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Certificate of Analysis

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Trade & Customs Intelligence

The world's best certificate of analysis extraction

Transform Certificates of Analysis (COA) into structured data for pharmaceutical, chemical, and food trade compliance. Extract test parameters, specifications, actual results, batch numbers, and laboratory certifications. Built-in validation ensures compliance with GMP, USP, and international pharmacopeia standards.

certificate-of-analysis.pdf


Document Type

Certificate of Analysis


Certificate Number

COA-2025-567890


Issue Date
Sep 28, 2025

Manufacturer

Name

PharmaChem Solutions India Pvt. Ltd.


Address

Plot 45, MIDC Taloja, Navi Mumbai, Maharashtra 410208, India


Facility License

FDA-IND-78901


Gmp Certification

WHO-GMP-2024-IND-456


Laboratory

Name

PharmaChem Quality Control Laboratory


Accreditation

ISO/IEC 17025:2017


Accreditation Number

NABL-T-4521


Address

On-site QC Laboratory


Quality Manager

Name

Dr. Priya Sharma


Designation

Head of Quality Control


Qualifications

Ph.D. Analytical Chemistry


Customer

Name

Generic Pharma Inc.


Address

500 Pharmaceutical Drive, Edison, NJ 08837, USA


Po Number

GP-2025-12345


Product Details

Product Name

Metformin Hydrochloride USP


Cas Number

1115-70-4


Hs Code

2942.00.5000


Batch Number

MET-2025-0892


Manufacturing Date
Sep 15, 2025

Expiry Date
Sep 14, 2028

Retest Date
Sep 14, 2027

Quantity Manufactured

2,000


Quantity Unit

KG


Packaging Type

HDPE Drums with liner


Number Of Containers

40


Storage Conditions

Store below 25°C in a dry place


Specifications

Pharmacopeia

USP-NF 2024


Monograph Reference

USP Metformin Hydrochloride


Test Results
13 items
Test NameSpecificationResultStatus

Description

White crystalline powder

White crystalline powder

Pass

Identification (IR)

Matches reference spectrum

Matches

Pass

Assay (HPLC)

98.5% - 101.0%

99.7%

Pass

Related Substances (Total)

NMT 0.5%

0.18%

Pass

Individual Unknown Impurity

NMT 0.10%

0.05%

Pass

Melting Point

222°C - 226°C

223.5°C

Pass

Loss on Drying

NMT 0.5%

0.22%

Pass

Sulfated Ash

NMT 0.1%

0.03%

Pass

Heavy Metals

NMT 20 ppm

<10 ppm

Pass

Particle Size (D90)

NMT 150 µm

98 µm

Pass

1-10 of 13


Overall Result

PASS - Complies with USP specifications


Additional Remarks

Batch released for commercial shipment. Stability testing ongoing as per ICH guidelines.


Release Date
Sep 28, 2025

Quality Approval
True

Signature Date
Sep 28, 2025

Pages

2

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DocuPipe ingests certificates of analysis from suppliers, laboratories, or freight forwarders. Route test result data to quality management systems, customs filing platforms, and inventory management systems via API.

Sources
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F
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Destinations
TMS
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