Acyclovir Sodium Powder Cas No.69657-51-8
Product Source: Synthetic
Product Specification: ≥98%
CAS No.: 69657-51-8
Molecular Formula: C₈H₁₂N₅NaO₃
Molecular Weight: 249.21 g/mol
Testing Method: HPLC
Active Ingredient: Acyclovir Sodium
Product Characteristics: White or off-white crystalline powder.
Product Packaging: 1kg/bag; 25kg/drum
Storage Conditions: Store in a cool, dry, dark place under sealed conditions. Storage in an inert atmosphere (e.g., nitrogen-filled) is recommended to maintain stability.
Shelf Life: 24 months
Acyclovir Sodium API Powder CAS 69657-51-8
Why Is The Sodium Salt Essential For Intravenous Antiviral Formulations?
1. API Characterization & Manufacturing Value
Xi'an Tihealth supplies pharmaceutical-grade Acyclovir Sodium API (CAS 69657-51-8), the highly water-soluble sodium salt of the synthetic purine nucleoside analogue, acyclovir. While the parent free base suffers from extremely poor aqueous solubility, this specialized sodium salt is engineered specifically to achieve the high concentrations required for parenteral administration, making it an indispensable raw material for sterile intravenous therapies targeting severe Herpes Simplex (HSV) and Varicella-Zoster (VZV) infections.
Manufactured under rigid cGMP protocols, our Acyclovir Sodium powder is optimized for both direct sterile injectables and lyophilized powder for injection (LPI). We exercise precise control over critical parameters, including pH stability, extremely low bacterial endotoxins, and the strict limitation of synthesis-related impurities such as guanine, ensuring exceptional pharmacokinetic performance and absolute batch-to-batch reliability.
2. Technical Data Sheet (TDS) & Specifications
| Quality Parameter | Specification Limit (USP / EP) |
|---|---|
| Physical Appearance | White to slightly yellowish crystalline powder |
| Assay (HPLC, Anhydrous Basis) | 98.0% – 101.0% |
| pH (10% Aqueous Solution) | 10.5 – 11.5 (Confirms sodium salt identity) |
| Guanine Impurity | ≤ 0.7% |
| Related Substances (HPLC) | Single Unknown Impurity ≤ 0.10%; Total Impurities ≤ 1.0% |
| Water Content (Karl Fischer) | Strictly controlled to optimize lyophilization behavior |
| Bacterial Endotoxins | Suitable for parenteral use (Compliant with formulation limits) |
3. Pharmacodynamics & Viral Kinase Selectivity
Selective TK Activation
Acyclovir acts as a prodrug that requires phosphorylation to become active. Its initial conversion to acyclovir monophosphate is catalyzed almost exclusively by viral thymidine kinase (TK). This unique mechanism restricts drug activation primarily to virus-infected cells, ensuring a high safety profile for uninfected host tissue.
Irreversible Chain Termination
After host cellular enzymes convert it to acyclovir triphosphate, it competes with deoxyguanosine triphosphate (dGTP) for viral DNA polymerase. Because the acyclovir molecule lacks a 3'-hydroxyl group, its incorporation into the growing viral DNA strand causes obligate chain termination, irreversibly halting viral replication.
4. Core Pharmaceutical Applications
- Sterile Injectable Manufacturing: The foundational API for formulating intravenous solutions used in critical care for severe herpes simplex encephalitis and initial genital herpes episodes in immunocompromised patients.
- Lyophilized Powder Development: Highly optimized for producing high-concentration powder for injection, delivering rapid reconstitution times and compliant particulate profiles.
- Neonatal & Critical Care: Applied in the formulation of critical antiviral regimens to manage severe neonatal HSV infections and VZV-related complications.
CRITICAL COMPLIANCE & HANDLING DIRECTIVE
Intended strictly for B2B industrial formulation, GMP manufacturing, and authorized R&D. Acyclovir Sodium is highly hygroscopic and chemically sensitive to atmospheric carbon dioxide (CO2), which can lower the pH and cause the precipitation of insoluble acyclovir base. Strict storage at 2°C to 8°C under a nitrogen-flushed atmosphere is mandatory to maintain full structural potency and lot integrity.
5. Frequently Asked Sourcing Questions
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