Unit Logam Berat

Heavy Metals Analysis — Competency & Records

Competency certifications and test records for heavy metal analysis in pharmaceutical products. Covering dissolution, weight uniformity, and heavy metal limit tests using GFAAS, CVAAS, and ICP-MS.

◈ Reference Guides

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Reference · Unit Logam Berat

Agilent 8900 ICP-MS Guide

7-chapter comprehensive operation guide. System overview, startup, MassHunter tuning, sample prep (USP 233), method development, and ICH Q3D compliance.

ICP-QQQ Operations USP 232/233 MassHunter

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Reference · Unit Logam Berat

Uniformity of Weight Test Guide

Comprehensive procedure guide for Ujian Keseragaman Berat (PKKK/300/UAT/037). Covers uncoated tablets, coated tablets, hard & soft capsules per USP 43 <2091>.

USP 43 Procedures Weight Variation Tablets & Capsules

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◈ Theory Competency Test

96.7%

Ujian Teori Kompetensi — Unit Pengujian Tradisional

Score: 29/30 · 30 Mac 2018

◈ Competency Tests (Ujian Kompetensi)

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Dissolution Test

Ujian Pengecaian

Measures the rate at which a pharmaceutical product dissolves in a specified medium. Critical for ensuring bioavailability and drug efficacy.

2018 ✓ 2022 ✓ 2025 ✓

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Weight Uniformity

Ujian Keseragaman Berat

Verifies that individual dosage units (tablets/capsules) have consistent weight within acceptable limits, ensuring dose accuracy.

2018 ✓ 2022 ✓ 2025 ✓

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Heavy Metal Limits — GFAAS

Ujian Had Logam As, Pb & Cd (GFAAS)

Graphite Furnace Atomic Absorption Spectrometry for detecting arsenic (As), lead (Pb), and cadmium (Cd) at trace levels in pharmaceutical products.

2022 ✓

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Mercury Limits — CVAAS

Ujian Had Logam Hg (CVAAS)

Cold Vapor Atomic Absorption Spectrometry specifically for mercury (Hg) quantification. Mercury's unique volatility requires this specialized technique.

Training

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Multi-Element — ICP-MS

Ujian Had Logam As, Hg, Pb & Cd (ICPMS)

Inductively Coupled Plasma Mass Spectrometry for simultaneous multi-element analysis. The gold standard for trace metal detection with sub-ppb sensitivity.

2018 ✓ 2022 ✓ 2025 ✓

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Mercury Analyzer — NIC RA-4300A

Latihan Penggunaan & Penyelenggaraan Asas

Hands-on training and basic maintenance on the NIC RA-4300A Mercury Analyzer. Conducted by Orbiting Scientific & Technology Sdn Bhd at NPRA.

Sep 2022 ✓ NIC ✓

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