Batch Number¶
Definition¶
A batch number is a unique alphanumeric identifier assigned to a specific production batch of a peptide product, enabling full traceability from manufacturing through quality testing to final distribution.
Overview¶
The batch number (also called lot number) is the key to product traceability. It links the physical product to its complete quality documentation, including raw materials, manufacturing records, in-process testing, and final COA results.
Technical Explanation¶
Batch Number Structure: Typical batch numbers encode information such as: - Production date (year, month) - Product identifier or code - Sequence number (within that production period) - Manufacturing line or site identifier
Traceability Chain: 1. Raw materials assigned to batch 2. Synthesis parameters recorded 3. In-process quality checks logged 4. Final HPLC/MS analysis linked to batch 5. COA issued with batch number 6. Product labeled with batch number 7. Customer receives product with matching COA
Global Standards: Batch numbering follows internal SOPs aligned with ISO and GMP guidelines for traceability.
Importance in Peptide Documentation¶
The batch number on the product label must match the batch number on the COA. This is the first and most important verification step when receiving peptide products. Mismatched batch numbers indicate a documentation or traceability failure.
Related Terms¶
Frequently Asked Questions¶
Q: Can two batches have the same batch number? A: No. Each batch must have a unique number for traceability. Reusing batch numbers would break the traceability chain.
Q: What if the product label and COA have different batch numbers? A: Do not use the product. Contact the supplier immediately for clarification. This indicates a quality system failure.