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Certificate of Analysis

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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

Viewer

JSON

document Type

Certificate of Analysis

certificate Number

COA-2025-567890

issue Date

2025-09-28

manufacturer

name: PharmaChem Solutions India Pvt. Ltd., address: Plot 45, MIDC Taloja, Navi Mumbai, Maharashtra 410208, India, facilityLicense: FDA-IND-78901, gmpCertification: WHO-GMP-2024-IND-456

laboratory

name: PharmaChem Quality Control Laboratory, accreditation: ISO/IEC 17025:2017, accreditationNumber: 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, poNumber: GP-2025-12345

product Details

productName: Metformin Hydrochloride USP, casNumber: 1115-70-4, hsCode: 2942.00.5000, batchNumber: MET-2025-0892, manufacturingDate: 2025-09-15, expiryDate: 2028-09-14, retestDate: 2027-09-14, quantityManufactured: 2000, quantityUnit: KG, packagingType: HDPE Drums with liner, numberOfContainers: 40, storageConditions: Store below 25°C in a dry place

specifications

pharmacopeia: USP-NF 2024, monographReference: USP Metformin Hydrochloride

Test Results

13 items

testName

specification

result

status

Description

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

Microbial Limits (TAMC)

NMT 1000 CFU/g

<100 CFU/g

Pass

Microbial Limits (TYMC)

NMT 100 CFU/g

<10 CFU/g

Pass

E. coli

Absent in 1g

Absent

Pass

overall Result

PASS - Complies with USP specifications

additional Remarks

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

release Date

2025-09-28

quality Approval

true

signature Date

2025-09-28

pages

{ "documentType": "Certificate of Analysis", "certificateNumber": "COA-2025-567890", "issueDate": "2025-09-28", "manufacturer": { "name": "PharmaChem Solutions India Pvt. Ltd.", "address": "Plot 45, MIDC Taloja, Navi Mumbai, Maharashtra 410208, India", "facilityLicense": "FDA-IND-78901", "gmpCertification": "WHO-GMP-2024-IND-456"}, "laboratory": { "name": "PharmaChem Quality Control Laboratory", "accreditation": "ISO/IEC 17025:2017", "accreditationNumber": "NABL-T-4521", "address": "On-site QC Laboratory"}, "qualityManager": { "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", "poNumber": "GP-2025-12345"}, "productDetails": { "productName": "Metformin Hydrochloride USP", "casNumber": "1115-70-4", "hsCode": "2942.00.5000", "batchNumber": "MET-2025-0892", "manufacturingDate": "2025-09-15", "expiryDate": "2028-09-14", "retestDate": "2027-09-14", "quantityManufactured": 2000, "quantityUnit": "KG", "packagingType": "HDPE Drums with liner", "numberOfContainers": 40, "storageConditions": "Store below 25°C in a dry place"}, "specifications": { "pharmacopeia": "USP-NF 2024", "monographReference": "USP Metformin Hydrochloride"}, "testResults": [ { "testName": "Description", "specification": "White crystalline powder", "result": "White crystalline powder", "status": "Pass"}, { "testName": "Identification (IR)", "specification": "Matches reference spectrum", "result": "Matches", "status": "Pass"}, { "testName": "Assay (HPLC)", "specification": "98.5% - 101.0%", "result": "99.7%", "status": "Pass"}, { "testName": "Related Substances (Total)", "specification": "NMT 0.5%", "result": "0.18%", "status": "Pass"}, { "testName": "Individual Unknown Impurity", "specification": "NMT 0.10%", "result": "0.05%", "status": "Pass"}, { "testName": "Melting Point", "specification": "222°C - 226°C", "result": "223.5°C", "status": "Pass"}, { "testName": "Loss on Drying", "specification": "NMT 0.5%", "result": "0.22%", "status": "Pass"}, { "testName": "Sulfated Ash", "specification": "NMT 0.1%", "result": "0.03%", "status": "Pass"}, { "testName": "Heavy Metals", "specification": "NMT 20 ppm", "result": "<10 ppm", "status": "Pass"}, { "testName": "Particle Size (D90)", "specification": "NMT 150 µm", "result": "98 µm", "status": "Pass"}, { "testName": "Microbial Limits (TAMC)", "specification": "NMT 1000 CFU/g", "result": "<100 CFU/g", "status": "Pass"}, { "testName": "Microbial Limits (TYMC)", "specification": "NMT 100 CFU/g", "result": "<10 CFU/g", "status": "Pass"}, { "testName": "E. coli", "specification": "Absent in 1g", "result": "Absent", "status": "Pass"} ], "overallResult": "PASS - Complies with USP specifications", "additionalRemarks": "Batch released for commercial shipment. Stability testing ongoing as per ICH guidelines.", "releaseDate": "2025-09-28", "qualityApproval": true, "signatureDate": "2025-09-28", "pages": 2 }

certificate-of-analysis.pdf

Viewer

JSON

document Type

Certificate of Analysis

certificate Number

COA-2025-567890

issue Date

2025-09-28

manufacturer

name: PharmaChem Solutions India Pvt. Ltd., address: Plot 45, MIDC Taloja, Navi Mumbai, Maharashtra 410208, India, facilityLicense: FDA-IND-78901, gmpCertification: WHO-GMP-2024-IND-456

laboratory

name: PharmaChem Quality Control Laboratory, accreditation: ISO/IEC 17025:2017, accreditationNumber: 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, poNumber: GP-2025-12345

product Details

specifications

pharmacopeia: USP-NF 2024, monographReference: USP Metformin Hydrochloride

Test Results

13 items

testName

specification

result

status

Description

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

Microbial Limits (TAMC)

NMT 1000 CFU/g

<100 CFU/g

Pass

Microbial Limits (TYMC)

NMT 100 CFU/g

<10 CFU/g

Pass

E. coli

Absent in 1g

Absent

Pass

overall Result

PASS - Complies with USP specifications

additional Remarks

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

release Date

2025-09-28

quality Approval

true

signature Date

2025-09-28

pages

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