Ganciclovir Powder Cas No.82410-32-0
Product Source: Synthetic
Specification: ≥99.0%
CAS No.: 82410-32-0
Molecular Formula: C₉H₁₃N₅O₄
Molecular Weight: 255.23
Testing Method: HPLC
Active Ingredient: Ganciclovir
Product Characteristics: White or off-white crystalline powder. Hygroscopic.
Product Packaging: 1kg/bag; 25kg/drum
Storage Conditions: Store sealed in a cool, dry, dark place.
Shelf Life: 24 months
Declaration of Use: This product is intended for industrial use or scientific research only.
Ganciclovir Free Base API Powder CAS 82410-32-0
Why Is Anhydrous Ganciclovir Preferred For Ophthalmic Formulations?
1. API Characterization & Formulation Value
Xi'an Tihealth manufactures high-purity Ganciclovir API in its anhydrous free base form (CAS 82410-32-0). This synthetic guanine nucleoside analogue is highly optimized for pharmaceutical formulations requiring long-term structural integrity and specific pH profiles. Unlike its highly hygroscopic and alkaline sodium salt counterpart, Ganciclovir free base exhibits superior rheological compatibility when incorporated into topical ophthalmic gels (carbomer-based), ocular ointments, and sustained-release solid oral dosage forms.
Leveraging advanced crystallization technologies, we strictly control the crystal habit to yield the thermodynamically stable polymorph (Form I). We offer custom micronization (D90 ≤ 10 μm) to ensure seamless dispersion, enhanced bioavailability for BCS Class IV applications, and a non-gritty, highly tolerated texture in sensitive ophthalmic delivery systems.
2. Technical Data Sheet (TDS) & Specifications
| Quality Parameter | Specification Limit (USP / EP) |
|---|---|
| Physical Appearance | White to off-white crystalline powder |
| Assay (HPLC, Dried Basis) | 99.0% – 101.0% |
| Particle Size Profile (D90) | Micronized available (≤ 10 μm, tailored for ophthalmic gels) |
| Polymorphic Form | Form I (Thermodynamically stable polymorph) |
| Hygroscopicity | Low (Significantly more stable than Ganciclovir Sodium) |
| Loss on Drying / Water Content | ≤ 1.0% |
| Heavy Metals | ≤ 10 ppm |
| Related Substances (HPLC) | Single Unknown Impurity ≤ 0.10%; Total Impurities ≤ 0.50% |
3. Advanced Ophthalmic & Oral Formulation Compatibility
Ophthalmic Viscosity Integrity
The absence of sodium ions in Ganciclovir free base prevents critical ionic interference and "salting-out" effects in sensitive carbomer or polyacrylic acid-based eye gel networks, preserving the formulation's designed rheology and viscosity.
Dissolution Kinetics Control
Engineered for BCS Class IV classifications, our micronized API (≤10μm) exponentially increases the specific surface area. This ensures homogenous dispersion in ocular gels and significantly improves dissolution uniformity in gastrointestinal fluids for oral tablets.
Low Hygroscopicity Handling
Simplifies bulk manufacturing and compounding processes. The extremely low moisture-binding affinity of Ganciclovir Base allows for safer, more predictable processing under standard cleanroom humidity controls, preventing premature hydrolytic degradation.
4. Pharmacodynamics & Viral DNA Polymerase Inhibition
Ganciclovir is a potent synthetic antiviral agent that selectively arrests cytomegalovirus (CMV) and herpes simplex virus (HSV) replication. Intracellularly, viral thymidine kinase (or UL97 kinase) monophosphorylates Ganciclovir, which cellular kinases then convert to the active form, Ganciclovir Triphosphate. This activated molecule acts as a competitive inhibitor of viral dGTP, incorporating directly into the viral DNA strand and inducing chain termination by inactivating viral DNA polymerase.
CRITICAL SAFETY & HANDLING NOTICE
Ganciclovir is classified as a highly potent active pharmaceutical ingredient (HPAPI) with documented teratogenic, mutagenic, and carcinogenic properties. Appropriate Personal Protective Equipment (PPE)-including double-gloving, respiratory protection, and handling within localized negative pressure containment systems (isolators)-is mandatory during raw material dispensing and formulation processes.
5. Frequently Asked Sourcing Questions
Why is Ganciclovir Base preferred over Ganciclovir Sodium for ophthalmic preparations?Hot Tags: ganciclovir powder cas no.82410-32-0, China ganciclovir powder cas no.82410-32-0 manufacturers, suppliers, factory, hialuronato de sodio hialuronato sodico sodium hyaluronate, , ,
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