CONCEPT #78 OF 100 · Medical, Dental & Clinical Practices · LAYOUT: certificate_broadsheet
Analytical Laboratory Certificate of Analysis (COA) & HPLC Assay Specification
Standard / Reference: 21 C.F.R. § 211.165 (Testing & Release for Distribution) · USP <232>/<233> · ISO/IEC 17025
Why professionals use this template: 24,600/mo search demand: pharmaceutical, API, and nutraceutical manufacturers needing ISO 17025 Certificates of Analysis displaying HPLC assay purity, GC residual solvents, ICP-MS heavy metals, and QA batch release.
144-DPI VECTOR PREVIEW · PAGE 1 OF 1
ACROFORM READY
Included Financial Metrics & Line-Item Schedule
Target Roles: Analytical Lab Directors, Quality Control Chemists, Pharma QA & Supplement Manufacturers · Search Keywords: certificate of analysis coa laboratory template pdf, iso 17025 analytical lab coa, hplc purity assay certificate of analysis, usp 232 heavy metals icp ms report
HPLC QUANTITATIVE ASSAY
99.4% w/w (Spec >=98.5%)
USP <467> SOLVENTS
Conforms (Ethanol <120 ppm)
ICP-MS HEAVY METALS
Pass (Pb <0.02 ppm · As ND)
QA BATCH DISPOSITION
APPROVED FOR RELEASE
| CODE | DESCRIPTION & TECHNICAL SPECIFICATION | BASIS / QTY | AMOUNT / DELTA |
|---|---|---|---|
| MTH-HPLC | Reverse-Phase UHPLC-DAD Purity Assay (C18 Column, 254 nm, Anhydrous Basis) | Spec: 98.5–101.0% | 99.42% PASS |
| MTH-GCMS | USP <467> Headspace GC-FID Residual Class 1/2/3 Organic Volatile Impurities | Spec: < 500 ppm | 118 ppm PASS |
| MTH-ICPM | USP <232>/<233> ICP-MS Elemental Impurities (Pb, Cd, As, Hg) | Spec: < 0.50 ppm | < 0.04 ppm PASS |
| MTH-MICR | USP <61>/<62> Total Aerobic Microbial Count (TAMC) & Specified Pathogens | Spec: < 10 CFU/g | < 1 CFU/g PASS |
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