Stability and Storage Guidelines for Latanoprost API

Latanoprost API, a prostaglandin analogue widely used in ophthalmic formulations, is a highly sensitive compound. Its chemical stability, shelf life, and overall efficacy depend heavily on how it is packaged, stored, and transported.

In this guide, we outline best practices for ensuring the maximum stability and regulatory compliance of Latanoprost API—from cold-chain storage to light protection and packaging materials.

✅ Chemignition Laboratory is a GMP-certified manufacturer, supplier, and exporter of Latanoprost API with a documented shelf life of up to 36 months.

1. Why Latanoprost Requires Strict Storage Conditions

Latanoprost is chemically active at extremely low concentrations (0.005% in eye drops), making it highly susceptible to:

• Degradation from light
• Oxidation due to exposure to air
• Hydrolysis in the presence of moisture
• Thermal breakdown at elevated temperatures

Therefore, maintaining a cold, light-resistant, and airtight environment is essential to preserve its pharmacological properties during long-term storage and global distribution.

2. Ideal Storage Temperature Range

• Recommended storage temperature:
  −20°C to −10°C
• Acceptable short-term range during shipping (if validated):
  2°C to 8°C for ≤7 days
• Avoid exposure to:
  • Room temperature for >24 hours
  • Repeated freeze-thaw cycles
  • Direct sunlight or fluorescent light

💡 Maintaining a cold-chain logistics process from manufacturer to formulator is essential for stability.

3. Standard Packaging Process for Latanoprost API Storage

Chemignition follows a validated, multilayered packaging process to ensure physical and chemical stability throughout the product lifecycle.

✅ Step-by-step packaging method:

1. Primary container:
   Place Latanoprost API in a glass or polypropylene (PP) vial. This prevents chemical interaction and moisture ingress.
2. Secondary containment:
   Insert the vial into a polyethylene/poly bag. Twist the mouth of the bag and secure it with a PVC strip.
3. Tertiary barrier:
   Place the sealed poly bag inside a triple-laminated aluminum foil bag. Seal it hermetically using a heat sealer.
4. Final container:
   Insert the aluminum pouch into an HDPE (high-density polyethylene) container to provide external insulation and protect against physical damage.
5. Labeling:
   Each pack is labeled with:
   • Batch number
   • Net quantity
   • Manufacturing & expiry date
   • GMP site address
   • Storage conditions

✅ This method ensures minimal exposure to moisture, light, oxygen, and mechanical stress.

4. Shelf Life of Latanoprost API

• Documented shelf life:
  36 months (3 years) under proper storage conditions
  (−20°C to −10°C, sealed, light-protected)
• Retest interval (if opened):
  Use within 30 days once opened and exposed to ambient air.
• Stability data available:
  • Accelerated stability
  • Real-time long-term data
  • Photostability (per ICH Q1B)

Chemignition provides full stability documentation with each batch for client regulatory submissions.

5. Signs of Latanoprost Degradation

If not stored properly, Latanoprost API may:

• Develop discoloration (from white/off-white to yellowish)
• Emit a slight acidic or rancid odor
• Lose assay potency (<98%)
• Show increased impurity levels in HPLC analysis

💬 Recommendation: Always inspect the API visually and confirm CoA compliance before formulation use.

6. Cold Chain Shipping Best Practices

Chemignition ships Latanoprost API globally using pharma-compliant logistics partners.

📦 We offer both air and sea freight options with real-time temperature assurance.

7. Compliance with Global Regulatory Standards

Chemignition’s packaging and storage approach complies with:

• ICH Q1A & Q1B (stability testing guidelines)
• GMP packaging standards
• US FDA and EMA guidelines for API transport
• BSE/TSE-free declarations and impurity profiles

✅ Full documentation is provided with each dispatch for customs and formulation registration.

Why Choose Chemignition for Latanoprost API?

• GMP certified facility
• Shelf life of 36 months with full real-time & accelerated stability data
• Packaged in multi-layer, cold-safe, light-protected containers
• CoA, MSDS, and transport certificates
• Delivered to 25+ countries with compliant cold-chain shipping

Conclusion

Stability and storage are not afterthoughts—they are critical quality factors for temperature-sensitive APIs like Latanoprost. Improper handling can lead to degraded product, reduced therapeutic efficacy, and failed regulatory audits.

By following best practices in packaging, storage (-20°C to -10°C), and documentation, you can preserve product quality and ensure a smooth path to formulation and approval.

✅ Partner with Chemignition Laboratory for long-term, GMP-certified supply of Latanoprost API, with 36-month shelf life, global shipping, and regulatory readiness.

📢 Ready to source Latanoprost API with validated packaging and storage protocols?

📩 Contact Chemignition Laboratory for a quote, sample, or documentation set.