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Traceability

Working standards for routine QC

Secondary working standards traceable to primary or certified reference materials — qualified under ISO/IEC 17025-style laboratory practice for daily HPLC, GC and titre use without consuming CRM inventory.

All impurities

17025

lab qualification

CRM

primary link

2–3 yrs

requalification typical

RRT

identity check

98–102%

assay band

ISO/IEC 17025 vs ISO 17034

ISO 17034 governs reference material producers who certify property values and uncertainties on the CRM certificate — Solenyx CRM lots follow that framework where applicable.

ISO/IEC 17025 governs testing and calibration laboratories. Working standards are often prepared and qualified inside a 17025 lab by comparison to a CRM, then used for routine release testing under that lab's quality system.

The working standard certificate states how it was assigned (bracketing, titration vs CRM) but does not replace a CRM for method transfer to a new site unless bridging studies are documented.

Reagent to compendial hierarchy

Indicative feature comparison for impurity and API standards used in QC.

FeatureFeatureReagent gradeWorking standardCompendial RSCRM (17034)
Traceability chainSupplier COALinked to CRM or primaryPharmacopeialCertified value + U
Uncertainty on assay—Reported ±%Monograph-definedExpanded U (k=2) typical
Routine release testing—YesYesOften reserved for qualification
Suitable for filing primary reference—With justificationYesYes
Requalification cycleN/A2–3 years indicativePer pharmacopeiaShelf life on CRM cert

Typical working standard qualification

Figures are indicative industry-typical values. Lot- and project-specific data appear on the quotation and certificate of analysis.

Assay vs CRM

98.0–102.0%

TV assignment method stated

Identity

IR, NMR or MS vs CRM

Fingerprint match

Purity profile

HPLC

Aligned to product method

Water / solvents

KF, Q3C

Corrected for assay

Label claim

Potency on label

As-is or anhydrous basis defined

Figures are indicative industry-typical values. Lot- and project-specific data appear on the quotation and certificate of analysis.

Indicative qualification protocol

  1. 01

    Select CRM or primary standard with valid certificate.

  2. 02

    Perform replicate assay (n ≥ 3) bracketing working material and CRM.

  3. 03

    Assign potency and expanded uncertainty if required by SOP.

  4. 04

    Approve in quality system; issue WS lot number and storage.

  5. 05

    Requalify on schedule or after major method change.

Deliverables

  • Working standard with unique lot
  • Qualification report with CRM traceability
  • Storage and expiry / requalification date
  • MSDS and handling guidance
  • Optional split units for multiple sites

Frequently asked questions

Often yes as the primary reference in your own site validation if traceability to CRM is documented. Agency questions focus on assignment uncertainty and change control.

Related

Certified Reference Materials

Impurities and API-related CRMs with certified property values, measurement uncertainty and metrological traceability — produced or distributed under principles aligned with ISO 17034 for method validation and lab accreditation.

View details

Custom Impurity Synthesis

When catalogue search does not return your peak, we design a synthesis or isolation route for deletion peptides, genotoxic alerts, nitrosamines, metabolites and chiral variants — with a documented package for qualification.

View details

Chiral Impurities

Enantiomers and diastereomers as traceable standards for chiral HPLC, chiral LC-MS and ICH Q6A/Q11-related impurity control — with stated enantiomeric or diastereomeric excess on the certificate of analysis.

View details

Intermediates & Fine Chemicals

Isolated intermediates, starting materials and fine chemicals that double as impurity references when carryover must be tracked in API specifications — each with identity data suitable for registration and supplier qualification.

View details
Next step

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