Pharmaceutical manufacturers, QC labs and regulatory teams all share one unshakable reality: trace elemental and organic impurities — even at microgram-per-kilogram levels — can change a drug’s safety, stability and regulatory acceptability. That’s why Certified Reference Materials (CRMs) and traceable ICP calibration standards are mission-critical tools for impurity control. GBJ supplies Inorganic Ventures certified reference materials and ICP calibration standards in Australia to help laboratories meet the demanding requirements of ICH, USP and regulatory authorities.
Why CRMs matter for pharmaceutical impurity testing
Regulators now require element-specific, instrumentally-based testing for elemental impurities (replacing older, non-specific “heavy metals” tests). ICH Q3D and USP chapters such as <232>/<233> set Permitted Daily Exposure (PDE) limits and define analytical procedures that frequently require ICP-MS or ICP-OES methods to reach single-digit microgram or lower quantitation. Using CRMs with traceability and clearly stated uncertainty budgets is the only practical way to demonstrate method accuracy, traceability and defensible results in regulatory submissions.
Choosing the right CRM or ICP calibration standard — practical criteria
Below are the selection criteria labs must prioritise, and how GBJ + Inorganic Ventures solutions address them.
- Traceability & accreditation
Pick CRMs produced to recognised RMP standards (ISO 17034) and with traceability to national metrology institutes (e.g., NIST). These credentials underpin the certificate of analysis (CoA) claims and are essential when reviewers ask for provenance and uncertainty. - Matrix compatibility
Pharma matrices vary (finished dose forms, excipient-rich mixes, oily APIs). Match CRM matrix to sample prep — e.g., acidified single-element or multi-element solutions for ICP-MS analyses — to reduce matrix effects and support accurate spike/recovery testing. Inorganic Ventures produces both single-element and multi-element stock CRMs designed for ICP workflows. - Concentration range & usability
Select working and stock concentrations that allow accurate dilutions to your method reporting limits while minimising waste. Mid-level stock standards (for example 100–1,000 µg/mL) commonly give flexibility for both calibration and QC spikes; Inorganic Ventures’ catalog offers a wide range of stock and custom concentrations to suit lab workflows. - Stability, homogeneity and uncertainty
A CoA should include homogeneity/stability data, expanded uncertainty (typically k=2), gravimetric preparation notes and storage instructions. This information is necessary for method validation and for satisfying auditors or regulatory reviewers. Inorganic Ventures publishes detailed RM documentation and stability guidance for ICP standards.
Technical tips for ICP-based elemental impurity testing
Use acid matrices appropriate for the elements analysed (HNO₃ vs HCl), because matrix choice affects element stability and instrument cleanliness. Inorganic Ventures discusses the effects of matrix on ICP standards and guides the preparation of ICP standards.
Prefer gravimetrically prepared stocks where possible — these reduce propagated uncertainty and simplify traceability statements in validation reports.
Maintain lot-specific CoAs and document the chain of custody from receipt to use; many suppliers (including Inorganic Ventures) provide lot-specific certificates and TCT packaging guidance to preserve expiration control.
Common compliance pitfalls and how to avoid them
Using non-traceable standards undermines the credibility of your impurity data. Always choose ISO-accredited / NIST-traceable CRMs.
Matrix mismatch between CRM and samples — leads to biased recoveries. Match matrix chemistry and validate recovery.
Ignoring uncertainty components — labs must include expanded uncertainty (k=2) in validation and reporting to meet regulatory expectations.
GBJ + Inorganic Ventures — practical advantages for Australian labs
GBJ acts as the local source for Inorganic Ventures’ ICP standards and CRMs, enabling Australian labs to procure ISO-grade, NIST-traceable materials without long import lead times. Their local presence simplifies compliance documentation, lot traceability, and post-sale support for method validation and routine QC use. If your lab performs ICP-MS or ICP-OES for elemental impurities, sourcing certified standards from a recognised RMP and local distributor reduces procurement friction and audit risk.
Quick checklist before you order
Is the CRM ISO 17034 accredited or produced by a recognised RMP?
Does the CoA show traceability to a primary institute (NIST) and provide expanded uncertainty?
Is the CRM matrix compatible with your digestion/sample prep?
Do stock concentrations permit accurate dilution to your method LOD/LOQ without excessive waste?
Final thoughts
Controlling pharmaceutical impurities is no longer optional — it’s a documented regulatory expectation backed by ICH and USP frameworks. Investing in ISO-grade, NIST-traceable CRMs and robust ICP calibration standards is an investment in defensible data, smoother audits and, ultimately, patient safety. GBJ’s distribution of Inorganic Ventures CRMs in Australia gives laboratories direct access to the technical documentation and product variety needed for compliant elemental-impurity programs.
For product details, CoAs and technical support on selecting the right ICP calibration standard or CRM for your impurity program, visit GBJ’s Inorganic Ventures page or contact their technical team directly.
For Further Enquiry Contact: sales@gbjpl.com.au