Compounding Reference

The vocabulary of a compounding-grade peptide API.

The terms a pharmacy QA officer and a procurement lead actually work from — the rules that decide which peptides may be compounded, the quality-system paperwork that makes an active fit for a release file, the tests on a Certificate of Analysis, and the procurement language on a quote. Each entry is defined plainly and sourced to the compendia and FDA/ICH frameworks, not to Vialdyne's own claims.

31 terms · four sections

§ 019 terms

Compounding & regulatory

The frameworks that decide which peptides a pharmacy may compound and under what controls — 503A and 503B, the USP compounding chapters, the bulks-list process, and beyond-use dating.

FDA Section 503ACompounding pharmacies: Section 503A of the Federal Food, Drug, and Cosmetic Act governs traditional, patient-specific compounding by state-licensed pharmacies. To compound with a bulk drug substance that is not a component of an FDA-approved drug, the substance must either have an applicable USP/NF monograph or appear on the FDA's 503A bulk drug substances list. Several peptides have been evaluated by the FDA's Pharmacy Compounding Advisory Committee for that list.
FDA Section 503BOutsourcing facilities: 503A covers patient-specific compounding by licensed pharmacies; 503B covers facilities that voluntarily register with the FDA as Outsourcing Facilities to compound larger batches, with or without patient-specific prescriptions. 503B facilities must comply with current Good Manufacturing Practice (cGMP) and are subject to FDA inspection, whereas 503A pharmacies are regulated primarily by state boards of pharmacy under USP standards.
503B Bulks ListCategory 1 / Category 2: Section 503B maintains its own list of bulk drug substances that Outsourcing Facilities may use, separate from the 503A list. While the FDA evaluates nominated substances, eligible bulks are placed in Category 1 (may be used pending final rulemaking) or Category 2 (significant safety risk — may not be used). A peptide can be under consideration for one list and not the other, so the destination facility type determines which list governs.
FDA PCACPharmacy Compounding Advisory Committee: The Pharmacy Compounding Advisory Committee is an FDA advisory body that reviews and makes recommendations on which bulk drug substances should be added to or removed from the 503A and 503B bulks lists. PCAC recommendations are advisory — the FDA makes the final determination — but they directly shape which peptides US compounding pharmacies can legally use, so committee dockets are watched closely by compounders and their suppliers.
USP <795>Nonsterile compounding: USP General Chapter <795> sets the minimum standards for compounding nonsterile preparations — the facilities, components, documentation, and default beyond-use dating that apply when the finished preparation is not required to be sterile. It is the nonsterile counterpart to <797> and governs items such as oral and topical compounds prepared from bulk APIs.
USP <797>Sterile compounding: USP <797> establishes the minimum standards for compounding sterile preparations, including cleanroom design and air quality, personnel training and garbing, environmental monitoring, sterility and endotoxin considerations, and beyond-use dating. Most injectable compounded peptides fall under <797>; the receiving pharmacy relies on the supplier's component documentation (identity, endotoxin, sterility where applicable) to support its own <797> compliance.
USP <800>Hazardous drugs: USP General Chapter <800> sets standards for handling hazardous drugs in healthcare settings to protect personnel and the environment, covering receipt, storage, compounding, and containment. It applies to any substance identified as hazardous on the NIOSH list; most peptide APIs are not NIOSH-listed, but pharmacies apply <800> handling to any component their assessment classifies as hazardous, so the determination is made at the receiving site.
Beyond-use dateBUD: A beyond-use date is the date after which a compounded preparation must not be used, assigned by the compounding pharmacy under USP <795>/<797> rather than printed by the API manufacturer. Default BUDs are conservative; a pharmacy may extend them only with supporting stability data for that specific formulation and container. Supplier stability and storage documentation informs, but does not set, the finished-preparation BUD.
Compounding vs. manufacturing: Compounding is the preparation of a tailored medication for an identified patient need (503A) or in limited batches by a registered Outsourcing Facility (503B); drug manufacturing is large-scale production of an FDA-approved product under a marketing application. The distinction governs which regulations apply. A peptide API supplier sells a starting material into the compounding workflow — it is not itself a finished drug product.

§ 0210 terms

Quality systems & documentation

The GMP, master-file, sterility, endotoxin, and stability vocabulary that defines whether an API is fit for a compounder's release file — the paperwork a QA officer audits before a lot is accepted.

cGMPCurrent Good Manufacturing Practice: Current Good Manufacturing Practice is the system of quality controls — facilities, validated processes, documentation, change control, and release testing — expected of pharmaceutical production. For active pharmaceutical ingredients the reference standard is ICH Q7. A supplier describing its peptide synthesis, purification, and release as performed under GMP-equivalent controls is signalling alignment with Q7, which a buyer can verify against the documentation provided.
ICH Q7GMP for APIs: ICH Q7 is the International Council for Harmonisation guideline on Good Manufacturing Practice for active pharmaceutical ingredients. It establishes expectations for quality systems, process controls, validation, change management, and documentation across the API lifecycle. Peptide manufacturers reference ICH Q7 to indicate that synthesis, purification, and release are performed under GMP-equivalent controls.
ICH Q11Development and manufacture of drug substances: ICH Q11 describes approaches to the development and manufacture of drug substances, including chemically synthesised entities such as peptides. It provides the framework for defining critical quality attributes (CQAs), critical process parameters (CPPs), the control strategy, and the justification of starting materials. It is the reference for explaining how a peptide's synthesis and purification are designed and controlled.
FDA DMFDrug Master File: A Drug Master File is a confidential submission to the FDA containing information about the facilities, processes, and controls used in manufacturing a drug component. For a peptide API the supplier typically files a Type II DMF, which the FDA can reference when reviewing a customer's drug application. A DMF on file indicates the manufacturer has assembled its chemistry, manufacturing, and controls package for FDA review.
ASMFActive Substance Master File: An Active Substance Master File is the European Union equivalent of an FDA Type II Drug Master File. It is split into an Applicant's Part (shared with the customer) and a Restricted Part (filed confidentially with the regulator), letting a supplier disclose proprietary process detail to authorities without exposing it to the customer. Suppliers serving EU compounders and manufacturers may maintain an ASMF.
EU GMP Annex 1Sterile manufacturing: EU GMP Annex 1 (revised 2022, applicable from 2023, with one provision from 2024) is the European GMP standard for the manufacture of sterile medicinal products. It establishes requirements for a contamination control strategy, cleanroom classification (Grade A–D), aseptic processing, lyophilization, and continuous environmental monitoring. Suppliers shipping sterile peptide products into EU-aligned markets map their controls to Annex 1.
Bacterial endotoxinBET · LAL: Bacterial endotoxins are lipopolysaccharide fragments from Gram-negative bacterial cell walls that can cause a febrile reaction if injected. The bacterial endotoxin test (BET), described in USP <85>, quantifies them — historically by Limulus Amebocyte Lysate (LAL) methods. For injectable peptides the endotoxin level must be below a calculated pharmacopeial limit; research-grade material is commonly specified at ≤0.25–1.0 EU/mg, with the exact limit depending on the intended dose.
SterilityUSP <71>: Sterility is the absence of viable microorganisms, demonstrated by the compendial sterility test in USP <71> (membrane filtration or direct inoculation, with a defined incubation period). Lyophilized API powder is generally supplied non-sterile and rendered sterile during downstream sterile fill-finish; a sterility result on a release packet applies to a sterile-filled presentation, not to bulk powder, which is instead controlled by bioburden.
BioburdenMicrobial limits · USP <61>/<62>: Bioburden is the population of viable microorganisms on or in a non-sterile material. It is controlled through microbial enumeration and the test for specified microorganisms in USP <61> and <62> (microbial limits). For a non-sterile peptide API, low microbial limits plus a clean endotoxin result give a downstream sterile-compounding pharmacy a defensible starting point before its own aseptic processing.
Stability programICH Q1A(R2): A stability program measures degradation over time under defined storage conditions, in line with ICH Q1A(R2). Accelerated stability runs at 40 °C / 75% relative humidity for up to six months; long-term stability runs at the labelled storage condition (commonly −20 °C or 2–8 °C) across the proposed re-test period. Each pull point typically tests HPLC purity, mass-spec identity, water content, and appearance, and the data set supports the assigned re-test date.

§ 037 terms

Analytical methods

The tests on a peptide Certificate of Analysis — what each one measures, the method behind it, and how to read the result.

Certificate of AnalysisCOA: A complete peptide COA documents product identity, batch identification, and the analytical results against specifications. At minimum, expect: product name, CAS number, batch/lot number, manufacture and re-test dates, appearance, identity by HPLC retention time and mass spectrometry, purity by HPLC, water content (Karl Fischer), counter-ion content, peptide (net) content by amino acid analysis, residual solvents, bacterial endotoxin, and microbial limits. Each result should reference the method, often a USP chapter.
HPLCHigh-performance liquid chromatography: Reversed-phase HPLC separates a peptide sample by hydrophobicity, producing a chromatogram in which the main peak is the target peptide and smaller peaks are impurities or sequence variants. Purity is reported as the main-peak area as a percentage of total integrated area (area-%); pharmaceutical-grade synthetic peptides are commonly specified at ≥98–99% with individual impurities capped at a low threshold. The method is validated to USP <1225>.
Mass spectrometryESI-MS / MALDI: Mass spectrometry confirms peptide identity by measuring molecular mass to within fractions of a Dalton. Electrospray ionization (ESI-MS) is the most common technique for peptides; matrix-assisted laser desorption/ionization (MALDI) is used for larger peptides and proteins. The observed mass is compared with the theoretical mass calculated from the sequence; a match within tolerance confirms the intact primary structure.
Sequence verificationLC-MS/MS: Primary sequence is confirmed by tandem mass spectrometry (LC-MS/MS), which fragments the peptide and reads the masses of the fragment ions to reconstruct the sequence. Edman degradation, an older N-terminal sequential-cleavage method, is used for shorter peptides or when LC-MS/MS is inconclusive. Full sequence verification is performed at development and reconfirmed periodically; routine release relies on retention-time match and intact-mass MS.
Karl Fischer titrationWater content · USP <921>: Karl Fischer titration determines the water content of a lyophilized peptide. Excess moisture accelerates hydrolysis, oxidation, and aggregation and shortens shelf life, so most peptide specifications cap water content at a low single-digit percentage. The method is described in USP <921>.
Net peptide contentAAA: Net (true) peptide content is the actual mass of peptide per gram of dry product, after subtracting water, counter-ions, and impurities, and is most directly determined by amino acid analysis (AAA), which hydrolyses the peptide and quantifies its constituent amino acids. It is typically 70–90% of the gross mass, the remainder being acetate or trifluoroacetate counter-ions and residual water — which is why dosing should be based on net content, not gross weight.
Residual solventsICH Q3C · USP <467>: Residual solvents are organic solvents left over from synthesis and purification (for peptides, commonly acetonitrile, and trace TFA from reversed-phase steps). They are limited and tested per ICH Q3C and USP <467>, which classify solvents by toxicity and set concentration limits. A residual-solvent result on the COA confirms the purification removed process solvents to within those limits.

§ 045 terms

Procurement & logistics

The counter-ion, MOQ, lead-time, and shipping terms used in B2B peptide-API procurement and on a quote sheet.

Counter-ionAcetate / TFA / HCl salt forms: Most peptides carry basic residues (Lys, Arg, His) that are protonated at neutral pH, so the dry powder is always a salt paired with an anion. Common counter-ions are acetate (preferred for injectable use), trifluoroacetate (TFA, residual from HPLC purification), and hydrochloride. Acetate-form material is generally specified for injectable compounding; TFA-form is acceptable for some research uses but is usually exchanged to acetate for pharmaceutical applications, so the counter-ion form should be confirmed on the COA.
MOQMinimum order quantity: MOQ varies widely by peptide complexity and demand. Catalog actives are commonly ordered by the gram or by vial count per SKU; custom-synthesised peptides may start at a defined gram-scale of lyophilized material. Established buyers placing forecasted recurring orders can often negotiate terms around their dispensing volume.
Lead time: Catalog peptides held in inventory typically ship within one to two weeks of order confirmation; make-to-order catalog peptides commonly require several weeks. Custom-synthesised peptides depend on sequence length, modifications, and scale — roughly four to six weeks for standard sequences up to about 30 residues, and longer for heavily modified sequences that need methodology development.
Incoterms 2020EXW · FOB · CIF · DDP: The ICC Incoterms 2020 define where cost and risk transfer between seller and buyer. The common terms for peptide shipments are EXW (buyer collects from the supplier), FOB (seller delivers to port), CIF (seller pays freight and insurance to the destination port), and DDP (seller handles all costs through customs clearance at the buyer's door). DDP gives a single all-inclusive landed price and is often preferred by pharmacies that do not want to act as importer of record.
Cold chain: Lyophilized peptides are generally stable at ambient temperature for the duration of typical international transit (a few days to a week) when packaged with phase-change materials, while long-term storage requires −20 °C for most peptides. Cold-chain shipping (gel packs or dry ice) is used for temperature-sensitive analogs, for shipments where ambient transit might run long, or when the buyer specifically requires temperature-logged delivery.

These are the short forms. The documentation behind them — the per-lot release packet, endotoxin and stability data, and DMF/ASMF support — is described on the Documentation page, and the 503A / 503B / EU-compounder fit is laid out under Compounding. Longer write-ups on individual frameworks live in the Brief.

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The vocabulary of a compounding-grade peptide API.