METHOD CODE: ZBL-M-ICP-05 • USP <232> / <233> & ICH Q3D

Heavy Metals Panel (ICP-MS)

Ultra-Trace Elemental Impurities Quantification for Toxic Heavy Metals (Lead, Arsenic, Cadmium, Mercury) with Parts-Per-Billion (ppb) Sensitivity using Inductively Coupled Plasma Mass Spectrometry.

Instrument Platform

Agilent 7900

ICP-MS Quadrupole

Detection Limit

< 1.0 ppb

Parts-per-billion limit

Sample Required

20 – 50 mg

Powder or 1 mL liquid

Standard Turnaround

4–6 Days

48h Rush option

TOXICOLOGICAL RELEVANCE

Why Heavy Metals Testing is Mandatory for Purity

Heavy metal contamination in peptides, raw APIs, and chemical syntheses originates from transition metal catalysts (e.g. palladium, platinum, ruthenium), mineral reagents, contaminated process water, or substandard glassware during manufacturing. Even microscopic trace amounts present severe bio-accumulation toxicity risks.

At Zenith BioChemical Laboratories HK, elemental impurity screening is performed using our Agilent 7900 ICP-MS with an Octopole Reaction System (ORS⁴) operating in helium collision cell mode to eliminate polyatomic spectral interferences (such as ⁴⁰Ar³⁵Cl⁺ on ⁷⁵As). Prior to plasma ionization, samples undergo closed-vessel microwave digestion in high-purity sub-boiled nitric acid (HNO₃), completely digesting the organic matrix while preventing the loss of volatile elements such as mercury.

CLASS 1 ELEMENTAL IMPURITIES

Core Heavy Metals Screened

Strict compliance with USP <232> and ICH Q3D Permitted Daily Exposure (PDE) limits.

Lead (Pb) • Mass 206/207/208

Neurotoxic heavy metal accumulating in bone and organs. Quantified down to 0.5 ppb with strict pharmacopeial threshold limits (< 0.5 ppm).

Arsenic (As) • Mass 75

Potent cellular toxin and enzyme inhibitor. Helium collision mode completely resolves argon chloride interferences for absolute accuracy.

Cadmium (Cd) • Mass 111/114

Nephrotoxic and osteotoxic element. Measured against multi-element NIST traceable reference calibration curves.

Mercury (Hg) • Mass 200/202

Volatile organic and inorganic neurotoxin. Stabilized with gold (Au) spikes during microwave digestion to prevent volatilization loss.

METHOD DETECTION & LIMITS

USP <232> / ICH Q3D Threshold Specifications

Element	USP <232> Parenteral Limit	Zenith Method LOD	Standard Status
Lead (Pb)	≤ 0.5 ppm (μg/g)	0.002 ppm (2.0 ppb)	Conforms to USP <232>
Arsenic (As)	≤ 1.5 ppm (μg/g)	0.005 ppm (5.0 ppb)	Conforms to USP <232>
Cadmium (Cd)	≤ 0.5 ppm (μg/g)	0.001 ppm (1.0 ppb)	Conforms to USP <232>
Mercury (Hg)	≤ 0.3 ppm (μg/g)	0.002 ppm (2.0 ppb)	Conforms to USP <232>
Nickel (Ni)	≤ 20.0 ppm (μg/g)	0.010 ppm (10.0 ppb)	Conforms to ICH Q3D

SUBMISSION PREPARATION

Submission Guidelines for ICP-MS

Sample Quantity: 20 – 50 mg dry powder or 1.0 mL liquid in metal-free polypropylene or PTFE vials.
Container: Avoid metal caps or unlined glass containers that could leach trace elements.
Destructive Testing: Samples are fully consumed by microwave acid digestion.
Reporting: Comprehensive report with parts-per-billion (ppb) and parts-per-million (ppm) quantitation tables.

Laboratory Fee

$85 / sample

4–6 Days (Standard) • 48h (Rush +50%)

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