APICOA Analytics & Bioanalysis

Independent Quality Testing & APICOA Verified\u2122 Certification

Every API ingredient undergoes rigorous third-party analytical testing by APICOA — including LC-MS/MS identity confirmation, purity validation, and contaminant screening — before receiving the APICOA Verified\u2122 certification.

99.8%
Pass Rate
<48hr
COA Turnaround
4
Testing Categories
20+
Analytical Methods
Analytical Methods

How APICOA Tests Every Batch

Four categories of analytical testing ensure every API ingredient meets pharmaceutical-grade identity, purity, safety, and quality standards.

Identity Confirmation

LC-MS/MS Identity Testing

Liquid Chromatography-Tandem Mass Spectrometry (LC-MS/MS) provides definitive molecular identification of each API ingredient. This gold-standard technique confirms the compound matches its labeled identity with >99.9% confidence.

Molecular weight confirmation
Fragmentation pattern analysis
Reference standard comparison
>99.9% identification confidence
Quantitative Analysis

Purity & Potency Validation

High-Performance Liquid Chromatography (HPLC) with UV/Vis detection quantifies the active ingredient concentration and identifies any impurities. Each batch must meet predefined acceptance criteria before certification.

HPLC-UV/Vis quantification
Impurity profiling
Assay value determination
Acceptance criteria verification
Safety Testing

Contaminant Screening

Comprehensive contaminant screening covers heavy metals (ICP-MS), residual solvents (GC-MS), microbial limits, and endotoxin testing. All results are compared against USP, EP, and ICH Q3D limits.

Heavy metals (Pb, Cd, As, Hg) via ICP-MS
Residual solvents via GC-MS
Microbial limits testing (USP <61>/<62>)
Bacterial endotoxin testing
Material Properties

Physical Characterization

Physical properties including appearance, color, particle size, moisture content, and melting point are documented for each batch. These parameters ensure the API meets pharmaceutical-grade specifications.

Visual appearance & color assessment
Karl Fischer moisture analysis
Particle size distribution
Melting point determination
Certification Workflow

From Sample to APICOA Verified\u2122

Every batch follows a strict 6-step testing and certification process before receiving the APICOA Verified\u2122 mark.

01

Sample Receipt & Logging

Samples arrive from Origin API's distribution hub with full chain-of-custody documentation. Each sample is logged, assigned a unique lab ID, and enters the testing queue.

02

Identity Confirmation

LC-MS/MS analysis confirms the molecular identity of the API ingredient matches its label claim. Results are compared against certified reference standards.

03

Purity & Potency Analysis

HPLC quantification determines the assay value (potency) and identifies any related substances or impurities above reporting thresholds.

04

Safety Screening

Heavy metals, residual solvents, microbial limits, and endotoxin levels are tested against pharmacopeial limits (USP, EP, ICH Q3D).

05

COA Generation

All results are compiled into a Certificate of Analysis with batch-specific data, test methods, acceptance criteria, and pass/fail determinations.

06

APICOA Verified™ Certification

Batches that pass all testing criteria receive the APICOA Verified™ mark. Digital verification is enabled, and the batch is approved for distribution.

Why APICOA

The APICOA Verified\u2122 Advantage

Independent, third-party verification that gives you and your customers confidence in every API ingredient.

Third-Party Independence

APICOA operates independently from Origin API, ensuring unbiased test results and true third-party verification of every batch.

Pharmaceutical-Grade Standards

Testing follows USP, EP, and ICH guidelines — the same standards used by FDA-regulated pharmaceutical manufacturers.

Digital Verification

Every APICOA Verified™ COA includes a digital verification code that can be validated online to confirm authenticity.

State-of-the-Art Equipment

LC-MS/MS, HPLC, ICP-MS, GC-MS, and other advanced analytical instruments ensure the highest analytical accuracy.

Trust Verified, Not Claimed

Every API ingredient we distribute comes with independent APICOA Verified\u2122 certification. See the difference third-party testing makes.