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How to store lyophilized peptides and keep a storage log

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Keep lyophilized (freeze-dried) peptides sealed in their original container under the conditions the documentation for that lot states, and record each step from receipt to disposition: the lot number, where and how the material is stored, every time the container is taken out or opened, and what finally happened to it. Manufacturer guidance, such as Bachem’s, describes keeping the freeze-dried solid tightly closed, cold and dry, and letting a cold container reach room temperature before it is opened so moisture from the air does not collect on it; a log is what lets anyone check later that this was done.

A certificate of analysis (COA, the lab’s report of what it measured) describes a lot at the time it was tested. It says nothing about what happened to your container after it left the supplier. The storage log is that record: an account of what was actually done, kept alongside the supplier’s documentation and your lab’s own procedures, not in place of them.

The record-keeping rules and guidance quoted below were written for drug manufacturing and for laboratory studies that support applications to the US Food and Drug Administration (FDA). They are cited here as well-tested models for lab records, not as rules that apply to every lab.

What do published guides say about storing freeze-dried peptides?

Start with the documentation for the specific product and lot. Storage needs can differ by material, form and packaging, and the conditions on the label or certificate are the ones to follow and to record. If the documentation is unclear, ask the supplier before the material goes into storage. How to Verify Any Peptide Supplier covers what a supplier should state about storage and shipping, and the data that should stand behind it.

Manufacturer guidance points the same way. Bachem’s “Handling and Storage Guidelines for Peptides” says the freeze-dried solid should be kept in a tightly closed container below freezing for longer storage, with colder storage preferred for the long term. It notes that peptides tend to be hygroscopic, meaning they take up water from the air, and that absorbed moisture reduces the peptide content and may lower stability. For that reason it advises letting a cold container reach room temperature in a desiccator, a sealed chamber kept dry with a drying agent, before the container is opened.

The ICH Q7 guide for active pharmaceutical ingredients sets out the same principles for stored materials in general. Materials should be handled and stored in a way that avoids degradation, contamination and cross-contamination (section 7.40). They should be kept under conditions and for a period that have no adverse effect on their quality, with the oldest stock normally used first (7.42), and re-evaluated as appropriate, for example after prolonged storage or exposure to heat or humidity (7.50).

What these sources share is that storage conditions matter and should be checkable afterwards. Where conditions are critical to the material, ICH Q7 says records of those conditions should be kept (10.10). That is the job of the log.

What should a storage and handling log record?

A log follows the material through a short list of events. Each row gives what to write down and the published model it is based on.

Event What to record Published model
Receipt Date, person receiving, product name as printed, lot number, quantity received, condition of the package and seals ICH Q7 7.20 and 6.30 (date of receipt, quantity and the supplier’s identification number recorded); 21 CFR 58.107(d) (receipt and distribution of each batch documented)
Identification and label An in-house code tied to the lot number; a container label with name, code, lot number, expiration date if any, and, where appropriate, storage conditions ICH Q7 7.24; 21 CFR 58.105(c)
Certificate on file Where the certificate for that lot is filed, and a note that its lot number matches the container 21 CFR 58.105(a) (characteristics determined and documented for each batch); ICH Q7 7.30 and 7.31 (supplier certificates of analysis, checked for reliability at regular intervals)
Storage location and conditions Freezer, shelf or box position; the conditions stated in the documentation; condition records where conditions are critical ICH Q7 10.10
Each removal or opening Date, time, person and reason; when the container went back, so the time out of storage is known ICH Q7 6.14 (entries made directly after the activity, naming the person)
Moves between locations Old and new location, date and person; a check that the label is still legible and matches ICH Q7 6.14; 21 CFR 58.107(c) (identification kept throughout distribution)
Disposition Final status (used up, expired, returned, rejected or discarded), date and person; rejected or returned material kept apart until a decision is made ICH Q7 7.24, 7.44, 10.11

Every entry should carry the lot number. That lets anyone go from a container to its certificate and its history, and back. Why lot traceability matters for research peptides explains what else the lot number connects.

What should happen when a delivery arrives?

The first entry is the one every later entry depends on, so receiving is worth doing the same way every time.

  1. Check the package before accepting it: labels, damage, broken seals and any sign of tampering or contamination, as ICH Q7 section 7.20 describes for incoming materials.
  2. Copy the lot number exactly as it is printed on the container. Do not shorten it.
  3. Find the certificate of analysis for that lot, not the newest one for the product, and file it where others in the lab can find it. How to Read a Peptide Certificate of Analysis covers what to check on it.
  4. Give the container an in-house code tied to the lot number (ICH Q7 7.24), if your lab uses codes.
  5. Label the container. 21 CFR 58.105(c) lists the fields: name, a code number, the batch (lot) number, the expiration date if there is one, and, where appropriate, the storage conditions needed to keep the material as it was characterized.
  6. Put the container in its assigned location under the stated conditions, and make the receipt entry in the log at the time.

If something does not match, such as a missing lot number, a certificate for a different lot or a broken seal, keep that container apart and labeled as on hold until the question is resolved. ICH Q7 holds incoming material in quarantine until it has been examined and released (7.20), and keeps quarantined, rejected or returned material in separate storage until a decision is made about it (10.11).

What makes a log entry trustworthy?

FDA’s guidance “Data Integrity and Compliance With Drug CGMP: Questions and Answers” (December 2018) says complete, consistent and accurate data should be attributable, legible, contemporaneously recorded, original or a true copy, and accurate, known by the acronym ALCOA (question 1.a). Applied to a storage log:

  • Attributable: each entry shows who made it, by initials or a personal login. The guidance notes that when a login is shared, no single person can be identified through it (question 5).
  • Legible: someone else can read the entry a year from now, and any code or abbreviation is defined. Shorthand that is clear today may not be later.
  • Contemporaneously recorded: the entry is made at the time the event happens, not reconstructed at the end of the week.
  • Original or a true copy: the first record is kept, or a true copy of it, rather than a retyped summary. ICH Q7 adds that corrections should be dated and signed and leave the original entry readable (section 6.14).
  • Accurate: the entry matches what happened: the right lot number, location, date and time.

The same guidance describes how blank forms and notebooks are controlled (question 6). Bound notebooks with numbered pages, stamped for official use, make missing pages and unofficial notebooks easy to spot. Numbered blank forms are reconciled once all of them are used, and incomplete or wrong forms stay in the record with the reason they were replaced. For electronic records, it describes systems that can save each entry as it is made (question 12). A paper storage log works best as a bound book with numbered pages; an electronic one works best when every entry is saved as it is made and carries the name of the person who made it.

How do I close a record and keep the log findable?

When a lot is used up, expires, or is returned, rejected or discarded, record the final status, the date and who recorded it. ICH Q7 asks that each batch’s code be used in recording its disposition, and that a system show the status of each batch (7.24). A closed record keeps inactive material from looking available, and it gives a clean boundary when the inventory is next reconciled.

Records outlast the material they describe. The US good laboratory practice rules, 21 CFR Part 58, describe an archive for study records (section 58.190): records stored in order and retrievable quickly, kept under conditions that limit deterioration, indexed, looked after by a named person and open only to authorized staff. A storage log kept that way can still answer a question about a lot long after its last container is gone.

Last reviewed: 2026-10-24

References

Frequently asked questions

How should lyophilized peptides be stored?

Sealed in the original container, under the conditions stated in the documentation for that lot. Manufacturer guidance, such as Bachem's, describes keeping the freeze-dried solid tightly closed, cold and dry, and letting a cold container reach room temperature before it is opened so moisture from the air does not collect on it.

What should a lab storage log record?

The lot number and receipt details, the in-house code and label, where the certificate of analysis is filed, the storage location and conditions, every removal or move with the date, time and person, and the final disposition.

What does ALCOA stand for?

Attributable, legible, contemporaneously recorded, original or a true copy, and accurate. FDA's 2018 data integrity guidance uses these five terms to describe complete, consistent and accurate data.

Does a storage log replace the certificate of analysis?

No. The certificate describes the lot when it was tested. The log records what happened to the material after it arrived, and the lot number links the two.