Standard Shelf Life

All Chemical Solutions™ Qualification Solutions are manufactured with a standard expiration period of two years from the date of manufacture.

This shelf life is supported by validated stability data that demonstrates product suitability for its intended qualification applications throughout the approved dating period.

For traceability and documentation purposes, both the manufacturing date and expiration date are listed on the Certificate of Analysis (COA) supplied with each product.

Using Qualification Solutions Within the Expiration Period

Qualification solutions may be used with confidence through the printed expiration date when stored and handled according to the supplied instructions.

The expiration date represents the validated time period during which product performance specifications are supported by stability data.

Laboratories should follow their internal SOPs, quality system requirements, and regulatory expectations regarding the use of materials approaching or exceeding their expiration date.

Extended Dating Requirements

Some laboratories require qualification materials with a longer remaining shelf life than standard inventory may provide.

For these situations, custom-manufactured batches may be available.

Typical considerations include:

• Approximately 4 to 5 weeks lead time after receipt of order
• Minimum order quantities may apply
• Production scheduling requirements may vary

Custom production can help laboratories align qualification materials with internal inventory management and quality requirements.

Product Shipping Standards

As part of standard operating practice, MICROSOLV generally ships qualification products with a minimum of six months of remaining shelf life.

This policy helps ensure customers receive products with sufficient usable dating for qualification scheduling, inventory control, and laboratory planning purposes.

Certificate of Analysis Documentation

Each product is supplied with a Certificate of Analysis that provides important quality and traceability information, including:

• Product identification
• Batch information
• Date of manufacture
• Expiration date
• Applicable quality data

The COA serves as an important component of many laboratory qualification and documentation programs.

Key Takeaways 

• Chemical Solutions™ Qualification Solutions have a standard two-year expiration period.
• Expiration dating is supported by validated stability studies.
• Manufacturing and expiration dates are listed on the Certificate of Analysis.
• Custom batches with longer remaining shelf life may be available.
• Additional lead time and minimum order quantities may apply for custom manufacturing.
• MICROSOLV standard practice is to ship products with at least six months of remaining shelf life.

For qualification kit specifications, product images, supported applications, and purchasing information, view PQ Kit™ and HSQ Kit™ Qualification Products and Ordering Information.