Every instrument we use, every method we run, and every result we issue is documented, validated, and traceable. You don't have to trust us — you can verify every claim we make about our analytical capabilities.
All instruments are calibrated on a defined schedule with traceable standards. Calibration records and system suitability data are documented on every COA.
LC-20AD
HPLC-UV Purity Analysis
ACQUITY UPLC H-Class
LC-MS/MS Identity Confirmation
Series 7900
Heavy Metal Screening
7890B with headspace sampler
Residual Solvents Analysis
Charles River Endosafe nexgen-PTS
Endotoxin Testing
Thermo Scientific
Microbial Limits Testing
All Aegis methods are validated against international reference standards and regulatory guidance. Testing is not performed to internal standards — it is performed to published, auditable ones.
Governing standard for all HPLC-UV purity methodology, system suitability, and calibration.
Moisture content determination for hygroscopic peptide powders on request.
Oral and parenteral elemental impurity acceptance limits used for ICP-MS pass/fail criteria.
Sample preparation and quantitation procedures for ICP-MS heavy metal analysis.
Standardized method for total aerobic microbial count (TAMC) determination.
Yeast and mold count (TYMC) and specified organism screening methodology.
Kinetic LAL turbidimetric endotoxin assay per current USP chapter.
GC headspace method for detection and quantification of ICH Q3C solvents.
Framework for method validation including accuracy, precision, linearity, and LOQ/LOD.
Guidance for classification and limits of residual solvents in pharmaceutical products.
Applied to LC-MS/MS identity confirmation methodology for complex peptides.
Regulatory guidance harmonized with USP <232>/<233> for elemental impurity control.
Every sample has a documented chain of custody from receipt through COA issuance. Nothing is assumed. Everything is recorded.
Unique Sample ID assigned. Sample weighed, logged, photographed, and entered into LIMS within 2 hours of receipt.
Preparation documented with analyst ID, date, diluent lot numbers, and reference standard lot/expiry. Witnessed where required.
Run sequence, instrument ID, column lot, calibration ID, and system suitability results recorded in LIMS.
Raw data reviewed by a second analyst for integration, acceptance criteria, and calculation accuracy before approval.
Lab director reviews and digitally signs off on the COA before issuance. Any out-of-specification results trigger investigation.
Certificate issued, write-protected, and simultaneously published to public verification database. PDF sent to client.
Measurement Accuracy
Intra-day CV (HPLC)
LOQ — Relative Purity
Heavy Metal Detection
Every instrument described on this page will be involved in testing your sample. No outsourcing. No contract labs. Results you can trust.