total impurities ≤ 0.5% |
|
Residual Solvents (GC) |
Complies with ICH Q3C limits (Methanol, Ethanol, Acetone) |
|
Particle Size Distribution |
15 µm - 35 µm (customizable upon request) |
Manufacturing & Supply
|
Operational Parameter |
Technical Standard |
|
Production Route |
Enantioselective synthesis via purified acyclovir intermediates |
|
Facility Compliance |
Current Good Manufacturing Practice (cGMP) certified production plant |
|
Cleanroom Standard |
ISO 8 classified environments for isolation, drying, and micronization |
|
Batch Capacity |
Industrial scale available from 100 kg to multi-ton annual supply |
|
Supply Chain Continuity |
Dual-sourcing strategy for critical raw materials to mitigate disruption risks |
Documentation
Regulatory Dossier: Drug Master File (DMF) available for reference.
Analytical Support: Certificate of Analysis (CoA) provided with every commercial batch.
Compliance Certification: Written Confirmation (WC), GMP Certificate, and CEP status documentation available upon execution of confidentiality agreements.
Safety Data: Comprehensive Safety Data Sheet (SDS) detailing handling, storage, and toxicological profiles.
Packaging
|
Packaging Layer |
Material Specification |
|
Inner Packaging |
Double-layer food-grade low-density polyethylene (LDPE) bags, heat-sealed |
|
Secondary Packaging |
Aluminum foil barrier bag vacuum-sealed for moisture and light protection |
|
Outer Packaging |
Rigid fiber drum with tamper-evident security seal |
|
Standard Net Weight |
25 kg / drum |
Pharmaceutical Application
Herpes Zoster Treatment: Utilized as the active pharmaceutical ingredient in oral tablets prescribed for the acute treatment of shingles in immunocompetent adults.
Herpes Simplex Management: Incorporated into solid oral dosage formulations targeting initial and recurrent episodes of genital herpes and herpes labialis.
Varicella Therapy: Applied in the manufacture of prescription medications designated for chickenpox management in pediatric and adult populations.
Suppressive Prophylaxis: Formulated into daily-dose regimens intended for chronic suppression of recurrent genital herpes infections.
FAQ
Q: What is the standard batch size available for commercial orders?
A: Standard commercial batches are produced at multi-hundred-kilogram scale, with pilot-scale batches available for formulation development and clinical trial requirements.
Q: Is impurity profiling data accessible for regulatory submissions?
A: Yes. Complete analytical impurity profiles covering known and unknown degradation products in alignment with ICH guidelines are included within the regulatory documentation package.
Q: Can the particle size distribution be adjusted for direct compression?
A: Yes. Micronization and particle size optimization services are available to meet specific flowability and dissolution rate requirements for direct compression tablet manufacturing.
Q: What stability testing data is available for this API?
A: Both long-term (25°C / 60% RH) and accelerated (40°C / 75% RH) stability data are maintained in accordance with ICH Q1A guidelines and supplied upon formal request.
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