Stability and Storage Guidelines for Tafluprost API

Tafluprost API, a potent prostaglandin analog used in ophthalmic formulations, requires precise handling to maintain its chemical integrity, efficacy, and safety. Improper storage conditions can lead to degradation, reduced potency, or contamination—ultimately compromising the final drug product.

This blog outlines best practices for the stability and storage of Tafluprost API, including Chemignition Laboratory’s specialized packaging methods, cold chain logistics, and shelf-life data.

Why Tafluprost API Requires Controlled Storage

Tafluprost is chemically sensitive to:

• Light
• Moisture
• Temperature fluctuations

Because of its sensitivity, especially in bulk API form, it must be stored and transported under strictly controlled conditions to retain stability and pass regulatory scrutiny.

Chemignition’s Tafluprost API Packaging Method

Chemignition Laboratory follows a multi-layered packaging process to ensure product integrity during transit and storage:

Step-by-Step Packaging Protocol:

1. Primary Container: Pack Tafluprost API in a sterile, inert glass or polypropylene vial.
2. Secondary Protection: Place the vial into a poly bag, twist the mouth tightly, and secure it using a PVC strip.
3. Tertiary Barrier: Insert the poly bag into a triple-laminated aluminum bag and seal it completely to protect from light and moisture.
4. Final Shipping Layer: Place the sealed aluminum bag inside a rigid HDPE container for impact protection during handling and shipping.

✅ This multilayer barrier system prevents contamination, photodegradation, and physical damage.

Recommended Storage Conditions

To preserve the stability of Tafluprost API, Chemignition advises:

• Storage Temperature: Store in a tightly closed, light-resistant container at a temperature between -20°C to -10°C.
• Humidity Protection: Keep away from high humidity environments. Avoid condensation inside containers.
• Avoid Frequent Access: Minimize repeated thawing and exposure during sampling or transfer.

Cold Chain Logistics with Data Logger Tracking

To ensure real-time monitoring during transportation, Chemignition ships Tafluprost API using cold chain logistics:

Cold Chain Features:

• Temperature maintained between -20°C to -10°C throughout transit
• Use of dry ice or refrigerant gel packs in insulated shippers
• Containers equipped with data loggers to track and record temperature conditions from dispatch to delivery
• Alarms triggered if temperature deviates beyond set limits

All temperature logs are shared with clients for complete transparency and quality assurance.

Stability Data – Shelf Life of Tafluprost API

Based on ICH stability testing conditions and in-house validation, Chemignition provides Tafluprost API with:

• Shelf Life: Up to 36 months under recommended storage conditions
• Stability Testing: Real-time and accelerated stability studies as per ICH guidelines (Q1A-R2)

Each batch comes with:

• Stability report (real-time and accelerated)
• Retest date printed on the COA
• Recommendation for storage post-opening

How Poor Storage Affects Tafluprost API

If not stored under optimal conditions, Tafluprost may:

• Degrade into related impurities
• Lose assay/potency over time
• Fail to meet regulatory limits for residual solvents or optical rotation
• Develop moisture content beyond pharmacopeial limits

Why Chemignition’s Storage Protocol Stands Out

• Multi-barrier packaging to resist moisture, light, and mechanical stress
• Cold chain transport with validated temperature control
• Real-time data logger for compliance and audit trails
• 36-month documented stability support
• Fully GMP and ISO 9001:2015 certified facility

Conclusion

Tafluprost API’s quality and efficacy depend not only on how it’s manufactured but also on how it’s packaged, stored, and shipped. Chemignition ensures complete protection with its robust packaging system and cold chain capabilities, backed by a 36-month stability guarantee.

For pharmaceutical companies, CMOs, and distributors, this level of care translates into regulatory readiness, product safety, and longer shelf life.